1000mg Formulation Clause Samples

1000mg Formulation. (a) The parties acknowledge that Depomed will use commercially reasonable efforts to submit a supplemental new drug application to the FDA and to obtain Regulatory Approval for a 1000mg formulation using metformin as the sole active pharmaceutical ingredient (the “1000mg Formulation”) to which Depomed has certain rights pursuant to the BLS Supply Agreements. (b) The provisions of Section 6.1 through 6.6 will not apply to the 1000mg Formulation unless and until Depomed obtains Regulatory Approval for the 1000mg Formulation, at which time such provisions will apply, except as follows: (i) Depomed shall have no obligation to continue to supply and distribute the 1000mg Formulation if Depomed, in the exercise of its reasonable business judgment after consultation with the JCC, determines that marketing the 1000mg Formulation in the Territory is not commercially feasible due to reasons related to intellectual property matters, safety, FDA, manufacturing or supply issues, or market conditions; and (ii) Depomed shall have no liability under this Agreement for any failure by BLS to timely deliver and supply the 1000mg Formulation under the BLS Supply Agreement in accordance with the terms thereof, and any such failure on the part of BLS shall not be a breach or default of this Agreement by Depomed (except to the extent that any such failure by BLS arises directly from Depomed’s failure to comply with its obligations, including paying amounts due, under such agreement).
View SourceView Similar (3)

Related to 1000mg Formulation

  • RE-WEIGHING PRODUCT Deliveries are subject to re- weighing at the point of destination by the Authorized User. If shrinkage occurs which exceeds that normally allowable in the trade, the Authorized User shall have the option to require delivery of the difference in quantity or to reduce the payment accordingly. Such option shall be exercised in writing by the Authorized User.

  • Reformulation of Products As of the Effective Date, and continuing thereafter, Products that ▇▇▇▇▇▇▇ directly manufactures, imports, distributes, sells, or offers for sale in California shall either: (a) be Reformulated Products pursuant to § 2.2, below; or (b) be labeled with a clear and reasonable exposure warning pursuant to §§ 2.3 and 2.4, below. For purposes of this Settlement Agreement, a “Reformulated Product” is a Product that is in compliance with the standard set forth in

  • Product NYISO will provide Energy Resource Interconnection Service and Capacity Resource Interconnection Service to Developer at the Point of Interconnection.

  • Product Quality Isoprene, (hereinafter referred to as “Product”) supplied and maintained on consignment at Belpre in accordance with Article 6, and will be in accordance with specifications set forth in Exhibit A. Seller will facsimile to the Buyer at time of shipment a Certificate of Analysis (COA). Seller will provide Buyer six (6) months advanced notification if there is a change in the manufacturing process that will affect the material specifications of Product provided to the Buyer. Product produced by the Seller in different plants is viewed as coming from different supply sources and requires separate qualifications. Product to be shipped for the Seller from third parties must be from a third party qualified by the Buyer based on Buyer’s criteria as specified in Exhibit B. Buyer will have the right to confirm each such shipment-conforms to the agreed specification; Seller must obtain approval prior to shipment any material that does not meet the Buyers specifications. If Seller deliveries Product failing to comply with the specifications set out in Exhibit A, Seller will reimburse Buyer for freight expenses associated with such shipment and be entitled at its option to i) require Seller to replace such defective Product at a price not to exceed the invoice value or ii) to reimburse the invoice value of the defective Product. If, Buyer has cause to complain that the quality of Product delivered to it pursuant to the Contract does not comply with the specification set out in Exhibit A, Buyer will give written notice specifying the nature of its complaint and the parties will promptly meet so as to resolve that complaint. In absence of any agreement to resolve the complaint the parties will appoint at their joint cost a mutually acceptable independent surveyor to examine whether the quality of Product as delivered complied with the specifications set forth in Exhibit A. In the absence of any written notice from Buyer to Seller within 30 days after delivery of the Product, the Product shall be deemed to have been delivered and accepted by Buyer in a satisfactory condition and in all respects in accordance with the specifications and Seller shall have no liability to Buyer with respect to that delivery.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.