Exhibit 10.1
EXECUTION COPY
CERTAIN
CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED
WITH “***”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN
FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL
TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT OF 1934.
ASSET
PURCHASE AND LICENSE AGREEMENT
BETWEEN
AVANIR
PHARMACEUTICALS INC.
XENEREX BIOSCIENCES INC.
EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC.
AND
EMERGENT BIOSOLUTIONS INC.
Dated
as of March 6, 2008
ASSET PURCHASE AND LICENSE AGREEMENT
This Asset Purchase and License
Agreement is entered into as of March 6, 2008 (the
“Agreement”) by and between Emergent Product
Development Gaithersburg Inc., a Delaware corporation
(“Buyer”), Emergent BioSolutions Inc., a Delaware
corporation (“Buyer Parent”), Avanir Pharmaceuticals
Inc., a California corporation (“Seller Parent”), and
Xenerex Biosciences Inc., a California corporation
(“Seller” and, together with Seller Parent, the
“Sellers”). Each party to this Agreement is sometimes
referred to herein as a “Party” or collectively, the
“Parties.” Capitalized terms used in this Agreement
shall have the meanings ascribed to them where defined or in
Article IX.
INTRODUCTION
WHEREAS, Seller Parent is a
pharmaceutical company focused on developing, acquiring and
commercializing therapeutic products for the treatment of chronic
diseases; and
WHEREAS, Seller is a wholly-owned
subsidiary of Seller Parent; and
WHEREAS, Seller owns the Product and
Sellers desire to transfer ownership of the Product and certain
rights related to the Product Line Operations to Buyer; and
WHEREAS, Buyer is the wholly-owned
subsidiary of Emergent BioSolutions Inc. and as an inducement to
the Sellers to enter into the transactions contemplated by this
Agreement, Buyer Parent will concurrently with the execution hereof
enter into this agreement with the Sellers whereby Buyer Parent
will assure payment of all of the financial obligations of the
Buyer; and
WHEREAS, upon the terms and subject
to the conditions of this Agreement, Sellers wish to sell the
Acquired Assets (including the Product and the Product Line
Operations), license the Xenerex Technology for use in the Anthrax
Field, and assign the Assumed Liabilities to Buyer, and Buyer
wishes to purchase the Acquired Assets (including the Product and
the Product Line Operations), license the Xenerex Technology and
assume the Assumed Liabilities from Seller.
NOW, THEREFORE, in consideration of
the foregoing and the representations, warranties, covenants,
agreements and provisions set forth herein, and for other good and
valuable consideration, the receipt and sufficiency of which are
hereby acknowledged, and intending to be legally bound hereby, the
Parties hereto agree as follows:
ARTICLE I
THE
ASSET PURCHASE
1.1 Purchase and Sale of
Assets . Upon the terms and subject to conditions of this
Agreement, Buyer shall purchase from Seller, and Seller shall sell,
transfer, convey, license,
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assign
and deliver to Buyer, at the Closing, for the consideration
specified below in Article II , all of its right, title
and interest in, to and under the Acquired Assets.
1.2 Assumption of Liabilities
.
(a) Upon
the terms and subject to the conditions of this Agreement, Buyer
shall assume and become responsible for, from and after the
Closing, the Assumed Liabilities.
(b) Notwithstanding
the terms of Section 1.2(a) or any other provision of this
Agreement to the contrary, Buyer shall not assume or become
responsible for, and Seller shall remain liable for, the Retained
Liabilities.
1.3 Consent of Third Parties
.
(a)
Assigned Contracts . On the Closing Date, Seller shall
assign to Buyer, and Buyer shall assume, the Assigned Contracts to
the extent provided in this Agreement. The list of all Assigned
Contracts is set forth in Schedule 1.3(a) hereto. To the
extent that the assignment of all or any portion of any Assigned
Contract shall require the consent of the other party thereto or
any other third party, this Agreement shall not constitute an
agreement to assign any such Assigned Contract if an attempted
assignment without any such consent would constitute a breach or
violation thereof. In order, however, to seek to provide Buyer the
full realization and value of every Assigned Contract of the
character described in the immediately preceding sentence
(i) as soon as practicable after the Closing, Seller and Buyer
shall cooperate, in all reasonable respects, to obtain any
necessary consents to the assignment of the Assigned Contracts,
provided that neither Party shall be required to make any payments
or agree to any material undertakings in connection therewith, and
(ii) until all such consents are obtained or all such Assigned
Contracts expire or are terminated, Seller and Buyer shall
cooperate, in all reasonable respects, to provide to Buyer the
benefits under the Assigned Contracts (with Buyer entitled to all
the gains and responsible for all the losses, Taxes, liabilities
and/or obligations thereunder). In connection with clause (ii) of
this Section 1.3(a), if requested in writing by Buyer, Seller
shall, at Buyer’s cost and expense, seek to enforce for the
benefit of Buyer all claims or rights of Seller arising under the
Assigned Contracts, and Buyer shall perform and comply with, at
Buyer’s cost, all of Seller’s obligations under the
Assigned Contracts as if Buyer was Seller thereunder.
