Below are a few of the special clauses that may be needed in your contracts with vendors for your pre-clinical research, clinical trials, or manufacturing. They may need to be included depending on what stage your drug is in, what the vendor is providing, and the context.
- Intellectual property rights
- GCP, GMP, or GLP
- Protocols, written instructions, and quality control
- International standards
- Legal compliance
- Audit, records, and governmental inspections
- Samples, animal use, human biological samples
- Investigators, trial site agreements, and transfer-of-obligations
- Confidentiality
- Publication
- Patenting
- Debarment, counterfeit drug representation, drug pedigree tracing
- Indemnification and limitation of liability
- Special rights to terminate (for example, if study approval is withdrawn or toxicological results support termination).
- Right to assign the contract if you sell your drug candidate or your company.