Manufacturing Party definition

Manufacturing Party shall have the meaning set forth in Section 7.3.

Manufacturing Party has the meaning set forth in Section 11.2.2(d).

Manufacturing Party shall have the meaning set forth in Section 8.1.

Examples of Manufacturing Party in a sentence

• The Manufacturing Party shall advise the other Parties immediately if an authorized agent of the FDA or other regulatory authority visits any of the Manufacturing Party's manufacturing facilities, or the facilities where the Collaboration Products are being manufactured, for an inspection with respect to the Collaboration Products.

• The Manufacturing Party shall furnish to the other Parties the report by such agency of such visit, to the extent that such report relates to Collaboration Products, within ten (10) business days of the Manufacturing Party's receipt of such report, and the other Parties shall have the right to comment on any response by the Manufacturing Party to such inspecting agency.

• The Manufacturing Party shall be entitled to charge Kallikrein LLC an amount equal to its Fully Absorbed Cost of Goods for such Collaboration Products.

• The Manufacturing Party selected pursuant to Section 7.3 above shall perform, or cause its contract manufacturer(s) to perform, quality assurance and control tests on each lot of Collaboration Products before delivery and shall prepare, or cause its contract manufacturer(s) to prepare and deliver, a written report of the results of such tests (for purposes of Sections 7.4, 7.5 and 7.6, such contract manufacturer(s) shall be included in the definition of the term "Manufacturing Party").

• The Manufacturing Party shall maintain such certificates for a period of not less than five (5) years from the date of manufacture and for so long as required under applicable requirements of the FDA or other applicable regulatory authority.

More Definitions of Manufacturing Party

Manufacturing Party means the Party who is responsible for the (i) manufacturing and supply of the Product for use during Development or (ii) commercial manufacture and supply of the Product.

Manufacturing Party means the Party who is from time to time ------------------- responsible for the (i) manufacturing and supply of the Licensed Products for use during Development or (ii) commercial manufacture and supply of the Licensed Products.

Manufacturing Party means the Party who is from time to time responsible for the (i) manufacturing and supply of the Antibody and/or the Product for use during Development or (ii) commercial manufacture and supply of the Antibody and/or the Product.

Manufacturing Party shall have the meaning set forth in Section 4.4.

Manufacturing Party has the meaning set forth in Section 5.3.2.1.

Manufacturing Party means either IMI or its designated third party contractor, who shall be bound by the responsibilities contained herein by separate agreement, but IMI shall have overall responsibility for compliance with the terms and conditions hereto applicable to any such Manufacturing Party.

Manufacturing Party means, with respect to each particular unit of Approved Product, the Party, or third party contract manufacturer if applicable, that manufactures into final form such Approved Product for distribution hereunder. For avoidance of doubt, neither Party shall be considered to be a Manufacturing Party under this Agreement as a result of the manufacture and supply to the other Party, or such third party contract manufacturer, of any components used by such other Party or contract manufacturer in the manufacture of the Approved Product.