(b)
Registrations and Applicable Permits . On the Closing Date,
Seller shall assign or transfer to Buyer, and Buyer shall assume,
the Registrations and Applicable Permits to the extent provided in
this Agreement. To the extent that the assignment or transfer of
all or any portion of any Registration or Applicable Permit shall
require the consent of the other party thereto or any other third
party, this Agreement shall not constitute an agreement to assign
or transfer any such Registration or Applicable Permit if an
attempted assignment or transfer without any such consent would
constitute a breach or violation thereof. In order, however, to
seek to provide Buyer the full realization and value of the
Registrations and Applicable Permits (a) as soon as
practicable after the Closing, Seller shall use commercially
reasonable efforts to obtain and Buyer shall cooperate, in all
reasonable respects to obtain any necessary consents to the
assignment of the Registrations and Applicable Permits, provided
that neither Party shall be required to make any payments or agree
to any material undertakings in connection therewith,
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and
(b) until all such consents are obtained or all such
Registrations and Applicable Permits expire or are terminated,
Seller and Buyer shall cooperate, in all reasonable respects, to
provide to Buyer the benefits under the Registrations and
Applicable Permits.
1.4 Asset License . Sellers
hereby grants to Buyer an exclusive (even as to Sellers) limited to
the Anthrax Field, worldwide, perpetual license under the Xenerex
Technology to Develop and Commercialize Products intended for use
in the Anthrax Field, with the right to grant sublicenses (the
“Asset License”). Any sublicense granted to a Third
Party, shall be in writing and include provisions which obligate
such a party to comply with all the terms and conditions of this
Agreement. Buyer shall remain fully responsible to Sellers for
performance of this Agreement.
1.5 Third Party Agreements .
Seller shall be solely responsible for all obligations under the
agreements listed in Schedule 1.5 (each such agreement a
“Third Party Agreement”). Seller shall maintain the
Third Party Agreements in good standing and not take any actions
(or omit or fail to take any actions) which would result in a
breach of any of such Third Party Agreements other than as
contemplated by this section. Seller agrees that it shall not
amend, modify or supplement or take any action or inaction with
respect to any of the Third Party Agreements in any manner that
would materially adversely affect Buyer’s rights under this
Agreement without the consent of Buyer, such consent not to be
unreasonably withheld or delayed. In the alternative, Seller may
arrange for the assignment of such Third Party Agreements (with the
consent of the applicable third party licensor, if required) to
Buyer at no transactional expense to Buyer. In addition, Seller
shall not sell, assign (except as permitted in Section 10.4
hereof), convey, pledge, hypothecate or otherwise transfer any of
the Third Party Agreements or Seller’s rights or obligations
thereunder, or otherwise make any commitments or offers in a manner
that materially conflicts with Buyer’s rights hereunder
without the consent of Buyer, such consent not to be unreasonably
withheld or delayed. Seller shall immediately notify Buyer upon
receipt by Seller of any notice from a licensor under any Third
Party Agreements of such licensor’s intent to (i) terminate
Seller’s rights that are sublicensed to Buyer hereunder, or
(ii) exercise its respective rights or remedies thereunder, or
(iii) otherwise take any other action, in each case that would
reasonably be expected to materially and adversely affect
Buyer’s rights. This provision shall not affect, in any
manner, the parties’ rights to assign this Agreement or
rights to the Xenerex Technology not transferred under this
Agreement as provided for in Section 10.4 of this
Agreement.
1.6 Technology Transfer .
Sellers shall, as reasonably requested by Buyer, furnish Buyer with
copies of, and provide Buyer with ongoing access to, all
information or documentation in the control of Sellers or any of
their Affiliates relating to, or necessary or useful to exploit the
Product, which information and documentation includes, but is not
limited to: (i) all Seller Know-How and (ii) all data,
documentation and information relating to or that may be necessary
or useful for the filing of an Investigational New Drug
Application, a Biologics License Application or their foreign
counterparts for any product having the Product as an active
ingredient (including all databases, toxicology reports, and other
regulatory, scientific and safety information). Sellers shall make
available to Buyer appropriate personnel of Sellers and any of
their Affiliates as reasonably requested by Buyer from time to
time, to assist in the effectuation of the technology transfer
contemplated by Section 6.3, at Seller’s expense for the
four-week period following the Closing, not to exceed eight
(8) hours per week during such
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period
(with any out-of-pocket expenses incurred during such period by the
Seller’s representatives and approved by Buyer in writing to
be reimbursed by Buyer to Seller), and at Buyer’s expense
thereafter. Sellers hereby assign to Buyer their rights in any
regulatory filings for products having the Product as an active
ingredient, to the extent any such regulatory filings exist.
Sellers agree to work diligently and in good faith to complete the
transfers set forth in this Section 1.6 from Seller to
Buyer.
1.7 Further Assurances . At
any time and from time to time after the Closing, at the reasonable
request of Buyer and without further consideration, Sellers shall
execute and deliver such other instruments of sale, transfer,
conveyance and assignment and take such actions as Buyer may
reasonably request to transfer, convey and assign to Buyer, and to
confirm Buyer’s rights to, title in and ownership of, the
Acquired Assets and to place Buyer in actual possession and
operating control thereof.
