Common use of Receipt of Product; Acceptance Clause in Contracts

Receipt of Product; Acceptance. 2.6.1 WC shall be entitled to reject any portion or all of any shipment of Products that does not conform to the Certificate of Analysis or otherwise fails to comply with the representations and warranties set forth in Section 5.2.1 (unless such non-conformity was attributable to an act or omission of WC or the common carrier once the Product was delivered by BMSLC to such common carrier provided that the Products were packaged for shipment in accordance with Section 2.5); provided that (a) WC shall notify BMSLC within fifteen (15) business days after receipt of such shipment if it is rejecting a shipment due to obvious physical damage or quantity discrepancies that are evident upon visual inspection of the packaged Products as shipped by BMSLC, and (b) in the case of Products having defects other than those obvious defects, WC shall notify BMSLC within fifteen (15) business days after WC becomes aware of such defect. Notwithstanding anything contained herein, WC shall have no obligation to inspect the Products beyond a visual inspection of each shipment for obvious physical damage or quantity discrepancies that are evident upon visual inspection of the packaged Products as shipped by BMSLC. Without in any way limiting BMSLC's indemnity obligation as set forth in Section 6.1, if no notice is provided by WC within such time periods (i.e., fifteen (15) business days), then WC shall be deemed to have accepted the shipment. Any notice of rejection by WC shall be accompanied by a reasonably detailed statement of its reasons for rejection and a report of any pertinent analysis performed by WC on the allegedly nonconforming Product, together with the methods and procedures used. BMSLC shall notify WC as promptly as reasonably possible, but in any event within ten (10) days after receipt of such notice of rejection, whether it accepts WC's assertions of nonconformity.

Appears in 2 contracts

Samples: Transitional Support and Supply Agreement (Warner Chilcott PLC), Transitional Support and Supply Agreement (Warner Chilcott Inc)

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Receipt of Product; Acceptance. 2.6.1 WC (a) The Company shall be entitled to reject any portion or all of any shipment of Products that does not conform to the Certificate of Analysis or otherwise fails to comply with the representations and warranties set forth in Section 5.2.1 5.02(a) (unless such non-conformity was attributable to an act or omission of WC the Company or the common carrier once the Product was delivered by BMSLC BMS to such common carrier provided that the Products were packaged for shipment in accordance with Section 2.5carrier); provided that , provided, that, (a) WC the Company shall notify BMSLC BMS within fifteen (15) 15 business days after receipt of such shipment if it is rejecting a shipment due to obvious physical damage damage, obvious packaging defect or quantity discrepancies that are evident upon visual inspection of the packaged Products as shipped by BMSLC, BMS and (b) in the case of Products having defects other than those obvious defects, WC the Company shall notify BMSLC BMS within fifteen (15) 15 business days after WC the Company becomes aware of such defect. Notwithstanding anything contained herein, WC the Company shall have no obligation to inspect the Products beyond a visual inspection of each shipment for obvious physical damage or quantity discrepancies that are evident upon visual inspection of the packaged Products as shipped by BMSLCBMS. Without in any way limiting BMSLC's BMS' indemnity obligation as set forth in Section 6.16.01, if no notice is provided by WC the Company within such time periods (i.e., fifteen (15) 15 business days), then WC the Company shall be deemed to have accepted the shipment. Any notice of rejection by WC the Company shall be accompanied by a reasonably detailed statement of its reasons for rejection and a report of any pertinent analysis performed by WC the Company on the allegedly nonconforming Product, together with the methods and procedures used. BMSLC BMS shall notify WC the Company as promptly as reasonably possible, but in any event within ten (10) 10 business days after receipt of such notice of rejection, whether it accepts WCthe Company's assertions of nonconformity. (b) Whether or not BMS accepts the Company's assertion of nonconformity, promptly upon receipt of a notice of rejection, unless otherwise specified by the Company, BMS shall use commercially reasonable efforts to provide replacement Products for those rejected by the Company in the original shipment. If the Product rejected by the Company from such original shipment ultimately is found to be nonconforming (whether pursuant to Section 2.05(c) or if BMS so acknowledges in writing), BMS shall bear all expenses for such replacement Product (including all transportation and/or disposal charges and cost of manufacture for such nonconforming Product), to the extent the Company previously paid for any corresponding nonconforming Product. If it is determined 13 subsequently that such Product was in fact conforming (whether pursuant to Section 2.05(c) or if the Company so acknowledges in writing), then the Company shall be responsible not only for the purchase price of the allegedly nonconforming Product (including all transportation charges), but also, upon receipt and acceptance by the Company in accordance with the procedures (and at the same price charged in the original shipment) set forth above, the replacement Product. Replacement shipments shall also be subject to the procedures contained in Section 2.05(a). BMS shall be under no obligation to accept a return of Product except as provided in this paragraph. (c) If BMS disagrees with any alleged nonconformity, then an independent Good Manufacturing Practices certified laboratory (or other expert) of recognized repute, reasonably acceptable to both Parties, shall analyze an aliquot sample or such other portions of a shipment, furnished by the Company from the shipment received by the Company, as may be necessary to substantiate whether the shipment rejected by the Company conformed in all material respects to the Certificate of Analysis and/or any other pertinent Specifications or otherwise failed to comply with the representations and warranties set forth in Section 5.02(a) at the time of delivery to the common carrier. The laboratory shall use such procedures and tests as the laboratory may consider necessary or appropriate to reach a conclusion. Both Parties agree to cooperate with the independent laboratory's reasonable requests for assistance in connection with its analysis hereunder. Both Parties shall be bound by the laboratory's results of analysis, which, absent manifest error, shall be deemed final as to any dispute over compliance of the Product in all material respects with the Certificate of Analysis and/or any other pertinent Specifications and/or the representations and warranties set forth in Section 5.02(a). If the laboratory analysis shows that the Products do not conform in all material respects to the Certificate of Analysis and/or any other pertinent Specifications and/or the representations and warranties set forth in Section 5.02(a) at the time of delivery to the common carrier, the costs of such analysis shall be paid by BMS. If the laboratory analysis shows that the Products do conform in all material respects to the Certificate of Analysis and/or any other pertinent Specifications and/or the representations and warranties set forth in Section 5.02(a) at the time of delivery to the common carrier, the costs of such analysis shall be paid by the Company. (d) If BMS acknowledges an alleged nonconformity (or if the laboratory concludes that the Product was nonconforming), BMS promptly (and in any case within thirty calendar days thereafter) shall make arrangements for the return, reworking or disposal, at BMS' option, of the nonconforming Product. If BMS requests that the Company dispose of such nonconforming Product, BMS shall give the Company written instructions as to how the Company or its agent shall, at BMS' expense and liability, lawfully dispose of any non-conforming Products, and the Company shall provide BMS with written certification of such destruction. BMS shall pay, or reimburse the Company, for any reasonable return shipping charges or out-of-pocket costs incurred by the Company for such return shipment or lawful disposal of such nonconforming Product in accordance with BMS' instructions.

