Specialized NDAs for clinical trials, compound licensing, CRO/CMO partnerships, and FDA submissions. Built for patent protection, regulatory compliance, and research integrity.
In biotech, premature disclosure can destroy patent rights worldwide. Our biotech NDAs include specific provisions for patent bar date protection, publication delays for patent filing, and clear invention ownership. Grace periods vary by jurisdiction (12 months US, none in Europe for most disclosures).
Learn about patent-protective provisions →Choose the right NDA for your life sciences situation
For clinical trial collaborations, investigator-initiated studies, and multi-site trial coordination. Includes IRB alignment, adverse event provisions, and publication rights.
For drug candidate licensing discussions, compound evaluations, and partnership negotiations. Strong IP protection with patent bar date awareness.
For research partnerships with academic institutions, joint research programs, and scientific collaborations. Balances open science with IP protection.
For Contract Research Organizations and Contract Manufacturing Organizations. Protects study data, manufacturing processes, and analytical methods.
For sharing FDA submission data, regulatory strategies, and agency correspondence. Protects competitive intelligence in regulatory filings.
What makes life sciences NDAs unique
Protect patentability with publication delays, invention assignment, and prior art protections.
Learn MoreSafeguard IND/NDA submissions, clinical data, and FDA correspondence from competitors.
Learn MoreEnsure data accuracy, prevent selective disclosure, and maintain scientific credibility.
Learn MoreProtect synthesis routes, formulations, and analytical methods as trade secrets.
Learn MoreAddress multi-jurisdiction filings, data transfer, and international patent considerations.
Learn MoreClauses that differentiate biotech NDAs from standard agreements
Requirements to promptly disclose inventions arising from shared information, with clear ownership rules for joint developments.
Right to delay publication 60-90 days to file patent applications, protecting worldwide patentability in non-grace-period jurisdictions.
Prohibition on using disclosed information to develop competing compounds or pursue the same therapeutic targets.
Obligations to maintain data accuracy, prevent selective disclosure, and ensure research reproducibility.
Clear delineation of who may reference shared data in regulatory submissions and under what conditions.
Biotech confidentiality involves complex patent, regulatory, and commercial considerations. While our templates provide a strong foundation, we strongly recommend having an experienced life sciences attorney review any NDA involving drug development, licensing, or clinical data before execution. Request a consultation.
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