Exhibit 10.1

 

[on Amylin Letterhead]

 

July 13, 2006

 

Alkermes Controlled Therapeutics Inc. II

88 Sidney Street

Cambridge, MA  02139

Attn:  Mike Landine

 

Dear Mr. Landine:

 

Amylin Pharmaceuticals, Inc. (“Amylin”) and Alkermes Controlled Therapeutics
Inc. II (“ACT II”) are parties to a Development and License Agreement effective
as of May 15, 2000, as amended (the “Development and License Agreement”),
pursuant to which the Parties are developing a synthetic exendin-4 long-acting
injectable product (“Exenatide LAR”) (capitalized terms used but not defined
herein shall have the meaning set forth in the Development and License
Agreement).  The Parties now wish to amend the Development and License Agreement
to incorporate the following additional terms and conditions set forth in this
letter agreement (the “Letter Agreement”):

 

1.             In connection with the development of Exenatide LAR, Amylin and
ACT II have agreed to conduct a single species nonclinical carcinogenicity
study, as described in the March 16, 2006 meeting of the Core Oversight Group,
which study will have three arms — a diluent control arm, a placebo microsphere
control arm and an Exenatide LAR arm (the “Carcinogenicity Study”).  In addition
to its existing obligations under the Development and License Agreement, ACT II
has agreed to supply Amylin solely for use in the Carcinogenicity Study and such
other studies as mutually agreed upon by both Parties, both placebo microspheres
(in the amount of either 240g or 1000g depending upon the final protocol(s) for
each of the Carcinogenicity Study and such other mutually agreed studies) and
diluent (in the amount of either 18.1L or 23.5L depending upon such final
protocol(s)).  Amylin will compensate ACT II for the technical and scientific
time devoted to the production of these materials at the FTE Hourly Rate and
reimburse ACT II for any reasonable out-of-pocket expenses incurred in
connection with the supply of these materials.  Payments to ACT II for the
supply of these materials shall be made within thirty days after receipt of
invoices therefor, and the provisions of Section 4.7(d) of the Development and
License Agreement regarding retention of records and audits by Amylin shall
apply with regard to payments under this Letter Agreement.

 

As additional consideration for ACT II’s supply of these materials, Amylin
agrees that ACT II will receive a separate report of any information, data
and/or results generated with respect to both the diluent control arm and the
placebo microsphere control arm of the Carcinogenicity Study as well as such
other information, data and/or results as may be mutually agreed upon by the
Parties in connection with any other studies mutually agreed upon by the Parties
(the “Data”).  Amylin and ACT II agree that, subject to Section 8.3(c) of the
Development and License Agreement, ACT II has the right to use the Data for any
and all purposes, except the research, development and commercialization of a
Product prior to the termination of the Development and License Agreement.  As
used in the prior sentence, the term “Product” means any Field Product the
manufacture, use, sale, offer for sale or import of which by a party, other than
one who has a right or license to the ACT II Patents, would infringe a Valid
Claim of any of the ACT II Patents.  In addition Amylin agrees that ACT II will
have the right to review the final protocol for the Carcinogenicity Study, and
Amylin agrees to consider in

 

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good faith any comments suggested by ACT II with respect to such final
protocol.  Amylin also agrees to furnish to ACT II copies of any proposed
communications to the FDA regarding the Carcinogenicity Study and to consider in
good faith any comments suggested by ACT II with respect thereto.  Amylin will
promptly inform ACT II of any written or oral communications received from the
FDA with respect to the Carcinogenicity Study and provide to ACT II a copy of
any such written communications or notes of any such oral communications.

 

2.             Except as specifically amended herein, all provisions of the
Development and License Agreement shall remain in full force and effect in
accordance with their terms.  In the event of a conflict between the provisions
of the Development and License Agreement and those of this Letter Agreement,
this Letter Agreement shall control.  This Letter Agreement and the Development
and License Agreement constitute the entire agreement between the Parties
regarding the subject matter hereof, and supersede all prior understandings and
agreements, whether written or oral, regarding the subject matter hereof.  No
amendment or modification of the terms and conditions of this Letter Agreement
shall be binding on either Party unless reduced to a writing referencing this
Letter Agreement and signed by an authorized officer of the Party to be bound.

 

3.             This Letter Agreement may be executed in two or more
counterparts, each of which shall be deemed an original for all purposes, but
all of which together shall constitute one and the same instrument.  This Letter
Agreement 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.

 

4.             This Letter Agreement shall be governed by and construed in
accordance with the laws of the State of Delaware, without giving effect to the
principles of conflict of laws.

 

If this Letter Agreement correctly sets forth our understanding, please sign in
the space provided below and return a copy of this Letter Agreement to me.

 

Sincerely yours,

 

Amylin Pharmaceuticals, Inc.

 

 

 

By

/s/ Lloyd A. Rowland

 

 

Lloyd A. Rowland

 

 

Vice President and General Counsel

 

 

 

 

 

Accepted and Agreed:

 

 

 

Alkermes Controlled Therapeutics Inc. II

 

 

 

By

/s/ Michael Landine

 

 

 

Printed Name

Michael Landine

 

 

 

Title

Vice President

 

 

 

Date

7-17-06

 

 

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