Exhibit 10.1
Confidential Materials omitted and filed
separately with the
Securities and Exchange Commission. Asterisks
denote omissions.
RESEARCH COLLABORATION AND
LICENSE AGREEMENT
THIS RESEARCH COLLABORATION AND
LICENSE AGREEMENT (
“Agreement” ) is made effective as of
November 24, 2004 ( “Effective Date” ) by
and between ACHILLION PHARMACEUTICALS, INC., a Delaware
corporation ( “Achillion” ), with its principal
place of business at 300 George Street, New Haven, Connecticut
06511, USA, and GILEAD SCIENCES, INC., a Delaware
corporation ( “Gilead” ), with its principal
place of business at 333 Lakeside Drive, Foster City, California
94404, USA. Achillion and Gilead are sometimes referred to in this
Agreement individually as a “Party” and
collectively as the “Parties” .
RECITALS
WHEREAS , Achillion has certain proprietary technology
in compounds for the prevention and treatment of chronic hepatitis
C infection;
WHEREAS , Gilead and Achillion desire to enter into a
collaboration to develop and commercialize Compounds (as
hereinafter defined) upon the terms and conditions set forth
herein;
WHEREAS , Gilead desires to obtain the right to develop
and commercialize Licensed Products in the Field (each as
hereinafter defined) and Achillion desires to grant such rights, in
each case upon the terms and conditions set forth
herein.
NOW, THEREFORE
, in consideration of the foregoing
premises and the mutual covenants herein contained, the Parties
hereby agree as follows:
AGREEMENT
Unless specifically set forth to the
contrary herein, the following terms, whether used in the singular
or plural, shall have the respective meanings set forth below.
References to “Articles”, “Sections” and
“subsections” in this Agreement shall be to Articles,
Sections and subsections respectively, of this Agreement unless
otherwise specifically provided:
“Achillion Annual Budget
Amount” means the
Annual Budget Amount allotted to Achillion in the
Budget.
“Achillion
Know-How” means
Know-How Controlled by Achillion (a) as of the Effective Date;
(b) that is developed or acquired in the course of the
Research Program; or (c)
that is developed or acquired outside of the
course of the Research Program that is necessary or useful to the
research, Development, manufacture, use, sale, offer for sale, or
importation of Compounds.
“Achillion
Patents” means
Patents Controlled by Achillion (a) that are listed in Exhibit
1.1; (b) as of the Effective Date; (c) that are
conceived, reduced to practice or acquired in the course of the
Research Program; or (d) that claim or are directed to the
research, Development, manufacture, use, sale, offer for sale or
importation of Compounds. The Patents listed in Exhibit 1.1 shall
be amended or supplemented from time to time by Achillion to
include any Patent Controlled by Achillion after the Effective Date
and during the Research Program Term which claims or is directed to
a composition of matter, or the manufacture or use thereof, that is
necessary or useful to the research, Development, manufacture, use,
sale, offer for sale or importation of Compounds.
“Achillion Research
Costs” means
Research Costs incurred by Achillion.
“Achillion
Technology” means
Achillion Patents and Achillion Know-How.
“ADR”
has the meaning given such term in
Section 12.1(b).
“ADR
Request” has the
meaning given such term in Section 12.1(b)(i).
“Affiliate” means any corporation or other entity which has
Corporate Control of, is under Corporate Control by, or is under
common Corporate Control with, a Party to this Agreement. An entity
shall be an Affiliate of a Party for only so long as such Corporate
Control exists.
“Annual Budget
Amount” means the
Research Costs for both Parties reflected in the Budget for each
calendar year in accordance with Section 2.4.
“Arbitration
Panel” has the
meaning given in Section 12.1(c)(i).
“Back-up
Compound” means any
Compound other than the Lead Compound.
“Back-up
Program” means the
component of the Research Program devoted to Back-up
Compounds.
“Blackout
Period” means the
period beginning on the Effective Date, and ending on
[**].
“Budget”
has the meaning given such term in
Section 2.4(a)(i).
“Calendar
Quarter” means the
respective periods of three (3) consecutive calendar months
ending on March 31, June 30, September 30
and December 31.
2
“Change of Corporate
Control” means,
with respect to a Party, the occurrence of any of the
following:
(a) any consolidation or merger of a
Party with or into any Third Party, or any other corporate
reorganization involving a Third Party (
“Merger” ), as long as the stockholders of such
Party immediately prior to the Merger own less than fifty percent
(50%) of the surviving entity’s voting power immediately
after the Merger;
(b) a change in the beneficial
ownership of fifty percent (50%) or more of the voting
securities of any Party (whether in a single transaction or series
of related transactions) where, immediately after giving effect to
such change, the legal or beneficial owner of more than fifty
percent (50%) of the voting securities of such Party is a
Third Party, excluding any equity investments by venture
capitalists or investment banks or other non-strategic investors,
who alone or with their Affiliates, are not themselves in the
business of developing and commercializing pharmaceutical products;
or
(c) the sale, transfer, lease,
license or other disposition to a Third Party of all or
substantially all of a Party’s assets in one or a series of
related transactions.
As used in this definition, “Party”
shall exclude Affiliates under Corporate Control by, or under
common Corporate Control with, such Party.
“CMC”
has the meaning given to such term
in Section 4.1.
“Combination
Product” means a
product that includes one or more pharmaceutically active
ingredients other than a Compound in combination with at least one
Compound. All references to Licensed Product in this Agreement
shall be deemed to include a Combination Product.
“Commercially Diligent
Efforts” mean those
efforts to research, Develop, commercialize and market Licensed
Products that are consistent with the usual practice followed by
pharmaceutical companies in pursuing the research, Development,
commercialization and marketing of their pharmaceutical products
with a comparable potential market, risk, and revenues.
“Compound”
has the meaning given in Exhibit
1.2.
“Confidential
Information” has
the meaning given such term in Section 7.1(a).
“Control”,
“Controls” and “Controlled”
mean, with respect to a particular
item of information or intellectual property right, that the
applicable Party owns or has a license to such item or right and
has the ability to grant to the other Party access to and a license
or sublicense (as applicable) under such item or rights as provided
for herein without violating the terms of any agreement or other
arrangement with any Third Party existing as of the Effective Date
or thereafter.
“Corporate
Control” means
(a) in the case of corporate entities, direct or indirect
ownership of at least fifty percent (50%) of the stock or
shares having the right to vote for the election of directors, and
(b) in the case of non-corporate entities, direct or indirect
ownership of at least fifty percent (50%) of the equity
interest with the power to direct the management and policies of
such non-corporate entities.
