Common use of Non-Conforming Drug Product Clause in Contracts

Non-Conforming Drug Product. Within fifteen (15) calendar days from the date of Production of any Batch pursuant to the Project Plan, AXXXXX shall promptly forward to CLIENT, or CLIENT’s designee, samples of such Batch. Within thirty (30) calendar days after receipt by CLIENT of the samples or fifteen (15) calendar days after receipt by CLIENT of the Released Executed Batch Record, whichever is later, CLIENT shall determine whether Drug Product conforms to ALTHEA’s Drug Product Specifications, Master Batch Record, ALTHEA’s current SOPs, and the Project Plan (collectively the “Product Requirements”). 5.1.1 If (a) any Batch of Drug Product conforms to the Product Requirements, or (b) CLIENT fails to notify AXXXXX within the applicable time period that any Batch of Drug Product does not conform to the Product Requirements, then CLIENT shall be deemed to have accepted the Drug Product and waived its right to revoke acceptance. 5.1.2 If CLIENT believes any Batch of Drug Product does not conform to the Product Requirements, it shall notify AXXXXX by telephone, including a detailed explanation of the non-conformity, and shall confirm such notice in writing via overnight delivery to AXXXXX. Upon receipt of such notice, AXXXXX will investigate such alleged non-conformity, and (i) if AXXXXX agrees such Drug Product is non-conforming, deliver to CLIENT a corrective action plan within thirty (30) calendar days after receipt of CLIENT’s written notice of non-conformity, or such additional time as is reasonably required if such investigation or plan requires data from sources other than CLIENT or AXXXXX, or (ii) if AXXXXX disagrees with CLIENT’s determination that the Batch of Drug Product is non-conforming, AXXXXX shall so notify CLIENT by telephone within the thirty (30) calendar day period and confirm such notice in writing by overnight delivery. 5.1.3 If the parties dispute whether Batch of Drug Product is conforming or non-conforming, samples of the Batch of Drug Product will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof if non-conforming, shall be binding upon the parties. CLIENT shall bear the costs of such laboratory or consultant, except as set forth in Section 5.2.

Non-Conforming Drug Product. Within fifteen (15) calendar days from the date of Production of any Batch pursuant to the Project Plan, AXXXXX XXXXXX shall promptly forward to CLIENT, or CLIENT’s designee, samples of such Batch. Within thirty (30) calendar days after receipt by CLIENT of the samples or fifteen (15) calendar days after receipt by CLIENT of the Released Executed Batch Record, whichever is later, CLIENT shall determine whether Drug Product conforms to ALTHEACLIENT’s Drug Product Specifications, Master Batch Record, ALTHEA’s current SOPs, and the Project Plan (collectively the “Product Requirements”). 5.1.1 If (a) any Batch of Drug Product conforms to the Product Requirements, or (b) CLIENT fails to notify AXXXXX XXXXXX within the applicable time period that any Batch of Drug Product does not conform to the Product Requirements, then CLIENT shall be deemed to have accepted the Drug Product and waived its right to revoke acceptance. 5.1.2 If CLIENT believes any Batch of Drug Product does not conform to the Product Requirements, it shall notify AXXXXX XXXXXX by telephone, including a detailed explanation of the non-conformity, and shall confirm such notice in writing via overnight delivery to AXXXXXXXXXXX. Upon receipt of such notice, AXXXXX XXXXXX will investigate such alleged non-conformity, and (i) if AXXXXX XXXXXX agrees such Drug Product is non-conforming, deliver to CLIENT a corrective action plan within thirty (30) calendar days after receipt of CLIENT’s written notice of non-conformity, or such additional time as is reasonably required if such investigation or plan requires data from sources other than CLIENT or AXXXXXXXXXXX, or (ii) if AXXXXX XXXXXX disagrees with CLIENT’s determination that the Batch of Drug Product is non-conforming, AXXXXX XXXXXX shall so notify CLIENT by telephone within the thirty (30) calendar day period and confirm such notice in writing by overnight delivery. 5.1.3 If the parties dispute whether Batch of Drug Product is conforming or non-conforming, samples of the Batch of Drug Product will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof if non-conforming, shall be binding upon the parties. CLIENT shall bear the costs of such laboratory or consultant, except as set forth in Section 5.2. 5.1.4 Manufacturing deviations and investigations which occur during Production of Drug Product and which do not cause the Production to be non-compliant with cGMP, shall not be deemed to cause such Drug Product to be non-conforming.

