Drafting Material Transfer Agreements for biological materials requires extensive knowledge of NIH guidelines, FDA regulations, IP protections, and biosafety standards. Attorneys spend hours researching compliance requirements, adapting templates from AUTM or university resources, and ensuring proper liability protections—all while coordinating with research institutions and technology transfer offices.
Material Transfer Agreements for biological materials require balancing complex regulatory compliance, biosafety requirements, IP allocation, and institutional policies. Manual drafting takes hours of specialized legal expertise to address NIH guidelines, export controls, select agent regulations, and technology transfer frameworks while protecting both parties' interests.
CaseMark automates the entire MTA drafting process, generating comprehensive, legally sound agreements that address biosafety classification, regulatory compliance, IP ownership, publication rights, and institutional requirements. Our AI ensures every provision meets NIH UBMTA standards, Bayh-Dole Act requirements, and export control regulations while customizing terms to your specific materials and research context.
This workflow is applicable across multiple practice areas and use cases
MTAs are foundational IP licensing documents that govern the transfer of biological materials while protecting intellectual property rights and establishing usage restrictions for research collaborations.
The workflow's focus on IP protection clauses, technology transfer, and licensing terms for biological materials directly aligns with IP licensing practice, where attorneys regularly negotiate material transfer terms as precursors to broader licensing agreements.
Healthcare attorneys at academic medical centers use MTAs to facilitate compliant transfers of biological materials between research institutions while addressing biosafety, liability, and regulatory requirements.
The workflow's integration of biosafety classifications, NIH compliance standards, and healthcare-specific liability provisions makes it essential for healthcare law practitioners managing biological material transfers in medical research settings.
In-house counsel at biotech and pharmaceutical companies use MTAs to manage corporate research collaborations and ensure compliance with institutional policies and governance frameworks.
The workflow serves corporate governance needs by providing standardized agreements that align with university policies and AUTM best practices, essential for managing institutional research relationships and regulatory compliance.
Attorneys handling cross-border biological material transfers use MTAs to address export control requirements and international regulatory compliance for research materials.
The workflow's optional export control assessment feature and governing law provisions are critical for international trade attorneys managing the complex regulatory landscape of biological material transfers across jurisdictions.
Biological MTAs must address unique regulatory frameworks including biosafety levels, select agent regulations, NIH guidelines for recombinant DNA, and export controls specific to biological materials. They require detailed provisions on derivatives and progeny, special handling and shipping requirements for viable organisms, and careful IP allocation that complies with the Bayh-Dole Act for federally funded research. CaseMark automatically incorporates all these specialized requirements based on your material specifications.
CaseMark creates sophisticated IP provisions that distinguish between the original materials, unmodified progeny, derivatives with substantial modifications, and inventions made using the materials. The system allocates ownership rights consistent with Bayh-Dole Act requirements for federally funded research while protecting provider interests through options, reach-through rights, or licensing provisions. You can customize the IP framework based on whether parties are academic institutions, commercial entities, or mixed collaborations.
Yes, CaseMark automatically generates compliance provisions based on the biosafety level and regulatory status you specify. The system incorporates appropriate biosafety containment requirements, select agent transfer procedures if applicable, export control representations and licensing obligations, and institutional biosafety committee approval requirements. All regulatory provisions are updated to reflect current CDC, NIH, ITAR, and EAR requirements.
CaseMark creates balanced publication review provisions that respect academic freedom while protecting proprietary interests. The system establishes reasonable review periods (typically 30-60 days), limits provider review rights to confidentiality protection and patent filing rather than censorship, and includes maximum delay periods for patent applications. These provisions comply with institutional policies at major research universities while giving providers necessary IP protection.
CaseMark generates comprehensive post-termination provisions requiring cessation of use, return or destruction of materials, and certification of compliance. The system addresses retention of samples for regulatory compliance, survival of confidentiality and IP provisions, and wind-down periods for completing ongoing experiments. You can customize whether derivatives created by the recipient remain subject to restrictions or whether the recipient retains certain rights after termination.