3
“Develop”
means the conduct of any
pre-clinical, clinical or other studies required for obtaining
Regulatory Approval (including without limitation manufacturing,
formulation, quality assurance and quality control activities) or
for commercialization of a Compound, along with any other clinical
studies, all in accordance with this Agreement. The terms
“Developing” and “Development” shall be
interpreted accordingly.
“Development
Committee” has the
meaning given such term in Section 3.1(a).
“Development
Plan” has the
meaning given such term in Section 3.2.
“Development Program
Term” means the
period commencing when Proof of Concept is established and ending
upon receipt of Regulatory Approvals from both the FDA and the
EMEA.
“Discover”
means the identification and
optimization of the preclinical properties of Compounds. The terms
“Discovering” and “Discovery” shall be
interpreted accordingly.
“Drug Approval
Application” shall
mean an application for Regulatory Approval of a Licensed Product,
including without limitation an IND or NDA.
“EMEA”
means the European Medicines
Agency, or a successor agency thereto.
“European
Market” means
Germany, France, Italy, Spain and the United Kingdom.
“External Research
Costs” means the
reasonable and actual out-of-pocket costs, approved in advance by
the Research Committee and reflected in the Budget, incurred by a
Party from a Third Party, without mark-up or overhead charges,
directly in furtherance of the Research Program. Examples of
External Research Costs that could be approved by the Research
Committee are the costs charged by Third Parties for materials to
make Compounds, contract researchers and/or toxicology studies.
“External Research Costs” shall not include any costs
reflected in the FTE Rate.
“FDA”
means the United States Food and
Drug Administration, or a successor federal agency
thereto.
“Field”
means all human and animal
therapeutic, diagnostic, and prophylactic uses, including, without
limitation, the treatment, prevention and prophylaxis of hepatitis
C viral infections.
“Field-Based
Personnel” has the
meaning given such term in Section 4.2(b)(i).
“First Commercial
Sale” means, with
respect to any Licensed Product, the first sale for end use or
consumption of such Licensed Product in a Major Market after all
required Regulatory Approvals with respect to such Licensed Product
have been granted by the Regulatory Authority of such Major Market.
For purposes of clarification, the first sale for end use or
consumption of a Licensed Product in a Major Market after
conditional approval has been granted will constitute a First
Commercial Sale for purposes of this Agreement.
4
“FTE”
means an annualized full-time
employee or equivalent, working no less than 1800 person hours per
calendar year, with part-time personnel pro-rated as partial
FTE’s.
“FTE Rate”
means the amount a Party will pay
the other Party over a consecutive twelve (12) month period
for one (1) FTE. Unless otherwise agreed by the
Parties:
(a) for Achillion FTEs conducting
scientific research activities for Gilead pursuant to the Research
Program, the FTE Rate will be [**] Dollars ($[**]), with an annual
cost of living adjustment (commencing January 1, 2006) in
accordance with CPI-U as published by the Department of Labor
Bureau of Labor Statistics; and
(b) for FTEs employed by the Parties
and identified in the Research Plan and Budget as conducting
activities in furtherance of the Research Program (other than
activities conducted pursuant to subparagraph (a) above), the
FTE Rate will be [**] Dollars ($[**]), with an annual cost of
living adjustment (commencing January 1, 2006) in accordance
with CPI-U as published by the Department of Labor Bureau of Labor
Statistics.
The FTE Rate shall reflect, and include, all
personnel costs (including normal vacations, sick days, holidays
and employee benefits), and costs of equipment, reagents, travel,
materials and supplies, allocation of general and administrative
expenses, repairs, maintenance, utilities, rent, support staff and
other overhead, for or associated with an FTE, provided that
payment by a Party of the FTE Rate shall not be deemed to give such
Party any ownership interest in any equipment, reagents or other
property purchased by the other Party using such research
funding.
“GAAP”
means United States Generally
Acceptable Accounting Principles.
“Gilead Annual Budget
Amount” means the
Annual Budget Amount allotted to Gilead in the Budget.
“Gilead
Know-How” means
Know-How Controlled by Gilead that is necessary or useful to the
research, Development, manufacture, use, sale, offer for sale, or
importation of Compounds.
“Gilead
Patents” means any
Patent Controlled by Gilead that is necessary or useful to the
research, Development, manufacture, use, sale, offer for sale, or
importation of Compounds.
“Gilead Research
Costs” means
Research Costs incurred by Gilead.
“Gilead
Technology” means
Gilead Patents and Gilead Know-How.
“HCV
Field” means the
treatment of chronic hepatitis C viral infections in
humans.
“IND”
means an Investigational New Drug
application, Clinical Study Application, Clinical Trial Exemption,
or similar application or submission for approval to conduct human
clinical investigations filed with or submitted to a Regulatory
Authority in conformance with the requirements of such Regulatory
Authority.
5
“Information”
means any and all information, data,
results, inventions, trade secrets, techniques, material, or
compositions of matter of any type or kind, including without
limitation all know-how and all other scientific, pre-clinical,
clinical, regulatory, manufacturing, marketing, personnel,
financial, legal and commercial information or data, whether
communicated in writing, orally or by any other method, which is
disclosed by one Party to the other Party in connection with this
Agreement; provided that the foregoing is related to a
Compound.
“Invention” means any process, method, use, composition of
matter, article of manufacture, discovery or finding, whether or
not patentable.
“Joint
Inventions” has the
meaning given such term in Section 9.1.
“Joint
Patents” has the
meaning given such term in Section 9.1.
“Know-How”
means all tangible and intangible
(a) techniques, technology, practices, trade secrets,
inventions (whether patentable or not), methods, knowledge,
know-how, skill, experience, test data and results (including
pharmacological, toxicological and clinical test data and results),
analytical and quality control data, results or descriptions,
software and algorithms and (b) compounds, compositions of
matter, cells, cell lines, assays, animal models and physical,
biological or chemical material Controlled by Party or its
Affiliates, in either case that are necessary or useful to the
research, Development, formulation, manufacture, use or sale of
Compounds.
“Lead
Compound” has the
meaning given such term in Section 2.2(a)(iv).
“Licensed
Product” means any
preparations in final form, bulk form or other form containing as
an active pharmaceutical ingredient one or more Compounds for sale
by prescription, over-the-counter or any other method, including
without limitation any Combination Product.
