Samples and Testing. 7.1 This Article 7 shall apply to Mayne Manufactured Product and Product from Inventory. In addition, this Article 7 is subject in all respects to Section 4.4 of this Agreement. 7.1.1 MAYNE shall obtain representative samples from each Batch of Product. MAYNE shall obtain, assay and analyze such samples in strict accordance with the Specifications and sufficient to meet the requirements of Applicable Law and shall promptly prepare a certificate of analysis from MAYNE’s quality assurance department certifying as to testing performed and certifying that the Finished Products are in strict accordance with the Specifications and Applicable Law (“Certificate of Analysis”); provided, however, that with respect to finished goods Product from Inventory, the foregoing provisions contained in this Section 7.1.1 shall apply to the extent required by Applicable Laws and cGMPs. Such Certificate of Analysis shall identify the Batch of Product to which it relates. MAYNE shall not supply or cause to be supplied any Product hereunder which does not conform to such Product’s Specifications or Applicable Law or which has not been manufactured in compliance with cGMPs or other Applicable Law. Each Product or the manufacture thereof that does not conform to the Specifications or cGMPs or other Applicable Law shall be disposed of in accordance with Applicable Laws. MAYNE shall make available in MAYNE’s facility upon SUPERGEN’s reasonable request all documentation relative to the manufacture, packaging, testing and release of a Batch and which demonstrates compliance with cGMPs and other Applicable Law. 7.1.2 In testing the Product, MAYNE shall use the analytical testing methods applicable to the Product under such Product’s registration, cGMP and Applicable Law. SUPERGEN or its designee may analyze any Product for purposes of determining whether the same meets Specifications and Applicable Law within seventy five (75) days from the date of receipt of Product and shall report any adverse findings to MAYNE within such seventy five (75) day period. MAYNE shall reasonably cooperate with and facilitate SUPERGEN or its designee in its analysis and testing of each of the Products. 7.1.3 If the analysis or assay of a sample of the Products, or any audit or inspection, performed by or for SUPERGEN indicates that Product or its manufacture does not meet its Specifications or Applicable Law and MAYNE’s analysis or assay of its sample from the same Batch indicates that the entire Batch does meet its Specifications and Applicable Law, SUPERGEN will so advise MAYNE, and a joint investigation will be conducted to determine the cause of the failure. If MAYNE and SUPERGEN disagree in good faith as to whether any Product meets or was manufactured in accordance with the applicable Specifications or Applicable Law, the matter will be submitted at the request of either Party to an independent third party, acceptable to both Parties (agreement not to be unreasonably withheld or delayed), for evaluation to determine whether the Product conformed or did not conform to the Specifications and Applicable Law and the conclusion of the independent third party test and evaluation shall be final and binding upon both Parties. If the Parties or the independent third party conclude that corrective action or retesting is appropriate, then such corrective action or retesting shall be performed in accordance with the manufacturer’s procedures for corrective action or retesting, as applicable, in each case that are reasonably acceptable to SUPERGEN and are reasonably expected to ensure compliance with Applicable Law. The fees and expenses of such independent third party shall be borne by the Party ultimately determined to have incorrectly judged whether a Product met the Specifications or Applicable Law. In the event any test results, or any audit or inspection, indicate that a Product in question failed to meet the Specifications or Applicable Law or in the event the Parties agree that such Finished Product failed to meet the Specifications or was not manufactured in compliance with cGMPs or Applicable Law, within thirty (30) days of reaching such agreement or obtaining such indication, MAYNE shall furnish or cause to be furnished replacement of such Product to SUPERGEN in substitution of the Product which did not conform to the Specifications or was not manufactured in compliance with cGMPs or Applicable Law and reimburse SUPERGEN for SUPERGEN’s reasonable expenses relating to re-analysis, sampling, processing, returns, disposal and/or destruction thereof. For clarity, in the event a Product is rejected by SuperGen, MAYNE shall provide replacement Product to SuperGen within thirty (30) days of the rejection unless MAYNE disputes the rejection in good faith by submitting the matter to an independent third party in accordance with the foregoing. In the event of such a dispute, MAYNE shall provide replacement Product to SuperGen within thirty (30) days after the decision of a third party adverse to MAYNE. Any Product determined by the third party, or agreed by the Parties, to not be defective shall be disposed of only in accordance with SuperGen’s written instructions. 7.1.4 SUPERGEN may return a Product to MAYNE for replacement, without charge to SUPERGEN, and MAYNE shall redeliver REPLACEMENT Product to SUPERGEN in an amount sufficient to replace the amount of returned Product; or SUPERGEN may obtain a credit or refund, in amounts equal to the price paid to MAYNE by SUPERGEN for the returned Product, in each case at SUPERGEN’s option and election, if such Product is not manufactured in accordance with cGMPs or Applicable Law or fails to meet the Specifications. Any credit shall be applied by the Parties at the earliest possible opportunity to set off against any amount that otherwise is due or would have been due from SUPERGEN to MAYNE. 7.1.5 SUPERGEN shall be responsible for disposing in accordance with Applicable Laws of Product from Inventory that did not conform with Specifications or cGMP requirements or was adulterated, in each case prior to assignment to MAYNE pursuant to the Purchase Agreement.
