Conditions of Supply. 4.1 Deliveries of the Contracted Product shall be at *** as indicated in the relevant Order (***, all costs included). 4.2 Without prejudice to Article 5, Supplier shall enclose in each lot of delivered Contracted Product (Supplier will use reasonable commercial efforts in good faith to *** the minimum number of lots to fulfill Orders where the minimum lot shall be not less than ***) a certificate of compliance stating that the Contracted Product meets the Specifications. The minimum quantity of Contracted Product per Order shall be ***. The Contracted Product delivered by Supplier shall have at least *** of *** or retest period, as set out in the certificate of analysis referred to in Article 4.3 (for example, if the retest period is ***, Customer will not accept batches of Contracted Product that are due to be retested earlier than *** months from their delivery). 4.3 Supplier shall perform all the *** and *** quality control tests and quality assurance reviews on the Contracted Product as are required by the Supplier’s last DMF (Drug Master File) for the *** control tests and the Specifications for the *** tests, and shall certify in writing to Customer that each batch of the Contracted Product delivered to Customer was manufactured in conformity therewith and that the Contracted Product contained in each shipment complies with the Specifications, and the other terms and conditions of this Contract. All deliveries of Contracted Product by Supplier shall be accompanied by all appropriate documentation required under applicable laws in order for Customer to offer the Contracted Product for sale, including (i) a certificate of analysis as provided for by the cGMP and (ii) a *** or quality control certification that the Contracted Product supplied hereunder has been manufactured in conformity with cGMPs and other applicable regulations, which will be added to the certificate of analysis form by Supplier. 4.4 Customer undertakes that it shall inspect each lot of the delivered Contracted Product promptly upon receipt at Customer’s plant, to verify that the lot is complete and was not damaged in shipment and will promptly inform Supplier of any non-compliance. Customer will subsequently test the Contracted Product in accordance with the Specifications. Supplier shall keep “***” samples of Contracted Product under proper storage conditions as specified in *** (***) and will be responsible for all *** testing of the Contracted Product, as required to meet *** requirements (as they may be amended from time to time). 4.5 In the event of *** the Specifications or shortages being found during the Customer’s tests as provided for in Article 4.4, Customer shall send a report to Supplier as soon as possible and in any event within *** weeks of receipt of the Contracted Product at Customer’s warehouse. Should Supplier and Customer agree that the claim is ***, Supplier undertakes to supply Customer free of charge and as soon as possible (but in any event not later than *** *** at Customer’s warehouse from the date of the notice of claim) with a *** quantity of the Contracted Product. Supplier shall also reimburse to Customer all *** costs and expenses incurred by it arising out of or in connection with the *** of the Contracted Product delivered by Supplier. Any dispute arising between Customer and Supplier concerning the *** of any delivery of Contracted Product with the Specifications which cannot be settled between the two Parties, shall be submitted to an independent expert appointed by both Parties and the relevant cost will be borne by the Party ***. The decision of said expert shall be binding on Supplier and Customer. However, in the event of dispute and whilst awaiting the decision ***, Supplier undertakes to supply Customer as soon as possible, but in any event not later than *** weeks at Customer’s warehouse from the date of the notice of claim, with a replacement quantity of the Contracted Product. The charges, including the fees and expenses of the expert, relating to any dispute described in this paragraph shall be paid by *** if the expert declares the delivery *** conformity with the Specifications and/or the relevant Order and by *** if the expert declares the delivery to be *** with the *** and/or the relevant Order. The sole remedy for shortages of the Contracted Product or the rejection of Contracted Product that does not *** shall be Supplier’s *** Contracted Product as soon as possible and *** in accordance with *** Article ***. 4.6 Upon request of Customer, Supplier agrees to provide Customer with the documentation described in the Quality Agreement. 4.7 The execution by Customer of any *** or ***, as well as of any other document released upon any *** and *** made at any time on the Contracted Product shall not discharge Supplier from any of its obligations and liabilities under Article 5 “Warranties”, or from any liability or responsibility deriving from the existence or the subsequent arising out or discovery of any ***, *** or *** affecting the Contracted Product.
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Samples: Supply Contract (Eurand N.V.), Supply Contract (Eurand N.V.)
Conditions of Supply. 4.1 Deliveries of the Contracted Product shall be at *** as Confidential Information, indicated in the relevant Order (by [...***...], all costs included)has been omitted from this filing and filed separately with the U.S. Securities and Exchange Commission.
