Exhibit 10.38


 


***Text
Omitted and Filed Separately


Confidential
Treatment Requested


Under
17 C.F.R. §§ 200.80(b)(4)


and
240.24b-2


 


AMENDMENT
TO DEVELOPMENT AND LICENSE AGREEMENT


 


THIS AMENDMENT TO DEVELOPMENT AND LICENSE AGREEMENT
(the “Amendment”) is entered into as of
October 24, 2005 (the “Amendment Effective Date”)
by and between AMYLIN
PHARMACEUTICALS, INC., a Delaware corporation (“Amylin”),
and ALKERMES CONTROLLED THERAPEUTICS
INC. II, a Pennsylvania corporation (“ACTII”).


 


WHEREAS, ACTII and Amylin are parties to that
certain Development and License Agreement dated May 15, 2000 (the “Agreement”); and


 


WHEREAS, the Parties desire to amend the Agreement as
set forth in this Amendment.


 


NOW, THEREFORE, in consideration of the premises and the covenants herein contained, the
Parties hereby agree to amend the Agreement as follows:


 


1.             Definitions.


 


1.1          All
capitalized terms used but not otherwise defined herein shall have the meanings
given to them in the Agreement.


 


1.2          Section 1.16 of the Agreement is hereby
amended and restated in its entirety as follows:


 


“1.16       “Inventions”
means any inventions or discoveries, whether or not patentable, conceived
pursuant to (i) the Product Development Plan during the term of this Agreement
or within three (3) months thereafter and (ii) the Project Plan or the
provision of Ongoing Technical Support during the term of the Tech Transfer
Agreement or within three (3) months thereafter.”


 


1.3          Section 1.29 of the Agreement is hereby
amended and restated in its entirety as follows:


 


“1.29       [INTENTIONALLY
OMITTED]”


 


1.4          The following new sections, beginning
with Section 1.34, are hereby inserted at the end of Section 1 of the
Agreement:


 


“1.34       “API”
shall have the meaning assigned to it in the Tech Transfer Agreement.”


 


“1.35       “Core
Oversight Group” means a group formed pursuant to Section 4.2.1(a).”


 

















 


“1.36       “Executive
Committee” means a committee formed pursuant to Section 4.2.2(a).”


 


“1.37       “Exenatide
LAR” shall have the meaning assigned to it in the Tech Transfer Agreement.”


 


“1.38       “First
Commercial Sale” means, with respect to Exenatide LAR, the first commercial
sale of such product in a country after all Regulatory Approvals for such
product have been obtained in such country.”


 


“1.39       “Four-Week
Exenatide LAR” means a Product that is a formulation of API and that is
designed to deliver API over a four-week period of time.”


 


“1.40       “Lilly”
means Eli Lilly and Company.”


 


“1.41       “Ongoing
Technical Support” shall have the meaning assigned to it in the Tech
Transfer Agreement.”


 


“1.42       “Project” shall have the meaning
assigned to it in the Tech Transfer Agreement.”


 


“1.43       “Project Plan” shall have the
meaning assigned to it in the Tech Transfer Agreement.”


 


“1.44       “RACI Task Analysis” means a list
of the major tasks required to perform the Product Development Plan to be
agreed by the Parties, including for each task: 
the person or Party that is responsible for final decision making; the
person or Party that is required to approve steps in the process; the person or
Party that needs to be consulted for input and direction, but not approve
decisions; and the person or Party that needs to be updated or informed, as
such RACI Task Analysis may be amended from time to time as provided herein.”


 


“1.45       “Tech Transfer” shall have the
meaning assigned to it in the Tech Transfer Agreement.”


 


“1.46       “Tech Transfer Agreement” means
the Technology Transfer and Construction Management Agreement to be entered
into between ACTII and Amylin concurrently herewith, as may be amended in
accordance with its terms.”


 


2.                                      NON-SUIT


 


2.1          Section 2.1 of the Agreement is
hereby amended by adding the following provision:


 


“(c)         Amylin and its Affiliates, sublicensees
and agents, agree, on a worldwide basis, not to sue ACTII or its Affiliates, or
any third party collaborating with ACTII or its Affiliates, for developing,
making, having made, using, selling, offering to sell or importing a product
outside the Field under patent rights held by Amylin or its Affiliates, or
either of their


 


2

















 


sublicenses or agents,
that cover or are an improvement to the process for the manufacture of
Exenatide LAR transferred to Amylin by ACTII pursuant to the Tech Transfer
Agreement.”