ARTICLE II
PURCHASE PRICE; ADDITIONAL PAYMENTS
2.1 Execution Date Payment .
In consideration of the transactions contemplated by this
Agreement, Buyer shall assume the Assumed Liabilities and pay to
Seller, by wire transfer of immediately available funds directly to
an account designated by Seller $100,000 (the “ Execution
Date Payment ”) and make the additional payments, if
applicable, set forth in this Article II. The parties
acknowledge that Buyer previously paid a non-refundable amount of
$50,000 (the “ Proposal Payment ”) in
conjunction with the submission of the Proposal on November 7,
2007 and that such amount shall constitute part of the purchase
price for the Acquired Assets. Buyer Parent agrees to be jointly
and severally liable for the complete and prompt payment of
Buyer’s payment obligations under this Agreement.
2.2 GMP Payment . In addition
to any other amounts due hereunder, upon release by AppTec of the
GMP Clinical Materials to Buyer and Buyer’s written
acceptance thereof (which acceptance will not be unreasonably
withheld, conditioned or delayed), Buyer shall, upon receipt of
Seller’s invoice, promptly pay to Seller, by wire transfer of
immediately available funds directly to an account designated by
Seller $100,000 (the “ GMP Payment ”).
2.3 Milestone Payments .
Subject to the achievement of the following, Buyer shall, upon
receipt of Seller’s invoice, promptly pay to Seller:
(a) In
addition to any other amounts due hereunder, upon the terms and
subject to the conditions set forth herein, upon the receipt of
official notification of an award of a grant or contract (a copy of
such notification to be promptly provided to the Sellers) from
NIAID (excluding grants or contracts for Commercial Sales) with
respect to AVP-21D9 in response to the Proposal (the “
NIAID Grant ”):
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(i) |
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$ * *
* if the aggregate amount of the NIAID Grant award is equal
to or greater than $* * *; or |
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(ii) |
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$* * * if the aggregate amount of the NIAID Grant award is less
than $* * *. |
In the
event the Buyer does not receive a NIAID Grant in response to the
Proposal, upon the acceptance by Buyer or any Affiliate of a grant
or contract from NIAID (excluding grants or contracts for
Commercial Sales) with respect to AVP-21D9 in response to any
proposal other than the Proposal:
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(i) |
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$* * * if the aggregate amount of the NIAID Grant award is
equal to or greater than $* * *; or |
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(ii) |
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$* * * if the aggregate amount of the NIAID Grant award is less
than $* * * but greater than $* * *. |
Buyer
shall make only one payment to Seller under this
Section 2.3(a). The payment under subsections (i) and
(ii) above shall be payable only one time. In no event shall
aggregate payments due under this Section 2.3(a) exceed $* *
*.
(b) If
(and only if) Buyer or any Affiliate receives aggregate payments
from the NIAID pursuant to the NIAID Grant of at least $* * * ,
Buyer shall promptly pay Seller, in addition to all other amounts
payable under this Article II, an amount equal to $* * *. The
payment due under this Section 2.3(b) is a one-time payment
and shall only be paid upon receipt of the first $* * * paid under
the NIAID Grant.
(c) If
(and only if) Buyer, any Affiliate or any sublicensee achieves Net
Sales of at least $* * * (for the avoidance of doubt, the $* * * of
Net Sales does not include the $* * * NIAID Grant described in
clause (b) above), Buyer shall promptly pay Seller, in
addition to all other amounts payable under this Article II,
an amount equal to $* * *. The payment due under this Section
2.3(c) is a one-time payment and shall only be paid upon receipt of
the first $* * * of Net Sales.
2.4 Sales-Based Contingent
Purchase Price Payments .
(a) In
addition to any other amounts due under Article II, upon the
terms and subject to the conditions set forth herein, in
consideration of the sale, transfer, conveyance, assignment and
delivery of the Acquired Assets, Buyer shall pay, or cause to be
paid, to Seller quarterly payments in arrears in accordance with
this Section 2.4(a) and Section 2.4(b) (the “
Sales-Based Contingent Purchase Price Payments ”)
based upon cumulative Net Sales of the Product or any product or
antibody made, produced, manufactured or sublicensed under the
Asset License. The payments shall be determined in accordance with
the following scale:
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(i) until
the amount of cumulative Net Sales is equal to $ * * * , * * *
percent (* * *%) of such Net Sales;
(ii) for
that portion of cumulative Net Sales equal to or greater than
$* * * but less than $* * * , * * * percent (* * *%) of such Net
Sales; and
(iii) for
that portion of cumulative Net Sales equal to or greater than $* *
* but less than $* * *, *** percent (***%) of such Net Sales;
and
(iv) for
that portion of cumulative Net Sales equal to or greater than $* *
*, * * * percent (* * *%) of such Net Sales.
(b)
Payment and Reports .
(i)
Quarterly Payment Reports . Buyer shall deliver to Seller,
within forty-five (45) days after the end of each calendar quarter,
a written accounting of Net Sales during the prior calendar
quarter. Such quarterly reports shall indicate (i) gross sales
of Product, an itemization of deductions made to gross sales to
reach Net Sales, Net Sales and cumulative Net Sales, and (ii) the
calculation of payment amounts owed to Seller from such gross sales
and Net Sales. Buyer shall deliver amounts due pursuant to
Section 2.4(a) to Seller for each calendar quarter
concurrently with the delivery to Seller of the accounting for such
calendar quarter.
