Manufacturing and Supply Plan definition

Manufacturing and Supply Plan means the plan for manufacture of the API and the Drug Product and its supply to the DNDi Territory and to the Entasis Territory to be developed and by the Parties in accordance with Clause 6;
Sample 1Sample 2Sample 3

Examples of Manufacturing and Supply Plan in a sentence

  • The Parties will further agree to appropriate audit rights for the purpose of the Manufacturing and Supply Plan.

  • Under their view of this system, although there is a “presumptive mid-term sentence,” the upper term is the statutory maximum sentence which the trial court has discretion to impose.

  • Specifically, the JCC shall be responsible for overseeing the preparation of, on an annual basis, a Worldwide Manufacturing and Supply Plan and a Europe/US Strategic Plan (which consists of a compilation of the Europe/US Development Plan, the US Brand Plan and the Europe Brand Plan, each as set forth below).

  • Notwithstanding the foregoing, in no event shall Genentech be obligated to Manufacture a higher volume of Active Product than (i) the reserved manufacturing capacity in the manufacturing facility(ies) of Genentech, its Affiliate(s) or sublicense(s) as set forth in the Manufacturing and Supply Plan, with respect to the ***** of the transition period, and (ii) the average of such manufacturing capacity reserved for the ***** of the transition period, with respect to the ***** of the transition period.

  • The TanNov JCC shall be established by the Parties for the purpose of reviewing, and recommending for approval by the TanNov JMC (as provided in Section 4.3(a)(i) above), an EA Commercialization Plan and an EA Development Plan (and, if applicable, an EA Manufacturing and Supply Plan, as contemplated in Section 4.3(a)(ii) above), and overseeing the execution of those EA Plans approved by the TanNov JMC.

  • Alba Iulia Municipality will try to access European funding for thermal-insulation of residential blocks.

  • Rights and responsibilities with respect to Development (including manufacturing development) of Anti-IgE Antibodies and Anti-IgE Products for Commercialization in East Asia and ROW, and the obligations for bearing the related costs, shall be as set forth in the Ancillary D&L Agreement, subject to Section 4.2(a) of this Agreement and any applicable Manufacturing and Supply Plan.

  • Notwithstanding the foregoing, in no event shall Novartis be obligated to Manufacture a higher volume of Active Product than (i) the reserved manufacturing capacity in the manufacturing facility(ies) of Novartis, its Affiliate(s) or sublicense(s) as set forth in the Manufacturing and Supply Plan, with respect to the ***** of the transition period, and (ii) the average of such manufacturing capacity reserved for the ***** of the transition period, with respect to the ***** of the transition period.

  • Notwithstanding the foregoing, Licensee reserves the right to decide each such manufacturing and supply matter in its sole and absolute discretion, including amending or modifying any Manufacturing and Supply Plan.

  • The Global Commercialization Plans shall also include: (i) the applicable Global Commercialization Budget; (ii) the Territory Commercialization Plans for the applicable Licensed Product; (iii) the Territory Commercialization Budgets for the applicable Licensed Product; (iv) the Commercial Manufacturing and Supply Plan for the applicable Licensed Product in respect of activities after Regulatory Approval of that Licensed Product; and (v) the Global Pricing Strategy for each Licensed Product.

Related to Manufacturing and Supply Plan

  • Supply Plan has the meaning set forth in the CAISO Tariff.

  • Manufacturing Agreement has the meaning set forth in Section 4.3.

  • Clinical Supply Agreement has the meaning set forth in Section 4.2.

  • Quality Agreement has the meaning set forth in Section 9.6.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Manufacturing Process means any process for—

  • Commercial Supply Agreement has the meaning set forth in Section 6.1.

  • Supply Agreement has the meaning set forth in Section 7.2.

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, as set forth in this Agreement, required to manufacture Product or Products using the Active Materials, Components, and Xxxx Back Items;

  • Development Plan has the meaning set forth in Section 3.2.

  • Collaborative pharmacy practice agreement means a written and signed

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • Marketing Plan means a plan or system concerning a material aspect of conducting business. Indicia of a marketing plan include any of the following:

  • Pharmacovigilance Agreement has the meaning set forth in Section 4.3.

  • Quality Plan means the quality plan to be produced by the Contractor in accordance with Schedule S2-10 (Quality Plan);

  • Development Plans means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.

  • Quality Assurance Plan or “QAP” shall have the meaning set forth in Clause 11.2;

  • Development Program means the implementation of the development plan.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.