Exhibit 10.42
PATENT LICENSE
AGREEMENT
dated
December 31,
2008
between
PDL BIOPHARMA,
INC.
and
ALEXION PHARMACEUTICALS,
INC.
[*] = Portions of this exhibit have been omitted
pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the
Commission.
TABLE OF
CONTENTS
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Page
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1.
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DEFINITIONS
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1
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2.
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LICENSE AND
OTHER RIGHTS
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5
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2.1.
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License
Grant
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5
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2.2.
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Sublicense
Rights
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5
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2.3.
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Additional
Other Licensed Products
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7
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2.4.
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Alexion Right
of First Refusal
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8
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2.5.
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No Other
License
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8
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2.6.
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Covenant Not to
Sue with Respect to PDL Queen Patent Family
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8
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2.7.
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Covenant Not to
Sue with Respect to Other PDL Patents
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12
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3.
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PAYMENTS;
ROYALTIES; REPORTS
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12
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3.1.
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Lump-Sum
Payments
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12
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3.2.
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Royalties and
Other Payments on Other Licensed Products
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12
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3.3.
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Sales Among
Affiliates
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13
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3.4.
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Combination
Products
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13
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3.5.
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Payment,
Currency Conversion
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13
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3.6.
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Currency
Transfer Restrictions
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14
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3.7.
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Royalty
Reports
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14
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3.8.
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Inspection
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14
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3.9.
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Withholding
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15
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3.10.
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Interest on
Overdue Payments
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15
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3.11.
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No Royalty
Offsets
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16
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4.
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INFRINGEMENT
OF PDL QUEEN PATENT FAMILY
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16
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4.1.
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Suits
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16
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5.
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REPRESENTATIONS AND WARRANTIES;
INDEMNIFICATION
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16
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5.1.
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Valid Agreement
and Certain Other Representations and Warranties
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16
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5.2.
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Disclaimers
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17
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5.3.
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No Other
Warranties
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17
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5.4.
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Indemnification
by Alexion
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17
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5.5.
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Indemnification
by PDL
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18
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6.
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CONFIDENTIALITY
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18
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6.1.
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Confidentiality
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18
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6.2.
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Exceptions
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19
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7.
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TERM AND
TERMINATION
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20
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7.1.
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Term
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20
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7.2.
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Termination
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20
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7.3.
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No
Waiver
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22
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7.4.
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Effect of
Expiration or Termination
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22
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7.5.
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Survival
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23
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i
[*] = Portions of this exhibit have been omitted
pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the
Commission.
TABLE OF CONTENTS
(continued)
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Page
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8.
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GOVERNANCE
PROVISIONS
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23
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8.1.
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Assignment
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23
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8.2.
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Entire
Agreement; Amendment
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24
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8.3.
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Severability
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24
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8.4.
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Notices
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24
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8.5.
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Choice of
Law
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25
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8.6.
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Dispute
Resolution
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26
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8.7.
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Waiver
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28
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8.8.
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Force
Majeure
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28
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8.9.
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Publicity
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28
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8.10.
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Headings
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28
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8.11.
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Construction
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28
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8.12.
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Successors and
Assigns
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28
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8.13.
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License
Survival During Bankruptcy
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28
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8.14.
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Counterparts
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29
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ii
[*] = Portions of this exhibit have been omitted
pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the
Commission.
C ONFIDENTIAL
E XECUTION C OPY
PATENT LICENSE
AGREEMENT
This Patent License Agreement (this
“ Agreement ”), effective as of
December 31, 2008 (“ Effective Date ”), is
made by and between PDL BioPharma, Inc., a Delaware corporation
having offices at 932 Southwood Boulevard, Incline Village, NV
89451 (“ PDL ”), and Alexion Pharmaceuticals,
Inc., a Delaware corporation having offices at 352 Knotter Drive,
Cheshire, CT 06410 (“ Alexion ”).
RECITALS
A. PDL and Alexion are parties to
that certain Settlement Agreement, dated of even date herewith
(“ Settlement Agreement ”), pursuant to which,
among other matters, PDL and Alexion have agreed to settle the
Litigation (as defined in the Settlement Agreement) and enter into
this Agreement; and
B. Alexion desires non-exclusive
licenses to the PDL Queen Patent Family (as defined below) to make,
have made, use, sell, offer for sale, import and export the
Licensed Homology Product (as defined below) and Other Licensed
Products (as defined below), and PDL is willing to grant such
non-exclusive licenses to Alexion under the terms and conditions of
this Agreement.
AGREEMENT
NOW THEREFORE, in consideration of
the mutual covenants herein contained and intending to be legally
bound, PDL and Alexion agree as follows:
Except as otherwise expressly
provided herein, the following terms used in this Agreement shall
have the definitions assigned to them in this Section 1 and shall
include the singular as well as the plural.