Non-Conforming Drug Product. Within fifteen (15) [+] calendar days from the date release of Production of any the executed Batch pursuant to the Project Plan, AXXXXX shall promptly forward Record to CLIENT, or CLIENT’s designee, samples of such Batch. Within thirty (30) calendar days after receipt by CLIENT of the samples or fifteen (15) calendar days after receipt by CLIENT of the Released Executed Batch Record, whichever is later, CLIENT shall determine whether the Drug Product conforms to ALTHEA’s the Drug Product Specifications, Master Batch Record, ALTHEA’s XXXX'x current SOPs, and the Project Plan (collectively the “"Product Requirements”"). 5.1.1 . If (a) any Batch batch of Drug Product conforms to the Product Requirements, or (b) CLIENT must accept the Drug Product. If CLIENT fails to notify AXXXXX XXXX within the applicable time [+] calendar day period that any Batch of the Drug Product does not conform to the Product Requirements, then CLIENT shall be deemed to have accepted the Drug Product and waived its right to revoke acceptance. 5.1.2 . If CLIENT believes any Batch batch of Drug Product does not conform to the Product Requirements, it shall notify AXXXXX XXXX by telephone, telephone including a detailed explanation of the alleged non-conformity, conformity and shall confirm such notice in writing via overnight delivery to AXXXXXdelivery. Upon receipt of such notice, AXXXXX XXXX will investigate such alleged non-conformity, and (i) if AXXXXX XXXX agrees such Drug Product is non-conformingconforming as a result of the negligence of XXXX, deliver to CLIENT a corrective action plan within thirty (30) [+] calendar days after receipt of CLIENT’s written 's notice of non-conformity, or such additional time as is reasonably required if such investigation or plan requires data from sources other than CLIENT or AXXXXXXXXX, or (ii) if AXXXXX XXXX disagrees with CLIENT’s 's determination that the Batch of Drug Product is non-conformingconforming as a result of the negligence of XXXX, AXXXXX XXXX shall so notify CLIENT by telephone within the thirty (30) [+] calendar day period and confirm such notice in writing by overnight delivery. 5.1.3 . If the parties dispute whether Batch of the Drug Product is conforming or non-conformingconforming or whether the non-conformity was caused by XXXX or CLIENT, samples of the Batch of Drug Product will be submitted to a mutually acceptable laboratory or consultant third party for resolution, whose determination of conformity or non-conformity, conformity and the cause thereof if non-conforming, party responsible therefore shall be binding upon the parties. CLIENT The incorrect party shall bear hear the costs of such laboratory third party. In the event XXXX agrees that the Drug Product is non-conforming as a result of the negligence of XXXX or consultantthe third party determines that the Drug Product is non-conforming solely as a result of the negligence of XXXX, except as set forth in Section 5.2then XXXX, at its expense, but subject to CLIENT, at its expense, supplying the replacement Bulk Drug Substance, and upon payment for the non-conforming Drug Product by CLIENT, shall replace such non-conforming Drug Product within [+] calendar days from receipt of replacement Bulk Drug Substance from CLIENT, or will refund the purchase price of the non-conforming Drug Product.

Non-Conforming Drug Product. Within fifteen (15) calendar days from the date of Production of any Batch pursuant to the Project Plan, AXXXXX XXXXXX shall promptly forward to CLIENT, or CLIENT’s designee, samples of such Batch. Within thirty (30) calendar days after receipt by CLIENT of the samples or fifteen (15) calendar days after receipt by CLIENT of the Released Executed Batch Record, whichever is later, CLIENT shall determine whether Drug Product conforms to ALTHEA’s Drug Product Specifications, Master Batch Record, ALTHEA’s current SOPs, and the Project Plan (collectively the “Product Requirements”). 5.1.1 If (a) any Batch of Drug Product conforms to the Product Requirements, or (b) CLIENT fails to notify AXXXXX XXXXXX within the applicable time period that any Batch of Drug Product does not conform to the Product Requirements, then CLIENT shall be deemed to have accepted the Drug Product and waived its right to revoke acceptance. 5.1.2 If CLIENT believes any Batch of Drug Product does not conform to the Product Requirements, it shall notify AXXXXX XXXXXX by telephone, including a detailed explanation of the non-conformity, and shall confirm such notice in writing via overnight delivery to AXXXXXXXXXXX. Upon receipt of such notice, AXXXXX XXXXXX will investigate such alleged non-conformity, and (i) if AXXXXX XXXXXX agrees such Drug Product is non-conforming, deliver to CLIENT a corrective action plan within thirty (30) calendar days after receipt of CLIENT’s written notice of non-conformity, or such additional time as is reasonably required if such investigation or plan requires data from sources other than CLIENT or AXXXXX, or (ii) if AXXXXX disagrees with CLIENT’s determination that the Batch of Drug Product is non-conforming, AXXXXX shall so notify CLIENT by telephone within the thirty (30) calendar day period and confirm such notice in writing by overnight delivery.of 5.1.3 If the parties dispute whether Batch of Drug Product is conforming or non-conforming, samples of the Batch of Drug Product will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof if non-conforming, shall be binding upon the parties. CLIENT shall bear the costs of such laboratory or consultant, except as set forth in Section 5.2.will

