Back-Up Manufacturer Sample Clauses

Back-Up Manufacturer. Prior to NK’s first Regulatory Filing of a New Drug Application for Products in the Territory, NeoPharm shall have completed the process whereby a second FDA approved Third Party shall become qualified to produce Products (the “Back-Up * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portion. Manufacturer”) in the event that the Primary Manufacturer is, for any reason, unable or unwilling to supply NeoPharm or NK with Product.
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Back-Up Manufacturer. If AcelRx fails [ * ] (a “Failure Event”), such Failure Event shall constitute a material breach of this Agreement and AcelRx shall grant a Third Party Manufacturer reasonably acceptable to Grünenthal the right to make and have made the Product for Grünenthal’s commercial sale in the Territory and promptly thereafter enable (at [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. AcelRx’s cost and expense) such Third Party Manufacturer with technology transfer to make such Product according to the then current Specifications. To the extent that Grünenthal has requested such Third Party Manufacturer be qualified in advance pursuant to Section 5.3(b) or otherwise pursuant to Section 2.4 of the License Agreement, such Third Party Manufacturer shall be qualified in advance. Following a Failure Event, Grünenthal shall no longer have an obligation to purchase and AcelRx shall no longer have an obligation to supply pursuant to this Agreement once such Third Party Manufacturer is qualified by Regulatory Approval to supply the Product for Grünenthal’s commercial sale in the Territory.
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Back-Up Manufacturer. The Parties shall discuss in good faith from time to time the desirability of qualifying one or more additional manufacturers of Product (each a “Back-Up Manufacturer”). Without limiting the foregoing, if the Parties agree to qualify a Back-Up Manufacturer, or if Oncothyreon requests the qualification of a Back-Up Manufacturer and Product sales in the United States are projected to exceed [*] units/Calendar Year within [*] years after such request, then Array shall exert Commercially Reasonable Efforts to effect the due qualification of a Back-Up Manufacturer, including without limitation by performing a Manufacturing Technology Transfer (as defined below) to the Back-Up Manufacturer as shall be more fully described in the agreement with the Back-Up Manufacturer.
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Back-Up Manufacturer. Notwithstanding anything in this Agreement to the contrary, Horizon may purchase three conforming exhibit batches of Product from a manufacturer other than Mikart to enable such other manufacturer to become qualified to manufacture the Product under the Health Registrations.
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Back-Up Manufacturer. In the event that, for a period of thirty (30) days, BMS is unable to supply or distribute the quantities of Product ordered, Cytogen shall have the right to arrange for supply and distribution of Product by a third party. At the request of Cytogen, BMS agrees to use its commercially reasonable efforts to assist Cytogen, at BMS' expense, in qualifying a third party selected by Cytogen to supply and distribute the Product during the period that BMS is unable to do so.
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Back-Up Manufacturer. Durata shall use its Commercially Reasonable Efforts to qualify with the EMA as well as to the other health authorities in the Territory an appropriate back up manufacturer for the Compound and an appropriate back up manufacturer for the Product (collectively referred to as the “Back up Manufacturer”) as soon as reasonably practicable after the Effective Date.
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Back-Up Manufacturer. In the event that DuPont is unable to supply or distribute the quantities of Product ordered, Berlex shall have the right to arrange for supply of Product by a third party. At the request of Berlex, DuPont agrees to take reasonable steps to assist Berlex, at Berlex's expense (reimbursement to be limited to DuPont's out of pocket expenses), in qualifying a third party selected by Berlex to manufacture and distribute the Product during the period that DuPont is unable to do so.
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Back-Up Manufacturer 
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Related to Back-Up Manufacturer

  • API A. Reliant shall supply to Cardinal Health for Manufacturing and Packaging, at Reliant’s sole cost, the API and applicable reference standards in quantities sufficient to meet Reliant’s requirements for each Product as further set forth in Article 4. Prior to delivery of any of the API or reference standard to Cardinal Health for Manufacturing and Packaging, Reliant shall provide to Cardinal Health a copy of the API Material Safety Data Sheet (“MSDS”), as amended, and any subsequent revisions thereto. Reliant shall supply the API, reference standards, and Certificate of Analysis FOB the Facility no later than thirty (30) days before the scheduled Manufacture Date upon which such API will be used by Cardinal Health. Upon receipt of the API, Cardinal Health shall conduct identification testing of the API. Cardinal Health shall use the API solely and exclusively for Manufacturing and Packaging under this Agreement. The maximum volume of API that Reliant supplies to Cardinal Health shall not exceed the amount reflected in the Firm Commitment and the next six (6) months of the Rolling Forecast.

