NAVY COOPERATIVE RESEARCH AND
DEVELOPMENT AGREEMENT
NMRC AND BIOPURE CORPORATION
AGREEMENT
TITLE: Restore Effective SUrvival in Shock
(RESUS)
AGREEMENT
NUMBER: NCRADA- NMRC– 03 – 1497
AGREEMENT
ADMINISTRATORS:
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Technology
Transfer Office:
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Dr. Charles
Schlagel
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Director,
Office of Technology Transfer
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Naval Medical
Research Center
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Silver Spring,
MD 20910-7500
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Tel:
301-319-7428, Fax: 301-319-7432
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Daniel
Freilich, CDR, MC, USNR
Head, Hematomimetics Program
Naval Medical Research Center
Combat Casualty Directorate
503 Robert Grant Avenue
Silver Spring, MD 20910-7500
Tel: 301-319-7152, Fax: 301-319-7486
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L. Bruce
Pearce, Ph.D
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Director
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Pharmacology
& Physiology
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Biopure
Corporation
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11 Hurley
Street
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Cambridge, MA
02141
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Tel:
617-234-6535, Fax: 617-234-6850
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Jane Kober
Senior Vice President
General Counsel, Secretary
Biopure Corporation
11 Hurley Street
Cambridge, MA 02141
Tel: 617-234-6511, Fax: 617-234-6507
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L. Bruce
Pearce, Ph.D
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Director
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Pharmacology
& Physiology
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Biopure
Corporation
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11 Hurley
street
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Cambridge, MA
02141
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Tel:
617-234-6535, Fax: 617-234-6850
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DEFINITIONS
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“Agreement”
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“Classified Information”
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“Collaborator”
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“Controlled Unclassified Information
(CUI)”
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“Cooperative Work”
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“Data”
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“Effective Date”
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“Exclusive License”
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“Government”
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“Government Purpose
Rights”
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“HBOC”
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“Information”
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“Intellectual Property”
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“Invention”
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“Invention Disclosure”
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“Made”
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“Militarily Critical Technologies
(MCT)”
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“Non-Subject Data”
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“Non-Subject Invention”
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“Patent
Application”
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“Principal Investigator
(PI)”
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“Proprietary Information”
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“Restricted Access
Information”
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“Subject
Data”
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“Subject
Invention”
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“Tangible
Property”
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“Unlimited Rights”
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OBJECTIVES
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RESPONSIBILITIES
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NMRC Personnel and Facilities
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BIOPURE Personnel and Facilities
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Security
Regulations and Directives
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REPRESENTATIONS AND WARRANTIES
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NMRC’s Representations and Warranties
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BIOPURE’s Representations and Warranties
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Joint
Representations
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Article 5.
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FUNDING
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5.1
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Payment
Schedule
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5.2
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Accounting
Records
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Article 6.
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REPORTS AND
PUBLICATIONS
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6.1
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Interim
Reports
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6.2
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Final
Reports
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6.3
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Agreement to
Confer Prior to Publication or Public Disclosure
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6.4
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Classified
Information
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Article 7.
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INTELLECTUAL
PROPERTY
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7.1
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Data
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7.1.1
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General
Provisions Applying to All Data
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7.1.1.1
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Ownership
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7.1.1.2
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No Implied
License
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7.1.1.3
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Marking of
Data
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7.1.1.3.1
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Data Provided
With Less Than Unlimited Rights
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7.1.1.3.2
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Data That are
Proprietary Information or Restricted Access Information
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7.1.1.3.3
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Data That are
Subject to 35 USC 205
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7.1.1.3.4
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Data That are
Classified Information, CUI, MCT, or Otherwise
Restricted
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7.1.1.4
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Protection of
Data
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7.1.1.5
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Release of Data
Under the Freedom of Information Act
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7.1.2
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Subject
Data
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7.1.2.1
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Delivery of
Requested Subject Data
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7.1.2.2
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Rights in
Subject Data
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7.1.3
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Rights in
Non-Subject Data
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7.2
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Copyrights
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7.2.1
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Copyright by
BIOPURE
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7.2.2
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Copyright
License to the Government
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7.2.3
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Copyright
Statement
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7.3
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Trademarks and
Service Marks
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7.3.1
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Ownership of
Trademarks and Service Marks
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7.3.2
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Obligation of
Employees to Report Trademarks and Service Marks
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7.3.3
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Obligation of
Collaborators to Notify Each Other
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7.3.4
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Responsibility
for Filing an Application for Trademark or Service Mark
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7.3.5
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License to Use
Trademark or Service Mark
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7.4
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Subject
Inventions
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7.4.1
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Obligation to
Report Subject Inventions
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7.4.1.1
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Collaborators’ Instruction to
Employees
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7.4.1.2