(ii)
Audits . Buyer shall keep, and shall require its Affiliates
and its and their sublicensees to keep, records of the latest three
(3) years relating to gross sales and Net Sales. For the sole
purpose of verifying the reports provided for in
Section 2.4(b), Buyer further agrees to permit such records to
be examined by an independent accounting firm selected by Seller at
Seller’s cost and expense and in the location(s) where such
records are maintained by Buyer and its Affiliates upon reasonable
notice, during regular business hours and without unreasonable
disruption to Buyer’s and its Affiliates’ operations.
Unless Seller obtains the prior written consent of Buyer, which
consent shall not be unreasonably withheld, such accounting firms
must be selected from U.S. accounting firms that are AICPA
registered accounting firms. Such audit shall not be performed more
frequently than once per calendar year nor more frequently than
once with respect to records covering any specific period of time.
Seller shall provide a copy of the results (and backup) of such
review promptly after Seller receives such results. If the review
reflects an underpayment to Seller, Buyer shall promptly remit such
underpayment to Seller, Together with a rate of interest equal to
an annual percentage rate of nine percent (9%), provided ,
that if Buyer notifies Seller that Buyer disagrees with the
determination of the underpayment amount and if thereafter the
Parties are unable to agree in good faith as to such underpayment
amount, then such matter shall be referred to a mutually agreed
independent auditor or valuation expert for resolution, and the
determination of such auditor or valuation expert shall be
conclusive and binding on the parties. If the underpayment is equal
to or greater than ten percent (10%) of the amount that was
otherwise due, Seller shall be entitled to have Buyer pay all of
the costs of such review, including the cost of the independent
auditor.
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(c)
Adjustments to Payments .
(i) If,
in any calendar quarter, sales of Follow-On Biological Products
reach *** percent (***%) worldwide market share (calculated on a
unit basis), then, the payment owed under Section 2.4 for Net Sales
shall be decreased by *** percent (***%) for the remainder of the
time period that payments are due pursuant to
Section 2.4.
(ii) On
a country-by-country basis, Buyer may reduce the amount of any
payments otherwise due to Seller under this Section 2.4 with
respect to Net Sales in such country by up to * * * percent (* *
*%) of any royalties or other amounts paid to Third Party(ies) to
permit the Development or Commercialization of the Product (or any
amounts paid to such Third Party(ies) in settlement of a claim of
infringement by the Product).
(d)
Duration of Payments . The amounts payable under this
Section 2.4 shall be paid on a country-by-country basis until
the earlier of (i) seven (7) years following the first
Commercial Sale of the Product in such country or
(ii) expiration or discontinuation of the last to expire Valid
Claim that Covers the Development or Commercialization of the
Product in such country.
ARTICLE III
CLOSING
3.1 Closing . Upon the terms
and subject to the conditions of this Agreement, the Closing shall
take place concurrently with the execution of this Agreement by the
Parties hereto (the “ Closing Date ”). The
Parties to this Agreement will exchange (or cause to be exchanged)
at the Closing the funds, agreements, instruments, certificates and
other documents, and do, or cause to be done, all of the things
respectively required of each Party as specified in
Sections 3.2(a) and 3.2(b)
3.2 Transactions at Closing
.
(a)
Seller’s Actions and Deliveries . At the Closing,
Seller shall:
(i) execute
and deliver to Buyer this Agreement;
(ii) execute
and deliver to Buyer a bill of sale in the form attached hereto as
Exhibit A ;
(iii) execute
and deliver to Buyer one or more patent assignments in the form
attached hereto as Exhibit B ;
(iv) execute
and deliver such other instruments of conveyance as Buyer may
reasonably request in order to effect the sale, transfer,
conveyance, assignment and license to Buyer of valid ownership of
the Acquired Assets;
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(v) deliver
to Buyer, or otherwise put Buyer in possession and control of, all
of the Acquired Assets of a tangible nature;
(vi) execute
and deliver to each other a cross-receipt evidencing the
transactions referred to in this Section 3.2(a); and
(vii) execute
and deliver an Incumbency and Officer’s Certificate from each
of Seller and Seller Parent in form and substance reasonably
satisfactory to Buyer.
(b)
Buyer’s Actions and Deliveries . At the Closing Buyer
shall:
(i) execute
and deliver to Sellers this Agreement;
(ii) execute
and deliver to Seller an instrument of assumption in the form
attached hereto as Exhibit C ;
(iii) execute
and deliver such other instruments as Sellers may reasonably
request in order to effect the assumption by Buyer of the Assumed
Liabilities;
(iv) pay
to Seller, payable by wire transfer of immediately available funds
to an account designated by Seller, the Execution Date
Payment;
(v) execute
and deliver to each other a cross-receipt evidencing the
transactions referred to in this Section 3.2(b); and
(vi) execute
and deliver an Incumbency and Officer’s Certificate from each
of Buyer and Buyer Parent in form and substance reasonably
satisfactory to Sellers.
ARTICLE IV
REPRESENTATIONS AND WARRANTIES OF SELLER AND SELLER
PARENT
Each of the Sellers, jointly and
severally, represents and warrants to Buyer that, except as set
forth in the Disclosure Schedule, the statements contained in this
Article IV are true and correct. The Disclosure Schedule shall
be arranged in sections and subsections corresponding to the
numbered sections and subsections contained in this
Article IV. The disclosures in any section or subsection of
the Disclosure Schedule shall qualify the corresponding section or
subsection in this Article IV as well as any other section or
subsection to which the nature of the disclosure made relates but
only to the extent it is reasonably apparent from a reading of the
disclosure that such disclosure is applicable to such other section
and subsection. Nothing in the Disclosure Schedules is intended to
broaden the scope of any representation, warranty or covenant of
Sellers contained in this Agreement. The inclusion of any
information in the Disclosure Schedules (or any update thereto)
shall not be deemed to be an admission or acknowledgment, in and of
itself, that such information is required by the terms hereof to be
disclosed, is material to the Business, has resulted in or would
result in a Material Adverse Effect or is outside the Ordinary
Course of Business.
