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Exhibit 10.1
Confidential materials omitted and filed
separately with the Securities and Exchange Commission.
Asterisks denote omissions.
COLLABORATION AGREEMENT
between
MEDIMMUNE, INC.
and
INFINITY PHARMACEUTICALS, INC.
dated as of August 25, 2006
COLLABORATION AGREEMENT
THIS COLLABORATION AGREEMENT dated as of the 25th day of August,
2006 (the " Agreement ") is made between MedImmune, Inc., a
Delaware corporation having its principal place of business at One
MedImmune Way, Gaithersburg, Maryland 20878 (" MedImmune ")
and Infinity Pharmaceuticals, Inc., a Delaware corporation having
its principal office at 780 Memorial Drive, Cambridge,
Massachusetts 02139 (" Infinity ").
R E C I T A L S
WHEREAS, the Parties wish to collaborate on the development and
commercialization of the Products (as defined herein);
NOW THEREFORE, in consideration of the premises and of the
covenants herein contained, the Parties hereto mutually agree as
follows:
ARTICLE 1
DEFINITIONS
For purposes of this Agreement, the terms defined in this
Article shall have the meanings specified below, whether used in
their singular or plural form:
1.1. " Active
Pharmaceutical Ingredient " or " API " means the active
ingredient in a drug responsible for its therapeutic effect
including isomer, ester, salt, hydrate, solvate, analog (i.e., one
or a limited number of individual atoms or functional groups have
been added, deleted or replaced, either with a different atom or
with a different functional group, or any one of a series of
organic compounds with a similar general formula, possessing
similar chemical properties), conjugate, polymorph, prodrug,
metabolic precursor or metabolite of such active ingredient.
1.2. "
Affiliate " with respect to either Party, means any
corporation or other entity which controls, is controlled by, or is
under common control with that Party. A corporation or
other
entity shall be regarded as in control of another
corporation or entity if it directly or indirectly owns or controls
more than fifty percent (50%) of the voting stock or other
ownership interest of the other corporation or entity, or if it
possesses, directly or indirectly, the power to direct or cause the
direction of the management and policies of the corporation or
other entity or the power to elect or appoint fifty percent (50%)
or more of the members of the governing body of the corporation or
other entity.
1.3. "
Applicable Percentage " means fifty percent (50%).
1.4. "
Business Day " shall mean each day of the week excluding
Saturday, Sunday and U.S. Federal holidays.
1.5. "
Claims " means all charges, complaints, actions, suits,
proceedings, hearings, investigations, claims, demands, judgments,
orders, decrees, stipulations and injunctions. For the
avoidance of doubt, Claims shall include Infringement Claims and
Product Liability Claims.
1.6. "
Collaboration Inventions " means:
(a)
Inventions conceived and/or reduced to practice during the Term by
an employee of a Party or any of its Affiliates and/or by a person
or entity obligated to assign such an Invention to a Party or any
of its Affiliates which Invention is directed to the development,
manufacture, use or sale of an Active Pharmaceutical Ingredient of
a Product; provided , however , with respect to
Products of a Project as to which a Party is an Opt-Out Party, such
Inventions are limited to those conceived and/or reduced to
practice during the Term and prior to one year after the Opt-Out
Date for such Project. For the avoidance of doubt, for
purposes of the foregoing, Inventions that are "directed to" an API
shall not include general formulations and general manufacturing
methodologies that are conceived and reduced to practice outside of
the course of performing activities pursuant to a Research and
Development Plan; and
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(b)
Inventions conceived and/or reduced to practice during the Term by
an employee of a Party or any of its Affiliates and/or by a person
obligated to assign such an Invention to a Party or any of its
Affiliates that is conceived and/or reduced to practice in the
course of performing activities pursuant to work conducted under a
Research and Development Plan.
1.7. "
Collaboration Know-How " means:
(a)
Know-How conceived and/or reduced to practice and/or developed
during the Term by an employee of a Party or any of its Affiliates
and/or by a person or entity obligated to assign Know-How to a
Party or any of its Affiliates which Know-How is directed to the
development, manufacture, use or sale of an Active Pharmaceutical
Ingredient of a Product; provided , however , with
respect to Products of a Project as to which a Party is an Opt-Out
Party, such Know-How is limited to that conceived and/or reduced to
practice and/or developed during the Term and prior to one year
after the Opt-Out Date for such Project. For the avoidance of
doubt, for purposes of the foregoing, Know-How that is "directed
to" an API shall not include general formulations and general
manufacturing methodologies that are conceived and reduced to
practice outside of the course of performing activities pursuant to
a Research and Development Plan; and
(b)
Know-How conceived and/or reduced to practice during the Term by an
employee of a Party or any of its Affiliates and/or by a person
obligated to assign such Know-How to a Party or any of its
Affiliates that is conceived and/or reduced to practice in the
course of performing activities pursuant to work conducted under a
Research and Development Plan.
1.8. "
Collaboration Patent Rights " means any Patent Rights that
claim a Collaboration Invention.
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1.9. "
Collaboration Rights " means individually and collectively
Collaboration Patent Rights, Collaboration Know-How and
Collaboration Inventions.
1.10. " Combination
Product " means a product that contains one or more active
components that are not Products in addition to Product.
1.11. " Development
Costs " with respect to Product, on a Product-by-Product basis,
means the reasonable costs incurred or accrued by a Party with
respect to work performed by a Party or its Affiliates or a Third
Party in accordance with a Research and Development Plan in
connection with research and development of Product, including
[***] for the purpose of submission of applications to obtain
Regulatory Approvals for Product which costs are limited to
[***]. All cost determinations made hereunder shall be made
in accordance with GAAP. As part of creating the initial
Research and Development Plans, the JDT will agree on consistent
policies governing direct and non-direct costs, including
allocation principles.
1.12. " Diligent
Effort " means the carrying out of obligations specified in
this Agreement in a diligent, expeditious and sustained manner,
consistent with the combined interests of the Parties including the
allocation of commercially reasonable personnel and financial
resources, but in no event less than that level of resources that
pharmaceutical and major biotechnology companies typically devote
to their own internally discovered products of similar market
potential at a similar stage in its development or product life,
taking into account the following factors to the extent reasonable
and relevant: issues of safety and efficacy, product profile,
difficulty in developing or manufacturing the Product,
competitiveness of alternative Third Party products in the
marketplace, the patent or other proprietary position of the
Product, the regulatory requirements involved and the potential
profitability of the Products marketed or to be marketed.
