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Contract Research Agreement

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Agreement for the Exploitation of a Secret Process with Option to Purchase Process

Agreement made on the , between (Name of Owner), a corporation organized and existing under the laws of the state of , with its principal office located at , referred to herein as Owner, and (Name of Manufacturer), a corporation organized and existing under the laws of the state of , with its principal office located at , referred to herein as Manufacturer.

Whereas, Owner has the exclusive knowledge, possession, and ownership of certain inventions, formulas, and processes, hereinafter called the Process, which Process may be generally described as ;

Owner has used the Process in making on a limited scale; and

Whereas, Manufacturer desires to manufacture and sell in profitable quantities, but it cannot do so without first obtaining the right to use the Process; and

Whereas, Owner is willing to grant such rights as Manufacturer requires on the terms set forth in this Agreement;

Now, therefore, for and in consideration of the mutual covenants contained in this agreement, and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties agree as follows:

1. Use of Process

Owner grants to Manufacturer the exclusive right to use the Process in the manufacture of and such other products as the parties may agree on from time to time. Owner will fully instruct and advise employees of Manufacturer in all aspects of the Process and in the practical application and use of the Process. From now on, Owner will devote to improvement and further development of the Process such time and effort as may be necessary for maximum feasible exploitation of the Process.

2. Warranty of Owner

Owner covenants and warrants that at no time previously has he imparted to anyone any part of the Process, that no person now has any knowledge obtained through Owner in regard to the same, and that he will at all times preserve the secrecy of the same.

3. Royalties

As consideration for the rights granted under this Agreement, Manufacturer will pay to Owner royalties according to the following schedule:

A. For an initial period ending (end date of period), % of the net selling price of all and other products manufactured and sold pursuant to this Agreement;

B. After said initial period, % of the net selling price of all and other products manufactured and sold pursuant to this Agreement.

C. Accrued royalties shall be paid on the day of each month. For purposes of this Agreement, net selling price means . Regardless of output and sales, the minimum royalty payable to Owner during the term of this Agreement shall be $ per month.

4. Best Efforts

Manufacturer shall begin manufacture and sale of , and such other products as are agreed on, without undue delay. It will devote its best efforts to establishing and expanding a market for the various products manufactured pursuant to this Agreement.

5. Accounting

Manufacturer shall keep complete and accurate records of all transactions relative to products manufactured and sold pursuant to this Agreement, and shall render statements to Owner on request. For the purpose of verifying such statements, Owner shall have the right to examine the books and records of Manufacturer relative to the transactions. Such examinations may be made at any time during regular business hours.

6. Option to Purchase Process

At any time within days from the date of this Agreement, Manufacturer shall have the right to purchase all rights of Owner in and to the Process. The purchase price shall be $. If Manufacturer elects to exercise the option, it shall give written notice to Owner, which notice shall designate a date, not later than the date set forth above, for effecting the transfer and paying the purchase price.

7. Owner’s Covenant not to Compete

As long as this Agreement is in force, Owner will not engage in any manner in the manufacture of products the same as or essentially similar to products manufactured and sold by Manufacturer pursuant to this Agreement, and Owner will not engage in any other enterprise that would tend to reduce the value of the Process or the rights granted under this Agreement.

8. Duration of Agreement and Termination

This Agreement shall continue in force until (date), unless, prior to that date, it becomes economically unfeasible to continue production of products through use of the Process. In the latter event, the Agreement will terminate on a date to be agreed on by the parties. For purposes of this Section 8, continuation of production will be economically unfeasible if and when . At the end of the initial term, the Agreement may be extended by mutual agreement of the parties. If either party elects not to extend the term, the Agreement will terminate on the above-mentioned date.

9. Liquidated Damages upon Breach

If either party defaults in performance required of the party under this Agreement, the other party shall be entitled to receive $ as liquidated damages from the defaulting party. Before either party may recover this sum, the other party shall have been given written notice of default or alleged default and a day period in which to remedy such default or alleged default.

10. Severability

The invalidity of any portion of this Agreement will not and shall not be deemed to affect the validity of any other provision. If any provision of this Agreement is held to be invalid, the parties agree that the remaining provisions shall be deemed to be in full force and effect as if they had been executed by both parties subsequent to the expungement of the invalid provision.

11. No Waiver

The failure of either party to this Agreement to insist upon the performance of any of the terms and conditions of this Agreement, or the waiver of any breach of any of the terms and conditions of this Agreement, shall not be construed as subsequently waiving any such terms and conditions, but the same shall continue and remain in full force and effect as if no such forbearance or waiver had occurred.