1.1. “ Affiliate. ” Any corporate
or other entity which, directly or indirectly, controls, is
controlled by, or is under common control with a Party during the
term of this Agreement, where “control” means the
ownership of more than fifty percent (50%) of the voting
shares of a corporation or other entity, or of decision-making
authority as to an unincorporated entity; provided ,
however , that such corporation or other entity shall be an
Affiliate only so long as such control exists.
1.2. “ Agreement. ” The meaning
specified in the Preamble to this Agreement.
1.3. “ Alexion. ” The meaning
specified in the Preamble to this Agreement.
1.4. “ Antibody Person. ” The
meaning specified in the Settlement Agreement.
[*] = Portions of this exhibit have been omitted
pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the
Commission.
C ONFIDENTIAL
E XECUTION C OPY
1.5. “ Asserted Homology Claims. ”
Claims 1, 2, 6, 8, 17, 18, 26, 33 and 35 of U.S. Patent
No. 5,693,761; claims 1, 2, 3 and 10-19 of U.S. Patent
No. 5,693,762; and claims 1, 2, 5, 6 and 25-28 of U.S. Patent
No. 6,180,370.
1.6. “ Bulk Product. ” An Other
Licensed Product supplied in a form other than a Finished Product
that can be converted into a Finished Product.
1.7. “ Combination Product. ” Any
product containing both a pharmaceutically active agent or
ingredient that constitutes an Other Licensed Product and one or
more other pharmaceutically active agents or ingredients that do
not constitute Other Licensed Products.
1.8. “ Confidential Information. ”
The meaning specified in Section 6.1.
1.9. “ Controlled Affiliate. ” Any
Affiliate which, directly or indirectly, is controlled by a Party
(where “controlled” has the meaning specified in
Section 1.1).
1.10. “ Discloser. ” The meaning
specified in Section 6.2(a).
1.11. “ Effective Date. ” The
meaning specified in the Preamble to this Agreement.
1.12. “ Finished Product. ” Any
Other Licensed Product in a form for use by an end user and not
intended for further chemical or genetic manipulation or
transformation.
1.13. “ Foreign Homology-Only Claims.
” Any claim of the PDL Foreign Queen Patents that does not
require, either through the text on its face or by operation of
applicable foreign law, that (a) one or more framework amino
acid(s) be replaced or substituted, or (b) the sequence of the
acceptor immunoglobulin heavy and/or light chain variable region
framework be a consensus sequence of human immunoglobulin heavy
and/or light chain variable region frameworks.
1.14. “ Independent Third Party. ”
Any Person that is not (a) Alexion, (b) an Affiliate of
Alexion, (c) a Sublicensee, or (d) an Affiliate of a
Sublicensee.
1.15.
“ Licensed
Homology Product. ” The antibody known generically as
eculizumab, identified in Biologics License Application
No. 125166/0, Figure 3.2.S.1.2.2 (currently marketed by
Alexion under the name Soliris ® ) and any antibody that has the
same variable region amino acid sequences as the variable region
amino acid sequences of eculizumab.
1.16. “ Licensed Products. ”
Collectively, the Licensed Homology Product and the Other Licensed
Products.
1.17. “Net
Sales.” The
aggregate gross revenues received from the sale or other
disposition of Other Licensed Products by Alexion or any of its
Affiliates or Sublicensees to an Independent Third Party, less
deductions for the following to the extent pertaining to Other
Licensed Products: (a) discounts, credits or allowances, if
any, actually granted on account of price adjustments, recalls,
rejection or return of items previously sold; (b) excise and
sales taxes,
2
[*] = Portions of this exhibit have been omitted
pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the
Commission.
C ONFIDENTIAL
E XECUTION C OPY
duties or other taxes and other governmental
charges imposed on and paid with respect to such sales (excluding
income or franchise taxes of any kind); (c) outer packing,
transport, freight, insurance, handling and other freight-related
costs; (d) trade, quantity and cash discounts and rebates,
charge-backs and retroactive price reductions (including, without
limitation, Medicaid rebates and rebates to social and welfare
systems and to governmental agencies, or any payor, administrator
or contractor (including, without limitation, managed health
organizations)); (e) allowances, charge-backs, refunds and
credits on account of rejected, damaged, outdated, returned,
withdrawn or recalled Other Licensed Product or on account of
retroactive price reductions affecting an Other Licensed Product;
and (f) up to five percent (5%) of such aggregate gross
revenues for co-pay assistance amounts and other payment assistance
amounts actually provided by Alexion or its Affiliates or
Sublicensees pursuant to any of their respective patient access or
similar programs for the benefit of patients who are not covered by
insurance (but only such portion of such amounts that are
applicable to an Other Licensed Product).
If Alexion or any of its Affiliates
or Sublicensees receives any non-cash consideration for any Other
Licensed Product sold or otherwise disposed of to such an
Independent Third Party, the reasonable fair market value of such
non-cash consideration on the date of such sale or disposition
shall be mutually agreed upon by the Parties.