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1.13. "
Disclosure Schedule " means the disclosure schedule
delivered by Infinity to MedImmune dated as of the Effective
Date.
1.14. "
Earnings " means the positive or negative amount that is
calculated on a Product-by-Product basis by deducting Product Costs
from Revenue.
1.15. " Effective
Date " means the date first set forth above.
1.16. " FDA "
means the United States Food and Drug Administration or any
successor agency with responsibilities comparable to those of the
United States Food and Drug Administration.
1.17. " Field "
means all fields of use.
1.18. " First
Commercial Sale " means the first sale of a Product for
consumption by the general public in a country.
1.19. " Fully
Absorbed Cost of Goods " with respect to Product, on a
Product-by-Product basis, means:
(a)
To the extent that manufacturing of Product or any component
thereof is performed by the Selling Party itself, the consolidated
fully burdened cost incurred by the Selling Party in the
manufacture of Product, which costs are limited to: [***] as
determined in accordance with GAAP; and
(b)
To the extent that manufacturing of Product or any component
thereof is performed for the Selling Party by a Third Party or by
the other Party, amounts paid by the Selling Party to such Third
Party or to the other Party in connection with the manufacturing of
Product or any component thereof.
1.20. " GAAP "
means the then current United States generally accepted accounting
principles, consistently applied.
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1.21. "
Hsp90 Diagnostic " means a product or service for
determining a person that is susceptible to treatment with a Hsp90
Therapeutic and/or monitoring such treatment and/or providing a
prognosis of such treatment, in each case such treatment being for
the purpose of treating and/or preventing a disease, disorder or
condition.
1.22. " Hsp90
Product " means an Hsp90 Diagnostic or an Hsp90
Therapeutic.
1.23. " Hsp90
Therapeutic " means one or more molecules that primarily (i.e.
the most potent activity) target and modulate one or more of Heat
Shock Protein 90 (Hsp90) [***] and compositions that contain such a
molecule(s). For the avoidance of doubt, the chemical
entities disclosed and/or claimed in the Patent Rights indicated in
Exhibit Y and IPI 504 (structure in Exhibit Z-1) are included as
Hsp90 Therapeutics.
1.24. " Hsp90
Project " means the research, development and commercialization
of one or more Hsp90 Products.
1.25. " Hedgehog
Diagnostic " means a product or service for determining a
person that is susceptible to treatment with a Hedgehog Therapeutic
and/or monitoring such treatment and/or providing a prognosis of
such treatment, in each case such treatment being for the purpose
of treating and/or preventing a disease, disorder or condition.
1.26. " Hedgehog
Product " means a Hedgehog Diagnostic or a Hedgehog
Therapeutic.
1.27. " Hedgehog
Therapeutic " means one or more molecules that primarily target
(i.e. the most potent activity) and modulate one or more member(s)
of the Hedgehog pathway and compositions that contain such a
molecule(s). For the avoidance of doubt, the chemical
entities disclosed and/or claimed in the Patent Rights indicated in
Exhibit Y [***] (structures in Exhibit Z-2) are included as
Hedgehog Therapeutics.
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1.28. "
Hedgehog Project " means the research, development and
commercialization of one or more Hedgehog Products.
1.29. " IND "
means an Investigational New Drug application filed with a
Regulatory Authority to obtain approval to conduct human clinical
trials of a Product for an Indication.
1.30. "
Indication " means a type of cancer (tumor type) or a
disease, disorder or a condition other than a type of cancer.
1.31. " Infinity
Existing Know-How " means any Know-How owned by or licensed to
Infinity as of the Effective Date which is directed to the
development, manufacture, use or sale of an Active Pharmaceutical
Ingredient of a Product. For the avoidance of doubt, for
purposes of the foregoing, Know-How that is "directed to" an API
shall not include general formulations and general manufacturing
methodologies that are conceived and reduced to practice outside of
the course of performing activities pursuant to a Research and
Development Plan.
1.32. " Infinity
Existing Patent Rights " means (i) any Patent Rights set forth
on Exhibit Y, (ii) any Patent Rights that may arise from the
Inventions set forth in Exhibit Y, and (iii) any Patent Rights
owned by or licensed to Infinity as of the Effective Date that
claim an Active Pharmaceutical Ingredient of a Product or the
manufacture or use thereof.
1.33. " Infinity
Existing Rights " means individually and collectively Infinity
Existing Patent Rights and Infinity Existing Know-How.
1.34. " Infinity
General Invention " means any Invention, other than a
Collaboration Invention or MedImmune General Invention (i) owned by
Infinity or any of its Affiliates before or during the Term and/or
(ii) licensed to Infinity or any of its Affiliates before or during
the Term, with the right in each case to grant a sublicense
hereunder in each case, which Invention is useful or necessary with
respect to the development, manufacture, use or sale of a
Product;
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provided, however , with respect to
Products of a Project as to which Infinity is an Opt-Out Party,
such Inventions that become owned or licensed with respect to such
Products during the Term are limited to those that become owned or
licensed during the Term and prior to one year after the Opt-Out
Date for such Project.
1.35. " Infinity
General Patent Rights " means any Patent Rights, other than
Collaboration Patent Rights, Infinity Existing Patent Rights or
MedImmune General Patent Rights, that claim an Infinity General
Invention.
1.36. " Infinity
General Know-How " means any Know-How, other than Collaboration
Know-How, Infinity Existing Know-How or MedImmune General Know-How,
(i) owned by Infinity or its Affiliates before or during the Term
or (ii) licensed to Infinity or any of its Affiliates before or
during the Term, with the right in each case to grant a sublicense
hereunder, in each case which Know-How is useful or necessary with
respect to the development, manufacture, use or sale of a Product;
provided, however , with respect to Products of a
Project as to which Infinity is an Opt-Out Party, such Know-How
that becomes owned or licensed with respect to such Products during
the Term is limited to Know-How that becomes owned or licensed
during the Term and prior to one year after the Opt-Out Date for
such Project.
1.37. " Infinity
General Rights " means individually and collectively Infinity
General Patent Rights, Infinity General Know-How and Infinity
General Inventions.
1.38. "
Infringement Claim " means a Claim by a Third Party that the
making, using, offering for sale, sale or importation of a Product
infringes any Third Party intellectual property right.
1.39. "
Invention " means all ideas, data, writings, inventions,
discoveries, improvements and other technology, whether or not
patentable or copyrightable.
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1.40. "
JCT " means the Joint Commercialization Team of Section
6.2.
