Common use of Determination of Deficiency Clause in Contracts

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon shall have 10 days to advise the Client by notice in writing that it disagrees with the contents of such Deficiency Notice. If the Client and Patheon fail to agree within 10 days after Patheon’s notice to the Client as to whether any Drug Product identified in the Deficiency Notice deviates from the Specifications, cGMPs, or Applicable Laws, then the parties shall mutually select an independent laboratory to evaluate if the Drug Product deviates from the Specifications or cGMPs. Such evaluation shall be binding on the parties, and if such evaluation certifies that Drug Product deviates from the Specifications, cGMPs, or Applicable Laws, the Client may reject those Drug Product in the manner contemplated in this Section 6.1. If such evaluation does not so certify in respect of any such Drug Product, then the Client shall be deemed to have accepted delivery of such Drug Product on the 40th day after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Drug Product, on the 40th day after discovery thereof by the Client, but in no event after the expiration date of the Drug Product).

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon shall have 10 days [ * ] to advise the Client by notice in writing that it disagrees with the contents of such Deficiency Notice. If the Client and Patheon fail to agree within 10 days [ * ] after Patheon’s 's notice to the Client as to whether any Drug Product identified in the Deficiency Notice deviates from the Specifications, Specifications or cGMPs, or Applicable Laws, then the parties shall mutually select an independent a laboratory to evaluate if the Drug Product deviates from the Specifications or cGMPs. Such evaluation shall be binding on the parties, and if such evaluation certifies that Drug any Product deviates [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. from the Specifications, Specifications or cGMPs, or Applicable Laws, the Client may reject those Drug such Product in the manner contemplated in this Section 6.1. If such evaluation does not so certify in respect of any such Drug Product, then the Client shall be deemed to have accepted delivery of such Drug Product on the 40th [ * ] day after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Drug Product, on the 40th [ * ] day after discovery thereof by the Client, but in no event after the expiration date of the Drug Product).

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon shall will have 10 ten days to advise the Client by notice in writing that it disagrees with the contents of such the Deficiency Notice. If the Client and Patheon fail to agree within 10 ten days after Patheon’s notice to the Client as to whether any Drug Product Products identified in the Deficiency Notice deviates deviate from the Specifications, cGMPs, or Applicable Laws, then the parties shall will mutually select an independent laboratory to evaluate if the Drug Product deviates Products deviate from the Specifications Specifications, cGMPs, or cGMPsApplicable Laws. Such This evaluation shall will be binding on the parties, and if such the evaluation certifies that Drug Product deviates any Products deviate from the Specifications, cGMPs, or Applicable Laws, the Client may reject those Drug Product Products in the manner contemplated set forth in this Section 6.16.1 and Patheon will be responsible for the cost of the evaluation. If such the evaluation does not so certify in respect for any of any such Drug Productthe Products, then the Client shall will be deemed to have accepted delivery of such Drug Product the Products on the 40th day after delivery ({or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Drug Product, on the 40th day after discovery thereof by the Client, but in no event not after the expiration date of the Drug Product)) and Client will be responsible for the cost of the evaluation.

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon shall will have 10 [***] days to advise the Client by notice in writing that it disagrees with the contents of such the Deficiency Notice. If the Client and Patheon fail to agree within 10 [***] days after Patheon’s 's notice to the Client as to whether any Drug Product identified in the Deficiency Notice was not manufactured in accordance with or deviates from (except for properly documented and approved deviations) the Specifications, cGMPscGMP, or Applicable Laws, then the parties shall mutually will select an independent laboratory of reputable standing reasonably acceptable to each party to evaluate if the Drug Product deviates from the Specifications or cGMPsProduct. Such This evaluation shall will be binding on the parties, and if such parties in respect of this Section 6 in the absence of manifest bias or error. If the evaluation certifies that Drug any Product was not manufactured in accordance with or deviates from (except for properly documented and approved deviations) the Specifications, cGMPs, cGMPs or Applicable Laws, then such Product shall be deemed to be rejected by Client and Patheon will be responsible for the Client may reject those Drug Product in cost of the manner contemplated in this Section 6.1evaluation. If such the evaluation does not so certify in respect of any such Drug Productcertify, then the Client shall will be deemed to have accepted delivery of such Drug the Product on the 40th [***] day after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Drug Product, on the 40th [***] day after discovery thereof by the Client, but in no event not after the expiration date of the Drug Product), and Client will be responsible for the cost of the evaluation.

