|
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
E XHIBIT
10.28
ASSET TRANSFER AND LICENSE
AGREEMENT
BETWEEN
ANZA THERAPEUTICS,
INC.
AND
CERUS
CORPORATION
Dated as of
November 20, 2007
TABLE OF
CONTENTS
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Page |
| ARTICLE I DEFINITIONS; RULES OF CONSTRUCTION |
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1 |
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SECTION 1.1
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Definitions. |
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1 |
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SECTION 1.2
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Rules of
Construction. |
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1 |
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| ARTICLE II TRANSFER OF ASSETS AND GRANT OF LICENSES; ASSUMPTION
OF LIABILITIES; CONSIDERATION; CLOSING |
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2 |
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SECTION 2.1
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Transfer
of Assets. |
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2 |
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SECTION 2.2
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Assignability and Consents |
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3 |
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SECTION 2.3
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Grant of
License. |
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4 |
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SECTION 2.4
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Liabilities. |
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5 |
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SECTION 2.5
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Consideration. |
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7 |
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SECTION 2.6
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Closing. |
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10 |
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SECTION 2.7
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Closing
Deliveries by Cerus. |
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10 |
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SECTION 2.8
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Closing
Deliveries by Anza. |
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10 |
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| ARTICLE III REPRESENTATIONS AND WARRANTIES OF CERUS |
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11 |
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| ARTICLE IV REPRESENTATIONS AND WARRANTIES OF ANZA |
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11 |
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| ARTICLE V ADDITIONAL AGREEMENTS |
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11 |
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SECTION 5.1
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Cooperation and Assistance. |
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11 |
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SECTION 5.2
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{Intentionally Omitted} |
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12 |
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SECTION 5.3
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Certain
Regulatory Matters. |
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12 |
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SECTION 5.4
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Supply of
Materials. |
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13 |
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SECTION 5.5
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Diligence. |
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14 |
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SECTION 5.6
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Reimbursement of Business Expenses. |
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14 |
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SECTION 5.7
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Certain
Employee Matters. |
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14 |
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SECTION 5.8
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Confidentiality. |
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14 |
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SECTION 5.9
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Ownership
of Inventions. |
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17 |
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SECTION 5.10
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Patent
Prosecution and Maintenance. |
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17 |
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SECTION 5.11
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Enforcement of Patents. |
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18 |
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SECTION 5.12
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Defense
of Infringement Claims. |
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20 |
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SECTION 5.13
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Covenant
Not to Compete. |
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20 |
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SECTION 5.14
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Tax
Matters. |
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21 |
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SECTION 5.15
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Certain
Accounting Matters. |
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22 |
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SECTION 5.16
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Redemption Option. |
|
23 |
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SECTION 5.17
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Certain
Termination Rights. |
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25 |
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SECTION 5.18
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Regulatory Matters and Bulk Sales Laws. |
|
26 |
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SECTION 5.19
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Novation
of Certain Transferred Contracts. |
|
26 |
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SECTION 5.20
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Abandonment of Certain Patents and Patent
Applications. |
|
26 |
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SECTION 5.21
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|
Further
Assurance. |
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26 |
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-i-
TABLE OF
CONTENTS
(Continued)
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Page |
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| ARTICLE VI CONDITIONS TO CLOSING |
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26 |
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SECTION 6.1
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Conditions to Obligations of Cerus. |
|
26 |
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SECTION 6.2
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Conditions to Obligations of Anza. |
|
28 |
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| ARTICLE VII INDEMNIFICATION |
|
29 |
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|
SECTION 7.1
|
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Survival
of Representations and Warranties and Covenants. |
|
29 |
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SECTION 7.2
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|
Indemnification. |
|
30 |
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| ARTICLE VIII MISCELLANEOUS |
|
33 |
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SECTION 8.1
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Governing
Law. |
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33 |
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SECTION 8.2
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Amendment. |
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33 |
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SECTION 8.3
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Expenses. |
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33 |
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SECTION 8.4
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Notices. |
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33 |
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SECTION 8.5
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Severability. |
|
34 |
|
SECTION 8.6
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|
Entire
Agreement. |
|
34 |
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SECTION 8.7
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|
Assignment. |
|
34 |
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SECTION 8.8
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|
Delays or
Omissions. |
|
34 |
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SECTION 8.9
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|
No Third
Party Beneficiaries. |
|
35 |
|
SECTION 8.10
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|
Counterparts. |
|
35 |
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-ii-
EXHIBITS
|
|
|
| Exhibit A |
|
Definitions and References |
| Exhibit B |
|
Royalties |
| Exhibit C |
|
Representations and Warranties of Cerus |
| Exhibit D |
|
Representations and Warranties of Anza |
| Exhibit E |
|
Transferred
Assets to be Delivered at Closing |
| Exhibit F |
|
Transferred
Assets to be Delivered within 90 Days after Closing |
| Exhibit G |
|
Budget |
| Exhibit H |
|
Cerus Press
Release |
| Exhibit I |
|
Assignment
Separate from Certificate |
| Exhibit J |
|
Transferred
Contracts Subject to Novation |
| Exhibit K |
|
WSGR Legal
Opinion |
| Exhibit L |
|
CGK Legal
Opinion |
| Exhibit M |
|
D. Cook
Employment Agreement |
| Exhibit N |
|
T. Dubensky
Employment Agreement |
| Exhibit O |
|
Assignment
and Novation Agreement |
| Exhibit P |
|
Amended and
Restated Exclusive License Agreement (JHU Ref: [ * ]
) |
| Exhibit Q |
|
Amended and
Restated Option and Exclusive License Agreement (JHU Ref: [ *
] ) |
| Exhibit R |
|
Amended and
Restated Exclusive License Agreement (JHU Ref: [ * ]
) |
| Exhibit S |
|
Selected
Transferred Contracts |
| Exhibit T |
|
Abandoned
Patents and Patent Applications |
| Exhibit U |
|
Assignment
and Assumption Agreement |
| Exhibit V |
|
Amended and
Restated Certificate of Incorporation |
| Exhibit W |
|
Bill of
Sale |
| Exhibit X |
|
Business
Employees |
| Exhibit Y |
|
Computer
Equipment |
| Exhibit Z |
|
FDA
Cross-Reference Letter |
| Exhibit AA |
|
FDA Transfer
Letters |
| Exhibit AB |
|
Investor
Rights Agreement |
| Exhibit AC |
|
Licensed
Know-How |
| Exhibit AD-1 |
|
Licensed
[ * ] Patent Rights |
| Exhibit AD-2 |
|
Licensed
[ * ] Patent Rights |
| Exhibit AE |
|
Patent
Assignment Agreement |
| Exhibit AF |
|
Right of
First Refusal and Co-Sale Agreement |
| Exhibit AG |
|
{Intentionally Omitted} |
| Exhibit AH |
|
Series A
Preferred Stock Purchase Agreement |
| Exhibit AI |
|
Site
License |
| Exhibit AJ |
|
Sublease |
| Exhibit AK |
|
Supply
Agreement |
| Exhibit AL |
|
Transferred
Contracts |
| Exhibit AM |
|
Transferred
Grants |
| Exhibit AN |
|
Transferred
Know-How |
| Exhibit AO |
|
Transferred
Patent Rights |
| Exhibit AP |
|
Transferred
Tangible Assets |
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-i-
|
|
|
|
Exhibit AQ
|
|
Transition Services Agreement |
|
Exhibit AR
|
|
Voting
Agreement |
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-ii-
ASSET TRANSFER AND LICENSE
AGREEMENT
This Asset Transfer and
License Agreement is made as of November 20, 2007 between Anza
Therapeutics, Inc., a Delaware corporation (“ Anza
”), and Cerus Corporation, a Delaware corporation (“
Cerus ”). Anza and Cerus are each referred to herein
as a “ Party ” and collectively as the “
Parties .”
RECITALS
A. Cerus is engaged in the
Business.
B. Anza desires to acquire,
and Cerus desires to transfer to Anza, Cerus’ rights to the
tangible and intangible assets, and to license to Anza certain
intangible assets, used in the conduct of the Business and
necessary for Anza to conduct the Business following the Closing,
subject to the terms and conditions of this Agreement.
C. The Parties intend that
the issuance of the Series AA Shares to Cerus in partial
consideration for the transfer of the Transferred Assets, when
taken together with the issuance of shares of Anza’s
Series A Preferred Stock to certain investors on the date
hereof, shall qualify as an exchange within the meaning of
Section 351 of the Code.
Now, therefore, in
consideration of the foregoing premises, the mutual
representations, warranties, covenants and other agreements set
forth herein and the mutual benefits to be gained by the
performance thereof, and for other good and valuable consideration,
the receipt and sufficiency of which are hereby acknowledged and
accepted, the Parties hereby agree as follows:
ARTICLE I
DEFINITIONS; RULES OF
CONSTRUCTION
SECTION 1.1
Definitions. Capitalized terms used in this Agreement
are defined on Exhibit A . Exhibit A also
contains references to terms defined in the body of this Agreement
and other Exhibits to this Agreement.
SECTION 1.2 Rules
of Construction . When a reference is made in this
Agreement to an Article, Section or Exhibit, such reference
shall be to an Article or Section of, or Exhibit to, this Agreement
unless otherwise indicated. The words “include,”
“includes” and “including” when used herein
shall be deemed in each case to be followed by the words
“without limitation.” The terms “hereof,”
“herein,” “hereby” and derivative or
similar words refer to this entire Agreement. The headings set
forth in this Agreement are for reference purposes only and shall
not affect in any way the meaning or interpretation of this
Agreement. Unless otherwise specifically provided or the context
otherwise requires, all references in this Agreement to Cerus shall
mean and refer to Cerus and its Subsidiaries. All references in
this Agreement to the Subsidiaries of a Party shall be deemed to
include all direct and indirect Subsidiaries of such Party. Unless
otherwise specifically provided,
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
all references in this Agreement to
monetary amounts or dollars shall mean and refer to United States
Dollars. The Parties agree that they have been represented by legal
counsel during the negotiation and execution of this Agreement and,
therefore, waive the application of any law, regulation, holding or
rule of construction providing that ambiguities in an agreement or
other document shall be construed against the party drafting such
agreement or document.
ARTICLE II
TRANSFER OF ASSETS AND
GRANT OF LICENSES; ASSUMPTION OF LIABILITIES; CONSIDERATION;
CLOSING
SECTION 2.1
Transfer of Assets . Upon the terms and subject to
the conditions set forth in this Agreement, Cerus hereby conveys,
assigns and transfers to Anza, and Anza hereby acquires from Cerus,
free and clear of any Encumbrances (other than Encumbrances arising
under the Transferred Contracts), all of Cerus’ right, title
and interest in and to the following assets (collectively, the
“ Transferred Assets ”):
(a) the Transferred
Intellectual Property;
(b) the Transferred
Contracts;
(c) the Transferred Tangible
Assets;
(d) the Transferred
Regulatory Submissions;
(e) the Transferred
Grants;
(f) the Transferred Books and
Records; and
(g) all rights, claims,
causes of action and credits, including all guarantees, warranties,
indemnities, rights of set-off and similar rights, in favor of
Cerus to the extent relating to any of the foregoing Transferred
Assets or any Assumed Liability, other than such rights, claims,
causes of action and credits to the extent relating to any Retained
Liability, including, without limitation, all causes of action for
past misappropriation or infringement of any Transferred
Intellectual Property and rights to damages and other remedies for
past misappropriation or infringement of any Transferred
Intellectual Property.
Notwithstanding anything
contained herein to the contrary, the Transferred Tangible Assets
are being assigned, transferred and conveyed to Anza “as
is,” “where is” and “with all
faults,” with no representations or warranties as to
merchantability, fitness or use, except as set forth in Article
III.
The transfer of the
Transferred Assets pursuant to this Agreement shall not include the
assumption of any Liability related to the Transferred Assets that
arose (including payments that became due) prior to the Effective
Time unless Anza expressly assumes that Liability pursuant to
Section 2.4(a).
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-2-
SECTION 2.2
Assignability and Consents . Notwithstanding anything to
the contrary contained in this Agreement, if the conveyance,
assignment, transfer or delivery or attempted conveyance,
assignment, transfer or delivery to Anza of any Transferred Asset
is (a) prohibited by any applicable Law or (b) would
require any authorizations, approvals, consents or waivers from a
third party to convey, assign, transfer or deliver such Transferred
Asset and such authorizations, approvals, consents or waivers have
not been obtained prior to the Closing Date (each, a “
Non-Assignable Asset ”), in either case, the Closing
shall proceed (subject to the Parties’ rights under
Article VI), but the Closing shall not constitute the
conveyance, assignment, transfer or delivery of such Non-Assignable
Asset, and this Agreement shall not constitute a conveyance,
assignment, transfer or delivery of such Non-Assignable Asset
unless and until such authorization, approval, consent or waiver is
obtained. After the Closing, the Parties shall continue to use
commercially reasonable efforts and cooperate with each other,
without additional consideration, to obtain any such authorization,
approval, consent or waiver as promptly as practicable. Once
authorization, approval or waiver of or consent for the conveyance,
assignment, transfer or delivery of any such Non-Assignable Asset
not conveyed, assigned, transferred or delivered at the Closing is
obtained, Cerus shall convey, assign, transfer and deliver such
Non-Assignable Asset to Anza at no additional cost to Anza.
Notwithstanding anything to the contrary contained in this
Agreement, Anza shall not assume any Liabilities with respect to a
Non-Assignable Asset until it has been conveyed, assigned,
transferred and delivered to Anza except to the extent related to
any rights and/or benefits obtained by Anza pursuant to such
Non-Assignable Asset. In addition, for so long as a Transferred
Contract remains a Non-Assignable Asset, Cerus agrees to cooperate
with Anza, as reasonably requested in writing by Anza, to extend
and make available to Anza any rights and/or benefits available
under such contract, provided that Anza pays all amounts and
fulfills all obligations arising from or associated with such
Non-Assignable Assets, other than to the extent such amounts or
obligations would constitute a Retained Liability if such
Non-Assignable Asset were conveyed, assigned, transferred or
delivered on the Closing Date. Without limiting the foregoing,
(a) upon the written request of Anza, Cerus agrees to exercise
rights (for example, elections or options) on Anza’s behalf
under such contract, at Anza’s expense, provided that all
Liabilities resulting from the exercise of such rights shall be
Liabilities solely of Anza, and Cerus shall not exercise any of its
rights under such contract unless requested or approved in writing
by Anza, (b) Cerus shall keep Anza informed as to Cerus’
written communications from the other party to such contract,
including notifying Anza in the event Cerus is notified with
respect to matters that require Cerus’ consent (or which
trigger an option or an election by Cerus) under such contract, or
regarding matters that affect Cerus’ or Anza’s rights
thereunder, (c) to the extent that Anza obtains the agreement
of the other party to such contract to modify, amend or otherwise
alter or waive any performance, obligation or provision of such
contract, Cerus agrees to take such actions and execute such
documents as Anza may reasonably request in writing to effect the
same, at Anza’s expense, provided that all Liabilities
resulting from such modification, amendment, alteration or waiver
shall be Liabilities solely of Anza, and (d) in the event that
Anza obtains an agreement from the other party to such contract to
transfer the rights under such contract directly to Anza, Cerus
shall transfer such rights to Anza in a writing reasonably
acceptable to Anza.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-3-
SECTION 2.3 Grant
of License .
(a) To Anza . Cerus
hereby grants to Anza a worldwide, irrevocable (except pursuant to
Section 2.3(d)) license, with the right to grant and authorize
sublicenses, under the Licensed Intellectual Property,
to make, have made, use, sell, offer to sell, and import
products (including [ * ] Products), to practice any method,
process or procedure, and to otherwise exploit the Licensed
Intellectual Property, in each case within the Anza Field of Use.
For clarity, it is understood that the foregoing licenses shall
include the right to make or have made S-59 Psoralen. Such license
shall be exclusive (even as to Cerus), except to the extent
provided in Section 2.3(b) below with respect to certain uses
of the Licensed Know-How.
(b) Cerus’ Retained
Rights . Notwithstanding the foregoing, the Parties agree that
Cerus retains the non-exclusive right to use and exploit the
Licensed Know-How (but not the Licensed [ * ] Patent Rights)
within the Anza Field of Use for purposes other than products
involving [ * ] .
(c) Rights in
Bankruptcy . All rights and licenses granted under or pursuant
to this Agreement by Cerus to Anza are, and shall otherwise be
deemed to be, for purposes of Section 365(n) of the U.S.
Bankruptcy Code and other similar foreign laws, licenses of rights
to “intellectual property” as defined under
Section 101 of the U.S. Bankruptcy Code or such foreign laws.
Anza, as a licensee of rights under this Agreement, shall retain
and may fully exercise all of its rights and elections under the
U.S. Bankruptcy Code and other similar foreign laws.
(d) Termination
.
(i) If Anza commits a
Fundamental Breach (as defined in Section 2.3(d)(iv)), then
Cerus may deliver notice of such Fundamental Breach to Anza. If
Anza fails to cure such Fundamental Breach within sixty
(60) days after such notice or to provide written notice to
Cerus within such sixty (60) day period that Anza disputes
such claim of Fundamental Breach, then Cerus may terminate the
license set forth in Section 2.3(a) upon written notice to
Anza.
(ii) If Cerus gives notice of
Fundamental Breach under this Section 2.3(d) and Anza disputes
such claim of Fundamental Breach and provides Cerus with written
notice of such dispute within sixty (60) days after
Cerus’ notice of a Fundamental Breach, then the issue of
whether a Fundamental Breach has occurred shall be resolved as
follows:
(1) The arbitration shall be
conducted by the Judicial Arbitration and Mediation Services, Inc.
(or any successor entity thereto) (“ JAMS ”)
under its rules of arbitration then in effect, except as modified
herein. The arbitration shall be conducted in the English language,
by a single arbitrator. The Parties and the arbitrator shall use
all reasonable efforts to complete any such arbitration within six
(6) months from the issuance of notice of a referral of any
such dispute to
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-4-
arbitration. The arbitrator shall
determine what discovery shall be permitted, consistent with the
goal of limiting the cost and time which the Parties must expend
for discovery, provided that the arbitrator shall permit such
discovery as he or she deems necessary to permit an equitable
resolution of the dispute.
(2) The Parties agree that
the decision of the arbitrator shall be the sole, exclusive and
binding remedy between them regarding the dispute presented to the
arbitrator. Any decision of the arbitrator may be entered in a
court of competent jurisdiction for judicial recognition of the
decision and an order of enforcement. The arbitration proceedings
and the decision of the arbitrator shall be deemed Proprietary
Information of the Parties under this Agreement.
(3) Unless otherwise mutually
agreed upon by the Parties, the arbitration proceedings shall be
conducted in San Francisco, California. The Parties agree that they
shall share equally the cost of the arbitration filing and hearing
fees and the cost of the arbitrator and administrative fees of
JAMS. Each Party shall bear its own costs and attorneys’ and
witnesses’ fees and associated costs and expenses.
(iii) If as a result of such
dispute resolution process it is determined that Anza committed a
Fundamental Breach, then Anza shall have sixty (60) days after
such determination to cure such Fundamental Breach. If such
Fundamental Breach is not cured by the end of such sixty
(60) day period, then Cerus may terminate the license set
forth in Section 2.3(a) upon written notice to Anza and Cerus
shall have the sole and exclusive right to exploit the Licensed
Intellectual Property without any limitation under this Agreement.
If such Fundamental Breach is cured within such sixty (60) day
period, then Cerus shall not have the right to terminate such
license on account of such Fundamental Breach.
(iv) For the purposes of this
Section 2.3(d), a “ Fundamental Breach ”
shall mean (a) any failure by Anza to timely pay one or more
amounts due to Cerus pursuant to this Agreement that individually
or collectively [ * ] , (b) any failure by Anza to
timely issue or deliver to Cerus any shares of Anza’s
Preferred Stock due to Cerus pursuant to this Agreement,
(c) any failure by Anza to satisfy any Assumed Liability in an
amount [ * ] , in accordance with Section 7.2(b)(iii),
or (d) any failure by Anza to comply with the indemnification
obligations set forth in Section 7.2(b) for an amount [ *
] .
SECTION 2.4
Liabilities .
(a) Assumed
Liabilities . On the Closing Date, Anza shall assume and agree
to discharge only (i) Liabilities arising from and after the
Effective Time under any Transferred Contract, including all
payments due after the Effective Time, but excluding any Liability
to the extent arising out of or relating to a breach of a
Transferred Contract that occurred prior to the Effective Time,
(ii) any Liability for Taxes attributable to the Transferred
Assets but only to the extent provided in Section 5.14 and
(iii) all Liabilities related to or arising from the operation
of the Business from and after the Effective Time or the ownership
of the Transferred Assets from and
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-5-
after the Effective Time, provided,
however, that the Liabilities described in this clause
(iii) shall not include any Liability incurred prior to the
Effective Time other than under a Transferred Contract in
accordance with clause (i) (the “ Assumed
Liabilities ”).
(b) Retained
Liabilities . All Liabilities of Cerus other than the Assumed
Liabilities (the “ Retained Liabilities ”) shall
remain the sole responsibility of Cerus. For the avoidance of
doubt, the Retained Liabilities shall include, without
limitation:
(i) any Liability of Cerus
under any Transferred Contract that arises after the Effective Time
to the extent arising out of or relating to any breach thereof that
occurred prior to the Effective Time;
(ii) any Liabilities of
Cerus, or any member of any consolidated, affiliated, combined or
unitary group of corporations of which Cerus or any of its
Subsidiaries is or has been a member, for Taxes attributable to the
Transferred Assets for any Pre-Closing Tax Period;
(iii) any Liabilities of
Cerus arising out of any product liability, patent infringement,
breach of warranty, government seizure, recall or similar claim for
injury to person or property or any other claim related to the
Transferred Assets or the Business, in each case to the extent
arising prior to the Closing (including all proceedings relating to
any such Liabilities);
(iv) any Liabilities of Cerus
with respect to any litigation or other claims related to the
Transferred Assets or the Business to the extent arising from any
event, circumstance or condition occurring or alleged to have
occurred prior to the Closing;
(v) any Liability of Cerus
related to (A) any product or service of Cerus not related to
the Business or (B) the operation or conduct by Cerus of any
business other than the Business;
(vi) any Liability of Cerus
arising out of (A) any suit, action or proceeding pending or
threatened as of the Closing, with respect to claims based upon
facts, events or circumstances occurring prior to the Closing, or
(B) any actual or alleged violation by Cerus or any of its
Affiliates of any Law applicable to Cerus or any of its
Affiliates;
(vii) any Liability of Cerus
or any ERISA Affiliate under or relating to (A) any employee
benefit plan, or relating to wages, bonuses, payroll, vacation,
sick leave, workers’ compensation, unemployment benefits,
pension benefits, employee stock option or profit-sharing plans,
health care plans or benefits, phantom stock, deferred compensation
or other similar plan or arrangement, or any other employee plans
or benefits of any kind, in each case, which Cerus or any ERISA
Affiliate has entered into, maintains or administers or has
maintained or administered, to which Cerus or any ERISA Affiliate
contributes or has contributed or is or has been required to
contribute, or under or with respect to which Cerus or any ERISA
Affiliate has or may have any Liability and (B) any actual or
alleged violation by Cerus or any of its Affiliates of any equal
employment or employment discrimination laws;
(viii) any Liability of Cerus
(including all costs and disbursements) incurred in connection with
the termination of employment of any Cerus employee prior to or in
connection with the Closing (including any Business Employee and
any Cerus employee who does not become employed by
Anza);
(ix) any Liability of Cerus
under Environmental Laws arising out of or relating to the
operation or conduct of the Business or the use or ownership of the
Transferred Assets, in each case before the Closing;
(x) any Liability of Cerus to
any of its Affiliates; and
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-6-
(xi) any other Liability of
Cerus resulting from the ownership, use, operation or maintenance
of the Transferred Assets by or on behalf of Cerus prior to the
Closing, or the operation or conduct of the Business by or on
behalf of Cerus prior to the Closing.
SECTION 2.5
Consideration .
(a) Consideration . As
consideration for the Transferred Assets and rights granted to Anza
hereunder, Anza shall:
(i) Assume the Assumed
Liabilities;
(ii) Issue to Cerus 5,000,000
shares of Anza’s Series AA Preferred Stock (the “
Series AA Shares ”), provided that (A) Cerus
shall execute and deliver the Investor Rights Agreement, Voting
Agreement and Right of First Refusal and Co-Sale Agreement and
(B) 1,000,000 of the Series AA Shares shall be held in escrow
in accordance with Section 5.16;
(iii) In the event that Anza
enters into a definitive agreement [ * ] , for the
development and commercialization of [ * ] vaccines using
the [ * ] , which agreement is signed and becomes effective
within [ * ] months following the Closing Date [ * ]
and provides for [ * ] development of [ * ] , Anza
shall provide to Cerus additional consideration as set forth in
paragraphs (1), (2) and (3) below.
(1) If the [ * ]
provides for [ * ] to Anza of [ * ] , then Cerus [
* ] .
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[ * ]
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[ * ]
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[ *
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[ * ]
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[ * ]
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[ *
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[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-7-
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[ * ]
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[ *
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[ * ]
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[ *
] |
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[ * ]
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[ *
] |
For purposes of calculating the [ *
] means [ * ] for which the [ * ] , provided that
[ * ] are not dependent on the [ * ] .
(2) If Anza actually receives
[ * ] of at least [ * ] , then Cerus [ * ]
.
The [ * ] clauses (1) and
(2) above shall each be conditioned upon [ * ]
customary representations and warranties [ * ] , and having
substantially [ * ] .
