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Biological Material Transfer Agreement Template for United States

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Key Requirements PROMPT example:

Biological Material Transfer Agreement

"I need a Biological Material Transfer Agreement for transferring cell lines from our university lab to a pharmaceutical company for research purposes, with strict confidentiality provisions and restrictions on commercial use until January 2025."

Document background
The Biological Material Transfer Agreement is essential when transferring biological materials between organizations for research, development, or commercial purposes in the United States. This document becomes necessary when sharing cell lines, plasmids, antibodies, transgenic animals, or other biological materials. It establishes clear guidelines for material usage, intellectual property rights, and regulatory compliance while protecting both provider and recipient interests. The agreement incorporates federal requirements from NIH, CDC, and other regulatory bodies, ensuring proper handling, safety protocols, and legal compliance in material transfer and usage.
Suggested Sections

1. Parties: Identifies the provider and recipient institutions, including full legal names and addresses

2. Background: Explains the context of the transfer and the purpose of the agreement

3. Definitions: Defines key terms including 'Material', 'Modifications', 'Commercial Purposes', and 'Derivative Material'

4. Material Transfer Terms: Specifies the biological material being transferred and conditions of transfer

5. Use Restrictions: Defines permitted and prohibited uses of the material

6. Compliance Requirements: Outlines regulatory compliance obligations and safety requirements

7. Intellectual Property Rights: Addresses ownership of materials and any resulting discoveries

8. Confidentiality: Specifies confidentiality obligations regarding the material and related information

9. Term and Termination: Defines agreement duration and termination conditions

Optional Sections

1. Publication Rights: Addresses rights to publish research results - include when material will be used in academic research

2. Commercial Use Provisions: Specifies terms for any commercial applications - include when commercial use might be contemplated

3. Cost Recovery: Details any fees associated with the transfer - include when provider charges for material preparation/shipping

4. Export Control: Addresses export control compliance - include when material crosses international borders

Suggested Schedules

1. Schedule A - Material Description: Detailed description of the biological material being transferred

2. Schedule B - Safety Data Sheet: Safety information and handling requirements

3. Schedule C - Transfer Protocols: Specific protocols for material handling and transfer

4. Schedule D - Required Permits: Copies of relevant permits and authorizations

5. Schedule E - Fee Schedule: Details of any applicable fees and payment terms

Authors

Alex Denne

Head of Growth (Open Source Law) @ tiktok³ÉÈ˰æ | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

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Industries

NIH Guidelines: National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules - Essential for any MTA involving genetic material or modified organisms

CDC Select Agent Regulations: 42 CFR Part 73 - Regulations governing the possession, use, and transfer of select agents and toxins that could pose a severe threat to public health and safety

USDA Biological Agent Regulations: Regulations specific to agricultural biological materials, including plant and animal pathogens

Export Control Regulations: EAR and ITAR regulations controlling the export of biological materials and related technical data to foreign countries

BMBL Guidelines: Biosafety in Microbiological and Biomedical Laboratories guidelines - Standard practices for safe handling of biological materials

USA PATRIOT Act: Regulations regarding security measures and restricted parties in biological material transfers

Bioterrorism Preparedness Act: Public Health Security and Bioterrorism Preparedness and Response Act - Requirements for security and tracking of biological agents

Patent Act: 35 U.S.C. - Federal patent law governing intellectual property rights related to biological materials and inventions

Bayh-Dole Act: Regulations governing intellectual property rights in federally funded research and development

NEPA: National Environmental Policy Act - Environmental impact considerations for biological material handling and disposal

Common Rule: 45 CFR Part 46 - Regulations for protection of human subjects in research, relevant if materials are derived from human subjects

HIPAA: Health Insurance Portability and Accountability Act - Privacy requirements for human-derived materials and associated data

State Biosafety Regulations: Varying state-specific requirements for handling and transfer of biological materials

Nagoya Protocol: International agreement on access to genetic resources and fair sharing of benefits from their utilization

Convention on Biological Diversity: International treaty governing the conservation and sustainable use of biological resources

Cartagena Protocol: International agreement on safe handling, transport, and use of living modified organisms

Teams

Employer, Employee, Start Date, Job Title, Department, Location, Probationary Period, Notice Period, Salary, Overtime, Vacation Pay, Statutory Holidays, Benefits, Bonus, Expenses, Working Hours, Rest Breaks,  Leaves of Absence, Confidentiality, Intellectual Property, Non-Solicitation, Non-Competition, Code of Conduct, Termination,  Severance Pay, Governing Law, Entire Agreemen

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