CMC definition
Examples of CMC in a sentence
Provider will provide to Senti such Services as stated in the applicable SoW for assistance in preparing, maintaining or updating the CMC section of any such regulatory application filed for a Product with a Regulatory Authority.
In addition, prior to submitting to each Regulatory Authority the CMC section (or any material change thereto) of any application for Regulatory Approval of a Product or a Senti Product that pertains to the Services rendered by or on behalf of Provider, Senti will submit such CMC section (or portion thereof pertaining to the Services rendered by or on behalf of Provider) for review by Provider.
X Regulatory writing to include all applicable forms and CMC sections, including responses to questions from Health Authorities X GMP Storage Deliverables: N/A Provide segregated GMP storage of manufactured products and product retains.
Subject to Section 3.5, Applied Biology IP shall be provided on an “as is” basis, and shall include the preclinical and clinical data, regulatory data and communications, CMC data, manufacturing processes and relationships (including ongoing formulation development efforts) that are set forth in Schedule I.
The approved or disputed invoice will be sent to the Contractor with either authorization to charge the appropriate Citibank CMC, pursuant to this provision, or instructions to make the necessary changes.