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Timely
Invention Disclosure by Inventors
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7.4.1.3
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Obligation to
Provide Invention Disclosures to the Other Collaborator
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7.4.2
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Determination
of Subject Inventions
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7.4.3
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Title to and
Ownership of Subject Inventions
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7.4.4
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Filing of
Patent Applications
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7.4.4.1
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Filing of
Patent Applications on Solely Made Inventions
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7.4.4.2
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Filing of
Patent Applications on Jointly Made Inventions
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7.4.4.3
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Preserving
Intellectual Property Rights
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7.4.4.4
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Filing
Deadlines
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7.4.4.5
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Copies and
Inspection
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7.4.4.5.1
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Copies of
Prosecution Papers
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7.4.4.5.2
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Access to
Patent Application File and Right to Make Copies
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7.4.4.6
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Rights of
Inventors if the Collaborators Decline to File a Patent
Application
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7.4.5
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Nonexclusive
License to Subject Inventions
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7.4.5.1
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Nonexclusive
License Grant
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7.4.5.2
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Confirmatory
Nonexclusive License Agreement
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7.4.6
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Option for
Exclusive License to Subject Inventions
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7.4.7
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Limitation on
Assignment of Licenses Granted Under This Agreement
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7.4.8
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Termination of
License Granted and Cancellation of Exclusive License Option to
Subject Inventions
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7.4.8.1
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Exclusive
Licenses and Exclusive License Option
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7.4.8.2
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Nonexclusive
Licenses
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7.5
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Non-Subject
Inventions
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7.5.1
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Ownership of
Non-Subject Inventions
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7.5.2
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Rights Under
Other Agreements
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7.5.3
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No License to
Non-Subject Inventions
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7.6
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Research
License
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Article 8.
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TANGIBLE
PROPERTY
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8.1
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Title to
Preexisting Tangible Property
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8.2
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Tangible
Property Purchased by Collaborators to Perform the Cooperative
Work
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8.3
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Title to
Developed Tangible Property
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8.4
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Tangible
Property Operational and Disposition Costs
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8.5
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Disposal of
Tangible Property
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Article 9.
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LIABILITY
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9.1
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Extent of
Government Liability
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9.2
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Extent of
BIOPURE Liability
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9.3
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Force
Majeure
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Article 10.
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GENERAL
PROVISIONS
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10.1
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Characteristics
of the Agreement
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10.1.1
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Entire
Agreement
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10.1.2
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Severability
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10.1.3
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Interpretation
of Headings
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10.2
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Agreement
Between Collaborators
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10.2.1
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Governing
Laws
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10.2.2
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Independent
Parties/Entities
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10.2.3
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Assignment
/Subcontracting
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10.2.3.1
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Third
Parties
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10.2.3.2
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Nontransfer
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10.2.3.3
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Foreign
Interference
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10.2.4
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Disputes
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10.2.4.1
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Settlement and
Resolution
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10.2.4.2
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Continuation of
Cooperative Work
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10.2.5
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Waivers
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10.2.6
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Use of Name or
Endorsements
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10.3
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Environment,
Safety, and Health
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10.4
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Public Release
of This Agreement
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Article 11.
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MODIFICATIONS AND NOTICES
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11.1
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Amendments
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11.2
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Termination
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11.2.1
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Termination by
Mutual Consent
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11.2.2
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Unilateral
Termination
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11.3
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Notices
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Article 12.
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SURVIVING
PROVISIONS
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Article 13.
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DURATION
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Article 14.
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SIGNATURES
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Appendix A
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Statement of
Work
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Appendix B
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Confirmatory
License Agreement
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Appendix C
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Third Party
Agreements
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v
NAVY COOPERATIVE RESEARCH AND
DEVELOPMENT AGREEMENT
Under authority
of the U.S. Federal Technology Transfer Act of 1986 (Public Law
99-502, 20 October 1986, as amended), Naval Medical Research
Center (NMRC) , located at 503 Robert Grant Avenue, Silver
Spring, MD 20910-7500 , and BIOPURE CORPORATION
(BIOPURE) , whose corporate headquarters are located at 11
Hurley Street, Cambridge, MA 02141, enter into this Cooperative
Research and Development Agreement (CRADA), which shall be binding
upon the Collaborators and their assignees according to the terms
and conditions hereof and for the term and duration set forth
herein.
The U.S.
Federal Technology Transfer Act of 1986, as amended, provides for
making the expertise, capabilities, and technologies of U.S.