1.41. " JDT "
means the Joint Development Team(s) of Article 3.
1.42. "
Know-How " means data, information, know-how, compounds and
reagents and the rights thereto other than Patent Rights.
1.42A " Litigation Expenses
" means court costs, reasonable fees of attorneys, accountants and
other experts or other expenses of litigation or other proceedings
or of any claim, default or assessment.
1.42B " Loss(es) " means
all damages (including all incidental and consequential damages
claimed by Third Parties), deficiencies, defaults, assessments,
dues, penalties, fines, costs, amounts paid in settlement,
liabilities, obligations, taxes, liens, losses, lost profits
claimed by Third Parties, expenses, costs and fees (including
without limitation interest, but excluding Litigation Expenses) and
includes all damages awardable pursuant to statute and treble
damages.
1.43. " Marketing
Expenses " means w ith respect to a Product, on a
Product-by-Product basis, the reasonable costs incurred or accrued
pursuant to a Marketing Plan by the Selling Party or reimbursed to
the Non-Selling Party pursuant to co-promotion under this
Agreement, with respect to pre-launch, launch, and post-launch
advertising and other marketing activities including, without
limitation, expenses of patient programs such as those involving
compassionate use, indigents, uninsured and underinsured, training,
disease information and management, and compliance; expenses
related to Promotional Materials, space or time in various media,
direct mail campaigns, samples, advertising agency fees and other
promotion activities; and phase IV studies (whether or not required
by a Regulatory Authority) which costs are limited to: [***].
All cost determinations made hereunder shall be made in accordance
with GAAP. Marketing Expenses do not include Selling
Expenses. Marketing Expenses incurred by
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a Selling Party with respect to a Product shall
not materially exceed the aggregate expenses associated with the
marketing (defined in the same way as Marketing Expenses) of
similar products by Third Parties that are pharmaceutical or major
biotechnology companies.
1.44. " Marketing
Plan " means the Marketing Plan of Section 6.2.
1.45. " MedImmune
General Invention " means any Invention, other than a
Collaboration Invention or Infinity General Invention (i) owned by
MedImmune or any of its Affiliates before or during the Term and/or
(ii) licensed to MedImmune or any of its Affiliates before or
during the Term, with the right in each case to grant a sublicense
hereunder, in each case, which Invention is useful or necessary
with respect to the development, manufacture, use or sale of a
Product; provided, however , with respect to Products
of a Project as to which MedImmune is an Opt-Out Party, such
Inventions that become owned or licensed with respect to such
Products during the Term are limited to those that become owned or
licensed during the Term and prior to one year after the Opt-Out
Date for such Project.
1.46. " MedImmune
General Patent Rights " means any Patent Rights, other than
Collaboration Patent Rights and Infinity General Patent Rights,
that claim a MedImmune General Invention.
1.47. " MedImmune
General Know-How " means any Know-How, other than Collaboration
Know-How, Infinity Existing Know-How and Infinity General Know-How,
(i) owned by MedImmune or its Affiliates before or during the Term
or (ii) licensed to MedImmune or any of its Affiliates before or
during the Term, with the right in each case to grant a sublicense
hereunder, in each case which Know-How is useful or necessary with
respect to the development, manufacture, use or sale of a Product;
provided, however , with respect to Products of a
Project as to which MedImmune is an Opt-Out Party, such Know-How
that becomes owned
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or licensed with respect to such Products
during the Term is limited to Know-How that becomes owned or
licensed during the Term and prior to one year after the Opt-Out
Date for such Project.
1.48. " MedImmune
General Rights " means individually and collectively MedImmune
General Patent Rights, MedImmune General Know-How and MedImmune
General Inventions.
1.49. " Net
Sales " means with respect to Product and Royalty Bearing
Product on a Product-by-Product and Royalty Bearing Product by
Royalty Bearing Product basis, the gross sales accrued in a
particular period for financial reporting purposes of any and all
Products and Royalty Bearing Product sold by a Selling Party or its
Affiliates to a Third Party and included in reported net sales
under GAAP after deducting for the following sales allowances and
expenses directly related to gross sales of the applicable Product
or Royalty Bearing Product, as determined by such Party under GAAP,
if not previously deducted, from the gross sales amount
invoiced:
(a)
trade, quantity and/or cash discounts, allowances or rebates,
including promotional, service or similar discounts or rebates and
discounts or rebates to governmental or managed care organizations,
to the extent actually given or allowed;
(b)
credits or allowances with respect to Products or Royalty Bearing
Products by reason of rejection, defects, recalls or returns, or
chargebacks;
(c)
any tax, tariff, duty or government charge (including any sales,
value added, excise or similar tax or government charge, but
excluding any income tax) levied on the sale, transportation or
delivery of any Product or Royalty Bearing Product;
(d)
a reasonable allowance for bad debt;
(e)
any charges for freight, postage, shipping or transportation, or
for insurance (if and to the extent included in the amount invoiced
to the Third Party); and
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(f)
any administrative fees owed to group purchasing organizations or
managed care entities for sale of such Products or Royalty Bearing
Products.
The Selling Party shall make periodic adjustments of the amounts
described in (a) through (f) to its initial accruals of such
amounts applied in a prior calendar quarter to reflect amounts
actually incurred or taken by such Party; provided, however,
that it shall use the same accrual that it uses for its own
financial accounting purposes, and that it shall account for
reserves and allowances for such Products or Royalty Bearing
Products in a manner consistent with its methods for establishing
reserves and allowances for other similar products.
(A) In the
event a Product or Royalty Bearing Product is sold as part of a
Combination Product and the Product or Royalty Bearing Product, as
well as each of the other clinically active components included in
the Combination Product (the "Other Products"), are sold separately
in the relevant country, the Net Sales from such Combination
Product, shall be the amount determined by multiplying the Net
Sales of the Combination Product, during the applicable reporting
period, by the fraction, A/A+B, where A is the average gross sales
price of the Product or Royalty Bearing Product when sold
separately in finished form and B is the average gross sales price
of the Other Products when such Other Products are sold separately
in finished form, in each case during the applicable reporting
period or, if sales of both the Product or Royalty Bearing Product,
and the Other Products did not occur in such period, then in the
most recent reporting period in which sales of both occurred.