 


3.                                      PAYMENTS TO ACTII


 


3.1          Section 3.4 of the Agreement is hereby amended and
restated in its entirety as follows:


 


“3.4         Payment for Four-Week Exenatide LAR.  According to Section 6, Amylin shall pay to
ACTII a transfer price based on Net Sales of all Four-Week Exenatide LAR
manufactured by ACTII.  For all Four-Week
Exenatide LAR that is not manufactured by ACTII and is instead manufactured by
a third party pursuant to Section 6.2 (“Failure to Supply”), below, Amylin
shall pay to ACTII a royalty on Net Sales at the rate of [***] percent
([***]%).  For all Four-Week Exenatide
LAR that is not manufactured by ACTII and is instead manufactured by a third
party pursuant to Section 6.3 (“Second Source”), below, Amylin shall pay to
ACTII a royalty on Net Sales at the rate of [***] percent ([***]%).  The royalty payable under this Section 3.4
will be payable only once with respect to a particular sale of Four-Week
Exenatide LAR regardless of there being more than one Valid Claim of an ACTII
Patent applicable to such Product”


 


3.2          Section 3.5
of the Agreement is hereby amended and restated in its entirety as follows:


 


“3.5         Royalties on Products Not
Manufactured by ACTII.  Until [***]
of the [***] full calendar year following the year in which the First
Commercial Sale of Exenatide LAR occurs, Amylin shall pay to ACTII a royalty on
Net Sales of Exenatide LAR at the following rates:  (i) [***] percent ([***]%) of Net Sales of
the [***] of Exenatide LAR sold or commercially disposed of for value during
any [***], or portion thereof, during such period and (ii) [***] percent ([***]%)
of Net Sales of the [***] of Exenatide LAR sold or commercially disposed of for
value during such [***], or portion thereof, during such period.  Except as otherwise provided in this
Agreement, Amylin shall pay to ACTII a royalty on Net Sales of Products not
manufactured by ACTII at the rate of [***] percent ([***]%).  The royalty payable under this Section 3.5
will be payable only once with respect to a particular sale of a Product
regardless of there being more than one Valid Claim of an ACTII Patent
applicable to such Product.”


 


4.                                      PRODUCT DEVELOPMENT PROGRAM


 


4.1          Section 4.1 of
the Agreement is hereby amended and restated in its entirety as follows:


 


“4.1         Scope.  ACTII shall have
principal responsibility for the formulation and non-clinical development
of a Product for use in the Field, including formulation, development and
optimization, stability testing, manufacturing of clinical supplies (except as
provided below), process scale-up, process validation and preparation of
the chemistry, manufacturing and controls (CMC) section of the NDA for
Exenatide LAR.  Amylin shall have principal responsibility for
toxicological and clinical development of a Product through Regulatory


 






***         CONFIDENTIAL TREATMENT REQUESTED


3

















 


Approval and sole
responsibility for commercialization of a Product.  Amylin and ACTII agree
to use the RACI Task Analysis as a tool to assign responsibilities for decision
making and to ensure information flow at the Project Working Team level with
respect to performance by the Parties under the Product Development Plan.  The RACI Task Analysis with respect to the
Product Development Plan may be amended from time to time during the term of
this Agreement upon mutual written agreement of ACTII and Amylin.  The Parties acknowledge that as a result of
such amendment, responsibilities for decision making may shift from one Party
to another. Each Party shall use Commercially Reasonable Efforts in performing its
functions under the Product Development Plan. 
Subsequent to Tech Transfer except as otherwise agreed by the Parties,
Amylin shall be responsible for the manufacture of any clinical supplies of
Products other than pilot phase material to be used in clinical studies prior
to Phase III Clinical Trials.  ACTII
acknowledges that Lilly may collaborate with Amylin in the development of a
Product, as a potential sublicensee of certain of Amylin’s rights hereunder.”


 


4.2          Section
4.2 of the Agreement is hereby amended and restated in its entirety as follows:


 


“4.2         Governance.