Non-Conforming Drug Product. Within fifteen (15) calendar days from the date of Production of any Batch pursuant to the Project Plan, AXXXXX shall promptly forward to CLIENT, or CLIENT’s designee, samples of such Batch. Within thirty (30) 30 calendar days after receipt by CLIENT Altus of the samples a particular Batch, or fifteen (15) 15 calendar days after receipt by CLIENT Altus of the Released Executed Batch RecordRecord for a delivered Batch, whichever is later, CLIENT Altus shall use reasonable efforts to determine whether Drug Product in the Batch conforms to ALTHEA’s Drug Product the Specifications, the Master Batch Record, ALTHEA’s current SOPsthe Process, and the Project Plan (collectively the “"Product Requirements”"). 5.1.1 8.1.1 If (a) any Altus determines that the particular Batch of Drug Product conforms to the Product Requirements, or (b) CLIENT fails to notify AXXXXX within the applicable time period that any Batch Altus shall give Xxxxxx written notice of Drug Product does not conform to the Product Requirements, then CLIENT such determination and Altus shall be deemed to have accepted the Drug Product and waived its right to revoke acceptanceacceptance [***] 8.1.2 If Altus does not give notice that a particular Batch fails to conform to the Product Requirements within the time frame specified above, then Altus shall be deemed to have accepted the Drug Product and waived its right to revoke acceptance [***]. 5.1.2 8.1.3 If CLIENT Altus believes any Batch of Drug Product does not conform to the Product RequirementsRequirements and that such failure to conform was caused by either (i) Althea's failure to conform to the Master Batch Record or other negligence of Xxxxxx in the performance of the Process, it or (ii) [***] of such Drug Product (either case, an "Xxxxxx Fault"), then Altus shall notify AXXXXX Xxxxxx by telephone, including a detailed explanation of the non-conformityconformity and the basis for Altus' belief that it was caused by an Xxxxxx Fault, and shall confirm such notice in writing via facsimile, email or overnight delivery to AXXXXXXxxxxx. [***] Upon receipt of such notice, AXXXXX Xxxxxx will investigate such alleged non-conformity, and (i) if AXXXXX agrees conformity using good faith commercially reasonable efforts. If Xxxxxx determines that such Drug Product is non-conformingconforming as a result of an Xxxxxx Fault, deliver to CLIENT a corrective action plan within thirty (30) calendar days after receipt Xxxxxx shall notify Altus of CLIENT’s written notice of non-conformity, or such additional time as is reasonably required if such investigation or plan requires data from sources other than CLIENT or AXXXXX, or (ii) if AXXXXX disagrees with CLIENT’s determination that the Batch of Drug Product is non-conforming, AXXXXX shall so notify CLIENT by telephone within the thirty (30) calendar day period and confirm such notice in writing by overnight delivery. 5.1.3 If the parties dispute whether Batch of Drug Product is conforming or non-conforming, samples of the Batch of Drug Product will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, promptly and the cause thereof if non-conforming, Parties shall be binding upon the parties. CLIENT shall bear the costs of such laboratory or consultant, except as set forth in proceed under Section 5.28.

