Legal Manufacturer definition

Legal Manufacturer means the Person with legal authority to design, manufacture, package and label a product or device before it is placed on the market, regardless of whether these operations are carried out by that Person itself or on its behalf by another Person.
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Legal Manufacturer means the manufacturer of a medical device in the meaning of the German Medical Devices Act (Hersteller), Directive ·98/79/EC and other Applicable Laws, i.e. the natural or legal person who is responsible for the design, manufacture, packaging and labeling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a Third Party.
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Legal Manufacturer means the “legal manufacturer” as defined by Applicable Law.
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Examples of Legal Manufacturer in a sentence

  • Centogene shall release and place on the market the Contract DBS Test Kits in accordance with the Specifications, Applicable Laws and Standards as the Legal Manufacturer under its own name in each country of the Territory.

  • Centogene will release and place on the market the Contract DBS Test Kits manufactured by Centogene in accordance with the Specifications, Applicable Laws and Standards as the Legal Manufacturer under its own name.

  • Centogene shall act as the Legal Manufacturer of the Contract DBS Test Kits and shall, subject to the provisions hereunder, solely bear all related legal and regulatory responsibility as the Legal Manufacturer of the Contract DBS Test Kits under Applicable Laws in the Territory as set forth under this Agreement.

  • EyePoint shall own and maintain all regulatory filings and Registrations for the Products in its own name, shall be the Legal Manufacturer of the Products, and shall be responsible for and act as the sole point of contact with the applicable regulatory authorities in connection therewith.

  • For the products which Producer remains Legal Manufacturer (as identified on Exhibit A), Producer shall maintain registrations in good standing with the support of the Purchaser, as further described in the Quality Agreements; provided, however, for purposes of clarify this does not include recertifications.

  • Licensor will handle complaints, analysis, trending and regulatory reporting until the date Licensee becomes the Legal Manufacturer of the Products and otherwise provide the services set forth below until that time.

  • The nature and urgency of a recall of Product will be decided by the Legal Manufacturer when appropriate, following discussions with the Supplier and, if appropriate, any Regulatory Agency.

  • Licensee is entitled to use such material until Licensee becomes the Legal Manufacturer of the Products.


More Definitions of Legal Manufacturer

Legal Manufacturer means the manufacturer of a medical device under Applicable Laws, i.e., the natural or legal person who is responsible for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a Third Party. ​​
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Legal Manufacturer means the party registered with the FDA as the manufacturer of the Product, which coincides with the US Regulatory Transfer.
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Related to Legal Manufacturer

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

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

  • Manufacturer means the person or body who is responsible to the approval authority for all aspects of the type approval process and for ensuring conformity of production. It is not essential that the person or body is directly involved in all stage of the construction of the vehicle, system, component or separate technical unit which is the subject of the approval process.

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

  • Original manufacturer means the original component manufacturer, the original equipment manufacturer, or the contract manufacturer.

  • Engine Manufacturer means CFM International, Inc.

  • Third Party Manufacturer means (i) a Third Party whose primary business is contract manufacturing, or (ii) a Third Party who has a contractual arrangement with Licensee or with a sublicensee of Licensee that includes manufacturing of Client Product and/or Drug Product by such Third Party for Licensee or such sublicensee.

  • Satellite Manufacturer means, with respect to any Satellite, the prime contractor and manufacturer of such Satellite.

  • Authorized aftermarket manufacturer means an organization that fabricates a part under a contract with, or with the express written authority of, the original component manufacturer based on the original component manufacturer’s designs, formulas and/or specifications.

  • Participating manufacturer means that term as defined in the master settlement agreement.

  • 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.

  • Drug store means a place whose principal business is, the

  • Original equipment manufacturer means a company that manufactures products that it has designed from purchased components and sells those products under the company's brand name.

  • MANUFACTURERS means M/s and shall include their legal representatives, successors, and assigns.

  • Successor manufacturer means a manufacturer that acquires, succeeds to, or assumes any part of the business of another manufacturer as the result of any of the following:

  • City-based manufacturer means a person who: (i) holds any appropriate city license; (ii) is subject to applicable city taxes; and (iii) owns, operates, or leases a manufacturing facility within the city.

  • Distributor means a person who distributes.

  • 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.

  • Distillery manufacturing license means a license issued in accordance with

  • Motor vehicle manufacturer means any of the following:

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Nonparticipating manufacturer means any tobacco product manufacturer that is not a participating manufacturer.

  • Medical marijuana means marijuana that is grown, processed, dispensed, tested, possessed, or used for a medical purpose.

  • Non-Participating Manufacturer means any Tobacco Product Manufacturer that is not a Participating Manufacturer.

  • Medical management technique means a practice which is used to control the cost or utilization of health care services or prescription drug use. The term includes, without limitation, the use of step therapy, prior authorization or categorizing drugs and devices based on cost, type or method of administration.

  • Manufactured good means a good brought to the construction site for incorporation into the building or work that has been--