Net Sales for Bulk Products shall be
calculated by multiplying the units of Finished Product to which
such Bulk Product is reasonably anticipated to be converted by the
established market price of the Finished Product on the date of
sale or disposition of such Bulk Product. By way of example and
without limitation, units of Finished Product may be measured in
grams or doses, as appropriate.
If Alexion or any of its Affiliates
or Sublicensees receive any consideration for the sale or other
disposition of any Other Licensed Product as part of a set of
bundled products, Net Sales for such Other Licensed Product shall
be calculated by reference to the average non-discounted unit price
for such Other Licensed Product when sold or otherwise disposed of
for cash other than as part of a set of bundled products. Net Sales
for Combination Products shall be calculated as set forth in
Section 3.4.
Net Sales shall not include the
disposition of any Other Licensed Product in connection with any of
the following so long as no consideration is received by Alexion or
any of its Affiliates or Sublicensees in connection with such
disposition: (i) any clinical trials or phase IV or other
studies; (ii) any regulatory or governmental purposes; or
(iii) any patient assistance programs or charitable or
promotional purposes.
Net Sales shall be determined in
accordance with U.S. generally accepted accounting principles
consistently applied.
1.18. “ No Contest Covenant. ” The
meaning specified in the Settlement Agreement.
1.19. “ Other Licensed Product. ”
Each product listed on Exhibit A (as such list may be modified from
time to time by Alexion in accordance with Section 2.3), the
manufacture, use, sale, offer for sale, importation or exportation
of which in a particular country would, but for the license granted
in Section 2.1(b), infringe a Valid Claim.
3
[*] = Portions of this exhibit have been omitted
pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the
Commission.
C ONFIDENTIAL
E XECUTION C OPY
1.20. “ Other PDL Patents. ” The
issued patents and patent applications (a) owned by PDL or any
of its Affiliates as of the Effective Date of this Agreement that
are not included in the PDL Queen Patent Family or
(b) exclusively licensed to PDL or any of its Affiliates and
in respect of which license it is reasonable to conclude that PDL
or any such Affiliate has standing to sue any other Person for
infringement (or in respect of which PDL or any of its Affiliates
otherwise has the right to assert infringement against any other
Person) as of the Effective Date of this Agreement that are not
included in the PDL Queen Patent Family.
1.21. “ Parties. ” PDL and
Alexion.
1.22. “ Party. ” Either PDL or
Alexion.
1.23. “ PDL Foreign Queen Patents.
” The meaning specified in the Settlement
Agreement.
1.24. “ PDL Queen Patent Family. ”
The meaning specified in the Settlement Agreement.
1.25. “ PDL Queen Patent Family Assignee.
” The meaning specified in Section 2.6(a).
1.26. “ Person. ” An individual,
partnership, limited liability company, corporation, joint stock
company, trust (including, without limitation, a business trust),
unincorporated association, joint venture, firm, enterprise or
other entity.
1.27. “ PTO. ” The U.S. Patent and
Trademark Office.
1.28. “ Recipient. ” The meaning
specified in Section 6.2(a).
1.29. “ Settlement Agreement. ” The
meaning set forth in the Recitals to this Agreement.
1.30. “ Soliris. ” The meaning
specified in the Recitals to the Settlement Agreement.
1.31. “ Sublicensee. ” Any
sublicensee to which Alexion has, pursuant to and in accordance
with Section 2.2, granted a sublicense under the license granted to
Alexion in Section 2.1(a), Section 2.1(b) and/or, if applicable,
Section 2.6(b) (a “ Primary Sublicensee ”); and
any sublicensee to which a Primary Sublicensee has, pursuant to and
in accordance with Section 2.2, granted a further sublicense under
the sublicense granted to such Primary Sublicensee by Alexion
pursuant to Section 2.1(a), Section 2.1(b) and/or, if applicable,
Section 2.6(b), respectively.
1.32. “ Sublicensee Covenant. ” The
meaning specified in Section 2.2(c).
4
[*] = Portions of this exhibit have been omitted
pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the
Commission.
C ONFIDENTIAL
E XECUTION C OPY
1.33. “ Third Party. ” A Person
that is not a Party or an Affiliate of a Party.
1.34. “ Valid Claim. ” Any claim
included in the PDL Queen Patent Family, which claim has not
expired or been disclaimed or been held unenforceable or invalid by
a governmental agency or court of competent jurisdiction by a
decision from which no appeal has been timely taken or may be
taken.
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2.
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LICENSE AND
OTHER RIGHTS
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2.1. License Grant.
Subject to the terms and conditions
of this Agreement, PDL hereby grants to Alexion and Alexion hereby
accepts:
(a) a worldwide, non-transferable
(except as provided in Section 8.1), non-exclusive license under
the Asserted Homology Claims and the Foreign Homology-Only Claims
to make, have made, use, sell, offer for sale, import and export
the Licensed Homology Product for all indications (which license
shall become fully paid-up upon Alexion’s payment in full of
the payments pursuant to Section 3.1); and
(b) a worldwide, royalty-bearing,
non-transferable (except as provided in Section 8.1), non-exclusive
license under all claims of the PDL Queen Patent Family to make,
have made, use, sell, offer for sale, import and export Other
Licensed Products.
2.2. Sublicense
Rights.
(a) Subject to Section 2.2(c) and
Section 2.2(d), Alexion shall have the right to grant sublicenses
under the license granted to Alexion in Section 2.1(a) in its sole
discretion. Subject to Section 2.2(c) and Section 2.2(d),
Alexion may grant any of its Affiliates or Sublicensees the right
to grant further sublicenses under the sublicense granted to such
Affiliate or Sublicensee pursuant to this Section 2.2(a) without
PDL’s prior written consent.
(b) Subject to Section 2.2(c) and
Section 2.2(d), Alexion shall have the right to grant sublicenses
under the license granted to Alexion in Section 2.1(b) with respect
to an Other Licensed Product solely to (i) any Person to which
Alexion also licenses other issued patents or patent applications
necessary for the research, development, manufacture, use,
marketing or sale of such Other Licensed Product, or (ii) any
of Alexion’s Affiliates; provided , however ,
that Alexion or any of its Affiliates (A) has, itself or
through a contractor engaged by Alexion or such Affiliate for
Alexion’s or its Affiliate’s benefit, undertaken
substantial development efforts in connection with such Other
Licensed Product that is the subject of any such sublicense, and/or
(B) owns or has exclusive rights to such Other Licensed
Product. Subject to Section 2.2(c) and Section 2.2(d),
Alexion may grant any of its Affiliates or Sublicensees the right
to grant further sublicenses under the sublicense granted to such
Affiliate or Sublicensee pursuant to this Section 2.2(b) without
PDL’s prior written consent. Alexion does not have the right
to grant any other sublicenses under the license granted to Alexion
in Section 2.1(b) without PDL’s prior written consent (which
consent shall not be unreasonably withheld, conditioned or
delayed).
5
[*] = Portions of this exhibit have been omitted
pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the
Commission.
C ONFIDENTIAL
E XECUTION C OPY
(c) Each sublicense granted under
the license(s) granted to Alexion in Section 2.1(a), Section 2.1(b)
and/or, if applicable, Section 2.6(b) (and each sublicense granted
under such sublicense) shall be in writing and shall (i) be
subject to all applicable terms and conditions of this Agreement
(including, without limitation, with respect to each sublicense
granted under the license granted to Alexion in Section 2.1(b) (and
each sublicense granted under such sublicense), the right of
Alexion to terminate such sublicense in the event of an uncured
payment breach or other uncured material breach of such sublicense
agreement by the Sublicensee of such sublicense agreement), in
respect of which PDL shall expressly be named as a third party
beneficiary of such agreement with the right to fully enforce its
rights with respect to such applicable terms and conditions of this
Agreement (including, without limitation, the right to fully
enforce the Sublicensee Covenant (as defined below in this Section
2.2(c)) with respect to such Sublicensee and to terminate such
sublicense agreement if such Sublicensee breaches such Sublicensee
Covenant), provided that PDL shall only exercise its third
party beneficiary rights after (x) it has notified Alexion
that it plans to exercise such rights and has given Alexion a
reasonable period of time to, as applicable, enforce
Alexion’s rights or terminate such sublicense agreement, and
(y) PDL and Alexion have reasonably coordinated with each
other in connection with the timing and exercise of such rights by
PDL (and in the event PDL exercises such rights, it will keep
Alexion reasonably apprised of the status of its efforts in
connection therewith (including, without limitation, by promptly
providing Alexion with copies of written communications with any
Sublicensees)), and (ii) include a covenant in such sublicense
agreement with such Sublicensee that such Sublicensee shall not
(A) intentionally provide direct monetary assistance to any
Third Party to Challenge (as such term is defined in the Settlement
Agreement) any of the PDL Queen Patent Family or
(B) intentionally file or otherwise initiate any lawsuit,
arbitration, interference, reexamination or opposition or any other
proceeding in which such Sublicensee alleges or seeks a
determination that any of the PDL Queen Patent Family is invalid or
unenforceable (the “ Sublicensee Covenant ”);
provided , however , that if a court of competent
jurisdiction holds in a decision from which no appeal may be taken
or has been timely taken that the Sublicensee Covenant is
unenforceable or invalid under applicable law, such Sublicensee
shall not be bound by the Sublicensee Covenant solely in the
jurisdiction to which such court decision applies. If a Sublicensee
breaches the Sublicensee Covenant by intentionally filing or
otherwise initiating any lawsuit, arbitration, interference,
reexamination or opposition proceeding or any other proceeding in
which such Sublicensee alleges or seeks a determination that any of
the PDL Queen Patent Family is invalid or unenforceable, Alexion
shall immediately notify PDL in writing thereof and shall
immediately terminate such sublicense agreement, provided ,
however , that Alexion has the right to so terminate such
agreement under applicable law. Notwithstanding the foregoing in
this Section 2.2(c), a Sublicensee shall not be obligated to
covenant and agree not to file or otherwise initiate or participate
in any lawsuit, arbitration, interference, reexamination or
opposition or any other proceeding that alleges or seeks a
determination that one or more claims of an issued patent within
the PDL Queen Patent Family is invalid or unenforceable,
provided that no Licensed Product forms any jurisdictional
basis on which such lawsuit, arbitration, interference,
reexamination or opposition or any other proceeding is filed or
continued. In addition to, and without limiting,
Section 3.5(f) of the Settlement Agreement, if a Sublicensee
is an Antibody Person that has an antibody that is not a Licensed
Product and that is in Phase III development or later, such
Sublicensee shall not, for so long as such Person is an Antibody
Person (that has an antibody that is not a Licensed
Product
6
[*] = Portions of this exhibit have been omitted
pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the
Commission.
