Acceptance/Rejection; Interim Replacement. (a) Santen may test or cause to be tested Compound supplied under this Section 8 in accordance with Santen's customary procedures within 30 days (subject to increase to 45 days if Inspire obtains the consent of the supplier) of its receipt at Santen's plant or that of its designee. Santen or its designee shall have the right to reject any shipment of Compound made to it under this Agreement that does not meet the Compound Specifications and applicable Manufacturing Standards when received by it at such destination when tested in accordance with the Testing Methods. All claims by Santen of non- conforming Compound shall be deemed waived unless made by Santen in writing and received by Inspire within such 30-day period. (b) All claims of non-conforming Compound shall be accompanied by a report of analysis (including a sample of the Compound from the batch analyzed) of the allegedly non-conforming Compound that shall have been made by Santen or its designee, using the Testing Methods. If, after its own analysis of such sample, Inspire confirms such non-conformity, then Inspire shall replace such shipment at its expense, including charges incurred by Santen for shipping and/or storage, if applicable. If, after its own analysis, Inspire does not confirm such non-conformity, the Parties shall agree to retest the shipment or otherwise in good faith attempt to agree upon a settlement of the issue. In the event that the Parties cannot resolve the issue, the Parties shall submit the disputed Compound to an independent testing laboratory, to be agreed upon by the Parties, for testing in accordance with the Testing Methods. Notwithstanding Section 14.13, the findings of such laboratory shall be binding on the Parties, absent manifest error. Expenses of such testing shall be borne by the Party adversely affected by such findings. In the event that any such shipment or batch thereof is ultimately agreed or found not to meet the Compound Specifications or Manufacturing Standards, Inspire agrees to replace such shipment at its expense, including charges incurred by Santen for shipping and/or storage, if applicable. Santen shall return any such rejected shipment to Inspire if so instructed by Inspire, at Inspire's expense. (c) During the pendency of any dispute concerning the conformity of a shipment of Compound to the Compound Specifications and applicable Manufacturing Standards, Inspire shall replace the shipment under dispute, at the request of Santen. Such replacement Compound shall be ordered in accordance with Section 8.3. (d) Notwithstanding any other provision of this Agreement, Santen shall not be required to pay for any shipment of Compound that fails to meet the Compound Specifications, but Santen shall be obligated to pay in full for any rejected shipment of Compound that is subsequently determined to meet the Compound Specifications. In the event that Santen pays for a shipment of Compound and subsequently rejects such shipment in accordance with the terms of this Agreement, Santen shall be entitled to a refund or credit equal to the amount paid with respect to such rejected shipment. Any such refund or credit shall be reflected in the statements submitted by Santen pursuant to Section 7.1(b).
Appears in 2 contracts
Sources: Development, License and Supply Agreement (Inspire Pharmaceuticals Inc), Development, License and Supply Agreement (Inspire Pharmaceuticals Inc)
Acceptance/Rejection; Interim Replacement. (a) Santen may 5.8.1 DUSA shall test or cause to be tested Compound Product supplied under this Section 8 5 in accordance with SantenDUSA's customary procedures within 30 [ * ] days (subject to increase to 45 days if Inspire obtains the consent of the supplier) of its receipt at SantenDUSA's plant facilities or that of its designee. Santen DUSA or its designee shall have the right to reject within said [ * ] days any shipment of Compound Product made to it under this Agreement that does not meet the Compound Specifications Specifica- EXECUTION COPY [ * ] = 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. tions and applicable Manufacturing Standards when received by it at such destination when tested in accordance with the Testing Methods. All claims by Santen of non- conforming Compound shall be deemed waived unless made by Santen in writing and received by Inspire within such 30-day period.
(b) 5.8.2 All claims of non-conforming Compound Product shall be accompanied by a report of analysis (including a sample of the Compound Product from the batch shipment analyzed) of the allegedly non-conforming Compound Product that shall have been made by Santen DUSA or its designee, using the Testing Methods. If, after its own analysis of such sample, Inspire confirms such .
5.8.3 If medac does not reasonably agree that the Product is non-conformity, then Inspire shall replace such shipment at its expense, including charges incurred by Santen for shipping and/or storage, if applicable. If, after its own analysis, Inspire does not confirm such non-conformityconforming, the Parties report of analysis referenced in Section 5.8.2 above shall agree be referred to retest the shipment or otherwise in good faith attempt to agree upon a settlement JDC (under the License and Development Agreement), and the resolution of the issue. In the event that the Parties cannot resolve the issue, the Parties shall submit the disputed Compound to an independent testing laboratory, to be agreed upon by the Parties, for testing in accordance with the Testing Methods. Notwithstanding Section 14.13, the findings of such laboratory matter shall be binding on determined according to Section 3.4 of the Parties, absent manifest error. Expenses of such testing shall be borne by the Party adversely affected by such findings. In the event that any such shipment or batch thereof is ultimately agreed or found not to meet the Compound Specifications or Manufacturing Standards, Inspire agrees to replace such shipment at its expense, including charges incurred by Santen for shipping and/or storage, if applicable. Santen shall return any such rejected shipment to Inspire if so instructed by Inspire, at Inspire's expenseLicense and Development Agreement.
(c) During the pendency of any dispute concerning the conformity of a shipment of Compound to the Compound Specifications and applicable Manufacturing Standards, Inspire shall replace the shipment under dispute, at the request of Santen. Such replacement Compound shall be ordered in accordance with Section 8.3.
(d) 5.8.4 Notwithstanding any other provision of this Agreement, Santen DUSA shall not be required to pay for any shipment [ * ] of Compound Product that fails to meet the Compound Specifications[ * ], but Santen DUSA shall be obligated to pay in full for any rejected shipment of Compound that is subsequently determined to meet the Compound Specifications[ * ]. In the event that Santen DUSA pays for a shipment of Compound Product and subsequently rejects such shipment in accordance with the terms of this Agreement, Santen DUSA shall be entitled to a refund or credit equal to the amount paid [ * ] with respect to such rejected shipment. Any such refund or credit shall be reflected in the statements submitted by Santen pursuant [ * ] to Section 7.1(b)medac from DUSA.
Appears in 2 contracts
Sources: Supply Agreement (Dusa Pharmaceuticals Inc), Supply Agreement (Dusa Pharmaceuticals Inc)