In the event that Anza consummates an
IPO or Liquidity Event after [ * ] but prior to [ * ]
, Anza shall pay to Cerus [ * ] , within ten
(10) Business Days after the closing of such IPO or Liquidity
Event, as applicable.
In the event that Anza consummates an
IPO or Liquidity Event before [ * ] , Anza shall pay to
Cerus [ * ] , within ten (10) Business Days after [
* ] due.
(3) Anza shall pay to Cerus
[ * ] percent ( [ * ] %) of [ * ] due to be
paid by [ * ] to Anza under [ * ] during the five
(5) year period following [ * ] , within ten
(10) Business Days after [ * ] , even if such [ *
] became due and payable within [ * ] but were not
actually received by Anza [ * ] .
(iv) Pay to Cerus royalties
as set forth on Exhibit B with respect to
Royalty-Bearing Covered Products; and
(v) Pay to Cerus:
(1) a one-time payment of
[ * ] upon dosing of the first patient in the first Phase
III Clinical Trial for the [ * ] for which a Phase III
Clinical Trial is conducted;
(2) a one-time payment of
[ * ] upon receipt of the first approval by the FDA of the
first BLA for the [ * ] for which such FDA approval is
obtained; and
(3) The following amounts at
such time as the annual Net Sales for either of the [ * ]
that are sold commercially in the United States or European Union
first equal or exceed the amount set forth in the table below for
[ * ] , provided such sales level is achieved within the
[ * ] :
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-8-
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Annual Net Sales of Such
[ * ]
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Time from First
Commercial Sale |
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Milestone Payment Amount |
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| $ |
[ |
* ] |
|
Within [ |
* ] |
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$ |
[ |
* ] |
| $ |
[ |
* ] |
|
Within [ |
* ] |
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$ |
[ |
* ] |
| $ |
[ |
* ] |
|
Within [ |
* ] |
|
$ |
[ |
* ] |
For such purposes, the
“ Time from First Commercial Sale ” shall mean
the [ * ] after the First Commercial Sale in the United
States or the European Union of [ * ] before such annual Net
Sales threshold is achieved with respect to [ * ] . For the
avoidance of doubt, each milestone payment under this clause
(3) is payable [ * ] ), it being understood that annual
Net Sales of [ * ] shall be calculated separately and not
combined in determining whether the applicable annual Net Sales
level has been achieved. In no event shall the aggregate milestone
payments made under this clause (3) [ * ] .
(4) Anza shall notify Cerus
in writing within thirty (30) days after the achievement of
any of the foregoing milestones under clauses (1), (2) or
(3) above by Anza or its Affiliate or Licensee, and shall pay
the amount corresponding to such milestone within thirty
(30) days after such achievement. For clarity, each milestone
payment under clauses (1) and (2) above is payable not
more than once, and in no event shall the aggregate milestone
payments made under clauses (1) and (2) above [ *
] .
(b) Allocation of
Payments . The Parties shall allocate the aggregate payments
made pursuant to Sections 2.5(a)(i), (ii) and (iii) among
the Transferred Assets, which allocation shall be prepared in a
manner consistent with Section 1060 of the Code and the
Treasury Regulations promulgated thereunder and mutually agreed by
Cerus and Anza (the “ Allocation ”), within
sixty (60) days following the Closing Date. If any additional
payments are made to Cerus pursuant to Section 2.5(a)(iii),
the Parties shall amend the Allocation to take into account such
payments. Each Party agrees to act reasonably in agreeing to the
Allocation. The Allocation (and any amendment thereto) shall be
conclusive and binding upon Cerus and Anza for all purposes, and
Cerus and Anza agree that all returns and reports and all financial
statements shall be prepared in a manner consistent with such
Allocation or any amendment thereto unless otherwise required by
the Internal Revenue Service or any other applicable taxing
authority. For the avoidance of doubt, any payments made pursuant
to Sections 2.5(a)(iv) or (v) shall be treated by the Parties
as payments of royalties.
(c) Transfer Taxes .
All transfer, documentary, sales, use, valued-added, gross
receipts, stamp, registration or other similar transfer Taxes
incurred in connection with the transfer and sale of the
Transferred Assets pursuant to this Agreement (“ Transfer
Taxes ”) shall be timely paid by Cerus. The Parties
hereto shall cooperate, to the extent reasonably requested and
legally permitted, to reduce any such Transfer Taxes, including,
without limitation, by using diligent efforts to transfer any
intellectual property by remote electronic transmission. The Party
required by Law to file a Tax Return with respect to such Transfer
Taxes shall do so within the time period prescribed by applicable
Law, and the other Party shall join in the execution of any such
Tax Returns and other
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-9-
documentation. All costs incurred in the
filing of such Tax Returns shall be borne equally by both Parties.
Cerus shall provide Anza with evidence satisfactory to Anza that
such Transfer Taxes have been timely paid by Cerus. Anza shall
promptly reimburse Cerus for one-half the amount of such Transfer
Taxes upon receipt of notice that such Transfer Taxes have been
paid. To the extent that Anza pays any such Transfer Taxes, Cerus
shall promptly reimburse Anza for one-half the amount of such
Transfer Taxes upon receipt of notice that such Transfer Taxes have
been paid.
SECTION 2.6
Closing . Subject to the terms and conditions of this
Agreement, the closing of the transactions contemplated by this
Agreement (the “ Closing ”), including the
transfer of the Transferred Assets, shall be held at the offices of
Wilson Sonsini Goodrich & Rosati, 650 Page Mill Road, Palo
Alto, California at 10:00 a.m. Pacific Standard Time on
November 20, 2007, contemporaneously with the execution and
delivery of this Agreement, or such later date as the Parties agree
upon in writing (the “ Closing Date
”).
SECTION 2.7
Closing Deliveries by Cerus . At the Closing,
Cerus shall deliver or cause to be delivered to Anza:
(a) an original of each
Transaction Document to which Cerus is a party, duly executed by
Cerus;
(b) an original FDA Transfer
Letter with respect to each of the Business Products (for delivery
by Anza to the FDA on behalf of Cerus), duly executed by
Cerus;
(c) the certificates and
other documents required to be delivered pursuant to
Section 6.2;
(d) all of the Transferred
Assets and other materials set forth on Exhibit E , in the
manner and form and to the location(s) reasonably specified by
Anza; and
(e) such other deeds, bills
of sale, assignments, certificates of title, documents and other
instruments of transfer and conveyance, and such copies of the
Transferred Intellectual Property and/or Licensed Intellectual
Property, as may reasonably be requested by Anza, each in form and
substance satisfactory to Anza and its legal counsel and duly
executed by Cerus, as applicable.
SECTION 2.8
Closing Deliveries by Anza . At the Closing,
Anza shall deliver to Cerus:
(a) an original of each
Transaction Document to which Anza is a party, duly executed by
Anza;
(b) the Series AA Shares
by delivery of a stock certificate registered in the name of Cerus
(excluding the stock certificate for the Holdback Shares, which
shall be delivered pursuant to Section 2.9, and the stock
certificate for the Escrow Shares, which shall be deposited with
the Escrow Holder pursuant to Section 5.16(f)); and
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-10-
(c) the certificates and
other documents required to be delivered pursuant to
Section 6.1.
SECTION 2.9
Further Deliveries by Cerus and Anza .
At or promptly following the Closing, but in no event later
than ninety (90) days thereafter, Cerus shall deliver or cause
to be delivered to Anza, in the manner and form and to the
location(s) reasonably specified by Anza, at Cerus’ expense,
the Transferred Assets and other materials listed on Exhibit
F hereto which were not delivered to Cerus on the Closing Date.
Promptly following Cerus’ satisfaction of the delivery
obligation set forth in the foregoing sentence, Anza shall deliver
to Cerus the certificate for the Holdback Shares. Following the
Closing, Cerus shall promptly deliver or cause to be delivered to
Anza any additional Transferred Assets not set forth on Exhibit
F or not delivered to Anza on the Closing Date, as such
additional Transferred Assets come to the attention of the
Parties.
ARTICLE III
REPRESENTATIONS AND
WARRANTIES OF CERUS
Except as set forth in the disclosure
schedule delivered by Cerus to Anza and dated as of the date hereof
(the “ Cerus Disclosure Schedule ”), which Cerus
Disclosure Schedule identifies the Section (or, if
applicable, subsection) of this Agreement to which such exception
relates (provided, however, that such disclosure shall also apply
to particular matters represented or warranted in other
Sections and subsections to the extent that it is readily
apparent from the text of such disclosure), Cerus hereby represents
and warrants to Anza, as of the date of this Agreement, as set
forth on Exhibit C .
ARTICLE IV
REPRESENTATIONS AND
WARRANTIES OF ANZA
Except as set forth in the disclosure
schedule delivered by Anza to Cerus and dated as of the date hereof
(the “ Anza Disclosure Schedule ”), which Anza
Disclosure Schedule identifies the Section (or, if
applicable, subsection) of this Agreement to which such exception
relates (provided, however, that such disclosure shall also apply
to particular matters represented or warranted in other
Sections and subsections to the extent that it is readily
apparent from the text of such disclosure), Anza hereby represents
and warrants to Cerus, as of the date of this Agreement, as set
forth on Exhibit D .
ARTICLE V
ADDITIONAL
AGREEMENTS
SECTION 5.1
Cooperation and Assistance . Without limiting the terms
and conditions of the Transition Services Agreement, Cerus shall
cooperate fully with and assist Anza, and shall make its personnel
reasonably available for up to eight (8) hours per week during
the twelve (12)
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-11-
week period following the Closing Date
in order to allow Anza to understand and implement the Transferred
Know-How and the Licensed Know-How and to utilize the Transferred
Know-How and the Licensed Know-How for the purposes contemplated in
this Agreement; provided, however, that Cerus shall not be
obligated hereunder to provide any assistance that Business
Employees are capable of providing to Anza and shall not have any
obligations under this Section 5.1 with respect to Intercept
Platelet or Plasma disposable kits, and further provided that
Cerus’ obligations under this Section 5.1 with respect
to UVA light devices shall be limited to providing instruction
regarding their maintenance and use. In addition, Cerus shall
(a) provide Anza with reasonable access to and/or copies of
Cerus’ Books and Records to the extent related to Licensed
[ * ] Patent Rights or Licensed Know-How and
(b) provide reasonable assistance to Anza to allow Anza to
access and enter into negotiations with any contract research
organization, contract manufacturer or other Third Party engaged by
Cerus or any of its Affiliates prior to the Closing Date in
connection with the Business; provided that, subject to
Section 2.2, such obligation shall not apply if the contract
between Cerus or its Affiliate and such contract research
organization, contract manufacturer or other Third Party is a
Transferred Contract. Further, Cerus shall use commercially
reasonable efforts to destroy, promptly after the Closing, all
copies of the Transferred Assets in its possession or Control
(including electronic copies), except that Cerus shall be permitted
to retain, solely for archival purposes, one (1) copy of
(i) any legal (including regulatory but excluding Intellectual
Property) or financial records within the Transferred Books and
Records, and (ii) any Transferred Contracts, in each case that
Cerus is required by law to retain or as may be required to protect
Cerus’ legitimate business interests consistent with this
Agreement. It is understood, however, that any failure by Cerus to
destroy copies of particular materials shall not constitute a
breach of this Agreement if doing so is not reasonably practicable
or if such item(s) (individually and collectively) are not
material.
SECTION 5.2 {
Intentionally Omitted }
SECTION 5.3
Certain Regulatory Matters .
(a) Cross-Reference
Right . Cerus shall provide Anza and its nominees a right to
reference, in association with Anza’s exercise of its rights
under this Agreement with respect to products utilizing S-59
Psoralen, any and all current and future regulatory filings and
other submissions made or filed with the FDA, the EMEA or any other
applicable Foreign Regulatory Authority, by Cerus, its Affiliates,
licensees, contractors, suppliers, successors, assigns and others
acting under authority of any such entity, that contain data that
is necessary or useful for Anza to obtain Regulatory Approval for
products utilizing S-59 Psoralen in the Anza Field of Use,
including any filings or submissions relating to the manufacturing,
toxicology, safety, stability and/or other characteristics of or
controls regarding S-59 Psoralen (such regulatory filings and
submissions, the “ [ * ] Regulatory Submissions
”). In connection with the foregoing right, (i) upon
request by Anza from time to time, Cerus shall provide Anza or its
nominee with full and prompt access to and copies of the [ *
] Regulatory Submissions, together with all correspondence and
documentation and data specifically relating to S-59 Psoralen, in
each case to the extent necessary or useful for obtaining
Regulatory Approval for products utilizing S-59 Psoralen in
the
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-12-
Anza Field of Use, and (ii) Anza or
its nominee shall have the right to make its own regulatory filings
and submissions with the FDA, the EMEA or any other Foreign
Regulatory Authority disclosing such data and/or any information
contained in the [ * ] Regulatory Submissions. Such rights
of reference, of access and to make regulatory filings and
submissions shall be limited to purposes relating to the Anza Field
of Use.
(b) Further Assurances
. Cerus shall take such actions as Anza reasonably requests to
implement and give effect to the foregoing provisions of this
Section 5.3, including (i) executing and delivering to
Anza a letter in substantially the form of the FDA Cross-Reference
Letter upon request by Anza, (ii) sending (or causing the
holder of a [ * ] Regulatory Submission to send) to the FDA,
the EMEA and/or any other Foreign Regulatory Authority such
additional letters of authorization as Anza may reasonably request
from time to time to give Anza the right of reference described in
Section 5.3(a) and (iii) providing Anza with timely
information regarding any changes to the manufacturing process for
GMP S-59 Psoralen to the extent that (1) such changes are
implemented while Cerus is supplying Anza with GMP S-59 Psoralen
pursuant to the Supply Agreement and (2) on account of such
changes, the document provided by Cerus pursuant to
Section 6.2(f)(viii) no longer accurately describes the
process for manufacturing GMP S-59 Psoralen.
(c) Safety Data
Exchange . In addition, the Parties agree to enter into, as
soon as reasonably practicable upon request of either Party, a
separate agreement setting forth the pharmacovigilance
responsibilities and procedures of the Parties for exchange of
safety information with respect to S-59 Psoralen (the “
Pharmacovigilance Agreement ”). The Pharmacovigilance
Agreement shall contain such terms as are reasonable and customary
for arrangements of this type, and shall in all events include such
terms as are necessary to ensure that each Party discloses safety
data in its possession and control in a manner that enables the
other Party to comply with applicable Laws pertaining to adverse
events and safety reporting with respect to S-59
Psoralen.
SECTION 5.4 Supply
of Materials .
(a) Cerus shall supply GMP
S-59 Psoralen, in addition to the Initial S-59 Psoralen Supply, and
UVA light devices and Intercept Platelet and Plasma disposable kits
in accordance with the Supply Agreement entered into by and between
the Parties of even date herewith.
(b) Supply Not Sole
Source . It is understood that the supply arrangements under
this Section 5.4 and the Supply Agreement are non-exclusive
and are not intended to prevent Anza from manufacturing such items
itself or procuring such items from one or more Third Parties.
Promptly following Anza’s request, Cerus shall transfer, or
cause to be transferred, to Anza or a Third Party manufacturer
designated by Anza all Licensed Know-How that is necessary or
useful for the manufacture of such GMP S-59 Psoralen and shall make
personnel of Cerus reasonably available to assist Anza and/or its
Third Party manufacturer(s) in implementing such Know-How. Anza
will promptly reimburse Cerus for reasonable out of pocket expenses
and internal labor costs incurred by Cerus at Anza’s request
in complying with this Section 5.4(b). For such purposes,
Cerus’ internal labor costs shall be determined on an hourly
basis at individual rates equal to Cerus’ direct
cash
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-13-
compensation expense (including accrued
bonus payments), workers’ compensation, payroll taxes and
benefits (not including equity compensation), but not including
corporate overhead or other charges, for Cerus personnel performing
such services.
SECTION 5.5
Diligence . Anza, directly or through its Affiliates,
Licensees and/or other contractors, intends to use commercially
reasonable efforts to develop and commercialize at least [ *
] , provided, however, that the decision to continue or
discontinue such efforts shall (as between the Parties) be in
Anza’s sole discretion.
SECTION 5.6
Reimbursement of Business Expenses . Anza shall, within
thirty (30) Business Days after the Closing Date, reimburse
Cerus for the direct expenses of the Business incurred between [
* ] , less the amount of $ [ * ] , provided that such
expenses are included within the budget attached hereto as
Exhibit G , up to a maximum aggregate amount of $ [ *
] plus any additional out-of-pocket expenses approved in
writing by David N. Cook, and the foregoing reimbursement
obligation shall supersede and replace any corresponding obligation
set forth in the Term Sheet.
SECTION 5.7
Certain Employee Matters .
(a) Business Employees
. Cerus’ employment of the Business Employees shall terminate
at midnight on the Closing Date. Prior to or in conjunction with
the Closing, Anza shall in good faith offer employment to the
Business Employees, pursuant to terms of written offer letters,
with such employment to commence on the first Business Day
immediately following the Closing Date. In the event any such
Business Employee accepts Anza’s offer of employment either
before or after the Closing, Anza shall be responsible for all
Liabilities (including but not limited to salaries and benefits,
including the maintenance of appropriate levels of workers’
compensation insurance) arising out of any such employment from and
after the initial date of such employment by Anza.
(b) Accrued Benefits .
Cerus shall pay each Business Employee any unused vacation time or
other employee benefits accrued through the date such Business
Employee’s employment with Cerus terminated, not later than
the Closing Date. In addition, Cerus shall pay Anza the amount of
$[ * ] on or before [ * ], which amount shall be further
distributed by Anza to the Business Employees, other than David N.
Cook or Thomas W. Dubensky, who remain employed by Anza as of the
date such payment is received.
(c) No Third Party
Beneficiaries . No provision of this Section 5.7 shall
create any third party beneficiary rights in any employee or former
employee (including any beneficiary or dependent thereof) of Cerus,
in respect of continued employment for any specified period or of
any other nature or kind whatsoever.
SECTION 5.8
Confidentiality .
(a) Proprietary
Information . Except as otherwise provided in this
Section 5.8, each Party (the “ Receiving Party
”) shall maintain in confidence and use only for purposes of
this
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-14-
Agreement any confidential information
and data disclosed and materials supplied to such Party by the
other Party (the “ Disclosing Party ”) under
this Agreement or any other Transaction Document (such information,
data and materials, collectively “ Proprietary
Information ”). For purposes of this Section 5.8,
(i) all “Confidential Information” disclosed
pursuant to the Confidentiality Agreement between Anza and Cerus
dated September 6, 2007 (the “ Prior Agreement
”) shall be deemed Proprietary Information of Cerus (and
hence Anza shall be considered the Receiving Party with respect
thereto) except to the extent it comprises Transferred Assets and
except as provided below, (ii) the Licensed Intellectual
Property solely to the extent it relates to the Anza Field of Use
shall be deemed Proprietary Information of both Cerus and Anza (and
hence each of Cerus and Anza shall be considered a Receiving Party
with respect thereto) regardless whether there is any disclosure
thereof from one Party to the other, and (iii) the Transferred
Intellectual Property shall be deemed Proprietary Information of
Anza (and hence Cerus shall be considered the Receiving Party with
respect thereto). The obligations of the Receiving Party under this
Section 5.8 not to disclose or use Proprietary Information of
the other Party shall not apply, however, to the extent that any
such information, data or materials:
(i) are or become generally
available to the public, or otherwise part of the public domain,
other than by acts or omissions of the Receiving Party in breach of
this Agreement;
(ii) are disclosed to the
Receiving Party, other than under an obligation of confidentiality,
by a Third Party who had no obligation not to disclose such
information, data or materials to others;
(iii) were already in the
possession of the Receiving Party, other than under an obligation
of confidentiality, prior to disclosure by the Disclosing Party, as
evidenced by written record, except to the extent such information,
data or materials comprise Transferred Assets or Licensed
Intellectual Property; or
(iv) are subsequently and
independently developed by the Receiving Party without use of or
reference to the Proprietary Information of the Disclosing
Party.
(b) Permitted
Disclosures . To the extent it is reasonably necessary or
appropriate for a Receiving Party to fulfill its obligations or
exercise its rights under this Agreement or any other Transaction
Document:
(i) a Receiving Party may
disclose Proprietary Information of the other Party to the
Receiving Party’s Affiliates, licensees and prospective
licensees, employees, consultants, outside contractors, clinical
investigators and other Persons on a need-to-know basis in
accordance with the exercise of rights granted to or retained by
such Receiving Party under this Agreement or any other Transaction
Document, provided that such Persons agree to be bound by
obligations of confidentiality and non-use with respect to such
Proprietary Information which are substantially similar in scope
and duration to those set forth in this
Section 5.8;
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-15-
(ii) a Receiving Party may
disclose Proprietary Information of the other Party to government
or other regulatory authorities to the extent that such disclosure
is required by applicable Law (including applicable securities
Laws), regulation or agency or court order, provided that the
Receiving Party shall provide reasonable advance notice to the
other Party to allow such Party to oppose such disclosure or to
request confidential treatment of such Proprietary
Information;
(iii) Cerus and its
Affiliates and licensees may disclose Proprietary Information
comprising the Licensed Intellectual Property that relates to the
Anza Field of Use (a) to patent offices to the extent that
such disclosure is reasonably necessary or useful to Prosecute and
Maintain any Licensed [ * ] Patent Rights, or (b) to
Governmental Authorities to the extent such disclosure is
reasonably necessary or useful to obtain any Regulatory Approval
for a product discovered, developed or commercialized by Cerus or
its Affiliates or licensees (subject to Anza’s exclusive
rights in the Transferred Intellectual Property and its license to
the Licensed Intellectual Property pursuant to
Section 2.3(a)); and
(iv) Anza and its Affiliates
and licensees may disclose Proprietary Information comprising the
Licensed Intellectual Property (a) to patent offices to the
extent that such disclosure is reasonably necessary or useful to
Prosecute and Maintain any Licensed [ * ] Patent Rights in
accordance with Section 5.10(b), or (b) to Governmental
Authorities to the extent such disclosure is reasonably necessary
or useful to obtain any authorization to conduct clinical studies
or to obtain any Regulatory Approval for a product within the Anza
Field of Use, provided, however, that Anza shall provide Cerus with
copies of and a reasonable opportunity to comment upon any such
regulatory filing and submission to the extent the same has
potential impact on the Cerus Field of Use and specifically relates
to S-59 Psoralen. Cerus’ opportunity to comment upon such
regulatory filings and submissions shall be at least ten
(10) days or such shorter period as is required under the
circumstances.
(v) For purposes of
Section 5.8(b)(i), (A) “rights granted to”
Anza shall mean rights in the Anza Field of Use and
(B) “rights granted to” Cerus and “rights
retained by” Cerus shall mean rights to use the Licensed
Intellectual Property outside the Anza Field of Use or, in the case
of Licensed Know-How, as permitted under Section 2.3(b)
above.
(c) Nondisclosure of
Terms; Press Release . Each Party agrees not to disclose the
terms of this Agreement to any Third Party without the prior
written consent of the other Party, except: (i) to such
Party’s advisors (including financial advisors, attorneys and
accountants), potential and existing investors and others on a
need-to-know basis, in each case under appropriate confidentiality
obligations which are substantially similar in scope and duration
to those set forth in this Section 5.8; (ii) potential or
actual acquirors or purchasers of such Party or of such
Party’s assets to which this Agreement relates or potential
or actual licensees or sublicensees, in each case under appropriate
confidentiality obligations which are substantially similar in
scope and duration to those set forth in this Section 5.8; or
(iii) to the extent necessary to comply with applicable Law
(including applicable securities Laws), regulations or agency or
court order, provided that the Party required to make such
disclosure shall promptly notify the other Party and (other than in
the case where such disclosure is necessary to comply with
applicable securities Laws) allow such other Party a
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-16-
reasonable time to oppose such
disclosure and/or to seek limitations on the portion of this
Agreement required to be disclosed. Notwithstanding the foregoing,
Cerus may issue a press release to announce the execution of this
Agreement, in the form attached hereto as Exhibit H
and, following the issuance of such press release, Anza and Cerus
may each disclose to Third Parties the information contained in
such press release without the need for further approval by the
other.
(d) Prior Agreement .
The Parties hereby terminate the Prior Agreement effective as of
the Closing Date.
SECTION 5.9
Ownership of Inventions .
(a) As between the Parties,
title to all inventions and other intellectual property rights made
solely by personnel of Anza in connection with this Agreement shall
be solely owned by Anza, and title to all inventions and other
intellectual property rights made solely by personnel of Cerus in
connection with this Agreement shall be solely owned by Cerus.
Title to all inventions and other intellectual property rights
made jointly by personnel of Anza and Cerus in connection with this
Agreement (such inventions and intellectual property rights, the
“ Joint IP ”) shall be jointly owned by the
Parties. Prosecution and Maintenance and enforcement of any Patent
Rights with respect to such Joint IP shall be solely as mutually
agreed upon by the Parties. Inventorship and rights of ownership of
any Patent Rights or other intellectual property rights conceived
and/or reduced to practice in the course of the performance of any
work under this Agreement shall be determined in accordance with
the applicable patent or other intellectual property laws of the
country in which such Patent Rights or other intellectual property
rights are made.
Except as expressly provided
in this Agreement, it is understood that neither Party shall have
any obligation to account to the other Party for profits from, or
to obtain any approval of the other Party to license, assign or
otherwise exploit, Joint IP and each Party hereby waives any right
it may have under the laws of any jurisdiction to require any such
accounting or approval.
SECTION 5.10
Patent Prosecution and Maintenance .