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon shall have 10 ten (10) days to advise the Client MDCO by notice in writing that it disagrees with the contents of such Deficiency Notice. If the Client MDCO and Patheon fail to agree within 10 ten (10) days after Patheon’s notice to the Client MDCO as to whether any Drug Product Products identified in the Deficiency Notice deviates deviate from the Specifications, cGMPs, or Applicable LawsManufacturing Requirements, then the parties Parties shall mutually select an independent laboratory to evaluate if the Drug Product deviates Products deviate from the Specifications or cGMPsManufacturing Requirements. Such evaluation shall be binding on the partiesParties, and if such evaluation certifies that Drug Product deviates any Products deviate from the SpecificationsManufacturing Requirements, cGMPs, or Applicable Laws, the Client MDCO may reject those Drug Product Products in the manner contemplated in this Section 6.1. In that event the evaluation costs will be borne by Patheon, otherwise MDCO will be responsible for the evaluation costs. If such evaluation does not so certify in respect of any such Drug ProductProducts, then the Client MDCO shall be deemed to have accepted delivery of such Drug Product Products on the 40th fortieth (40th) day after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Drug Product, on the 40th fortieth (40th) day after discovery thereof by the ClientMDCO, but in no event after the expiration date of the Drug Product).

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon shall will have 10 ten days to advise the Client by notice in writing that it disagrees with the contents of such the Deficiency Notice. If the Client and Patheon fail fall to agree within 10 ten days after Patheon’s 's notice to the Client as to whether any Drug Product identified Products Identified in the Deficiency Notice deviates deviate from the Specifications, cGMPs, or Applicable Laws, then the parties shall will mutually select an independent laboratory to evaluate if If the Drug Product deviates Products deviate from the Specifications Specifications, cGMPs, or cGMPsApplicable Laws. Such This evaluation shall will be binding on the parties, and if such . If the evaluation certifies that Drug Product deviates any Products deviate from the Specifications, cGMPs, or Applicable Laws, the Client may reject those Drug Product Products in the manner contemplated in this Section 6.16.1 and Patheon will be responsible for the cost of the evaluation. If such the evaluation does not so certify in respect for any of any such Drug Productthe Products, then the Client shall will be deemed to have accepted delivery of such Drug Product the Products on the 40th day after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Drug Product, on the 40th day after discovery thereof by the Client, but in no event not after the expiration date of the Drug Product)) and Client will be responsible for the cost of the evaluation.

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon shall have 10 days to advise the Client by notice in writing that it disagrees with the contents of such Deficiency Notice. If the Client and Patheon fail to agree within 10 days after Patheon’s notice to the Client as to whether any Drug Product Products identified in the Deficiency Notice deviates deviate from the Specifications, Specifications or cGMPs, or Applicable Laws, then the parties shall mutually select an independent laboratory within five days from the parties’ failure to agree, which independent laboratory shall evaluate if the Drug Product deviates Products deviate from the Specifications or cGMPs. The parties shall cause the independent laboratory to conduct its evaluation as promptly as practicable, and in any event within 30 days from the date of selection of the laboratory. Such evaluation shall be binding on the parties, and if such evaluation certifies that Drug Product deviates any Products deviate from the Specifications, Specifications or cGMPs, or Applicable Laws, the Client may reject those Drug Product Products in the manner contemplated in this Section 6.1. If such evaluation does not so certify in respect of any such Drug ProductProducts, then the Client shall be deemed to have accepted delivery of such Drug Product Products on the 40th day after delivery (ordate the evaluation is delivered by the independent laboratory to the parties. The expenses of such testing shall be borne by Patheon if the non-conformity with the Specifications or cGMPs is confirmed by the independent laboratory, in the case of any defects not reasonably susceptible to discovery upon receipt of the Drug Product, on the 40th day after discovery thereof and otherwise by the Client, but in no event after the expiration date of the Drug Product).