Non-Conforming Drug Product. Within fifteen (15) calendar days from *** after the date of Production of any Batch pursuant to the Project Plan, AXXXXX BPS shall promptly forward to CLIENTNTI, or CLIENTto NTI’s designee, reasonable quantities of samples of such BatchBatch as specified in the MBR. Within thirty (30) calendar *** days after receipt by CLIENT NTI (or by NTI’s designee) of the samples samples, or fifteen (15) calendar within *** days after receipt by CLIENT NTI (or by NTI’s designee) of the Released Executed Batch Record, whichever is later, CLIENT NTI shall determine whether such Batch of Drug Product conforms to ALTHEA’s Drug Product Specifications, the Master Batch Record, ALTHEA’s current BPS SOPs, Specifications and the Project Plan (collectively the “Product Requirements”). 5.1.1 If (a) any Batch of Drug Product conforms to the Product Requirements, or (b) CLIENT NTI fails to notify AXXXXX BPS within the applicable time period that any Batch of Drug Product does not conform to the Product Requirements, then CLIENT NTI shall be deemed to have accepted the Drug Product and waived its right to revoke acceptance. 5.1.2 If CLIENT NTI believes any Batch of Drug Product does not conform to the Product Requirements, it shall notify AXXXXX BPS by telephone, telephone (including a detailed explanation of the non-conformity), and thereafter shall confirm such notice in writing via overnight delivery to AXXXXXBPS. Upon BPS’ receipt of such notice, AXXXXX BPS will investigate such alleged non-conformity, and (ia) if AXXXXX BPS agrees that such Batch of Drug Product is non-conforming, deliver to CLIENT NTI a corrective action plan within thirty (30) calendar *** days after receipt of CLIENTNTI’s written notice of non-conformity, or such additional time as is may be reasonably required if such investigation or plan by BPS requires data from sources other than CLIENT NTI or AXXXXXBPS, or (iib) if AXXXXX BPS disagrees with CLIENTNTI’s determination that the such Batch of Drug Product is non-conforming, AXXXXX BPS shall so notify CLIENT NTI by telephone within the thirty (30) calendar day period *** period, and shall confirm such notice in writing by overnight deliverydelivery to NTI. 5.1.3 If the parties reasonably dispute whether a Batch of Drug Product is conforming or non-conforming, samples of the such Batch of Drug Product will be submitted to a mutually acceptable outside laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof if non-conforming, shall be binding upon the parties. CLIENT The party that incorrectly determined the conformity or non-conformity (as the case may be) of the Batch of Drug Product shall bear the costs cost of such outside laboratory or consultant, except as set forth in Section 5.2.

Non-Conforming Drug Product. Within fifteen (15) calendar days from the date of Production of any Batch pursuant to the Project Plan, AXXXXX XXXXXX shall promptly forward to CLIENT, or CLIENT’s designee, samples of such Batch. Within thirty (30) calendar days after receipt by CLIENT of the samples or fifteen (15) calendar days after receipt by CLIENT of the Released Executed Batch Record, whichever is later, CLIENT shall determine whether Drug Product conforms to ALTHEACLIENT’s Drug Product Specifications, Master Batch Record, ALTHEA’s current SOPs, and the Project Plan (collectively the “Product Requirements”). 5.1.1 If (a) any Batch of Drug Product conforms to the Product Requirements, or (b) CLIENT fails to notify AXXXXX XXXXXX within the applicable time period that any Batch of Drug Product does not conform to the Product Requirements, then CLIENT shall be deemed to have accepted the Drug Product and waived its right to revoke acceptance. 5.1.2 If CLIENT believes any Batch of Drug Product does not conform to the Product Requirements, it shall notify AXXXXX XXXXXX by telephone, including a detailed explanation of the non-conformity, and shall confirm such notice in writing via overnight delivery to AXXXXXXXXXXX. Upon receipt of such notice, AXXXXX XXXXXX will investigate such alleged non-conformity, and (i) if AXXXXX XXXXXX agrees such Drug Product is non-conforming, deliver to CLIENT a corrective action plan within thirty (30) calendar days after receipt of CLIENT’s written notice of non-conformity, or such additional time as is reasonably required if such investigation or plan requires data from sources other than CLIENT or AXXXXXXXXXXX, or (ii) if AXXXXX XXXXXX disagrees with CLIENT’s determination that the Batch of Drug Product is non-conforming, AXXXXX XXXXXX shall so notify CLIENT by telephone within the thirty (30) calendar day period and confirm such notice in writing by overnight delivery. 5.1.3 If the parties dispute whether Batch of Drug Product is conforming or non-conforming, samples of the Batch of Drug Product will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof if non-conforming, shall be binding upon the parties. CLIENT shall bear the costs of such laboratory or consultant, except as set forth in Section 5.2. 5.1.4 Manufacturing deviations and investigations which occur during Production of Drug Product and which do not cause the Production to be non-compliant with cGMP, shall not be deemed to cause such Drug Product to be non-conforming. XXXXXX CONFIDENTIAL 9

