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Contract Research Agreement

Contract Research Agreement Template for United States

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Key Requirements PROMPT example:

Contract Research Agreement

"I need a Contract Research Agreement for a pharmaceutical company sponsoring a 12-month clinical trial study at a university research center, starting March 2025, with specific provisions for data sharing and publication rights."

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Document background
The Contract Research Agreement serves as a critical legal framework for organizations engaging in commissioned research activities within the United States. This document is essential when a company, institution, or agency wants to outsource research activities while maintaining control over the process and results. It addresses key aspects such as research methodology, data ownership, confidentiality, regulatory compliance, and risk allocation. The agreement is particularly important in regulated industries where research must comply with federal guidelines, such as FDA requirements or NIH standards.
Suggested Sections

1. Parties: Identification and details of the contracting parties

2. Background: Context of the research agreement and relationship between parties

3. Definitions: Key terms used throughout the agreement

4. Scope of Work: Detailed description of research to be conducted

5. Timeline and Deliverables: Project milestones and expected outputs

6. Payment Terms: Financial arrangements and payment schedule

7. Intellectual Property Rights: Ownership and usage rights of research outputs

8. Term and Termination: Duration of agreement and conditions for early termination

9. Governing Law: Jurisdiction and applicable laws governing the agreement

Optional Sections

1. Confidentiality: Terms for handling sensitive information and trade secrets

2. Export Control: Compliance with ITAR and EAR regulations for controlled technologies

3. Publication Rights: Terms and conditions for publishing research results

4. Force Majeure: Provisions for unforeseen circumstances affecting research performance

5. Insurance and Indemnification: Requirements for insurance coverage and liability provisions

Suggested Schedules

1. Schedule A - Research Protocol: Detailed methodology and procedures for conducting the research

2. Schedule B - Budget Breakdown: Detailed cost structure and financial allocation

3. Schedule C - Personnel Schedule: List of key researchers and their responsibilities

4. Schedule D - Equipment Schedule: Inventory of equipment to be used or purchased

5. Schedule E - Data Management Plan: Procedures for data collection, storage, and sharing

Authors

Alex Denne

Head of Growth (Open Source Law) @ tiktok³ÉÈË°æ | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

alex.den.21@genieai.co
Clauses




























Industries

Intellectual Property Laws: Key federal statutes including Patent Act (35 U.S.C.), Copyright Act (17 U.S.C.), Trade Secrets Act, and Bayh-Dole Act for federally funded research

Research-Specific Regulations: Common Rule (45 CFR 46) for human subject research, FDA regulations, NIH Guidelines for federal funding, and HIPAA for medical/health data

Data Protection and Privacy: State-specific privacy laws, GDPR compliance considerations for EU data/subjects, and general data security regulations

Employment Laws: Fair Labor Standards Act, state employment laws, non-compete regulations, and worker classification rules

Contract Law: Uniform Commercial Code, state-specific contract laws, and Statute of Frauds requirements

Export Control Laws: International Traffic in Arms Regulations (ITAR) and Export Administration Regulations (EAR)

Industry-Specific Regulations: GMP/GLP requirements, environmental regulations, and industry-specific safety standards

Antitrust Laws: Sherman Act, Clayton Act, and Federal Trade Commission Act governing competition and market behavior

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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