“Major
Market” means each
of the United States of America, Japan and each of the five
(5) countries of the European Market.
“NDA”
means a New Drug Application,
Biologics License Application, Worldwide Marketing Application,
Regulatory Approval application or similar application or
submission for Regulatory Approval of a Licensed Product filed with
a Regulatory Authority to obtain marketing approval for a
biological or pharmaceutical product in that country or in that
group of countries.
“Net
Difference” has the
meaning give such term in Section 2.4(c)(iii).
“Net
Sales” means, with
respect to a given period of time, the total amount invoiced by
Gilead or its Related Gilead Parties for sales of Licensed Products
to a Third Party (whether an end-user, wholesaler or otherwise) in
the Territory, less the following deductions with respect to such
sale, to the extent applicable to the Licensed Product and to the
extent actually allowed and/or taken: (a) trade, cash and
quantity credits, discounts, credits, and refunds,
(b) allowances or credits for returns or rejected Licensed
Product and a reasonable allowance for bad debt expense consistent
with GAAP; (c) prepaid freight and insurance; (d) sales
taxes and other
6
governmental charges (including value added and
similar taxes, but solely to the extent not otherwise creditable or
reimbursed and excluding any income tax) actually paid by Gilead or
its Related Gilead Parties in connection with the sale; and
(e) customary rebates (including, for this purpose, discounts
provided by means of chargebacks or rebates) actually granted to
managed health care organizations, federal, state, or local
governments (or their agencies) (including without limitation
Medicaid rebates), all to the extent in accordance with GAAP as
consistently applied across all products of Gilead.
Where Licensed Product is sold in
the form of a Combination Product containing one or more active
pharmaceutical ingredients ( “API” ) in addition
to a Compound, the Net Sales for such Combination Product for
purposes of determining royalties payable under this Agreement will
be calculated by multiplying the Net Sales of such Combination
Product (without regard to the adjustment established by this
paragraph) by the fraction A/(A+B) where A is the Net Selling Price
for the stock keeping unit most comparable to the component of the
Licensed Product containing that Compound as the sole API, if sold
separately, in such country during the relevant fiscal quarter (or
if not available in that quarter, the most recent available fiscal
quarter), and B is the Net Selling Price for the stock keeping
unit, most comparable to the component containing other APIs, if
sold separately, in such country during the relevant fiscal
quarter. For clarity, if there are three or more APIs (including
the Compound), additional B terms calculated in the same manner,
shall be included in the denominator so that such fraction shall be
A/(A+B1+B2+ ).
If, on a country-by-country basis,
one or more of the other APIs in the Combination Product are not
sold separately in said country, the Net Sales for the purpose of
determining royalties payable under this Agreement for the
Combination Product shall be calculated by multiplying the Net
Sales of such Combination Product (without regard to the adjustment
established by this paragraph) by the fraction A/C where A is the
Net Selling Price for the stock keeping unit most comparable to the
component of the Licensed Product containing the relevant Compound
as the sole API, if sold separately, in such country during the
relevant fiscal quarter (or if not available in that quarter, the
most recent available fiscal quarter) and C is the Net Selling
Price for the Combination Product in such country during the
relevant fiscal quarter (or if not available in that quarter, the
most recent available fiscal quarter).
If, on a country-by-country basis,
the Licensed Product containing a Compound as the sole API is not
sold separately in said country during the relevant fiscal quarter
but one or more of the other APIs in the Combination Product are
sold separately in said country during the relevant fiscal quarter
(or if not available in that quarter, the most recent available
fiscal quarter), the Net Sales for the Combination Product shall be
calculated by multiplying the Net Sales of such Combination Product
(without regard to the adjustment established by this paragraph) by
the fraction (1-(D/C)) where D is the Net Selling Price for the
stock keeping unit most comparable to the product containing the
other API as the sole API and C is the Net Selling Price for the
Combination Product in such country during the relevant fiscal
quarter (or if not available in that quarter, the most recent
available fiscal quarter).
If, on a country-by-country basis,
the Licensed Product containing a Compound as the sole API is not
sold separately in a country and one or more of the other APIs in
the Combination Product are not sold separately in such country,
the Net Sales of the Combination
7
Product shall be deemed to be the Net Sales of
such Combination Product (without regard to the adjustment
established by this paragraph) multiplied by the fraction A/C where
A is the Net Selling Price on an average worldwide basis for the
stock keeping unit most comparable to the Licensed Product
containing the relevant Compound as the sole API, and C is the Net
Selling Price for the Combination Product on an average worldwide
basis.
For clarification, sale of a
Licensed Product by Gilead or its Related Gilead Parties to Gilead
or Related Gilead Parties for resale by such entity to an
unaffiliated Third Party shall not be deemed a sale for purposes of
“Net Sales” hereunder, but the sale of such Licensed
Product by such entity to an unaffiliated Third Party (whether an
end-user, wholesaler, distributor, or otherwise) shall be deemed to
be a sale by Gilead of a Licensed Product to a Third Party for
purposes of calculating Net Sales hereunder and royalties owed by
Gilead under Section 6.5. Further, transfers or dispositions
of Licensed Products in commercially reasonable quantities
(consistent with Gilead’s usual practice as applied to other
compounds and products of a similar nature) and without receipt of
compensation, or if sold on a not-for-profit basis for charitable
or promotional purposes or for pre-clinical or clinical
Development, manufacturing scale-up or regulatory purposes prior to
receiving Regulatory Approval shall not be deemed
“sales” for purposes of “Net Sales”
hereunder.
If Gilead intends to sell a
Combination Product in any country in the Territory where the
Compound contained in the Licensed Product is not sold separately
in such country, “Net Sales” for the Licensed Product
shall be determined pursuant to Section 5.7.
“Net Selling
Price” means the
Net Sales (as defined in the first paragraph of the definition of
“Net Sales”, without giving effect to the subsequent
paragraphs of such definition) of a product divided by the number
of units of product sold.
“New HCV
Compound” means any
compound (other than a Compound) that is useful to prevent or treat
chronic hepatitis C viral infections in humans that as of the
Effective Date is, or at any time during the term of this Agreement
will be, under the Control of Achillion.
“Offer
Notice” has the
meaning given such term in Section 6.12(a).
“Offsetting
IP” means:
(a) Know-How, Patents or information
owned by a Third Party that is required for the research,
Development, manufacture, use, sale, offer for sale or importation,
of Compounds; and
(b) any other Third Party
intellectual property rights, not included in clause (a), for which
Gilead pays Third Party Royalties, provided that Achillion has
consented to have such intellectual property rights included as
Offsetting IP, with such consent not to be unreasonably
withheld.
