• Home
  • About
  • Contracts Done
  • Differentiators
  • Testimonials
  • Tips and Q&A
    • – Negotiation Tips
    • – Termination for Convenience
  • Contact

Life Science Contracts Attorney

978-749-9828 Ralph Bakkensen (MA, ME, NH, OR) - “The devil AND THE DEAL are in the details."

Special Clauses You May Need

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  • Special rights to terminate (for example, if study approval is withdrawn or toxicological results support termination).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.

 

 

Pages

  • Do you need me?
  • Contracts Done
  • Special Clauses You May Need
  • Some Vendors Whose Contracts I’ve Reviewed for Clients
  • Differentiators
  • Profile
  • Testimonials
  • Contact
  • Tips and Q&A
    • – Confidentiality Agreements

Copyright 2014-2017 Ralph Bakkensen

Ralph Bakkensen

Attorney for Biotech/Pharma & Other Life Science Contracts

Call 978-749-9828 or write Ralph@Bakkensen.com

MA, ME, NH, & OR

Attorney Advertising