Drug Product Clause Samples
The 'Drug Product' clause defines what is meant by the term 'Drug Product' within the context of the agreement. Typically, this clause specifies the particular pharmaceutical product, including its formulation, dosage form, and any relevant regulatory status or approvals. For example, it may clarify whether the term refers to a finished, packaged medication ready for distribution or an intermediate product still in development. By clearly establishing the scope and characteristics of the 'Drug Product,' this clause ensures all parties have a shared understanding, reducing ambiguity and potential disputes regarding the subject of the contract.
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 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 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. 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 drug product consists of 2 components, ETX2514 and sulbactam. Descriptions of each component are provided.
Drug Product. MediciNova shall have the sole right to manufacture the Product for the use in the MediciNova Territory.
Drug Product. The composition of the RPV LA is provided in Table 2. to those currently approved since the drug Table 2: Nominal composition of Rilpivirine 300-mg/mL prolonged release suspension for injection (G001) Components Quality Referencea Function Composition per Unit Dose Rilpivirine (R278474) Active drug substance 600 900 Poloxamer 338 Glucose Monohydrate Sodium Dihydrogen Phosphate Monohydrate Citric Acid Monohydrate Sodium Hydroxide Water for Injection . ./ . ./ . ./ 100 150 38.50 57.75 4 6 q.s. ad 2 mL q.s ad 3 mL a Where multiple compendia are listed, the compendium specific to the region of the submission is applied. The 300-mg/mL drug product is packaged in a 4-mL clear glass vial with rubber injection stopper and sealed with an aluminum cap, and stored at 5 °C. The drug product is supplied as a medicinal product kit which contains the drug product vial, a sterile-packed plastic syringe, a sterile-packed safety needle and a sterile-packed vial adapter. The drug product is aseptically manufactured by , , , and aseptically filling it into glass vials. Two different dosage units, 600-mg and 900-mg dose, are obtained by filling the vials to a fill volume allowing an extractable volume of 2.0 mL and 3.0 mL, respectively.