C ONFIDENTIAL
E XECUTION C OPY
and that is in Phase III development
or later), be obligated to covenant and agree not to file or
otherwise initiate or participate in any lawsuit, arbitration,
interference, reexamination or opposition or other proceeding that
seeks a determination that one or more claims of an issued patent
within the PDL Queen Patent Family is invalid or unenforceable,
provided that no Licensed Product forms any jurisdictional
basis on which such lawsuit, arbitration, interference,
reexamination or opposition or other proceeding is filed or
continued or thereafter becomes a subject of such lawsuit,
arbitration, interference, reexamination or opposition or other
proceeding.
(d) Alexion shall provide a written
summary to PDL within forty-five (45) days following the end
of each calendar quarter during the term of this Agreement
specifying the name of each Sublicensee, territory and scope of the
rights sublicensed under this Agreement (or further sublicensed
under any sublicense agreement granted under this Agreement) during
such quarter; provided , however , that no such
written summary shall be required for a calendar quarter in the
event that, during such calendar quarter, there are (i) no
rights sublicensed under this Agreement by Alexion and (ii) no
rights further sublicensed by any Sublicensee under any sublicense
granted to such Sublicensee under this Agreement. For the avoidance
of doubt, Alexion shall remain liable for all obligations under
this Agreement with respect to sales and other dispositions of
Other Licensed Products under each sublicense granted under the
license granted to Alexion (and each sublicense granted under such
sublicense) in Section 2.1(b) (including, without limitation,
royalty payment obligations under Section 3.2).
2.3. Additional Other Licensed
Products. Alexion may, in
its sole discretion, add any product to Exhibit A from time
to time, provided that Alexion or any of its Affiliates
(a) has performed, itself or through a contractor engaged by
Alexion or such Affiliate for Alexion’s benefit, substantial
development work with respect to such product, (b) owns or has
the exclusive rights to manufacture, use, sell, offer for sale,
import, export and/or otherwise exploit such product (
provided that, with respect to any such product for which
Alexion has any such exclusive rights only for a particular
geographic territory, Alexion’s corresponding license rights
under Section 2.1(b) with respect to such product shall be limited
to such geographic territory) and/or (c) owns or has the
non-exclusive rights to manufacture, use, import or export such
product in order to support regulatory filings or sales in
countries or geographic territories in which Alexion or such
Affiliate has the exclusive right to sell or offer for sale such
product. In the event Alexion desires to add any such product to
Exhibit A , Alexion shall so notify PDL in writing and, upon
PDL’s receipt of such written notification, such product
shall be deemed to be added to Exhibit A and shall be an
Other Licensed Product hereunder. For each Other Licensed Product
added to Exhibit A by Alexion pursuant to this Section 2.3
after the first three (3) Other Licensed Products added to
Exhibit A by Alexion hereunder, in addition to the royalties
Alexion is obligated to pay pursuant to Section 3.2, Alexion shall
pay to PDL a one-time, non-refundable, lump-sum payment pursuant to
Section 3.2. Notwithstanding anything in this Agreement, in the
event that Alexion breaches the No Contest Covenant and fails to
cure such breach as provided in Section 6.2 of the Settlement
Agreement, then PDL may, subject to all of the terms and conditions
set forth in the Settlement Agreement, invoke its right under
Section 6.2 of the Settlement Agreement to terminate
Alexion’s right under this Section 2.3 of this Agreement to
add any products to Exhibit A of this Agreement.
7
[*] = Portions of this exhibit have been omitted
pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the
Commission.