(B)
In the event a Product or Royalty Bearing Product is sold as part
of a Combination Product and average gross sales price cannot be
determined for such Product or Royalty Bearing Product and all
Other Product(s) included in the Combination Product, Net Sales,
shall be calculated by multiplying the Net Sales of the Combination
Product by the
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fraction C/(C+D) where C is the standard
Fully-Absorbed Cost of Goods of the Product or Royalty Bearing
Product and D is the standard fully-absorbed cost of the Other
Products, calculated in the same manner as Fully Absorbed Cost of
Goods, in each case during the applicable reporting
period.
1.50. "
Opt-Out-Date " has the meaning of Section 12.1.
1.51. "
Opt-Out-Party " has the meaning set forth in Section
12.1.
1.52. " Non-Selling
Party " means, on a Product-by-Product basis, on a
country-by-country basis, any Party who is not a Selling Party,
provided that such Party is not an Opt-Out Party with respect to
the Project of which the Product is a member.
1.53. " Patent
Rights " means United States and foreign patents, patent
applications, provisional patent applications, certificates of
invention, applications for certificates of invention, divisions,
continuations, continuations-in-part, non-provisional patent
applications claiming priority benefit of a provisional
application, continued prosecution applications, national and
regional stage counterparts, together with any extensions,
registrations, confirmations, reissues, re-examinations or renewals
of the above as well as supplementary protection certificates
therefore, and any other form of government-issued patent
protection directed to the inventions claimed in the foregoing.
1.54. " Party "
means Infinity or MedImmune and collectively the "Parties".
1.55. " Phase I
Clinical Trial " means, as to a Product, the first controlled
and lawful study in humans of the safety of such Product, which is
prospectively designed to generate sufficient data (if successful)
to commence a Phase II Clinical Trial of such Product, as further
exemplified in Federal Regulation 21 C.F.R. 312.21(a), or
corresponding non-US applicable laws.
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1.56. "
Phase II Clinical Trial " means, as to a Product, a
controlled and lawful study in humans of the safety, dose ranging
and efficacy of such Product, which is prospectively designed to
generate sufficient data (if successful) to commence a Pivotal
Trial of such Product, as further exemplified in Federal Regulation
21 C.F.R. 312.21(b), or corresponding non-US applicable
laws.
1.57. " Pivotal
Trial " means, as to a Product, a controlled and lawful study
in humans of the clinical benefit of such Product, which is
prospectively designed to generate sufficient data (if successful)
to support Regulatory Approval (including Subpart H) of such
pharmaceutical product or label expansion of such pharmaceutical
product, as further exemplified in Federal Regulation 21 C.F.R.
312.21(c).
1.58. " Primary
Contact Person " has the meaning set forth in Section 2.7
hereof.
1.59. " Product
" means an Hsp90 Product and/or Hedgehog Product.
1.60. " Product
Costs " means on a Product-by-Product basis the aggregate of
all expenses of either Party (including accruals legitimately
chargeable against profits) in connection with the
commercialization, manufacture and distribution of Product,
consisting of only the following:
[***].
1.60B " Product Liability
Claim " means (i) a Claim by a Third Party that a Product has
resulted in personal injury or death or (ii) a medical monitoring
Claim by a Third Party (e.g., a Claim in anticipation of or
intended to prevent or forestall personal injury or death as the
result of a Product).
1.61. " Product
Revenues " means on a Product-by-Product basis any and all
revenue received by the Selling Party for Product (other than Net
Sales ) and/or rights to Product and/or under an agreement
with respect to Product (other than Net Sales), including, but not
limited to,
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(a) monies received pursuant to a license(s) such
as upfront fees, milestones, royalties, monies received for
marketing rights and/or distribution rights and (b) and monies
received as damages and/or in settlement of a legal action(s) with
respect to Product.
1.62. " Project
" means Hedgehog Project and/or Hsp90 Project.
1.63. " Promotional
Materials " means advertising, promotional, educational and
communication materials, in whatever form or medium, for marketing,
advertising and promotion of a Product for distribution to a Third
Party (including without limitation medical professionals) and to a
Party’s sales force in accordance with the terms of the
Marketing Plan.
1.64. " Recall
Expense " means the cost and expense calculated in accordance
with GAAP for recall or market withdrawal of Product required or
requested by a governmental authority having jurisdiction thereover
or as a result of a decision of the Selling Party, including, but
not limited to, expenses incurred for replacement of Product.
1.65. " Regulatory
Approval(s) " means any and all approvals from regulatory
authorities in any country or region required lawfully to
manufacture and market Product in any such country or region,
including without limitation any Product pricing and reimbursement
approvals where applicable.
1.66. " Regulatory
Authority " means any national (e.g., the FDA), supra-national
(e.g., the EMEA) or other regulatory agency or governmental entity
involved in the granting of Regulatory Approval for, or in the
regulation of human clinical studies of, Product.
1.67. " Research
and Development Plan " means for each Project each research and
development plan and amendments thereto that is approved by the
JDT.
1.68. " Revenue
" means on a Product-by-Product basis the aggregate of Net Sales
and Product Revenues.
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1.69. "
Royalty Percentage " means on a Product-by-Product basis the
following percentage depending on the stage of development of each
Product in the Project as of the Opt-Out Date for the
Project:
|
Opt-Out Date
|
|
Percentage
|
|
i. Up to dosing of a patient in a Phase I
Clinical Trial
|
|
[***] Percent ([***]%)
|
|
ii. After dosing of a patient in a Phase I
Clinical Trial and up to dosing of a patient in a Phase II Clinical
Trial
|
|
[***] Percent ([***]%)
|
|
iii. After dosing of a patient in a Phase II
Clinical Trial up to dosing of a patient in a Pivotal
Trial
|
|
[***] Percent ([***]%)
|
|
iv. After dosing of a patient in a Pivotal Trial
up to filing for Regulatory Approval in the United
States.
|
|
[***] Percent ([***]%)
|
|
v. After filing for Regulatory Approval in the
United States and thereafter.
|
|
[***] Percent ([***]%)
|
1.70. "
Royalty Bearing Product " means a Product of a Project as to
which Project a Party has exercised Opt-Out rights under Article
12.
1.71. " Selling
Expenses " means with respect to a Product, on a
Product-by-Product basis, the reasonable costs incurred or accrued
by the Selling Party with respect to the selling of the Product in
the Territory which costs are limited to: [***]. All cost
determinations made hereunder shall be made in accordance with
GAAP. Selling Expenses incurred by a Selling Party with
respect to a Product shall not materially exceed the aggregate
expenses associated with the selling (defined in the same way as
Selling Expenses) of similar products by Third Parties that are
pharmaceutical or major biotechnology companies.