Federal laboratories accessible to other Federal agencies; units of
State or local government; industrial organizations (including
corporations, partnerships and limited partnerships, and industrial
development organizations); public and private foundations;
nonprofit organizations (including universities); or other persons
in order to improve the economic, environmental, and social
well-being of the United States by stimulating utilization of U.S.
Federally funded technology developments and/or
capabilities.
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expertise and capabilities for the
execution of pre-clinical HBOC studies
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the
capability, interest, and experience in conducting complex and
international clinical trials that will facilitate the execution
and completion of a pivotal civilian trauma clinical
trial
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authored the draft clinical protocol
for the clinical trial(s) planned herein titled ( RESUS: Restore
Effective SUrvival in Shock: A pivotal, randomized, controlled,
and open-labeled trial of the hemoglobin based oxygen carrier
(HBOC), bovine polymerized hemoglobin (Hemopure), for the
pre-hospital resuscitation of patients with severe hemorrhagic
shock)
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in
accordance with the U.S. Federal Technology Transfer Act, desires
to make this expertise and technology available for use in the
public and private sectors.
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the
knowhow and capability to manufacture hemoglobin based oxygen
carriers, specifically HBOC-201 (Hemopure)
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expertise in the use of HBOCs
including the the design and execution of twenty two (22) clinical
trials over ten (10) years specifically investigating the use
of HBOCs developed by BIOPURE .
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the
sponsorship and oversight of over 200 laboratory studies to
investigate the pharmacology, physiology and toxicology of
HBOCs
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preclinical data in the use of HBOCs
in resuscitation from hemorrhagic shock
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the
interest, capabilities, and technical expertise to transition for
public use the results of Naval research and
development.
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Page 1
HEMORRHAGIC
SHOCK: Hemorrhage
accounts for the preponderance of potentially salvageable combat
casualty mortalities and is a large contributor to deaths in
civilians where there is a long pre-hospital time frame. It is thus
paramount to maximize resuscitative techniques that address these
injuries. The current standard of care in the field or pre-hospital
setting relies on hemostasis, fluid resuscitation, and evacuation.
Although blood transfusion may be lifesaving, the capability is
costly and sometimes unavailable. A safe and efficacious oxygen
carrying resuscitative fluid that can augment microcirculatory flow
and increase tissue oxygenation is urgently needed to decrease
potentially avoidable fatalities. Hemoglobin based oxygen carriers
(HBOCs) are chemically modified hemoglobin solutions that may be
room temperature stable with a long shelf life, may be free of
communicable pathogens, and have no ABO/Rh or other blood antigens.
Due to their high oxygen and CO 2 carrying capability,
oxygen delivery and tissue oxygenation significantly increase.
Smaller volumes of fluid may be required with these products.
Research suggests that HBOCs are likely to improve cardiovascular
parameters and tissue perfusion, reverse anaerobic metabolism, and
decrease morbidity and mortality. Hemoglobin substitutes are
potentially ideal resuscitative fluids for hemorrhagic shock
casualties.
HEMOPURE: Hemopure Ò is the tradmark for an ultrapure,
bovine-derived, polymerized hemoglobin solution with a hemoglobin
concentration of 13 g/dL and an osmotic pressure similar to whole
blood. The source of bovine hemoglobin is controlled herds with
known origins and medical histories. Hemopure on-loads and
off-loads oxygen and appears safe in animal and human studies.
Hemopure has been utilized in 22 clinical trials, including a Phase
III trial in patients undergoing orthopedic surgery that included
stabilized trauma patients, and the results of some of the other
clinical trials of Hemopure have been published in peer-reviewed
journals.
NOW THEREFORE,
the Collaborators agree as follows.
As
used in this Agreement, the following terms shall have the meanings
defined below, which are equally applicable to both the singular
and plural forms of nouns or any tense of verbs.
1.1
“Agreement” means this Cooperative Research and
Development Agreement (CRADA) with its Appendices.
1.2
“Classified Information” means all Data classified in
accordance with the national security laws of the United
States.
1.3
“Collaborator” means the Navy participant or the
Non-Navy participant represented and bound by the signatories of
this Agreement.
1.4
“Controlled Unclassified Information (CUI)” means
Government Data, Information, or materials provided to or resulting
from this Agreement that may be export controlled, sensitive, for
official use only, or otherwise protected by law, executive order,
or regulation.
1.5
“Cooperative Work” means the tasks performed under this
Agreement as described in the Statement of Work
(Appendix A).
1.6
“Data” means recorded information of any kind
regardless of the form or method of the recording, including
computer software.
Page 2
1.7
“Effective Date” means the date of the last signature
of the Collaborators executing this Agreement.
1.8
“Exclusive License” means the grant by the owner of
Intellectual Property or the exclusive right to make, use, or sell
a patented invention.