C ONFIDENTIAL
E XECUTION C OPY
2.4. Alexion Right of First
Refusal. Subject to the
exclusive licenses and rights set forth on Exhibit C that
PDL has granted to a Third Party prior to the Effective Date, in
the event that PDL determines in good faith to offer any exclusive
license(s) to any claim(s), issued patent(s) or patent applications
included in the PDL Queen Patent Family, PDL shall first notify
Alexion in writing of (a) the type of transaction that PDL is
planning on pursuing, (b) the field (including, without
limitation, the specific target or indication, if applicable) and
the geographic territory of such proposed exclusive license and the
relevant issued patent(s), patent applications or claim(s) to be
exclusively licensed, and (c) the general economic terms
proposed by PDL for such license (a “ PDL Notice
”). If Alexion is interested in obtaining an exclusive
license under the claim(s), issued patent(s) or patent applications
included in the PDL Queen Patent Family in the field and geographic
territory, and on the general economic terms, described in the PDL
Notice, then Alexion shall so notify PDL in writing (an “
Alexion Notice ”) within thirty (30) days from
Alexion’s receipt of such PDL Notice. In such event, Alexion
and PDL each hereby agree to exclusively negotiate in good faith
the terms and conditions of such license for a period of ninety
(90) days from the date of such Alexion Notice (a “
Negotiation Period ”). If the Parties agree on all of
the terms and conditions of the exclusive license agreement during
the Negotiation Period, then the Parties shall execute a written
exclusive license agreement containing such terms and conditions.
If the Parties are unable to agree on all of the terms and
conditions of such exclusive license within the Negotiation Period,
then PDL shall thereafter be free to enter into an agreement for
the exclusive license described in the PDL Notice with any Third
Party on terms and conditions that, in the aggregate and taken as a
whole, are in PDL’s good faith judgment more advantageous to
PDL than the terms and conditions last offered to PDL by
Alexion.
2.5. No Other License.
Alexion expressly acknowledges and
agrees that, except for the licenses expressly granted to Alexion
in Section 2.1 and Section 2.6(b), no licenses to the PDL Queen
Patent Family and no licenses to any Other PDL Patents, or to any
know-how, trade secrets or other intellectual property, are
included in this Agreement or granted by implication, estoppel or
otherwise. As between Alexion and PDL, subject to the licenses
granted to Alexion in Section 2.1 and Section 2.6(b), PDL retains
all right, title and interest in and to all of the PDL Queen Patent
Family and Other PDL Patents.
2.6. Covenant Not to Sue with
Respect to PDL Queen Patent Family.
(a) PDL covenants and agrees not to,
and to cause its Controlled Affiliates and each of its and their
respective exclusive licensees (to the extent it is reasonable to
conclude that such licensee has standing to sue any other Person
for infringement of any PDL Queen Patent Family that is not an
Asserted Homology Claim or a Foreign Homology-Only Claim) not to,
assert, initiate, file or otherwise commence anywhere in the world
any proceeding or action (including, without limitation, any
litigation, arbitration, interference or other proceeding), at law
or in equity, against Alexion or any of Alexion’s Affiliates
or any successors or assigns of Alexion or any of Alexion’s
Affiliates or any Sublicensee to which Alexion has granted a
sublicense under the license granted to Alexion in Section 2.1(a)
and/or, if applicable, Section 2.6(b) (but only for so long as such
Sublicensee has an effective sublicense granted under and in
accordance with this Agreement) claiming that the manufacture, use,
sale, offer for sale,
8
[*] = Portions of this exhibit have been omitted
pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the
Commission.
C ONFIDENTIAL
E XECUTION C OPY
importation or exportation of the
Licensed Homology Product infringes any claim of the PDL Queen
Patent Family that is not an Asserted Homology Claim or a Foreign
Homology-Only Claim. Prior to any sale, assignment or other
transfer by PDL or any of its Controlled Affiliates of all or
substantially all of its rights (which, for the avoidance of doubt,
does not include any grant of a non-exclusive license) in and to
(or any grant by PDL or any of its Controlled Affiliates of any
exclusive license, in respect of which license it is reasonable to
conclude that such exclusive licensee has standing to sue for
infringement of any patent included in the PDL Queen Patent Family
that includes a claim that is not an Asserted Homology Claim or a
Foreign Homology-Only Claim, under) any issued patent or patent
application included in the PDL Queen Patent Family that includes a
claim that is not an Asserted Homology Claim or a Foreign
Homology-Only Claim to any other Person (each such other Person, a
“ PDL Queen Patent Family Assignee ”), PDL
shall, and shall cause its Controlled Affiliates (and its and their
exclusive licensees to the extent it is reasonable to conclude that
such licensee has standing to sue any other Person for infringement
of any PDL Queen Patent Family that is not an Asserted Homology
Claim or a Foreign Homology-Only Claim) to: (i) require each
PDL Queen Patent Family Assignee to acknowledge and agree in
writing (A) to be bound by this Section 2.6(a) with respect to
such issued patent or patent application, (B) that Alexion (or
its successor, assign or Sublicensee, as applicable) is a third
party beneficiary of such agreement with the right to fully enforce
its rights set forth in this Section 2.6(a) and (C) to require
and obligate any Person to whom such PDL Queen Patent Family
Assignee subsequently sells, assigns or otherwise transfers
ownership of such issued patent or patent application (or grants an
exclusive license under such issued patent or patent application,
in respect of which license it is reasonable to conclude that such
exclusive licensee has standing to sue for infringement of such
issued patent or patent application) to acknowledge and agree in
writing to be bound by this Section 2.6(a) in connection with any
subsequent sale(s), assignment(s) or other transfer(s) of such
issued patent or patent application; and (ii) provide Alexion
(or its successor or assign, as applicable) with a certification
executed by PDL and such PDL Queen Patent Family Assignee,
confirming that the obligations set forth above in subclause
(i) of this Section 2.6(a) have been, with respect to PDL and
such PDL Queen Patent Family Assignee, fully complied
with.
