Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will have [...***...] days to advise Client by notice in writing that it disagrees with the contents of the Deficiency Notice. If Client and Patheon fail to agree within […***…] days after Patheon’s notice to Client as to whether any Products identified in the Deficiency Notice deviate from the Specifications, cGMPs, or Applicable Laws, then the parties will mutually select an independent laboratory to evaluate if the Products deviate from the Specifications, cGMPs, or Applicable Laws. This evaluation will be binding on the parties. If the evaluation certifies that any Products deviate from the Specifications, cGMPs, or Applicable Laws, Client may reject those Products in the manner contemplated in this Section 6.1 and Patheon will be responsible for the cost of the evaluation. If the evaluation does not so certify for any of the Products, then Client will be deemed to have accepted delivery of the Products on the […***…] day after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Product, on the […***…] day after discovery thereof by Client, but not after the expiration date of the Product) and Client will be responsible for the cost of the evaluation.
Appears in 2 contracts
Samples: Product Agreement (Horizon Pharma, Inc.), Product Agreement (Horizon Pharma, Inc.)
Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will have [...…***...…] days to advise Client by notice in writing that it disagrees with the contents of the Deficiency Notice. Should Patheon fail to provide such notice to Client within the […***…] day period, then Patheon will be deemed to agree with the contents of the Deficiency Notice. If Client and Patheon fail to agree within […***…] days after Patheon’s 's notice to Client as to whether any Products identified in the Deficiency Notice deviate from the Specifications, cGMPs, or Applicable Lawsare Non-Conforming Products, then the parties Parties will mutually select an independent laboratory or expert to evaluate if the Products deviate from the Specifications, cGMPs, or Applicable Lawsare Non-Conforming Products. This evaluation will be binding on the partiesParties. If the evaluation certifies independent laboratory or expert determines that any Products deviate from the Specifications, cGMPs, or Applicable Lawsare Non-Conforming Products, Client may reject those Products in the manner contemplated in this Section 6.1 and Patheon will be responsible for the cost of the evaluation. If the evaluation does not so certify for any of independent laboratory determines that the ProductsProducts conform to the Product Warranties, then Client will be deemed to have accepted delivery of the Products on the […***…] day after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Product, on the […***…] day after discovery confirmation thereof by Client, but not after the expiration date of the Product) and Client will be responsible for the cost of the evaluation.
Appears in 2 contracts
Samples: Product Agreement (Acadia Pharmaceuticals Inc), Product Agreement (Acadia Pharmaceuticals Inc)
Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will have [...***...] ten days to advise Client by notice in writing that it disagrees with the contents of the Deficiency Notice. If Client and Patheon fail to agree within […***…] ten days after Patheon’s notice to Client as to whether any Products identified in the Deficiency Notice deviate from the Specifications, cGMPs, or Applicable Laws, then the parties will mutually select an independent laboratory to evaluate if the Products deviate from the Specifications, cGMPs, or Applicable Laws. This evaluation will be binding on the parties. If the evaluation certifies that any Products deviate from the Specifications, cGMPs, or Applicable Laws, Client may reject those Products in the manner contemplated in this Section 6.1 and Patheon will be responsible for the cost of the evaluation. If the evaluation does not so certify for any of the Products, then Client will be deemed to have accepted delivery of the Products on the […***…] day after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Product, on the […***…] day after discovery thereof by Client, but not after the expiration date of the Product) and Client will be responsible for the cost of the evaluation. *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Appears in 2 contracts
Samples: Manufacturing Services Agreement (Santarus Inc), Manufacturing Services Agreement (Santarus Inc)
Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will have [...…***...…] days to advise Client by notice in writing that it disagrees with the contents of the Deficiency Notice. If Client and Patheon fail to agree within […***…] days after Patheon’s 's notice to Client as to whether any Products identified in the Deficiency Notice deviate from the Specifications, cGMPs, or Applicable Laws, then the parties will mutually select an independent laboratory to evaluate if the Products deviate from the Specifications, cGMPs, or Applicable Laws. This evaluation will be binding on the parties. If the evaluation certifies that any Products deviate from the Specifications, cGMPs, or Applicable Laws, Client may reject those Products in the manner contemplated in this Section 6.1 and Patheon will be responsible for the cost of the evaluation. If the evaluation does not so certify for any of the Products, then Client will be deemed to have accepted delivery of the Products on the […***…] day after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Product, on the […***…] day after discovery thereof by Client, but not after the expiration date of the Product) and Client will be responsible for the cost of the evaluation.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Horizon Pharma PLC)
Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will have [...***...] days to advise Client by notice in writing that it disagrees with the contents of the Deficiency Notice. If Client and Patheon fail to agree within […***…] ten days after Patheon’s 's notice to Client as to whether any Products identified in the Deficiency Notice deviate from the Specifications, cGMPs, or Applicable Laws, then the parties will mutually select an independent qualified investigator and/or laboratory to evaluate if the Products deviate from the Specifications, cGMPs, or Applicable Laws. This evaluation will be binding on the parties. If the evaluation certifies that any Products deviate from the Specifications, cGMPs, or Applicable Laws, Client may reject those Products in the manner contemplated in this Section 6.1 and Patheon will be responsible . for the cost of the evaluation. If the evaluation does not so certify for any of the Products, then Client will be deemed to have accepted delivery of the Products on the […***…] day after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Product, on the […***…] day after discovery thereof by Client, but not after the expiration date of the Product) and Client will be responsible for the cost of the evaluation.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Akebia Therapeutics, Inc.)
Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will have [...***...] days to advise Client by notice in writing that it disagrees with the contents of the Deficiency Notice. If Client and Patheon fail to agree within […***…] ten days after Patheon’s 's notice to Client as to whether any Products identified in the Deficiency Notice deviate from the Specifications, cGMPs, or Applicable Laws, then the parties will mutually select an independent qualified investigator and/or laboratory to evaluate if the Products deviate from the Specifications, cGMPs, or Applicable Laws. This evaluation will be binding on the parties. If the evaluation certifies that any Products deviate from the Specifications, cGMPs, or Applicable Laws, Client may reject those Products in the manner contemplated in this Section 6.1 and Patheon will be responsible for the cost of the evaluation. If the evaluation does not so certify for any of the Products, then Client will be deemed to have accepted delivery of the Products on the […***…] day after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Product, on the […***…] day after discovery thereof by Client, but not after the expiration date of the Product) and Client will be responsible for the cost of the evaluation.
Appears in 1 contract
Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will have [...***...] days to advise Client by notice in writing that it disagrees with the contents of the Deficiency Notice. If Master Manufacturing Services Agreement Client and Patheon fail to agree within […***…] days after Patheon’s 's notice to Client as to whether any Products identified in the Deficiency Notice deviate from the Specifications, cGMPs, or Applicable Laws, then the parties will mutually select an independent laboratory to evaluate if the Products deviate from the Specifications, cGMPs, or Applicable Laws. This evaluation will be binding on the parties. If the evaluation certifies that any Products deviate from the Specifications, cGMPs, or Applicable Laws, Client may reject those Products in the manner contemplated in this Section 6.1 and Patheon will be responsible for the cost of the evaluation. If the evaluation does not so certify for any of the Products, then Client will be deemed to have accepted delivery of the Products on the […***…] day after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Product, on the […***…] day after discovery thereof by Client, but not after the expiration date of the Product) and Client will be responsible for the cost of the evaluation.