“Patent
Costs” shall mean
all reasonable and actual out-of-pocket costs incurred by a Party
for work performed before and after the Effective Date associated
with filing, prosecuting, issuing and maintaining Achillion
Patents, including interference, opposition, reexamination and
reissue actions; provided that the other Party shall prior to
payment have the right to review and
8
comment on any such costs that exceed $[**] for
any calendar month, and any amount reasonably objected to by such
other Party shall not constitute Patent Costs.
“Patents”
mean (a) all patents,
certificates of invention, applications for certificates of
invention, and patent applications, including without limitation
patent applications under the Patent Cooperation Treaty and the
European Patent Convention, provisional, non-provisional, and
abandoned patent applications throughout the world, together with
(b) any renewal, divisional, continuation (in whole or in
part), or continued prosecution applications of any of such
patents, certificates of invention and patent applications, and any
and all patents or certificates of invention issuing thereon, and
any and all reissues, reexaminations, extensions, divisional,
renewals, substitutions, confirmations, supplemental protection
certificates, registrations, revalidations, revisions, and
additions of or to any of the foregoing, and any foreign
counterparts of any of the foregoing and any other patents and
patent applications claiming priority back to any of the
foregoing.
“Phase 1 Clinical
Trial” means a
human clinical trial in any country to initially evaluate the
safety and/or pharmacological or antigenic effect of a Licensed
Product in humans or that would otherwise satisfy the requirements
of 21 CFR § 312.21(a) or the equivalent laws, rules or
regulations in the European Union or Japan.
“Phase 2 Clinical
Trial” means a
human clinical trial in any country to initially evaluate the
effectiveness of a Licensed Product (whether as a primary or
secondary endpoint) for a particular indication or indications in
humans with the disease or indication under study or that would
otherwise satisfy the requirements of 21 CFR § 312.21(b) or
the equivalent laws, rules or regulations in the European Union or
Japan.
“Phase 3 Clinical
Trial” means a
pivotal human clinical trial in any country the results of which
could be used to establish safety and efficacy of a Licensed
Product to support Regulatory Approval and as a basis for a NDA or
that would otherwise satisfy the requirements of 21 CFR §
312.21(c) or the equivalent laws, rules or regulations in the
European Union or Japan.
“Proof of
Concept” has the
meaning given such term in Exhibit 1.3.
“Proof of Concept
Program” means the
component of the Research Program devoted to the Lead
Compound.
“Regulatory
Approval” means all
governmental approvals (including pricing and reimbursement
approvals), product and/or establishment licenses, registrations or
authorizations necessary for the manufacture, use, storage, import,
export, transport and/or sale of a Licensed Product in a
jurisdiction.
“Regulatory
Authority” means
any applicable government regulatory authority necessary to obtain
approval to manufacture, market and sell a Licensed Product in the
Territory, including the FDA in the United States and the EMEA in
the European Market.
“Related Gilead
Party” means
Gilead’s sub-licensees (which term does not include
distributors or Affiliates of Gilead) permitted under this
Agreement outside the United States of
9
America and the European Market. Notwithstanding
the foregoing, in no event shall Achillion be considered a Related
Gilead Party.
“Related Gilead Party
Royalties” means
royalties paid by a Related Gilead Party to Gilead or its
Affiliates for Net Sales of Licensed Products.
“Research Cost
Cap” means the
maximum amount, set forth in Section 2.4(b), (a) of
Research Costs that the Parties are required to spend in total by
both Parties in furtherance of the Research Program, and
(b) for which the Parties may receive reimbursement pursuant
to Section 2.4(c).
“Research
Costs” means
(a) the reasonable and actual personnel costs of a Party,
determined at the FTE Rate, and (b) External Research Costs
reasonably and actually incurred by such Party, in each case
reasonably incurred in furtherance of the Research Program by or
for the account of such Party after the Effective Date; provided
that such costs are consistent with the Research Plan and the
Budget, and are specifically attributable to the Development of
Compounds. For purposes of clarity, costs for activities that
advance the Research Program but are not required for obtaining
Proof of Concept shall not be included under the Research Plan and
the full amount of such costs shall be borne by Gilead.
“Research
Committee” means
the committee described in Section 2.1.
“Research
Plan” has the
meaning given such term in Section 2.2(a)(i).
“Research
Program” means the
research and development program for the Compounds described in
Section 2.3.
“Research Program
Term” has the
meaning given such term in Section 2.3(c).
“Royalty
Rights” has the
meaning given such term in Section 6.12(a).
“Royalty
Term” means, with
respect to a Licensed Product, for each country in the Territory,
the period of time commencing on the First Commercial Sale of such
Licensed Product in any country and ending the later of
(a) [**] years after the date of First Commercial Sale in
such country, or (b) the expiration of the last Valid Patent
Claim of an Achillion Patent or Joint Patent in such country. Upon
expiration of the Royalty Term for a Licensed Product in a country,
Gilead may thereafter continue to sell such Licensed Product in
such country on a royalty-free basis.
“Sublicense
Royalty” has the
meaning given such term in Section 6.5(b).
“Third
Party” means an
entity other than Gilead and its Related Gilead Parties, and
Achillion.
“Third Party Infringement
Losses” has the
meaning given such term in Section 11.1.
“Third Party
Royalties” means
up-front, milestone, royalty and any other similar payments paid by
Gilead or any Related Gilead Party to any Third Party for
Offsetting IP for the
10
development, manufacture, use sale, offer for
sale, or importation of Compounds or Licensed Products.
“Territory” means all of the countries in the world, and
their territories and possessions.
“Valid Patent
Claim” means a
claim of an issued and unexpired Patent, which has not been revoked
or held unenforceable or invalid by a decision of a court or other
governmental agency of competent jurisdiction, and which is not
appealable or has not been appealed within the time allowed for
appeal, and which has not been disclaimed, denied or admitted to be
invalid or unenforceable through reissue, re-examination or
disclaimer, otherwise.
2.1 Research
Committee
(a) Formation and
Duration. Within ten
(10) days after the Effective Date, Achillion and Gilead shall
establish the Research Committee ( “Research
Committee” ). Except to the extent otherwise provided by
mutual written agreement of the Parties, the Research Committee
shall disband upon the later of Proof of Concept or expiration of
the Research Program Term.
(b) Authority.
