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 [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED
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 term “
Drug Product. The dosage form in the final immediate packaging intended for human clinical or commercial use.
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. 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. During the Term, Novartis shall place each Purchase Order for vials of Drug Product in accordance with its current Forecast at least [**] prior to the required delivery date specified in such Purchase Order. Subject to Section 3.4(a), the vials of Drug Products ordered by Novartis as set forth in each Purchase Order will be firm and binding on both Parties. For the avoidance of doubt, all Purchase Orders placed by Novartis for vials of Drug Products shall be consistent with the Maximum Yearly Capacity.
Drug Product. If the Drug Substance met or is deemed to meet Product Requirements, but the Drug Product constitutes Catalent Nonconforming Product, [***] shall [***] the [***] at [***] for [***]. In the re-performance of its Drug Product Services, Catalent shall use replacement Bulk Drug Substance, Raw Materials, Process Consumables, and Components. Regardless of whether such replacement Bulk Drug Substance, Raw Materials, Process Consumables, and Components are provided by Client or Catalent, [***] the [***] of the [***] and [***] the [***] of the [***] , and [***]. The remedies described in this Section 4.2.1 shall be Client’s sole remedies under this Section 4.2.1.
Drug Product. Subject to compliance with Section 9.2, NeoRx agrees to indemnify and defend Xxxxxxx Pharma, its Affiliates and/or its Sublicensees, and their [ * ] Confidential Treatment Requested. respective agents and employees, from and against any and all losses, liabilities, damages, costs, fees and expenses, including reasonable legal costs and attorneys' fees ("Losses") resulting from a Third Party claim, suit or action based upon: