Manufacturing Designee definition

Manufacturing Designee means any Person other than a Respondent that has been designated by an Acquirer to manufacture a Divestiture Product for that Acquirer.
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Manufacturing Designee means any Person other than a Respondent that has been designated by the Acquirer to perform any part of the manufacturing process, including the finish or packaging of a Divestiture Product on behalf of that Acquirer.
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Manufacturing Designee means any Person other than the Respondent that has been designated by the Acquirer to manufacture Habitrol for the Acquirer.
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Examples of Manufacturing Designee in a sentence

  • For any Supplied Product that is made in a facility owned by Respondents, Respondents shall transfer such manufacturing to a facility owned, controlled, or operated by the Acquirer or, at the option of the Acquirer, to its Manufacturing Designee.

  • Not interfere, directly or indirectly, with the hiring or employing by the relevant Acquirer or its Manufacturing Designee of any Relevant Employees, not offer any incentive to such employees to decline employment with that Acquirer or its Manufacturing Designee, and not otherwise interfere with the recruitment of any Relevant Employees by the Acquirer.

  • For any Supplied Product that, after the Acquisition Date, is made in a facility owned by Respondent Upjohn or Respondent Viatris, Respondents shall transfer such manufacturing to a facility owned, controlled, or operated by Respondent Pfizer or, at the option of the Acquirer, to its Manufacturing Designee.

  • Thus, in the ultimate controlling entity’s consolidated financial statements, the comparative amounts remain the same.

  • Among other things, the Monitor shall report in writing to the Commission concerning progress by the Acquirer or the Acquirer’s Manufacturing Designee toward obtaining FDA approval to manufacture each Otezla Product and obtaining the ability to manufacture each Otezla Product in commercial quantities, in a manner consistent with cGMP, independently of Respondents.

  • Effective upon the occurrence of any of the circumstances specified in Section 8.1 (Termination of Exclusive Purchase) hereof, Nisso shall disclose all Manufacturing Technology to Replidyne and/or the Manufacturing Designee, for Replidyne’s use in the production of the Drug Substance and the Drug Product only.

  • In case Replidyne requires Nisso to disclose the Manufacturing Technology to the Manufacturing Designee pursuant to this Section 8.4, Replidyne shall be responsible to have such Manufacturing Designee observe the terms and conditions of this Agreement.

  • DSP and Nisso shall assist Replidyne and/or the Manufacturing Designee as reasonably necessary to effectively enable Replidyne or the Manufacturing Designee to manufacture the Drug Substance.

  • Theratechnologies shall have the right to request a copy of any agreement between TaiMed and a Manufacturing Designee in connection with the manufacture and supply of Product to Theratechnologies, provided that TaiMed may redact therefrom any financial terms or other similar type of information or any confidential information in such agreement.

  • Respondents shall transfer the Product Manufacturing Technology related to the Divestiture Products to the Acquirer, or at the Acquirer’s option, to its Manufacturing Designee, in a manner consistent with the Technology Transfer Standards.


More Definitions of Manufacturing Designee

Manufacturing Designee means any Person other than Respondent or Baxter that has been designated by an Acquirer to manufacture a Generic Injectable Product for that Acquirer.
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Manufacturing Designee means any Person other than a Respondent that has been designated by an Acquirer to manufacture a Canine Health Product on behalf of the Acquirer.
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Manufacturing Designee means any Person other than a Respondent that has been designated by an Acquirer to perform any part of the manufacturing process, including the finish and/or packaging, of a Divestiture Product on behalf of an Acquirer.
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Manufacturing Designee has the meaning set forth in Section 6.1.1.
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Related to Manufacturing Designee

  • Manufacturing Process means any process for—

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

  • 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.

  • API means the American Petroleum Institute.

  • 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;

  • 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.

  • 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.

  • 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.

  • Distillery manufacturing license means a license issued in accordance with

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

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • 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.

  • 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.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Good Manufacturing Practice or “GMP” means the current good manufacturing practices (cGMP) and all applicable governmental rules and regulations as applied at the site(s) of manufacture and control, as amended from time to time and in effect during the term of this License Agreement.

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

  • 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.

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

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

  • Product Specification means a product specification for a Medical Device set out in Schedule 2;

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • 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.