For the duration of the Research
Program Term, the Research Committee will oversee the
Parties’ activities in furtherance of the Research Program as
follows:
(i) The Research Committee will review and if
necessary revise the Research Plan and the Budget, coordinate
activities under the Research Plan, confer regarding the status of
the Research Program, review relevant data, consider and advise on
any technical issues that arise, set research priorities, review
project milestones, advise on clinical and pre-clinical
development, regulatory, and manufacturing matters and strategies,
and review and advise on financial matters relating to the Research
Program.
(ii) In no event shall the Research Committee have
the right to (A) modify or amend the terms and conditions of
this Agreement; (B) determine which personnel of a Party
perform Research Program activities or act as such Party’s
representatives on the Research Committee; or (C) determine
any matter involving prosecution, defense or enforcement of
Patents.
(c) Composition
(i) Gilead shall designate three (3) named
representatives of Gilead and Achillion shall designate three
(3) named representatives of Achillion. Each Party shall
appoint its respective representatives to the Research Committee
and, from time to time, may substitute one or more of its
representatives.
(ii) Additional representatives or consultants of a
Party may from time to time, with the consent of the other Party
(with such consent not to be unreasonably withheld) attend Research
Committee meetings, subject to such representative’s and/or
consultant’s written
11
agreement to comply with the
confidentiality and non-use obligations equivalent to those set
forth in Section 7, and provided that such additional
representatives shall have no vote.
(iii) The Research Committee may establish such
working groups or sub-committees as it may choose from, time to
time to accomplish its purposes.
(iv) Members of the Research Committee may also serve
as members of the Development Committee.
(d) Governance
(i) The Research Committee shall be chaired by a
representative of Gilead.
(ii) Decisions of the Research Committee shall be
made by unanimous vote, with each Party’s representatives on
the Research Committee collectively having one
(1) vote.
(iii) In the event that the Research Committee cannot
or does not, after good faith efforts, reach agreement on an issue,
such issue shall be referred to the Executive Vice President of
Research and development for Gilead and the Chief Executive Officer
for Achillion. Such officers of the Parties shall meet promptly
thereafter and shall negotiate in good faith to resolve such issue.
If they cannot resolve such issue within [**] of commencing such
negotiations, then the resolution and/or course of conduct shall be
[**].
(e) Meetings
(i) The Research Committee shall meet at least once
each Calendar Quarter in accordance with a schedule established by
mutual written agreement of the Parties, with the location for such
meetings determined by agreement of the Parties.
(ii) Either Party may call for non-scheduled meetings
of the Research Committee for good cause, which shall occur at
mutually agreeable times.
(iii) The Research Committee upon mutual agreement may
meet by means of teleconference, videoconference or other similar
communications equipment.
(iv) No Research Committee meeting may be conducted
unless at least two (2) representatives of each Party are
participating.
(v) Each Party shall bear its own expenses related
to the attendance at Research Committee meetings.
(f) Records.
The Research Committee chair, or
his/her designee, shall have responsibility for preparing minutes
of each Research Committee meeting. Such minutes shall provide a
description, in reasonable detail, of the Research Program progress
to date, updates to the Budget, the discussions at the meeting, a
list of any actions or determination approved by the Research
Committee and any disagreements not resolved by the Research
Committee. Such
12
minutes shall be circulated to all
members of the Research Committee within thirty (30) days
following the Research Committee meeting.
2.2 Research
Plan
(a) Content
(i) The Parties shall, within sixty (60) days
of the Effective Date, agree on a plan ( “Research
Plan” ), which shall be consistent with the Initial
Research Plan attached as Exhibit 2.2 hereto.
(ii) The Research Plan will describe the Research
Program. Such description shall include, among other things:
project milestones; timelines; the tasks to be conducted by the
Parties; responsibilities of the Parties, the resources to be made
available by each Party during the Research Program Term, the
number of Achillion FTEs to be utilized (which shall include [**]
FTEs during the Research Program Term to work on the Back-up
Program); the number of Gilead FTEs to be utilized; the Budget;
matters relating to clinical and pre-clinical development,
regulatory filings and manufacturing; and such other matters as the
Research Committee considers appropriate.
(iii) In the event of any conflict between the
Research Plan and this Agreement, this Agreement shall
prevail.
(iv) The Research Plan will provide that the Parties
will pursue Development of one Compound at any time as a lead
Compound (a “Lead Compound” ), and will specify
those activities to be included in the Proof of Concept
Program.
(v) The Research Plan will provide for Development
of one or more Back-up Compounds, and will specify those activities
to be included in the Back-up Program.
(1) Back-up Compounds may be Developed by both
Parties pursuant to the Back-up Program as specified by the
Research Plan, by Achillion pursuant to Section 2.4(d), or by
Gilead outside the Research Program, subject to the limitations of
Section 2.4(d)(iv).
(2) The Research Committee may amend the Research
Plan to provide for reduction or termination of further development
of the Lead Compound in favor of one or more Back-up Compounds. Any
election by the Research Committee to reduce or terminate further
development of the Lead Compound in favor of development of a
Back-up Compound shall be made on a commercially reasonable basis.
If any Back-up Compound is so selected in favor of the Lead
Compound, such Back-up Compound shall be designated by the Research
Committee as the Lead Compound for purposes of this
Agreement.
(b) Amendment.
The Research Plan may be amended
from time to time by the Research Committee. Notwithstanding
anything in this Agreement to the contrary, no amendment to the
Research Plan that would transfer to Gilead any responsibility or
activity previously assigned to Achillion shall be made without
Achillion’s consent; provided however,
13
that such consent shall not be
required for any such amendment that is necessitated by
Achillion’s failure to perform such responsibility or
activity in a satisfactory or timely manner.
2.3 Research
Program
(a) Conduct of the
Program
(i) The Research Program will be conducted by each
Party pursuant to and consistent with the Research Plan.
(ii) Subject to the terms and conditions of this
Agreement, each Party shall be responsible for managing and
controlling their personnel and performing their respective tasks
pursuant to the Research Plan.
(iii) Each Party shall conduct the Research Program in
good scientific manner, and in compliance in all material respects
with all requirements of applicable laws, rules and
regulations.
(iv) Each Party shall use Commercially Diligent
Efforts in the Research Program, including without limitation
allocation of sufficient time, effort, equipment and facilities to
the Research Program, and shall use personnel with sufficient
skills and experience as are required to accomplish the Research
Program in accordance with the terms of this Agreement and the
Research Plan.
