Back to top

NAVY COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT BETWEEN NMRC AND BIOPURE CORPORATION

Research and Development Agreement

NAVY COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT BETWEEN NMRC AND BIOPURE CORPORATION | Document Parties: NAVY COOPERATIVE | NMRC AND BIOPURE CORPORATION You are currently viewing:
This Research and Development Agreement involves

NAVY COOPERATIVE | NMRC AND BIOPURE CORPORATION

. RealDealDocs™ contains millions of easily searchable legal documents and clauses from top law firms. Search for free - click here.
Title: NAVY COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT BETWEEN NMRC AND BIOPURE CORPORATION
Date: 10/5/2005
Industry: Biotechnology and Drugs     Sector: Healthcare

NAVY COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT BETWEEN NMRC AND BIOPURE CORPORATION, Parties: navy cooperative , nmrc and biopure corporation
50 of the Top 250 law firms use our Products every day
 

NAVY COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT

BETWEEN

NMRC AND BIOPURE CORPORATION

AGREEMENT TITLE: Restore Effective SUrvival in Shock (RESUS)

AGREEMENT NUMBER: NCRADA- NMRC– 03 – 1497

AGREEMENT ADMINISTRATORS:

 

 

 

NMRC

 

 

Technology Transfer Office:

 

Dr. Charles Schlagel

 

 

Director, Office of Technology Transfer

 

 

Naval Medical Research Center

 

 

Silver Spring, MD 20910-7500

 

 

Tel: 301-319-7428, Fax: 301-319-7432

 

 

 

Principal Investigator:

 

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

 

 

 

BIOPURE CORPORATION

 

 

Preferred Contact:

 

L. Bruce Pearce, Ph.D

 

 

Director

 

 

Pharmacology & Physiology

 

 

Biopure Corporation

 

 

11 Hurley Street

 

 

Cambridge, MA 02141

 

 

Tel: 617-234-6535, Fax: 617-234-6850

 

 

 

Legal Counsel:

 

 

 

 

Jane Kober
Senior Vice President
General Counsel, Secretary
Biopure Corporation
11 Hurley Street
Cambridge, MA 02141
Tel: 617-234-6511, Fax: 617-234-6507

 

 

 

Principal Investigator:

 

L. Bruce Pearce, Ph.D

 

 

Director

 

 

Pharmacology & Physiology

 

 

Biopure Corporation

 

 

11 Hurley street

 

 

Cambridge, MA 02141

 

 

Tel: 617-234-6535, Fax: 617-234-6850

i


 

TABLE OF CONTENTS

PREAMBLE

 

 

 

Article 1.

 

DEFINITIONS

1.1  

 

“Agreement”

1.2  

 

“Classified Information”

1.3  

 

“Collaborator”

1.4  

 

“Controlled Unclassified Information (CUI)”

1.5  

 

“Cooperative Work”

1.6  

 

“Data”

1.7  

 

“Effective Date”

1.8  

 

“Exclusive License”

1.9  

 

“Government”

1.10

 

“Government Purpose Rights”

1.11

 

“HBOC”

1.12

 

“Information”

1.13

 

“Intellectual Property”

1.14

 

“Invention”

1.15

 

“Invention Disclosure”

1.16

 

“Made”

1.17

 

“Militarily Critical Technologies (MCT)”

1.18

 

“Non-Subject Data”

1.19

 

“Non-Subject Invention”

1.20

 

“Patent Application”

1.21

 

“Principal Investigator (PI)”

1.22

 

“Proprietary Information”

1.23

 

“Restricted Access Information”

1.24

 

“Subject Data”

1.25

 

“Subject Invention”

1.26

 

“Tangible Property”

1.27

 

“Unlimited Rights”

 

 

 

Article 2.

 

OBJECTIVES

 

 

 

Article 3.

 

RESPONSIBILITIES

 

 

 

3.1  

 

NMRC Personnel and Facilities

3.2  

 

BIOPURE Personnel and Facilities

3.3  

 

Security Regulations and Directives

 

 

 

Article 4.

 

REPRESENTATIONS AND WARRANTIES

 

 

 

4.1

 

NMRC’s Representations and Warranties

4.2

 

BIOPURE’s Representations and Warranties

4.3

 

Joint Representations

ii


 

 

 

 

 

 

 

 

 

 

Article 5.

 

FUNDING

 

 

 

 

 

 

 

 

 

5.1

 

Payment Schedule

5.2

 

Accounting Records

 

 

 

 

 

 

 

 

 

Article 6.

 

REPORTS AND PUBLICATIONS

 

 

 

 

 

 

 

 

 

6.1

 

Interim Reports

6.2

 

Final Reports

6.3

 

Agreement to Confer Prior to Publication or Public Disclosure

6.4

 

Classified Information

 

 

 

 

 

 

 

 

 

Article 7.