Appears in 1 contract
Sources: Supply Agreement (Supergen Inc)
Samples and Testing. 7.1 This Article 7 4.1 Final release testing shall apply be conducted according to Mayne Manufactured Product and Product from Inventorythe Specifications. In additionRelease testing shall be conducted per the required regulations in different regulatory jurisdictions. For product designated for use in the US, this Article 7 is subject in [***] on behalf of Abraxis shall complete all respects to Section 4.4 the release testing followed by a paper verification by AADi. For product designated for the EU, the [***] on behalf of this AgreementAbraxis or Celgene ‘Qualified Person’ (QP) shall perform the product release on behalf of AADi, or alternatively, if mutually agreed by the Parties, product release shall be performed under subcontract.
7.1.1 MAYNE 4.2 Abraxis’ product development personnel (or those Third Party contract manufacturing organizations or contract laboratories that are specifically authorized by Abraxis) shall obtain a representative samples sample from each Batch batch of ProductLicensed Product produced by Abraxis. MAYNE Abraxis shall obtain, assay and analyze perform release testing of such samples in strict accordance with the procedures set forth in the Specifications and sufficient to meet shall provide a Certificate of Analysis for each batch. Abraxis shall provide AADi with a copy of the requirements Certificate of Applicable Law and Analysis in the format agreed upon by the Parties. All such activities shall promptly prepare a certificate of analysis from MAYNE’s quality assurance department certifying as to testing performed and certifying that the Finished Products are be conducted in strict accordance with the Specifications terms of the GMP Agreement.
4.3 Rejection and Applicable Law (“Certificate Replacement of Analysis”); provided, however, Licensed Products Certain identified information marked with [***] has been excluded from this exhibit because it is not material and is of the type that with respect the registrant treats as private and confidential.
4.3.1 AADi and/or its designee shall have [***] following Abraxis making the Licensed Product available to finished goods AADi to reject such Licensed Product from Inventory, on the foregoing provisions contained in this Section 7.1.1 shall apply grounds that all or part of the Licensed Product fails to the extent required by Applicable Laws and cGMPs. Such Certificate of Analysis shall identify the Batch of Product to which it relates. MAYNE shall not supply or cause to be supplied any Product hereunder which does not conform to such Product’s Specifications or Applicable Law or which has not been manufactured in compliance with cGMPs or other Applicable Law. Each Product or the manufacture thereof that does not conform to the Specifications or cGMPs or other Applicable Law cGMP (as set forth in the GMP Agreement), which rejection shall be disposed accomplished by giving written notice to Abraxis summarizing the manner in which all or part of in accordance with Applicable Laws. MAYNE shall make available in MAYNE’s facility upon SUPERGEN’s reasonable request all documentation relative such Licensed Product fails to meet the manufacture, packaging, testing and release of a Batch and which demonstrates compliance with cGMPs and other Applicable Lawforegoing requirements.
7.1.2 In testing the Product, MAYNE 4.3.2 Abraxis shall use the analytical testing methods applicable respond in writing to the Product under such Product’s registration, cGMP and Applicable Law. SUPERGEN or its designee may analyze any Product for purposes of determining whether the same meets Specifications and Applicable Law a rejection notice from AADi within seventy five (75) days [***] from the date of receipt of such rejection notice in accordance with Section 4.3.1 above. If Abraxis does not agree with AADi’s determination that such Licensed Product fails to conform to the Specifications or cGMP (as set forth in the GMP Agreement), then Abraxis and AADi shall report any adverse findings use reasonable efforts to MAYNE within resolve such seventy five (75) day perioddisagreement as promptly as possible. MAYNE Without limiting the foregoing, Abraxis and AADi shall reasonably cooperate with discuss in good faith mutually acceptable testing procedures pursuant to which both Abraxis and facilitate SUPERGEN or its designee in its analysis and testing of each of the Products.
