Drug Product. At the request of Merck, and if agreed to by the Parties, such agreement not to be unreasonably withheld, conditioned or delayed, the Parties shall discuss and agree on the terms pursuant to which Moderna would Manufacture and supply of Drug Product to
Drug Product. Except to the extent that Patheon has failed to provide the Manufacturing Services in accordance with the Patheon Manufacturing Responsibilities and as set forth in section 6.2 hereof, Patheon shall not be liable nor have any responsibility for any deficiencies in, or other liabilities associated with, any Drug Product manufactured by it, including, without limitation, the costs and expenses of any Recall (collectively, “Drug Product Claims”). For greater certainty, Patheon shall have no obligation for any Drug Product Claims to the extent such Drug Product Claim (i) is caused by deficiencies with respect to the Specifications, the safety, efficacy or marketability of the Drug Product or any distribution thereof, (ii) results from a defect in a Component that is not reasonably discoverable using the test methods set forth in the Specifications, (iii) results from a defect in the Active Compounds or Granulations (as the case may be) or Components supplied by the Client, (iv) is caused by actions of third parties occurring after such Drug Product is shipped by Patheon pursuant to Section 5.5, (v) is caused by actions or omissions of third party suppliers of Components in which deficiencies or defects were not detected or were not detectable by Patheon after conducting tests in accordance with the Specifications, (vi) is due to packaging or labelling defects or omissions for which Patheon has no responsibility, or (vii) is due to any other breach by the Client of its obligations under this Agreement.
Drug Product. The amounts forecasted by Bioverativ for each month within the Semi-Binding Forecast period may not be changed by Bioverativ to be more than fifty percent (50%) above or fifty percent (50%) below the number of Lots by Presentation for such month when it first appeared in the Semi-Binding Forecast.
Drug Product. The Binding Forecast for any month (i) may not be more than fifty percent (50%) above or fifty percent (50%) below the number of Lots respectively by Presentation for such month when it first appeared in the Semi- Binding Forecast and (ii) may not be changed from the quantities forecasted for such month in the first Binding Forecast to include such month, without the prior written consent of Biogen on a case-by-case basis.
Drug Product. The dosage form in the final immediate packaging intended for human clinical or commercial use.
Drug Product. The term “
Drug Product. At the request of Xxxxx, and if agreed to by the Parties, such agreement not to be unreasonably withheld, conditioned or delayed, the Parties shall discuss and agree on the terms pursuant to which Moderna would Manufacture and supply of Drug Product to 33 Merck. If the Parties agree to enter into an agreement with respect to the Manufacture and supply of Drug Product, such agreement will include similar terms and conditions, including similar quality standards and audit rights, as set forth in this Section 4 and Exhibit A; provided, that the Parties acknowledge and agree that different pricing will need to be negotiated with respect to the Manufacture and supply of Drug Product.
Drug Product. Company shall provide invoices to Client for Drug Product upon each Release to The Client (e.g. finished bulk, finished packaged, or finished packaged and labeled, including serialization).
Drug Product. The Batch Price for Drug Product shall be [**]. The deliverables for a Drug Product Batch include [**]. Upon completion of [**], and annually thereafter, the JSC will evaluate and, if appropriate, recommend reasonable modifications to the Batch Price for Drug Product that are reflective of and consistent with [**].
Drug Product. If the parties agree that a Non-Conforming Batch of Product that is Drug Product is the result of [***], Manufacturer shall, at Tectonic’s sole option, (A) Manufacture a new Batch of Drug Product that is a conforming Batch as soon as reasonably possible (using [***] efforts to prioritize the Manufacture of the new Batch within [***] upon request by Tectonic) and [***] for such replacement Batch, and Tectonic shall provide sufficient Drug Substance for the replacement Batch, or (B) within [***] after Tectonic’s election of the option in this subsection (ii), [***] for the Non-Conforming Batch. Furthermore, for the avoidance of doubt, if Tectonic requests Manufacturer to Manufacture a new Batch under this Section 6.5(a), Manufacturer shall provide a free slot for Batch Manufacturing to replace such non-conforming Batch as soon as reasonably possible.