 

INTELLECTUAL PROPERTY

 

 

 

 

 

 

 

 

 

7.1

 

Data

 

 

7.1.1

 

General Provisions Applying to All Data

 

 

 

 

7.1.1.1

 

Ownership

 

 

 

 

7.1.1.2

 

No Implied License

 

 

 

 

7.1.1.3

 

Marking of Data

 

 

 

 

 

 

7.1.1.3.1

 

Data Provided With Less Than Unlimited Rights

 

 

 

 

 

 

7.1.1.3.2

 

Data That are Proprietary Information or Restricted Access Information

 

 

 

 

 

 

7.1.1.3.3

 

Data That are Subject to 35 USC 205

 

 

 

 

 

 

7.1.1.3.4

 

Data That are Classified Information, CUI, MCT, or Otherwise Restricted

 

 

 

 

7.1.1.4

 

Protection of Data

 

 

 

 

7.1.1.5

 

Release of Data Under the Freedom of Information Act

 

 

7.1.2

 

Subject Data

 

 

 

 

7.1.2.1

 

Delivery of Requested Subject Data

 

 

 

 

7.1.2.2

 

Rights in Subject Data

 

 

7.1.3

 

Rights in Non-Subject Data

7.2

 

Copyrights

 

 

7.2.1

 

Copyright by BIOPURE

 

 

7.2.2

 

Copyright License to the Government

 

 

7.2.3

 

Copyright Statement

7.3

 

Trademarks and Service Marks

 

 

7.3.1

 

Ownership of Trademarks and Service Marks

 

 

7.3.2

 

Obligation of Employees to Report Trademarks and Service Marks

 

 

7.3.3

 

Obligation of Collaborators to Notify Each Other

 

 

7.3.4

 

Responsibility for Filing an Application for Trademark or Service Mark

 

 

7.3.5

 

License to Use Trademark or Service Mark

7.4

 

Subject Inventions

 

 

7.4.1

 

Obligation to Report Subject Inventions

 

 

 

 

7.4.1.1

 

Collaborators’ Instruction to Employees

 

 

 

 

7.4.1.2

 

Timely Invention Disclosure by Inventors

 

 

 

 

7.4.1.3

 

Obligation to Provide Invention Disclosures to the Other Collaborator

 

 

7.4.2

 

Determination of Subject Inventions

 

 

7.4.3

 

Title to and Ownership of Subject Inventions

 

 

7.4.4

 

Filing of Patent Applications

 

 

 

 

7.4.4.1

 

Filing of Patent Applications on Solely Made Inventions

 

 

 

 

7.4.4.2

 

Filing of Patent Applications on Jointly Made Inventions

iii


 

 

 

 

 

 

 

 

 

 

 

 

 

 

7.4.4.3

 

Preserving Intellectual Property Rights

 

 

 

 

7.4.4.4

 

Filing Deadlines

 

 

 

 

7.4.4.5

 

Copies and Inspection

 

 

 

 

 

 

7.4.4.5.1

 

Copies of Prosecution Papers

 

 

 

 

 

 

7.4.4.5.2

 

Access to Patent Application File and Right to Make Copies

 

 

 

 

7.4.4.6

 

Rights of Inventors if the Collaborators Decline to File a Patent Application

 

 

7.4.5

 

Nonexclusive License to Subject Inventions

 

 

 

 

7.4.5.1

 

Nonexclusive License Grant

 

 

 

 

7.4.5.2

 

Confirmatory Nonexclusive License Agreement

 

 

7.4.6

 

Option for Exclusive License to Subject Inventions

 

 

7.4.7

 

Limitation on Assignment of Licenses Granted Under This Agreement

 

 

7.4.8

 

Termination of License Granted and Cancellation of Exclusive License Option to Subject Inventions

 

 

 

 

7.4.8.1

 

Exclusive Licenses and Exclusive License Option

 

 

 

 

7.4.8.2

 

Nonexclusive Licenses

7.5

 

Non-Subject Inventions

 

 

7.5.1

 

Ownership of Non-Subject Inventions

 

 

7.5.2

 

Rights Under Other Agreements

 

 

7.5.3

 

No License to Non-Subject Inventions

7.6

 

Research License

 

 

 

 

 

 

 

 

 

Article 8.

 

TANGIBLE PROPERTY

 

 

 

 

 

 

 

 

 

8.1

 

Title to Preexisting Tangible Property

8.2

 

Tangible Property Purchased by Collaborators to Perform the Cooperative Work

8.3

 

Title to Developed Tangible Property

8.4

 

Tangible Property Operational and Disposition Costs

8.5

 

Disposal of Tangible Property

 

 

 

 

 

 

 

 

 

Article 9.