7.1.3 If the analysis or assay of AADi will re-test a sample of the Productsdisputed Licensed Product to determine whether such Licensed Product so conforms. Notwithstanding the foregoing, or any audit or inspectionin the event Abraxis and AADi are unable to resolve such disagreement within [***] of the date of the applicable rejection notice, performed by or either Party may submit a sample of the allegedly non-conforming Licensed Product for SUPERGEN indicates that Product or its manufacture does not meet its Specifications or Applicable Law and MAYNE’s analysis or assay of its sample from the same Batch indicates that the entire Batch does meet its Specifications and Applicable Law, SUPERGEN will so advise MAYNE, tests and a joint investigation will be conducted to determine the cause of the failure. If MAYNE and SUPERGEN disagree in good faith determination as to whether any or not such Licensed Product meets or was manufactured in accordance with the applicable Specifications or Applicable Law, the matter will be submitted at the request of either Party so conforms to an independent third party, acceptable to both testing organization mutually agreed upon by the Parties (agreement the “Laboratory”), the appointment of which shall not to be unreasonably withheld or delayed), for evaluation to determine whether the Product conformed or did not conform to the Specifications and Applicable Law and the conclusion delayed by either Party. The determination of the independent third party test and evaluation Laboratory with respect to all or part of any Licensed Product shall be final and binding upon both the Parties. If the Parties or the independent third party conclude that corrective action or retesting is appropriate, then such corrective action or retesting shall be performed in accordance with the manufacturer’s procedures for corrective action or retesting, as applicable, in each case that are reasonably acceptable to SUPERGEN and are reasonably expected to ensure compliance with Applicable Law. The fees and expenses of the Laboratory making such independent third party determination shall be borne equally by the Party ultimately determined to have incorrectly judged whether a AADi and Abraxis.
4.3.3 Licensed Product met accepted by Abraxis as not meeting the Specifications or Applicable Law. In cGMP (as set forth in the event any test resultsGMP Agreement), or any audit or inspection, indicate that a Product in question failed to meet the Specifications or Applicable Law or in the event the Parties agree that such Finished Product failed to meet the Specifications or was not manufactured in compliance with cGMPs or Applicable Law, within thirty (30) days of reaching such agreement or obtaining such indication, MAYNE shall furnish or cause to be furnished replacement of such Product to SUPERGEN in substitution of the Product which did not conform to the Specifications or was not manufactured in compliance with cGMPs or Applicable Law and reimburse SUPERGEN for SUPERGEN’s reasonable expenses relating to re-analysis, sampling, processing, returns, disposal and/or destruction thereof. For clarity, in the event a Product is rejected by SuperGen, MAYNE shall provide replacement Product to SuperGen within thirty (30) days of the rejection unless MAYNE disputes the rejection in good faith by submitting the matter to an independent third party in accordance with the foregoing. In the event of such a dispute, MAYNE shall provide replacement Product to SuperGen within thirty (30) days after the decision of a third party adverse to MAYNE. Any Product determined by the third partyLaboratory not to so conform, shall be returned by AADi to Abraxis, or agreed disposed of, as directed by Abraxis. Abraxis shall replace all such rejected Licensed Product within the Partiesshortest possible time, to not be defective shall be disposed but in any event, within [***] after its receipt of only in accordance with SuperGen’s written instructions.
7.1.4 SUPERGEN may return a Product to MAYNE for replacement, without charge to SUPERGEN, and MAYNE shall redeliver REPLACEMENT Product to SUPERGEN in an amount sufficient to replace the amount notice of returned Product; or SUPERGEN may obtain a credit or refund, in amounts equal to the price paid to MAYNE by SUPERGEN for the returned Product, in each case at SUPERGEN’s option and electionsuch rejection (or, if applicable, the Laboratory’s determination that such Licensed Product was non-conforming). If AADi rejects Licensed Product before the date on which payment therefor is due, AADi may withhold payment for such Licensed Product or the rejected portion thereof until replacement product is made available to AADi. Certain identified information marked with [***] has been excluded from this exhibit because it is not manufactured in accordance with cGMPs or Applicable Law or fails to meet material and is of the Specifications. Any credit shall be applied by type that the Parties at the earliest possible opportunity to set off against any amount that otherwise is due or would have been due from SUPERGEN to MAYNEregistrant treats as private and confidential.
7.1.5 SUPERGEN shall be responsible for disposing in accordance with Applicable Laws of Product from Inventory that did not conform with Specifications or cGMP requirements or was adulterated, in each case prior to assignment to MAYNE pursuant to the Purchase Agreement.
Appears in 1 contract