|
|
|
|
Document Preview Collaboration Agreement |
||||
|
|
||||
|
Click "Add to Cart" button to purchase document. |
||||
|
|
||||
|
Title: |
Collaboration Agreement |
|||
|
Entities: |
Adolor Corp.; GlaxoSmithKline plc; Shire Pharmaceuticals Group plc; Dechert LLP; Morgan, Lewis & Bockius |
|||
|
Date: |
2003 |
|||
|
Size: |
Preview shows 27KB of 382KB total |
|||
|
Price: |
$99 |
|||
|
ID: |
#371481 |
|||
|
|
||||
|
||||
|
|
||||
|
Start of Preview |
||||
COLLABORATION AGREEMENT
dated as of April 14, 2002
by and between
ADOLOR CORPORATION
and
GLAXO GROUP LIMITED
{PAGE}
TABLE OF CONTENTS
{TABLE}
{CAPTION}
Page
{S} {C}
ARTICLE 1 DEFINITIONS ............................................................ 1
ARTICLE 2 RIGHTS AND OBLIGATIONS ................................................. 16
2.1 License Grants from Adolor to GSK ........................................ 16
2.2 License Grant from GSK to Adolor ......................................... 17
2.3 Sublicensing and Subcontracting .......................................... 18
2.4 Trademarks and Housemarks ................................................ 19
2.5 Intellectual Property .................................................... 26
2.6 Exclusivity .............................................................. 26
2.7 OTC Rights ............................................................... 27
ARTICLE 3 GOVERNANCE OF DEVELOPMENT AND COMMERCIALIZATION OF PRODUCTS ............ 27
3.1 Joint Steering Committee ................................................. 27
3.2 Joint Development Committee .............................................. 30
3.3 Joint Marketing Committee ................................................ 32
3.4 Joint Supply Committee ................................................... 34
3.5 Minutes of Committee Meetings ............................................ 36
3.6 Expenses ................................................................. 37
3.7 Initial Coordination Efforts ............................................. 37
ARTICLE 4 DEVELOPMENT OF PRODUCTS ................................................ 37
4.1 Responsibilities of the Parties .......................................... 37
4.2 Obligations for Development .............................................. 38
4.3 Additional Products ...................................................... 38
4.4 U.S. Development Plans ................................................... 40
4.5 Implementation of U.S. Development Plans ................................. 41
4.6 Development Funding ...................................................... 41
4.7 Development in the ROW ................................................... 43
4.8 Fulfillment of Obligations ............................................... 44
4.9 Transfer of Data ......................................................... 44
4.10 Right to Audit ........................................................... 44
ARTICLE 5 CO-PROMOTION, DETAILING AND COMMERCIALIZATION .......................... 45
5.1 U.S. Marketing Plans ..................................................... 45
5.2 Marketing Funding ........................................................ 47
5.3 Implementation of U.S. Marketing Plans ................................... 48
5.4 Obligations for Commercialization ........................................ 48
5.5 Commercialization Responsibilities ....................................... 49
5.6 Detailing Efforts ........................................................ 50
5.7 Detailing and Marketing Requirements ..................................... 51
5.8 Sales Force Incentive Compensation for POI Products ...................... 51
5.9 Detailing Reports ........................................................ 52
{/TABLE}
i
{PAGE}
TABLE OF CONTENTS
(continued)
{TABLE}
{CAPTION}
Page
{S} {C}
5.10 Training .......................................................................... 52
5.11 Commercialization in the ROW ...................................................... 53
ARTICLE 6 FINANCIAL PROVISIONS ....................................................... 54
6.1 Upfront Payment ................................................................... 54
6.2 Milestone Payments ................................................................ 55
6.3 Marketing Contribution for Collaboration Products ................................. 55
6.4 Payment of Royalties on Net Sales in the ROW ...................................... 57
6.5 Payment of Royalties on Net Sales of GI Products in the United States ............. 57
6.6 Royalty Responsibilities; Net Sales Reports ....................................... 58
6.7 Reports ........................................................................... 59
6.8 Payment Upon Expiration of the Adolor Product Promotion Term ...................... 62
6.9 GAAP .............................................................................. 62
6.10 Currencies ........................................................................ 62
6.11 Manner of Payments ................................................................ 63
6.12 Interest on Late Payments ......................................................... 63
6.13 Tax Withholding ................................................................... 63
6.14 Financial Records; Audits ......................................................... 63
ARTICLE 7 Promotional Materials AND Samples .......................................... 64
7.1 Promotional Materials ............................................................. 64
7.2 Samples for the United States ..................................................... 66
ARTICLE 8 INFORMATION CONCERNING THE COLLABORATION Products .......................... 67
8.1 Statements Consistent with Labeling ............................................... 67
8.2 Medical Inquiries ................................................................. 67
8.3 Standard Operating Procedures ..................................................... 68
ARTICLE 9 REGULATORY MATTERS ......................................................... 68
9.1 Communications and Meetings with Governmental Authorities ......................... 68
9.2 Filings with Governmental Authorities ............................................. 70
9.3 In the ROW ........................................................................ 71
9.4 Approval of Labeling and Promotional Materials .................................... 72
9.5 Regulatory Information ............................................................ 72
9.6 Exchange of Drug Safety Information ............................................... 73
9.7 Recalls Or Other Corrective Action ................................................ 73
9.8 Events Affecting Integrity or Reputation .......................................... 75
9.9 Sharing of Regulatory Filings ..................................................... 75
ARTICLE 10 ORDERS; SUPPLY AND RETURNS ................................................. 75
10.1 Orders and Terms of Sale in the United States for Adolor Products ................. 75
10.2 Orders and Terms of Sale in the United States for GI Products ..................... 75
{/TABLE}
ii
{PAGE}
TABLE OF CONTENTS
(continued)
{TABLE}
{CAPTION}
Page
{S} {C}
10.3 Orders and Terms of Sale in the ROW ............................................. 76
10.4 Misdirected Orders .............................................................. 76
10.5 Product Returns ................................................................. 76
10.6 Supply of API Compound and Collaboration Product for Development
of Collaboration Products ....................................................... 77
10.7 Supply of API Compound for Commercialization of Collaboration Products .......... 78
10.8 Supply of Collaboration Products for Commercialization .......................... 79
10.9 Shortages ....................................................................... 80
10.10 Product Suppliers ............................................................... 81
10.11 Standard Terms of Supply ........................................................ 81
ARTICLE 11 GSK PRODUCT .............................................................. 84
11.1 GSK Product Right and License ................................................... 84
11.2 Adolor Selection Process and Timeframe .......................................... 84
11.3 GSK Product Agreement ........................................................... 85
11.4 No Selected GSK Product ......................................................... 85
ARTICLE 12 CONFIDENTIAL INFORMATION ................................................. 86
12.1 Confidential Information ........................................................ 86
12.2 Permitted Disclosure and Use .................................................... 86
12.3 Publications .................................................................... 87
12.4 Public Announcements ............................................................ 87
12.5 Confidentiality of this Agreement ............................................... 87
12.6 Survival ........................................................................ 87
ARTICLE 13 REPRESENTATIONS AND WARRANTIES; COVENANTS ................................ 87
13.1 Mutual Representations and Warranties ........................................... 87
13.2 Additional GSK Representations and Warranties ................................... 88
13.3 Additional Adolor Representations and Warranties ................................ 89
13.4 Covenants ....................................................................... 90
13.5 Disclaimer of Warranty .......................................................... 90
ARTICLE 14 INDEMNIFICATION .......................................................... 91
14.1 Indemnification by GSK .......................................................... 91
14.2 Indemnification by Adolor ....................................................... 91
14.3 Procedure for Indemnification ................................................... 92
14.4 Assumption of Defense ........................................................... 93
14.5 Product Liability Claims in the United States ................................... 93
14.6 Insurance ....................................................................... 94
14.7 Limitation of Liability ......................................................... 94
{/TABLE}
iii
{PAGE}
TABLE OF CONTENTS
(continued)
{TABLE}
{CAPTION}
Page
{S} {C}
ARTICLE 15 PATENT INFRINGEMENT .......................................................... 95