12. Governing Law

This Agreement shall be governed by, construed, and enforced in accordance with the laws of the State of .

13. Notices

Any notice provided for or concerning this Agreement shall be in writing and shall be deemed sufficiently given when sent by certified mail if sent to the respective address of each party as set forth at the beginning of this Agreement.

14. Attorney’s Fees

In the event that any lawsuit is filed in relation to this Agreement, the unsuccessful party in the action shall pay to the successful party, in addition to all the sums that either party may be called on to pay, a reasonable sum for the successful party's attorney fees.

15. Entire Agreement

This Agreement shall constitute the entire agreement between the parties and any prior understanding or representation of any kind preceding the date of this Agreement shall not be binding upon either party except to the extent incorporated in this Agreement.

16. Modification of Agreement

Any modification of this Agreement or additional obligation assumed by either party in connection with this Agreement shall be binding only if placed in writing and signed by each party or an authorized representative of each party.

17. Assignment of Rights

The rights of each party under this Agreement are personal to that party and may not be assigned or transferred to any other person, firm, corporation, or other entity without the prior, express, and written consent of the other party.

18. In this contract, any reference to a party includes that party's heirs, executors, administrators, successors and assigns, singular includes plural and masculine includes feminine.

WITNESS our signatures as of the day and date first above stated.

By:

By:

Enter text✕

What a Contract Research Agreement Is and when it applies

A Contract Research Agreement (CRA) is a written contract between a sponsor and a contract research organization (CRO) or research institution that defines the scope, deliverables, timelines, payments, intellectual property rights, confidentiality, and regulatory responsibilities for a research project. CRAs allocate risk, set milestone payments and acceptance criteria, and require compliance with applicable laws and standards for data protection and human-subjects research where relevant. Typical users include pharmaceutical sponsors, academic research centers, medical device companies, and clinical trial service providers, all of whom rely on clear allocation of rights and obligations to reduce disputes.

Why a clear CRA matters for research projects

A well-drafted CRA clarifies expectations, protects confidential and regulated data, preserves intellectual property, and sets measurable deliverables and payment triggers to reduce project disputes and regulatory exposure.

Why a clear CRA matters for research projects

Typical parties who prepare or sign a CRA

The Contract Research Agreement is used across organizations that fund, perform, or oversee research. Use this section to locate the role most like yours.

  • Sponsors and Clinical Operations teams — pharmaceutical or biotech companies that commission studies and control study design, funding, and IP strategy for the project.
  • Contract Research Organizations and Principal Investigators — entities contracted to perform the work and responsible for delivery, data integrity, and regulatory reporting.
  • Legal, Procurement, and Compliance teams — reviewers who negotiate liability, indemnity, confidentiality, and data protection clauses before execution.

Each signer should confirm they have authority to bind their organization and that the CRA aligns with internal approval workflows and regulatory obligations.

Who signs and their typical responsibilities

Sponsor — Study Director

The sponsor’s study director oversees project objectives, approves protocols and budgets, and ensures payments and regulatory filings occur. The signatory should have delegated contracting authority and understand IP and liability allocations.

CRO — Authorized Officer

The CRO signatory accepts responsibility for performing deliverables, maintaining study records, complying with applicable regulations, and providing warranties and indemnities where negotiated. Authority should be documented in corporate resolution or delegation.

Core sections to include in a professional CRA

A comprehensive CRA organizes responsibilities, protects sensitive data, and anticipates common disputes. The following elements are typically required and should be explicit and measurable.

Scope of Work

Describe study objectives, tasks, milestones, and acceptance criteria in measurable terms so deliverables and completion are unambiguous and auditable.

Deliverables & Milestones

List reports, datasets, regulatory submissions, and due dates with associated payment triggers and criteria for acceptance or rework.

Payment Terms

State total fees, payment schedule (e.g., milestone-based or time-and-materials), invoice timing, currency, and late-payment remedies or interest rates.

Confidentiality & Data Protection

Include confidentiality obligations, permitted disclosures, data handling standards, and security controls for protected health information where applicable.

Intellectual Property

Clarify ownership of background IP, foreground IP, license rights, and obligations for patent prosecution and costs allocation.

Warranties & Indemnities

Allocate risk through limited warranties, indemnity for third-party claims, limitations on liability, and insurance requirements where appropriate.

