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Title: |
Development and Marketing Collaboration Agreement |
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Date: |
2001 |
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Preview shows 18KB of 250KB total |
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$90 |
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#146663 |
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DEVELOPMENT AND MARKETING COLLABORATION AGREEMENT
BETWEEN
BIOGEN, INC. AND ICOS CORPORATION
July 11, 2001
{PAGE}
CONTENTS
{TABLE}
{S} {C}
RECITALS................................................................... 1
AGREEMENT.................................................................. 2
ARTICLE 1 DEFINITIONS...................................................... 2
ARTICLE 2 SCOPE OF THE COLLABORATION....................................... 14
2.1 Purpose......................................................... 14
2.2 Guiding Principles.............................................. 14
2.3 Efforts; Cooperation............................................ 15
2.4 Allocation of Activities........................................ 15
2.5 Exclusive Relationship.......................................... 15
ARTICLE 3 MANAGEMENT OF THE COLLABORATION.................................. 16
3.1 Joint Steering Committee........................................ 16
3.2 Joint Project Team.............................................. 18
3.3 Joint Commercialization Team.................................... 20
3.4 Joint Patent Committee.......................................... 21
ARTICLE 4 DEVELOPMENT...................................................... 22
4.1 Development Efforts............................................. 22
4.2 Development Plan and Responsibilities........................... 22
4.3 Clinical Trials................................................. 24
4.4 Clinical Trial Applications, Drug Approval Applications,
Package Labels and Inserts...................................... 24
4.5 Regulatory Meetings and Communications.......................... 26
4.6 Development Costs............................................... 27
4.7 Development Opt-Out............................................. 28
4.8 Third Party Research Agreements; Use of Third Parties........... 29
4.9 Transfer of Materials........................................... 30
4.10 Compliance With GLP/GCP and Applicable Laws..................... 30
ARTICLE 5 COMMERCIALIZATION IN THE TERRITORY............................... 31
5.1 Joint Commercialization Efforts................................. 31
5.2 Pricing......................................................... 32
5.3 Marketing Responsibilities/Marketing Materials.................. 32
5.4 Sales Efforts in the Territory.................................. 34
5.5 Customer Service................................................ 35
5.6 Distribution Activities......................................... 36
5.7 Recalls......................................................... 36
ARTICLE 6 CONSIDERATION/COST ALLOCATION.................................... 37
6.1 Percentage...................................................... 37
6.2 Reimbursable Commercial Cost Sharing............................ 37
6.3 Upfront Fee..................................................... 37
{/TABLE}
[ * ] designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the Commission.
{PAGE}
{TABLE}
{S} {C}
6.4 Forgiveable Loan................................................ 37
6.5 Milestone Payments to ICOS...................................... 39
6.6 Records of Net Sales and Commercialization Costs................ 41
ARTICLE 7 MANUFACTURE AND SUPPLY........................................... 42
7.1 Technology Transfer............................................. 42
7.2 Clinical Supplies............................................... 42
7.3 Commercial Supplies............................................. 42
7.4 Use of Third Parties............................................ 43
7.5 Decision-Making................................................. 44
7.6 Compliance With GMP............................................. 44
7.7 Records and Examination......................................... 44
ARTICLE 8 LICENSES......................................................... 44
8.1 License to ICOS Within the Field in the Territory............... 44
8.2 License to Biogen Within the Field in the Territory............. 45
8.3 Unblocking Licenses............................................. 45
8.4 Right to Grant Licenses/Sublicenses............................. 45
8.5 ICOS In-License................................................. 46
8.6 Third Party Licenses............................................ 46
ARTICLE 9 TRADEMARKS AND SERVICEMARKS...................................... 47
9.1 Product Trademarks.............................................. 47
9.2 Party Trademarks on Licensed Product Promotional Materials...... 47
9.3 Trademark Licenses.............................................. 47
9.4 Trademark Use Requirements...................................... 48
9.5 Infringement of Trademarks/Prosecution and Defense.............. 49
9.6 Costs of Enforcement and Defense of Trademarks.................. 49
ARTICLE 10 CONFIDENTIALITY................................................. 50
10.1 Confidentiality................................................. 50
10.2 Authorized Disclosure........................................... 50
10.3 Survival........................................................ 51
10.4 Termination of Prior Agreement.................................. 51
10.5 Publications.................................................... 51
10.6 Publicity Review................................................ 52
ARTICLE 11 INTELLECTUAL PROPERTY........................................... 53
11.1 Ownership of Intellectual Property.............................. 53
11.2 Disclosure of Patentable Inventions............................. 54
11.3 Patent Due Diligence............................................ 54
11.4 Patent Filings.................................................. 55
11.5 Patent Interferences............................................ 58
{/TABLE}
[ * ] designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the Commission.