(v) Notwithstanding anything else to the contrary in
this Agreement, all activities conducted under the Research Program
shall continue only until expiration of the Research Program
Term.
(b) Use of Third
Parties. Achillion shall
be entitled to utilize the services of Third Parties to perform
Research Program activities only upon the prior written consent of
Gilead (not to be unreasonably withheld) or as specifically set
forth in the Research Plan. In the event that either Party utilizes
the services of Third Parties to perform Research Program
activities, such Party shall obtain the written agreement of each
such Third Party, prior to the time such Third Party initiates
work, to (A) assign ownership of Inventions related to
Compounds made in the course of Research Program activities to such
Party and (B) maintain confidentiality of any Research Program
activities or Information, and any Confidential Information in
accordance with Section 7.
(c) Research Program
Term. The Research Plan
will provide that the term of the Research Program (
“Research Program Term” ) will expire upon
establishment of Proof of Concept in a Compound, unless the Parties
otherwise agree in an amendment to the Research Plan, in which case
the Research Program Term will expire on the date agreed by the
Parties. If Gilead elects to utilize Achillion FTEs to perform
additional research pursuant to Section 2.4(d), the Research
Program Term will continue until at least the end of the period
that Gilead so elects to have Achillion FTEs conduct such
activities.
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2.4 Costs Incurred for the
Research Program
(a) Budget
(i) The Research Plan shall include a budget (
“Budget” ), which shall specify the amount
anticipated to be spent in each calendar year of the Research
Program Term, for all research and development activities to be
conducted in furtherance of the Research Program, broken into such
categories as the Research Committee considers
appropriate.
(ii) Any proposed amendment to the Budget may be
submitted by either Party to the Research Committee for
consideration. The Research Committee shall agree on any amendment
to the Budget as an amendment to the Research Plan, in accordance
with Section 2.1(d)(ii).
(b) Research Cost Cap.
The Parties have agreed on a
Research Cost Cap of [**] Dollars ($[**]). The amount of the
Research Cost Cap may only be increased or decreased by written
agreement of the Parties, signed by the Chief Executive Officer for
Achillion and the Executive Vice President for Research and
Development for Gilead.
(c) Reimbursement for Research
Costs
(i) [**] Percent ([**]%) of each Party’s
Research Costs incurred between the Effective Date and the date
Proof of Concept is established shall be reimbursed by the other
Party to the extent allowed, and pursuant to the procedure set
forth in, this Section 2.4(c).
(ii) Within [**] following the end of each Calendar
Quarter during the Research Program Term, each Party will send a
statement of the Research Costs incurred by such Party to the other
Party (in such form and manner as the Parties shall agree from time
to time); provided, however, that for any calendar year:
(1) Achillion shall not seek or obtain reimbursement
for Research Costs that (A) would result in reimbursement to
Achillion of a total amount in any calendar year that exceeds [**]%
of the Achillion Annual Budget Amount; or (B) would result in
total reimbursement for all Research Costs that would exceed the
Research Cost Cap; and
(2) Gilead shall not seek or obtain reimbursement
for Research Costs that (A) would result in reimbursement to
Gilead in any calendar year of a total amount that exceeds [**]% of
the Gilead Annual Budget Amount; or (B) would result in total
reimbursement for all Research Costs that would exceed the Research
Cost Cap.
(iii) The Research Committee shall determine whether
the amounts reflected in the Parties’ statements are
consistent with this Section 2.4 within [**] after receipt of
the statements described in Section 2.4(c)(ii) and determine
the net difference ( “Net Difference” ) between
the amounts reflected in such two statements. For purposes of this
Section 2.4(c)(iii), the third sentence of
Section 2.1(d)(iii) shall not apply.
(iv) Following the determination pursuant to
Section 2.4(c)(iii), the Party that incurred the lower
Research Costs in such Calendar Quarter shall pay to the
other
15
Party, within [**] of the end of
such Calendar Quarter, an amount equal to [**] Percent ([**]%) of
the Net Difference for such Calendar Quarter.
(d) Development of Back-up
Compounds After Proof of Concept
(i) Within [**] after Proof of Concept is
established, Gilead may request that Achillion provide additional
research support, for a period of up to [**] after Proof of Concept
is established, by conducting research and Development work on
Back-up Compounds or in other areas. The Parties will negotiate in
good faith the number of Achillion FTEs to be used and the work to
be performed, and an extension to the Research Program Term, and
will reflect any such agreement in an amendment to the Research
Plan.
(ii) If Gilead requests that Achillion provide
additional research support pursuant to above clause 2.4(d)(i),
Gilead shall reimburse Achillion for [**] Percent ([**]%) of the
cost of Achillion FTEs requested. Such reimbursement will be at the
applicable FTE Rate. Such reimbursement shall be prorated for the
number of workdays actually worked by each FTE.
(iii) Within [**] following the end of each Calendar
Quarter during which Achillion FTEs performed services pursuant to
this Section 2.4(d)(iii), Achillion will send a statement of
the amount owed by Gilead, and Gilead shall pay such amounts due
within [**] of receipt of such invoice.
(iv) If, after Proof of Concept is established,
Gilead wishes to Discover Back-up Compounds, and if the Parties
agree that Achillion has the resources and capability to undertake
such Discovery, Gilead shall offer to Achillion the opportunity to
undertake such activities pursuant to this Section 2.4(d)(iv).
If Achillion agrees to undertake such activities, Gilead shall fund
not less than [**] Achillion FTEs at the FTE Rate to Discover
Back-up Compounds, for a period ending upon the earlier of
(1) the conclusion of [**] years after Gilead commences such
Discovery activities, or (2) Gilead ceases such Discovery
activities on Back-up Compounds.
2.5 Records and
Reports
(a) Records. Achillion and Gilead shall each
maintain records, in sufficient detail and in good scientific
manner appropriate for patent and regulatory purposes, in
laboratory notebooks (or equivalent), which shall fully and
properly reflect all work done and results achieved in the
performance of the Research Program by such Party.
(b) Copies and Inspection of Records. No more
frequently than once each calendar year during the Research Program
Term and for six (6) months thereafter, each Party shall have
the right, during normal business hours and upon reasonable notice,
to inspect and copy all records of the other Party referred to in
Section 2.5(a); provided, however, that neither Party shall
have the right to review or copy records to the extent that such
records contain information that does not relate directly to
Compounds, and either Party, in lieu of providing such access to
its records, may elect to provide copies of the relevant records to
the other Party. The receiving Party shall maintain such records
and the information disclosed therein in confidence in accordance
with Section 7.