 

LIABILITY

 

 

 

 

 

 

 

 

 

9.1

 

Extent of Government Liability

9.2

 

Extent of BIOPURE Liability

9.3

 

Force Majeure

 

 

 

 

 

 

 

 

 

Article 10.

 

GENERAL PROVISIONS

 

 

 

 

 

 

 

 

 

10.1

 

Characteristics of the Agreement

 

 

10.1.1

 

Entire Agreement

 

 

10.1.2

 

Severability

 

 

10.1.3

 

Interpretation of Headings

10.2

 

Agreement Between Collaborators

 

 

10.2.1

 

Governing Laws

 

 

10.2.2

 

Independent Parties/Entities

 

 

10.2.3

 

Assignment /Subcontracting

 

 

 

 

10.2.3.1

 

Third Parties

 

 

 

 

10.2.3.2

 

Nontransfer

 

 

 

 

10.2.3.3

 

Foreign Interference

iv


 

 

 

 

 

 

 

 

 

 

 

 

10.2.4

 

Disputes

 

 

 

 

10.2.4.1

 

Settlement and Resolution

 

 

 

 

10.2.4.2

 

Continuation of Cooperative Work

 

 

10.2.5

 

Waivers

 

 

10.2.6

 

Use of Name or Endorsements

10.3

 

Environment, Safety, and Health

10.4

 

Public Release of This Agreement

 

 

 

 

 

 

 

 

 

Article 11.

 

MODIFICATIONS AND NOTICES

 

 

 

 

 

 

 

 

 

11.1

 

Amendments

11.2

 

Termination

 

 

11.2.1

 

Termination by Mutual Consent

 

 

11.2.2

 

Unilateral Termination

11.3

 

Notices

 

 

 

 

 

 

 

 

 

Article 12.

 

SURVIVING PROVISIONS

 

 

 

 

 

 

 

 

 

Article 13.

 

DURATION

 

 

 

 

 

 

 

 

 

Article 14.

 

SIGNATURES

 

 

 

 

 

 

 

 

 

Appendix A

 

Statement of Work

 

 

 

 

 

 

 

 

 

Appendix B

 

Confirmatory License Agreement

 

 

 

 

 

 

 

 

 

Appendix C

 

Third Party Agreements

v


 

NAVY COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT

BETWEEN

NMRC

AND

BIOPURE CORPORATION

PREAMBLE

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.

NMRC has:

 

expertise and capabilities for the execution of pre-clinical HBOC studies

 

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

 

 

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)

 

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.

BIOPURE has:

 

the knowhow and capability to manufacture hemoglobin based oxygen carriers, specifically HBOC-201 (Hemopure)

 

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 .

 

 

the sponsorship and oversight of over 200 laboratory studies to investigate the pharmacology, physiology and toxicology of HBOCs

 

preclinical data in the use of HBOCs in resuscitation from hemorrhagic shock

 

 

the interest, capabilities, and technical expertise to transition for public use the results of Naval research and development.

Page 1


 

BACKGROUND:

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.

Article 1. DEFINITIONS

          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.

Article 2. OBJECTIVES

     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


 

Article 5. FUNDING

     5.1 Payment Schedule

          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.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Year 1 FY03

 

 

Year 2 FY04

 

 

Year 3 FY05

 

 

Year 4 FY 06

 

 

Total

 

Biopure

 

$

643,125

 

 

$

3,756,875

 

 

$

3,756,875

 

 

$

596,000

 

 

$

8,752,875

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NMRC

 

$

700,000

 

 

$

1,500,000

 

 

$

1,500,000

 

 

$

300,000

 

 

$

4,000,000

 

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.

     5.2 Accounting Records

      NMRC and BIOPURE will share accounting records for the Collaborative Work on a quarterly basis.

Article 6. REPORTS AND PUBLICATIONS

     6.1 Interim Reports

The Collaborators shall regularly share with each other written Data relating to the Cooperative Work.

Page 7


 

     6.2 Final Reports

          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 Data

          7.1.1 General Provisions Applying to All Data

                    7.1.1.1 Ownership

                         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 Marking of Data

                         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 Subject Data

                    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 Copyrights

          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 Subject Inventions

               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).

             &nbs


 
SITE SEARCH

AGREEMENTS / CONTRACTS

Document Title:

Entire Document: (optional)

Governing Law:(optional)


Try our advanced search >>
 

CLAUSES

Search Contract Clauses >>

Browse Contract Clause Library>>

Get Email Updates
Email:
This is only a partial view of this document. We have millions of legal documents and clauses drafted by top law firms. learn more search for free browse for free learn more