15.1 Prosecution and Maintenance of Patents .............................................. 95
15.2 Patent Infringement ................................................................. 98
15.3 Notice of Certification ............................................................. 99
15.4 Assistance .......................................................................... 100
ARTICLE 16 TERM AND TERMINATION ......................................................... 100
16.1 Term ................................................................................ 100
16.2 Extension of Adolor Product Promotion Term .......................................... 100
16.3 Termination for Breach .............................................................. 100
16.4 Termination for Safety Related Reasons .............................................. 100
16.5 Termination by GSK with Respect to Adolor Products .................................. 101
16.6 Termination by GSK With Respect to the OBD Chronic Product .......................... 102
16.7 Termination by GSK With Respect to GI Products Other Than the OBD Chronic Product ... 103
16.8 Termination by Adolor ............................................................... 104
16.9 Effects of Expiration of the Adolor Product Promotion Term .......................... 106
16.10 Effects of Expiration of the GI Product Promotion Term .............................. 107
16.11 Effects of Expiration of the ROW Term ............................................... 108
16.12 Effect of Termination ............................................................... 109
16.13 Effect of Termination for Safety Related Reasons .................................... 111
16.14 General Effects of Termination ...................................................... 111
ARTICLE 17 LIMITATIONS ON PURCHASES OF EQUITY SECURITIES ................................ 111
17.1 Purchases of Equity Securities ...................................................... 111
17.2 Exceptions for Purchasing Securities of Adolor ...................................... 112
ARTICLE 18 MISCELLANEOUS ................................................................ 113
18.1 Relationship of the Parties ......................................................... 113
18.2 Registration and Filing of this Agreement ........................................... 113
18.3 Force Majeure ....................................................................... 113
18.4 Governing Law ....................................................................... 114
18.5 Dispute Resolution; Arbitration ..................................................... 114
18.6 Assignment .......................................................................... 115
18.7 Notices ............................................................................. 115
18.8 Severability ........................................................................ 117
18.9 Headings ............................................................................ 117
18.10 Waiver .............................................................................. 117
18.11 Entire Agreement .................................................................... 117
18.12 No License .......................................................................... 117
18.13 Third Party Beneficiaries ........................................................... 117
18.14 Counterparts ........................................................................ 118
{/TABLE}
iv
{PAGE}
COLLABORATION AGREEMENT
This COLLABORATION AGREEMENT ("Agreement") dated as of April 14, 2002
---------
(the "Effective Date"), is made by and between ADOLOR CORPORATION, a Delaware
--------------
corporation and having its principal office at 620 Pennsylvania Drive, Exton,
Pennsylvania 19341 ("Adolor"), and GLAXO GROUP LIMITED, a United Kingdom
------
corporation, and having its principal office at Glaxo Wellcome House, Berkeley
Avenue, Greenford, Middlesex, UB6 0NN, United Kingdom ("GSK"). Adolor and GSK
---
may be referred to as a "Party" or together, the "Parties".
----- -------
RECITALS
WHEREAS, Adolor is currently developing a compound known as alvimopan
for postoperative bowel dysfunction and other gastrointestinal disorders;
WHEREAS, GSK has significant experience in the development, marketing
and promotion of pharmaceutical products and believes it can make significant
contributions to the successful development and commercialization of alvimopan;
WHEREAS, GSK and Adolor have complementary technology, capabilities and
resources which are necessary for the development and commercialization of the
Collaboration Products;
WHEREAS, GSK and Adolor are willing to undertake such development and
commercialization activities and investment based on the coordination of such
activities and investment provided by this Agreement similar to that of a single
entity with respect to the Collaboration Products; and
WHEREAS, GSK and Adolor believe that a collaboration pursuant to this
Agreement for the development, promotion and commercialization of alvimopan
would be desirable and fully compatible with their respective business
objectives and provide the most effective and efficient means to ensure that the
Collaboration Products are developed and commercialized so as to maximize the
return on investment for GSK and Adolor.