(b) Without limiting the foregoing
in Section 2.6(a), and subject to the terms and conditions of
this Agreement, PDL hereby grants to Alexion and Alexion hereby
accepts a worldwide, non-transferable (except as provided in
Section 8.1), non-exclusive, sublicensable (but only to the same
extent that the license under Section 2.1(a) is sublicensable under
Section 2.2(c), and subject to Section 2.2(c) and Section 2.2(d))
license under all claims of the PDL Queen Patent Family that are
not Asserted Homology Claims or Foreign Homology-Only Claims to
make, have made, use, sell, offer for sale, import and export the
Licensed Homology Product for all indications, which license shall
be effective as of the Effective Date and shall become fully
paid-up upon Alexion’s payment in full of the payments
pursuant to Section 3.1, but Alexion may only exercise its
rights under the foregoing license in this Section 2.6(b) solely in
the event and solely to the extent that:
(i) the covenant set forth in
Section 2.6(a) is held to be unenforceable or invalid under, or in
contravention of, applicable law by any court of competent
jurisdiction, provided that Alexion may only exercise its
rights under the foregoing license in this Section
2.6(b)
9
[*] = Portions of this exhibit have been omitted
pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the
Commission.
C ONFIDENTIAL
E XECUTION C OPY
as a result of such court decision
solely with respect to any patents issued by, or patent
applications pending in, a patent office or similar governmental
agency with effect in the jurisdiction to which such court decision
applies; or
(ii) (A) PDL and/or any of its
Controlled Affiliates, and/or any PDL Queen Patent Family Assignee
does not comply with Section 2.6(a) (including, without limitation,
(1) in connection with any sale, assignment or other transfer
of all or substantially all of its rights in and to (or any grant
by PDL or any of its Controlled Affiliates of any exclusive
license, in respect of which license it is reasonable to conclude
that such exclusive licensee has standing to sue for infringement
of any patent included in the PDL Queen Patent Family that includes
a claim that is not an Asserted Homology Claim or a Foreign
Homology-Only Claim, under) any issued patent or patent application
included in the PDL Queen Patent Family that includes a claim that
is not an Asserted Homology Claim or a Foreign Homology-Only Claim,
or (2) any PDL Queen Patent Family Assignee (including,
without limitation, any exclusive licensee of any such issued
patent or patent application to the extent it is reasonable to
conclude that such exclusive licensee has standing to sue any other
Person for infringement of any PDL Queen Patent Family that is not
an Asserted Homology Claim or a Foreign Homology-Only Claim) does
not agree in writing prior to or effective as of the closing of
such sale, assignment, acquisition, exclusive license or other
transfer (or thereafter fails to comply with such agreement) to
comply with Section 2.6(a) with respect to such issued patent or
patent application or such agreement with a PDL Queen Patent Family
Assignee is held to be unenforceable or invalid under, or in
contravention of, applicable law by any court of competent
jurisdiction), provided that Alexion may only exercise its
rights under the foregoing license in this Section 2.6(b) as a
result of such non-compliance with respect to such issued patent or
patent application; and/or (B) an Affiliate of PDL that is not
a Controlled Affiliate of PDL commits an act or omission that, if
it was an act or omission of PDL or its Controlled Affiliate, would
not comply with Section 2.6(a); and/or (C) any exclusive
licensee under any claim of the PDL Queen Patent Family that is not
an Asserted Homology Claim or a Foreign Homology-Only Claim
(regardless of whether it is reasonable to conclude that such
licensee has standing to sue any other Person for infringement of
any PDL Queen Patent Family that is not an Asserted Homology Claim
or a Foreign Homology-Only Claim) commits an act or omission that,
if it was an act or omission of PDL or its Controlled Affiliate,
would not comply with Section 2.6(a); or
(iii) this Agreement or the covenant
set forth in Section 2.6(a) is rejected by a trustee in connection
with a bankruptcy proceeding and the bankruptcy court (or any other
court of competent jurisdiction) has determined that
Section 365(n) of the U.S. Bankruptcy Code does not apply to
such a covenant; or
(iv) any issued patent or patent
application included in the PDL Queen Patent Family subject to the
covenant set forth in Section 2.6(a) is transferred, assigned or
otherwise disposed of in connection with a bankruptcy proceeding
free and clear of such covenant, provided that Alexion may
only exercise its rights under the foregoing license in this
Section 2.6(b) as a result of such disposition only with respect to
such issued patent or patent application; or
10
[*] = Portions of this exhibit have been omitted
pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the
Commission.