(a) By Cerus . Subject
to Section 5.10(b), Cerus shall have the right, at its
expense, to Prosecute and Maintain the Licensed [ * ] Patent
Rights, using [ * ] or other counsel chosen by Cerus that is
reasonably acceptable to Anza. In connection with such Prosecution
and Maintenance, Cerus shall: (i) provide Anza with semiannual
updates with respect to the status of Prosecution and Maintenance
of the Licensed [ * ] Patent Rights; (ii) furnish to
Anza copies of all material documents filed with or received from
any patent office after the Closing Date in the course of such
Prosecution and Maintenance, provided that such documents pertain
to the Anza Field of Use; and (iii) allow Anza reasonable
opportunity to comment on material documents before being filed
with any patent office with respect to the Licensed [ * ]
Patent Rights to the extent that such documents pertain to the Anza
Field of Use; provided, however, that in each case, prior to
disclosure to Anza hereunder, Cerus shall have the right to redact
any information that is not related to the Anza Field of Use. If
Anza believes in good faith that the patent counsel undertaking
such Prosecution and Maintenance is not performing at a level
acceptable to Anza, Anza may bring its concerns to Cerus and Cerus
shall take into account such reasonable concerns when deciding
whether to chose alternative counsel to perform such Prosecution
and Maintenance activities.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-17-
(b) By Anza
.
(i) In the event that Cerus
elects not to Prosecute and Maintain any patent application within
the Licensed [ * ] Patent Rights having claims pertaining to
the Anza Field of Use or pay any fee related thereto in any
country, Cerus shall promptly notify Anza of such election, but in
no case later than thirty (30) days prior to any required
action relating to the Prosecution and Maintenance of such patent
application. In such event, Anza shall have the right, at its
option, to control the Prosecution and Maintenance of such patent
application in Cerus’ name. If Anza assumes the Prosecution
and Maintenance of a patent application pursuant to the preceding
sentence, such Prosecution and Maintenance shall be conducted at
Anza’s expense, [ * ] .
(ii) In the event that Anza
elects not to Prosecute and Maintain any patent application within
the Transferred Patent Rights having claims pertaining to the Anza
Field of Use or pay any fee related thereto in any country, Anza
shall promptly notify Cerus of such election, but in no case later
than thirty (30) days prior to any required action relating to
the Prosecution and Maintenance of such patent application. In such
event, Cerus shall have the right, at its option, to require that
Anza continue the Prosecution and Maintenance of such patent
application in Anza’s name, under Anza’s control and at
Cerus’ expense, to the extent that such Prosecution and/or
Maintenance would not limit or interfere with Anza’s ability
to Prosecute and Maintain other patent applications within the same
patent family in the same country, as reasonably determined by
Anza.
(c) Cooperation . Each
Party shall cooperate with the other Party in connection with all
activities relating to the Prosecution and Maintenance of the
Licensed [ * ] Patent Rights undertaken by such other Party
pursuant to this Section 5.10, including making available to
such other Party any documents reasonably necessary or appropriate
for the Prosecution and Maintenance of any Licensed [ * ]
Patent Rights in a timely manner and, if and as appropriate,
signing (or causing to have signed) all documents relating to the
Prosecution and Maintenance of any Licensed [ * ] Patent
Rights.
SECTION 5.11
Enforcement of Patents .
(a) Notice . If either
Party, directly or through an Affiliate or licensee, learns of any
actual or possible, direct or indirect, infringement of the
Licensed [ * ] Patent Rights by the making, having made,
use, sale, offer for sale or importation of any product or other
activity in the Anza Field of Use by another person or entity (to
the extent such infringement is within the Anza Field of Use, an
“ Infringement ”), it shall promptly provide
written notice to the other Party of such Infringement and shall
promptly supply such other Party with all evidence it possesses
pertaining to such Infringement.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-18-
(b) Infringement
Action .
(i) Cerus (directly or
through its nominee) shall have the first right, but not the
obligation, to seek to abate any Infringement, or to file suit
against an infringing person or entity with respect to such
Infringement, if one or more of the allegedly infringed Licensed
[ * ] Patent Rights claims the composition of matter,
manufacture or use of psoralen or a product made through the use of
psoralen or method of inactivating microorganisms, subject to
subsection (b)(ii)(A) below. In the event that Cerus or its nominee
does not, within [ * ] months from date of a request by Anza
to do so, take action to abate such Infringement, Anza shall have
the right, but not the obligation, to enforce the Licensed [ *
] Patent Rights in connection with such Infringement in its own
name, and at its own cost and expense.
(ii) Anza (directly or
through its nominee) shall have the first right, but not the
obligation, to seek to abate any Infringement, or to file suit
against an infringing person or entity with respect to such
Infringement, if (A) if such Infringement relates to a product
involving a [ * ] or (B) none of the allegedly
infringed Licensed [ * ] Patent Rights claims the
composition of matter, manufacture or use of psoralen or a product
made through the use of psoralen or method of [ * ] . In the
event that Anza or its nominee does not, within [ * ] months
from date of a request by Cerus to do so, take action to abate such
Infringement, Cerus shall have the right, but not the obligation,
to enforce the Licensed [ * ] Patent Rights in connection
with such Infringement in its own name, and at its own cost and
expense.
(c) Cooperation . In
any suit, action or other proceeding in connection with an
Infringement (an “ Infringement Action ”), the
Party assuming the primary role in the Infringement Action (the
“ Controlling Party ”) shall keep the
non-Controlling Party reasonably informed of the progress of such
Infringement Action. The non-Controlling Party shall cooperate
fully with the Controlling Party, including, either as required by
law or at the request of the Controlling Party, by joining as a
nominal party and executing such documents as may reasonably be
required, all at the expense of the Controlling Party. In any case,
the non-Controlling Party shall have the right, in the event it is
not required or requested to be joined, to participate in any
Infringement Action with counsel of its own choice at its own
expense.
(d) Settlement and
Recoveries . The Controlling Party with respect to any
Infringement Action may not settle any such action, or otherwise
consent to any adverse judgment in any such action, that imposes a
financial obligation on the non-Controlling Party, or which
restricts the scope of, or admits the unenforceability or
invalidity of, any Patent Rights within the Licensed [ * ]
Patent Rights without the express written consent of the
non-Controlling Party, which consent shall not be unreasonably
withheld. Any recovery obtained by Anza or Cerus as a result of an
Infringement Action shall be shared as follows:
(i) the Controlling Party
shall first be entitled to recoup all of its out-of-pocket costs
and expenses (including reasonable attorneys’ fees) incurred
in connection with such Infringement Action, whether the recovery
is by settlement or otherwise;
(ii) the non-Controlling
Party, if joined or cooperating in such Infringement Action at its
own expense, shall then be entitled to recover its out-of-pocket
costs and
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-19-
expenses (including reasonable
attorneys’ fees) incurred in connection with such
Infringement Action (and if the amount of the recovery is less than
the total amounts in clause (i) above and this clause (ii),
then the Parties shall share such recovery in proportion to the
amounts to be reimbursed under such clauses (i) and
(ii));
(iii) if Anza is the
Controlling Party, then Anza shall pay Cerus, within thirty
(30) days of the receipt of such recovery, an amount equal to
[ * ] of such recovery, and the amount of any recovery
remaining after such payment shall be retained by Anza;
and
(iv) if Cerus is the
Controlling Party, then [ * ] of the amount of any recovery
remaining shall be retained by Cerus and [ * ] of the amount
of any recovery remaining shall be delivered to Anza within thirty
(30) days of the receipt of such recovery.
SECTION 5.12
Defense of Infringement Claims . If any product or
activity covered by the Licensed [ * ] Patent Rights becomes
the subject of a claim or assertion of infringement of Patent
Rights of a Third Party, the Party first having notice of the claim
or assertion shall promptly notify the other Party, and the Parties
shall promptly confer to consider the claim or assertion and the
appropriate course of action. Unless the Parties otherwise agree in
writing, each Party shall have the right to defend itself against a
suit that names such Party as a defendant; provided that the other
Party shall have the right to join such suit at its own expense if
such suit pertains to or has a reasonably anticipatable impact on
such other Party’s rights with respect to the Licensed [ *
] Patent Rights. Neither Party shall enter into any settlement
of any action described in this Section 5.12, or otherwise
consent to an adverse judgment in any such action, that imposes a
financial obligation on the other Party, or that admits the
infringement of any Patent Rights of a Third Party, without the
other Party’s written consent, which consent shall not be
unreasonably withheld or delayed. In any event, each Party shall
reasonably assist the other Party and cooperate in connection with
any litigation described in this Section 5.12 in which such
Party is not named as a defendant, at the defending Party’s
request and expense. If Anza is required, as a result of any
judgment or settlement of any action described in this
Section 5.12, to pay a royalty to a Third Party to make, have
made, offer for sale, sell and/or import a Covered Product for
which it owes royalties to Cerus pursuant to Exhibit B ,
such amounts shall be deemed amounts required to be paid to a Third
Party with respect to such Covered Product, and may be deducted
from the amounts payable to Cerus with respect to such Covered
Product under this Agreement to the extent permitted under
Section 2(a) of Exhibit B .
SECTION 5.13
Covenant Not to Compete .
(a) Cerus agrees that Anza
shall be entitled to protect and preserve the going concern value
of the Business following the Closing to the extent permitted by
Law, that Anza would not have entered into this Agreement absent
the provisions of this Section 5.13 and, therefore, that,
(i) for the period from the Closing Date hereof until [ *
] thereafter (the “ Applicable Period ”),
Cerus and any Restricted Affiliate shall not, directly or
indirectly, research, develop, manufacture, market, promote, sell
or import any Competing Products anywhere in the world, and
(ii) for the period from the end of the Applicable Period
until [ * ] thereafter (the “ Listeria-Specific
Period ”), Cerus and any Restricted Affiliate shall not,
directly or indirectly, research, develop, manufacture,
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-20-
market, promote, sell or import any
Competing Listeria Products anywhere in the world. As used herein,
“ Restricted Affiliate ” means (A) any
Person that is an Affiliate of Cerus as of the Effective Date or
(B) any Person that becomes an Affiliate of Cerus after the
Effective Date, provided that Cerus controls such Affiliate,
“ Competing Product ” means any product or
service within the Anza Field of Use, and “ Competing
Listeria Product ” means any product or service [ *
] that [ * ] or any component thereof. Without limiting
the foregoing, during the Applicable Period, Cerus and the
Restricted Affiliates shall not provide funding to, invest in or
perform any services on behalf of any Third Party for the purpose
of, or grant a license or other authorization to any Third Party
for, researching, developing, manufacturing, marketing, promoting,
selling or importing any Competing Product for use anywhere in the
world, and during the Listeria-Specific Period, Cerus and the
Restricted Affiliates shall not provide funding to, invest in or
perform any services on behalf of any Third Party for the purpose
of, or grant a license or other authorization to any Third Party
for, researching, developing, manufacturing, marketing, promoting,
selling or importing any Competing Listeria Product for use
anywhere in the world.
(b) If a court determines
that the foregoing restrictions are too broad or otherwise
unreasonable under applicable Law, including with respect to time
or geography, the court is hereby requested and authorized by the
Parties to revise the foregoing restrictions to include the maximum
restrictions allowable under applicable Law. Each of the Parties
acknowledges, however, that this Section 5.13 has been
negotiated by the Parties and that the Applicable Period is
reasonable in light of the circumstances pertaining to the
Parties.
(c) Notwithstanding any other
provision of this Agreement, it is understood and agreed that the
remedy of indemnification pursuant to Article VII and other
remedies at Law would be inadequate in the case of any breach of
the covenants contained in this Section 5.13, and,
accordingly, Anza shall be entitled to equitable relief, including
the remedy of specific performance, with respect to any breach or
attempted breach of such covenants.
SECTION 5.14 Tax
Matters .
(a) Responsibility for
Taxes and Tax Matters .
(i) Subject to
Section 5.14(a)(iii), Cerus will be responsible for the
preparation and filing of all Tax Returns of Cerus (including Tax
Returns required to be filed after the Closing Date) to the extent
such Tax Returns include or relate to Cerus’ use or ownership
of the Transferred Assets on or prior to the Closing Date.
Cerus’ Tax Returns to the extent they relate to the
Transferred Assets shall be true, complete and correct and prepared
in accordance with applicable Law. Cerus will be responsible for
and make all payments of Taxes shown to be due on such Tax Returns
to the extent they relate to the Transferred Assets.
(ii) Subject to
Section 5.14(a)(iii), Anza will be responsible for the
preparation and filing of all Tax Returns it is required to file
with respect to Anza’s ownership or use of the Transferred
Assets attributable to taxable periods (or portions thereof)
commencing after the Closing Date. Anza’s Tax Returns, to the
extent they relate to the Transferred Assets, shall be
true,
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-21-
complete and correct and prepared in
accordance with applicable Law. Anza will be responsible for and
make all payments of Taxes shown to be due on such Tax Returns to
the extent they relate to the Transferred Assets.
(iii) In the case of any real
or personal property Taxes (or other similar Taxes) attributable to
the Transferred Assets for which Taxes are reported on a Tax Return
covering a period commencing before the Closing and ending
thereafter (a “ Straddle Period Tax ”), any such
Straddle Period Taxes shall be prorated between Anza and Cerus on a
per diem basis. The Party required by Law to pay any such Straddle
Period Tax (the “ Paying Party ”) shall file the
Tax Return related to such Straddle Period Tax within the time
period prescribed by Law and shall timely pay such Straddle Period
Tax. To the extent any such payment exceeds the obligation of the
Paying Party hereunder, the Paying Party shall provide the other
Party (the “ Non-Paying Party ”) with notice of
payment, and within ten (10) Business Days of receipt of such
notice of payment, the Non-Paying Party shall reimburse the Paying
Party for the Non-Paying Party’s share of such Straddle
Period Taxes.
(b) Cooperation . To
the extent relevant to the Transferred Assets, each Party shall
(i) provide the other with such assistance as may reasonably
be required in connection with the preparation of any Tax Return
and the conduct of any audit or other examination by any taxing
authority or in connection with judicial or administrative
proceedings relating to any liability for Taxes and
(ii) retain and provide the other with all records or other
information that may be relevant to the preparation of any Tax
Returns, or the conduct of any audit or examination or other
proceeding relating to Taxes. Cerus shall retain all documents,
including prior years’ Tax Returns, supporting work schedules
and other records or information with respect to all sales, use and
employment Tax Returns and, absent the receipt by Cerus of the
relevant tax clearance certificates, shall not destroy or otherwise
dispose of any such records for six (6) years after Closing
without the prior written consent of Anza.
(c) Wage Withholding .
Cerus and Anza shall utilize the alternate procedure set forth in
Revenue Procedure 2004-53 with respect to wage withholding for any
Business Employees.
(d) Reporting . Anza
and Cerus each agree to: (i) report the transactions
contemplated by this Agreement in a manner consistent with the
intent of the Parties that the issuance of the Series AA Shares to
Cerus in partial consideration for the transfer of the Transferred
Assets, when taken together with the issuance of shares of
Anza’s Series A Preferred Stock to certain investors on the
date hereof, shall qualify as an exchange within the meaning of
Section 351 of the Code to the extent permitted by applicable
Law, and each such Party agrees that it will not take a position
inconsistent therewith; (ii) timely file the information
required by Treasury Regulation Section 1.351-3 with its
income Tax Return for the year in which the Series AA Shares are
issued; and (iii) comply with the record keeping requirements
of Treasury Regulation Section 1.351-3.
SECTION 5.15
Certain Accounting Matters . Upon the reasonable request
of Anza in connection with its efforts to effect an IPO during the
period prior to the [ * ] anniversary of the
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-22-
Closing Date, Cerus shall, at
Anza’s expense, provide reasonable assistance to Anza in
Anza’s efforts to prepare those historical financial
statements required to comply with then applicable accounting
requirements under the Securities Act, including providing Anza
with access to Cerus’ outside auditors for such
purposes.
SECTION 5.16
Redemption Option .
(a) Redemption Option
. Anza shall have the option (the “ Redemption Option
”) to redeem a portion of the Series AA Shares, at the
price of [ * ] per share (the “ Redemption
Price ”), as follows:
(i) in the event that
(A) Anza does not receive notice of the award of the [ *
] Grant by December 31, 2008 or (B) the 2008 federal
budget does not include a [ * ] specifically for the [ *
] Grant, Anza shall have the option to redeem 1,000,000
Series AA Shares, effective as of such date;
(ii) in the event that Anza
receives notice of the award of the [ * ] Grant by
December 31, 2008 and the 2008 federal budget includes a [
* ] specifically for the [ * ] Grant in an amount of at
least $1,000,000, but the aggregate monies received by Anza over
the term of such [ * ] Grant are less than $1,000,000, Anza
shall have the option to redeem the number of Series AA
Shares, rounded to the nearest whole share, equal to (A) the
difference between $1,000,000 and such aggregate monies, divided by
(B) one dollar ($1.00), effective as of the expiration of its
term; or
(iii) in the event that Anza
receives notice of the award of the [ * ] Grant by
December 31, 2008 and the 2008 federal budget includes a [
* ] specifically for the [ * ] Grant in an amount of
less than $1,000,000, Anza shall have the option to redeem the
number of Series AA Shares, rounded to the nearest whole
share, equal to (A) the difference between $1,000,000 and the
amount of such line item, divided by (B) one dollar ($1.00),
effective as of the notice of the award of the [ * ]
Grant.
With respect to subsection (a)(i) above,
Anza’s right to redeem the Series AA Shares shall be subject
to Anza’s obligation to submit an application for the [ *
] Grant to the [ * ] in a timely manner. Provided that
the [ * ] Grant has been awarded to Anza, with respect to
subsection (a)(ii) above, Anza’s right to redeem the Series
AA Shares shall be subject to Anza’s obligation to use
commercially reasonable good faith efforts to perform all
activities necessary to receive at least $1,000,000 over the term
of such [ * ] Grant.
(b) Exercise . The
effective date for exercise of the Redemption Option as set forth
under clause (i) or (ii) above, as applicable, is
referred to herein as the “ Redemption Date .”
Anza may exercise the Redemption Option as to all, but not less
than all, of such number of Series AA Shares as is determined
in Section 5.16(a) (the “ Redemption Shares
”) at any time following the Redemption Date by delivering
written notice of its intent to exercise such Redemption Option
(the “ Redemption Notice ”), with a copy to the
Escrow Holder, no later than 5:00 p.m. Pacific Standard Time on the
date that is one (1) year following the Redemption Date. The
Redemption Notice shall set forth in reasonable detail information
relating to the redemption under this Section 5.16 and the
calculation of the number of Redemption Shares being
redeemed.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-23-
(c) Aggregate Redemption
Price . If Anza decides to exercise the Redemption Option, Anza
shall, within thirty (30) days from the date the Redemption
Notice is delivered to Cerus pursuant to subsection (b) above,
deliver a check to Cerus, with a copy to the Escrow Holder, in an
amount equal to the product of (i) the Redemption Price and
(ii) the number of Redemption Shares (the “ Aggregate
Redemption Price ”). Upon delivery of payment of the
Aggregate Redemption Price, Anza shall become the legal and
beneficial owner of the Redemption Shares and all related rights
and interests therein, and Anza shall have the right to retain and
transfer to its own name the number of Redemption Shares being
redeemed by Anza.
(d) Rights of the
Parties . In the event that the Redemption Option is exercised,
upon and following the receipt by Cerus of the Aggregate Redemption
Price, Cerus shall have no right whatsoever to retain the
Redemption Shares. In the event that the Redemption Option is
terminated, whether by failure of Anza to deliver the Redemption
Notice to Cerus within one (1) year following the Redemption
Date or otherwise as set forth in this Agreement, upon and
following such termination the only remaining right of Cerus under
this Agreement shall be the right to retain the Redemption Shares,
and Cerus shall have no right whatsoever to receive the Aggregate
Redemption Price.
(e) Escrow of Shares .
To facilitate exercise of the Redemption Option, a certificate
issued in the name of Cerus for 1,000,000 Series AA Shares (the
“ Escrow Shares ”) shall be held by the
Secretary of Anza as escrow holder (the “ Escrow
Holder ”), along with an Assignment Separate from
Certificate (in the form attached hereto as Exhibit I )
executed by Cerus in blank, until the earlier of
(i) expiration of the [ * ] Grant and (ii) receipt
of $1,000,000 pursuant to such [ * ] Grant.
(i) The Escrow Holder is
hereby directed to permit transfer of the Redemption Shares in
escrow only in accordance with this Agreement and instructions
signed by both Parties.
(ii) If Anza or any assignee
exercises the Redemption Option, the Escrow Holder, upon receipt of
a copy of the Redemption Notice from the proposed transferee, shall
take all steps necessary to accomplish such transfer.
(iii) When the Redemption
Option expires unexercised, the Escrow Holder shall promptly cause
the certificate for the Escrow Shares to be released and delivered
to Cerus.
(iv) The Escrow Holder shall
be obligated only for the performance of such duties as are
specifically set forth herein and may rely and shall be protected
in relying or refraining from acting on any instrument reasonably
believed by the Escrow Holder to be genuine and to have been signed
or presented by the proper Party or Parties. The Escrow Holder
shall not be liable for any act that he/she may do or omit to do
hereunder as Escrow Holder while acting in good
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-24-
faith and in the exercise of his/her own
good judgment, and any act done or omitted by the Escrow Holder
pursuant to the advice of his/her own attorneys shall be conclusive
evidence of such good faith.
(v) Anza and Cerus hereby
jointly and severally expressly agree to indemnify and hold
harmless the Escrow Holder and his/her designees against any and
all claims, losses, liabilities, damages, deficiencies, costs and
expenses, including reasonable attorneys’ fees and expenses
of investigation and defense, incurred or suffered by the Escrow
Holder and his/her designees, directly or indirectly, as a result
of any of his/her actions or omissions or those of his/her
designees while acting in good faith and in the exercise of his/her
judgment under this Agreement or written instructions from Anza and
Cerus.
(vi) The Escrow
Holder’s responsibilities as Escrow Holder hereunder shall
terminate if he/she shall resign by written notice to each Party.
In the event of any such termination, the Parties shall jointly
appoint a successor Escrow Holder.
(vii) The Escrow Holder is
expressly authorized to, and hereby does, delegate his/her duties
as Escrow Holder hereunder to the law firm of Wilson Sonsini
Goodrich & Rosati, P.C., which delegation shall survive
his/her resignation as Escrow Holder.
(viii) If, from time to time
during the term of the Redemption Option, there is (A) any
cash or stock dividend, stock split or other change with respect to
the Escrow Shares being held in escrow or (B) any merger or
sale of all or substantially all of Anza’s assets or other
acquisition of Anza, any and all new, substituted or additional
securities or property to which Cerus is entitled by reason of
Cerus’ ownership of the Escrow Shares being held in escrow
shall be deposited with the Escrow Holder and shall be included
within the definition of Escrow Shares. All numbers contained in,
and all calculations required to be made pursuant to, this
Agreement with respect to the Escrow Shares shall be adjusted as
appropriate to reflect the events set forth in subclauses
(A) and (B) or a similar transaction effected by Anza
after the date hereof.
SECTION 5.17
Certain Termination Rights . Notwithstanding any other
provision of this Agreement, Anza may, from time to time, terminate
its rights under this Agreement as to any particular patent or
patent application within the Licensed [ * ] Patent Rights
or the Transferred Patent Rights by giving Cerus written notice
thereof. From and after the effective date of a termination under
this Section 5.17, (a) with respect to a particular
patent or application within the Licensed [ * ] Patent
Rights, such patent or patent application shall cease to be within
the Licensed [ * ] Patent Rights for all purposes of this
Agreement, and all rights and obligations of Anza with respect to
such patent or patent application shall terminate, and
(b) with respect to a particular patent or application within
the Transferred Patent Rights, Anza shall promptly assign such
patent or patent application to Cerus and thereafter such patent or
patent application shall cease to be within the Transferred Patent
Rights for all purposes of this Agreement, and all rights and
obligations of Anza with respect to such patent or patent
application shall terminate.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-25-
SECTION 5.18
Regulatory Matters and Bulk Sales Laws . Anza
acknowledges that it will be responsible for obtaining and
maintaining the federal and state permits and licenses required in
order for Anza to carry on the Business or use the Transferred
Assets after the Closing, and, except for any obligation expressly
set forth in this Agreement, that Cerus will not have duties or
obligations to Anza with respect to any such permits and
licenses.
SECTION 5.19
Novation of Certain Transferred Contracts . Promptly
following the Closing, Anza shall submit in writing to each
counterparty to the Transferred Contracts listed in Exhibit
J a request for such counterparty to: (i) recognize Anza
as the successor in interest of Cerus to such Transferred Contract;
and (ii) enter into a novation agreement. Anza shall use
reasonable commercial efforts to execute and consummate such
novation agreements. It is understood, however, that such novation
agreements shall not be deemed to transfer to Anza any Retained
Liability or to limit Cerus’ indemnification obligations with
respect to Retained Liabilities pursuant to
Section 7.2(a)(iii).
SECTION 5.20
Abandonment of Certain Patents and Patent Applications .
Within [ * ] after the Closing Date, Cerus shall
(a) expressly abandon the patents and patent applications
listed on Exhibit T (the “ Abandoned Patents
”) that have not already been abandoned or expired, by
submitting appropriate documents to effect such abandonment to the
patent office(s) in the applicable jurisdiction(s) and
(b) deliver to Anza reasonable written evidence of such
abandonment of such Abandoned Patents. In addition, Cerus hereby
agrees that it shall not take any actions to revive any of the
Abandoned Patents.