 


4.2.1        Core
Oversight Group.


 


(a)           The
committee known as the Steering Committee that was initially formed by the
Parties under the Agreement shall after the Amendment Effective Date be known
as the Core Oversight Group.  The Core Oversight
Group shall operate and have the authority described in this Section 4.2,
including the general authority over the management of the Product Development
Plan and the Project Working Team, and shall have the further authority over
the management of the Project as described in Article 3 of the Tech Transfer
Agreement.


 


(b)           ACTII
and Amylin shall each appoint three (3) representatives as their
representatives to serve on the Core Oversight Group.  A Party may change its representatives from
time to time by giving written notice to the other Party.


 


(c)           The
Core Oversight Group shall generally meet at such times as it may decide and at
least once per calendar quarter.  The
location of Core Oversight Group meetings shall alternate between ACTII’s
offices and Amylin’s offices unless otherwise agreed by the Parties.  Minutes of a meeting setting forth decisions
of the Core Oversight Group shall be prepared by the Party hosting the meeting.  Minutes will become official when agreed to
by all members of the Core Oversight Group. 
Each Party will bear all expenses associated with attendance of its
representatives at meetings.  If the Core
Oversight Group members all agree, a meeting may be held by telephone.


 


(d)           Decisions
of the Core Oversight Group shall be made by unanimous vote, with each member
having one vote.  If the Core Oversight
Group is unable to reach a unanimous vote on any issue, the issue shall be
referred to the Executive Committee for resolution.


 


(e)           Within
fifteen (15) days after the receipt of a proposed Product Development Plan or
any amendments thereto from the Project Working Team or referral of any


 


4

















 


matter on which the Project Working Team did not reach consensus, the
Core Oversight Group shall meet to consider the resolution of such matter or
recommending approval of such proposed Product Development Plan or amendments
to the Executive Committee, as applicable. 
The Core Oversight Group shall also settle any disputes among the
Project Working Team.


 


4.2.2        Executive Committee.


 


(a)           Within
thirty (30) days after the Amendment Effective Date, the Parties shall form an
Executive Committee.  The Executive
Committee shall operate and have the authority described in this Section 4.2,
including the general authority over the progress, budget and strategic
direction of the Product Development Plan, and shall have the further authority
over the progress, budget and strategic direction of the Project as described
in Article 3 of the Tech Transfer Agreement.


 


(b)           ACTII
and Amylin shall each appoint two (2) representatives as their representatives
to serve on the Executive Committee.  A
Party may change its representatives from time to time by giving written notice
to the other Party.


 


(c)           The Executive Committee shall
generally meet at such times as it may decide and at least twice per calendar
year.  The location of Executive
Committee meetings shall alternate between ACTII’s offices and Amylin’s offices
unless otherwise agreed by the Parties, with the first meeting being held at
Amylin’s office.  Minutes of a meeting
setting forth decisions of the Executive Committee shall be prepared by the
Party hosting the meeting.  Minutes will
become official when agreed to by all members of the Executive Committee.  Each Party will bear all expenses associated
with attendance of its representatives at meetings.  If the Executive Committee members all agree,
a meeting may be held by telephone.


 


(d)           Decisions of the Executive Committee
shall be made by unanimous vote, with each member having one vote.  Except as otherwise specifically set forth in
Sections 3.3(a)(i) and (iii) of the Tech Transfer Agreement, if the Executive
Committee is unable to reach a unanimous vote on any issue over which it has
decision-making authority, the issue shall be referred to Amylin’s Chief
Executive Officer (or successor position), who shall make the final decision
regarding such issue.


 


(e)           Within fifteen (15) days after the
receipt of a proposed Product Development Plan or any amendments thereto from
the Core Oversight Group or referral of any dispute by the Core Oversight
Group, the Executive Committee shall meet to consider approval of such plan or
amendments or resolution of such dispute. 
The Executive Committee, or the Core Oversight Group if and to the
extent so designated by the Executive Committee, shall periodically review the
Product Development Plan from a strategic perspective, the status of efforts to
implement it and shall make any changes to the Product Development Plan that it
deems necessary to accomplish the purpose of this Agreement.”


