CMC Information definition

CMC Information means Information related to the chemistry, manufacturing and controls of the Licensed Products, as specified by the FDA, NMPA and other applicable Regulatory Authorities.

CMC Information means Information related to the chemistry, manufacturing and controls of a product, as specified by the FDA, EMA and other applicable Regulatory Authorities.

CMC Information means the CMC information intended or required for the submission of an IND or BLA.

Examples of CMC Information in a sentence

• In the event additional Moderna CMC Information not currently contained within regulatory documents [***], the Parties shall mutually agree [***].

• Notwithstanding anything in this Agreement to the contrary, during the POC Term for a given Program, except with respect [***], Moderna may redact from documents provided or made available to Merck or its Affiliates, and otherwise decline to disclose or provide Merck access to, Moderna CMC Information and proprietary manufacturing processes relating to Moderna CMC Information from such Program.

• For clarity, during preparation and submission of the BLAs, if Pfizer receives any correspondence from any Regulatory Authorities, including that relates to the CMC Information, Pfizer will provide OPKO a full and complete copy, of such communication.

• To the extent Daewoong requires such information to comply with applicable Laws or to determine whether to conduct a recall, Ampio shall promptly disclose to Daewoong any CMC Information related to such nonconformance, adulteration, misbranding or other related issue.

• The risk assessed level of the Council’s Unearmarked Reserves is£10.5m based on updated robustness statements.The Unearmarked Reserves can be utilised for invest to save projects provided they are repaid within 3 years and do not fall below the minimum level of £6m.Earmarked Reserves as set out below are assumed to be fully allocated to support the Council change programme, severance costs, affordable housing and identified funding risks.

More Definitions of CMC Information

CMC Information means the chemistry, manufacturing and control information required for the submission of a BLA.

CMC Information means all Data regarding a Party’s (or its contract manufacturer’s) chemistry, manufacturing and controls filed or required to be filed to in connection with the Development or Commercialization of the Products.

CMC Information means Information related to the chemistry, manufacturing and controls of the Products, as specified by the FDA and other applicable Regulatory Authorities.

CMC Information means the chemistry, manufacturing, and control information filed by Valera from time to time with the FDA with respect to the Product.

CMC Information means the chemistry, manufacturing and control information intended or required for the submission of a CTA.

CMC Information means information or data related to, or contained in, the DMFs or the CMC section (or equivalent thereof) of any MAA or other Regulatory Approval for the Licensed Products, or IND or CTA, or any other similar data or information.

CMC Information means information related to the chemistry, manufacturing and controls of a FSRA or a FSRA Product, as specified by FDA, EMA or other applicable Regulatory Authority.