1.72. " Selling
Party " means, with respect to a given Product in a country,
(i) MedImmune and its Affiliates unless MedImmune becomes an
Opt-Out-Party, in which case, if Infinity at such time is a
Non-Selling Party, Infinity may become the Selling Party or (ii)
Infinity and its
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Affiliates, if Infinity becomes the Selling Party
for such Product in such country under Section 5.4.
1.73. "
Sublicensee " means any person or entity (other than a
contract distributor having no right to promote, market or sell the
Product) that receives from a Selling Party a permitted sublicense
to promote, market, or sell the Product.
1.74. " Term "
has the meaning set forth in Section 14.1.
1.75. "
Territory " means the world.
1.76. " Third
Party " means any entity other than Infinity or MedImmune and
their respective Affiliates.
1.77. " Valid
Claim " means an issued claim of an unexpired patent, included
within Collaboration Patent Rights and/or Infinity Existing Patent
Rights and/or patents licensed to a Selling Party under this
Agreement which has not been abandoned with no rights remaining,
disclaimed, held permanently revoked, or held invalid or
unenforceable by a court of competent jurisdiction or
administrative agency in an unappealed or unappealable decision,
and which has not been admitted to be invalid or unenforceable
through reissue or disclaimer or otherwise.
1.78. " Worldwide
Net Sales " means (i) aggregate Net Sales by the Selling Party
and its Affiliates and (ii) aggregate net sales (calculated in the
same manner as Net Sales) by Sublicensees of the Selling Party and
its Affiliates and any further sublicensees.
ARTICLE 2
RESEARCH AND DEVELOPMENT COSTS
2.1
For each Project, MedImmune and Infinity, shall prepare a rolling
research and development plan for the earlier of a three-year
period or through projected Product approval which shall describe
the research and development activities for the applicable Project,
including
17
without limitation research, pre-clinical
studies, toxicology, formulation activities, manufacturing
development, scale up of production process, and clinical trials as
appropriate for the stage of research and development which shall
be updated annually. The research and development plan shall
also include a summary of the estimated costs expected to be
incurred under the research and development plan during the covered
period and a description of, and budget for, all activities
proposed for such period under the research and development
plan. In addition, the research and development plan shall
specify the responsibilities and work to be performed by each
Party, identify the number of personnel to be used by each Party in
performing activities in connection with the research and
development plan, as well as activities to be performed by Third
Parties.
2.2
For each Project, MedImmune and Infinity each agree that it shall
cause the JDT to approve a Research and Development Plan for each
calendar year that includes a level of efforts, resources and
monies sufficient to research, develop and manufacture Product and
to seek Regulatory Approval of Product in at least the United
States, Europe and Japan. The initial rolling three-year
Research and Development Plan for each Project shall be prepared
and approved within thirty (30) days of the Effective Date and
shall be consistent with the plan separately provided by Infinity
to MedImmune on August 22, 2006.
2.3
(a) The
research and development plan prepared by the Parties (except for
the initial Research and Development Plan), shall be submitted to
the JDT for approval by no later than June 30 of the calendar year
preceding the three (3) calendar years covered therein. The
research and development plan approved by the JDT in amended or
unamended form for a Project shall be the Research and Development
Plan for the Project. The Research and Development Plan shall
always be a rolling three year plan and the Research and
Development
18
Plan shall be updated or amended at least
annually by no later than August 1 st
of each year preceding the year for which the
update is being made.
(b)
Notwithstanding Section 2.3(a), the Research and Development Plans
approved by the JDT after the initial Research and Development Plan
with respect to the periods covered by the initial Research and
Development Plan shall be consistent with the initial Research and
Development Plan unless a change is required thereto as a result of
a clinical hold, unavailability of clinical supply of Product
and/or material events affecting the initial Research and
Development Plan, in which case the Research and Development Plan
for such period and the corresponding expenditures by the Parties
thereunder will be adjusted accordingly by agreement of the
JDT.
2.4
In a calendar year, unless approved in writing by the Parties,
neither Party shall incur or enter into contracts to incur
Development Costs that exceed [***] percent ([***]%) of the amount
of the budget allocated to such Party for such calendar year under
a Research and Development Plan.
2.5
Each Party shall report to the other Party through the JDT, the
Development Costs actually incurred by each Party in a calendar
quarter within twenty (20) calendar days after the end of the
applicable calendar quarter. The JDT shall determine the
aggregate Development Costs for the applicable calendar quarter and
determine the amount of Development Costs that should have been
allocated to MedImmune based on the Applicable Percentage, and the
Development Costs that should have been allocated to Infinity based
on the Applicable Percentage. The JDT shall report such
calculation to both Parties within ten (10) Business Days after
receiving the reports thereby communicating its determination as to
Development Costs owed. To the extent that a Party has
incurred Development Costs in excess of the Development
19
Costs that should have been incurred by such
Party based on the Applicable Percentage, within (30) days, the
other Party shall pay to such Party such excess so that each Party
bears the Applicable Percentage of such aggregate Development Costs
for such calendar quarter.
2.6
Each Party shall keep and shall cause each of its Affiliates and
their contractors to keep full and accurate records and books of
account containing all particulars that may be necessary for the
purpose of calculating Development Costs to be charged to the other
Party pursuant to this Agreement. Such books of account shall
be kept by a Party at its places of business and, with all
necessary supporting data shall, for the three (3) years next
following the end of the calendar year to which each shall pertain
be open for inspection by auditors, which may be the other
Party’s internal audit team or an independent certified
accounting firm selected by the other Party and reasonably
acceptable to the Party whose books are being inspected upon
reasonable notice during normal business hours at the other
Party’s expense for the sole purpose of verifying Development
Costs in compliance with this Agreement, but in no event more than
once each calendar year. All information and data offered
shall be used only for the purpose of verifying Development
Costs. In the event that such inspection shall indicate that
in any calendar year the charges for Development Costs were
overstated by at least five percent (5%), then the Party whose
books are being inspected shall pay the cost of the
inspection. All underpayments and overpayments revealed by
such audit are immediately due and payable. Upon the
expiration of three (3) years after a calendar year, the
Development Costs reported by a Party for such period shall be
binding on both Parties, except to the extent that inspection
during such period indicated an overpayment or underpayment.