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4.1 Organization, Qualification
and Corporate Power . Each of the Sellers is a corporation duly
organized, validly existing and in corporate and tax good standing
under the laws of the State of California. Seller has all requisite
corporate power and authority to own, lease and operate, as
applicable, the Acquired Assets.
4.2 Authorization of
Transaction . Each of the Sellers has all requisite power and
authority to execute and deliver this Agreement and the Ancillary
Agreements to which it is a party and to perform its obligations
hereunder and thereunder. The execution and delivery by each of the
Sellers of this Agreement and the Ancillary Agreements to which it
is a party and the performance by each of the Sellers of this
Agreement and each Ancillary Agreement to which it is a party and
the consummation by each of the Sellers of the transactions
contemplated hereby and thereby have been duly and validly
authorized by all necessary corporate action on the part of each of
the respective Sellers. Each of this Agreement and the Ancillary
Agreements has been duly and validly executed and delivered by each
of Sellers that is a party thereto and constitutes a valid and
binding obligation of Sellers, enforceable against each of the
Sellers in accordance with its terms except as may be limited by
the effects of bankruptcy, insolvency, fraudulent conveyance,
reorganization, moratorium and other similar Laws relating to or
affecting creditors’ rights generally and general equitable
principles (whether considered in a proceeding in equity or at
law).
4.3 Noncontravention . Except
as disclosed on Schedule 4.3(c), neither the execution and
delivery by Sellers of this Agreement or any of the Ancillary
Agreements, nor the consummation by Sellers of the transactions
contemplated hereby or thereby, does or will (a) conflict with
or violate any provision of the Articles of Incorporation or
by-laws of either of the Sellers, (b) require on the part of either
of the Sellers any notice to or filing with, or any permit,
authorization, consent or approval of, any Governmental Entity,
(c) conflict with, result in a breach of, constitute (with or
without due notice or lapse of time or both) a default under,
result in the acceleration of obligations under, create in any
party the right to terminate, modify or cancel, or require any
notice, consent or waiver under, any contract or instrument to
which either of the Sellers is a party or by which either of the
Sellers is bound or to which any of its assets is subject,
(d) result in the imposition of any Lien upon any of the
Acquired Assets or (e) violate any order, writ, injunction,
decree, statute, rule or regulation applicable to Seller or any of
its respective properties or assets.
4.4 Absence of Certain Changes
. Between December 31, 2006 and the date of this Agreement,
there has not been with respect to the Product Line
Operations:
(a) any
Material Adverse Effect, except that Sellers have reorganized and
downsized their operations and have terminated the employment of
all personnel working on the Product Line Operations and the
Xenerex Technology except for one person, and Sellers have greatly
reduced the amount of laboratory and research space used for the
development of the Product Line Operations and the Xenerex
Technology, resulting in a substantial slowdown in development
efforts;
(b) any
incurrence, assumption or guarantee of any material Liability in
the Ordinary Course of Business other than restructuring and other
restructuring charges for
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personnel and facilities incurred in connection with the downsizing
described in Section 4.4(a); or
(c) any
material transaction, agreement or event except as described in
Section 4.4(a) outside the Ordinary Course of Business.
4.5 Taxes . There are no Liens
for Taxes upon the Acquired Assets except those relating to Taxes
that are not yet due and payable.
4.6 Ownership and Condition of
Assets .
(a) Except
with respect to Product Line Intellectual Property (which is
subject to Section 4.7) and the Books and Records, Seller is the
true, lawful and sole owner, and has good title to the Product and
Seller’s rights in the Assigned Contracts (subject to the
rights of each counterparty in such Assigned Contracts), free and
clear of all Liens. Upon execution and delivery by Seller to Buyer
of the instruments of conveyance referred to in Section 3.2,
Buyer will become the true, lawful and sole owner of, and will
receive good title to, the Product and Seller’s rights in the
Assigned Contracts (subject to the rights of each counterparty in
such Assigned Contracts), free and clear of all Liens.
(b) Seller
has the lawful right to use the Books and Records. Upon execution
and delivery by Seller to Buyer of the instruments of conveyance
referred to in Section 3.2, Buyer will have the lawful right
to use the Books and Records.
(c) The
Acquired Assets, together with the assets licensed pursuant to the
license set forth in Section 1.4 are sufficient for the
conduct of the Product Line Operations except that Seller does not
have any right to Commercialize any Product other than AVP-21D9.
Each tangible Acquired Asset is free from material defects, has
been maintained in accordance with normal industry practice, and is
in good operating condition and repair (subject to normal wear and
tear).
4.7 Intellectual Property .
Notwithstanding anything to the contrary set forth in this
Agreement, the representations set forth in this Section 4.7
constitute Seller Parent’s and Seller’s sole
representations with respect to Product Line Intellectual Property,
except for the representations set forth in Sections 4.2, 4.3,
4.5, and 4.10.