1.9
“Government” means the Government of the United States
of America.
1.10
“Government Purpose Rights” means the right of the
Government to use, duplicate, or disclose Data, in whole or in
part, and in any manner, for Government purposes only, and to have
or permit others to do so for Government purposes only. Government
Purpose Rights includes competitive procurement, but does not
include the right to have or permit others to use Data for
commercial purposes.
1.11
“HBOC” means hemoglobin based oxygen
carrier.
1.12
“Information” means all Data, Intellectual Property,
and commercial and financial information. (Chapter 5
Subsection II of Title 5 USC)
1.13
“Intellectual Property” means the property of ideas,
examples of which include, but are not limited to, patents,
trademarks, copyrights, and trade secrets.
1.14
“Invention” means any invention or discovery that is or
may be patentable or otherwise protected under Title 35, United
States Code, or any novel variety of plant that is or may be
patentable under the Plant Variety Protection Act. [15 USC
3703(9)]
1.15
“Invention Disclosure” means the document identifying
and describing to organizational management the Making of an
Invention.
1.16
“Made” when used in conjunction with any Invention
means the conception or first actual reduction to practice of such
Invention. [15 USC 3703(10)]
1.17
“Militarily Critical Technologies (MCT)” means those
technologies identified in the Militarily Critical Technologies
List and under the Export Administration Act of 1979, as
amended.
1.18
“Non-Subject Data” means any Data that are not Subject
Data.
1.19
“Non-Subject Invention” means any Invention that is not
a Subject Invention.
1.20 “Patent
Application” means an application for patent protection for
an Invention with any domestic or foreign patent-issuing
authority.
1.21
“Principal Investigator (PI)” means that person having
the responsibility for the performance of the Cooperative Work on
behalf of a Collaborator.
1.22
“Proprietary Information” means information that
embodies trade secrets developed at private expense or business,
commercial, or financial information that is privileged or
confidential provided that such information:
Page 3
is not known or
available from other sources without obligations concerning its
confidentiality;
has not been
made available by the owners to others without obligation
concerning its confidentiality;
is not already
available to the Government without obligation concerning its
confidentiality; and
has not been
developed independently by persons who have had no access to the
information. (FAR/DFARS Definition)
1.23
“Restricted Access Information” means Subject Data
generated by NMRC that would be Proprietary Information if
the Information had been obtained from a non-Federal Collaborator
participating in a CRADA (15 USC 3710a). Under 15 USC
3710a(c)(7)(B), the Collaborators mutually may agree to provide
appropriate protection to Subject Data generated by NMRC
(Restricted Access Information) against public dissemination or
release under the Freedom of Information Act (FOIA) for a period of
up to five (5) years after development of the
Information.
1.24
“Subject Data” means that Data first recorded in the
performance of the Cooperative Work.
1.25
“Subject Invention” means any Invention Made in the
performance of the Cooperative Work.
1.26
“Tangible Property” means personal or real property
that can be physically touched or held.
1.27
“Unlimited Rights” means the right to use, modify,
reproduce, release, disclose, perform, or display Data or computer
programs in whole or in part, in any manner and for any purpose
whatsoever, and to have or permit others to do so.
To test the
hypothesis that for selected pre-hospital hemorrhagic shock
patients, the use of Hemopure in the resuscitation, stabilization
and management of these patients will provide an appropriate
medical treatment with measurable benefit. To utilize a randomized
and controlled trial in multiple civilian shock trauma centers to
test the safety and efficacy of HBOC and compare it with
“usual care” for the pre-hospital resuscitation of
patients with hemorrhagic shock. Upon successful completion and
confirmation of test hypothesis, the clinical trial is expected to:
(1) transform resuscitative technology; (2) lead to FDA
approval for pre-hospital use; (3) following regulatory
approval, be applicable to trauma care in Tactical Casualty Combat
Care and the En Route Care System, naval vessels, NASA, and
civilian trauma; and (4) lead to procurement and deployment of
Hemopure. It is understood that neither party represents to the
other that these objectives can be met.
Page 4
Article 3.
RESPONSIBILITIES
The
Collaborators shall provide personnel, facilities, and equipment
necessary for, and shall perform, the Cooperative Work.
3.1 NMRC
Personnel and Facilities
The
Cooperative Work done by NMRC will be performed under the
program guidance of Daniel Freilich, CDR, MC, USNR, PI,
NMRC Code 032, who has the responsibility for the scientific
and technical conduct of the Cooperative Work performed within the
facilities of NMRC or done on behalf of NMRC by third
parties in support of this Agreement.
BIOPURE personnel who perform Cooperative Work at
NMRC facilities will be supervised by the BIOPURE
PI.