4.2 Without prejudice 6.1 All sales made by Celgene shall, except where otherwise agreed in writing, be subject to Article 5, Supplier shall enclose in each lot of delivered Contracted Product (Supplier will use reasonable commercial efforts in good faith to *** the minimum number of lots to fulfill Orders where the minimum lot terms herein and a separate Technical and Quality Agreement which shall be not less negotiated and executed as soon as practicable and no later than [...***) a certificate ...] from the Effective Date. Any inconsistency between the terms of compliance stating that the Contracted Product meets the Specifications. The minimum quantity Agreement and any applicable conditions of Contracted Product per Order sale shall be ***. The Contracted Product delivered by Supplier shall have at least *** of *** or retest period, as set out in the certificate of analysis referred to in Article 4.3 (for example, if the retest period is ***, Customer will not accept batches of Contracted Product that are due to be retested earlier than *** months from their delivery).
4.3 Supplier shall perform all the *** and *** quality control tests and quality assurance reviews on the Contracted Product as are required governed by the Supplier’s last DMF (Drug Master File) for the *** control tests and the Specifications for the *** tests, and shall certify in writing to Customer that each batch terms of the Contracted Product delivered Agreement. For the avoidance of doubt, Celgene’s obligation to Customer was manufactured in conformity therewith and that Supply the Contracted Product contained in each shipment complies with the Specifications, and the other terms and conditions of Products to BeiGene under this Contract. All deliveries of Contracted Product by Supplier Agreement shall be accompanied by all appropriate documentation required under applicable laws in order for Customer to offer the Contracted Product for sale, including not commence until (i) a certificate of analysis as provided for by the cGMP Technical and Quality Agreement and (ii) a *** the Safety Data Exchange Agreement as provided in Section 10.2 are duly executed and become effective.
6.2 Without prejudice to any other right or remedy of Celgene, if BeiGene is in arrears with any payment due to Celgene under this Agreement, then Celgene may elect not to deliver the Product (except against payment in full in cash of all the amounts owing to Celgene by BeiGene) and/or Celgene may suspend further deliveries under any unfilled purchase orders (until payment in full of the amounts owing by BeiGene is received). All monies owing to Celgene from BeiGene under this Agreement shall become immediately due and payable, and Celgene shall be entitled to recover possession of any Product supplied to BeiGene to the extent permitted by law for which payment has not been made in full.
6.3 All sales to BeiGene shall be final, and no Product shall be returned without the prior written authorization of Celgene, except as otherwise specifically provided herein.
6.4 Each shipment of Product shall contain such quality control certification that the Contracted Product supplied hereunder has been manufactured in conformity with cGMPs certificates and other applicable regulationsdocumentation as are necessary to show that Product conforms with the Specifications at the time of delivery by Celgene. In the event that BeiGene determines that any Product did not conform with the Specifications at the time of delivery by Celgene, which will be added to the certificate of analysis form by Supplier.
4.4 Customer undertakes that it BeiGene shall inspect each lot provide a statement of the delivered Contracted Product promptly upon receipt at Customer’s plant, to verify that the lot is complete and was not damaged in shipment and will promptly inform Supplier of any non-compliance. Customer will subsequently test the Contracted Product in accordance with the Specifications. Supplier shall keep “conformity by means of registered mail within [...***” samples of Contracted Product under proper storage conditions as specified in *** (***) and will be responsible for all *** testing of the Contracted Product, as required to meet *** requirements (as they may be amended from time to time).
4.5 In the event of *** the Specifications or shortages being found during the Customer’s tests as provided for in Article 4.4, Customer shall send a report to Supplier as soon as possible and in any event within *** weeks ...] of receipt of the Contracted Product Product, providing details of the problem and any available documentation; provided, that, if such non-conformity was latent at Customer’s warehouse. Should Supplier and Customer agree that the claim is time of delivery by Celgene, then BeiGene shall so notify Celgene within [...***, Supplier undertakes to supply Customer free ...] of charge and its discovery of such non-conformity. The sole obligation that this shall entail for Celgene is the immediate replacement as soon as possible (but in any event not later than *** *** at Customer’s warehouse from the date commercially practical of the notice Product not conforming to the Specifications, at Celgene's expense, with due observation of claim) with a *** quantity customs and foreign exchange regulation. All quantities of the Contracted ProductProduct not conforming to the Specifications shall, at Celgene’s direction and expense, either be destroyed or returned to Celgene. Supplier In no event shall also reimburse to Customer all *** costs and expenses incurred any such non-conforming quantities be used or sold by it arising out BeiGene. If BeiGene does not notify in writing Celgene within the time limits foreseen hereinabove of or in connection with the *** any quality impairment of the Contracted Product delivered supplied by Supplier. Any dispute arising between Customer and Supplier concerning Celgene, then the *** of any delivery of Contracted Product with the Specifications which cannot be settled between the two Parties, shall be submitted deemed to an independent expert appointed have been approved and accepted by both Parties BeiGene. BeiGene shall adhere to Celgene’s instructions regarding storage and transport conditions for the relevant cost will be borne Product (temperature, humidity, etc.).
