Formulated Bulk Product definition

Formulated Bulk Product means Licensed Product in the Field formulated into solution or in a lyophilized form, ready for storage or shipment to a manufacturing facility, to allow processing into the final dosage form.
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Formulated Bulk Product means (a) the Existing Product Formulation formulated into solution or in a lyophilized form, and (b) any other form of any Product to be supplied by Regeneron under a Supply Agreement that is ready for storage or shipment to a manufacturing facility to allow processing into the final dosage form.
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Formulated Bulk Product means (a) with respect to a Monotherapy PDGF Product, the PDGF Receptor Antibody included therein; (b) with respect to a Combination PDGF Product combined in a single formulation, Aflibercept, the PDGF Receptor Antibody and any other active ingredients included therein; or (c) with respect to any other Licensed Product, including, without limitation, any other Combination PDGF Product, each of the PDGF Receptor Antibody and, if applicable, Aflibercept and any other active ingredients included therein, in each case ((a), (b) and (c)), formulated into solution or in a lyophilized form, ready for storage or shipment to a manufacturing facility, to allow processing into the Finished Product.
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Examples of Formulated Bulk Product in a sentence

  • Until such time as Commercial Supply Requirements are being Manufactured, Regeneron will use Commercially Reasonable Efforts to provide an adequate and timely supply of Formulated Bulk Product for Clinical Supply Requirements of Licensed Products in the Field in the Territory in accordance with the Manufacturing Plan.

  • Regeneron may use its Manufacturing facilities or, subject to Sanofi’s prior written approval, such approval not to be unreasonably withheld or delayed, Sanofi or Third Parties to Manufacture such Formulated Bulk Product.

  • Regeneron will timely identify, and enter into an agreement with, a Third Party or Third Parties or Sanofi (or use its own facilities, if Regeneron has such capabilities) to perform the filling, packaging, labeling and testing of the Formulated Bulk Product and supply Finished Product for Clinical Supply Requirements for Licensed Products for use under this Agreement.

  • If an entity other than Regeneron is to be used to Manufacture Formulated Bulk Product for Clinical Supply Requirements, preference shall be given to Sanofi or an Affiliate of Sanofi that is qualified to Manufacture the applicable Licensed Product in accordance with applicable Good Practices and where the estimated Manufacturing Cost is comparable to that of Third Party Manufacturers.

  • The Formulated Bulk Product Manufactured by or on behalf of Regeneron for Clinical Supply Requirements will be billed to Sanofi by Regeneron at the Manufacturing Cost per Part I of Schedule 1 as a Development Cost.

  • Each Party will timely notify and seek the approval of the other Party, which approval shall not be unreasonably withheld or delayed, for any Manufacturing changes for the Formulated Bulk Product or Finished Product that are reasonably likely to have an adverse impact on (a) the quality of the Licensed Products supplied under this Agreement or (b) the regulatory status of the Licensed Products in the Territory, including requirements to support or maintain any Approvals.

  • If the approved training is during the regular school day, committee members shall be given professional release time to attend such training up to two days per year.

  • The Manufacturing Plan will include arrangements for the Manufacture of back-up Formulated Bulk Product for Licensed Product requirements at a Party or a Third Party back-up Manufacturing facility.

  • Regeneron plans to expand its facilities in Rensselaer, New York (the “Expansion Plans”) to help provide an adequate and timely supply of Formulated Bulk Product for Clinical Supply Requirements (as those terms are defined in the License Agreement) of Licensed Products.

  • Manufacture and Supply of Clinical Supply Requirements of Formulated Bulk Product.


More Definitions of Formulated Bulk Product

Formulated Bulk Product means Product formulated into solution at the DS Facility that is ready for storage or shipment to KINIKSA or to KINIKSA’s designee to allow for further processing.
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Related to Formulated Bulk Product

  • Reformulated Products means Products that contain concentrations less than or equal to 0.1% (1,000 parts per million (ppm)) of DEHP when analyzed pursuant to U.S. Environmental Protection Agency testing methodologies 3580A and 8270C or other methodology utilized by federal or state government agencies for the purpose of determining the phthalate content in a solid substance.

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

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Cannabis product means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Manufactured end product means any end product in product and service codes (PSCs) 1000-9999, except—

  • Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh).

  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.