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.

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

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

Examples of CMC Information in a sentence

• Following such assignment and transfer of title, Licensor shall not challenge the title of Licensee in and to the Licensed Know-How and Data and CMC Information.

• From and after such assignment and transfer, Licensor shall be excluded from practicing under the Licensed Patents or from any use of the Licensed Know-How and Data and CMC Information (except as necessary for Licensor to comply with its obligations hereunder or Applicable Law) and all of the foregoing, to the extent relating to the Licensed Technology and not published or publicly available, shall be deemed to be Confidential Information of Licensee.

• Any such transfer of CMC Information as set forth in this Section 4.1 is conditioned on Licensee establishing appropriate firewalls or equivalent means to ensure that such CMC Information is protected from unauthorized disclosure and is used only for legal and regulatory compliance purposes and not for any other purpose.

• Licensor does hereby grant to Licensee the right, but not the obligation, to acquire all right, title and interest in and to the Licensed Technology and to all related filings with Regulatory Authorities, Data and CMC Information related to the Licensed Molecules (the “Buyout”).

• Following exercise of the Buyout, as provided below, Licensee shall acquire all right, title and interest in the Licensed Technology and all related filings with Regulatory Authorities, Data and CMC Information related to the Licensed Molecules upon (i) the receipt by each Party of any approvals required under Applicable Law, (ii) the payment to Licensor of the Buyout Payment, and (iii) closing of the transfer of title to the Licensed Technology on the Closing Buyout Date.

More Definitions of CMC Information

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 Tirasemtiv or a Product, as specified by FDA, EMA or other applicable Regulatory Authority.

CMC Information means Information related to the chemistry, manufacturing and controls of the Product, 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, investigational or otherwise, and as specified by the FDA, EMA, and other applicable Regulatory Authorities.

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

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 information related to the chemistry, manufacturing and controls of the Compound or Products, as specified by the applicable Regulatory Authorities.