(a)
Ownership; Sufficiency. The AVP Anthrax Patents constitute
all patents and patent applications owned by Sellers necessary or
useful for the exploitation of the Product and the conduct of the
Product Line Operations. Section 4.7(a) of the Disclosure
Schedule lists, with respect to the AVP Anthrax Patents, the
applicable application or patent number, title, and jurisdiction in
which filing was made, date of filing or issuance. Seller is the
owner of and has good title to the AVP Anthrax Patents in existence
as of the Closing Date, free and clear of any Lien. All assignments
to the Seller of AVP Anthrax Patents in existence as of the Closing
Date have been properly executed and recorded. All issuance,
renewal, maintenance and other payments that are or have become due
with respect thereto have been timely paid by or on behalf of
Seller. The AVP Anthrax Patents will be owned by the Buyer
immediately following the
10
Closing
on the same terms and conditions as they were held by the Seller
immediately prior to the Closing.
(b)
Prosecution Matters. Subject to 4.7(a), there are no
inventorship challenges, opposition or nullity proceedings or
interferences declared, commenced or provoked, or to the knowledge
of Seller, threatened, with respect to any AVP Anthrax Patents in
existence as of the Closing Date. In Application
No. 11/041,763, the Seller copied claims from U.S. Patent
Publication No. 20060258842, published on November 16, 2006 to
Groen et al. and PCT Publication No. WO 2005/120567, published
on December 22, 2005 to Groen et al. (IQ Corporation), which
claims were subsequently cancelled. Seller and entities involved in
the prosecution of the AVP Anthrax Patents (such as Seller’s
attorneys, inventors, agents) have complied with their duty of
candor and disclosure to the United States Patent and Trademark
Office and any foreign patent office requiring such disclosure with
respect to all patent applications filed by or on behalf of Seller
and have made no material misrepresentation in such applications.
To the extent that patent applications are pending, Seller may
still be in the process submitting Information Disclosure
Statements in the United States, or equivalent submissions in
Foreign Patent Offices.
(c)
Protection Measures. Seller has taken reasonable measures to
protect the proprietary nature of the Product Line Intellectual
Property, and to maintain in confidence all trade secrets and
information comprising a part thereof. To the Knowledge of the
Seller, there has been no: (i) unauthorized disclosure of any third
party proprietary information in the possession, custody or control
of Seller, or (ii) breach of Seller’s security
procedures wherein information has been disclosed to a third
person.
(d)
Non-infringement of Third Party Rights. To the knowledge of
the Seller, the Product Line Operations do not infringe or violate,
or constitute a misappropriation of, any Patents and Know-How
rights of any Third Party. Sellers have not received any complaint,
claim or notice, or threat of any of the foregoing (including any
notification that a license under any patent is or may be required.
Sellers have provided or made available to Buyer copies of all
complaints, claims, notices or threats concerning any alleged
infringement by the Product, in its possession.
(e)
Infringement of Seller’s Rights. To the knowledge of
Seller, no third party (including, without limitation, any current
or former employee, founder, inventor of any Product Line Patent,
or consultant to Seller) is infringing, violating or
misappropriating any of the Product Line Intellectual Property.
Sellers have provided or made available to Buyer copies of all
complaints, claims, notices or threats concerning the infringement,
violation or misappropriation of any Product Line Intellectual
Property.
(f)
Outbound IP Agreements. Section 4.7(f) of the
Disclosure Schedule identifies each license, covenant or other
agreement pursuant to which Seller has assigned, transferred,
licensed, distributed or otherwise granted any right or access to
any person or entity, or covenanted not to assert any right, with
respect to any past, existing or future Product Line Intellectual
Property. Neither of the Sellers is a member of or party to any
patent pool, industry standards body, trade association or other
organization pursuant to the rules of which it is obligated to
license any existing or future Product Line Intellectual Property
to any person.
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(g)
Inbound IP Agreements. Section 4.7(g) of the Disclosure
Schedule identifies each agreement, contract, assignment or other
instrument between Seller and a third party which are part of the
Acquired Assets.
(h)
Employee and Inventor Assignments . Schedule 4.7(h)
identifies each employee of Seller materially involved in the
research or development of the Product, and any inventor of the AVP
Anthrax Patents has executed a valid and binding written agreement
expressly or in substance assigning to Seller all right, title and
interest in any inventions and works of authorship, whether or not
patentable, invented, created, developed, conceived and/or reduced
to practice during the term of such employee’s employment and
all Patents and Know-How rights therein.
(i)
Support and Funding . The U.S. Government may have certain
rights to the AVP Anthrax Patents by virtue of one or more Grants
Received. Except as set forth on Schedule 4.7(i) of the
Disclosure Schedule, Seller has not received any direct support,
funding, resources or assistance from any federal, state, local or
foreign governmental or quasi-governmental agency or funding source
in connection with the development or exploitation of the Product
or conduct of the Product Line Operations or any facilities or
equipment used in connection therewith.
4.8 Biological Materials . To
Seller’s Knowledge, the Biological Materials listed on
Schedule 9.1(d) constitute all of the Biological Materials. To
Sellers’ Knowledge, all Biological Materials in the
possession of AppTec have been developed, produced and stored in
accordance with Good Laboratory Practices as defined by the U.S.
