| name | mta-biological |
| title | Material Transfer Agreement — Biological Materials |
| description | Drafts Material Transfer Agreements for biological materials between research institutions and commercial entities. Covers material characterization (BSL levels, select agents, GMOs), permitted use, IP allocation, publication rights, and regulatory compliance (NIH Guidelines, Bayh-Dole, ITAR/EAR, select agent regulations). Use when drafting MTAs, biological material transfer terms, or research collaboration agreements involving biological specimens. |
| author | CaseMark |
| author_url | https://github.com/CaseMark/skills/tree/main/skills/legal/mta-biological |
| license | Apache-2.0 |
| version | 0.1.0 |
| execution_mode | open |
| jurisdiction | us |
| practice | contracts |
| language | en |
Material Transfer Agreement — Biological Materials
Drafts MTAs governing transfer of biological materials between research institutions and/or commercial entities, balancing scientific collaboration with IP protection, biosafety compliance, and regulatory requirements. Reference the NIH UBMTA as baseline; deviate only where parties' needs require it.
Prerequisites
Gather before drafting:
- Parties — legal names, addresses, departments, signatories, institutional type (university/foundation/corporate)
- Material — scientific nomenclature, strain/cell line IDs (ATCC, RRID), physical form, quantity, BSL classification, select agent status, GMO details
- Upstream restrictions — prior MTAs or third-party IP encumbrances
- Research scope — project description, grant number, funding source (federal/private), PI names
- Regulatory status — export control classification (ITAR/EAR), IBC approvals, IACUC/IRB if applicable
- Commercial intent — whether recipient anticipates commercialization of derivatives
Quick Start
For a standard academic-to-academic transfer of non-select-agent, non-GMO materials under federal funding:
- Start from UBMTA framework
- Confirm Bayh-Dole compliance (non-negotiable for federal funding)
- Use research-only permitted use with prohibition on commercial use and third-party transfer
- Apply three-tier IP allocation (background → Provider retains; materials → Provider; new inventions → inventive party)
- Include 30-day publication review period (no veto right)
- Add standard AS-IS disclaimers in conspicuous format
Drafting Workflow
1. Parties & Authority
- Full legal name, address, department, authorized signatory with binding authority
- PI is agent of institution (not a party); institution bears compliance responsibility
- Public institutions: confirm statutory contracting authority and sovereign immunity considerations
- Conditions precedent: IBC approval, export control clearance, conflict-of-interest review
- International transfers: allocate responsibility for foreign government approvals
2. Material Description
Draft with scientific precision:
- Taxonomy (genus/species/strain), identifiers (ATCC, RRID), physical form, storage conditions
- Biosafety: BSL-1 through BSL-4 classification and containment requirements
- Select agents: confirm both parties' CDC/USDA registration if applicable
- GMO status: nature of modifications, NIH Guidelines compliance, IBC approvals
