Final Manufacturing definition

Final Manufacturing means all activities occurring anywhere in the world required to prepare the Product for commercial sale in the Territory, including secondary packaging and labeling with the approved packaging and label for the country in the Territory in which it is to be sold; stability or other testing; quality control; and release of the Product for sale in the Territory.
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Final Manufacturing means all activities required to prepare Product supplied by Viela to MTPC as finished drug product for commercial sale in the Territory, including primary and secondary packaging and labeling with the approved packaging and label for the country in the Territory in which it is to be sold; stability or other testing; quality control; and release of the Product for sale in the Territory.
Sample 1
Final Manufacturing means all activities required to prepare the Product (which, for clarity, is to be supplied by ARIAD to Otsuka as finished drug product in bulk packaging except as set forth in Section 10.2) for commercial sale in the Territory, including primary and secondary packaging and labeling with the approved packaging and label for the country in the Territory in which it is to be sold; stability or other testing; quality control; and release of the Product for sale in the Territory.
Sample 1

Examples of Final Manufacturing in a sentence

  • Subject to Section 10.2.1, with effect from the Effective Date, ARIAD SWISSCO shall be responsible for the Final Manufacturing of all Product, including performing secondary packaging, labeling and providing product inserts and final release and stability testing in accordance with the Marketing Authorization and Regulatory Requirements in the country in the Territory that is the intended market for such lot of Product, and in accordance with all Applicable Laws.

  • The Launch Quantities shall be shipped to Otsuka sufficiently in advance of the anticipated First Commercial Sale in the Territory, in order to allow Otsuka sufficient time to complete Final Manufacturing in advance of the anticipated First Commercial Sale in the Territory, provided that Otsuka submits a binding purchase order for the Launch Quantities before the anticipated First Commercial Sale in accordance with the lead time requirements set forth in the Supply Agreement.

  • With respect to any Third Party License that is necessary or useful for Otsuka to perform Final Manufacturing of Product in the Territory and is not necessary for such Final Manufacturing to conform to any specifications provided by ARIAD under this Agreement, [***] shall have the final decision-making authority and responsibility for negotiating such Third Party License and for making any payments due thereunder, at its sole cost and expense.

  • For clarity, the Transfer Price shall only be payable for Bulk Product to be used for Final Manufacturing for commercial requirements for the Territory, and shall not be payable for Bulk Product supplied by ARIAD for Final Manufacturing for use in clinical studies or promotional samples of Product or for investigational use, such as for process validation and performance qualification testing.

  • Except as set forth in Section 10.2, Otsuka shall be responsible for the Final Manufacturing of all Product, including performing primary and secondary packaging, labeling and providing product inserts in accordance with the Registrations, final release and stability testing in accordance with the Regulatory Authorization in the country in the Territory that is the intended market for such lot of Product, and in accordance with all Applicable Laws.

  • Otsuka shall be responsible for performing cGMP compliance and quality assurance reviews and inspections of the sites used for Final Manufacturing in accordance with Otsuka’s standard procedures regarding the same.

  • Emphasis is on activities that support countries’ abilities to cope with shocks and build resilience to future shocks; address internal displacement crises; and transition from violence to peace, including through the development of joint programming with the UN on disarmament, demobilization and reintegration in post-conflict settings.

  • Employees who work less than 12 months shall have the option of receiving twelve (12) equal pay checks.

  • Throughout the Term, ARIAD shall use commercially reasonable efforts to supply Otsuka free of charge with Know-how that is necessary or useful for Otsuka to research, develop, Commercialize or conduct Final Manufacturing of the Product in the Territory in accordance with this Agreement, including access to Know-how and information that, prior to the Effective Date hereof, was made available to Otsuka in read-only mode.

  • Indonesia was engaged in this effort before clear blocs had emerged in the UN; indeed, the Indonesian question of the 1940s has been cited by some actors as an important foundation for the later emergence of the Asia-Africa bloc.


More Definitions of Final Manufacturing

Final Manufacturing means all activities required to prepare the Product (which, for clarity, is to be supplied by ARIAD to Otsuka as finished drug product in bulk packaging except as set forth in Section 10.2) for commercial sale in the Territory, including primary and secondary packaging and labeling with the approved packaging and label for the country in the Territory in which it is to be sold; stability or other testing; quality control; and release of the Product for sale in the Territory. Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Sample 1

Related to Final Manufacturing

  • Remanufacturing means the activity of overhauling, retrofitting, fabricating, or repairing a product or its component parts for ultimate sale at retail.

  • Manufacturing means all activities directed to sourcing of necessary raw materials, producing, processing, packaging, labeling, quality assurance testing, release of a Licensed Product or Licensed Product candidate, whether for Development or Commercialization. When used as a verb, “Manufacture” means to engage in Manufacturing.

  • 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 Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Manufacturing Process means any process for—

  • Manufacturing Facilities means facilities engaged in the mechanical or chemical transformation of materials or substances into new products and shall include:

  • Tobacco product manufacturer means an entity that after the date of enactment of this act directly (and not exclusively through any affiliate) meets 1 or more of the following:

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • 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.

  • Manufacturing Technology means any and all patents, patent applications, know-how, and all intellectual property rights associated therewith that are owned or controlled by Licensor, 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 Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, set forth in this Agreement, required to manufacture Product or Products from Active Materials and Components;

  • cGMP means current Good Manufacturing Practices as specified in the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • 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 Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

  • Good Manufacturing Practice or “GMP” means the current good manufacturing practices applicable from time to time to the manufacturing of a Product or any intermediate thereof pursuant to Applicable Law.

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • Current Good Manufacturing Practices or “cGMP” means applicable Good Manufacturing Practices as specified in the United States Code of Federal Regulations and/or the EU Good Manufacturing Guidelines, and any successor legislation from time to time, prevailing at the time of the manufacture of the Product.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Good Manufacturing Practices or “GMP” means, with respect to the United States, the minimum then-current good manufacturing practices for methods, facilities, and controls to be used for the manufacture, processing, packing, or holding of a drug to assure that it meets the requirements of the Federal Food, Drug, and Cosmetic Act for safety and has the identity and strength and meets the quality and purity characteristics, specified in 21 C.F.R. Parts 210 and 211, as may be amended, and, with respect to any other country or jurisdiction, the equivalent regulations in such other country or jurisdiction.

  • Contract Manufacturer means a company that produces goods under contract for another company under the label or brand name of that company.

  • API means American Petroleum Institute.

  • Manufacture means the production of products in a factory using labour, materials, components and machinery and includes other related value-adding activities.

  • Third Party Manufacturer means any person, firm or company which carries out the reproduction of Work and/or manufactures and/or prints the Licensed Publication on behalf of the Licensee;

  • Clinical nurse specialist means a registered nurse with relevant post-basic qualifications and 12 months’ experience working in the clinical area of his/her specified post-basic qualification, or a minimum of four years’ post-basic registration experience, including three years’ experience in the relevant specialist field and who satisfies the local criteria.