SECTION 5.21
Further Assurance . On and after the Closing Date,
Cerus shall from time to time, at the reasonable request of Anza,
execute, acknowledge and deliver, or cause to be executed,
acknowledged and delivered, such further conveyances, notices and
assumptions and such other instruments, and take such other
actions, as Anza may reasonably request in order to more
effectively consummate the transactions contemplated hereby and to
transfer fully to Anza good and marketable title to the Transferred
Assets and all of the titles, rights, interests, remedies, powers
and privileges intended to be conveyed under the Transaction
Documents (including assistance in the collection or reduction to
possession of any of the Transferred Assets). On and after the
Closing Date, Anza shall from time to time, at the reasonable
request of Cerus, execute, acknowledge and deliver, or cause to be
executed, acknowledged and delivered, such further notices and
assumptions and such other instruments, and take such other
actions, as Cerus may reasonably request in order to more
effectively consummate the transactions contemplated hereby and to
transfer fully to Anza the Assumed Liabilities.
ARTICLE VI
CONDITIONS TO
CLOSING
SECTION 6.1
Conditions to Obligations of Cerus . The obligation
of Cerus to effect the Closing is subject to the satisfaction, at
or prior to the Closing, of each of the following conditions (any
of which may be waived by Cerus in whole or in part):
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-26-
(a) Representations,
Warranties and Covenants . The representations and warranties
of Anza contained in this Agreement shall be true and correct as of
the Closing Date. Anza shall have performed all agreements and
covenants required by this Agreement to be performed by it prior to
or on the Closing Date. Cerus shall have received a certificate as
to satisfaction of the conditions set forth in this
Section 6.1(a) dated as of the Closing Date and executed by a
duly authorized officer of Anza.
(b) No Actions or
Proceedings . No Action shall be pending or threatened by or
before any Governmental Authority challenging or seeking to make
illegal, to materially delay or otherwise to restrain or prohibit
the consummation of the transactions contemplated by this
Agreement.
(c) Resolutions of
Anza . Cerus shall have received a true and complete copy,
certified by the Secretary or an Assistant Secretary of Anza, of
the resolutions duly and validly adopted by the board of directors
of Anza evidencing its authorization of the execution and delivery
of the Transaction Documents and the consummation of the
transactions contemplated by this Agreement.
(d) Consents and
Approvals . Anza and Cerus shall have received, each in form
and substance satisfactory to Anza in its reasonable discretion,
all authorizations, consents, orders and approvals of all
Governmental Authorities that Cerus in its reasonable discretion
deems necessary or desirable for the consummation of the
transactions contemplated by this Agreement.
(e) Anza Restated
Certificate . The Anza Restated Certificate shall have been
duly authorized, executed and filed with and accepted by the
Delaware Secretary of State.
(f) Documents
.
(i) Cerus shall have received
from Anza all of the documents and agreements set forth in
Section 2.8.
(ii) The Financing Agreements
shall have been executed and delivered by all of the parties
thereto, other than Cerus.
(iii) Cerus shall have
received an opinion from Wilson Sonsini Goodrich & Rosati,
counsel to Anza, in the form attached hereto as Exhibit K
.
(iv) David N. Cook, Ph.D.
shall have been offered, and shall have accepted, a position as
Chief Executive Officer of Anza;
(v) Thomas W. Dubensky, Ph.D.
shall have been offered, and shall have accepted, a position as
Chief Scientific Officer of Anza;
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-27-
(vi) Anza shall have
delivered an employment offer letter to each of the Business
Employees offering a position of employment with Anza.
(g) Consent to Sublease
and Site License . California Development, Inc. shall have
given its written consent to the Sublease and Holmgren Partners
shall have given its written consent to the Site
License.
SECTION 6.2
Conditions to Obligations of Anza . The obligation of
Anza to effect the Closing is subject to the satisfaction, at or
prior to the Closing, of each of the following conditions (any of
which may be waived by Anza in whole or in part):
(a) Representations,
Warranties and Covenants . The representations and warranties
of Cerus contained in this Agreement shall be true and correct as
of the Closing Date. Cerus shall have performed all agreements and
covenants required by this Agreement to be performed by it prior to
or on the Closing Date. Anza shall have received a certificate as
to satisfaction of the conditions set forth in this
Section 6.2(a) dated as of the Closing Date and executed by a
duly authorized officer of Cerus.
(b) No Actions or
Proceedings . No Action shall be pending or threatened by or
before any Governmental Authority challenging or seeking to make
illegal, to materially delay or otherwise to restrain or prohibit
the consummation of the transactions contemplated by this
Agreement.
(c) Resolutions of
Cerus . Anza shall have received a true and complete copy,
certified by the Secretary or an Assistant Secretary of Cerus, of
the resolutions duly and validly adopted by the board of directors
of Cerus evidencing its authorization of the execution and delivery
of the Transaction Documents and the consummation of the
transactions contemplated by this Agreement.
(d) Consents and
Approvals . Anza and Cerus shall have received, each in form
and substance satisfactory to Anza in its reasonable discretion,
all authorizations, consents, orders and approvals of all
Governmental Authorities that Anza in its reasonable discretion
deems necessary or desirable for the consummation of the
transactions contemplated by this Agreement.
(e) Anza Restated
Certificate . The Anza Restated Certificate shall have been
duly authorized, executed and filed with and accepted by the
Delaware Secretary of State.
(f) Documents
.
(i) Anza shall have received
from Cerus all of the documents, agreements and other Transferred
Assets set forth in Sections 2.7(e) and 5.16(e).
(ii) Anza shall have received
an opinion from Cooley Godward Kronish LLP, counsel to Cerus, in
the form attached hereto as Exhibit L .
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-28-
(iii) The Financing
Agreements shall have been executed and delivered by all of the
parties thereto, including Cerus, other than Anza.
(iv) David N. Cook, Ph.D.
shall have executed and delivered to Anza an Employment Agreement
in the form attached hereto as Exhibit M .
(v) Thomas W. Dubensky, Ph.D.
shall have executed and delivered to Anza an Employment Agreement
in the form attached hereto as Exhibit N .
(vi) The license agreements
between Cerus and The Johns Hopkins University (“ JHU
”) included among the Transferred Contracts shall have been
assigned to Anza and novated and amended and restated versions of
such agreements in the forms attached hereto as Exhibits O,
P, Q and R shall have been executed and delivered by JHU. It is
understood, however, that such novation shall not be deemed to
transfer to Anza any Retained Liabilities or to limit Cerus’
indemnification obligations with respect to the Retained
Liabilities pursuant to Section 7.2(a)(iii).
(vii) Anza shall have
received from Cerus executed Third Party consents to the assignment
of the Transferred Contracts listed on Exhibit S
.
(viii) Anza shall have
received from Cerus a document in “common technical document
(CTD)” format in English that is based upon Cerus’
planned regulatory filing in Australia with respect to the
manufacture of S-59 Psoralen.
(g) Consent to Sublease
and Site License . California Development, Inc. shall have
given its written consent to the Sublease and Holmgren Partners
shall have given its written consent to the Site
License.
ARTICLE VII
INDEMNIFICATION
SECTION 7.1
Survival of Representations and Warranties and Covenants
. The representations and warranties of Anza and Cerus contained in
this Agreement, and in any certificate or other instrument
delivered by Anza or Cerus pursuant to this Agreement (other than
the Supply Agreement), shall survive the Closing for a period of
[ * ] , unless otherwise expressly provided for in this
Agreement (the “ Survival Period ”), at which
time they shall terminate. Notwithstanding the foregoing, the
Survival Period for the representations and warranties in Sections
[ * ] of Exhibit C (the “ Surviving
Representations ”) shall survive the Closing for a period
of [ * ] , unless otherwise expressly provided for in this
Agreement. The covenants and agreements contained herein shall
survive following the Closing in accordance with their respective
terms. Following the expiration of the applicable Survival Period,
no Party shall make any claim for, or be subject to any Liabilities
in respect of, any breach of such representations and warranties
(except with respect to claims for indemnification for which
written notice of such claim, pursuant to Section 7.2(c)(i),
has been given prior to the expiration of the Survival
Period).
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-29-
SECTION 7.2
Indemnification .
(a) Indemnification by
Cerus . Cerus shall indemnify and hold harmless Anza and its
Affiliates, officers, directors, employees, agents, successors and
assigns (each, a “ Anza Indemnified Party ”)
from and against any and all liabilities, losses, damages, costs
and expenses, interest, awards, judgments and penalties (including,
without limitation, reasonable attorneys’ fees and expenses)
(collectively, “ Losses ”) suffered or incurred
by them arising out of or resulting from the following:
(i) the breach of any
representation or warranty made by Cerus contained in this
Agreement or in any certificate or other instrument delivered by
Cerus pursuant to this Agreement;
(ii) the breach of any
covenant or agreement by Cerus contained in this
Agreement;
(iii) the Retained
Liabilities solely to the extent that such Losses are
(A) incurred as a result of Third Party Claims made against a
Anza Indemnified Party with respect to such Retained Liability or
(B) directly incurred by Anza as a result of Anza’s
fulfillment of Cerus’ obligations under any Retained
Liability in the event that such fulfillment is reasonably required
for Anza to maintain or exercise the rights granted to it under
this Agreement; or
(iv) any claim by any current
or former Cerus employee or independent contractor directly arising
out of or resulting from the transactions contemplated by this
Agreement, including the termination of their employment or
independent contractor relationship with Cerus.
(b) Indemnification by
Anza . Anza shall indemnify and hold harmless Cerus and its
Affiliates, officers, directors, employees, agents, successors and
assigns (each a “ Cerus Indemnified Party ”)
from and against any and all Losses suffered or incurred by them
arising out of or resulting from the following:
(i) the breach of any
representation or warranty made by Anza contained in this Agreement
or in any certificate or other instrument delivered by Anza
pursuant to this Agreement;
(ii) the breach of any
covenant or agreement by Anza contained in this
Agreement;
(iii) the Assumed Liabilities
solely to the extent that such Losses are incurred as a result of
Third Party Claims made against a Cerus Indemnified Party with
respect to such Assumed Liability;
(iv) the practice of the
Transferred Intellectual Property or Licensed Intellectual Property
by or on behalf of Anza or its Affiliates or Licensees, solely to
the extent that such Losses are incurred as a result of Third Party
Claims made against a Cerus Indemnified Party and do not result
from a breach by Cerus of any representation or warranty;
or
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-30-
(v) the research,
development, manufacture, distribution, use, testing, promotion,
marketing, or sale or other disposition of a Covered Product by or
on behalf of Anza or its Affiliates or Licensees, solely to the
extent that such Losses are incurred as a result of Third Party
Claims made against a Cerus Indemnified Party and do not result
from a breach by Cerus of any representation or
warranty.
(c) Indemnification
Procedure .
(i) Whenever any Loss is
asserted against or incurred by a Anza Indemnified Party or Cerus
Indemnified Party (the “ Indemnified Party ”)
which the Indemnified Party has determined has given or could give
rise to a right of indemnification under this Agreement, the
Indemnified Party will give written notice thereof (a “
Claim ”) to the other Party (the “
Indemnifying Party ”). The Indemnified Party will
furnish to the Indemnifying Party in reasonable detail such
information as the Indemnified Party may have with respect to the
Claim. The failure to give such notice will not relieve the
Indemnifying Party of its indemnification obligations under this
Agreement, unless the failure to give such notice is materially
prejudicial to an Indemnifying Party’s ability to defend an
action by a Third Party giving rise to such Claim (a “
Third Party Claim ”).
(ii) In the case of a Third
Party Claim, within thirty (30) days after delivery of such
notice, the Indemnifying Party may, upon written notice thereof to
the Indemnified Party, and at its expense, undertake the defense of
such Third Party Claim with attorneys of its own choosing. In the
event that the Indemnifying Party does not assume control of such
defense, the Indemnified Party may undertake the defense of such
Third Party Claim.
(iii) The Party not
controlling such defense may participate therein at its own
expense, provided that if the Indemnifying Party assumes control of
such defense and the Indemnified Party reasonably concludes, based
on advice from counsel, that the Indemnifying Party and the
Indemnified Party have conflicting interests with respect to such
action, suit, proceeding or claim, the Indemnifying Party will be
responsible for the reasonable fees and expenses of counsel to the
Indemnified Party solely in connection therewith, provided further,
however, that in no event will the Indemnifying Party be
responsible for the fees and expenses of more than one counsel in
any one jurisdiction for all Indemnified Parties.
(iv) The Party controlling
such defense will keep the other Party advised of the status of
such action, suit, proceeding or claim and the defense thereof and
will consider recommendations made by the other Party with respect
thereto. As reasonably requested by, and at the expense of, the
Party controlling such defense, the other Party will cooperate in
such defense and make available to the Party controlling such
defense all witnesses, pertinent records, materials and information
in such other Party’s possession or under such other
Party’s control relating thereto.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-31-
(v) The Indemnified Party
will not agree to any settlement of such action, suit, proceeding
or claim without the prior written consent of the Indemnifying
Party, which will not be unreasonably withheld or delayed. The
Indemnifying Party will not consent to entry of any judgment or
enter into any settlement that admits fault on the part of the
Indemnified Party, except with the prior written consent of the
Indemnified Party, which consent will not be unreasonably withheld
or delayed. In the event that the Indemnified Party refuses to
consent to the entry of a judgment or a settlement for which the
Indemnifying Party is solely and entirely responsible and has
indicated its sole and entire responsibility in writing to the
Indemnified Party, following such refusal, the liability of the
Indemnifying Party to the Indemnified Party will be fixed at the
amount of any money damages provided in the proposed judgment or
settlement.
(d) Limitations on
Indemnification .
(i) The indemnification
provided in this Article VII shall be the sole and exclusive remedy
after the Closing for damages available to the Parties for breach
of any of the representations or warranties contained herein;
provided, however, this exclusive remedy for damages does not
preclude a Party from bringing an action for (A) fraud or
(B) specific performance or other equitable remedy to require
a Party to perform its obligations under this Agreement.
(ii) Notwithstanding anything
to the contrary herein, [ * ] provided that [ * ]
cured within [ * ] days after notice form [ * ] , the
aggregate Liability [ * ] under this Article VII for Losses
arising from or attributable to any breach of the representations
and warranties made by Cerus in this Agreement or any certificate
or other instrument delivered by Cerus pursuant to this Agreement
[ * ] shall be limited to $ [ * ] , provided,
however, that with respect to any such Losses in excess of $ [ *
] , Anza shall have the right to cause the forfeiture of,
and/or to offset such excess Losses against, the contingent
consideration otherwise payable pursuant to Sections 2.5(a)(iii),
(iv) and (v) in an amount equal to the specified amount
of such Losses.
(iii) UNDER NO CIRCUMSTANCES
WILL A PARTY BE LIABLE TO THE OTHER PARTY FOR LOST PROFITS, LOST
OPPORTUNITIES, OR ANY OTHER PUNITIVE, SPECIAL, OR CONSEQUENTIAL
DAMAGES IRRESPECTIVE OF THE THEORY UNDER WHICH SUCH ACTION IS
BROUGHT, WHETHER IT WAS CAUSED OR ALLEGEDLY CAUSED BY THE
NEGLIGENCE OF SUCH PARTY OR WHETHER OR NOT SUCH PARTY HAS BEEN
ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, [ * ]
OBLIGATIONS UNDER THIS AGREEMENT THAT IS NOT CURED [ * ]
AFTER NOTICE [ * ] . NOTWITHSTANDING THE FOREGOING, NOTHING
IN THIS SECTION 7.2(d)(iii) SHALL LIMIT OR RESTRICT A PARTY’S
INDEMNIFICATION OBLIGATION WITH RESPECT TO THIRD PARTY CLAIMS
PURSUANT TO THIS ARTICLE VII.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-32-
ARTICLE
VIII
MISCELLANEOUS
SECTION 8.1
Governing Law . This Agreement shall be governed by and
construed in accordance with the laws of the State of California
without regard to conflicts-of-laws principles that would require
the application of any other law.
SECTION 8.2
Amendment . This Agreement may not be amended, modified
or supplemented except by an instrument in writing signed by Cerus
and Anza.
SECTION 8.3
Expenses . All costs and expenses, including, without
limitation, fees and disbursements of counsel, financial advisors
and accountants, incurred in connection with this Agreement and the
Transaction hereby shall be paid by the Party incurring such costs
and expenses, whether or not the Closing shall have
occurred.
SECTION 8.4
Notices . All notices and other communications
hereunder shall be in writing and shall be deemed given if
delivered personally or by commercial messenger or courier service,
mailed by registered or certified mail (return receipt requested)
or sent via facsimile (with acknowledgment of complete
transmission) to the Parties at the following addresses (or at such
other address for a Party as shall be specified by like notice),
provided, however, that notices sent by mail shall not be deemed
given until received:
If to Anza, to:
Anza Therapeutics,
Inc.
2550 Stanwell
Drive
Concord, CA 94520
Attention: David N. Cook,
Ph.D.
Facsimile No.:
(925) 671-9272
with a copy (which shall not
constitute notice) to:
Wilson Sonsini
Goodrich & Rosati, P.C.
650 Page Mill Road
Palo Alto, CA
94304
Attention: Kenneth A.
Clark
Facsimile No.:
(650) 493-6811
If to Cerus, to:
Cerus Corporation
2411 Stanwell
Drive
Concord, CA 94520
Attention: Chief Legal
Officer
Facsimile No.:
(925) 288-6001
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-33-
with a copy (which shall not
constitute notice) to:
Cooley Godward Kronish
LLP
Five Palo Alto
Square
Palo Alto, CA
94306
Attention: Suzanne S.
Hooper
Facsimile No.:
(650) 849-7400
SECTION 8.5
Severability . In the event that any provision of this
Agreement or the application thereof becomes or is declared by a
court of competent jurisdiction to be illegal, void or
unenforceable, the remainder of this Agreement shall continue in
full force and effect and the application of such provision to
other persons or circumstances shall be interpreted so as
reasonably to effect the intent of the Parties. The Parties further
agree to replace such void or unenforceable provision of this
Agreement with a valid and enforceable provision that will achieve,
to the extent possible, the economic, business and other purposes
of such void or unenforceable provision.
SECTION 8.6 Entire
Agreement . This Agreement, along with the other
Transaction Documents and instruments delivered in connection
herewith, constitutes the entire agreement of the Parties with
respect to the subject matter hereof and supersedes all prior
agreements, representations, undertakings and understandings, both
written and oral, between Cerus and Anza with respect to the
subject matter hereof.
SECTION 8.7
Assignment . Subject to this Section 8.7, this
Agreement shall not be assignable by either Party to any Third
Party without the prior written consent of the other Party.
Notwithstanding the foregoing, either Party may assign this
Agreement, without the written consent of the other Party,
(a) to an Affiliate, provided that the assigning Party
guarantees the performance of this Agreement by such Affiliate, or
(b) to a successor to all or substantially all of such
assigning Party’s assets, stock or business to which this
Agreement relates (whether by stock purchase, asset purchase,
merger or otherwise), provided that any such assignee agrees in
writing to be bound by the terms of this Agreement. In addition,
Cerus may assign its right to receive payment hereunder to any
Third Party without the consent of Anza. Any assignment of this
Agreement in contravention of this Section 8.7 shall be null
and void.
SECTION 8.8 Delays
or Omissions . Except as expressly provided herein, no
delay or omission to exercise any right, power or remedy accruing
to any Party to this Agreement upon any breach or default of the
other Party under this Agreement shall impair any such right, power
or remedy of such non-defaulting Party, nor shall it be construed
to be a waiver of any such breach or default, or an acquiescence
therein, or of or in any similar breach or default thereafter
occurring, nor shall any waiver of any single breach or default be
deemed a waiver of any other breach or default theretofore or
thereafter occurring. Any waiver, permit, consent or approval of
any kind or character on the part of any Party of any breach or
default under this Agreement, or any waiver on the part
of
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-34-
any Party of any provisions or
conditions of this Agreement, must be in writing and shall be
effective only to the extent specifically set forth in such
writing. All remedies, either under this Agreement or by law or
otherwise afforded to any Party to this Agreement, shall be
cumulative and not alternative.
SECTION 8.9 No
Third Party Beneficiaries . This Agreement shall be binding
upon and inure solely to the benefit of the Parties and their
permitted successors and assigns, and nothing herein, express or
implied, is intended to or shall confer upon any other Person any
legal or equitable right, benefit or remedy of any nature
whatsoever under or by reason of this Agreement.
SECTION 8.10
Counterparts . This Agreement may be executed in
counterparts, all of which together shall constitute one and the
same instrument.
(The remainder of this
page is intentionally left blank.)
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-35-
In witness whereof, the
Parties hereto have caused this Agreement to be executed as of the
date first written above by their respective duly authorized
officers.
|
|
|
| ANZA THERAPEUTICS, INC. |
|
|
| By: |
|
/s/ David N. Cook
|
|
|
David N.
Cook, Ph.D. |
|
|
President
and Chief Executive Officer |
|
| CERUS CORPORATION |
|
|
| By: |
|
/s/ Claes Glassell
|
|
|
Claes
Glassell |
|
|
President
and Chief Executive Officer |
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
EXHIBIT
A
Definitions and
References
“ Abandoned
Patents ” shall have the meaning specified in
Section 5.20.
“ Act ”
shall have the meaning specified in
Section 5.10(d).
“ Action ”
shall mean any claim, action, suit, arbitration, proceeding or
investigation by or before any Governmental Authority.
“ Affiliate
” shall mean, with respect to any specified Person, any
corporation or other entity that directly, or indirectly through
one or more intermediaries, controls, is controlled by or is under
common control with such Person. As used in this definition,
“control” (including, with correlative meanings, the
terms “controlled by” and “under common control
with”) shall mean: (a) to possess, directly or
indirectly, the power to affirmatively direct the management and
policies of such corporation or other entity, whether through
ownership of voting stock or other ownership interest or by
contract relating to voting rights or corporate governance; or
(b) direct or indirect beneficial ownership of at least fifty
percent (50%) (or such lesser percentage which is the maximum
allowed to be owned by a foreign entity in a particular
jurisdiction) of the voting stock or other ownership interest in
such corporation or other entity.
“ Aggregate
Redemption Price ” shall have the meaning specified in
Section 5.16(c).
“ Agreement
” shall mean this Asset Transfer and License Agreement dated
as of November 20, 2007 and all amendments hereto made in
accordance with the provisions of Section 8.2.
“ Allocation
” shall have the meaning specified in
Section 2.5(b).
“ Anza ”
shall have the meaning specified in the first paragraph of this
Agreement.
“ Anza Disclosure
Schedule ” shall have the meaning specified in the first
paragraph of Article IV.
“ Anza Field of
Use ” shall mean the treatment and/or prevention of any
disease or condition [ * ] involving [ * ] , provided
that [ * ] within the Cerus Field of Use shall not
be within the Anza Field of Use. As used herein, it is understood
that [ * ] , in whole or in part, as an element of the [
* ] .
“ Anza Indemnified
Party ” shall have the meaning specified in
Section 7.2(a).
“ Anza Material
Adverse Effect ” shall mean any event, change or effect
that, when taken individually or together with all other events,
changes and effects, is or is reasonably likely (a) to be
materially adverse to the business or assets of Anza or (b) to
prevent or materially delay or impair the ability of Anza to
perform its obligations under this Agreement.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
“ Anza Restated
Certificate ” shall mean Anza’s Amended and
Restated Certificate of Incorporation in the form attached hereto
as Exhibit V .
“ Applicable
Period ” shall have the meaning specified in
Section 5.13(a).
“ Assignment and
Assumption Agreement ” shall mean the Assignment and
Assumption Agreement in the form attached hereto as
Exhibit U .
“ Assumed
Liabilities ” shall have the meaning specified in
Section 2.4(a).
“ Bill of Sale
” shall mean the Bill of Sale in the form attached hereto as
Exhibit W .
“ BLA ”
shall mean a Biological License Application, as more fully defined
in 21 C.F.R. §601.2 et. seq., or its successor
regulation.
“ Books and
Records ” shall mean all books, records, files,
documents, data, information and correspondence, including: all
records with respect to supply sources; all pre-clinical, clinical,
research and process development data, results and reports relating
to products or of any materials used in the research, development,
manufacture, marketing, sale or other commercialization of
products, including all raw data relating to clinical trials of
products, all case report forms relating thereto and all
statistical programs developed (or modified in a manner material to
the use or function thereof) to analyze clinical data; all market
research data, market intelligence reports, statistical programs
(if any) used for marketing, sales, research and/or development;
promotional, advertising and marketing materials, sales forecasting
models, medical education materials, sales training materials, web
site content and advertising and display materials; all records,
including vendor and supplier lists, manufacturing records,
sampling records (including retained samples), standard operating
procedures and batch records, related to manufacturing processes;
all laboratory notebooks relating to products or relating to their
biological, physiological, mechanical or other properties or
compositions; all invention disclosure forms; all adverse
experience reports and files related thereto (including source
documentation) and all periodic adverse experience reports and all
data contained in electronic databases relating to periodic adverse
experience reports; all analytical and quality control data; and
all correspondence, minutes or other communications with the FDA or
Foreign Regulatory Authorities.
“ Business
” shall mean the business and activities of Cerus and its
Affiliates related to the research, development, Regulatory
Approval, manufacture, distribution, marketing, sale, promotion
and/or other commercialization of [ * ] (except to the
extent such [ * ] , in humans or animals in any country of
the world.
“ Business
Contract ” shall have the meaning specified in
Section 8(a) of Exhibit C .
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-2-
“ Business Day
” shall mean any day that is not a Saturday, Sunday or other
day on which banks are required or authorized by Law to be closed
in the United States.
“ Business
Employees ” shall mean the employees of Cerus listed on
Exhibit X .
“ Business
Intellectual Property ” shall mean Intellectual Property
and Know-How that has been used in or is reasonably necessary to
conduct the Business as currently conducted or currently
contemplated by Cerus to be conducted.