 


4.3          Subsections (c) and (d) to Section 4.3 of the
Agreement are hereby amended and restated in their entirety as follows:


 


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“(c)         As a general principle, the Project
Working Team will use the RACI Task Analysis to agree to responsibilities,
approvals, consultations and information flow under the Product Development
Plan.  Except as provided in the succeeding
sentence of this paragraph, in the event that the Project Working Team members
do not reach consensus with respect to a matter that is within the purview of
the Project Working Team within fifteen (15) days after the meeting in which
they consider such matter, such matter may be referred by either Party to the
Core Oversight Group for resolution. 
Amylin’s representatives on the Project Working Team shall have the sole
right to determine how to proceed with respect to any commercialization
activity related to a Product.  No vote
of the Project Working Team shall be taken unless a majority of the members of
the Project Working Team are present, including at least one (1) representative
of each Party.  The Project Working Team
shall keep minutes of any meeting at which a decision is to be reached and
shall circulate such minutes to all members of the Project Working Team and the
Core Oversight Group.  Responsibility for
the preparation of the minutes shall rest with the hosting party.  Minutes shall be deemed approved unless any
member of the Project Working Team objects to the accuracy of such minutes
within five (5) days of receipt.  A Party
desiring to refer a matter on which consensus has not been reached by the
Project Working Team to the Core Oversight Group shall make its referral in writing
to all Core Oversight Group members within twenty (20) days of the meeting at
which the matter was considered.  Action
pursuant to any matter referred to the Core Oversight Group shall be suspended
pending a determination by the Core Oversight Group or the referral of the
matter to the Executive Committee for resolution.  A Party may at any time request
reconsideration of any issue if it in good faith believes that substantial
changes in circumstances have occurred that necessitate such reconsideration.


 


(d) (i)      The Project Working Team shall develop,
and present to the Core Oversight Group for consideration, a detailed
development plan to address fully, consistent with the terms of this Agreement,
the key elements reasonably necessary for the research, development,
formulation, and manufacture of Products through Regulatory Approval and the
budgeted FTEs and other expenses related to all work to be conducted under the
development plan (“Product Development Plan”). 
The Product Development Plan shall be based on an initial product
development plan, a first draft of which is attached as Exhibit B
to this Agreement.  The product to be the
subject of the initial product development plan shall be Exenatide LAR.  Should Amylin determine at any time during
the course of this Agreement that it wishes to develop and commercialize an
additional Field Product, or that it wishes to discontinue development and
commercialization of Exenatide LAR and instead develop and commercialize a
different Field Product, the Parties will negotiate in good faith whether to
develop such additional or different Field Product and, if so, any appropriate
alterations or additions to the provisions of this Agreement, including but not
limited to its financial provisions.  In
the event that Amylin discontinues the development and commercialization of
Exenatide LAR and the Parties are unable to agree upon the development of a
different Field Product within 180 days of such discontinuation, then this
Agreement shall terminate as if Amylin had terminated this Agreement under
Section 9.2(b).  The Project Working Team
shall be responsible for implementing the Product Development Plan, addressing
fully the appropriate strategy for development and Regulatory Approval of a
Product, developing the responsibilities and procedures for handling any and
all regulatory issues related to a Product and for addressing all issues that
develop during the course of implementing the Product Development Plan.  Such implementation efforts shall
include:  (A) establishing comprehensive
and detailed plans


 


6

















 


designed to accomplish the goals of the Product
Development Plan, including a plan pursuant to which ACTII will perform
technical and scientific work under this Agreement, (B) allocating tasks and
coordinating activities required to carry out the objectives of the Product
Development Plan, (C) monitoring progress of the Product Development Plan, (D)
monitoring the FTEs worked and expenditures made under the Product Development
Plan and (E) discharging such other obligations as are assigned to the Project
Working Team under this Agreement or by the Core Oversight Group.


 


(ii)           The Project
Working Team may propose modifications to the Product Development Plan to the
Core Oversight Group for its approval and recommendation to the Executive
Committee.  No modification may be
implemented unless approved by the Executive Committee or any authorized
designee.”


 


4.4          Sections 4.4, 4.5 and 4.6 of the
Agreement are hereby amended and restated in their entirety as follows:


 


“4.4         Quarterly
Reports.  Within 30 days following
the end of each calendar quarter each Party shall provide the Core Oversight
Group and the Project Working Team with quarterly status reports summarizing
its research and development efforts under the Product Development Plan during
such quarter.  This report shall include
a general summary of important events and milestones achieved, personnel
changes, learning points and such other matters as the Party believes are
relevant or that the Core Oversight Group may request.