  • Product Recall (a) If any governmental agency with jurisdiction over the recall of any goods supplied hereunder provides written notice to Buyer or Seller, or Buyer or Seller has a reasonable basis to conclude, that any goods supplied hereunder could possibly create a potential safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a defect or a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal requirement so as to make it advisable, or required, that such goods be recalled and/or repaired, Seller or Buyer will promptly communicate such relevant facts to each other. Buyer shall determine whether a recall of the affected goods is warranted or advisable, unless Buyer or Seller has received notice to that effect from any governmental agency with jurisdiction over the recalled goods.

  • Shipment If any of the Major Components associated with any Unit is not Shipped on or before (with the prior approval of the Buyer) the Scheduled Major Component Shipment Date set forth in Attachment 1 for reasons attributable to the Seller and not excused elsewhere in this Contract, the Seller shall pay as liquidated damages, and not as a penalty, a sum calculated in accordance with the table below for each Unit for each day of delay after the Scheduled Major Component Shipment Date as set forth in Attachment 1 until actual Shipment of the last Major Component for such Unit: Days after Scheduled Major Component Shipment Date Liquidated Damages (per day or partial day) *** *** *** *** *** *** Such liquidated damages, if any, shall be computed based on the date of Shipment of the last Major Component for a given Unit and such computations shall disregard any part of or accessory to the Major Component which may be shipped separately and arrive later unless such part of or accessory to the Major Component is necessary for the installation of the Major Component.

  • Product The term “

  • Product Quality (a) Tesoro warrants that all Products delivered under this Agreement or any Purchaser Order shall meet the latest applicable pipeline specifications for that Product upon receipt at the applicable Terminal and contain no deleterious substances or concentrations of any contaminants that may make it or its components commercially unacceptable in general industry application. Tesoro shall not deliver to any of the Terminals any Products which: (a) would in any way be injurious to any of the Terminals; (b) would render any of the Terminals unfit for the proper storage of similar Products; (c) would contaminate or otherwise downgrade the quality of the Products stored in commingled storage; (d) may not be lawfully stored at the Terminals; or (e) otherwise do not meet applicable Product specifications for such Product that are customary in the location of the Terminal. If, however, there are Products that do not have such applicable specifications, the specifications shall be mutually agreed upon by the Parties. Should Tesoro's commingled Products not meet or exceed the minimum quality standards set forth in this Agreement or any applicable Purchase Order, Tesoro shall be liable for all loss, damage and cost incurred thereby, including damage to Products of third parties commingled with Tesoro's unfit Products.

  • Defective Product If Client rejects Products under Section 6.1 and the deviation is determined to have arisen from Patheon’s failure to provide the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws, Patheon will credit Client’s account for Patheon’s invoice price for the defective Products. If Client previously paid for the defective Products, Patheon will promptly, at Client’s election, either: (i) refund the invoice price for the defective THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Products; (ii) offset the amount paid against other amounts due to Patheon hereunder; or (iii) replace the Products with conforming Products without Client being liable for payment therefor under Section 3.1, contingent upon the receipt from Client of all Active Materials and Client-Supplied Components required for the manufacture of the replacement Products. For greater certainty, Patheon’s responsibility for any loss of Active Materials in defective Product will be captured and calculated in the Active Materials Yield under Section 2.2.

  • Product Supply 5.2.1 HEMISPHERX undertakes and agrees to supply to IMPATIENTS on an exclusive basis, IMPATIENTS’ requirements of Product ordered in accordance with the terms of this Agreement, for distribution and sale in the Territory, limited to EAP use of Product in accordance with Early Access Approvals.

  • Defective Products None of the Group Companies has manufactured, sold or supplied products which are, or were, in any material respect, faulty or defective, or which do not comply in any material respect with any representations or warranties expressly made by such Group Company, or with all applicable regulations, standards and requirements.

  • Product Recalls The Company is not aware of any pattern or series of claims against the Company or any of its subsidiaries which reasonably could be expected to result in a generalized product recall relating to products sold by the Company or any of its subsidiaries, regardless of whether such product recall is formal, informal, voluntary or involuntary.

  • Supplier Selection If Customer selects a seat or galley supplier that is not on the Boeing recommended list, such seat or galley will become BFE and the provisions of Exhibit A, Buyer Furnished Equipment Provisions Document, of the AGTA will apply.

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