Step-by-step: executing a Contract Research Agreement

Follow these sequential tasks to complete and execute a CRA with clarity and auditability.

  • 01
    Prepare Draft: Assemble SOW, budget, and data protection terms before circulating the draft.
  • 02
    Legal Review: Have counsel review IP, indemnity, and regulatory clauses for risk allocation.
  • 03
    Internal Approvals: Obtain procurement, finance, and compliance sign-offs consistent with delegated authority.
  • 04
    Execution & Record: Execute by authorized signers and retain fully signed copies with an audit trail.

Where to send the CRA and how routing typically works

Routing depends on organizational roles and regulatory context; use documented steps to ensure required reviewers receive the agreement in order.

  • Upload: Upload the final draft to your contract repository or eSignature platform.
  • Place Fields: Add signature, date, and initial fields plus conditional payment fields as needed.
  • Send to Signers: Route to signers in the required sequence with authentication enabled where appropriate.
  • Archive: Store executed copies and audit logs in the contract management system for retention compliance.

Configuring an online CRA signing workflow

Set up the digital workflow to match your approval and security requirements before inviting signers.

Field Configuration
Signer Authentication Email, SMS code, or KBA as required
Conditional Fields Show/hide payment fields based on role
Templates Create reusable CRA templates with fixed exhibits
Notifications Configure reminders and completion alerts

Digital signing and distribution methods for CRAs

Use platforms that support required security, audit trails, and integrations to preserve chain of custody and document integrity.

  • Integrations: Salesforce, NetSuite, Microsoft 365, Google Workspace supported
  • File Formats: PDF, DOCX, HTML, Excel accepted
  • Authentication Options: Email links, SMS codes, SSO, advanced auth

Choose a platform that meets your compliance needs (HIPAA BAA if PHI is present) and that captures an auditable trail of signing events and actions.

Key timelines and processing expectations in a CRA

CRAs set specific dates and performance windows; track these carefully to avoid cure periods and payment disputes.

Execution Deadline:

Parties typically must sign within 30–60 days of final negotiation

Payment Schedule:

Milestone payments often Net 30 after invoice receipt

Milestone Due Dates:

Deliverable deadlines should be calendar-dated with acceptance windows

Regulatory Reporting:

Report adverse events within required regulatory timeframes

Record Retention:

Retain study records per retention schedule and legal requirements

Common preparation mistakes to avoid when drafting a CRA

  • Vague scope language that lacks measurable deliverables leading to disputes and scope creep.
  • Failing to assign foreground IP or to define license scope and duration clearly for deliverables.
  • Omitting a BAA or specific data security controls when PHI will be accessed or transmitted.
  • Missing termination and liability caps, which can cause disproportionate financial exposure on breach.

Risks and potential penalties from an incorrect or incomplete CRA

Breach Liability: Damages and litigation exposure for nonperformance
Regulatory Fines: HIPAA penalties for PHI mishandling (45 CFR §164)
IP Disputes: Loss of ownership or royalty claims
Payment Disputes: Withheld payments and interest charges
Enforceability Issues: Invalid signatures where statutory exceptions apply
Data Breach Costs: Notification, remediation, and reputational harm

Typical vendor pricing and feature comparison for eSignature platforms

Compare starting prices and common enterprise features relevant to CRA execution; signNow appears first in the vendor list per platform comparisons.

signNow DocuSign Adobe Sign PandaDoc HelloSign
Starting Price $8/user/mo $15/user/mo $14/user/mo $19/user/mo $15/user/mo
Free Trial Yes, 7-day free trial No No Yes, limited Yes, limited
Bulk Send Yes Yes Yes Yes No
Audit Trail Yes Yes Yes Yes Yes
HIPAA Compliant Yes Yes Yes No No

How organizations use CRAs in practice

Real-world examples show practical variations in CRA use across sectors and the operational benefits of clear agreements.

Optica Ventures LLC

The interface is simple and easy-to-use for our team; more importantly, it is just as easy for our customers.

  • Optica used digital signing to accelerate counterparty execution.
  • This reduced turnaround for complex agreements, improved recordkeeping for audits, and streamlined customer interactions without in-person meetings.

Fertility Centers of Illinois

We can process and execute all of these documents online with 100% compliance and built-in security.

  • The center used electronic workflows for consent and data agreements.
  • The result was consistent documentation, easier access for authorized staff, and a reliable audit trail for regulatory review and patient records.

Frequently asked questions about Contract Research Agreements

Answers to common legal, execution, and compliance questions when preparing or signing a CRA.


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