 


4.5           Governance Following Product
Launch.  As soon as practicable
following launch of the Product in a Major Market Country, the Parties shall
meet to review whether it is appropriate to continue the Product Development
Plan under the day-to-day management of the Project Working Team,
or whether the objectives of the Project Working Team have been substantially
achieved and it is appropriate to disband or reorganize the Project Working
Team.  Regardless of whether the Parties
elect to disband or reorganize the Project Working Team, the Executive
Committee shall continue to provide overall direction to development of
Products.


 


4.6           Other Working Teams.  The Core Oversight Group and Project Working
Team, with the approval of the Core Oversight Group, may appoint one or more
other working teams (“Working Teams”) to perform such functions as the Core
Oversight Group or Project Working Team, as applicable, may determine.  Unless a Party elects not to participate on a
particular Working Team, all Working Teams shall have at least one
representative of each Party.  Working
Teams may provide advice and make recommendations to the Project Working Team,
but shall have no authority to bind the Project Working Team or either Party.”


 


5.                                      FOUR-WEEK EXENATIDE LAR


 


5.1          Section 6 of the Agreement is hereby
amended and restated in its entirety as follows:


 


“6            Four-Week Exenatide LAR.


 


6.1           Manufacturing
Agreement.  In the event Amylin
decides to proceed with the development and commercialization of Four-Week
Exenatide LAR, then Amylin and ACTII


 


7

















 


shall proceed in accordance with Section 4.3(d)(i).  If the Parties negotiate a Four-Week
Exenatide LAR Product Development Plan, then ACTII shall have the option to be
the exclusive manufacturer of Four-Week Exenatide LAR for a period of [***]
([***]) [***] after the first commercial sale in a Major Market Country of
Four-Week Exenatide LAR, and, if ACTII exercises this option, ACTII shall
exclusively manufacture and supply Four-Week Exenatide LAR, in the amounts and
at such delivery times as required by Amylin, its Affiliates, sublicensees and
Co-Marketers.  ACTII shall decide whether
to exercise this option prior to the commencement of Phase III Clinical Trials
for Four-Week Exenatide LAR.  Upon
ACTII’s exercise of this option and prior to the commencement of Phase III
Clinical Trials for Four-Week Exenatide LAR, or sooner if agreed by Amylin and
ACTII, the Parties shall negotiate in good faith and enter into a manufacturing
and supply agreement (the “Manufacturing Agreement”) on the terms provided in
this Section 6 and such other terms to be mutually agreed upon, including
but not limited to, provisions dealing with ACTII’s responsibility to incur all
capital expenditures necessary to develop manufacturing capability for
Four-Week Exenatide LAR (subject to the last sentence of this Section 6.1),
minimum purchase requirements for Four-Week Exenatide LAR, forecasting of
Amylin’s requirements for Four-Week Exenatide LAR, delivery times and terms,
rejection of Four-Week Exenatide LAR, recall of Four-Week Exenatide LAR,
inspection of ACTII’s manufacturing facilities, indemnification, and Amylin’s
and ACTII’s responsibilities with respect to compliance with global
governmental regulations and force majeure. 
The agreement shall provide that Amylin will supply sufficient
quantities of API for use in the manufacture of Four-Week Exenatide LAR for
commercialization at no cost to ACTII. 
Under the agreement Amylin shall pay ACTII a transfer price equal to the
greater of (a) [***]% of Net Sales of Four-Week Exenatide LAR and (b) [***]
dollars ($[***]) for each dose of Four-Week Exenatide LAR.  Such $[***] price shall be adjusted annually
by ACTII in accordance with the annual percentage change in the Consumer Price
Index (U.S. Bureau of Labor Statistics for all urban consumers, U.S. City
Average — all items less food and energy (October 1999 equals 178.3 (Reference
CUUR0000 SAOL1E)).  The Parties shall
also negotiate in good faith provisions for inclusion in the agreement
regarding payment by Amylin to ACTII of some portion of the transfer price at
the time of shipment of Four-Week Exenatide LAR and quarterly reconciliation of
the balance of the transfer price owed on Net Sales of Four-Week Exenatide
LAR.  The agreement shall also include
provisions regarding the manufacturing options provided to Amylin in Sections
6.2 and 6.3 below.  In addition the
agreement shall include provisions regarding the reimbursement of ACTII by
Amylin of any costs and expenses ACTII has incurred to design, construct,
commission or validate any manufacturing facility, or portion thereof,
including the purchase of equipment, to permit the manufacture of Four-Week
Exenatide LAR in the event that Amylin does not develop Four-Week Exenatide LAR
and commercialize it for a period of [five] ([5]) [years] after its first
commercial sale in a Major Market Country.