16
3.1 Development
Committee
(a) Formation and Duration. No later than ten
(10) days after Proof of Concept is established, Achillion and
Gilead shall establish the Development Committee (
“Development Committee” ). Except to the extent
otherwise provided by mutual written agreement of the Parties, the
Development Committee shall disband at the end of the Development
Program Term.
(b) Activities of the Development
Committee. The
Development Committee will act in an advisory capacity to Gilead
and, in such capacity, will review and comment on the Development
Plan and monitor, evaluate, discuss and comment on the Development
Plan and the progress reports provided by Gilead pursuant to
Section 3.1(d)(ii).
(c) Attendance
(i) Gilead shall designate three (3) named
representatives of Gilead and Achillion shall designate three
(3) named representatives of Achillion. Each Party shall
appoint its respective representatives to the Development Committee
and, from time to time, may substitute one or more of its
representatives.
(ii) Additional representatives or consultants of a
Party may from time to time, with the consent of the other Party
(with such consent not to be unreasonably withheld) attend
Development Committee meetings, subject to such
representative’s and/or consultant’s written agreement
to comply with the confidentiality and non-use obligations
equivalent to those set forth in Section 7.
(iii) The Development Committee may establish such
working groups or sub-committees as it may choose from time to time
to accomplish its purposes.
(d) Meetings
(i) The Development Committee shall meet at least
once each Calendar Quarter in accordance with a schedule
established by mutual written agreement of the Parties, with the
location for such meetings determined by agreement of the
Parties.
(ii) Prior to each meeting, Gilead shall provide
written progress reports to the Development Committee, describing
Gilead’s Development activities and progress attained during
the prior Calendar Quarter.
(iii) Either Party may call for non-scheduled meetings
of the Development Committee for good cause, which shall occur at
mutually agreeable times.
(iv) The Development Committee upon mutual agreement
may meet by means of teleconference, videoconference or other
similar communications equipment.
17
(v) No Development Committee meeting may be
conducted unless at least two (2) representatives of each
Party are participating.
(vi) Each Party shall bear its own expenses related
to the attendance at Development Committee meetings.
(e) Records. The Development Committee chair,
or his/her designee, shall have responsibility for preparing
minutes of each Development Committee meeting. Such minutes shall
provide a description of the discussions at the meeting, a list of
any actions or determinations approved by the Development Committee
and any disagreements not resolved by the Development Committee.
Such minutes shall be circulated to all members of the Development
Committee within thirty (30) days following the Development
Committee meeting.
3.2 Development Plan. Gilead shall,
within [**] after Proof of Concept is established, draft a
development plan ( “Development Plan” ) and
deliver the Development Plan to the Development Committee. The
Development Plan shall describe Gilead’s planned Development
activities. The Development Plan shall at all times include a
designation of [**].
3.3 Clinical Development. After Proof
of Concept is established, Gilead and its Related Gilead Parties
shall be solely responsible, at its sole expense, for all clinical
Development of Licensed Products worldwide, including the conduct
of any clinical Development of Licensed Products.
3.4
Regulatory
(a) Filings. Between the Effective Date and
the date Proof of Concept is established, Achillion shall be
responsible for and shall file and own all Drug Approval
Applications. Upon establishment of Proof of Concept, Gilead shall
become responsible for, and Achillion will transfer to Gilead, all
Drug Approval Applications, and thereafter Gilead shall file and
own all Drug Approval Applications and shall be responsible for all
communications with Regulatory Authorities in relation thereto (to
the extent permitted by law).
(i) Prior to establishment of Proof of Concept,
Gilead and Achillion will collaborate to facilitate regulatory
activities. In furtherance of that goal, Achillion shall promptly
forward to Gilead copies of all Drug Approval Applications and
communications with and decisions of Regulatory Authorities. Gilead
shall have the right to review, comment upon and participate in any
decision made with respect to a Drug Approval Application, and will
be given notice of any in-person or telephonic meetings with
Regulatory Authorities sufficient to permit Gilead’s
participation in such meetings. Within ten (10) days of the
Effective Date, Achillion shall provide Gilead with copies of any
documents and communications described in this
Section 3.4(a)(i) then in Achillion’s possession, and
shall provide Gilead with any additional relevant information or
assistance that Gilead reasonably requests.
(ii) The Parties shall, as soon as practicable after
Proof of Concept is established, cooperate to transfer and provide
copies of (to the extent that they are not then in Gilead’s
possession) all Drug Approval Applications, Information, data,
protocols, clinical study reports and Know-How that is reasonably
required for Gilead to obtain Regulatory Approval for
18
any Licensed Product. Further,
Gilead shall keep Achillion reasonably apprised of the progress of
all Drug Approval Applications through the progress reports
presented to the Development Committee, and will provide Achillion
copies of all reasonably requested regulatory filings within a
reasonable time after their submission to the relevant Regulatory
Authority.
(b) Labeling. To the extent permitted by law
and Regulatory Authorities, Gilead shall identify Achillion as the
licensor of each Licensed Product on the packaging and labeling for
such Licensed Product in each country of the Territory in a manner
approved in advance in writing by Achillion, such consent not to be
unreasonably withheld.
3.5 Diligence. Gilead shall use
reasonably diligent efforts to Develop at least one Licensed
Product in the HCV Field [**]. Solely for purposes of this
Section 3.5, “reasonably diligent efforts” means
those efforts that are consistent with the usual practice that a
pharmaceutical company would reasonably undertake in pursuing the
Development of a licensed product with a comparable potential
market, risk, and revenues, assuming that such pharmaceutical
company [**].
4.1 Manufacturing. As soon as
practicable, and in any event within sixty (60) days of the
Effective Date, Achillion shall transfer to Gilead all material
information relating to the manufacture of Compounds or Licensed
Products, including but not limited to data, Information and
Achillion Know-How that is reasonably required or related to the
manufacturing of Compounds or Licensed Products, manufacturing
specifications, raw materials, intermediates, API, and clinical
supplies; provided, however, that Achillion may retain any
materials, information or data that is reasonably required or
necessary for Achillion to conduct Development pursuant to the
Research Program or otherwise pursuant to this Agreement, to
conduct development outside of the scope of this Agreement to the
extent permitted by this Agreement, or to fulfill its existing
obligations to Third Parties to the extent permitted by this
Agreement. Gilead shall thereafter be responsible for the
chemistry, manufacturing and control ( “CMC” )
of Compounds, clinical supplies and Licensed Products, and
Achillion shall cooperate fully with Gilead and will provide Gilead
with any information, materials reasonably available or assistance
that Gilead reasonably requests.