Appears in 1 contract

Samples: Supply Agreement (Galen Holdings PLC)

Receipt of Product; Acceptance. 2.6.1 WC shall be entitled to reject any portion or all of any shipment of Products that does not conform to the Certificate of Analysis or otherwise fails to comply with the representations and warranties set forth in Section 5.2.1 (unless such non-conformity was attributable to an act or omission of WC or the common carrier once the Product was delivered by BMSLC WSP to such common carrier provided that the Products were packaged for shipment in accordance with Section 2.5); provided that (a) WC shall notify BMSLC WSP within fifteen (15) business days [REDACTED] after receipt of such shipment if it is rejecting a shipment due to obvious physical damage or quantity discrepancies that are evident upon visual inspection of the packaged Products as shipped by BMSLCWSP, and (b) in the case of Products having defects other than those obvious defects, WC shall notify BMSLC WSP within fifteen (15) business days [REDACTED] after WC becomes aware of such defect. Notwithstanding anything contained herein, WC shall have no obligation to inspect the Products beyond a visual inspection of each shipment for obvious physical damage or quantity discrepancies that are evident upon visual inspection of the packaged Products as shipped by BMSLCWSP. Without in any way limiting BMSLCWSP's indemnity obligation as set forth in Section 6.1, if no notice is provided by WC within such time periods (i.e., fifteen (15) business days[REDACTED]), then WC shall be deemed to have accepted the shipment. Any notice of rejection by WC shall be accompanied by a reasonably detailed statement of its reasons for rejection and a report of any pertinent analysis performed by WC on the allegedly nonconforming Product, together with the methods and procedures used. BMSLC WSP shall notify WC as promptly as reasonably possible, but in any event within ten (10) days [REDACTED] after receipt of such notice of rejection, whether it accepts WC's assertions of nonconformity.