 


6.2           Failure to Supply.  Should ACTII ever fail to supply any or all of
Amylin’s (as well as any Affiliate, sublicensee or Co-Marketer of
Amylin’s) needs for Four-Week Exenatide LAR to the extent Amylin has forecasted
such needs, ACTII shall have the first right to secure a third party to
manufacture that amount of Four-Week Exenatide LAR which ACTII has failed or
anticipates failing to supply.  Such
third party shall be approved by Amylin, which approval may not be unreasonably
withheld.  In the event that ACTII is
unable to secure a third party manufacturer, or ACTII continues to fail to
supply all of Amylin’s (as well as any Affiliate, sublicensee or Co-Marketer of
Amylin’s) needs for Four-Week Exenatide LAR for more than [***] ([***]) [***],
Amylin may do any of the following:  (i) elect
to make


 






***         CONFIDENTIAL TREATMENT REQUESTED


 


8

















 


nonexclusive the license grant to ACTII with respect
to Four-Week Exenatide LAR granted in accordance with Section 6.1, above,
(ii) terminate the Manufacturing Agreement with ACTII for ACTII’s breach
(should said breach be material), and (iii) either by itself and/or by
utilizing the services of a third party, manufacture and supply Four-Week
Exenatide LAR or components thereof (without an obligation to pay to ACTII any
transfer price payments on such Four-Week Exenatide LAR manufactured by Amylin
or such third party).  Any Four-Week
Exenatide LAR sold by Amylin, its Affiliates, sublicensees or Co-Marketers
under this Section 6.2 shall be subject to the applicable royalty payment
provided in Section 3.4, above.


 


6.3           Second Source.  After the expiration of ACTII’s manufacturing
exclusivity period of [***] ([***]) [***], as described in Section 6.1,
above, Amylin may do any of the following: 
(i) elect to make nonexclusive the license grant to ACTII with respect
to Four-Week Exenatide LAR granted in accordance with Section 6.1, above,
or (ii) either by itself and/or by utilizing the services of a third party,
manufacture and supply Four-Week Exenatide LAR or components thereof (without
an obligation to pay to ACTII any transfer price payments on such Four-Week
Exenatide LAR manufactured by Amylin or such third party).  Any Four-Week Exenatide LAR sold by Amylin,
its Affiliates, sublicensees or Co-Marketers under this Section 6.3 shall
be subject to the applicable royalty payment provided in Section 3.4,
above.


 


6.4           ACTII Cooperation.  In the event Amylin exercises its rights
pursuant to Sections 6.2 or 6.3, above, to provide for manufacture of
Four-Week Exenatide LAR other than by ACTII, ACTII shall transfer to Amylin or
a third party, as appropriate, any ACTII Know-How required to enable
Amylin or such third party to manufacture Four-Week Exenatide LAR and provide
such assistance as is reasonably necessary to assist such manufacture and
supply.  Amylin shall pay ACTII the FTE
Hourly Rate for time spent by ACTII personnel in such technology transfer.”


 


6.                                      USE OF MATERIALS AND INFORMATION


 


6.1          The following new
section is hereby inserted at the end of Section 8 of the Agreement:


 


“8.6         Disclosure to Collaboration Partner.  Notwithstanding anything to the contrary in
this Agreement, Amylin may disclose the terms of this Agreement and
Confidential Information of ACTII to Lilly as necessary or appropriate for the
research, development or commercialization of Products; provided that Lilly is
subject to obligations of confidentiality comparable to those contained
herein.”


 


7.                                      PROSECUTION AND MAINTENANCE OF PATENTS


 


7.1          Subsections
(a) and (b) of Section 10.2 of the Agreement are hereby amended and restated in
their entirety as follows:


 


“(a)         ACTII’s Obligations to Prosecute.  ACTII shall file and control prosecution and
maintenance of patent applications for all ACTII Patents, including ACTII
Patents claiming Inventions owned by ACTII, and, subject to consultation rights
granted to Amylin in Section 10.2(b) below, patents claiming Inventions owned
jointly by ACTII and Amylin (“Joint Inventions”) and be responsible for related
interference proceedings in 


 