Food and Drug Administration (“GLP”).
4.9 Contracts . Seller has
made available or delivered to Buyer a complete and accurate copy
of each Assigned Contract. The Assigned Contracts include all of
the contracts and agreements to which Seller or any of its
Affiliates is a party that relate primarily or exclusively to the
Product Line Operations. Neither Seller nor any of its Affiliates
is a party to or bound by any contract, agreement or arrangement
(written or oral) that is material to the Product Line Operations,
except for the Assigned Contracts. All of the Assigned Contracts
are in full force and effect. All of the Assigned Contracts are
valid and binding and are enforceable in accordance with their
terms against Seller and, to Seller’s Knowledge, all other
parties thereto. Except as set forth in Section 4.9 of the
Disclosure Schedule, all of the Assigned Contracts are freely
assignable to Buyer pursuant to this Agreement without the consent
of any party thereto. To the knowledge of Seller, no condition
exists or event has occurred as a result of action or inaction by
Seller or any other person that, with notice or lapse of time or
both, would constitute (a) default of any Assigned Contract by
Seller, or any other party thereto or (b) a basis for force
majeure or other claim of excusable delay or non-performance
under any Assigned Contract against Seller or against any other
party thereto.
4.10 Litigation . There is no
action, suit, litigation, proceeding, claim, governmental
investigation or administrative action pending or, to
Seller’s Knowledge, threatened directly or indirectly
involving the Product, the Product Line Operations, the Acquired
Assets, any Assigned Contract or the transactions contemplated
hereby or by any of the Ancillary Agreements, which has had or
would, individually or in the aggregate, reasonably be expected to
cause a Material Adverse Effect.
12
4.11 Permits . All permits,
licenses, franchises or authorizations from any Governmental Entity
that are required for the Product Line Operations are listed on
Schedule 4.11 (collectively, the “ Applicable
Permits ”) and are valid and in full force and effect and
Seller is not in violation of or in default under any Applicable
Permit. No suspension or cancellation of any such Applicable Permit
has been threatened in writing.
4.12 Legal Compliance . Seller
is, and has since December 31, 2005 been, in material
compliance with all applicable laws (including rules and
regulations thereunder) of any Governmental Entity, relating to the
Product Line Operations, the Acquired Assets and the use of the
Acquired Assets.
4.13 Regulatory Compliance
.
(a) Seller
has delivered or made available to Buyer true, correct and complete
copies of all material written communications between Seller, on
the one hand, any applicable Medical Product Regulatory Authority
on the other hand, relating to the Product, including copies of any
pre-Investigational New Drug Application meeting packages submitted
by Seller for the Product, and any similar state or foreign
regulatory submission made by or on behalf of Seller, including all
supplements and amendments thereto. There have been no meetings or
oral discussions between Seller, on the one hand, any applicable
Medical Product Regulatory Authority on the other hand, relating to
the Product.
(b) The
conduct of the production and Development activities related to the
Product Line Operations has been conducted in material compliance
with current Good Manufacturing Practices and other applicable
rules and regulations of the FDA. Buyer acknowledges and Seller
represents that Product scale up has been outsourced to Third
Parties. Sellers agree to require vendors to conduct studies to be
performed under the U01 in accordance with Good Laboratory
Practices.
(c) Seller
has not been and is not, and to Sellers Knowledge none of its
subcontractors engaged in the Development or production of the
product have been or is, subject to any adverse FDA inspection,
finding of deficiency, finding of non-compliance, warning,
investigation, penalty for corrective or remedial action or other
compliance or enforcement action relating to Seller’s
operations, the Product, or any of Seller’s other
products.
(d) Neither
Seller nor any of Seller’s officers, employees or agents
acting for Seller is subject to any pending or threatened
investigation by (A) the FDA pursuant to its “Fraud,
Untrue Statements of Material Facts, Bribery, and Illegal
Gratuities” policy set forth in 56 Fed. Reg. 46191
(September 10, 1991) or any amendments thereto, (B) the
Department of Health and Human Services Office of Inspector
General, Department of Justice, or other Governmental Entity
pursuant to the Federal Anti-Kickback Statute (42 U.S.C.
§1320a-7(b)), or the Federal False Claims Act, or similar
state or foreign law. Neither Seller nor any of Seller’s
officers, employees or agents acting for Seller has committed any
act, made any statement or failed to make any statement that would
reasonably be expected to provide a basis for action under any of
the statutes, regulations or policy referred to in the preceding
sentence. Neither Seller nor any of Seller’s officers,
employees or agents acting for Seller has been convicted of any
crime or engaged in any conduct that would reasonably be expected
to result in (A)
13
debarment under 21 U.S.C. §335a or any similar state or
foreign law or (B) exclusion under 42 U.S.C. §1320a-7 or
any similar state or foreign law.
4.14 Environmental Matters
.
(a) Seller
and the conduct of the Product Line Operations are and have been in
compliance with applicable Environmental Laws, except for any
failure to comply with Environmental Laws that would not reasonably
be expected to result in a Material Adverse Effect.
(b) There
is no pending or, to the knowledge of Seller, threatened action,
suit, notice of violation or judicial or administrative proceeding,
investigation or claim relating to Environmental Matters, including
Off-Site Liabilities or any violation of Environmental Law,
involving the Product Line Operations, or any property currently,
or, to the knowledge of Seller, formerly owned or operated by
Seller in connection with the Product Line Operations.