NOW, THEREFORE, in consideration of the foregoing premises and the
representations, covenants and agreements contained herein, Adolor and GSK,
intending to be legally bound, hereby agree as follows:
ARTICLE 1
DEFINITIONS
For purposes of this Agreement, the following initially capitalized
terms, whether used in the singular or plural, shall have the following
meanings:
1.1 "AAA" shall have the meaning set forth in Section 18.5.2.
---
{PAGE}
1.2 "Additional Product" means a ** Product and any Product other
------------------
than a POI Product, an OBD Acute Product, an OBD Chronic Product, a ** Product
or an ** Product included by the Parties pursuant to Section 4.3.
1.3 "Adolor Housemark" means the name and logo of Adolor or an
----------------
Affiliate of Adolor as identified by Adolor to GSK from time to time.
1.4 "Adolor Invention" means an Invention that is conceived or reduced
----------------
to practice by an employee or agent of Adolor solely or jointly with a Third
Party.
1.5 "Adolor Know-How" means all present and future Know-How that
---------------
relates to the Collaboration Products, the Compound or the Adolor Inventions, to
the extent necessary for GSK to perform its obligations or enjoy its rights
under this Agreement, and which during the Term are in Adolor's or any of its
Affiliates' possession or control and are or become owned by, or otherwise may
be licensed by, Adolor. Adolor Know-How does not include any Adolor Patents.
1.6 "Adolor Patents" means all Patent Rights covering the
--------------
Collaboration Products, the Compound or the Adolor Inventions which are or
become owned by Adolor or Adolor's Affiliates, or as to which Adolor or Adolor's
Affiliates are or become licensed, now or in the future, with the right to grant
the sublicense rights granted to GSK under this Agreement, which Patent Rights
cover the making, having made, use, offer for sale, sale or importation of
Collaboration Products, and which existing Patent Rights are more specifically
set forth on Schedule 1.6.
------------
1.7 "Adolor Product Marketing Contribution" means an amount equal to
-------------------------------------
** for Adolor Products in the applicable reporting period in the United States
less the following amounts: (a) ** of the Adolor Product constituting such **;
(b) the **; (c) royalties paid to ** on account of sales of Adolor Products in
**; and (d) **.
1.8 "Adolor Product Promotion Term" means the period of time beginning
-----------------------------
on the Effective Date and ending ** years after First Commercial Sale of a POI
Product in the United States unless otherwise extended pursuant to the
provisions of Section 16.2.
1.9 "Adolor Product Trademarks" shall have the meaning set forth in
-------------------------
Section 2.4.1.
1.10 "Adolor Products" means a POI Product, an OBD Acute Product or any
---------------
Additional Product designated by the Parties as an Adolor Product pursuant to
Section 4.3.
1.11 "Adolor Reconciliation Report" shall have the meaning set forth in
----------------------------
Section 6.7.5(a).
1.12 "Adolor Report" shall have the meaning set forth in Section 6.7.3.
-------------
1.13 "Adverse Drug Experience" means any of: an "adverse drug
-----------------------
experience," a "life-threatening adverse drug experience," a "serious adverse
drug experience," or an "unexpected adverse drug experience," as those terms are
defined at either 21 C.F.R.(S)312.32 or 21 C.F.R.(S)314.80.
** = Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
-2-
{PAGE}
1.14 "Affiliate" of a Party means any Person, whether de jure or de
---------
facto, which directly or indirectly controls, is controlled by, or is under
common control with such Person for so long as such control exists, where
"control" means the decision-making authority as to such Person and, further,
where such control shall be presumed to exist where a Person owns more than
fifty percent (50%) of the equity (or such lesser percentage which is the
maximum allowed to be owned by a foreign corporation in a particular
jurisdiction) having the power to vote on or direct the affairs of the entity.
1.15 "API Compound" means bulk quantities of Compound prior to the
|
End of Preview |
Home Intelligence Services Subscriptions News About Us