Exhibit 10.1

 

Execution Copy

 

AMENDMENT NO. 1 TO

 

COLLABORATION AGREEMENT

 

This Amendment No. 1 (“Amendment No. 1”) to the Collaboration Agreement dated as
of April 14, 2002 by and between Adolor Corporation, a Delaware corporation,
(“Adolor”) and Glaxo Group Limited, a United Kingdom corporation (“GSK”) (the
“Collaboration Agreement”) is entered into as of the 22nd day of June, 2004 by
and between Adolor and GSK and shall be effective as of June 24, 2003.

 

RECITALS

 

WHEREAS the Parties have been collaborating in the Development of alvimopan
pursuant to the terms of the Collaboration Agreement; and

 

WHEREAS, the Parties have determined to amend Article 3 “Governance of
Development and Commercialization of Products” in the manner set forth below.

 

NOW THEREFORE, intending to be legally bound, the Parties agree as follows:

 

1. Capitalized terms used in this Amendment No.1 shall have the same meanings as
in the Collaboration Agreement, unless otherwise defined herein.

 

2. Section 1.79 of the Collaboration Agreement defining the term “Joint
Development Committee” shall be deleted in its entirety and replaced with the
following Section 1.79.

 

  “1.79 “Asset Management Team” shall have the meaning set forth in Section
3.2.1.”

 

Every place that the term “Joint Development Committee” appears throughout the
Collaboration Agreement shall be replaced by the term “Asset Management Team.”

 

3. Section 1.81 of the Collaboration Agreement defining the term “Joint
Marketing Committee” shall be deleted in its entirety and replaced with the
following Section 1.81:

 

  “1.81 “Joint U.S. Marketing Team” shall have the meaning set forth in Section
3.3.1.”

 

Every place that the term “Joint Marketing Committee” appears throughout the
Collaboration Agreement shall be replaced by the term “Joint U.S. Marketing
Team.”

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4. Section 1.82 of the Collaboration Agreement defining the term “Joint Supply
Committee” shall be deleted in its entirety and every place that the term “Joint
Supply Committee” appears throughout the Collaboration Agreement shall be
replaced by the term “Asset Management Team.”

 

5. Section 3.2.1, of the Collaboration Agreement shall be deleted in its
entirety and replaced with the following Section 3.2.1.

 

  “3.2 Asset Management Team

 

  3.2.1 Members; Officers; Subteams . The Parties have established an Asset
Management Team (the “Asset Management Team”), to which GSK and Adolor shall
designate an equal number of representatives, up to a maximum total of twenty
(20) members on such Asset Management Team. Each of GSK and Adolor may replace
any or all of its representatives on the Asset Management Team at any time upon
written notice to the other Party. Such representatives shall include
individuals who have clinical trial and regulatory experience, expertise in
pharmaceutical drug Development, Commercialization and manufacturing and supply
of drugs. A Party may designate a substitute to temporarily attend and perform
the functions of such Party’s designee at any meeting of the Asset Management
Team. GSK and Adolor each may, on advance notice to the other Party, invite
non-member representatives of such Party to attend meetings of the Asset
Management Team. The Asset Management Team shall be chaired on an annual
rotating basis by a representative of either Adolor or GSK, as applicable, with
Adolor providing the chairperson for the annual term beginning July 1, 2003
through June 30, 2004. The chairperson shall appoint a secretary of the Asset
Management Team, who shall be a representative of the other Party and who shall
serve for the same annual term as such chairperson. The Asset Management Team
shall operate as a joint team for the Development and coordination of the
Commercialization of Compound. In carrying out its responsibilities as set forth
in Section 3.2.2, the Asset Management Team shall have the authority but not the
obligation to establish one or more subteams with representation from each of
GSK and Adolor to take on and coordinate activities as identified by the Asset
Management Team (each a “Subteam” together, the “Subteams”). By way of example
and not limitation, Subteams may be designated for: commercial; supply/chemistry
and manufacturing; clinical and statistical; nonclinical; and regulatory. For
each Subteam established, the Asset Management Team shall have the authority to:
determine the disciplines that need to be represented from each of GSK and
Adolor, delegate activities to

 

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the Subteam, approve the charter for the Subteam, set up procedural mechanisms
for the Subteam to interact with the Asset Management Team, and disband the
Subteam. Notwithstanding any such delegation of activities to a Subteam, the
Asset Management Team shall be fully responsible for all of the responsibilities
set forth in Section 3.2.2, including all activities delegated to the Subteams.”