Appears in 1 contract
Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will shall have [...***...] days * to advise the Client by notice in writing that it disagrees with the contents of the such Deficiency Notice. If the Client and Patheon fail fail, after good faith discussions, to agree within […***…] days * after Patheon’s notice to the Client as to whether any Products identified in the Deficiency Notice deviate from the Specifications, Specifications or cGMPs, or Applicable Laws, then the parties will shall mutually select an independent laboratory to evaluate if the Products deviate from the Specifications, cGMPs, or Applicable Laws****. This Such evaluation will shall be binding on the parties. If the , and if such evaluation certifies that any Products deviate from ****, the Specifications, cGMPs, or Applicable Laws, Client may reject those Products in the manner contemplated in this Section 6.1 and Patheon will be responsible for the cost of the evaluation6.1. If the such evaluation does not so certify for in respect of any of the such Products, then the Client will shall be deemed to have accepted delivery of the such Products on the […***…] day * after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Product, on the […***…] day * **** CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. after discovery thereof by the Client, but not in no event after the expiration date of the Product) and Client will be responsible for the cost ). The decision of the evaluationlaboratory shall be binding on the parties, and the party that the decision disfavours shall bear the costs charged by such laboratory in connection with its decision.
Appears in 1 contract
Samples: Manufacturing Agreement (Vanda Pharmaceuticals Inc.)
Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will have [...***...] days to advise Client by notice in writing that it disagrees with the contents of the Deficiency Notice. If Client and Patheon fail to agree within […***…] days after Patheon’s 's notice to Client as to whether any Products identified in the Deficiency Notice deviate from the Specifications, cGMPs, or Applicable Laws, then the parties will mutually select an independent laboratory to evaluate if the Products deviate from the Specifications, cGMPs, or Applicable Laws. This evaluation will be binding on the parties. If the evaluation certifies that any Products deviate from the Specifications, cGMPs, or Applicable Laws, Client may reject those Products in the manner contemplated in this Section 6.1 and Patheon will be responsible for the cost of the evaluation. If the evaluation does not so certify for any of the Products, then Client will be deemed to have accepted delivery of the Products on the […***…] day after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Product, on the […***…] day after discovery thereof by Client, but not after the expiration date of the Product) and Client will be responsible for the cost of the evaluation.. (c)
Appears in 1 contract
Samples: Services Agreement
Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will have [...***...] days to advise Client by notice in writing that it disagrees with the contents of the Deficiency Notice. If Client and Patheon fail to agree within […***…] days after Patheon’s 's notice to Client as to whether any Products identified in the Deficiency Notice deviate from the Specifications, cGMPs, or Applicable Laws, then the parties will mutually select an independent laboratory to evaluate if the Products deviate from the Specifications, cGMPs, or Applicable Laws. This evaluation will be binding on the parties. If the evaluation certifies that any Products deviate from the Specifications, cGMPs, or Applicable Laws, Client may reject those Products in the manner contemplated in this Section 6.1 and Patheon will be responsible for the cost of the evaluation. If the evaluation does not so certify for any of the Products, then Client will be deemed to have accepted delivery of the Products on the […***…] day after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Product, on the […***…] day Master Manufacturing Services Agreement after discovery thereof by Client, but not after the expiration date of the Product) and Client will be responsible for the cost of the evaluation.
Appears in 1 contract
Samples: Product Agreement (Horizon Therapeutics Public LTD Co)
Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will have [...***...] days to advise Client Penwest by notice in writing that it disagrees with the contents of the Deficiency Notice. If Client Penwest and Patheon fail to agree within […***…] days after Patheon’s notice to Client Penwest as to whether any Products identified in the Deficiency Notice deviate from the Specifications, the Manufacturing Process, cGMPs, or Applicable applicable Laws, then the parties Parties will mutually select an independent laboratory to evaluate if whether the Products deviate from the Specifications, the Manufacturing Process, cGMPs, or Applicable applicable Laws. This evaluation will be binding on the partiesParties. If the evaluation certifies that any Products deviate from the Specifications, the Manufacturing Process, cGMPs, or Applicable applicable Laws, Client Penwest may reject those Products in the manner contemplated in this Section 6.1 and Patheon will be responsible for the cost of the evaluation[**]. If the evaluation does not so certify for any of the Products, then Client Penwest will be deemed to have accepted delivery of the Products on the […***…] day after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Product, on the […***…] day after discovery thereof by ClientPenwest or its customer(s), but not after the expiration date of the Product) and, as between Penwest and Client will be responsible for the cost of the evaluationPatheon, [**].