2.7
MedImmune and Infinity shall each designate an initial primary
contact person (" Primary Contact Person ") who shall be
responsible for the interactions between the Parties
20
related to this Agreement. The Primary
Contact Persons shall attempt to promptly resolve any disputes that
arise under a Project and, if they are unable to do so, such
dispute shall be referred to the JDT. Each Party may change
its Primary Contact Person upon written notice to the other
Party. Each Party’s Primary Contact Person may also
serve as one of its representatives on the JDT. The Primary
Contact Person for each Party shall designate for each Project one
or more employees of such Party as members of a project team(s),
who shall meet as often as needed to coordinate the work of the
Parties under the applicable Research and Development
Plan.
(a)
Infinity shall transfer to MedImmune Infinity Existing Know-How,
Collaboration Know-How and Infinity General Know-How, as
applicable, as requested by MedImmune to the extent the same is
necessary or useful to enable MedImmune to perform its obligations
and exercise its rights under this Agreement.
(b)
MedImmune shall transfer to Infinity MedImmune General Know-How and
Collaboration Know-How, as applicable, as requested by Infinity to
the extent the same is necessary or useful to enable Infinity to
perform its obligations and exercise its rights under this
Agreement.
ARTICLE 3
JOINT DEVELOPMENT TEAM
3.1
(a)
Until the Opt-Out-Date for a Project, each Project shall be managed
and directed by a committee initially composed of six (6) members
(which may be adjusted by the JDT, as long as there is an even
number of members), with MedImmune appointing one-half of the
members and Infinity one-half of the members (the " JDT
"). MedImmune and Infinity may
21
also appoint such non-voting ex-officio members
of the JDT as each Party may deem appropriate, provided that any
such ex-officio member that is not an employee signs an appropriate
confidentiality agreement.
(b)
The JDT shall meet at least once each calendar quarter in person or
by telephone or by video conference. A quorum for the conduct
of business at any meeting of the JDT shall consist of at least one
representative of MedImmune and at least one Infinity
representative. Each of Infinity and MedImmune, shall have
one vote, and subject to Section 3.1(d) all decisions shall be
reached by a unanimous vote. The Parties shall cause the JDT
to review and vote on each submitted research and development
plan. The JDT has the authority to approve Research and
Development Plans.
(c)
The JDT shall review each approved Research and Development Plan at
least once each year or at the request of any member, and shall
decide whether or not to amend the Research and Development Plan,
as the case may be.
(d)
If there is a tie vote in the JDT, or if the JDT is unable to
resolve a dispute referred to the JDT, Infinity and MedImmune agree
to exert all reasonable efforts to arrive at a mutually acceptable
resolution, including a meeting between their CEO’s or a
person designated by a CEO. In the event that there is a tie
vote or dispute as to a Project that is not resolved by the
respective CEOs or their designees within thirty (30) days after
submission to the CEOs, then such shall be resolved by binding
arbitration in accordance with Exhibit A.
(e)
The JDT shall be responsible for providing advice with respect to
and generally supervising research and development pursuant to all
Research and Development Plans and for deciding disputes between
the Parties with respect to work to be performed under any Research
and Development Plan. It is specifically understood, however,
that the day-to-day
22
management of the activities allocated to either
Party under any Research and Development Plan shall be managed by
such Party rather than the JDT.
(f)
The JDT shall keep accurate minutes of its deliberations which
shall record all proposed decisions and all actions recommended or
taken. The Parties shall alternate responsibility for the
preparation of the draft minutes on an annual basis. Draft
minutes shall be sent to all members of the JDT within fifteen (15)
days after each meeting and shall be approved, if appropriate, or
amended and approved as amended within thirty (30) days by a quorum
of the JDT. All records of the JDT shall at all times be
available to both Infinity and MedImmune.
(g)
With respect to a Project, the JDT shall cease to have voting
authority as to all Products of a Project upon Regulatory Approval
for the first Product of such Project. Thereafter, the JDT
shall continue to exist as a sub-committee of the JCT, reporting to
and advising the JCT with respect to development matters. If
either Party becomes an Opt-Out Party with respect to a Project,
the JDT with respect to such Project shall cease to exist.
(h)
The chairperson of the JDT shall have the following roles and
responsibilities: (a) to call meetings of the JDT, send notice of
each such meeting and designate the time, date and place of each
such meeting; (b) to convene or poll the members of the JDT by
other permitted means; (c) to establish the agenda for each meeting
of the JDT, subject to the right of any member of the JDT to add
additional agenda items at any meeting; (d) to prepare comments to
the draft minutes prepared by the secretary of the JDT and
communicate with the secretary to finalize the draft minutes prior
to circulation to all members of the JDT; and (e) to execute, along
with the secretary of the JDT, the final minutes of the meetings of
the JDT. The chairperson shall alternate each calendar year
between a member appointed by Infinity and a
23
member appointed by MedImmune, with a member
appointed by Infinity being the first chairperson for each JDT, and
serving until the end of calendar year 2007.
(i)
Each Party shall provide the JDT with quarterly written reports
regarding the status of the activities for the Project.
(j)
Each Party shall be responsible for all travel and related costs
and expenses for its members, designees and non-JDT invitees to
attend meetings of, and otherwise participate in, the JDT.
(k)
If a JDT member cannot attend a particular JDT meeting, such member
may send a designate authorized to make decisions.
ARTICLE 4
RESEARCH, DEVELOPMENT AND REGULATORY
4.1
With respect to a Project each Party that has not become an Opt-Out
Party agrees to perform the work assigned to that Party under a
Research and Development Plan for that Project. All such work
will be conducted, in a professional manner and at a level of
quality appropriate to major biotechnology companies.
4.2
Each Party shall prepare a written report prior to a scheduled
meeting of the JDT with respect to the work performed by such Party
under a Research and Development Plan and deliver such report to
the JDT prior to the scheduled meeting.
4.3
In preparing a research and development plan and subsequent
approval thereof by the JDT or JCT pursuant to this Agreement, work
thereunder shall be assigned to a Party based upon the respective
Parties ability to perform such activity. Subject to the
preceding sentence, the Parties contemplate that Infinity will have
primary responsibility for activities involving
24
expertise in development of small molecules such
as lead identification and optimization, medicinal chemistry,
preclinical development, early translational clinical development
through initial evidence of safety and efficacy in humans, process
chemistry and development and manufacturing scale-up, and that
MedImmune shall have primary responsibility for pivotal clinical
trials, for obtaining worldwide Regulatory Approval and for
commercialization.