Appears in 1 contract

Samples: Transitional Support and Supply Agreement (Warner Chilcott PLC)

Receipt of Product; Acceptance. 2.6.1 WC (a) Promptly after each Delivery Date, and prior to the labeling and packaging of such Bulk Product, Aratana, or its designee, shall conduct (i) a visual inspection of the Bulk Product for defects or damages and (ii) an inspection of all associated quality assurance documents, including, without limitation, the Certificate of Analysis and Certificate of Compliance delivered in accordance with Section 4.1. Aratana shall be entitled to reject and return any portion or all of any shipment of Products Bulk Product that does not conform to the Certificate of Analysis Specification or otherwise fails to comply with the representations and warranties warranty set forth in Section 5.2.1 7.2(b) (unless such non-conformity was nonconformity or noncompliance is attributable to an act or omission of WC or Aratana after the common carrier once the time such Bulk Product was delivered Delivered by BMSLC to such common carrier provided that the Products were packaged for shipment in accordance with Section 2.5Pacira); provided provided, that (a) WC shall notify BMSLC within fifteen (15) business days after receipt Aratana provides notice of non-conformance discovered by Aratana based on such shipment if it is rejecting a shipment due to obvious physical damage or quantity discrepancies that are evident upon visual inspection and inspection of the packaged Products as shipped by BMSLC, and (bassociated quality assurance document or any other non-conformance to the warranties provided in Section 7.2(b) in the case of Products having defects other than those obvious defects, WC shall notify BMSLC within fifteen (15) business [***] calendar days after WC becomes aware Delivery of such defectBulk Product. Notwithstanding anything contained herein, WC shall have no obligation to inspect the Products beyond a visual inspection of each shipment for obvious physical damage or quantity discrepancies that are evident upon visual inspection of the packaged Products as shipped by BMSLC. Without in any way limiting BMSLC's indemnity obligation as set forth in Section 6.1, if If no notice is provided by WC Aratana within such time periods (i.e., fifteen (15) business days)period, then WC Aratana shall be deemed to have accepted the shipmentshipment and all such Bulk Product Delivered to Aratana shall be deemed to materially conform with the Specification. Any notice of rejection by WC Aratana shall specify the shipment and Purchase Order number and shall be accompanied by a reasonably detailed statement of its Aratana’s exact reasons for rejection and along with reasonable evidence of the alleged nonconformity or noncompliance (including a sample of the Bulk Product from the shipment tested) and, if applicable, a report of any pertinent analysis performed by WC Aratana on the allegedly nonconforming or noncomplying Bulk Product, together with the methods and procedures usedused to determine such non-conformity. BMSLC Pacira shall notify WC Aratana in writing as promptly as reasonably possiblepracticable, but in any event within ten (10) days [***] Business Days after receipt of such notice of rejection, whether it Pacira accepts WC's Aratana’s assertions of nonconformitynonconformity or noncompliance. (b) Whether or not Pacira accepts Aratana’s assertion of nonconformity or noncompliance, promptly upon receipt of a notice of rejection, Pacira shall use commercially reasonable efforts to provide replacement Bulk Product for the quantity of Bulk Product rejected by Aratana in the original shipment as soon as reasonably possible but no later than [***] days after the date of receipt of the notice of rejection. Aratana shall remain responsible for the purchase price for the allegedly nonconforming or noncomplying Bulk Product; provided, however, if the Bulk Product rejected by Aratana from such original shipment ultimately is found to be nonconforming or noncomplying (whether pursuant to Section 4.3(a) or if Pacira acknowledges such in writing), Pacira shall bear all costs and expenses of such replacement Bulk Product (including the purchase price thereof and/or disposal charges for such nonconforming or noncomplying Bulk Product). If it is determined subsequently that such Bulk Product was in fact conforming (whether pursuant to Section 4.3(a) or if Aratana acknowledges such in writing), then Aratana shall be responsible for the purchase price for the allegedly nonconforming Bulk Product, as well as, upon receipt and acceptance by Aratana in accordance with the procedures set forth herein, the replacement Bulk Product, which shall be purchased at the then-effective purchase price for such Bulk Product. Replacement shipments shall also be subject to the procedures contained in this Section 4.3(b). Pacira shall be under no obligation to accept a return of Bulk Product except as provided for in this Section 4.3. (c) If Pacira disagrees with any alleged nonconformity or noncompliance, then the Parties shall have [***] days from the date of Pacira’s receipt of Aratana’s notification pursuant to Section 4.2(a) to resolve any such dispute. If such dispute is not resolved in the [***] day period then an independent cGMP-certified laboratory (or other expert or consultant) of recognized repute (the “Laboratory”), selected by Pacira and reasonably acceptable to Aratana, shall analyze an aliquot sample or such other portions of a shipment, furnished by Aratana from the shipment received and rejected by Aratana, as may be necessary to substantiate whether the shipment rejected by Aratana conformed in all material respects to the Specification at the time of Delivery to, which analysis shall be performed in compliance with applicable FDA regulations for re-testing of pharmaceutical products. The Parties agree to cooperate with the Laboratory’s reasonable requests for assistance in connection with its analysis hereunder. The Parties shall be bound by the Laboratory’s results of analysis, which, absent manifest error, shall be deemed final as to any dispute over compliance of the Bulk Product in all material respects with the Specification at the time of Delivery. The fees and expenses of the Laboratory making such determination shall be by the Party against which the determination is made, or if the Laboratory cannot place the fault noticed and complained about, then the Parties shall share equally such costs. (d) If Pacira accepts rejection of any shipment due to nonconformity or noncompliance (or if not, then following the decision of the Laboratory that the shipment was nonconforming), Pacira shall promptly (and in any case within [***] Business Days thereafter) make arrangements for the return, reworking or disposal, at Pacira’s option, of any nonconforming or noncomplying Bulk Product. If Pacira requests that Aratana dispose of such nonconforming or noncomplying Bulk Product, Pacira shall give Aratana written instructions as to how Aratana or its agent should dispose of such nonconforming or noncomplying Bulk Product, and Aratana shall provide Pacira with written certification of such destruction. Pacira shall pay (or reimburse Aratana) for any reasonable return shipping charges or out-of-pocket costs or expenses incurred by Aratana for such return shipment or lawful disposal of such nonconforming or noncomplying Bulk Product.