3.2 BIOPURE
Personnel and Facilities
The
Cooperative Work done by BIOPURE will be performed under the
program guidance of L. Bruce Pearce , Ph.D. who has
the responsibility for the scientific and technical conduct of the
Cooperative Work performed within the facilities of BIOPURE
or done on behalf of BIOPURE by third parties in support of
this Agreement.
NMRC personnel who perform Cooperative Work at
BIOPURE facilities will be supervised by the NMRC
PI.
3.3 Security
Regulations and Directives
Each
Collaborator will abide by the safety and security regulations and
directives of the host facility in which the Cooperative Work is
being performed.
Article 4.
REPRESENTATIONS AND WARRANTIES
4.1 NMRC
’s Representations and Warranties
NMRC hereby warrants and represents to BIOPURE as
follows:
4.1.1
NMRC is a Federal laboratory of the U.S. Department of the
Navy (Navy) as defined by 15 USC 3710a(d)(2)(A) and Department of
Defense Instruction 5535.8, dated May 14, 1999.
4.1.2
The performance of the activities specified by this Agreement is
consistent with the Office of Naval Research’s Future Naval
Capability for “ low volume resuscitation fluids that
inhibit shock”, and “oxygen-carrying blood substitutes
(artificial blood)” and technology transfer missions of
NMRC (15 USC 3710a).
4.1.3
The Department of the Navy official executing this Agreement for
NMRC has the requisite power and authority to enter into
this Agreement and to bind NMRC to perform according to the
terms of this Agreement.
Page 5
4.2 BIOPURE
’s Representations and Warranties
BIOPURE hereby warrants and represents to NMRC as
follows:
4.2.1
BIOPURE is not directly or indirectly controlled by a
foreign company or government [Executive Order 12591,
Section 4 (a)]. BIOPURE , as of the Effective Date of
this Agreement, is a corporation duly organized, validly existing,
and in good standing under the laws of Delaware.
4.2.2
The official executing this Agreement for BIOPURE has the
requisite power and authority to enter into this Agreement and to
bind BIOPURE to perform according to the terms of this
Agreement.
4.2.3
The Board of Directors and stockholders of BIOPURE have
taken all actions required by law, its Certificate of
Incorporation, its bylaws or otherwise, to authorize the execution
and delivery of this Agreement.
4.2.4
The execution and delivery of this Agreement does not contravene
any material provision of, or constitute a material default under,
any agreement binding on BIOPURE . Furthermore, the
execution and delivery of this Agreement does not contravene any
material provision of, or constitute a material default under, any
valid order of any court, or any regulatory agency or other body
having authority to which BIOPURE is subject.
4.2.5
BIOPURE is not presently subject to debarment or suspension
by any agency of the Government. Should BIOPURE be debarred
or suspended during the term of this Agreement or thereafter,
BIOPURE will notify NMRC within thirty (30) days
of receipt of a final notice. NMRC may then elect to
terminate this Agreement and any licenses and options granted under
this Agreement.
4.2.6
BIOPURE is a small business as defined in 15 USC 632 and
implementing regulations (13 CFR 121.101 et seq.) of the
Administrator of the Small Business Administration.
4.3 Joint
Representations
The
Collaborators make the following representations.
4.3.1
There is no express or implied warranty as to any research,
Invention, or product, whether tangible or intangible. In
particular, the Collaborators make no express or implied warranty
as to the merchantability or fitness for a particular purpose of
any research, Invention, or product, whether tangible or
intangible. Likewise, the Collaborators make no express or implied
warranty as to any Cooperative Work, Subject Invention, Subject
Data, or other product resulting from the Cooperative Work. The
Preamble to this Agreement does not constitute or contain
representations or warranties by any Collaborator.
4.3.2
The use and dissemination of Information and materials exchanged
under this Agreement will be in accordance with all U.S. laws and
regulations, including those pertaining to national security and
export control. Nothing in this Agreement shall be construed as a
license to export Information or to permit any disclosure in
violation of law, regulation, or Department of Defense policy. The
exporting Collaborator is responsible for obtaining any export
licenses that may be required by U.S. Federal law.
Page 6
The
ability to carry out the tasks listed in the Statement of Work
(Appendix A) is dependent on the availability of funds.
BIOPURE and NMRC agree to pay for the cooperative
work in accordance with the payment schedule below. The schedule
below is an initial estimate of program costs. Collaborators
understand that the costs of the clinical trial (as defined in
Appendix A) may be altered by requirements set forth by the
FDA and factors that will become clearly evident only after
reviewing data obtained in the course of the trial. In this regard
both parties understand the estimates of cost set forth on the date
of this Agreement are subject to and likely to change. Accordingly,
both parties agree to assist each other to identify and secure
additional funding from other sources (e.g. private investment,
institutional grants and awards, and government funding/awards,
etc.) to complete the clinical trial and final report.
