CMC/Process Development definition

CMC/Process Development means (i) the development and, as far as applicable, validation of a process for the Manufacture of the Product (covering the Compound and inactive ingredients, packaging materials, and intermediates), including, without limitation, manufacturing descriptions, batch records, quality control procedures and analytical methods (both in-process, post-process, final release and stability controls), reference standards and stability protocols as well as the corresponding reports and other regulatory documentation; (ii) the planning, Manufacturing, monitoring and dispatch of non-clinical samples and clinical samples of the Product; and (iii) any documentary and medical writing and regulatory affairs activities directly related to the activities set forth in subclauses (i) and (ii).
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CMC/Process Development means the development of one or more processes for the manufacture and packaging of the Bulk Product for Clinical Development and Commercialization, and shall include, without limitation, formulation, production, fill/finish, sourcing of components, raw materials, and packaging supplies for the Bulk Product, development of methods and controls appropriate for Regulatory Approval, including assays, quality control and quality assurance methodology and stability protocols.
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CMC/Process Development means the development of a process for the manufacture of a drug substance and pharmaceutical product for commercial scale, including, without limitation, the validation of raw material acceptance specifications (both active and inactive ingredients), validation of the manufacturing process and the analytical methods, manufacturing directions, batch records, regulatory methods and controls, product and process specifications, quality control procedures, stability testing (including both room temperature and accelerated), assays, reference standards, in-process controls, preliminary and final release methodology and stability protocols, process development protocols and reports, for both drug substance and pharmaceutical product.
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Examples of CMC/Process Development in a sentence

  • Such CMC/Development, Manufacture and Supply Agreement shall, amongst other things, provide that Bayer shall: (i) use Commercially Reasonable Efforts to perform certain CMC/Process Development activities; and (ii) supply all of Licensee’s, its Affiliates’ and Sublicensees’ clinical and commercial requirements of the Product.

  • Immediately upon such transfer, Licensee agrees to use Commercially Reasonable Efforts to diligently carry out the CMC/Process Development and Manufacture of the Product in the Territory for use in the Field for all commercially reasonable Indications, including without limitation, the Initial Two Indications.

  • Within sixty (60) days after the Effective Date, or as soon as practicable thereafter, the Parties shall enter into a separate written agreement describing the rights and obligations of the Parties with respect to the CMC/Process Development, and Manufacture and supply of all Licensee’s, its Affiliates’ and Sublicensees’ requirements of clinical or commercial supply of the Product by Bayer (the “CMC/Development, Manufacture and Supply Agreement”).

  • Bayer shall retain sole responsibility and ownership of the DMFs even after the transfer of responsibility for the CMC/Process Development and Manufacture of the Product to Licensee, as set forth in Section 4.3.2 below; provided, however, that Bayer shall have the right (but not the obligation), at any time thereafter, to assign and transfer sole responsibility and ownership of the DMFs to Licensee upon twenty (20) days notice to Licensee.

  • Notwithstanding the foregoing, data and documentation associated with any IND, IND Equivalents, NDAs or NDA Equivalents relating to the CMC/Process Development and Manufacture of the Compound and the Product shall be excluded from such data transfer and shall not be transferred or made available to Licensee until such time as Bayer transfers responsibility for CMC/Process Development and Manufacture of the Product to Licensee, as set forth in Section 4.3.2 below.

  • The Parties shall use Commercially Reasonably Efforts to complete such CMC/Process Development [***].

  • Technical Committee reasonably detailing its progress on such CMC/Process Development, including without limitation manufacturing process, components and composition and specifications and test methods, for the Oral Product.

  • The Joint Technical Committee may, however, reasonably determine that, for the purposes of obtaining Regulatory Approval for a Product, CoTherix should manufacture, or arrange for a Third Party Manufacturer to manufacture, Active Drug Substance for Preclinical Development and/or CMC/Process Development.

  • Each Party shall own and maintain its own database of data accumulated from all CMC/Process Development of Active Drug Substance and each Product, preclinical trial data accumulated from all Preclinical Development of Active Drug Substance and each Product, clinical trial data accumulated from all Clinical Development of each Product and adverse drug reaction information for each Product.

  • Both Parties shall dedicate resources sufficient to complete such CMC/Process Development under this Section 7.1(a) within the timeline described above.

Related to CMC/Process Development

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.

  • Commercial Development means any development on private land that is not heavy industrial or residential. The category includes, but is not limited to: hospitals, laboratories and other medical facilities, educational institutions, recreational facilities, plant nurseries, car wash facilities, mini-malls and other business complexes, shopping malls, hotels, office buildings, public warehouses and other light industrial complexes.

  • Research and development means (1) theoretical analysis, exploration, or experimentation; or (2) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. Research and development does not include the internal or external administration of radiation or radioactive material to human beings.

  • site development plan means a dimensioned plan drawn to scale that indicates details of the proposed land development, including the site layout, positioning of buildings and structures, property access, building designs and landscaping;

  • Infill development means new construction on a vacant commercial lot currently held as open space.