“ Business
Products ” shall mean the products known as of the date
of this Agreement as CRS-100 and CRS-207.
“ Cerus ”
shall have the meaning specified in the first paragraph of this
Agreement.
“ Cerus Disclosure
Schedule ” shall have the meaning specified in the first
paragraph of Article III.
“ Cerus Field of
Use ” shall mean (a) (i) the ex vivo
treatment of blood supplies and blood products (including without
limitation plasma, platelets and/or red blood cells) to inactivate
pathogens and leukocytes in such blood supplies and blood products
and (ii) the use of such treated blood supplies and blood
products and products arising therefrom and (b) the ex
vivo [ * ] of leukocytes and use of such treated
leukocytes for immune response modulation for therapy or
prophylaxis.
“ Cerus Financing
Agreements ” shall mean, collectively, the Investor
Rights Agreement, the Voting Agreement and the Right of First
Refusal and Co-Sale Agreement.
“ Cerus Indemnified
Party ” shall have the meaning specified in
Section 7.2(c).
“ Cerus Material
Adverse Effect ” shall mean any event, change or effect
that, when taken individually or together with all other events,
changes and effects, is or is reasonably likely (a) to be
materially adverse to the Business or Transferred Assets or
(b) to prevent or materially delay or impair the ability of
Cerus to perform its obligations under this Agreement.
“ Charter
Documents ” shall mean, with respect to a business
entity, the certificate of incorporation, bylaws or other similar
governing instruments and organizational documents of such
entity.
“ Claim ”
shall have the meaning specified in
Section 7.2(c)(i).
“ Closing
” shall have the meaning specified in
Section 2.6.
“ Closing Date
” shall have the meaning specified in
Section 2.6.
“ Code ”
shall mean the Internal Revenue Code of 1986, as
amended.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-3-
“ Combination
Product ” shall have the meaning specified on
Exhibit B .
“ Commercial
Software Rights ” shall mean commercially available
software programs.
“ Competing Listeria
Product ” shall have the meaning specified in
Section 5.13(a).
“ Competing
Product ” shall have the meaning specified in
Section 5.13(a).
“ Computer
Equipment ” shall mean all of the equipment listed on
Exhibit Y.
“ Contract
” shall mean any and all written or legally binding oral
commitments, contracts, purchase orders, sales orders, leases,
subleases, licenses, easements, commitments, arrangements,
undertakings, evidence of indebtedness, security or pledge
agreements or other agreements.
“ Control
” (including any variations such as “ Controlled
” and “ Controlling ”), in the context of
intellectual property rights of a Party, shall mean that such Party
or its Subsidiary owns or possesses rights to intellectual property
sufficient to grant the applicable license, sublicense or access
(as appropriate) under this Agreement, without violating the terms
of any agreement with a Third Party existing at the time such Party
would first be required hereunder to grant such license, sublicense
or access.
“ Controlling
Party ” shall have the meaning specified in
Section 5.11(c).
“ Conversion
Shares ” shall mean the shares of Anza’s Common
Stock issuable upon conversion of the Series AA
Shares.
“ Covered KBMA
Product ” shall mean an immunotherapy product that [ *
] , the composition of matter, manufacture or use of which, at
some point during its commercialization is covered by [ * ]
.
“ Covered Listeria
Product ” shall mean an immunotherapy product that [ *
] , the composition of matter, manufacture or use of which at
some point during its commercialization is covered by [ * ]
. For clarity, a product that is a Covered Listeria Product shall
not also be a Covered KBMA Product.
“ Covered
Product ” shall mean a Covered KBMA Product or a Covered
Listeria Product.
“ Disclosing
Party ” shall have the meaning specified in
Section 5.8(a).
“ [ * ] Grant
” shall mean a grant, pursuant to a [ * ]
appropriation in the 2008 [ * ] , with respect to [ *
] vaccines or other technologies unique to Anza.
“ Effective Time
” shall mean the time at which the Closing is
consummated.
“ EMEA ”
shall mean the European Medicines Agency, or any successor
thereto.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-4-
“ Encumbrance
” shall mean any security interest, pledge, mortgage, lien
(including, without limitation, environmental and Tax liens),
charge, encumbrance or adverse claim or any restriction on use,
transfer or receipt of income.
“ Environmental
Law ” shall mean any Law and any judicial or
administrative interpretation thereof, including any judicial or
administrative order, consent decree, judgment, stipulation,
injunction, permit, authorization, policy, opinion or agency
requirement, in each case having the force and effect of Law,
relating to the pollution, protection, investigation or restoration
of the environment or health and safety as affected by the
environment or natural resources, including those relating to the
use, handling, presence, transportation, treatment, storage,
disposal, release, threatened release or discharge of Hazardous
Materials or noise, odor, wetlands, pollution or
contamination.
“ Equity
Financing ” shall mean a sale of a series of Anza’s
Preferred Stock in a transaction or series of related transactions
to investors for capital raising purposes with aggregate gross
proceeds of at least $ [ * ] , prior to and excluding an IPO
or other public offering of securities.
“ ERISA
Affiliate ” shall mean any other Person under common
control with Cerus within the meaning of Section 414(b), (c),
(m) or (o) of the Code and the regulations issued
thereunder.
“ Escrow Holder
” shall have the meaning specified in
Section 5.16(e).
“ Escrow Shares
” shall have the meaning specified in
Section 5.16(e).
“ Excluded Books and
Records ” shall mean (a) all Books and Records
related to human resources and any other employee related files and
records containing personal information regarding an employee;
(b) all Books and Records related solely to Licensed [ * ]
Patent Rights; and (c) all Books and Records comprising the
regulatory files related to the Intercept Blood System for
platelets, plasma and/or red blood cells, including without
limitation the [ * ] Regulatory Submissions.
“ FDA ”
shall mean the United States Food and Drug Administration and any
successor agency thereto.
“ FDA
Cross-Reference Letter ” shall mean a letter to be
executed by Cerus and addressed to the FDA stating that Anza has
certain rights to cross-reference the [ * ] Regulatory
Submissions, in substantially the form attached hereto as
Exhibit Z .
“ FDA Transfer
Letter ” shall mean a letter executed by Cerus and
addressed to the FDA stating that Anza has acquired the applicable
Transferred IND and has been designated as the sponsor for such
Transferred IND in connection with such acquisition, in
substantially the form attached hereto as Exhibit AA
.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-5-
“ Financing
Agreements ” shall mean, collectively, the Series A
Purchase Agreement, the Investor Rights Agreement, the Voting
Agreement and the Right of First Refusal and Co-Sale
Agreement.
“ First Commercial
Sale ” means the first bona fide commercial sale of a
Covered Product following issuance of all applicable Regulatory
Approvals (including, with respect to sales in the European Union,
an MAA) required prior to commercial sale in the applicable
country.
“ Foreign Regulatory
Authority ” shall mean any agency, commission, official
or other instrumentality of any foreign country or other foreign
political subdivision, including a notified body, that performs a
function for such country or political subdivision similar to the
function performed by the FDA for the United States.
“ Governmental
Authority ” shall mean any national, federal, state,
municipal, local or other government, governmental, regulatory or
administrative authority, agency or commission or any court,
tribunal, or judicial or arbitral body.
“ Governmental
Order ” shall mean any order, writ, judgment, injunction,
decree, stipulation, or award entered by or with any Governmental
Authority.
“ [ * ]
.
“ [ * ]
.
“ [ * ]
.
“ [ * ]
.
“ [ * ]
.
“ [ * ]
.
“ [ * ]
.
“ [ * ]
.
“ Hazardous
Materials ” shall mean (i) any petroleum, petroleum
products, byproducts or breakdown products, radioactive materials,
asbestos-containing materials or polychlorinated biphenyls or
(ii) any chemical, material or other substance defined or
regulated as toxic or hazardous or as a pollutant or contaminant or
waste under any Environmental Law.
“ Holdback
Shares ” shall mean [ * ] of the Series AA
Shares.
“ ICH ”
shall mean The International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for
Human Use.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-6-
“ Indemnified
Party ” shall have the meaning specified in
Section 7.2(c)(i).
“ Indemnifying
Party ” shall have the meaning specified in
Section 7.2(c)(i).
“ Infringement
” shall have the meaning specified in
Section 5.11(a).
“ Infringement
Action ” shall have the meaning specified in
Section 5.11(c).
“ Initial S-59
Psoralen Supply ” shall mean [ * ] of GMP S-59
Psoralen from Cerus’ research and development stock of such
material.
“ Intellectual
Property ” shall mean any or all of the following and all
statutory and/or common law rights throughout the world in, arising
out of or associated with any or all of the following:
(a) Patent Rights, (b) the protection of trade and
industrial secrets and confidential information, and (c) any
similar, corresponding or equivalent rights to any of the
foregoing, including priority rights and the right to enforce and
recover remedies for any of the foregoing.
“ Investor Rights
Agreement ” shall mean the Investor Rights Agreement by
and among Anza and the stockholders named therein in the form
attached hereto as Exhibit AB .
“ IPO ”
shall mean an underwritten initial public offering pursuant to an
effective registration statement filed under the Securities Act
covering the offer and sale of Anza’s Common
Stock.
“ JAMS ”
shall have the meaning specified on Exhibit B
.
“ JHU ”
shall have the meaning specified in
Section 6.2(f)(vi).
“ Know-How
” shall mean any information related to the research,
manufacture, preparation, development or commercialization of a
product or technology, including, without limitation, product
specifications, processes, product designs, plans, trade secrets,
ideas, concepts, inventions, formulae, chemical, pharmacological,
toxicological, pharmaceutical, physical, analytical, stability,
safety, quality assurance, quality control and clinical data,
technical information, research information and other confidential
or proprietary technical and business information, whether or not
embodied in any documentation or other tangible materials. If
Know-How is embodied in tangible materials, including biological
materials, chemical compounds or the like, such tangible materials
shall be deemed included within the Know-How.
“ Knowledge
” (a) with respect to Cerus shall mean the knowledge of
officers (at the vice president level and above) or directors of
Cerus with responsibility for, or supervision of, the relevant
matters, and (b) with respect to Anza shall mean the knowledge
of officers (at the vice president level and above) or directors of
Anza with responsibility for, or supervision of, the relevant
matters.
“ Law ”
shall mean any national, federal, state, municipal or local or
other statute, law, ordinance, regulation, rule, code, order, other
requirement or rule of law.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-7-
“ Liabilities
” shall mean any and all debts, liabilities and obligations,
whether accrued or fixed, absolute or contingent, matured or
unmatured or determined or determinable, including, without
limitation, those arising under any Law (including, without
limitation, any environmental Law), Action or Governmental Order
and those arising under any contract, agreement, arrangement,
commitment or undertaking.
“ Licensed
Intellectual Property ” shall mean the Licensed [ *
] Patent Rights and the Licensed Know-How.
“ Licensed
Know-How ” shall mean all Know-How Controlled by Cerus as
of the Closing Date, or Controlled by Cerus after the Closing Date
and required to be provided to Anza under Section 5.3 or 5.4,
in each case that is related to and/or used in connection with
(a) Cerus’ technology for [ * ] , but [ *
] or (b) Cerus’ technology for [ * ] ,
including the information and items described on
Exhibit AC .
“ Licensed [ * ]
Patent Rights ” shall mean: (a) the Patent
Rights listed on Exhibit AD-1 ; (b) reissues,
patents of addition, divisions, renewals, continuations,
continuations-in-part, substitutions, extensions (including
supplemental protection certificates), registrations,
confirmations, re-examinations and foreign counterparts of the
Patent Rights listed on Exhibit AD-1 , in each case
solely to the extent directed to the subject matter of the Patent
Rights listed on Exhibit AD-1 ; and (c) the Patent
Rights listed on Exhibit AD-2 and reissues, patents of
addition, divisions, renewals, continuations,
continuations-in-part, substitutions, extensions (including
supplemental protection certificates), registrations,
confirmations, re-examinations and foreign counterparts of the
Patent Rights listed on Exhibit AD-2 , in each case (in
the case of this clause (c)) solely with respect to those claims of
such Patent Rights that are not limited (expressly or otherwise) to
[ * ] . The Parties acknowledge that, as of the
Effective Time, all of the claims of the Patent Rights listed on
Exhibit AD-2 are limited to [ * ] .
“ Licensee
” shall mean a Third Party to whom Anza has granted the right
(a) to sell, market and/or promote one or more Covered
Products or (b) to practice the Transferred Intellectual
Property or Licensed Intellectual Property. As used in this
Agreement, “Licensee” shall (i) include a
distributor of a Covered Product which has responsibility for
marketing and promotion of such Covered Product within its
distribution territory and (ii) not include a wholesaler or
reseller of a Covered Product which is not responsible for
marketing and promotion of such Covered Product.
“ Liquidity
Event ” shall mean: (i) the acquisition of Anza by
another entity by means of any transaction or series of related
transactions to which Anza is party (including, without limitation,
any stock acquisition, reorganization, merger or consolidation but
excluding any sale of stock for capital raising purposes) other
than a transaction or series of related transactions in which the
holders of the voting securities of Anza outstanding immediately
prior to such transaction or series of related transactions retain,
immediately after such transaction or series of transactions, as a
result of shares in Anza held by such holders prior to such
transaction, at least a majority of the total voting power
represented by the outstanding voting securities of Anza or such
other surviving or resulting entity (or if Anza or such other
surviving or resulting entity is a wholly-owned subsidiary
immediately
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
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DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-8-
following such acquisition, its parent);
(ii) a sale, lease or other disposition of all or
substantially all of the assets of Anza and its Subsidiaries taken
as a whole by means of any transaction or series of related
transactions, except where such sale, lease or other disposition is
to a wholly-owned subsidiary of Anza; (iii) any liquidation,
dissolution or winding up of Anza, whether voluntary or
involuntary; or (iv) the redemption or repurchase of shares
representing a majority of the outstanding voting power of
Anza.
“ Listeria-Specific
Period ” shall have the meaning specified in
Section 5.13(a).
“ Losses ”
shall have the meaning specified in Section 7.2(a).
“ MAA ”
shall mean a Marketing Authorisation Application or a successor
filing with the EMEA for purposes of obtaining marketing approval
in the European Union.
“ Major Market
Claim ” means a Valid Claim in the Licensed [ * ]
Patent Rights or the Transferred Patent Rights [ * ] . For
the purposes of determining the number of Major Market Claims, [
* ] .
“ [ * ] ”
shall mean cash milestone payments payable [ * ] to Anza
under the [ * ] for the achievement of a research,
development or commercialization event with respect to a Covered
Product, in each case less (i) the amount of any withholding
Taxes or other amounts that are deducted from the amount paid to
Anza and not subsequently received by or credited to Anza and
(ii) the amount of research and development expenses incurred
by Anza, after the [ * ] and before the date of achievement
of such event, in the course of Anza’s performance of its
obligations under the [ * ] pursuant to a research or
development plan in the program for which the milestone is met, to
the extent that such expenses (1) have not been reimbursed by
and are not eligible for reimbursement [ * ] or any Third
Party and (2) have not been previously deducted from other
milestone payments. For the avoidance of doubt, [ * ] shall
exclude any up-front payments, license issuance fees, license
renewal, maintenance or similar fees, amounts paid for the purchase
of equity securities from Anza (to the extent the amount for such
equity purchase does not exceed the fair market value of such
equity), royalties or similar amounts payable as a percentage of
net sales, gross sales or profits, bona fide loans made [ *
] to Anza, payments for internal and external research,
development, manufacturing and/or commercialization activities
(including costs for reagents, materials and equipment, salaries,
patent costs and other administration and overhead costs) and
amounts paid for the sale of all or substantially all of the
business or assets of Anza (whether by merger, sale of stock, sale
of assets or otherwise). Notwithstanding the foregoing, premiums
paid in excess of fair market value in connection with the purchase
of equity securities from Anza shall be included among [ * ]
, provided that such amounts are paid upon the achievement of a
research, development or commercialization event as described above
and are not paid as up-front payments, license issuance fees or
otherwise.
“ Net Sales
” shall mean the gross amounts actually received by Anza, its
Affiliates or Licensees from sales of Covered Products to Third
Party customers, less reasonable and customary deductions for any:
(i) credits, allowances, samples, discounts and rebates
actually given to such
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-9-
customers (including those granted to
managed-care entities, entities that manage patient drug benefits
and government agencies, as well as on account of rejections or
returns); (ii) freight and insurance costs to the extent
incurred by Anza or its Affiliates or Licensees with respect to
Covered Products and itemized in the invoice provided to such
customers; (iii) trade, quantity or cash discounts actually
given; (iv) retroactive price reductions actually given; and
(v) sales, value-added and other direct Taxes (including
customs, duties and other similar governmental charges) collected
by Anza, its Affiliates or Licensees directly in connection with
the sale of Covered Products to Third Party customers. Sales among
Anza and its Affiliates or Licensees for resale shall be excluded
from the computation of Net Sales, provided that the subsequent
resale shall be included in Net Sales hereunder. Transfers to
Licensees or others for use solely in clinical trials or other
research or development activities, or for amounts less than the
direct manufacturing costs therefor as described in
Section 2(c) of Exhibit B , shall not be deemed a sale
for purposes of calculating Net Sales.
“ Non-Assignable
Asset ” shall have the meaning specified in
Section 2.2(a).
“ Non-Paying
Party ” shall have the meaning specified in
Section 5.14(a)(iii).
“ Ordinary Course of
Business ” means an action or activity that is consistent
in nature, scope and magnitude with the past practices of Cerus
with respect to the ongoing conduct of the Business.
“ Party ”
and “ Parties ” shall have the meaning specified
in the first paragraph of this Agreement.
“ Patent Assignment
Agreement ” shall mean the Patent Assignment Agreement in
the form attached hereto as Exhibit AE .
“ Patent Rights
” shall mean all patents and patent applications (including
provisional applications), and all patents issuing thereon
(including utility, model and design patents and certificates of
invention), together with all reissue patents, patents of addition,
divisions, renewals, continuations, continuations-in-part,
substitutions, extensions (including supplemental protection
certificates), registrations, confirmations, re-examinations and
foreign counterparts of any of the foregoing.
“ Paying Party
” shall have the meaning specified in
Section 5.14(a)(iii).
“ Person ”
shall mean an individual, partnership, corporation, association,
joint venture, trust, unincorporated organization or governmental
entity (or any department, agency or political subdivision
thereof).
“ Pharmacovigilance
Agreement ” shall have the meaning specified in
Section 5.3(c).
“ Phase III Clinical
Trial ” shall mean a human clinical trial, the principal
purpose of which is to establish safety and efficacy in patients
with the disease being studied, as further described in
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-10 -
21 C.F.R. §312.21(c) or its
successor regulation, or which is designed and intended to be of a
size and statistical power sufficient to serve as a pivotal study
to support the filing of an NDA or MAA for the indication being
studied.
“ [ * ] Regulatory
Submissions ” shall have the meaning specified in
Section 5.3(a).
“ Pre-Closing Tax
Period ” means any Tax period ending on or before the
Closing Date and the portion of any Straddle Period ending on the
Closing Date.
“ Prior
Agreement ” shall have the meaning specified in
Section 5.8(a).
“ Properties
” shall have the meaning specified in Section 13(a) of
Exhibit C .
“ Proprietary
Information ” shall have the meaning specified in
Section 5.8(a).
“ Prosecution and
Maintenance ” shall mean, with respect to any patent or
patent application, the preparing, filing, prosecuting and
maintenance of such patent or patent application, as well as
re-examinations, reissues, requests for patent term extensions and
the like with respect to such patents, together with the conduct of
interferences, the defense of oppositions and other similar
proceedings with respect thereto, and “ Prosecute and
Maintain ” shall have the correlative meaning.
“ PTO ”
shall mean the United States Patent and Trademark
Office.
“ Receiving
Party ” shall have the meaning specified in
Section 5.8(a).
“ Redemption
Date ” shall have the meaning specified in
Section 5.16(b).
“ Redemption
Notice ” shall have the meaning specified in
Section 5.16(b).
“ Redemption
Option ” shall have the meaning specified in
Section 5.16(a).
“ Redemption
Price ” shall have the meaning specified in
Section 5.16(a).
“ Redemption
Shares ” shall have the meaning specified in
Section 5.16(b).
“ Registered
Business Intellectual Property ” shall mean Registered
Intellectual Property that has been used in or is reasonably
necessary to conduct the Business as currently conducted or
currently contemplated by Cerus to be conducted.
“ Registered
Intellectual Property ” shall mean Intellectual Property
that has been registered, filed, certified or otherwise perfected
or recorded with or by any Governmental Authority anywhere in the
world.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-11 -
“ Regulatory
Approval ” shall mean all approvals, licenses,
registrations or authorizations of all Governmental Authorities in
a country for the manufacture, use, storage, import, marketing and
sale of a product in such country, including any pricing and
reimbursement approvals.
“ Required
Permits ” shall have the meaning specified in
Section 6(a) of Exhibit C .
“ Restricted
Affiliate ” shall have the meaning specified in
Section 5.13(a).
“ Retained
Liabilities ” shall have the meaning specified in
Section 2.4(b).
“ Right of First
Refusal and Co-Sale Agreement ” shall mean the Right of
First Refusal and Co-Sale Agreement by and among Anza and the
stockholders named therein in the form attached hereto as
Exhibit AF .
“ Royalty-Bearing
Covered Product ” shall have the meaning specified on
Exhibit B .
“ Rule 144
” shall have the meaning specified in Section 17(h) of
Exhibit C .
“ Securities Act
” shall mean the Securities Act of 1933, as
amended.
“ Selected
Contracts ” shall mean those Transferred Contracts that
are not mutual or unilateral nondisclosure agreements.
“ Series A
Purchase Agreement ” shall mean the Series A
Preferred Stock Purchase Agreement by and among Anza and the
stockholders named therein in the form attached hereto as
Exhibit AH .
“ Series AA
Shares ” shall have the meaning specified in
Section 2.5(a)(ii).
“ Site License
” shall mean the Single Site License between the Parties in
the form attached hereto as Exhibit AI .
“ Straddle
Period ” means any Tax period beginning on or before and
ending after the Closing Date.
“ Straddle Period
Tax ” shall have the meaning specified in
Section 5.14(a)(iii).
“ Sublease
” shall mean the Sublease between the Parties in the form
attached hereto as Exhibit AJ .
“ Subsidiary
” shall mean any corporation or other entity, whether or not
existing on the date hereof, in which the Anza or Cerus, as the
context requires, directly or indirectly through subsidiaries or
otherwise, beneficially owns at least fifty percent (50%) of
either the equity interest or voting power of or in such
corporation or other entity.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-12-
“ Supply
Agreement ” shall mean the Supply Agreement by and
between the Parties of even date herewith in the form attached
hereto as Exhibit AK .
“ Survival
Period ” shall have the meaning specified in
Section 7.1.
“ Surviving
Representations ” shall have the meaning specified in
Section 7.1.
“ Tax ” or
“ Taxes ” shall mean: (i) any and all
federal, state, local and foreign taxes, assessments and other
governmental charges, duties, impositions and liabilities,
including taxes based upon or measured by gross receipts, income,
profits, sales, use and occupation, and value added, ad valorem,
transfer, franchise, withholding, payroll, recapture, employment,
excise and property taxes, together with all interest, penalties
and additions imposed with respect to such amounts; (ii) any
liability for the payment of any amounts of the type described in
clause (i) as a result of being or ceasing to be a member of
an affiliated, consolidated, combined or unitary group for any
period (including, without limitation, any liability under Treas.
Reg. Section 1.1502-6 or any comparable provision of foreign,
state or local law); and (iii) any liability for the payment
of any amounts of the type described in clause (i) or
(ii) as a result of any express or implied obligation to
indemnify any other Person or as a result of any obligations under
any agreements or arrangements with any other Person with respect
to such amounts and including any liability for taxes of a
predecessor entity.
“ Tax Return
” shall mean any return, declaration, estimate, report, claim
for refund or information return or statement relating to Taxes,
including any schedule or attachment thereto, and including any
amendment thereof.
“ Term Sheet
” shall mean the Summary of Terms for Investment in Anza,
Inc. executed by each of Cerus, Sofinnova Ventures, Kleiner Perkins
Caufield & Byers and Versant Ventures on or about
August 22, 2007.
“ Third Party
” means any Person other than Anza, Cerus or their respective
Affiliates.
“ Third Party
Claim ” shall have the meaning specified in
Section 7.2(c)(i).
“ Time from First
Commercial Sale ” shall have the meaning specified in
Section 2.5(a)(v)(3).
“ Transaction
Documents ” shall mean, collectively, this Agreement, the
Supply Agreement, the Transition Services Agreement, the Sublease,
the Site License, the Bill of Sale, the Assignment and Assumption
Agreement and the Patent Assignment Agreement.
“ Transferred
Assets ” shall have the meaning specified in
Section 2.1.
“ Transferred Books
and Records ” shall mean (a) originals of all of the
Books and Records that are solely related to the Business and
Controlled by Cerus, but excluding the Excluded Books
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-13-
and Records, provided that Cerus shall
be permitted to retain, solely for archival purposes, one
(1) copy of (i) any legal (including regulatory but
excluding Intellectual Property) or financial records within the
Transferred Books and Records as required by law or as may be
required to protect Cerus’ legitimate business interests
consistent with this Agreement, (ii) any Transferred
Contracts, that Cerus is required by law to retain or as may be
required to protect Cerus’ legitimate business interests
consistent with this Agreement; and (b) copies of any Books
and Records Controlled by Cerus that relate to the Business and to
other businesses or assets of Cerus, but excluding the Excluded
Books and Records, provided , that Cerus shall have the
right to redact from such copies information to the extent such
information does not relate to Business.