Each
Collaborator will fund the trial in the amounts and at the
approximate times listed in the table below.
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Year 1 FY03
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Year 2 FY04
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Year 3 FY05
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Year 4 FY 06
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Total
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$
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643,125
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$
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3,756,875
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$
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3,756,875
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$
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596,000
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$
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8,752,875
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$
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700,000
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$
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1,500,000
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$
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1,500,000
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$
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300,000
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$
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4,000,000
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Neither
collaborator will charge against its obligations set forth in the
table above any costs for the time of its own personnel. All
amounts shall be applied to payments to third parties and out of
pocket expenditures such as travel and other necessary
disbursements. The Collaborators will cooperate to ensure that
quarterly expenditures are made in the approximate ratios as the
commitments set forth in the table above. For example, NMRC
plans to contract with and pay two full-time clinical research
coordinators and two part time associate investigators (trauma
specialists) to participate in the trial, including training, and
medical monitoring. Consequent BIOPURE will concurrently
fund such other expenses as will cause the Collaborators
expenditures to be in the prescribed ratio.
NMRC and
BIOPURE will share accounting records for the Collaborative
Work on a quarterly basis.
Article 6.
REPORTS AND PUBLICATIONS
The
Collaborators shall regularly share with each other written Data
relating to the Cooperative Work.
Page 7
The
Collaborators shall complete their final report of the results of
the clinical trial within four (4) months of the completion,
termination, or expiration of this Agreement that includes the
results of the clinical trial and a list of all Subject Inventions
Made.
6.3 Agreement to
Confer Prior to Publication or Public Disclosure
The
Collaborators agree to confer and consult prior to any publication
or public disclosure of Subject Data to ensure that no Proprietary
Information, Restricted Access Information, Government Classified
Information, CUI, or MCT Information is released and that patent
rights are not compromised. Prior to any such publication or public
disclosure of Subject Data, each Collaborator shall be offered a
period not less than thirty (30) days and not to exceed sixty
(60) days, unless otherwise mutually agreed in writing by the
Collaborators, to review any proposed abstract, publication,
presentation, or other document for public disclosure that contains
Subject Data. For the purposes of this Article, the term
“disclosure” shall include, but not be limited to,
submission of any manuscript for peer review prior to publication.
It is the responsibility of the Collaborator intending to make
public disclosure of Subject Data to notify the other Collaborator
of such intent.
If
a Collaborator objects to a proposed public disclosure, that
Collaborator must so notify the other Collaborator within thirty
(30) days of the date of notice of intent to disclose
publicly. If no objection is received by the Collaborator intending
to make public disclosure, concurrence is assumed. If a
Collaborator objects on the grounds that patent rights may be
compromised, a Patent Application must be filed by the responsible
Collaborator (as defined in 7.4.4 below) within ninety
(90) days of the date of notification of intent to make public
disclosure, or by another date mutually agreed to by the
Collaborators. If a Collaborator objects to the release of
Information on the grounds that the Information is Proprietary
Information, Restricted Access Information, or Information whose
dissemination is restricted by U.S. securities laws or regulations,
the disclosure shall be postponed until the Information no longer
meets the definitions of Proprietary Information, Restricted Access
Information, or is no longer covered by U.S. securities laws or
regulations.
6.4 Classified
Information
Any
presentation that includes Subject Data that are Classified
Information or otherwise restricted Data must have prior review and
approval by NMRC pursuant to the pertinent securities laws,
regulations, and directives.
Article 7.
INTELLECTUAL PROPERTY
7.1.1
General Provisions Applying to All Data
Each
Collaborator shall have title to all Data generated by that
Collaborator. All clinical trial Data will be deemed to have been
generated by BIOPURE .
Page 8
7.1.1.2
No Implied License
Unless
otherwise specifically provided, the Collaborators agree that the
exchange of Data of any kind does not confer a license to any
Invention claimed in any patent or Patent Application or to the
subject matter of any copyright, trademark/service mark, or other
form of Intellectual Property protection.
7.1.1.3.1
Data Provided With Less Than Unlimited Rights
Each
Collaborator shall mark all Data that it provides with less than
Unlimited Rights with a marking that clearly identifies the limited
rights.