Appears in 1 contract
Samples: Manufacturing Services Agreement (Penwest Pharmaceuticals Co)
Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will have [...…***...…] days to advise Client by notice in writing that it disagrees with the contents of the Deficiency Notice. If Client and Patheon fail to agree within […***…] days after Patheon’s notice to Client as to whether any Products identified in the Deficiency Notice deviate from the Specifications, cGMPs, or Applicable Laws, then the parties will mutually select an independent laboratory to evaluate if the Products deviate from the Specifications, cGMPs, or Applicable Laws. This evaluation will be binding on the parties. If the evaluation certifies that any Products deviate from the Specifications, cGMPs, or Applicable Laws, Client may reject those Products in the manner contemplated in this Section 6.1 and Patheon will be responsible for the cost of the evaluation. If the evaluation does not so certify for any of the Products, then Client will be deemed to have accepted delivery of the Products on the […***…] day after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Product, on the […***…] day after discovery thereof by Client, but not after the expiration date of the Product) and Client will be responsible for the cost of the evaluation.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Horizon Pharma PLC)
Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will shall have [...***...[ * ] days to advise Client inform Customer by notice in writing that it disagrees with the contents of the such Deficiency Notice. If Client Customer and Patheon fail to agree within […***…[ * ] days after Patheon’s 's notice to Client Customer as to whether any Products identified in the Deficiency Notice deviate from the Specifications, cGMPs, cGMPs or Applicable Laws, then the parties will shall mutually select an independent laboratory to evaluate suitable third party expert if the Products deviate from the Specifications, Specifications or cGMPs, or Applicable Laws. This Such evaluation will shall be binding on the parties. If the , and if such evaluation certifies that any Products deviate from the Specifications, Specifications or cGMPs, or Applicable Laws, Client Customer may reject those Products in the manner contemplated in this Section 6.1 6.1. In that event and Patheon assuming that failure is solely due to Patheon’s act or omission, the evaluation costs will be borne by Patheon, otherwise the Customer will be responsible for the cost of the evaluationevaluation costs. If the such evaluation does not so certify for any of the Productsshow Patheon’s fault, then Client will Customer shall be deemed to have accepted delivery of the such Products on the […***…[ * ] day after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Product, on the […***…[ * ] day after discovery thereof by ClientCustomer, but not in no event after the expiration date of the Product) and Client will be responsible for the cost of the evaluation).
Appears in 1 contract
Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will have [...…***...…] days to advise Client by notice in writing that it disagrees with the contents of the Deficiency Notice. Should Patheon fail to provide such notice to Client within the […***…] day period, then Patheon will be deemed to agree with the contents of the Deficiency Notice. If Client and Patheon fail to agree within […***…] days after Patheon’s notice to Client as to whether any Products identified in the Deficiency Notice deviate from the Specifications, cGMPs, or Applicable Lawsare Non-Conforming Products, then the parties Parties will mutually select an independent laboratory or expert to evaluate if the Products deviate from the Specifications, cGMPs, or Applicable Lawsare Non-Conforming Products. This evaluation will be binding on the partiesParties. If the evaluation certifies independent laboratory or expert determines that any Products deviate from the Specifications, cGMPs, or Applicable Lawsare Non-Conforming Products, Client may reject those Products in the manner contemplated in this Section 6.1 and Patheon will be responsible for the cost of the evaluation. If the evaluation does not so certify for any of independent laboratory determines that the ProductsProducts conform to the Product Warranties, then Client will be deemed to have accepted delivery of the Products on the […***…] day after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Product, on the […***…] day after discovery confirmation thereof by Client, but not after the expiration date of the Product) and Client will be responsible for the cost of the evaluation.
Appears in 1 contract