“ Transferred
Contracts ” shall mean those contracts listed on
Exhibit AL .
“ Transferred
Grants ” shall mean the grants listed on
Exhibit AM .
“ Transferred
INDs ” shall mean, collectively, (i) Investigational
New Drug Application Numbered [ * ] filed with the FDA on [ * ] and
effective as of [ * ] and (ii) Investigational New Drug
Application Numbered [ * ] filed with the FDA on [ * ] and
effective as of [ * ].
“ Transferred
Intellectual Property ” shall mean the Transferred Patent
Rights and the Transferred Know-How.
“ Transferred
Know-How ” shall mean all Know-How owned and Controlled
by Cerus as of the Closing Date that (a) is or has been used
in the Business, including the information listed on
Exhibit AN and all intellectual property rights in any
inventions or other subject matter within such Know-How, to the
extent not included in the Transferred Patent Rights or the
Licensed [ * ] Patent Rights, and (b) is not Licensed
Know-How.
“ Transferred Patent
Rights ” shall mean (a) the Patent Rights listed on
Exhibit AO and (b) reissues, patents of addition,
divisions, renewals, continuations, continuations-in-part,
substitutions, extensions (including supplemental protection
certificates), registrations, confirmations, re-examinations and
foreign counterparts of such Patent Rights.
“ Transferred
Regulatory Submissions ” shall mean the Transferred INDs,
and all files and records related thereto in Cerus’ Control
as of the Closing Date.
“ Transferred
Tangible Assets ” shall mean all tangible assets listed
on Exhibit AP .
“ Transfer Taxes
” shall have the meaning specified in
Section 2.5(c).
“ Transition
Services Agreement ” shall mean the Transition Services
Agreement in the form attached hereto as Exhibit AQ
.
“ Valid Claim
” shall mean (i) a claim of an issued and unexpired
patent (including all supplemental protection certificates issued
thereon) within the Transferred Patent Rights or the
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-14-
Licensed [ * ] Patent Rights,
that has not been held un-patentable, invalid or unenforceable by a
court or other government agency of competent jurisdiction from
which no appeal can be taken or for which no appeal was filed
during the time therefor or has not been admitted to be invalid or
unenforceable through reissue, re-examination, disclaimer or
otherwise; or (ii) a claim of a pending patent application,
which claim has been pending less than [ * ] years from the
date such claim takes priority for filing purposes, unless or until
such claim thereafter issues as a claim of an issued patent (from
and after which time the same shall be deemed a Valid Claim subject
to clause (i) above).
“ Voting
Agreement ” shall mean the Voting Agreement by and among
Anza and the stockholders named therein in the form attached hereto
as Exhibit AR .
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-15-
EXHIBIT
B
Royalties
1. Royalty Rates
.
(a) First Covered KBMA
Product . Subject to the terms and conditions of the Agreement,
Anza shall pay to Cerus royalties at the rate of [ * ]
percent ( [ * ] %) of Net Sales of the first Covered KBMA
Product that is sold commercially by or under authority of Anza or
its Affiliate or Licensee.
(b) [ * ] Covered
Listeria Products . Subject to the terms and conditions of the
Agreement, Anza shall pay to Cerus royalties on the combined Net
Sales of the [ * ] Covered Listeria Products that are sold
commercially by or under authority of Anza or its Affiliate or
Licensee at the following rates:
|
|
|
|
Combined Annual Net Sales
of the [ * ]
Covered Listeria
Products
|
|
Royalty
Rate
|
| Portion up
to and including $ [ * ] |
|
[ *
] % of such Net Sales |
|
|
| Portion
above $ [ * ] |
|
[ *
] % of such Net Sales |
Each Covered KBMA Product and
Covered Listeria Product bearing royalties pursuant to this
Section 1 is referred to herein as a “
Royalty-Bearing Covered Product .” For clarity, it is
understood that in no case shall royalties apply or be owed
hereunder with respect to more than [ * ] Covered KBMA [
* ] or more than [ * ] Covered Listeria [ * ]
.
(c) Major Market
Claims . With respect to any Royalty-Bearing Covered Product
the composition of matter, manufacture or method of use of which is
not covered by any Valid Claims in the country of sale, but is
covered by at least [ * ] Major Market Claims, then
Anza’s obligation to pay royalties under this Section 1
with respect to sales of such Royalty-Bearing Covered Product in
such country of sale [ * ] .
2. Certain Additional
Terms .
(a) Third Party
Payments . If Anza or its Affiliate or Licensee becomes
obligated to pay a Third Party royalties with respect to a
Royalty-Bearing Covered Product under any agreement (including a
Transferred Contract) to license or acquire intellectual property
rights which cover or are used in a Royalty-Bearing Covered
Product, then Anza may deduct [ * ] percent ( [ * ]
%) of the royalties paid to such Third Party from the royalties
payable to Cerus with respect to such Royalty-Bearing Covered
Product pursuant to Section 1 above, provided that in no event
shall the amounts paid to Cerus pursuant to Section 1 above
with respect to such
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
Royalty-Bearing Covered Product in any
reporting period be reduced by the combination of this clause
(a) and Section 5.10(b) of the Agreement to less than
[ * ] percent ( [ * ] %) of the amount that would
otherwise be payable to Cerus. Notwithstanding the foregoing, in
the case of a royalty paid to a Third Party in connection with a
Royalty-Bearing Covered Product that is a Combination Product under
Section 2(b) below, where such royalty is based upon
intellectual property rights that cover only the independently
therapeutically active product or ingredient sold in combination
with such Royalty-Bearing Covered Product, such royalty shall not
be deductible pursuant to this Section 2(a).
(b) Combination
Products . In the event that a Royalty-Bearing Covered Product
is sold for a single price in combination with another
independently therapeutically active product, or as a
co-formulation with another independently therapeutically active
ingredient (including, in each case, any adjuvant), for which no
royalty would be due hereunder if sold separately (a “
Combination Product ”), the Net Sales from such
Combination Product for purposes of calculating the amounts payable
by Anza to Cerus under Section 1 above shall be calculated by
multiplying the Net Sales of the Combination Product by the
fraction A/(A + B), where A is the average gross selling price
during the same calendar quarter of a Covered Product that differs
from such Combination Product solely in that it does not contain
such independently therapeutically active product or ingredient,
and B is the average gross selling price during such calendar
quarter of such other therapeutically active product or ingredient.
For the purposes of this Section 2(b), no antigen expressed in
a Covered Product shall be considered independently therapeutically
active. In the event that separate sales of such Covered Product or
such other therapeutically active product or ingredient were not
made during the previous calendar quarter, the Net Sales from such
Combination Product shall be reasonably allocated between such
Covered Product and such other therapeutically active product or
ingredient, based upon their relative values. If the Parties cannot
agree upon such allocation, then such dispute shall, upon written
notice of either Party to the other Party, be referred for
resolution by final, binding arbitration in accordance with the
following provisions:
(i) The arbitration shall be
conducted by the Judicial Arbitration and Mediation Services, Inc.
(or any successor entity thereto) (“ JAMS ”)
under its rules of arbitration then in effect, except as modified
herein. The arbitration shall be conducted in the English language,
by a single arbitrator. The arbitrator shall engage an independent
expert with experience in the subject matter of the dispute to
advise the arbitrator. The Parties and the arbitrator shall use all
reasonable efforts to complete any such arbitration within six
(6) months from the issuance of notice of a referral of any
such dispute to arbitration. The arbitrator shall determine what
discovery shall be permitted, consistent with the goal of limiting
the cost and time which the Parties must expend for discovery,
provided that the arbitrator shall permit such discovery as he or
she deems necessary to permit an equitable resolution of the
dispute.
(ii) The Parties agree that
the decision of the arbitrator shall be the sole, exclusive and
binding remedy between them regarding the dispute presented to the
arbitrator. Any decision of the arbitrator may be entered in a
court of competent jurisdiction for judicial recognition of the
decision and an order of enforcement. The arbitration proceedings
and the decision of the arbitrator shall be deemed Proprietary
Information of the Parties under the Agreement.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-2-
(iii) Unless otherwise
mutually agreed upon by the Parties, the arbitration proceedings
shall be conducted in San Francisco, California. The Parties agree
that they shall share equally the cost of the arbitration filing
and hearing fees, the cost of the independent expert retained by
the arbitrator and the cost of the arbitrator and administrative
fees of JAMS. Each Party shall bear its own costs and
attorneys’ and witnesses’ fees and associated costs and
expenses.
(c) One Royalty . No
more than one royalty payment shall be due under the Agreement with
respect to a sale of a particular Royalty-Bearing Covered Product
(e.g., even if such Royalty-Bearing Covered Product is covered by
multiple Valid Claims). No royalty shall be payable under the
Agreement with respect to any Royalty-Bearing Covered Products sold
by Anza or its Affiliates or Licensees for [ * ] therefor,
which [ * ] shall not include [ * ] .
3. Royalty Term
.
(a) With respect to a
Royalty-Bearing Covered Product the composition of matter,
manufacture or method of use of which is covered by one or more
Valid Claims in the country of sale, Anza’s obligation to pay
royalties under Section 1 above shall continue with respect to
sales of such Royalty-Bearing Covered Product in such country of
sale until the later of (i) expiration of the last Valid Claim
so covering such Royalty-Bearing Covered Product or its manufacture
or use in such country or (ii) the [ * ] anniversary of the
First Commercial Sale of such Royalty-Bearing Covered Product in
such country of sale. Thereafter, no further royalties shall be due
with respect to such Royalty-Bearing Covered Product in such
country of sale.
(b) With respect to a
Royalty-Bearing Covered Product the composition of matter,
manufacture or method of use [ * ], Anza’s obligation to pay
royalties under Section 1 above with respect to sales of such
Royalty-Bearing Covered Product [ * ] shall continue until [ * ]
such Royalty-Bearing Covered Product [ * ]. Thereafter, no further
royalties shall be due with respect to such Royalty-Bearing Covered
Product [ * ].
(c) Notwithstanding the
foregoing, Anza’s obligation to pay royalties under
Section 1 above with respect to sales of a Royalty-Bearing
Covered Product in a particular country shall terminate [ *
] in which there is Generic Competition with respect to such
Royalty-Bearing Covered Product in such country. For purposes of
this Section 3, “ Generic Competition ”
with respect to a Royalty-Bearing Covered Product in a country
shall be deemed to exist in any [ * ] in which:
(i) there are [ * ] in such country that cover the
composition of matter, manufacture or use of such Royalty-Bearing
Covered Product, (ii) one or more Generic Versions (as defined
below) of such Royalty-Bearing Covered Product are being marketed
in such country and (iii) such Generic Version(s) represent a
total prescription unit volume of at least [ * ] percent (
[ * ] %) of the prescription volume of such Royalty-Bearing
Covered Product in such country in such [ * ] (as measured
by a [ * ] or any other independent pharmaceutical sales
auditing firm reasonably agreed upon by the Parties); and “
Generic Version ” shall mean a
non-proprietary
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-3-
product that: (x) is substantially
identical to the Royalty-Bearing Covered Product, including active
pharmaceutical ingredient and formulation, (y) obtained
Regulatory Approval solely by establishing equivalence to the
Royalty-Bearing Covered Product, without a requirement to conduct
any clinical trials regarding the efficacy of such product, and
(z) is legally marketed in such country by an entity other
than Anza, its Affiliates or its Licensees.
4. Payments
.
(a) Royalty Payment
Terms . Anza shall pay to Cerus the royalties described in
Section 1 above no later than sixty (60) days after the
end of the calendar quarter in which the applicable Net Sales were
received.
(b) Payment Method .
All payments by one Party to the other Party under the Agreement
shall be paid in United States Dollars. If any currency conversion
shall be required in connection with the payment of any royalties
under the Agreement, such conversion shall be made by using the
exchange rate for United States Dollars reported by The Wall Street
Journal (United States, Western Edition) on the last Business Day
of the calendar quarter to which such royalty payments
relate.
(c) Exchange Control .
If at any time legal restrictions prevent the prompt remittance of
part or all royalties with respect to any country where a
Royalty-Bearing Covered Product is sold, Anza shall make such
payments by depositing, or causing to be deposited, the amount of
such payments in local currency to Cerus’ account in a bank
or other depository designated by Cerus in such country.
(d) Overdue Payments .
In the event any royalty or milestone payment payable by Anza to
Cerus under the Agreement is not made when due, such outstanding
payment shall accrue interest (from the date such payment is due
through and including the date upon which full payment is made) at
the prime rate as reported by the Chase Manhattan Bank, New York,
New York on the date such payment is due, plus an additional [ *
] percent ( [ * ] %) (or the maximum rate permitted by
applicable law).
(e) Withholding Taxes
. Anza shall be entitled to deduct from any payment due to Cerus
under the Agreement the amount of any withholding Taxes payable on
the amounts owing to Cerus hereunder that Anza is required to
withhold. Anza shall use good faith efforts to cooperate with Cerus
to minimize any such Taxes required to be withheld. Anza shall
promptly deliver to Cerus proof of payment of all such Taxes,
together with copies of all communications from or with any
Governmental Authority with respect thereto. Cerus shall provide
Anza with all forms or documentation required to evidence such
withholding under applicable taxation laws, treaties or agreements
applying to such withholding or as necessary to claim a
benefit.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-4-
5. Reports, Records and
Accounting .
(a) Reports .
Commencing upon the First Commercial Sale in any country of a
Royalty-Bearing Covered Product, Anza shall furnish to Cerus a
written report for each calendar quarter during the term of the
Agreement showing, on a country-by-country basis:
(i) the gross sales of all
Royalty-Bearing Covered Products sold by Anza, its Affiliates and
Licensees during such calendar quarter and the calculation of Net
Sales, in United States Dollars, of the Royalty-Bearing Covered
Products from such gross sales;
(ii) the calculation of
royalties owed to Cerus upon such Net Sales of the Royalty-Bearing
Covered Products;
(iii) the withholding Taxes,
if any, required by law to be deducted in respect of such
royalties;
(iv) the date of the First
Commercial Sale of each Royalty-Bearing Covered Product in each
applicable country;
(v) the exchange rates, if
any, used in determining the amount of Net Sales in United States
Dollars, as more specifically provided in Section 4(b) above;
and
(vi) any reductions to or
deductions from royalty payments taken by Anza pursuant to
Section 2(a), (b) and/or (c) above and/or
Section 5.10(b) of the Agreement.
Reports to be provided by
Anza to Cerus under this Section 5(a) shall be due sixty
(60) days following the end of each calendar
quarter.
(b) Records . Anza
shall keep, and shall require that its Affiliates and Licensees
keep, complete and accurate books of account and records in
sufficient detail to enable the amounts payable under the Agreement
to be determined. Such books and records shall be kept at the
principal place of business of Anza or its Affiliate or Licensee,
as the case may be, for at least thirty-six (36) months
following the end of the calendar year to which such books and
records pertain.
(c) Audits
.
(i) Audit Rights .
Upon at least thirty (30) days prior written notice from Cerus
and not more than once in each calendar year, Anza shall permit,
and shall require its Affiliates and shall use commercially
reasonable efforts to require its Licensees to permit, an
independent certified public accounting firm of nationally
recognized standing, selected by Cerus and reasonably acceptable to
Anza, to have access during normal business hours to such books of
account and records of Anza, and its Affiliates and Licensees, at
such party’s principal place of business, as may be
reasonably necessary to (A) verify the accuracy of the royalty
reports hereunder
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-5-
for any calendar year ending not more
than thirty six (36) months prior to the date of such request
or (B) determine whether other payments were owed to Cerus
during any calendar year ending not more than thirty six
(36) months prior to the date of such request. If Anza is
unable to obtain from any Licensee a right for Cerus to audit the
books of account and records of such Licensee, Anza shall obtain
the right to inspect and audit such Licensee’s books and
records for itself and shall exercise such audit rights on behalf
of Cerus upon Cerus’ written request, provided that Cerus
agrees to reimburse and does promptly reimburse Anza for the costs
incurred by Anza to perform such audit, and disclose the results of
any such audit to Cerus in accordance with Section 5(c)(ii)
below.
(ii) Audit Results .
If an audit pursuant to Section 5(c)(i) above establishes that
additional royalties or other payments were owed to Cerus during
the period covered by such audit, Anza shall promptly remit to
Cerus: (i) the amount of such additional royalties or other
payments and (ii) interest on such amount which shall be
calculated pursuant to Section 4(d) above. In the event such
audit establishes that amounts were overpaid by Anza during such
period, the amount of such overpayment shall promptly be refunded
to Anza. The fees charged by such accounting firm in connection
with any audit pursuant to Section 5(c)(i) above (including
such fees charged in connection with an audit by Anza at
Cerus’ request) shall be paid by Cerus, provided, however,
that if a discrepancy in favor of Cerus of more than [ * ]
percent ( [ * ] %) of the amount due under the Agreement for
the period being audited is established, then Anza shall pay the
reasonable fees and expenses charged by such accounting firm in
connection with such audit.
(iii) Confidential
Information . Cerus shall treat all financial information
subject to review under this Section 5 as confidential, and
shall cause its accounting firm to retain all such financial
information in confidence. In addition, Cerus’ accounting
firm shall be required to execute a reasonable confidentiality
agreement prior to commencing any audit pursuant to
Section 5(c)(i) above.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-6-
EXHIBIT
C
Representations and
Warranties of Cerus
1. Organization .
Cerus is duly incorporated, validly existing and in good standing
under the laws of the State of Delaware and has all requisite power
and authority to own or lease its assets, including the Transferred
Assets, and to carry on the Business as currently conducted by it.
Cerus is duly authorized to conduct the Business and is in good
standing in each jurisdiction where such qualification is required
to own the Transferred Assets or conduct the Business, except where
the failure to be so qualified or in good standing would not have a
Cerus Material Adverse Effect. No Affiliates of Cerus are presently
or have in the past been engaged in the operation or conduct of the
Business.
2. Authority . Cerus
has all necessary corporate power and authority and has taken all
actions necessary to enter into this Agreement, to execute and
deliver the Transaction Documents to which it is a party and to
carry out the transactions contemplated thereby. The board of
directors of Cerus has taken all action required by Law and the
Charter Documents of Cerus to be taken by it to duly authorize
(a) the execution and delivery of the Transaction Documents to
which it is a party and (b) the consummation of the
transactions contemplated thereby. No other corporate proceedings
on the part of Cerus are necessary to authorize the Transaction
Documents and the transactions contemplated thereby. Each
Transaction Document to which Cerus is a party has been duly and
validly executed and delivered by Cerus and, when executed and
delivered by Anza, shall constitute a legal, valid and binding
obligation of Cerus, enforceable against it in accordance with its
terms, except (i) as enforcement may be limited by bankruptcy,
insolvency and other laws affecting the rights of creditors
generally and (ii) as the remedy of specific performance and
injunctive and other forms of equitable relief may be subject to
equitable defenses and to the discretion of a court of competent
jurisdiction before which any proceeding may be brought.
3. Subsidiaries .
Section 3 of the Cerus Disclosure Schedule lists all
Subsidiaries of Cerus, and Cerus is not a member of (nor is the
Business conducted through) any partnership, nor is Cerus a
participant in any joint venture. No Subsidiary of Cerus owns,
beneficially or of record, or has any rights, title or interest in,
to or under any Transferred Asset or Licensed Intellectual Property
or conducts any part of the Business, and there are no employees or
independent contractors of any Subsidiary of Cerus employed or
engaged in the Business or who perform tasks that are necessary for
the proper operation of the Business.
4. No Conflict . The
execution and delivery by Cerus of the Transaction Documents to
which Cerus is a party and the performance by Cerus of its
obligations set forth therein do not and will not (a) violate,
conflict with or result in the breach of any provision of the
Charter Documents of Cerus, (b) conflict with or violate any
Law or Governmental Order applicable to Cerus or any of the
Transferred Assets or (c) conflict with, result in any breach
of, constitute a default (or event which with the giving of notice
or lapse of time, or both, would constitute a default) under,
require any consent under or give to others any rights of
termination, amendment, acceleration, suspension,
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
revocation or cancellation of or result
in the creation of any Encumbrance on any of the Transferred Assets
pursuant to any note, bond, mortgage or indenture, Contract,
agreement, lease, sublease, license, permit, franchise or other
instrument or arrangement to which Cerus is a party or by which any
of such Transferred Assets is bound or affected, except where such
violation, conflict, breach, failure to obtain consent or grant
rights or creation of any Encumbrance would not have a Cerus
Material Adverse Effect.
5. Governmental Consents
and Approvals . The execution and delivery by Cerus of the
Transaction Documents to which Cerus is a party and performance by
Cerus of its obligations set forth therein do not and will not
require any consent, approval, authorization or other order of,
action by, filing with or notification to any Governmental
Authority, except where such violation, conflict, breach, failure
to obtain consent or grant rights or creation of any Encumbrance
would not have a Cerus Material Adverse Effect.
6. Permits; Compliance
with Laws .
(a) Required Permits .
Cerus is in possession of all material authorizations, licenses,
permits, certificates, approvals, exemptions, consents,
confirmations, orders, registrations, product registrations,
concessions, franchises, waivers and clearances of an Governmental
Authority (including all authorizations under the Food, Drug and
Cosmetic Act, the Public Health Services Act and the Controlled
Substances Act, and the regulations of the FDA and the United
States Drug Enforcement Agency promulgated thereunder) necessary
for Cerus to use, test, manufacture, distribute, own, lease and
operate the Transferred Assets and to carry on the Business as
currently conducted (the “ Required Permits ”),
and all Required Permits are valid and in full force and effect. It
is expressly acknowledged and agreed that Cerus shall not be
obligated to transfer to Anza any such Required Permits.
(b) Compliance . The
Business has been and is currently being conducted by Cerus in
material compliance with all Required Permits and applicable Law by
which any Transferred Asset is bound. No Governmental Authority has
notified Cerus that the Business or the Transferred Assets were or
are in material violation of any Law or Required Permit or the
subject of any investigation in any jurisdiction where the Business
is conducted and, to the Knowledge of Cerus, there are no
reasonably anticipatable grounds for the same.
(c) Notice . No
Governmental Authority has notified Cerus of any facts or
circumstances which would lead to any suspension, loss of or
material modification to any Required Permit or refusal by a
Governmental Authority to renew or accept for filing any Required
Permit on terms less advantageous, individually or in the
aggregate, to Cerus than the terms of those Required Permits
currently in force and, to the Knowledge of Cerus, there are no
facts or circumstances providing reasonably anticipatable grounds
for the same.
7. Litigation . There
are no Actions by or against Cerus relating to the Business, the
Transferred Assets or the Business Employees which are currently
pending, or, to the Knowledge of Cerus, threatened to be brought,
before any Governmental Authority. Neither Cerus nor any of
the
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-2-
Transferred Assets is subject to any
Governmental Order (nor, to the Knowledge of Cerus, are there any
such Governmental Orders threatened to be imposed by any
Governmental Authority) which has had or would be reasonably
expected to have a Cerus Material Adverse Effect.
8. Selected Contracts
.
(a) Business Contracts
. Section 8(a) of the Cerus Disclosure Schedule sets
forth a complete and accurate list of all Contracts directly
relating to or affecting the Business, the Transferred Assets or
the Assumed Liabilities to which Cerus is a party or otherwise
bound as of the date of this Agreement that are material to and/or
necessary or useful for the continued operation of the Business
after the Closing but excluding all Contracts relating to [ *
] or DNA repair that are not license agreements or expressly
related to immunotherapy, (each, a “ Business Contract
”), including the following:
(i) research and development
agreements;
(ii) collaboration
agreements;
(iii) supply
agreements;
(iv) outstanding purchase
orders;
(v) manufacturing
agreements;
(vi) distribution
agreements;
(vii) agreements with
contract research organizations and agreements with investigators
or institutions relating to pre-clinical and clinical
trials;
(viii) equipment or property
lease agreements;
(ix) agreements relating to
the use by Cerus of intellectual property rights owned by a Third
Party or relating to the use by a Third Party of intellectual
property rights owned by Cerus (including inbound and outbound
license agreements);
(x) agreements relating to
the disposition or acquisition of assets other than in the Ordinary
Course of Business or any interest in any business
enterprise;
(xi) agreements that relate
to any joint venture, partnership or other association;
(xii) material transfer
agreements;
(xiii) software license
agreements, other than license agreements for “off the
shelf” or “shrink wrap” software;
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-3-
(xiv) employment, consulting
and scientific or other advisor agreements;
(xv) confidentiality,
non-disclosure or proprietary information agreements;
(xvi) service
agreements;
(xvii) agreements restricting
Cerus from carrying out any activities related to the
Business;
(xviii) agreements which
relate to the provision of computer hardware or software, including
maintenance and consultancy and disaster recovery arrangements,
other than such licenses or agreements arising from the purchase of
“off the shelf” or “shrink wrap”
products;
(xix) agreements relating to
the settlement of legal proceedings;
(xx) security agreements;
and
(xxi) agreements which
require a Third Party consent to assignment.
(b) Validity; Breach .
Each Selected Contract is valid, binding and in full force and
effect. Cerus and, to the Knowledge of Cerus, any other party
thereunder, has performed all material obligations required to be
performed by such party under the Selected Contracts, and Cerus is
not in material breach or default under any Selected Contract and,
to the Knowledge of Cerus, no other party to any Selected Contract
is (with or without the lapse of time or the giving of notice, or
both) in material breach or default thereunder. Cerus has not
received any written notice (i) that it has breached or
defaulted under any Selected Contract or (ii) of the intention
of any party to terminate any Selected Contract, nor, to the
Knowledge of Cerus, has Cerus received oral notice of such breach,
default or intent to terminate. Complete and correct copies of all
Selected Contracts and amendments thereto that are in effect as of
the date of this Agreement have been delivered to Anza.
