Related Manufacturing Agreement definition

Related Manufacturing Agreement means any supply or quality agreement entered into between the Parties or their Affiliates pursuant to this Agreement.
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Related Manufacturing Agreement means any supply or quality agreement entered into between the Parties or their respective Affiliates with respect to the Product. ​
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Related Manufacturing Agreement means any supply or quality agreement entered into between the Parties or their respective Affiliates with respect to the Product. 1.106 “Related Party” means a Party and its Affiliates. For clarity, Related Party shall not include any distributors, wholesalers or the like unless such entity is an Affiliate of the applicable Party. 1.107 “Royalty Territory” means all countries and territories within the Territory except for the Major Markets. 1.108 “Sales and Distribution” means all sales and distribution activities for the Product in connection with Commercialization thereof, including customer service, handling of returns, order processing, inventory, warehousing, shipping, serialization compliance, invoicing, booking of sales, distribution and collection of receivables. 1.109 “Sales Representative” of a Party means (a) an employee of such Party or an Affiliate of such Party engaged by such Party or Affiliate to Promote the Product on behalf of such Party or such Affiliate, or (b) an Approved Subcontractor, including a CSO, engaged by such Party or Affiliate (to the extent permitted in this Agreement) to Promote the Product on behalf of such Party or such Affiliate, excluding, in each case ((a) and (b)), (i) those employees or independent contractors of either Party or such an Affiliate that are solely engaged in telemarketing, professional education or other indirect activities in support of direct selling, and (ii) Medical Science Liaisons of a Party or such Affiliate. For clarity, “Sales Representatives” do not include employees or Approved Subcontractors engaged in Hospital and Organized Customer Activities. 1.110 “Samples” means Product units which are not intended to be sold or traded, which are intended to be distributed to authorized health care professionals, and which are intended to promote the sale of such prescription drug in accordance with 21 U.S.C. §§353(c) and (d), and the applicable regulations of Title 21 of the U.S. Food and Drug Administration governing
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Examples of Related Manufacturing Agreement in a sentence

  • With respect to liability for Manufacturing Losses (whether incurred in connection with the Parties’ performance of their respective obligations under this Agreement or a Related Manufacturing Agreement, or otherwise), the provisions of this ARTICLE 13 shall apply to the allocation of financial responsibility between the Parties.


More Definitions of Related Manufacturing Agreement

Related Manufacturing Agreement means the Related Manufacturing Agreement attached hereto as Appendix 11.
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Related to Related Manufacturing Agreement

  • Manufacturing Agreement has the meaning set forth in Section 2.6.

  • Clinical Supply Agreement shall have the meaning set forth in Section 7.2.

  • Collaborative pharmacy practice agreement means a written and signed

  • Supply Agreement has the meaning set forth in Section 7.1.

  • Commercial Supply Agreement has the meaning set forth in Section 4.1 (Supply Agreement).

  • Marketing Agreement means an agreement entered into, with the director, by producers, distributors, processors, or handlers pursuant to this act and binding only on those signing the agreement.

  • 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 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.

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

  • Distillery manufacturing license means a license issued in accordance with

  • Manufacturing Process means any process for—

  • 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.

  • Collaboration Agreement has the meaning set forth in the Recitals.

  • 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.

  • Supply Agreements has the meaning set forth in Section 7.1.

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

  • Collaborative practice agreement means a written agreement

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

  • Development Agreement has the meaning set forth in the Recitals.

  • Training Agreement means an agreement registered under the provisions of the Industrial and Commercial Training Act 1985.

  • 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;

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

  • 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.

  • Technology Transfer Agreement has the meaning given in Section 2.2(e).

  • 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.

  • Good Manufacturing Practices or “GMP” shall mean the then current Good Manufacturing Practices as such term is defined from time to time by the FDA or other relevant Governmental Authority having jurisdiction over the development, manufacture or sale of the Product in the Territory pursuant to its regulations, guidelines or otherwise.