CMC Know-How definition

CMC Know-How means all information, techniques and technical information known to CMC or developed during the Services (excluding the CHEF1 Technology or improvements thereto) that are not of general public knowledge.
CMC Know-How means the Know-How relating to the chemistry, Manufacture, and controls of an API and/or Licensed Product (such as the data and information typically contained in the CMC section of an NDA), including data, procedures, techniques, and information resulting from any: test method development and stability testing, process development, process validation, process scale-up, formulation development, delivery system development, quality assurance and quality control development, and other related activities.
CMC Know-How means the Know-how made, conceived or first reduced to practice by or on behalf of either Party (or its Affiliates), or jointly by or on behalf of the Parties (or their Affiliates), in the conduct of the activities under the CMC Development Plan.

Examples of CMC Know-How in a sentence

  • In no event shall BMS be obligated to provide Eiger with more than [ * ] FTE hours of technical assistance and consultation in connection with the BMS Know-How transferred under Section 3.1 to the extent the Know-How does not relate to manufacturing Know-How, and (y) [ * ] FTE hours technical assistance and consultation in connection with the BMS Know-How transferred under Section 3.1 to the extent it relates to manufacturing (including CMC) Know-How.

  • During the Term, Licensor shall, upon Company’s written request, provide full and prompt disclosure of, and shall license, and hereby does license, to Company as a part of Licensed Know-How, any Know-How (including CM&C Know-How) that becomes Controlled by Licensor or any of its Affiliates after the Effective Date that is reasonably necessary for Company to manufacture Licensed Product or complete the Chemistry, Manufacturing and Controls section of a regulatory submission document included in a BLA.

  • Arrowhead shall bear the expenses incurred by Arrowhead in transferring any such CMC Know-How (including any payments due to its counterparties under any Current Manufacturing Agreements or Pre-Existing Licenses from Third Parties).

  • EXECUTION VERSION designated Affiliate and Third Party sublicensees and subcontractors records or copies of all CMC Know-How.

  • Know-How (including CM&C Know-How) or Licensor Materials, promptly following such disclosure, transfer to Company written or electronic copies of such Licensor Know-How (including CM&C Know-How) and reasonable quantities of such Licensor Materials.


More Definitions of CMC Know-How

CMC Know-How means all information, techniques and technical information known to CMC or developed during the Services (excluding [***]) that are not of general public knowledge. [ ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. CMC CONFIDENTIAL 20
CMC Know-How means developments and inventions made by or on behalf of the Seller or its Affiliates relating to (i) [***]; (ii) [***]; and (iii) [***];
CMC Know-How means [* * *].
CMC Know-How means the Know-How relating to the chemistry, Manufacture, and controls of the Active Substance and/or Licensed Product (such as the data and information typically contained in the CMC section of an NDA), including data, procedures, techniques, and information resulting from any: test method development and stability testing, process development, process validation, process scale-up, formulation development, delivery system development, quality assurance and quality control development, and other related activities, but excluding any Know-How pertaining to assays for measuring telomerase activity and/or telomere length (such as included in the Geron Assay Know-How).
CMC Know-How means the Arrowhead Know-How relating to the CMC of ARO- HBV, any Licensed Construct or any Licensed Product, including data, procedures, techniques, and information resulting from any test method development and stability testing, process development, process validation, process scale-up, formulation development, delivery system development, quality assurance and quality control development, and other related activities. 1.49 “Collaboration Activities” means the Parties’ activities (performed directly or, as may be permitted hereunder, on their behalf through their Affiliates, Third Party sublicensees or Third Party contractors or subcontractors) performed under this Agreement. 1.50 “Combination Product” means (a) a single pharmaceutical formulation containing as its Active Ingredients (i) one or more Licensed Constructs, and (ii) one or more Active Ingredients other than a Licensed Construct; (b) a bundle of products comprised of (i) one or more single pharmaceutical formulations comprising at least one Licensed Construct, and (ii) one or more other therapeutically effective or Prophylactically Active Products,
CMC Know-How means the Arrowhead Know-How relating to the chemistry, Manufacture, and controls of ARO-HBV, any Licensed Construct or any Licensed Product, including data, procedures, techniques, and information resulting from any test method development and stability testing, process development, process validation, process scale-up, formulation development, delivery system development, quality assurance and quality control development, and other related activities.
CMC Know-How all information, techniques and technical information known to CMC or developed during the Services (excluding the CHEF1 Technology or improvements thereto) which is not Customer Know-How or of general public knowledge;