7.1.1.3.2
Data That are Proprietary Information or Restricted Access
Information
BIOPURE shall place a proper proprietary marking on each
medium used for recording Data that BIOPURE delivers to
NMRC under this Agreement that BIOPURE asserts is
Proprietary Information. BIOPURE shall request in writing if
it wishes Subject Data generated by NMRC to be marked as
Restricted Access Information. The Collaborators together shall
confer to determine if such marking is appropriate, with reference
to the Definitions of Article 1. If the Collaborators mutually
agree to the marking then:
(a) For
Non-Subject Data that are Proprietary Information, the marking
shall read:
“PROPRIETARY INFORMATION OF
BIOPURE–NMRC MAY USE ONLY FOR PURPOSE OF CRADA NUMBER
“NCRADA- NMRC -03-1497”;
(b) For
Subject Data that are Proprietary Information, the marking shall
read:
“PROPRIETARY INFORMATION OF BIOPURE
–GOVERNMENT HAS GOVERNMENT PURPOSE RIGHTS UNDER CRADA NUMBER
“NCRADA- NMRC -03-1497”;
(c) For
Data that are Restricted Access Information, the marking shall
read:
“RESTRICTED ACCESS INFORMATION –
PROTECT IN ACCORDANCE WITH CRADA NUMBER
“NCRADA-NMRC-03-1497” UNTIL [INSERT DATE: NOT TO EXCEED
FIVE (5) YEARS FROM THE GENERATION OF A RESTRICTED ACCESS
INFORMATION DOCUMENT]”.
7.1.1.3.3
Data That are Subject to 35 USC 205
NMRC shall mark Data it provides under this Agreement that
disclose one or more Inventions in which the Government owns or may
own a right, title or interest, and that are subject to
confidentiality under 35 USC 205. Such Data shall be
marked:
“NMRC DATA PROTECTED FROM RELEASE OR DISCLOSURE UNDER
35 USC 205. ”
Page 9
7.1.1.3.4
Data That are Classified Information, CUI, MCT, or Otherwise
Restricted
Each
Collaborator shall mark all Data that are Classified Information,
CUI, MCT, or otherwise restricted by U.S. security or export
control laws or regulations that it provides under this
Agreement.
7.1.1.4
Protection of Data
Except
for the rights granted in Article 7.1.2.2, Data shall be
protected in accordance with the proper markings of its owner and
as provided by, at a minimum, the requirements of 15 USC 3710a.
Proprietary Information will be protected only if it is properly
marked as such. Information provided in intangible form that is
Proprietary Information must be designated Proprietary Information
at the time it is delivered, followed within fifteen (15) days
by a writing summarizing the exact Information to be protected. The
Collaborator receiving Information in an intangible form that is
designated as Proprietary Information shall be responsible for
protecting the Information as Proprietary Information during the
fifteen (15) day notification period. After the fifteen
(15) day period, if no written summary has been received, the
receiving Collaborator need not continue to protect the Information
received in intangible form.
Restricted
Access Information shall be protected from public dissemination for
up to five (5) years, as mutually agreed.
Classified
Information, CUI, MCT, or otherwise restricted Information shall be
protected in accordance with the security laws of the United
States.
7.1.1.5
Release of Data Under the Freedom of Information Act
Data
in the possession of NMRC that are not marked CUI,
Proprietary Information of BIOPURE or Restricted Access
Information must be released by NMRC where such release is
required pursuant to a request under the Freedom of Information Act
(FOIA) (5 USC 552). NMRC shall protect Data that are
properly marked CUI, Proprietary Information of BIOPURE or
Restricted Access Information from release under the FOIA for as
long as the marked Data meet the definition of CUI, Proprietary
Information or Restricted Access Information. Prior to release of
any such Data , NMRC shall promptly notify BIOPURE of
any request for Data of BIOPURE regardless of whether the
requested Data are marked Proprietary Information.
7.1.2.1
Delivery of Requested Subject Data
Each
Collaborator shall have the right to review and receive delivery of
all Subject Data generated by the other Collaborator. Requested
Subject Data shall be delivered to the requesting Collaborator
within fifteen (15) days of the request.
7.1.2.2
Rights in Subject Data
Except
as represented in Article 4.3.2, the Collaborators shall have
Unlimited Rights in all Subject Data that are not Proprietary
Information or Restricted
Page 10
Access
Information. Notwithstanding 15 USC 3710a, BIOPURE grants
Government Purpose Rights in any Subject Data furnished by
BIOPURE to NMRC under this Agreement that are
properly marked as Proprietary Information. The Government has
Government Purpose Rights in Subject Data that are Restricted
Access Information.
7.1.3
Rights in Non-Subject Data
The
Collaborators shall have Unlimited Rights in any Non-Subject Data
delivered under this Agreement that are not Proprietary
Information.