Notwithstanding the foregoing, Cerus makes no representation or
warranty hereunder that there exist any Business Contracts
authorizing Cerus to use, make, have made, sell, offer to sell or
import UVA light devices and/or disposable kits in the Anza Field
of Use or authorizing Cerus to license to any Third Party the right
to use, make, have made, sell, offer to sell or import UVA light
devices and/or disposable kits in the Anza Field of Use.
(c) Restrictions on
Business Activities . There is no Selected Contract relating to
noncompetition, exclusivity, field of use, most favored nation or
otherwise or any Governmental Order to which Cerus is a party, or
which is otherwise binding upon Cerus, which relates directly or
indirectly to any Transferred Asset, in any case which has or
reasonably would be expected to have the effect of prohibiting or
impairing (i) any transaction contemplated by this Agreement
or (ii) as a result of any transaction contemplated by this
Agreement, the conduct of the Business by Anza as it is currently
being conducted. Notwithstanding anything to the contrary in this
Agreement, Cerus makes no representation or warranty that there
exists any Contract authorizing Cerus to use, make, have made,
sell, offer to sell or import UVA light devices and/or disposable
kits in the Anza Field of Use or authorizing Cerus to license to
any Third Party the right to use, make, have made, sell, offer to
sell or import UVA light devices and/or disposable kits in the Anza
Field of Use.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-4-
(d) Assignability .
Cerus has the full and unencumbered right to assign and transfer to
Anza all of Cerus’ rights in and under the Transferred
Contracts without incurring, or causing Anza to incur, any
obligation to any Third Party (other than those obligations assumed
by Anza pursuant to the Transferred Contracts).
9. Intellectual
Property .
(a) Registered Business
Intellectual Property . Section 9(a) of the Cerus
Disclosure Schedule lists all Registered Business Intellectual
Property owned or Controlled by, filed in the name of or applied
for by Cerus or its Affiliates and lists all proceedings or actions
(other than non-adversarial proceedings or actions associated with
the procurement of Patent Rights) before any Governmental Authority
relating to any Registered Business Intellectual
Property.
(b) Validity . Each
Patent Right within the Transferred Patent Rights and Licensed [
* ] Patent Rights is subsisting, and all necessary
registration, maintenance and renewal fees in connection with such
Patent Rights that are required to be paid prior to the date of
this Agreement have been paid, and all necessary documents and
certificates in connection with such Patent Rights that are
required to be filed prior to the date of this Agreement have been
filed with the relevant Governmental Authorities for the purposes
of perfecting, prosecuting and maintaining such Patent Rights.
There are no actions that must be taken by Cerus within sixty
(60) days of the date of this Agreement, including the payment
of any registration, maintenance or renewal fees or the filing of
any responses to PTO office actions (or equivalent actions of any
equivalent authority anywhere in the world), for the purposes of
obtaining, maintaining, perfecting or preserving or renewing any
Patent Right within the Transferred Patent Rights. In each case in
which Cerus has acquired ownership of any Transferred Intellectual
Property and Licensed Intellectual Property from any Person, Cerus
has obtained a valid and enforceable assignment sufficient to
irrevocably transfer all rights in such Transferred Intellectual
Property and Licensed Intellectual Property (including the right to
seek past and future damages with respect thereto) to Cerus. Cerus
has recorded each such assignment of Transferred Patent Rights and
Licensed [ * ] Patent Rights with the relevant Governmental
Authority, including the PTO or its respective equivalent in any
relevant foreign jurisdiction, as the case may require.
(c) Enforceability .
Cerus has no Knowledge of any facts or circumstances that would
render any issued Patent Right within the Transferred Patent Rights
or Licensed [ * ] Patent Rights invalid or unenforceable. In
addition, Cerus has not entered into any agreement with any Person
not to assert any charge of infringement of the Transferred Patent
Rights and/or Licensed [ * ] Patent Rights against such
Person, which would impact Anza’s ability to enforce the
Transferred Patent Rights and/or Licensed [ * ] Patent
Rights (solely in the Anza Field of Use pursuant to
Section 5.11 of the Agreement) after the Closing.
Notwithstanding the foregoing, Cerus makes no representation or
warranty hereunder with respect to any Licensed [ * ] Patent
Rights that relate to UVA light devices and/or disposable
kits.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-5-
(d) Encumbrances .
Each item of Transferred Intellectual Property and Licensed
Intellectual Property, solely with respect to the Anza Field of
Use, is free and clear of all Encumbrances. Cerus is the exclusive
owner, and has good title against all others, of all right, title
and interest in, to and under all Transferred Patent Rights and
Licensed [ * ] Patent Rights.
(e) Transferability .
All Transferred Intellectual Property will be fully transferable,
alienable and licensable by Anza, without restriction and without
payment of any kind to any Third Party. All Licensed Intellectual
Property will be fully sublicensable by Anza, without restriction
and without payment of any kind to any Third Party.
(f) Rights from Third
Parties . To the extent that any Transferred Intellectual
Property and Licensed Intellectual Property has been developed or
created by a Third Party for Cerus, including any employee or
independent contractor of Cerus, Cerus has a written Contract with
such Third Party pursuant to which Cerus either (i) has
obtained ownership of, and is the exclusive owner of, or
(ii) has obtained an exclusive license (sufficient for the
conduct of the Business as currently conducted and as currently
proposed to be conducted) to such Transferred Intellectual Property
and Licensed Intellectual Property.
(g) Employees and
Independent Contractors . All current and former employees and
independent contractors of Cerus have entered into a valid and
binding written agreement with Cerus sufficient to vest title in
Cerus of all Business Intellectual Property created by such
employees and independent contractors in the scope of their
employment or engagement with Cerus, as applicable, and providing
for the non-use and non-disclosure of confidential information
relating to the Business.
(h) Improvements . No
Person who has licensed Business Intellectual Property to Cerus has
ownership rights or license rights to improvements made by Cerus in
such Business Intellectual Property in Anza’s Field of Use.
Notwithstanding the foregoing, Cerus makes no representation or
warranty hereunder with respect to any improvements that relate to
UVA light devices and/or Intercept Platelet or Plasma disposable
kits.
(i) Transfers . Other
than pursuant to material transfer agreements (of which copies have
been provided to Anza and/or its legal counsel) for research
purposes within the scope of each such material transfer agreement,
Cerus has not transferred ownership of, or granted any license of
or right to use, or authorized the retention of any rights to use
or joint ownership of, any Intellectual Property that is or was
Business Intellectual Property, to any other Person.
(j) Contracts . The
Contracts listed in Section 8(a) of the Cerus Disclosure
Schedule constitute all the Contracts to which Cerus is a
party with respect to any Business Intellectual
Property.
(k) No Infringement by
Cerus . To the Knowledge of Cerus, the operation of the
Business as currently conducted by Cerus has not, does not and will
not when conducted by Anza in substantially the same manner
following the Closing infringe or misappropriate any
Intellectual
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-6-
Property of any Person, violate any
right of any Person (including any right to privacy or publicity)
or constitute unfair competition or trade practices under the Laws
of any jurisdiction, and Cerus has not received notice from any
Person claiming that such operation infringes or misappropriates
any Intellectual Property of any Person or constitutes unfair
competition or trade practices under the Laws of any jurisdiction
(nor does Cerus have Knowledge of any reasonably anticipatable
basis therefor). There are no pending or, to the Knowledge of
Cerus, threatened claims (including interferences, oppositions and
similar proceedings) challenging the Transferred Intellectual
Property or the Licensed Intellectual Property nor has Cerus
received any “offer to license” letters from any Person
inviting Cerus to license any Business Intellectual Property.
Notwithstanding the foregoing, Cerus makes no representation or
warranty hereunder with respect to the operation or planned
operation of the Business insofar as such operations involve UVA
light devices and/or disposable kits.
(l) No Infringement by
Third Parties . To the Knowledge of Cerus, no Person is
infringing or misappropriating any Transferred Intellectual
Property or Licensed Intellectual Property.
(m) Third Party Rights
. Cerus has heretofore disclosed in writing to Anza all Patent
Rights of Third Parties to the Knowledge of Cerus relating to the
Business Products and all written non-infringement and/or validity
analyses prepared by Cerus’ outside counsel with respect
thereto prepared by or on behalf of Cerus, and, to the Knowledge of
Cerus, there are no Patent Rights of Third Parties that would be
necessarily infringed by any implementation of the Covered
Products.
(n) Restrictions . No
Transferred Intellectual Property or Licensed Intellectual Property
is subject to any proceeding or outstanding Governmental Order or
any settlement agreement or stipulation that restricts in any
manner the use, transfer or licensing thereof by Cerus or that may
affect the validity, use or enforceability of such Transferred
Intellectual Property or Licensed Intellectual Property.
(o) Grants and Funding
. Except for those grants listed in Section 9(o) of the Cerus
Disclosure Schedule, Cerus has not received any grant, loan,
subsidy, investment or other source of funding from any
Governmental Authority relating to the Business. To the Knowledge
of Cerus, no facilities of a university, college, other educational
institution or research center or Governmental Authority or funding
from any Governmental Authority or other source other than the
capital markets or general corporate funds of Cerus was used in the
development of the Transferred Intellectual Property or Licensed
Intellectual Property. Notwithstanding the foregoing, Cerus makes
no representation or warranty under this Section 9(o) with
respect to any work done by Cerus or [ * ] or any of its
Affiliates that is predominantly related to the Cerus Field of Use.
To the Knowledge of Cerus, no current or former employee or
independent contractor of Cerus who was involved in, or who
contributed to, the creation or development of any Transferred
Intellectual Property or Licensed Intellectual Property has
performed services for any Governmental Authority, university,
college or other educational institution or research center during
a period of time during which such employee or independent
contractor was creating or developing any Transferred Intellectual
Property or Licensed Intellectual Property.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-7-
(p) Disclosures .
Cerus has made available to Anza, either through disclosures made
to Anza or by virtue of the access that David N. Cook and Thomas W.
Dubensky have to Cerus’ records related to the
immunotherapy/vaccine program, all material preclinical and
clinical data in Cerus’ possession or Control as of the date
of this Agreement with respect to all clinical and preclinical
product candidates undergoing development in connection with the
Business, including the Business Products.
(q) Royalties . Except
pursuant to the Transferred Contracts, Cerus is not required,
pursuant to any Contract, to make or accrue any royalty or other
payment to any Third Party in connection with sale of any clinical
and preclinical product candidates undergoing development in
connection with the Business, including the Business
Products.
(r) Security . Cerus
has taken all reasonable steps that are required to protect its
rights in confidential information and trade secrets included in
the Transferred Know-How and Licensed Know-How. To the Knowledge of
Cerus, there have been no material breaches of security affecting
the information, assets or data of the Business.
(s) Exercise of Option
. Cerus has duly exercised, and not revoked its exercise of, the
option described in Section 2.3 of the Option and Exclusive
License Agreement between Cerus and The Johns Hopkins University
(reference number [ * ] ) dated April 8, 2003, prior to
the expiration of such option.
10. Title to Assets;
Sufficiency of Assets .
(a) Title . Cerus has,
and at the Closing, Cerus will deliver to Anza good and marketable
title to the Transferred Assets free and clear of all Encumbrances,
except as otherwise provided in the Transferred Contracts, and a
valid and binding license under the Licensed Intellectual Property
pursuant to Section 2.3(a).
(b) Sufficiency . To
the Knowledge of Cerus, the Transferred Assets, the license granted
pursuant to Section 2.3(a) and the rights and benefits
provided under the Transition Services Agreement, the Supply
Agreement, the Sublease and the Site License constitute all of the
assets, Contracts and rights, excluding the Required Permits,
required for the continued operation of the Business by Anza as
conducted by Cerus during the past twelve
(12) months.
(c) GMP S-59 Psoralen
. To the Knowledge of Cerus, the Initial S-59 Psoralen Supply was
manufactured in accordance with current Good Manufacturing Practice
regulations and stored by Cerus or its agent in accordance with
applicable specifications and requirements in all material
respects.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-8-
11. Regulatory
Compliance .
(a) Compliance . Cerus
is in compliance in all material respects with all applicable
statutes, rules and regulations of the FDA, with respect to the
clinical testing, manufacture, collection, labeling, storing,
testing or distribution of Business Products, including current
“Good Manufacturing Practice,” or cGMP, regulations,
“Good Clinical Practice,” or GCP, regulations,
“Good Laboratory Practice,” or GLP, regulations,
“Informed Consent” and “Institutional Review
Board” regulations and all applicable requirements relating
to the protection of human subjects for its clinical trials as
required by the FDA. Cerus has all requisite permits, approvals,
registrations, licenses and the like, each as required by the FDA
to conduct the Business as currently conducted. Cerus is in
compliance in all material respects with the registration and
listing requirements set forth at 21 U.S.C. §360 and all
similar applicable foreign laws and regulations, in each case
solely to the extent applicable to the Business.
(b) Proceedings .
Cerus has not received notice of, and is not subject to, any
adverse inspection, finding of deficiency, finding of
non-compliance, compelled or voluntary recall, investigation,
penalty for corrective or remedial action or other compliance or
enforcement action, in each case relating to any of the Business
Products or to the facilities in which the Business Products are
manufactured, collected or handled, by the FDA or Foreign
Regulatory Authorities. There are no pending or, to the Knowledge
of Cerus, threatened actions, proceedings or complaints by the FDA
or Foreign Regulatory Authorities which would materially prohibit
or impede the conduct of the Business as currently
conducted.
(c) False Statements .
Cerus has not made any false statements on, or material omissions
from, the applications, reports and other submissions to the FDA or
Foreign Regulatory Authorities or any other records and
documentation prepared or maintained to comply with the
requirements of the FDA or Foreign Regulatory Authorities, in each
case relating to the Business Products.
Cerus is not the subject of
any pending or, to the Knowledge of Cerus, threatened investigation
with respect to the Business Products by the FDA pursuant to its
“Fraud, Untrue Statements of Material Facts, Bribery, and
Illegal Gratuities” Final Policy set forth in 56 Fed. Reg.
46191 (September 10, 1991) and any amendments thereto, or any
foreign equivalent. Cerus has not committed any act, made any
statement or failed to make any statement, in each case with
respect to the Business Products that would provide a reasonably
anticipatable basis for the FDA to invoke its policy with respect
to “Fraud, Untrue Statements of Material Facts, Bribery, and
Illegal Gratuities” and any amendments thereto, or any
foreign equivalent.
(d) Misbranding and
Adulteration . Cerus has not received any notification, written
or oral, that remains unresolved from the FDA or a Foreign
Regulatory Authority indicating that any of any Business Products
is misbranded or adulterated as defined in 21 U.S.C. §321, et
seq., as amended, and the rules and regulations promulgated
thereunder.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-9-
(e) Recalls . No
Business Product has been recalled, suspended or discontinued as a
result of any action by the FDA or any Foreign Regulatory
Authority, by Cerus or, to the Knowledge of Cerus, by any licensee
or distributor of any Business Product.
(f) Trials . All
pre-clinical and clinical trials conducted by or under the
authority of Cerus with regard to the Business Products were and
are being conducted in material compliance with experimental
protocols, procedures and controls pursuant to accepted
professional scientific standards used within the pharmaceutical
industry and all applicable Laws promulgated by the FDA.
(g) Debarment . To the
Knowledge of Cerus, none of the employees or agents of Cerus have
been disqualified or debarred by the FDA for any purpose, or have
been charged with or convicted under United States federal Laws for
conduct relating to the development or approval or otherwise
relating to the regulation of any drug product under the Generic
Drug Enforcement Act of 1992 (21 U.S.C. §335a).
12. Suppliers . Cerus
has used commercially reasonable efforts to maintain, and, to the
Knowledge of Cerus, currently maintains, good working relationships
with all of the suppliers of goods to the Business. Section 12
of the Cerus Disclosure Schedule specifies for the period
beginning January 1, 2007 to the date of this Agreement the
names of all suppliers of goods to the Business. None of such
suppliers has given Cerus notice terminating, canceling or
threatening to terminate or cancel any Contract or relationship
with Cerus relating to the Business. To the Knowledge of Cerus,
such suppliers are manufacturing and otherwise operating in
compliance with applicable FDA requirements with respect to the
products and materials supplied to Cerus.
13. Environmental
Matters .
(a) Required Permits .
Cerus, to the extent related to any property or facility owned,
leased or operated by Cerus in the conduct of the Business (the
“ Properties ”), has obtained the material
Required Permits required by Environmental Laws and necessary for
the conduct of the Business, and Cerus is in material compliance
with such material Required Permits and other requirements of
Environmental Law.
(b) Violations .
Cerus, to the extent related to the Business or the Properties, has
not received any written notice from any Governmental Authority or
any other Person or entity alleging a material violation of, or
material liability under, Environmental Laws which has not been
fully resolved.
(c) Proceedings . No
notice, registration, reporting or other filing or investigation,
response or corrective action is required by Cerus under any
Environmental Law in connection with, or as a result of, the
execution and delivery of this Agreement, or the consummation of
the transactions contemplated hereby.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-10-
14. Taxes .
(a) Filing of Tax
Returns . Cerus has duly and timely filed (or caused to be
filed) with the appropriate taxing authorities all Tax Returns that
Cerus was required to file relating to the Transferred Assets or
the Business through the date hereof and all such Tax Returns filed
are complete and accurate in all respects insofar as they relate to
the Transferred Assets or the Business. All Taxes owed by Cerus
(whether or not shown on any Tax Return) relating to the
Transferred Assets or the Business have been paid. Cerus is not
currently the beneficiary of any extension of time within which to
file any Tax Return with respect to the Transferred Assets or the
Business.
(b) Liens . There are
no liens for Taxes (other than for current Taxes not yet due and
payable) on any of the Transferred Assets. None of the Transferred
Assets are property that is required to be treated for Tax purposes
as being owned by any other Person.
(c) Audits,
Investigations, Disputes or Claims . No deficiencies for Taxes
have been claimed, proposed or assessed by any taxing authority or
other Governmental Authority against Cerus with respect to the
Transferred Assets or the Business, and there are no pending or, to
the Knowledge of Cerus, threatened audits, investigations, disputes
or claims or other actions for or relating to any Liability for
Taxes with respect to the Transferred Assets or the Business, and
there are no matters under discussion with any Governmental
Authorities with respect to Taxes that are likely to result in an
additional Liability for Taxes with respect to the Transferred
Assets or the Business. With respect to the Transferred Assets or
the Business, Cerus has not waived any statute of limitations in
respect of Taxes or agreed to any extension of time with respect to
a Tax assessment or deficiency.
(d) Tax Sharing
Agreements . There are no Tax-sharing agreements or similar
arrangements (including indemnity arrangements) with respect to or
involving the Transferred Assets or the Business, and after the
Closing Date the Transferred Assets and the Business shall not be
bound by any such Tax-sharing agreements or similar arrangements or
be subject to any Liability thereunder for amounts due in respect
of periods prior to the Closing Date.
(e) Withholding .
Cerus has withheld and paid all Taxes concerning the Business
required to have been withheld and paid in connection with amounts
paid or owing to any employee, independent contractor, creditor,
stockholder or other Third Party.
15. Absence of Certain
Changes or Events . Between September 30, 2007 and the
date of this Agreement, there has not been a Cerus Material Adverse
Effect and, except as contemplated by this Agreement, Cerus has
conducted the Business only in the Ordinary Course of Business and
has not, with respect to the Business or any of the Transferred
Assets:
(a) subjected any of the
Transferred Assets to any material Encumbrances;
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-11-
(b) sold, transferred,
leased, subleased, licensed or otherwise disposed of, other than in
the Ordinary Course of Business, to any Third Party, any
Transferred Assets or assets necessary for the conduct of the
Business as currently conducted;
(c) sold, licensed or
sublicensed or otherwise transferred any rights to any Third Party
under any Transferred Assets, other than in the Ordinary Course of
Business;
(d) accelerated, cancelled,
modified or terminated any Transferred Contract, other than in the
Ordinary Course of Business;
(e) surrendered, revoked or
otherwise terminated any material Required Permits, except in
connection with any renewal or reissuance thereof;
(f) incurred any Assumed
Liabilities, other than in the Ordinary Course of
Business;
(g) waived, released or
assigned any rights, which rights, but for such waiver, release or
assignment, would have been classified as Transferred Assets, other
than in the Ordinary Course of Business;
(h) experienced any damage,
destruction or casualty loss (whether or not covered by insurance)
with respect to any Transferred Asset other than as a result of
ordinary wear and tear, where applicable;
(i) delayed or postponed the
payment of any Assumed Liability outside the Ordinary Course of
Business;
(j) made any election or
change to any election in respect to Taxes, adopted or changed any
accounting method in respect to Taxes, entered into any Tax
allocation agreement, Tax sharing agreement, Tax indemnity
agreement or closing agreement, settled or compromised on any
claim, notice, audit report or assessment in respect of Taxes,
consented to any extension or waiver of the limitation period
applicable to any claim or assessment in respect of Taxes, changed
any annual Tax accounting period, filed any amended Tax Return or
surrendered any right to claim a Tax refund; or
(k) agreed, whether in
writing or otherwise, to do any of the foregoing, except as
expressly contemplated by this Agreement.
16. Bulk Transfer Laws
. There are no current or past creditors of Cerus to whom any
Law requires the delivery of notice or from whom any form of
consent is required in conjunction with undertaking the
transactions contemplated by this Agreement, and the “bulk
transfer laws” of any state in which the Transferred Assets
are located do not apply to the transfer of those Transferred
Assets under this Agreement.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-12-
17. Investment
Representations .
(a) No Registration .
Cerus understands that the Series AA Shares and the Conversion
Shares have not been, and will not be, registered under the
Securities Act by reason of a specific exemption from the
registration provisions of the Securities Act, the availability of
which depends upon, among other things, the bona fide nature of the
investment intent and the accuracy of Cerus’ representations
as expressed herein or otherwise made pursuant hereto.
(b) Investment Intent
. Cerus is acquiring the Series AA Shares and the Conversion
Shares for investment for its own account, not as a nominee or
agent and not with the view to, or for resale in connection with,
any distribution thereof, and Cerus has no present intention of
selling, granting any participation in or otherwise distributing
the same. Cerus further represents that it does not have any
contract, undertaking, agreement or arrangement with any Person to
sell, transfer or grant participation to such person or entity or
to any third person or entity with respect to any of the
Series AA Shares or the Conversion Shares.
(c) Investment
Experience . Cerus has substantial experience in evaluating and
investing in private placement transactions of securities in
companies similar to Anza and acknowledges that Cerus can protect
its own interests. Cerus has such knowledge and experience in
financial and business matters so that Cerus is capable of
evaluating the merits and risks of its investment in
Anza.
(d) Speculative Nature of
Investment . Cerus understands and acknowledges that Anza has a
limited financial and operating history and that an investment in
Anza is highly speculative and involves substantial risks. Cerus
can bear the economic risk of Cerus’ investment and is able,
without impairing Cerus’ financial condition, to hold the
Series AA Shares and the Conversion Shares for an indefinite
period of time and to suffer a complete loss of Cerus’
investment.
(e) Access to Data .
Cerus has had an opportunity to ask questions of, and receive
answers from, the officers of Anza concerning the Transaction
Documents and the transactions contemplated thereby, as well as
Anza’s business, management and financial affairs, which
questions were answered to its satisfaction. Cerus believes that it
has received all the information Cerus considers necessary or
appropriate for deciding whether to purchase the Series AA
Shares and the Conversion Shares. Cerus acknowledges that any
business plans prepared by Anza have been, and continue to be,
subject to change and that any projections included in such
business plans or otherwise are necessarily speculative in nature,
and it can be expected that some or all of the assumptions
underlying such projections will not materialize or will vary
significantly from actual results.
(f) Accredited
Investor . Cerus is an “accredited investor” within
the meaning of Regulation D, Rule 501(a), promulgated by
the Securities and Exchange Commission under the Securities Act and
shall submit to Anza such further assurances of such status as may
be reasonably requested by Anza.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-13-
(g) Residency . The
principal place of business of Cerus is correctly set forth in
Section 8.4.
(h) Rule 144 .
Cerus acknowledges that the Series AA Shares and the
Conversion Shares must be held indefinitely unless subsequently
registered under the Securities Act or an exemption from such
registration is available. Cerus is aware of the provisions of
Rule 144 promulgated under the Securities Act (“
Rule 144 ”) which permit limited resale of shares
purchased in a private placement subject to the satisfaction of
certain conditions, including among other things, the existence of
a public market for the shares, the availability of certain current
public information about Anza, the resale occurring not less than
one (1) year after a party has purchased and paid for the
security to be sold, the sale being effected through a
“broker’s transaction” or in transactions
directly with a “market maker” and the number of shares
being sold during any three (3) month period not exceeding
specified limitations. Cerus understands that the current public
information referred to above is not now available and that Anza
has no present plans to make such information available. Cerus
acknowledges and understands that, notwithstanding any obligation
under the Investor Rights Agreement, Anza may not be satisfying the
current public information requirement of Rule 144 at the time
Cerus wishes to sell the Series AA Shares or the Conversion
Shares, and that, in such event, Cerus may be precluded from
selling such shares under Rule 144, even if the other
requirements of Rule 144 have been satisfied. Cerus
acknowledges that, in the event all of the requirements of
Rule 144 are not met, registration under the Securities Act or
an exemption from registration will be required for any disposition
of the Series AA Shares or the Conversion Shares. Cerus
understands that, although Rule 144 is not exclusive, the
Securities and Exchange Commission has expressed its opinion that
persons proposing to sell restricted securities received in a
private offering other than in a registered offering or pursuant to
Rule 144 will have a substantial burden of proof in
establishing that an exemption from registration is available for
such offers or sales and that such persons and the brokers who
participate in the transactions do so at their own risk.