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon APP shall have 10 [**] days to advise the Client MDCO by notice in writing that it disagrees with the contents of such Deficiency Notice. If the Client MDCO and Patheon APP fail to agree within 10 [**] days after Patheon’s APP's notice to the Client MDCO as to whether any Drug Product identified in the Deficiency Notice deviates deviate from the Specifications, cGMPs, or Applicable LawsManufacturing Requirements, then the parties Parties shall mutually select an independent laboratory to evaluate if the Drug Product deviates deviate from the Specifications or cGMPsManufacturing Requirements. Such evaluation shall be binding on the partiesParties, and if such evaluation certifies that Drug any Product deviates deviate from the SpecificationsManufacturing Requirements, cGMPs, or Applicable Laws, the Client MDCO may reject those Drug Product in the manner contemplated in this Section 6.1. In that event the evaluation costs will be borne by APP, otherwise MDCO will be responsible for the evaluation costs. If such evaluation does not so certify in respect of any such Drug Product, then the Client MDCO shall be deemed to have accepted delivery of such Drug Product on the 40th [**] day after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Drug Product, on the 40th [**] day after discovery thereof by the ClientMDCO, but in no event after the expiration date of the Drug Product).

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon shall will have 10 ten days to advise the Client by notice in writing that it disagrees with the contents of such the Deficiency Notice. If the Client and Patheon fail to agree within 10 ten days after Patheon’s 's notice to the Client as to whether any Drug Product Products identified in the Deficiency Notice deviates deviate from the Specifications, cGMPs, or Applicable Laws, then the parties shall will mutually select an independent laboratory or consultant to evaluate if the Drug Product deviates Products deviate from the Specifications Specifications, cGMPs, or cGMPsApplicable Laws. Such This evaluation shall will be binding on the parties, and if such . If the evaluation certifies that Drug Product deviates any Products deviate from the Specifications, cGMPs, or Applicable Laws, the Client may reject those Drug Product Products in the manner contemplated in this Section 6.16.1 and Patheon will be responsible for the cost of the evaluation. If such the evaluation does not so certify in respect for any of any such Drug Productthe Products, then the Client shall will be deemed to have accepted delivery of such Drug Product the Products on the 40th day after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Drug Product, on the 40th day after discovery thereof by the Client, but in no event not after the expiration date of the Drug Product)) and Client will be responsible for the cost of the evaluation. [***Confidential Treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been separately filed with the Commission.]

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon shall have 10 ten (10) days to advise the Client Éclat by notice in writing that it disagrees with the contents of such Deficiency Notice. If the Client Éclat and Patheon fail to agree within 10 ten (10) days after Patheon’s notice to the Client Éclat as to whether any Drug Product Products identified in the Deficiency Notice deviates deviate from the Specifications, cGMPs, cGMPs or Applicable Laws, then the parties shall mutually select an independent laboratory to evaluate if the Drug Product deviates Products deviate from the Specifications or cGMPs. Such evaluation shall be binding on the parties, and if such evaluation certifies that Drug Product deviates any Products deviate from the Specifications, Specifications or cGMPs, or Applicable Laws, the Client Éclat may reject those Drug Product Products in the manner contemplated in this Section 6.1. In that event the evaluation costs will be borne by Patheon, otherwise Éclat will be responsible for the evaluation costs. If such evaluation does not so certify in respect of any such Drug ProductProducts, then the Client Éclat shall be deemed to have accepted delivery of such Drug Product Products on the 40th day after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Drug Product, on the 40th day after discovery thereof by the ClientÉclat, but in no event after the expiration date of the Drug Product).