Non-Conforming Drug Product. Within fifteen (15) calendar days from the date of Production of any Batch pursuant to the Project Plan, AXXXXX shall promptly forward to CLIENT, or CLIENT’s designee, samples of such Batch. Within thirty sixty (3060) calendar days after receipt by CLIENT of the samples or fifteen (15) calendar days after receipt by CLIENT of the Batch and the Released Executed Batch Record, whichever is laterRecord for the Batch, CLIENT shall determine whether Drug Product conforms to ALTHEA’s the Drug Product Specifications, the Master Batch Record, ALTHEA’s current SOPs, and the Project Plan (collectively the “Product Requirements”). 5.1.1 If (a) any Batch of Drug Product conforms is approved by CLIENT as conforming to the Product Requirements, or (b) CLIENT fails to notify AXXXXX within the applicable time period set forth above, or such longer period as may be agreed, that any Batch of Drug Product does not conform to the Product Requirements, then CLIENT shall be deemed to have accepted the Drug Product and waived its right to revoke acceptance. 5.1.2 If CLIENT believes any Batch of Drug Product does not conform to the Product Requirements, it shall notify AXXXXX by telephone, including a detailed explanation of the non-conformity, and shall confirm such notice in writing via overnight delivery to AXXXXX. Upon receipt of such notice, AXXXXX will investigate such alleged non-conformity, and (i) if AXXXXX agrees such Drug Product is non-conforming, deliver to CLIENT a corrective action plan within thirty (30) calendar days after receipt of CLIENT’s written notice of non-conformity, or such additional time as is reasonably required if such investigation or plan requires data from sources other than CLIENT or AXXXXX, or (ii) if AXXXXX disagrees with CLIENT’s determination that the Batch of Drug Product is non-conforming, AXXXXX shall so notify CLIENT by telephone within the thirty (30) calendar day period and confirm such notice in writing by overnight delivery. 5.1.3 If the parties dispute whether a Batch of Drug Product is conforming or non-conforming, samples of the Batch of Drug Product will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof if non-conforming, shall be binding upon the parties. Unless the Batch is determined to be non-conforming as set forth in this Section 5. 3 due to the fault of AXXXXX, CLIENT shall bear the costs of such laboratory or consultant, except as set forth in Section 5.2.

Non-Conforming Drug Product. Within fifteen (15) calendar days from the date of Production of any Batch pursuant to the Project Plan, AXXXXX XXXXXX shall promptly forward to CLIENT, or CLIENT’s designee, samples of such Batch. Within thirty sixty (3060) calendar days after receipt by CLIENT of the samples or fifteen (15) calendar days after receipt by CLIENT of the Batch and the Released Executed Batch Record, whichever is laterRecord for the Batch, CLIENT shall determine whether Drug Product conforms to ALTHEA’s the Drug Product Specifications, the Master Batch Record, ALTHEA’s current SOPs, and the Project Plan (collectively the “Product Requirements”). 5.1.1 If (a) any Batch of Drug Product conforms is approved by CLIENT as conforming to the Product Requirements, or (b) CLIENT fails to notify AXXXXX XXXXXX within the applicable time period set forth above, or such longer period as may be agreed, that any Batch of Drug Product does not conform to the Product Requirements, then CLIENT shall be deemed to have accepted the Drug Product and waived its right to revoke acceptance. 5.1.2 If CLIENT believes any Batch of Drug Product does not conform to the Product Requirements, it shall notify AXXXXX XXXXXX by telephone, including a detailed explanation of the non-conformity, and shall confirm such notice in writing via overnight delivery to AXXXXXXXXXXX. Upon receipt of such notice, AXXXXX XXXXXX will investigate such alleged non-conformity, and (i) if AXXXXX XXXXXX agrees such Drug Product is non-conforming, deliver to CLIENT a corrective action plan within thirty (30) calendar days after receipt of CLIENT’s written notice of non-conformity, or such additional time as is reasonably required if such investigation or plan requires data from sources other than CLIENT or AXXXXXXXXXXX, or (ii) if AXXXXX XXXXXX disagrees with CLIENT’s determination that the Batch of Drug Product is non-conforming, AXXXXX XXXXXX shall so notify CLIENT by telephone within the thirty (30) calendar day period and confirm such notice in writing by overnight delivery. 5.1.3 If the parties dispute whether a Batch of Drug Product is conforming or non-conforming, samples of the Batch of Drug Product will be submitted to a mutually acceptable laboratory or consultant for resolution, whose determination of conformity or non-conformity, and the cause thereof if non-conforming, shall be binding upon the parties. Unless the Batch is determined to be non-conforming as set forth in this Section 5. 3 due to the fault of XXXXXX, CLIENT shall bear the costs of such laboratory or consultant, except as set forth in Section 5.2.