6.5 The Product supplied by the Party ***. The decision of said expert Celgene under this Agreement shall be binding on Supplier available for Selling, as applicable, by BeiGene in the indications, formulations and Customer. Howeverpresentations described in Schedule B attached hereto.
6.6 Subject always to the provisions set out in Section 3.2.4 c) of the Agreement, in the event that a Product batch fails required import testing in the Territory, then BeiGene shall notify Celgene in writing promptly upon becoming aware of dispute such failure and whilst awaiting the decision Parties shall mutually agree on subsequent actions.
6.7 Celgene will use Commercially Reasonable Efforts to supply Product to BeiGene with the minimum remaining shelf life as indicated in Schedule B attached hereto * Confidential Information, indicated by [...***...], Supplier undertakes to supply Customer as soon as possible, but in any event not later than *** weeks at Customer’s warehouse has been omitted from the date of the notice of claim, with a replacement quantity of the Contracted Product. The charges, including the fees this filing and expenses of the expert, relating to any dispute described in this paragraph shall be paid by *** if the expert declares the delivery *** conformity filed separately with the Specifications and/or U.S. Securities and Exchange Commission. (hereinafter referred as the relevant Order “Minimum Remaining Shelf Life”). In the event that Celgene is only able to propose Product with less than the Minimum Remaining Shelf Life to BeiGene, BeiGene has the right to refuse shipment. Also, if any Product is supplied hereunder by Celgene with remaining shelf life below the said Minimum Remaining Shelf Life, and by *** if the expert declares the delivery to be *** thereafter such Product remains unsold with the *** and/or the relevant Order. The sole remedy for shortages of the Contracted Product or the rejection of Contracted Product that does not *** shall be Supplier’s *** Contracted Product as soon as possible and *** in accordance with *** Article less than [...***...] remaining shelf life, Celgene shall replace all such expired Product with fresh Product, at Celgene’s cost, or refund BeiGene for such Product at their relevant Product Purchase Price at the time of supply by Celgene, in which case BeiGene shall either return to Celgene or destroy the said Product, as indicated in writing by Celgene, and in case of a destruction, BeiGene shall give Celgene all reasonable documented proof of such destruction and allow Celgene to carry out any inspection it may deem necessary in relation thereto. Furthermore, it is understood and agreed by both Parties that Celgene will in no event replace at its own costs or refund BeiGene for any stocks of the Product which has expired as a result of BeiGene’s failure to adhere to the FEFO rule, the replacement being in such case at BeiGene’s own cost.
4.6 Upon request of Customer, Supplier agrees 6.8 In the event that a tender obtained by BeiGene within the Territory requires that Celgene directly distribute the Products to provide Customer with the documentation described an end user in the Quality AgreementTerritory, then the parties will mutually agree on a reasonable estimate of all such costs directly related to the distribution of such Products and, subject to the foregoing, all such costs that are within the estimate shall be borne by BeiGene.
4.7 The execution by Customer of any *** or ***, as well as of any other document released upon any *** and *** made at any time on the Contracted Product shall not discharge Supplier from any of its obligations and liabilities under Article 5 “Warranties”, or from any liability or responsibility deriving from the existence or the subsequent arising out or discovery of any ***, *** or *** affecting the Contracted Product.
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Conditions of Supply. 4.1 Deliveries of the Contracted Product shall be at *** Customer’s warehouse as indicated in the relevant Order (***CIP, all costs included).