***         CONFIDENTIAL TREATMENT REQUESTED


 


9

















 


accordance with reasonable commercial standards and reasonable
principles of intellectual property protection, all at ACTII’s expense.  For prosecution and maintenance of patents
and patent applications claiming Joint Inventions, ACTII shall use external
counsel of its choosing, subject to the consent of the General Counsel of
Amylin, which consent shall not unreasonably be withheld.  ACTII shall endeavor to ensure that all ACTII
Patents, and patents claiming Joint Inventions are filed before any public
disclosure of the inventions claimed therein to maximize the scope of
protection of such patents filed outside the United States.  ACTII shall furnish Amylin with copies of all
substantive communications between ACTII and applicable patent offices
regarding patents and patent applications claiming Inventions.


 


(b)           Consultation; No Disclosure by
Amylin.  ACTII and Amylin shall
discuss and evaluate Joint Inventions and confer with each other regarding the
advisability of filing patent applications in the United States and in foreign
countries to cover Joint Inventions. 
ACTII shall provide to Amylin (i) draft patent applications, and (ii)
draft official correspondence to national or international patent authorities
which purports to amend the scope of the claims presented in the originally
filed application, each to be provided sufficiently in advance of filing for
Amylin to have the opportunity to comment thereon, and at least 30 days prior
to the contemplated filing date whenever possible.  Any reasonable requests made by Amylin
pertaining to such drafts shall be reflected in such drafts, provided that
Amylin provides such input to ACTII sufficiently in advance of such proposed
submission date to permit inclusion therein. 
Amylin shall endeavor to delay any public disclosure of the subject
matter of any patent application filed or to be filed by ACTII under this
Agreement until after filing by ACTII of such patent application.  Should the respective patent counsel of ACTII
and Amylin be unable to agree, within thirty (30) days (or earlier if such time
period might affect patentability) of a set of claims being presented by one
Party to the other, as to the inventorship of any patent application claiming
an Invention in which each Party claims its employee or agent is an inventor,
the Parties shall refer such dispute to a neutral patent attorney or other
appropriately qualified person mutually agreed upon by the Parties.  Such neutral third party shall be instructed
to complete his/her determination as to inventorship within thirty (30) days of
referral of the dispute (or earlier if such time period might affect
patentability).  Such neutral third
party’s determination regarding the referred issue shall be final and binding
upon the Parties.  The Party whose
position did not agree with the neutral third party’s determination will pay
the fees associated with such neutral third party decision, unless neither
Party’s position prevails in which case the Parties will share on a 50/50 basis
the fees associated with such neutral third party’s decision.”


 


8.                                      MISCELLANEOUS PROVISIONS


 


8.1                      Governing Law.  This Amendment shall be governed by and
construed in accordance with the laws of the State of Delaware, without giving
effect to the principles of conflicts of laws.


 


8.2                      Entire Agreement.  Except as specifically
amended by this Amendment, the Agreement shall remain in full force and
effect.  If there is any inconsistency or
conflict between any provision in this Amendment and any provision in the
Agreement, the provision in this Amendment shall control.


 


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8.3                      Headings.  Any headings and captions
included herein are for convenience of reference only and shall not be used to
construe this Amendment.


 


8.4                      Counterparts; Facsimile.  This Amendment shall become
binding when any one or more counterparts hereof, individually or taken
together, shall bear the signature of each of the Parties hereto.  This Amendment may be executed in
counterparts, each of which shall be an original as against any Party whose
signature appears thereon, but all of which together shall constitute but one
and the same instrument.  This Amendment
may be executed and delivered by facsimile and upon such delivery the facsimile
signature will be deemed to have the same effect as if the original signature
had been delivered to the other Party.


 


IN WITNESS WHEREOF,
the Parties have duly executed and delivered this AMENDMENT TO DEVELOPMENT AND LICENSE AGREEMENT as of the Amendment Effective
Date.


 


 


 


	
  AMYLIN
  PHARMACEUTICALS, INC.

  	
   

  	
  ALKERMES CONTROLLED
  THERAPEUTICS INC. II

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Daniel M. Bradbury

  	
   

  	
  By:

  	
  /s/ Michael Landine

  	
   

  
	
   

  	
   

  
	
  Title:

  	
  Chief Operating Officer

  	
   

  	
  Title: 

  	
  Vice President, Corporate Development

  	
   

  



 


 


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