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
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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
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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 Exe