(i) No Public Market .
Cerus understands and acknowledges that no public market now exists
for any of the securities issued by Anza and that Anza has made no
assurances that a public market will ever exist for Anza’s
securities.
18. Brokers or Finders
. Neither Cerus nor any of its representatives have incurred any
obligation or liability, contingent or otherwise, for brokerage or
finders’ fees or agents’ commissions or other similar
payments in connection with the transactions contemplated by this
Agreement.
19. Disclosure
. To the actual knowledge of the executive officers of Cerus,
no representation or warranty or other statement made by Cerus in
the Transaction Documents, the Cerus Disclosure Schedule or
any other document or certificate delivered in connection therewith
contains any untrue statement or omits to state a material fact
necessary to make any of them, in light of the circumstances in
which it was made, not misleading. To the actual knowledge of the
executive officers of Cerus, there are no facts that have
application to Business (other than general economic or industry
conditions) and that may materially adversely affect the assets,
business, prospects, financial condition or results of operations
of the Business that has not been set forth in this Agreement or
the Cerus Disclosure Schedule.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-14-
EXHIBIT
D
Representations and
Warranties of Anza
1. Organization
. Anza is duly organized, validly existing and in good
standing under the laws of the State of Delaware and has all
requisite power and authority to own or lease its assets and to
carry on its business as currently conducted by it. Anza is duly
authorized to conduct its business and is in good standing in each
jurisdiction where such qualification is required, except where the
failure to be so qualified or in good standing would not have a
Anza Material Adverse Effect.
2. Authority
. Anza has all necessary corporate power and authority and has
taken all actions necessary to enter into this Agreement, to
execute and deliver the Transaction Documents and the Cerus
Financing Agreements to which it is a party and to carry out the
transactions contemplated thereby. The board of directors of Anza
has taken all action required by Law and the Charter Documents of
Anza to be taken by it to duly authorize (a) the execution and
delivery of the Transaction Documents and Cerus Financing
Agreements to which it is a party and (b) the consummation of
the transactions contemplated thereby. No other corporate
proceedings on the part of Anza are necessary to authorize the
Transaction Documents, the Cerus Financing Agreements and the
transactions contemplated thereby. Each Transaction Document and
Cerus Financing Agreement to which Anza is a party has been duly
and validly executed and delivered by Anza and, when executed and
delivered by Cerus, shall constitute a legal, valid and binding
obligation of Anza, enforceable against it in accordance with its
terms, except (i) as enforcement may be limited by bankruptcy,
insolvency and other laws affecting the rights of creditors
generally and (ii) as the remedy of specific performance and
injunctive and other forms of equitable relief may be subject to
equitable defenses and to the discretion of a court of competent
jurisdiction before which any proceeding may be brought
.
3. No Conflict
. The execution and delivery by Anza of the Transaction
Documents and the Cerus Financing Agreements to which Anza is a
party and the performance by Anza of its obligations set forth
therein do not and will not (a) violate, conflict with or
result in the breach of any provision of the Charter Documents of
Anza, (b) conflict with or violate any Law or Governmental
Order applicable to Anza or (c) conflict with, result in any
breach of, constitute a default (or event which with the giving of
notice or lapse of time, or both, would constitute a default)
under, require any consent under or give to others any rights of
termination, amendment, acceleration, suspension, revocation or
cancellation of or result in the creation of any Encumbrance on any
of the assets or properties of Anza pursuant to any note, bond,
mortgage or indenture, Contract, agreement, lease, sublease,
license, permit, franchise or other instrument or arrangement to
which Anza is a party or by which any of such assets or properties
is bound or affected.
4. Capitalization
. As of immediately prior to the Closing, (i) the
authorized capital stock of Anza consists of (a) 40,000,000
shares of Common Stock, [ * ] of which are issued and
outstanding and (b) 25,000,001 shares of Preferred Stock, of
which 5,000,000 shares are designated
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
Series AA Preferred Stock, [ *
] of which are issued or outstanding, and of which 20,000,001
shares are designated Series A Preferred Stock, [ * ]
of which are issued or outstanding, and (ii) Anza has reserved
4,704,500 shares of Common Stock for issuance under Anza’s
2007 Stock Plan. The Common Stock and the Preferred Stock have the
rights, preferences, privileges and restrictions set forth in the
Anza Restated Certificate. The outstanding shares of Common Stock
and Preferred Stock have been duly authorized and validly issued in
compliance with applicable federal and state securities Laws, and
are fully paid and nonassessable. Except for the conversion
privileges of the Preferred Stock, the rights provided pursuant to
the Investor Rights Agreement and the Right of First Refusal and
Co-Sale Agreement or as otherwise described in this Agreement,
there are no options, warrants or other rights to purchase any of
Anza’s authorized and unissued capital stock.
5. Financial
Statements . Anza was recently formed, has not yet begun
significant operations, and has not prepared any financial
statements. Anza is not a guarantor or indemnitor of any
indebtedness of any other person, firm, corporation or other
entity. Except as contemplated by the Transaction Documents, Anza
has no material liabilities and no material contingent
liabilities.
6. Agreements;
Actions.
(a) Except for the
Transaction Documents and the Cerus Financing Agreements and the
transactions contemplated thereby, there are no Contracts,
agreements, instruments or arrangements, proposed transactions,
judgments, orders, writs or decrees to which Anza is a party or to
its Knowledge by which it is bound.
(b) Anza has not
(i) accrued, declared or paid any dividends, or authorized or
made any distribution upon or with respect to any class or series
of its capital stock, (ii) incurred or guaranteed any
indebtedness for money borrowed, (iii) made any loans or
advances to any person, other than ordinary advances for travel
expenses, or (iv) sold, exchanged or otherwise disposed of any
of its assets or rights.
(c) Anza has not engaged in
any discussion (i) with any representative of any other
business or businesses regarding the consolidation or merger of
Anza with or into any such other business or businesses,
(ii) with any corporation, partnership, limited liability
company, or other business entity or any individual regarding the
sale, conveyance or disposition of all or substantially all of the
assets of Anza, or a transaction or series of related transactions
in which more than fifty percent (50%) of the voting power of
Anza is disposed of, or (iii) regarding any other form of
acquisition, liquidation, dissolution or winding up of
Anza.
7. Obligations to Related
Parties . No employee, officer, director or, to Anza’s
Knowledge, stockholder of Anza or member of his or her immediate
family is indebted to Anza, nor is Anza indebted (or committed to
make loans or extend or guarantee credit) to any of them other than
(i) for payment of salary for services rendered during the
most recent payroll period, (ii) reimbursement for reasonable
expenses incurred on behalf of Anza and (iii) for other
standard employee benefits made generally available to all
employees (including stock option agreements outstanding under any
stock option plan approved by Anza’s Board of Directors and
stock purchase
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-2-
agreements approved by Anza’s
Board of Directors). To Anza’s Knowledge, none of such
persons has any direct or indirect ownership interest in any firm
or corporation with which Anza is affiliated or with which Anza has
a business relationship, or any firm or corporation that competes
with Anza, except in connection with the ownership of stock in
publicly-traded companies. To Anza’s Knowledge, no employee,
officer, director or stockholder, nor any member of their immediate
families, is, directly or indirectly, interested in any material
contract with Anza (other than such contracts as relate to any such
person’s ownership of capital stock or other securities of
Anza).
8. Litigation . There
are no Actions pending against Anza or its properties or officers
(in their capacities as such) (nor has Anza received notice of any
threat thereof) before any Governmental Authority that questions
the validity of the Transaction Documents, the Cerus Financing
Agreements or the right of Anza to enter into them, or the right of
Anza to perform its obligations contemplated thereby. Anza is not a
party or subject to any Governmental Order (nor, to the Knowledge
of Anza, are there any such Governmental Orders threatened to be
imposed by any Governmental Authority) which has had or would be
reasonably expected to have a Anza Material Adverse Effect. There
is no Action initiated by Anza currently pending or which Anza
currently intends to initiate.
9. Brokers or Finders
. Neither Anza nor any of its representatives have incurred
any obligation or liability, contingent or otherwise, for brokerage
or finders’ fees or agents’ commissions or other
similar payments in connection with the transactions contemplated
by this Agreement.
10. Validity of Shares
The Series AA Shares, when issued and delivered in
compliance with the provisions of this Agreement, will be validly
issued, fully paid and nonassessable. The Conversion Shares have
been duly and validly reserved and, when issued in compliance with
the provisions of this Agreement, the Anza Restated Certificate and
applicable Law, will be validly issued, fully paid and
nonassessable. The Series AA Shares and the Conversion Shares
will be free of any Encumbrances, other than any Encumbrances
created by or imposed upon Cerus, provided, however, that the
Series AA Shares and the Conversion Shares are subject to
restrictions on transfer under United States state and/or federal
securities Laws and as set forth in the Investor Rights Agreement.
Except as set forth in the Investor Rights Agreement, the
Series AA Shares and the Conversion Shares are not subject to
any preemptive rights or rights of first refusal.
11. Governmental Consents
and Approvals . The execution and delivery by Anza of the
Transaction Documents and Cerus Financing Agreements to which Anza
is a party, and performance by Anza of its obligations set forth
therein, do not and will not require any consent, approval,
authorization or other order of, action by, filing with or
notification to any Governmental Authority.
12. Compliance with
Laws . Anza is not in material violation of any applicable Law
in respect of the conduct of its business or the ownership of its
properties. No Governmental Authority has notified Anza that its
business is or was in material violation of any Law or Required
Permit or the subject of any investigation in any jurisdiction
where such business is conducted and, to the Knowledge of Anza,
there are no reasonably anticipatable grounds for the
same.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-3-
13. Absence of Certain
Changes or Events . Since Anza’s inception, there has not
been a Anza Material Adverse Effect. Anza was formed solely for the
purpose of engaging in the Business, has engaged in no other
business activities and has conducted its operations solely to the
extent related to the transactions contemplated by the Transaction
Documents and Cerus Financing Agreements.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
-4-
Exhibit
E
T
RANSFERRED A SSETS TO
BE D ELIVERED AT C
LOSING
The following items to the extent that
they are Transferred Assets shall be delivered at Closing in the
manner and form as set forth below:
Regulatory &
Quality
CRS-100 regulatory files and supporting
documentation (hard copy and electronic formats) relating to [ *
]
CRS-207 regulatory files and supporting
documentation (electronic formats) relating to [ * ]
CRS-207 regulatory files and supporting
documentation (hard copy and electronic formats) relating to [ *
]
Regulatory or Quality Documents as
described on Exhibit AN Transferred Know-How and Exhibit
AC Licensed Know-How to the extent that such documents are
denoted as “QC” in the column entitled
“Department” on such exhibits
Institutional Review Board approvals for
[ * ] and related materials
Institutional Biosafety Committee (IBC)
meeting minutes and related materials
Institutional Animal Care and Use
Committee (IACUC) meeting minutes and related materials
Clinical Records and
Data
CRS-100 and CRS-207 clinical study files
and documents, including site-specific informed consents, CRO
documents, site documents, vendor documents (e.g. data
management/lab vendors) and guidelines, protocols and
manuals
CRS-100 and CRS-207 clinical study
data
Material
Contracts
Patent Rights listed in Exhibit
AO Transferred Patent Rights, by instruction to Cerus’
patent counsel to deliver the files for such Patent Rights to
Anza
Tangible Assets
Transferred Tangible Assets listed in
Exhibit AP (including the [ * ] ) by leaving
such
Transferred Tangible Assets in the
facility located at 2550 Stanwell Drive or by moving
such
Transferred Tangible Assets to the
facility located at 2550 Stanwell Drive
Materials (including but not limited to:
[ * ]) as described on Exhibit AN Transferred
Know-How
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
Exhibit
F
T
RANSFERRED A SSETS TO
BE D ELIVERED WITHIN
90 D AYS AFTER C
LOSING
The following items to the extent that
they are Transferred Assets shall be delivered within ninety
(90) days after Closing in the manner and form as set forth
below:
Manufacturing Records and
Information
CRS-100 and CRS-207 chemistry,
manufacturing, and control documentation, including but not limited
to manufacturing batch records, methods qualification and
validation, and shipping
Financial Records and
Information
Grant awards listed in Exhibit AM
Transferred Grants
Government and third party financial
audits
Information and data related to
breakdown of historical expenditures by immunotherapy
program
Intellectual Property Records and
Information
Transferred Books and Records comprising
the laboratory notebooks or containing the pages listed
below
Records and information relating to
Intellectual Property Rights comprising the Transferred Know-How
and Transferred Patent Rights, including but not limited to
invention disclosure forms and patent prosecution files by
instruction to Cerus’ patent counsel to deliver such records
and information to Anza
Material
Contracts
Originals of Contracts listed in
Exhibit AL Transferred Contracts
Electronic Records and
Data
All data on servers related to
immunotherapy program including but not limited to email archives,
documents located on the Qumas DocCompliance electronic document
management system, and electronic data related to specific software
programs for testing, auditing, regulatory filings and other
related functions of the Business
Laboratory
Notebooks
Transferred Books and Records that
comprise the following laboratory notebooks or contain the specific
pages referenced within the following laboratory notebooks,
provided that the Parties acknowledge that the page numbers
provided below are estimates only and the actual pages to be
delivered to Anza shall include only the pages of such notebooks
containing Transferred Assets:
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No.
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Date issued
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Original
Owner
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Location
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Microfiche Roll
no.
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Pages
(approx.)
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|
[ * ]
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|
[ * ] |
|
[ * ] |
|
[ * ] |
|
[ * ] |
|
[ * ] |
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
2 of 7
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
3 of 7
Exhibit
G
B
UDGET
[ * ]
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
1 of 1
Exhibit
H
C ERUS P
RESS R ELEASE
CERUS ANNOUNCES SPIN-OFF
OF IMMUNOTHERAPY BUSINESS
- Cerus to focus resources
solely on blood safety business –
CONCORD, Calif. – November X, 2007
— Cerus Corporation (NASDAQ:CERS) announced today that it has
spun-off certain assets that make up its immunotherapy programs,
including Cerus’ Listeria and KBMA platform technologies, to
a newly-formed independent company financed by a syndicate of
leading venture capital firms. Cerus received an equity interest of
approximately 15.5% of the new company’s fully diluted
equity. Subject to the satisfaction of milestones, Cerus is
eligible to receive up to an additional $1.5 million of equity in
the new company or, under certain circumstances, in cash. In
addition to equity, Cerus is eligible to receive future cash
milestone payments of up to in excess of $90 million, as well as
royalty payments, if vaccine candidates generated from the
transferred assets are successfully developed and commercialized.
Cerus is no longer funding operations of the immunotherapy business
that has been transferred to the new company. As part of the
transaction, David N. Cook, Ph.D. and Thomas W. Dubensky, Ph.D.
have joined the new company as CEO and chief scientific officer,
respectively. Both were members of Cerus’ executive
management team.
“The completion of this
transaction allows Cerus to focus organizational and financial
resources solely on our core strengths in the blood safety
business,” said Claes Glassell, president and chief executive
officer, Cerus Corporation. “We remain confident that the
immunotherapy programs and technologies that we have transferred to
the new company will ultimately prove to represent important
advances in the treatment of cancer and infectious diseases. On a
personal note, we wish David Cook, Tom Dubensky and the many very
capable scientific, clinical and regulatory people associated with
our immunotherapy business continued success in their new
roles.”
With the spin-off of the immunotherapy
business completed, Cerus is now solely focused on commercializing
the INTERCEPT Blood System. Both the INTERCEPT platelet and plasma
systems have been approved and are being sold in Europe and in
other countries that recognize the CE mark. Cerus has worldwide
rights to the INTERCEPT Blood System, except in Asia, where Cerus
has licensed marketing rights to the platelet and plasma systems to
BioOne Corporation. In addition to its direct sales force in
Europe, Cerus has engaged country-specific distributors in Spain,
Portugal, Greece, Turkey, Kuwait, Russia and other CIS countries.
Cerus has conducted Phase III clinical trials of the platelet and
plasma systems in the United States and is in early-stage clinical
development of a modified red blood cell system.
ABOUT CERUS
Cerus Corporation is a
biopharmaceutical company focused on the development and
commercialization of the INTERCEPT Blood System ® . The INTERCEPT
®
system is designed to inactivate blood-borne pathogens in donated
blood components intended for transfusion. The company currently
markets the INTERCEPT system for both platelets and plasma in
Europe. The company is also in Phase I clinical trials for
development of the INTERCEPT system for red blood cells in the
United States.
C ERUS P
RESS R ELEASE
1 of 2
INTERCEPT and the INTERCEPT Blood System
are trademarks of Cerus Corporation.
This press release contains
forward-looking statements, including, without limitation,
statements related to Cerus’ receipt of future equity and
cash milestone and royalty payments and the therapeutic and
commercial potential of the immunotherapy programs that have been
spun-off to the new company. Words such as
“anticipated,” “may” and similar
expressions are intended to identify forward-looking statements.
These forward-looking statements are based upon Cerus’
current expectations. Forward-looking statements involve risks and
uncertainties. Cerus’ actual results and the timing of events
could differ materially from those anticipated in such
forward-looking statements as a result of these risks and
uncertainties, which include, without limitation, risks related to
the early stage of development and high risk of failure of the
vaccine programs that have been spun-off to the new company. These
and other risk factors are discussed under “Risk
Factors” in Cerus’ Quarterly Report on Form 10-Q for
the quarter ended September 30, 2007. Cerus expressly
disclaims any obligation or undertaking to release publicly any
updates or revisions to any forward-looking statements contained
herein.
###
C ERUS P
RESS R ELEASE
2 of 2
Exhibit
I
A SSIGNMENT
S EPARATE F ROM C
ERTIFICATE
For value received, the undersigned
Transferor does hereby assign and transfer to the Transferee named
immediately below:
{
} a total of (**{
}**) shares of the Series AA Preferred Stock of ANZA THERAPEUTICS,
INC., represented by the certificate(s) currently standing in the
name of the undersigned on the books of the company, as listed
below:
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|
Certificate
Number
|
|
Number of
Shares
|
|
Certificate
Dated
|
|
Certificate currently in the
possession
of: |
|
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|
The undersigned Transferor
does hereby irrevocably constitute and appoint WILSON
SONSINI GOODRICH & ROSATI, PROFESSIONAL
CORPORATION , attorney to transfer the said stock as listed
above on the books of the company, with full power of substitution
in the premises.
Dated:
, ,
2007
|
| TRANSFEROR: |
|
| CERUS
CORPORATION |
|
|
/s/ Claes Glassell
|
| Signature |
|
|
Claes Glassell
|
| Print Name
signed above |
|
|
President and Chief Executive
Officer
|
| Title, if
any |
A SSIGNMENT
S EPARATE F ROM C
ERTIFICATE
1 of 1
Exhibit
J
T
RANSFERRED C ONTRACTS S
UBJECT TO N
OVATION
[ * ]
1 of 1
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
Exhibit K
WSGR Legal
Opinion
[ * ]
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
Exhibit L
CGK Legal
Opinion
[ * ]
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
Exhibit M
ANZA THERAPEUTICS,
INC.
DAVID N. COOK EMPLOYMENT
AGREEMENT
[ * ]
1.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
Exhibit N
ANZA THERAPEUTICS,
INC.
THOMAS W. DUBENSKY, JR.
EMPLOYMENT AGREEMENT
[ * ]
1.
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
Exhibit O
ASSIGNMENT AND NOVATION
AGREEMENT
This Assignment and Novation
Agreement (this “ Agreement ”) is made as of
November 15, 2007 among Cerus Corporation, a Delaware
corporation (“ Cerus ”), Anza Therapeutics,
Inc., a Delaware corporation (“ Anza ”), and The
Johns Hopkins University, as Maryland Corporation, (“
JHU ”). Cerus, Anza and JHU are each referred to
herein as a “ Party ” and collectively as the
“ Parties .”
RECITALS
A. Cerus and JHU are parties
to (i) that certain Option and Exclusive License Agreement
dated April 8, 2003 ( [ * ] ), (ii) that certain
Exclusive License Agreement dated December 4, 2003 ( [ *
] ), and (iii) that certain Exclusive License Agreement
dated May 24, 2006 ( [ * ] ), in each case including
any and all amendments and modifications thereto (the “
Contracts ”).
B. Anza and Cerus have
entered into that certain Asset Transfer and License Agreement (the
“ Asset Agreement ”) pursuant to which Cerus has
transferred substantially all of the assets of its vaccines and
immunotherapy business to Anza (the “ Asset Transfer
”).
C. It is a condition to the
closing (the “Closing” ) under the Asset
Agreement that Cerus assign and transfer its rights and obligations
under the Contracts to Anza, subject to the terms and conditions
set forth herein.
D. JHU desires to consent to
the foregoing assignment and transfer of the Contracts by Cerus to
Anza and to recognize Anza as the successor party to the Contracts,
subject to the terms and conditions set forth herein.
Now, therefore, in
consideration of the foregoing premises, the mutual
representations, warranties covenants and other agreements set
forth herein and the mutual benefits to be gained by the
performance thereof, and for other good and valuable consideration,
the receipt and sufficiency of which are hereby acknowledged and
accepted, the Parties hereby agree as follows:
1. Assignment and
Transfer; Consent . Contingent upon and effective as of the
Closing, Cerus hereby assigns and transfers the Contracts to Anza,
and JHU consents to such assignment and transfer of the Contracts
by Cerus to Anza.
2. Assumption .
Contingent upon and effective as of the Closing, Anza agrees to be
bound by and to perform the Contracts in accordance with the
conditions contained in the Contracts and assumes all obligations
and duties of Cerus under the Contracts due now or accruing after
the Closing, as if Anza were the original party to the Contracts as
of the Closing.
3. Acceptance of
Substitute Performance . Contingent upon and effective as of
the Closing, JHU recognizes Anza as Cerus’ successor in
interest in and to the Contracts and agrees to look solely to Anza
for the performance of the obligations and duties under the
Contracts
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
without recourse to Cerus. It is
intended that this substitute performance by Anza constitute a
novation of the obligations and duties under the Contracts formerly
owed by Cerus. Notwithstanding the foregoing, Cerus shall continue
to comply with any confidentiality provisions under the Contracts
in the same manner as would apply under the survival provisions of
the Contracts, to the extent applicable. Additionally Cerus agrees
that its indemnification obligations will continue with respect to
claims arising prior to Closing.
4. Consideration .
Contingent upon and effective as of the Closing, as consideration
for JHU’s consent to the foregoing assignment and novation of
the Contracts, Anza agrees to pay to JHU [ * ] dollars ($
[ * ] ) within fifteen (15) business days of
Closing.
5. Miscellaneous
.
(a) Confidentiality .
Except as required by law, from the date hereof until (and only to
the extent) disclosed publicly by Cerus or Anza, JHU shall not
disclose to any third party any information about the Asset
Transfer, or the terms or conditions or any other facts relating
thereto, including, without limitation, the fact that discussions
are taking place with respect thereto or the status
thereof.
(b) Governing Law .
This Agreement shall be governed by and construed in accordance
with the laws of the State of California without regard to
conflicts-of-laws principles that would require the application of
any other law.
(c) Counterparts .
This Agreement may be executed in counterparts, all of which
together shall constitute one and the same instrument.
(The remainder of this
page is intentionally left blank.)
-2-
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
In witness whereof, the
Parties have caused this Agreement to be executed as of the date
first written above by their respective duly authorized
officers.
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| CERUS CORPORATION |
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ANZA THERAPEUTICS, INC. |
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| By: |
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/s/ Claes Glassell
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By: |
|
/s/ David N. Cook
|
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|
Claes
Glassell |
|
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David N. Cook, Ph.D. |
|
|
President
and Chief Executive Officer |
|
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President
and Chief Executive Officer |
|
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| THE JOHNS HOPKINS UNIVERSITY |
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| By: |
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/s/ Wesley D.
Blakeslee
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Wesley D.
Blakeslee |
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Executive
Director |
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|
-3-
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
Exhibit
P
A MENDED
AND R ESTATED E
XCLUSIVE L ICENSE A
GREEMENT (JHU R EF : [ *
])
[ * ]
Page 1 of 1
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
Exhibit
Q
A MENDED
AND R ESTATED O PTION
AND E XCLUSIVE L
ICENSE A GREEMENT
BETWEEN T HE J OHNS H
OPKINS U NIVERSITY & A
NZA T HERAPEUTICS , I
NC . JHU R EF : [ * ]
[ * ]
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
Exhibit
R
A MENDED
AND R ESTATED E
XCLUSIVE L ICENSE A
GREEMENT BETWEEN T HE
J OHNS H OPKINS U
NIVERSITY & A NZA T
HERAPEUTICS , I NC . JHU
[ * ] N O . : [ * ]
[ * ]
[ * ] = C ERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS
DOCUMENT , MARKED BY
BRACKETS , HAS BEEN
OMITTED AND FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION
PURSUANT TO R ULE 24
B -2 OF THE S
ECURITIES E XCHANGE A
CT OF 1934, AS
AMENDED .
Exhibit
S
S ELECTED T
RANSFERRED C ONTRACTS
[ * ]
[ * ] = C
ERTAIN CONFIDENTIAL
INFORMATION CONTAINED
IN THIS DOCUMENT ,
MARKED BY BRACKETS ,
HAS BEEN OMITTED
AND FILED SEPARATELY
WITH THE S ECURITIES
AND E XCHANGE C
OMMISSION PURSUANT TO
R ULE 24 B -2 OF
THE S ECURITIES E
XCHANGE A |