CMC Data definition

CMC Data means any data included in the CMC portion of a Regulatory Filing or in any supporting development reports thereto, in each case, with respect to any Licensed Product in any country in the world.

CMC Data means the chemistry, manufacturing and controls data for each Research Product, product Directed to a ROFN Target, Licensed Compound or Licensed Product, as applicable, required by Applicable Law to be included or referenced in, or that otherwise supports, an application for Regulatory Approval.

CMC Data means the chemistry, manufacturing and controls data required by Applicable Law to be included in a New Drug Application (as defined in the FFDCA and the regulations promulgated thereunder) for a Product or in any other Marketing Authorization outside the United States.

Examples of CMC Data in a sentence

• Under the Second Indication Development Plan and other future development plans for Additional Indications activities will primarily be managed and conducted by Otsuka at its own cost and expense save that GW Pharma shall be responsible for the generation of all relevant CMC Data at its own cost and expense.

• The Parties agree that Otsuka shall have no right to exercise its license right granted under Section 2.1 to use the Manufacturing GW Pharma Know-How or GW Pharma CMC Data to make and have made Licensed Products or BDS unless and until it is permitted to do so under the terms of the Manufacturing and Supply Agreement.

• Promptly after the Effective Date, Biocon shall provide to Equillium true and complete copies of Biocon’s updated Investigator’s Brochure for all available CHO-derived ITO formulations and related supporting materials, and all preclinical, toxicology and CMC Data existing as of the Effective Date for all available CHO-derived ITO formulations; in each case, at Biocon’s sole expense, subject to Section 4.2(a)(iii).

• The budget set forth in the First Indication Development Plan (the “Development Budget”) shall set out the Third Party costs projected to be incurred by GW Pharma in the performance of its obligations under such Development Plan (including the cost to GW Pharma of relevant clinical trial insurance) other than the costs to GW Pharma of generating the CMC Data (“Development Costs”).

• CONFIDENTIAL TREATMENT REQUESTED EXECUTION COPY Evaluation of CMC Data for Pharmaceutical Developability Assessment (Early pharmaceutical developability assessment) **** Conventional oral dosage form ****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

More Definitions of CMC Data

CMC Data means any and all information contained in, as well as data supporting, the Chemistry, Manufacturing and Control section of an IND or NDA for the Product, and any similar information or data required with respect to any other Regulatory Approval.

CMC Data means CMC data generated with respect to the Product that is Controlled at any time during the Term of this Agreement by a Party, or any Affiliate, subcontractor, agent, sublicensee thereof, or jointly by any of the foregoing.

CMC Data means any and all information contained in, as well as data supporting, the “Chemistry, Manufacturing and Control” and facilities sections (or sections corresponding thereto) of a Drug Approval Application, including any drug master files referenced therein.

CMC Data means the chemistry, manufacturing and controls data required by Applicable Law to be included in a BLA for a Licensed Product.

CMC Data means the data contained in the chemistry, manufacturing and controls section of a submission for Regulatory Approval of the Product in the Field in the Territory.

CMC Data means any data included in the CMC or in any supporting development reports thereto, in each case, with respect to any Licensed Product in any country in the world.

CMC Data means those data required by Part 2 of the Annex to Directive 2001/83/EC (including, without limitation, any updates and/or amendments thereto) including the qualitative and quantitative particulars of the constituents, the description of the manufacturing method and the controls and tests carried out at all relevant stages of the manufacturing process.