4.4
(a)
Infinity will file, own and maintain the INDs with respect to a
given Product until the earlier of the end of a Phase II Clinical
Trial meeting with the FDA or immediately prior to the initiation
of the first Pivotal Trial in any country with respect to such
Product. At the earlier of the end of a Phase II Clinical
Trial meeting with the FDA or immediately prior to initiation of
the first Pivotal Trial for a given Product in any country Infinity
will transfer all INDs with respect to such Product to MedImmune in
all countries in which MedImmune is the Selling Party and
thereafter the Selling Party in a country will file, own and
maintain all INDs and Regulatory Approvals for such Product in such
country. The owner of the IND in the United States shall be
responsible for the global product safety database for tracking
safety issues with respect to the Product.
(b)
The owner of the IND shall within the time permitted under
applicable regulations, file or cause to be filed with the FDA and
any other applicable Regulatory Authority, all notices,
assignments, documents or other materials required by the laws of
the Territory to be filed in connection with such Product.
The owner of the IND shall be responsible for developing Product
labeling, package inserts, imprinting and packaging data as
appropriate, for the Product. The owner of the IND shall be
responsible for all regulatory compliance activities with respect
to such Product. The other Party shall provide any
information and assistance reasonably requested by the owner of the
IND for any regulatory filing, Product
25
labeling development, and all regulatory
compliance activities with respect to such Product. The other
Party agrees that time is of the essence with regard to these
matters and will take all steps necessary to respond to the owner
of the IND in a timely manner. The owner of the IND agrees
that, to the extent reasonably possible given such time
constraints, prior to the Opt-Out Date for a Project, the other
Party shall have a reasonable opportunity to review and comment
upon regulatory filings and all substantive correspondence to or
from the FDA or comparable Regulatory Authorities with respect to
such Products of such Project and that the owner of the IND shall
consider such comments in determining its activities with respect
to interactions with the FDA and comparable Regulatory
Authorities. The Selling Party and the Non-Selling Party with
respect to a Product shall have the right to attend meetings with
Regulatory Authorities with respect to such Product, however, the
Party that is not the owner of the IND shall participate in such
meetings only as an observer.
(c)
On a country-by-country basis, the Selling Party shall have
responsibility (subject to any responsibility provided to Infinity
in any co-promotion agreement entered into pursuant to Section
6.4), to respond to questions and inquiries relating to the Product
raised by health care professionals and customers and shall, if so
requested by the Non-Selling Party, provide the Non-Selling Party
with details of such questions and inquiries received and responses
given. The Selling Party will establish and implement
effective procedures and mechanisms for responding to such
questions and inquiries.
(d)
On a country-by-country basis, the Selling Party shall assume all
responsibility (subject to any responsibility provided to Infinity
in any co-promotion agreement entered into pursuant to Section 6.4)
for all correspondence and communication with physicians and other
health care professionals relating to the Product. The
Selling Party shall keep such
26
records and make such reports as shall be
reasonably necessary to document such communications in compliance
with all applicable regulatory requirements and shall, if so
requested by the Non-Selling Party, make available to the
Non-Selling Party such records and reports. The Non-Selling
Party shall refer all such questions regarding the Products to the
Selling Party in a timely manner.
(e)
Each Party shall promptly upon the Effective Date of this Agreement
and thereafter at all times during the Term promptly disclose to
the other Party all significant information of which it becomes
aware, which it can legally disclose and which it reasonably
believes will have a material commercial impact on the detailing,
promotion, marketing and sale of the Product in accordance with
this Agreement.
(f)
The owner of the IND shall have full responsibility for completing
and filing the annual report and all other required reports in the
Territory for the Product.
(g)
Effective upon filing of an IND for a Product, the owner of the IND
shall be responsible for reporting adverse experiences and
reactions with respect to the Product in conformance with all
applicable laws, rules and regulations. Each of
Infinity and MedImmune shall send to the other, throughout such
period, copies of all such adverse experience or reaction reports,
with all "Serious" and "Unexpected" adverse experiences (and
relevant government reporting forms) sent to the other Party no
later than five (5) calendar days of such Party’s receipt,
and all adverse experiences or reactions other than "Serious" or
"Unexpected" adverse experiences (and relevant government reporting
forms) sent to the other party no later than 30 calendar days after
such Party’s receipt. MedImmune and Infinity will
develop pharmacovigilance procedures to comply with applicable
regulations and orders of Regulatory Authorities.
27
(h)
Notwithstanding anything else in this Section 4.4 to the contrary,
during the period that the JDT has decision making authority for a
Project, the actions of the owner of the IND pursuant to this
Section 4.4 shall be consistent with the decisions of the JDT and
the Research and Development Plan.
4.5
The Selling Party of a Product in the United States will be
responsible for manufacturing or having manufactured such Product
for worldwide use. In the event that both Parties and/or
their Affiliates are Selling Parties of a given Product in the
Territory, the Parties shall establish a supply and quality
agreement for such Product which shall provide for the equitable
allocation of Product among countries in the Territory and other
commercially reasonable terms. If the Selling Party of a
Product in the United States fails to meet its supply
responsibilities, the Selling Party for such Product in any other
country shall have the right to manufacture and have manufactured
such Product for use and sale in such other country.
ARTICLE 5
LICENSES AND NON-COMPETE
5.1
(a) For
each Project, Infinity hereby grants to MedImmune, a worldwide and,
subject to Section 5.4, sublicensable right and license that is
co-exclusive with Infinity under the Infinity General Rights,
Infinity Existing Rights and Collaboration Rights to make, have
made, use, sell, offer to sell and import Product in the Field in
accordance with the terms and conditions of this Agreement, and
such license shall automatically terminate (i) for all Products of
a Project as to which MedImmune becomes an Opt-Out Party effective
as of the Opt-Out Date and (ii) in each country for each Product as
to which MedImmune becomes the Non-Selling Party except for a
non-exclusive license to make and have made Products in any country
of the world for sale
28
in a country where MedImmune is the Selling
Party. On a Project-by-Project basis, if MedImmune has not
become an Opt-Out Party, Infinity agrees not to exercise any or
grant any rights or licenses under any of the rights and licenses
retained by Infinity under this Section 5.1(a) with respect to
Product in any country of the Territory, except to the extent
useful or necessary to perform its obligations or exercise its
rights under this Agreement (including under any co-promotion
agreement entered into pursuant to Section 6.4.) or to make and
have made such Product in any country of the world for sale in a
country where Infinity is the Selling Party.