-ii-
{PAGE}
{TABLE}
{S} {C}
11.6 Initial Filings if Made Outside of the United States............ 59
11.7 Enforcement of Patent Rights.................................... 59
11.8 Third Party Patents, Trade Secrets and Trademarks............... 61
11.9 [ * ]........................................................... 62
11.10 ICOS In-License/Third Party Licenses............................ 62
ARTICLE 12 REPRESENTATIONS AND WARRANTIES................................... 62
12.1 Representations and Warranties.................................. 62
12.2 Limitation of Representations and Warranties.................... 63
ARTICLE 13 INFORMATION AND ADVERSE DRUG EVENTS AND REPORTS.................. 64
13.1 Information..................................................... 64
13.2 Complaints...................................................... 64
13.3 Adverse Drug Events............................................. 64
ARTICLE 14 TERM AND TERMINATION............................................. 65
14.1 Term............................................................ 65
14.2 Voluntary Termination by Either Party........................... 65
14.3 Termination License Agreement Provisions........................ 68
14.4 Termination for Breach.......................................... 71
14.5 Effect of Termination for Breach................................ 73
14.6 Bankruptcy...................................................... 74
14.7 Surviving Rights................................................ 74
14.8 Accrued Rights; Surviving Obligations........................... 75
ARTICLE 15 INDEMNIFICATION.................................................. 75
15.1 Indemnification in the Territory................................ 75
15.2 Insurance....................................................... 77
ARTICLE 16 DISPUTE RESOLUTION............................................... 77
16.1 Disputes........................................................ 77
16.2 Arbitration..................................................... 78
16.3 Matters to Proceed to Court..................................... 78
ARTICLE 17 MISCELLANEOUS.................................................... 78
17.1 Assignment...................................................... 78
17.2 Legal Compliance................................................ 78
17.3 Retained Rights................................................. 79
17.4 Force Majeure................................................... 79
17.5 Further Actions................................................. 79
17.6 No Right to Use Names........................................... 79
17.7 Notices......................................................... 79
17.8 Waiver.......................................................... 81
17.9 Severability.................................................... 81
{/TABLE}
[ * ] designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the Commission.
-iii-
{PAGE}
{TABLE}
{S} {C}
17.10 Governing Law................................................... 81
17.11 Ambiguities..................................................... 81
17.12 Headings........................................................ 81
17.13 Counterparts.................................................... 82
17.14 Entire Agreement................................................ 82
17.15 Independent Contractors......................................... 82
{/TABLE}
Exhibits
Exhibit A Financial Planning, Accounting and Reporting
Exhibit B Development Plan
Exhibit C Form of Promissory Note
Exhibit D Press Release
Schedules
Schedule 1.5 Biogen Patents
Schedule 1.43 ICOS In-License
Schedule 1.45 ICOS Patents
Schedule 1.53 LFA-1 Mediated Cell Adhesion Assay
Schedule 4.8 Third Party Research Agreements
Schedule 6.4(c)(ii) Registration Rights
[ * ] designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the Commission.
-iv-
{PAGE}
DEVELOPMENT AND MARKETING
COLLABORATION AGREEMENT
This Development and Marketing Collaboration Agreement (this "Agreement")
---------
is entered into on this 11/th/ day of July, 2001 (the "Effective Date"), by and
between Biogen, Inc., a Massachusetts corporation ("Biogen"), and ICOS
------
Corporation, a Delaware corporation ("ICOS"). Biogen and ICOS may each be
referred to in this Agreement individually as a "Party" and collectively as the
-----
"Parties".
-------
RECITALS
1. Each Party has an interest in the research and development of small
molecule LFA-1 Antagonists as a potential therapy in the treatment of certain
diseases.
2. ICOS has several small molecule LFA-1 Antagonists with potential
therapeutic value.
3. By combining their substantial experience and expertise, the Parties
wish, for the exclusive and mutual benefit of both, to work collaboratively to
expedite the research, development, regulatory approval and commercialization of
products containing a small molecule LFA-1 Antagonist.
4. By working together, the Parties wish to reduce cost barriers to
research and development that each would face if acting individually, [ * ].
5. The Parties believe that a collaboration will lower their costs,
expedite the drug approval and delivery process, establish an effective and
efficient manufacturing and distribution system for products containing a small
molecule LFA-1 Antagonist, [ * ].
6. [ * ]
7. ICOS and Biogen each wish to grant to the other certain exclusive
licenses under each Party's respective intellectual property rights to permit
the other Party to participate in exclusive and mutually beneficial
collaborative development, marketing, co-promotion and sales efforts for
products containing small molecule LFA-1 Antagonists and to maintain an
exclusive collaboration with respect to the products covered by this Agreement.
[*] designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the Commission.
{PAGE}
AGREEMENT
NOW, THEREFORE, in consideration of the premises and the mutual covenants
and agreements contained in this Agreement, and for other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, the
Parties, intending to be legally bound, agree as follows:
ARTICLE 1
DEFINITIONS
The following capitalized terms, whether used in the singular or the
plural, shall have the following meanings as used in this Agreement unless
otherwise specifically indicated:
1.1 "Affiliate(s)" shall mean, with respect to any person or entity, any
other person or entity which controls, is controlled by or is under common
control with such person or entity. A person or entity shall be regarded as in
control of another entity if it owns or controls, directly or indirectly, (a) in
the case of corporate entities more than [ * ] of the equity securities in the
subject entity entitled to vote in the election of directors and (b) in the case
of an entity that is not a corporation, more than [ * ] of the equity securities
or other ownership interests with the power to direct the management and
policies of such subject entity or entitled to elect the corresponding
management authority.
1.2 "Annual Workplan/Budget" shall mean the detailed schedule of
Development activities prepared by the Joint Project Team which sets out the
schedule, nature, and allocation of responsibilities of each Party for
Development work and the agreed upon budget for such activities. The Annual
Workplan/Budget shall be prepared by the Joint Project Team, subject to approval
by the JSC, as specified in Section 4.2.
1.3 "As Adjusted for Inflation" shall mean an adjustment to a dollar
figure by a percentage equal to the amount, if any, by which the [ * ].
Adjustments shall take place on January 1, 2006 and every five years thereafter.
If [ * ] is discontinued, unavailable or otherwise substantially revised, a
comparable index shall be used.
1.4 "Biogen Know-how" shall mean any and all Know-how which is within the
Control of Biogen or any of its Affiliates as of the Effective Date or during
the Term of this Agreement, and is necessary or useful for a Party to Develop,
Commercialize, manufacture, sell, import or use Licensed Products in the Field
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