CMC. This is because simulation runs are cloned closer to the (truncating) time limit, incurring computation overhead that may yield no rare event observations. Auto- matic importance functions sensitive to simulation time are an interesting line of research: we addressed this again in the conclusions. On the other hand, our method performs best when operating with large time horizons, such that the rarity of unrelT is only lightly influenced by T 2. 2 This complements standard model checking, where time-bounded properties with large time bounds entail memory problems [25].
CMC. In the event that this Agreement is terminated prior to Commercialization and unless Inspirevax elects to continue the CMC development of the BDX Product, Oragenics will be responsible for all costs relating to the termination of the Combination Product Phase 2b/3 CMC development including the CDMO termination costs and any non-refundable reservation fees. If Inspirevax elects to continue CMC development of the BDX Product with its own funding and the CDMO’s activities are not terminated, there will be no termination costs to be paid by either party. For avoidance of doubt, in such case, Inspirevax will not have to compensate Oragenics for the non-refundable reservation fees.
CMC. Edison shall provide reasonable assistance to Penwest for Penwest’s preparation of the chemistry, manufacturing and controls (CMC) section of any IND filed or proposed to be filed by Penwest for a Specified Compound or Product, including requisite stability, pharmacology and/or toxicology data.
CMC. “CMC” means the FDA Department of Chemistry, Manufacturing and Controls.
CMC. Neos shall, in consultation with Cornerstone’s development staff, prepare and provide regulatory data and documentation and draft CMC respecting the manufacture of [***] Confidential portions of the exhibit have been omitted and filed separately with the Securities and Exchange Commission. each Product, all in compliance with applicable Regulations. Cornerstone shall critically review and provide corrections to the CMC section in a timely fashion. Neos shall use commercially reasonable efforts to be prepared for any FDA pre-approval inspection of the Manufacturing Site. Neos shall cooperate with Cornerstone to respond to any FDA information requests relating to the CMC section that may arise during Federal or State Authorities Regulatory review and approval processes and, upon Cornerstone’s reasonable request, will provide other assistance related to obtaining marketing authorization for any Product. Cornerstone shall promptly ( but in no event later than ten (10) days following receipt or mailing or the discussion, as applicable) provide Neos with copies of all correspondence and summaries of all material conversations between Cornerstone and the FDA regarding each of the Products.
CMC. CMC shall indemnify, defend and hold harmless Customer and its affiliates, and each of its respective officers, directors, employees, agents, independent contractors, successors and assigns from and against liability for any third party claims based upon the CMC IaaS infringing or misappropriating any U.S. patent, copyright, or trademark of such third party. Notwithstanding the foregoing, in no event will CMC have any obligations or liability under this Section 16.2 arising from: (i) Customer’s use of CMC IaaS in a modified, unauthorized or unintended form; (ii) Customer’s violation of this Agreement; (iii) Customer’s use of the non-current versions of the CMC IaaS; or (iv) any Customer Content.16.3
CMC. Medgenics will be solely responsible for all chemistry, manufacturing and control activities for the Licensed Product to support Regulatory Approval for the initial indication in the Field in the Territory and the European Union, which, for clarity includes all CMC activities up to and including manufacturing process development, commercial scale-up and validation. Medgenics will bear all costs and expenses incurred in connection with the Manufacture of clinical supplies of Licensed Product for Development for the initial indication in the Field in the Territory and the European Union (including failed batches and any batches, or parts thereof, that are Manufactured after the Effective Date, in anticipation of clinical studies but which are not actually used), and disposal of clinical samples, and, for clarity, none of such costs will be included in Allowable Expenses. ***** Confidential Information has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to this omitted information.
CMC. Medgenics will be solely responsible for all chemistry, manufacturing and control activities for the Licensed Product to support Regulatory Approval in the Field in the Territory, which, for clarity includes all CMC activities up to and including manufacturing process development, commercial scale-up and validation. Medgenics will bear all costs and expenses incurred in connection with the Manufacture of clinical supplies of Licensed Product for Development in the Field in the Territory (including failed batches and any batches, or parts thereof, that are Manufactured after the Effective Date, in anticipation of clinical studies but which are not actually used), and disposal of clinical samples, and, for clarity, none of such costs will be included in Allowable Expenses.
CMC. Seller has obtained the right (including under any Patent Rights and other Intellectual Property Rights) to use all information, data, and all other materials (including any formulations and manufacturing processes and procedures) developed or delivered by any third party under any agreements between Seller and any such third party with respect to the Compound and Products, and Seller has the rights under each such agreement to transfer such information, data, and other materials to Purchaser and its designees and to grant Purchaser the right to use such information, data and other materials in the Development, manufacture, and Commercialization of the Compound or the Products without restriction.