NMRC has a limited right to use, reproduce, and disclose
only to Government employees for use in support of the Cooperative
Work any Non-Subject Data that are properly marked as Proprietary
Information and are provided by BIOPURE under this
Agreement. Such Proprietary Information can be used only for the
purpose of performing the Cooperative Work unless consent to other
use or disclosure is obtained from BIOPURE in
writing.
BIOPURE shall have a limited right to use, reproduce, or
disclose Non-Subject Data that may describe one or more Inventions
in which the Government owns or may own a right, title or interest,
if such Non-Subject Data are provided by NMRC under this
Agreement. In accordance with 35 USC 205, such Non-Subject Data are
to be held in confidence. Such Non-Subject Data shall be properly
marked by NMRC and the limited rights of BIOPURE
shall be defined by a separate non-disclosure agreement.
7.2.1
Copyright by BIOPURE
BIOPURE may copyright works of authorship prepared pursuant
to this Agreement if eligible for copyright protection under Title
17 USC.
7.2.2
Copyright License to the Government
BIOPURE grants to the Government a nonexclusive,
irrevocable, paid-up license in copyrighted works of authorship,
including software (17 USC 106) prepared pursuant to this Agreement
for any purpose, consistent with the rights in Data described in
Article 7.1.
7.2.3
Copyright Statement
BIOPURE shall include the following statement on any text,
drawing, mask work or other work of authorship, that may be
copyrighted under 17 USC, that is created in the performance of
this Agreement:
“The U.S.
Government has a copyright license in this work pursuant to a
Cooperative Research and Development Agreement with Navy Medical
Research Center .”
7.3 Trademarks and
Service Marks
7.3.1
Ownership of Trademarks and Service Marks
Page 11
The
Collaborator first establishing a trademark or service mark for
goods or services with which the mark is used shall be considered
the owner of the mark.
7.3.2
Obligation of Employees to Report Trademarks and Service
Marks
Employees
of both Collaborators shall report the adoption of a trademark or
service mark associated with the Cooperative Work to their employer
within thirty (30) days of the first use of the mark. Use
includes internal use of any product or service of the Cooperative
Work.
7.3.3
Obligation of Collaborators to Notify Each Other
Each
Collaborator shall notify the other Collaborator within thirty
(30) days of their employee’s report of the first use of
a trademark or service mark.
7.3.4
Responsibility for Filing an Application for Trademark or Service
Mark
The
Collaborator owning a trademark or service mark shall establish the
use of the mark in intra- and interstate commerce and shall be
responsible for filing all applications for trademark or service
mark registration as appropriate.
7.3.5
License to Use Trademark or Service Mark
The
Collaborator owning the trademark or service mark as defined in
Article 7.3.1, shall grant a paid-up, irrevocable,
nonexclusive license to the other Collaborator for use of the
trademark or service mark on the goods or services for which the
mark is intended to be used.
7.4.1.1
Obligation to Report Subject Inventions
7.4.1.2
Collaborators’ Instructions to Employees
Each
Collaborator shall instruct its employees to submit an Invention
Disclosure to that Collaborator for all innovations, solutions to
technical problems, or unique increases to the general body of
knowledge resulting from the Cooperative Work. For the purposes of
this Article, these innovations, solutions, and increases to
knowledge shall be deemed Inventions.
7.4.1.2
Timely Invention Disclosure by Inventors
Within
ninety (90) days of Making an Invention resulting from the
Cooperative Work, unless a shorter time period is required by
circumstances, the inventor(s) shall submit an Invention Disclosure
to their employer.
In
the case of an Invention Made jointly by inventors from both
Collaborators, the inventors shall submit an Invention Disclosure
with their respective employer.
7.4.1.3
Obligation to Provide Invention Disclosures to the Other
Collaborator
Page 12
Each
Collaborator shall provide the other Collaborator with a copy of
each Invention Disclosure reporting a Subject Invention within
sixty (60) days of receiving the Invention Disclosure from its
inventor(s).
7.4.2
Determination of Subject Inventions
The
Collaborators shall review each Invention Disclosure resulting from
the Cooperative Work and shall confer and consult to determine
whether an Invention Disclosure represents a Subject
Invention.
7.4.3
Title to and Ownership of Subject Inventions
Each
Collaborator shall be entitled to own the Subject Inventions of its
employees. Each Collaborator shall cooperate with the other
Collaborator to obtain inventor signatures on Patent Applications,
assignments or other documents required to secure Intellectual
Property protection. For any Invention Made jointly by employees of
the Collaborators, each Collaborator shall have ownership of the
Subject Invention in the form of an undivided interest.
7.4.4
Filing of Patent Applications
7.4.4.1
Filing of Patent Applications on Solely Made Inventions
Each
Collaborator has primary responsibility for filing Patent
Applications on the Subject Inventions of its
employee(s).
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