(b)
For each Product in each country as to which Infinity is the
Selling Party, MedImmune agrees to grant and hereby grants to
Infinity a sublicensable right and license under Collaboration
Rights and MedImmune General Rights that is co-exclusive with
MedImmune to (i) make and have made such Product in any country of
the world for sale in such countries, and (ii) use, sell, offer to
sell and import such Products in such countries in the Field, in
accordance with the terms and conditions of this Agreement, and
such license shall automatically terminate for a Project (and for
each Product in the Project) as to which Infinity becomes an
Opt-Out Party effective as of the Opt-Out Date. On a
Project-by-Project basis, if Infinity has not become an Opt-Out
Party, MedImmune agrees not to exercise any or grant any rights or
licenses under any of the rights and licenses retained by MedImmune
under this Section 5.1(b) with respect to a Product in any country
of the Territory, as to which Infinity is the Selling Party, except
to the extent useful or necessary to perform its obligations or
exercise its rights under this Agreement including the rights and
licenses granted to MedImmune under Section 5.1.
(c)
Any license granted under this Section 5.1 that is a sublicense
shall be in accordance with the terms of the license agreement
under which the sublicense is granted.
29
5.2
(a) For
each Project, MedImmune hereby grants to Infinity a co-exclusive
worldwide right and license under the MedImmune General Rights and
Collaboration Rights to make, have made, use and import Product of
said Project in the Field, but only to the extent useful or
necessary to perform Infinity’s obligations or exercise its
rights under a Research and Development Plan, which license shall
automatically terminate for a Project (and for each Product in the
Project) as to which Infinity becomes an Opt-Out Party effective as
of the Opt-Out Date. On a Project-by-Project basis, if
Infinity has not become an Opt-Out Party, MedImmune agrees not to
exercise any or grant any rights or licenses under any of the
rights and licenses retained by MedImmune under this Section 5.2(a)
to develop, market or sell a Product in any country of the
Territory, except to the extent useful or necessary to perform its
obligations or exercise its rights under this Agreement including
the rights and licenses granted to MedImmune under Section
5.1.
(b)
Any license granted under this Section 5.2 that is a sublicense
shall be in accordance with the terms of the license agreement
under which the sublicense is granted.
5.3
[Purposely Omitted]
5.4
(a) Either
Party is free to grant sublicenses to its Affiliates with respect
to the licenses granted to it by the other Party hereunder;
provided , however , that such Party shall remain
liable for all of its obligations hereunder and shall ensure that
its Affiliates comply with all obligations of such Party
hereunder.
(b)
In the event that MedImmune decides to grant a (sub)license to any
Third Party with respect to sales of a Product in the United States
or in one or more countries outside of the United States and at
such time Infinity is a Non-Selling Party with respect to such
Product in the United States or such other countries, as the case
may be, MedImmune shall provide
30
written notice to Infinity of such
decision. In the event that Infinity desires to become a
Selling Party for such Products in the United States or in such
other countries, Infinity shall provide written notice thereof to
MedImmune within thirty (30) days after receipt of such
notice. The Parties thereafter shall discuss in good faith
the ability of Infinity at such time to market and sell such
Product in the United States or such one or more countries, as the
case may be, in a manner that protects the profit interests of both
Parties. If the Parties do not reach agreement as to such
issue, then Infinity shall have the right to submit such issue to
arbitration pursuant to Exhibit A.
(c)
If Infinity does not provide MedImmune the notice of Section 5.4(b)
or if Infinity does not submit the issue to arbitration within ten
(10) days after notice that MedImmune does not agree with Infinity
becoming the Selling Party or if in the arbitration it is
determined that Infinity does not have such capabilities of Section
5.4(b), then MedImmune shall have the right to (sub)license such
Products in such countries to a Third Party, subject to
Infinity’s consent as to the entity who will be the
Sublicensee which consent shall not be unreasonably withheld or
delayed.
(d)
If MedImmune agrees that Infinity should be the Selling Party for
such Products in the United States or such other countries or if it
is determined in an arbitration that Infinity has the
qualifications of Section 5.4(b) for becoming the Selling Party for
such Products in the United States or such other countries, as the
case may be, then with respect thereto, Infinity shall become the
Selling Party (with the right to sublicense commercialization
rights with the consent of MedImmune, such consent not to be
unreasonably withheld) and MedImmune the Non-Selling Party.
31
(e)
For Europe, if MedImmune proposes to grant a (sub)license for a
plurality of countries in Europe, then Infinity’s rights
under this Section 5.4 (except Section 5.4(a)) shall require that
Infinity meets the qualifications to become a Selling Party for all
of such countries.
(f)
If Infinity becomes the Selling Party in any country, MedImmune
will, transfer all Promotional Materials, customer lists and other
information in its possession related to the promotion of the
applicable Product in such country to Infinity and perform such
services as Infinity may reasonably request with the goal of
effecting a smooth transition of the promotion duties previously
performed by MedImmune. The Parties shall equally share the
expense thereof.
(g)
If Infinity becomes the Selling Party in a country for a Product,
to the extent legally permitted, MedImmune shall, with respect to
the applicable Product in such country, transfer to Infinity any
and all INDs, Regulatory Approvals, regulatory filings and price
approvals.
(h)
If Infinity becomes the Selling Party in the United States for all
Products of a Project, Infinity shall assume MedImmune’s
right to cast the deciding vote and appoint the Chairman of the
Joint Commercialization Team for such Project pursuant to Section
6.2.
5.5
(a)
Neither Party shall, and each Party shall ensure that its
Affiliates shall not, develop, market or sell a Product except in
accordance with the terms and conditions of this Agreement.
(b)
If a Party becomes an Opt-Out Party with respect to a Project, then
the obligations of Section 5.5(a) with respect to Products of such
Project shall terminate two (2) years after the Opt-Out Date for
such Project other than those that (i) embody or use Collaboration
Rights or Infinity Existing Rights or (ii) contain an Active
Pharmaceutical
32
Ingredient for a Product that was researched
and/or developed prior to the applicable Opt-Out Date.
(c)
If either Party or any of its Affiliates signs a definitive
agreement with respect to a merger or acquisition by operation of
which such Party or its Affiliate would (i) acquire a Product or
(ii) be acquired by or merge with a Third Party who has a Product
(a Product described in clause (i) or (ii), an " Acquired
Product "), then such Party or its Affiliate (or the relevant
entity with the Acquired Product) shall have six (6) months from
the signing date of such definitive agreement to either receive the
consent of the other Party to develop and commercialize the
Acquired Product or divest itself of such Acquired Product and,
during such six (6) month period, the development, marketing,
and/or sale
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