4.15 Specifications . The
specifications included in Schedule 4.15 of the Disclosure
Schedule (the “ Specifications ”) are the
specifications that are used by Seller to produce AVP-21D9 at a 100
liter scale as of the date hereof, and the GMP Clinical Materials
to be released by Apptec shall satisfy the Specifications.
4.16 Clinical and Scientific
Data.
(a) To
Sellers’ knowledge, Seller has made available to Buyer all
available pre-clinical study data, including raw data and reports,
created by Seller, or any third party on behalf of Seller relating
to the Product (“Scientific Data”) and in
Seller’s possession. Seller will following the Closing,
continue to take commercially reasonable steps to make available or
assist Buyer in obtaining access to all Scientific Data.
(b) Seller
either owns and has possession, or has the right to use and full
rights of access to, all Scientific Data.
(c) There
have been no human clinical studies conducted in connection with
the Product.
(d) The
Proposal is materially consistent with the Scientific Data.
ARTICLE V
REPRESENTATIONS AND WARRANTIES OF BUYER AND BUYER
PARENT
Buyer and Buyer Parent, as the case
may be, represent and warrant to Seller as follows:
5.1 Organization and Corporate
Power . Buyer and Buyer Parent are corporations duly organized,
validly existing and in good standing under the laws of the State
of Delaware. Buyer and Buyer Parent have all requisite corporate
power and authority to carry on the businesses in which they are
engaged and to own and use the properties owned and used by
them.
14
5.2 Authorization of the
Transaction . Buyer and Buyer Parent have all requisite power
and authority to execute and deliver this Agreement and the
Ancillary Agreements and to perform their respective obligations
hereunder and thereunder. The execution and delivery by Buyer and
Buyer Parent of this Agreement and the Ancillary Agreements and the
consummation by Buyer of the transactions contemplated hereby and
thereby have been duly and validly authorized by all necessary
corporate action on the part of Buyer and Buyer Parent. This
Agreement and the Ancillary Agreements have been duly and validly
executed and delivered by Buyer and Buyer Parent and constitute
valid and binding obligations of Buyer and Buyer Parent enforceable
against them in accordance with their respective terms.
5.3 Noncontravention . Neither
the execution and delivery by Buyer and Buyer Parent of this
Agreement or the Ancillary Agreements, nor the consummation by
Buyer and Buyer Parent of the transactions contemplated hereby or
thereby, will (a) conflict with or violate any provision of
the Certificate of Incorporation or by-laws of Buyer or Buyer
Parent, (b) require on the part of Buyer or Buyer Parent any
filing with, or permit, authorization, consent or approval of, any
Governmental Entity, (c) conflict with, result in breach of,
constitute (with or without due notice or lapse of time or both) a
default under, result in the acceleration of obligations under,
create in any party any right to terminate, modify or cancel, or
require any notice, consent or waiver under, any contract or
instrument to which Buyer or Buyer Parent is a party or by which it
is bound or to which any of its assets is subject, except for
(i) any conflict, breach, default, acceleration, termination,
modification or cancellation which would not adversely affect the
consummation of the transactions contemplated hereby or
(ii) any notice, consent or waiver the absence of which would
not reasonably be expected to adversely affect or delay the
consummation of the transactions contemplated hereby, or
(d) violate any order, writ, injunction, decree, statute, rule
or regulation applicable to Buyer, Buyer Parent or any of their
respective properties or assets.
5.4 Compliance with Applicable
Law . Buyer conducts its business in compliance with all
applicable laws, except for violations, if any, which would not,
individually or in the aggregate, reasonably be expected to
materially affect or delay the ability of Buyer to consummate the
transactions contemplated hereby.
5.5 Litigation . There is no
material action, suit, litigation, proceeding, claim or
investigation pending, or to the knowledge of Buyer, threatened
that is reasonably likely to adversely affect or delay
Buyer’s or Buyer Parent’s performance under this
Agreement or the consummation of the transactions contemplated
herein.
5.6 Brokers’ Fees .
Buyer does not have any liability or obligation to pay any fees or
commissions to any broker, finder or agent with respect to the
transactions contemplated by this Agreement.
15
ARTICLE VI
COVENANTS; OTHER AGREEMENTS
6.1 Proprietary Information .
From and after the Closing, Sellers shall not disclose or make use
of (except to pursue its rights, under this Agreement or the
Ancillary Agreements), and shall use their best efforts to cause
all of its Affiliates not to disclose or make use of, any
knowledge, information or documents of a confidential nature or not
generally known to the public with respect to Acquired Assets or
Buyer or its business, except to the extent that such knowledge,
information or documents shall have become public knowledge other
than through improper disclosure by Seller or an Affiliate. Sellers
shall enforce, for the benefit of Buyer, all confidentiality,
invention assignments and similar agreements between either Seller
or Seller Parent and any other party relating to the Acquired
Assets. Except with respect to the Xenerex Technology not licensed
or assets not sold under this Agreement, the Buyer shall be
entitled to assume the control of any litigation, action,
arbitration or proceeding in connection with the enforcement of any
of the rights associated with the Acquired Assets at Buyer’s
expense. Notwithstanding the foregoing or any other provision in
this Agreement, Sellers may mar
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