 

6. Section 3.2.2(f) shall be revised to delete from the first line of that
Section the following: “At each meeting of the Joint Development Committee,” and
to replace that language with the following: “Quarterly the Asset Management
Team shall”

 

7. Section 3.2.2 shall be further amended to delete the current Section 3.2.2(h)
and to add the following provisions:

 

“(h) Coordinate Development and Commercialization of the Collaboration Products
in the ROW with the Development and Commercialization of the Collaboration
Products in the United States;

 

(i) Coordinate life cycle management of, and intellectual property protection
for, the Collaboration Products in the United States and the ROW;

 

(j) Manage and oversee the activities in relation to manufacture and supply of
API Compound and Collaboration Products for use in Development and
Commercialization and establish procedures and protocols for testing API
Compound and Collaboration Products to ensure that such API Compound and
Collaboration Products comply with the specifications (the “Testing Protocol”).
The Parties will utilize such Testing Protocol with respect to API Compound and
Collaboration Product that they may receive from Product Suppliers to ensure
that such API Compound or Collaboration Product meets specifications;

 

(k) Recommend and coordinate necessary adjustments to the manufacturing schedule
to ensure it is meeting the needs for all Collaboration Products;

 

(l) Coordinate allocation of API Compound in the event of a shortage between the
United States and the ROW, it being understood that, in the event of a shortage,
allocation of API Compound shall be as follows: (i) requirements for use in POI
Products for Commercialization in the United States shall have first priority;
(ii) requirements for use in POI Products for Commercialization in the ROW shall
have second priority; (iii) requirements for use in Collaboration Products
(other than POI Product) in the United States shall have third priority; (iv)
requirements for use in Collaboration Products (other than POI Product) for
Commercialization in

 

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the ROW shall have fourth priority; and (v) requirements for use in all other
Products containing API Compound shall have fifth priority. The foregoing
priority allocations may be revised by the Asset Management Team based on the
relative commercial value of such Collaboration Products;

 

(m) Review the quality of the manufacture of the Collaboration Products,
reviewing as appropriate reports of the manufacturers of API Compound and
Collaboration Products and reports as to the quality of any packaging that bears
the relevant trademarks or housemarks of the Parties (as owned by or licensed to
the relevant Party under Section 2.4) as prescribed by this Agreement;

 

(n) Recommend and implement optimal inventory levels and safety stock targets;

 

(o) Set improvement targets and monitor performance against these targets for
cost, yield, delivery and other appropriate measures;

 

(p) Establish guidelines to facilitate improved efficiencies and compliance with
current Good Manufacturing Practices by Product Suppliers; and

 

(q) Have such other responsibilities as may be assigned to the Asset Management
Team pursuant to this Agreement or as may be mutually agreed upon by the Parties
from time to time.”

 

8. Section 3.2.5 shall be amended to add the following sentence as the last
sentence of Section 3.2.5 : “Notwithstanding the foregoing any matter relating
to supply of API Compound or any Collaboration Product assigned for
decision-making to a Party in Article 10 or in the further agreements between
the Parties contemplated thereby shall not be subject to referral to the Joint
Steering Committee.”

 

9. Section 3.4, including Section 3.4.1, 3.4.2, 3.4.3 and 3.4.4, shall be
deleted in its entirety.

 

10. The term “committee” throughout the Collaboration Agreement shall also be
read to refer to the “team” as and if the context requires.

 

11. Except as specifically set forth above, the Collaboration Agreement remains
in full force and effect as originally executed.

 

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IN WITNESS WHEREOF, the Parties have executed this Amendment No.1 as of this
22nd day of June 2004.

 

ADOLOR CORPORATION

 

GLAXO GROUP LIMITED

By:

 

/s/ Bruce A. Peacock

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By:

 

/s/ Leo Nuttall

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Name:

 

Bruce A. Peacock

 

Name:

 

Leo Nuttall

Title:

 

President and Chief Executive Officer

 

Title:

 

Corporate Director

 

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