C ONFIDENTIAL
E XECUTION C OPY
(v) any patent included in the PDL
Queen Patent Family subject to the covenant set forth in Section
2.6(a) is asserted against (or any proceeding or action is
otherwise initiated, filed or otherwise commenced anywhere in the
world, at law or in equity, against) Alexion, any of
Alexion’s Affiliates, any successors or assigns of Alexion or
any of Alexion’s Affiliates, or any Sublicensee to which
Alexion has granted a sublicense under the license granted to
Alexion in Section 2.1(a) and/or, if applicable, Section 2.6(b), or
any Sublicensee of any such Sublicensee (but, with respect to any
of the foregoing Sublicensees, only if such Sublicensee, at the
time of such assertion, has an effective sublicense granted under
and in accordance with this Agreement), in each of the foregoing
cases, with respect to the Licensed Homology Product;
provided that this subsection (v) only entitles Alexion
to exercise the foregoing license in this Section 2.6(b) as a
result of such assertion only with respect to such
patent.
(c) Each Party agrees, covenants,
represents and warrants, and shall cause its Affiliates (and with
respect to Alexion, its Sublicensees (and all Sublicensees of such
Sublicensees), and with respect to PDL, its exclusive licensees of
any patent included in the PDL Queen Patent Family that includes a
claim that is not an Asserted Homology Claim or a Foreign
Homology-Only Claim in respect of which it is reasonable to
conclude that such exclusive licensees have standing to sue any
other Person for infringement of such patent) to agree, covenant,
represent and warrant, that it will not challenge the validity or
enforceability of the covenant set forth in Section 2.6(a) or any
of the other provisions set forth in this Section 2.6.
(d) For the avoidance of doubt,
notwithstanding anything contained herein, nothing in this Section
2.6 limits the license grant set forth in Section
2.1(a).
(e) If any patent included in the
PDL Queen Patent Family subject to the covenant set forth in
Section 2.6(a) is asserted by a Person with standing against (or
any proceeding or action is otherwise initiated, filed or otherwise
commenced by a Person with standing anywhere in the world, at law
or in equity, asserting any such patent) against Alexion or any of
Alexion’s Affiliates (or any successors or assigns of Alexion
or any of Alexion’s Affiliates or any Sublicensee to which
Alexion has granted a sublicense under the license granted to
Alexion in Section 2.1(a)) with respect to the Licensed Homology
Product, then, notwithstanding anything contained in this Agreement
or the Settlement Agreement, and solely with respect to such
patent, neither Alexion nor its Affiliates (nor any of its or their
successors or assigns nor any Sublicensee to which Alexion has
granted a sublicense under the license granted to Alexion in
Section 2.1(a)) shall be bound by or otherwise have any obligation
under the No Contest Covenant or any other provision set forth in
Section 3 of the Settlement Agreement (and such provisions
shall be of no force and effect) solely in connection with such
proceeding or action and solely for the period of time beginning on
the date such proceeding or action is filed or otherwise commences
and ending on the date of a final decision by a relevant court of
competent jurisdiction or arbitral body, as applicable, in
connection with such proceeding or action from which no appeal has
been timely taken or may be taken.
11
[*] = Portions of this exhibit have been omitted
pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the
Commission.
C ONFIDENTIAL
E XECUTION C OPY
2.7. Covenant Not to Sue with
Respect to Other PDL Patents. PDL covenants and agrees not to, and to cause
its Affiliates not to, assert, initiate, file or otherwise commence
anywhere in the world any proceeding or action (including, without
limitation, any litigation, arbitration, interference or other
proceeding), at law or in equity, against Alexion or any of
Alexion’s Affiliates or any successors or assigns of Alexion
or any of Alexion’s Affiliates or any Sublicensee to which
Alexion has granted a sublicense under the license granted to
Alexion in Section 2.1(a), or any Sublicensee of any such
Sublicensee (but with respect to any of the foregoing Sublicensees,
only for so long as such Sublicensee has an effective sublicense
granted under and in accordance with this Agreement), claiming that
the manufacture, use, sale, offer for sale, importation or
exportation of the Licensed Homology Product infringes any claim of
any Other PDL Patent.
|
3.
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PAYMENTS;
ROYALTIES; REPORTS
|
3.1. Lump-Sum
Payments. In
consideration of the licenses granted to Alexion in Section 2.1(a)
and Section 2.6(b), the cov