4.2 Commercial and Product
Support Activities
(a) Gilead Activities. Except as provided in
Section 4.2(b), Gilead and its Related Gilead Parties shall be
solely responsible, at its expense, for marketing and
commercialization of one or more Licensed Products.
(b) Achillion
Activities
(i) Achillion may make a one-time election to have
field-based personnel ( “Field-Based Personnel”
) support Gilead’s commercial activities in the United States
relating to Licensed Products to the extent and pursuant to the
procedures set forth in this Section 4.2(b). The Parties will
agree on the number of Field-Based Personnel that will support such
activities and the duration of their period of service; provided
that the number of such Field
19
Based Personnel shall be up to [**]
individuals at any given time, or such greater number as the
Parties mutually agree, and Field-Based Personnel shall serve, if
Achillion so elects, for a period lasting up to [**]. Such Field
Based Personnel (A) may be full- or part-time employees and
(B) may be either (I) [**] assigned to work with
physicians and other professionals [**] or (II) [**].
(ii) Gilead shall provide Achillion with a written
notice, at any time after commencement of a Phase 3 Clinical Trial
and no less than [**] before the filing of an NDA, to the effect
that it intends to file such an NDA. Within [**] following receipt
of such notice, Achillion shall provide Gilead with a written
notice (A) indicating that it wishes to designate Field-Based
Personnel to support Gilead’s commercial activities relating
to Licensed Products; and (B) describing in reasonable detail
the number and type of Field-Based Personnel it wishes to nominate
to support Gilead.
(iii) As soon as practicable after receiving notice
from Achillion pursuant to Section 4.2(b)(ii), the Parties
shall meet and negotiate in good faith the identity of the
Field-Based Personnel and the manner of their participation, taking
into consideration the extent to which they have specialized
knowledge or expertise related to the specific activity proposed to
be conducted; whether they operate in geographic areas where
Achillion has market presence or proximity; and the extent to which
they are qualified by appropriate experience and qualifications to
perform the work assigned to such Field-Based Personnel in a
capable and professional manner.
(iv) All Field-Based Personnel shall operate under
the supervision and control of Gilead’s Medical Affairs or
National Accounts Divisions. Gilead may assign Field-Based
Personnel to operate in any region of the United States it deems
appropriate. All Field-Based Personnel shall comply with
Gilead’s internal rules and regulations, including
Promotional Guidelines, and shall be trained by Gilead at
Gilead’s expense.
(v) Gilead shall have the right to remove any
Field-Based Personnel designated by Achillion from their position
for failures of performance or if Gilead reasonably determines such
Field-Based Personnel have not complied with Gilead’s
internal rules and regulations, including Gilead’s
Promotional Guidelines. If Achillion elects for any reason to
reduce the number of Field Based Personnel utilized pursuant to
this Section 4.2(b), Achillion shall give Gilead not less than
[**] prior written notice.
(c) Cooperation and
Interaction
(i) Gilead will supply Achillion with a copy of its
plan for commercializing a Licensed Product and will present and
discuss such plan with Achillion. Senior management of Achillion
shall be invited to attend such portions of conferences and
meetings that pertain to the commercialization of Licensed
Products.
(ii) Relevant Achillion Field-Based Personnel shall
receive similar information and attend and participate at a similar
level to equivalent Gilead personnel, including
20
but not limited to formal training,
remote training, core skills training (including updates on medical
practice, regulatory guidelines and presentation skills), national
conferences, regional meetings, educational events, speaker’s
bureaus, regional consultants meetings, medical conferences
(including pre-conference briefing and booth staffing) and Phase
3b/4 program meetings.
(iii) Subject to Section 4.2(b)(iv), the Parties
agree to consult with each other in good faith from time to time as
necessary or appropriate as to matters that arise in connection
with the use of Field-Based Personnel pursuant to this
Section 4.2(b). Such consultations may cover matters such as
the deployment, management and removal of Field-Based Personnel.
Each Party shall each designate a principal contact for the purpose
of conducting any such consultations.
4.3 Achillion’s Costs. All costs
associated with any activities undertaken by Achillion pursuant to
Section 4.2, including salary, benefits and travel of
Field-Based Personnel designated pursuant to
Section 4.2(b)(ii) and (iii), shall be borne solely by
Achillion, except as otherwise expressly provided in
Section 4.2(b)(iv).
4.4 Diligence. Gilead shall, itself
and/or through Related Gilead Parties, at its own expense, use
Commercially Diligent Efforts to commercialize and market [**] in
the HCV Field [**].
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5.
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LICENSES AND
COVENANTS
|
5.1 License Grants to Gilead. Subject
to the terms of this Agreement, Achillion hereby grants to Gilead
an exclusive (even as to Achillion except to the extent provided
below), royalty-bearing (as set forth in Section 6.5) license,
with the right to sublicense subject to Section 5.3(d), under
Achillion Technology to Develop, make, have made, use, sell, have
sold, offer for sale and import Compounds and Licensed Products in
the Field in the Territory; provided, however, that Achillion
retains such rights under Achillion Technology as are necessary to
perform its obligations under the Research Plan.
5.2 License Grant to Achillion.
Subject to the terms and conditions of this Agreement, Gilead
hereby grants to Achillion a non-exclusive, royalty-free license,
without the right to sublicense, under Gilead Technology solely to
perform Achillion’s obligations to conduct the Research
Program.
5.3 Negative
Covenants
(a) No Use of Achillion Technology. For a
period beginning on the Effective Date and ending upon the
expiration of the last to expire Royalty Term, Achillion shall not
Develop or use Achillion Technology for Compounds, or permit any
Third Party to conduct any such activities with respect to
Achillion Technology for Compounds, except as expressly provided in
this Agreement.
(b) No Research. Except as otherwise
expressly provided in this Agreement, for a period beginning on the
Effective Date and ending upon the expiration of the last to expire
Royalty Term, Achillion shall not: (1) on its own behalf or
for any Third Party conduct any
21
Development or commercialization of
any Compound; nor (2) grant to any Third Party any license or
other right to conduct any research, Development or
commercialization of any Compound, unless Gilead consents pursuant
to this Agreement.
(c) No Implied
Licenses. No right or
license under any Patents or Informati