4.2 Without prejudice to Article 5, Supplier shall enclose in each lot of delivered Contracted Product (Supplier will use reasonable commercial efforts in good faith to *** use the minimum number of lots to fulfill Orders where the minimum lot shall be not less than [***]) a certificate of compliance stating that the Contracted Product meets the Specifications. The minimum quantity of Contracted Product per Order shall be [***]. The Contracted Product delivered by Supplier shall have at least [*** ] of *** residual shelf life or retest period, as set out in the certificate of analysis referred to in Article 4.3 (for example, if the retest period is ***6 months, Customer will not accept batches of Contracted Product that are due to be retested earlier than *** 4.8 months from their delivery). [*] Confidential treatment requested.
4.3 Supplier shall perform all the *** in-process and *** final release quality control tests and quality assurance reviews on the Contracted Product as are required by the Supplier’s last DMF (Drug Master File) for the *** in-process control tests and the Specifications for the *** final release tests, and shall certify in writing to Customer that each batch of the Contracted Product delivered to Customer was manufactured in conformity therewith and that the Contracted Product contained in each shipment complies with the Specifications, and the other terms and conditions of this Contract. All deliveries of Contracted Product by Supplier shall be accompanied by all appropriate documentation required under applicable laws in order for Customer to offer the Contracted Product for sale, including (i) a certificate of analysis as provided for by the cGMP and (ii) a *** quality assurance or quality control certification that the Contracted Product supplied hereunder has been manufactured in conformity with cGMPs and other applicable regulations, which will be added to the certificate of analysis form by Supplier.
4.4 Customer undertakes that it shall inspect each lot of the delivered Contracted Product promptly upon receipt at Customer’s plant, to verify that the lot is complete and was not damaged in shipment and will promptly inform Supplier of any non-compliance. Customer will subsequently test the Contracted Product in accordance with the Specifications. Supplier shall keep “***reserve/retention” samples of Contracted Product under proper storage conditions as specified in *** cGMPs (***Eudralex, volume 4, part II, chapter 11.7) and will be responsible for all *** stability testing of the Contracted Product, as required to meet *** ICH (International Conference of Harmonization) requirements (as they may be amended from time to time).
4.5 In the event of *** deviations from the Specifications or shortages being found during the Customer’s tests as provided for in Article 4.4, Customer shall send a report to Supplier as soon as possible and in any event within *** four (4) weeks of receipt of the Contracted Product at Customer’s warehouse. Should Supplier and Customer agree that the claim is ***valid, Supplier undertakes to supply Customer free of charge and as soon as possible (but in any event not later than *** *** two (2) weeks at Customer’s warehouse from the date of the notice of claim) with a *** replacement quantity of the Contracted Product. Supplier shall also reimburse to Customer all *** shipping costs and expenses incurred by it arising out of or in connection with the *** claimed non-compliance of the Contracted Product delivered by Supplier. Any dispute arising between Customer and Supplier concerning the *** conformity of any delivery of Contracted Product with the Specifications which cannot be settled between the two Parties, shall be submitted to an independent expert appointed by both Parties and the relevant cost will be borne by the Party ***in default. The decision of said expert shall be binding on Supplier and Customer. However, in the event of dispute and whilst awaiting the decision ***of the expert, Supplier undertakes to supply Customer as soon as possible, but in any event not later than *** two (2) weeks at Customer’s warehouse from the date of the notice of claim, with a replacement quantity of the Contracted Product. The charges, including the fees and expenses of the expert, relating to any dispute described in this paragraph shall be paid by *** Supplier if the expert declares the delivery *** not to be in conformity with the Specifications and/or the relevant Order and by *** Customer if the expert declares the delivery to be *** in conformity with the *** Specifications and/or the relevant Order. The sole remedy for shortages of the Contracted Product or the rejection of Contracted Product that does not *** meet the Specifications shall be Supplier’s *** supply of replacement Contracted Product as soon as possible and *** reimbursement of costs in accordance with this Article 4.5. [*** Article ***] Confidential treatment requested.
4.6 Upon request of Customer, Supplier agrees to provide Customer with the documentation described in the Quality Agreement.
4.7 The execution by Customer of any *** inspection or ***test, as well as of any other document released upon any *** inspections and *** tests made at any time on the Contracted Product shall not discharge Supplier from any of its obligations and liabilities under Article 5 “Warranties”, or from any liability or responsibility deriving from the existence or the subsequent arising out or discovery of any ***defect, *** damage, discrepancy, lack of quality or *** irregularity affecting the Contracted Product.
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