Appears in 1 contract

Samples: Supply Agreement (Aratana Therapeutics, Inc.)

Receipt of Product; Acceptance. 2.6.1 WC (a) Promptly after each Delivery Date, and prior to the labeling and packaging of such Bulk Product, Aratana shall conduct (i) a visual inspection of the Bulk Product for defects or damages and (ii) an inspection of all associated quality assurance documents, including, without limitation, the Certificate of Analysis delivered in accordance with Section 4.1. Aratana shall be entitled to reject and return any portion or all of any shipment of Products Bulk Product that does not conform to the Certificate of Analysis Specification or otherwise fails to comply with the representations and warranties warranty set forth in Section 5.2.1 7.2(b) (unless such non-conformity was nonconformity or noncompliance is attributable to an act or omission of WC or Aratana after the common carrier once the time such Bulk Product was delivered Delivered by BMSLC to such common carrier provided that the Products were packaged for shipment in accordance with Section 2.5Pacira); provided provided, that (a) WC shall notify BMSLC within fifteen (15) business days after receipt Aratana provides notice of non-conformance discovered by Aratana based on such shipment if it is rejecting a shipment due to obvious physical damage or quantity discrepancies that are evident upon visual inspection and inspection of the packaged Products as shipped by BMSLC, and (bassociated quality assurance document or any other non-conformance to the warranties provided in Section 7.2(b) in the case of Products having defects other than those obvious defects, WC shall notify BMSLC within fifteen (15) business [**] calendar days after WC becomes aware Delivery of such defectBulk Product. Notwithstanding anything contained herein, WC shall have no obligation to inspect the Products beyond a visual inspection of each shipment for obvious physical damage or quantity discrepancies that are evident upon visual inspection of the packaged Products as shipped by BMSLC. Without in any way limiting BMSLC's indemnity obligation as set forth in Section 6.1, if If no notice is provided by WC Aratana within such time periods (i.e., fifteen (15) business days)period, then WC Aratana shall be deemed to have accepted the shipmentshipment and all such Bulk Product Delivered to Aratana shall be deemed to materially conform with the Specification. Any notice of rejection by WC Aratana shall specify the shipment and Purchase Order number and shall be accompanied by a reasonably detailed statement of its Aratana’s exact reasons for rejection and along with reasonable evidence of the alleged nonconformity or noncompliance (including a sample of the Bulk Product from the shipment tested) and, if applicable, a report of any pertinent analysis performed by WC Aratana on the allegedly nonconforming or noncomplying Bulk Product, together with the methods and procedures usedused to determine such non-conformity. BMSLC Pacira shall notify WC Aratana in writing as promptly as reasonably possiblepracticable, but in any event within ten (10) days [**] Business Days after receipt of such notice of rejection, whether it Pacira accepts WC's Aratana’s assertions of nonconformitynonconformity or noncompliance. (b) Whether or not Pacira accepts Aratana’s assertion of nonconformity or noncompliance, promptly upon receipt of a notice of rejection, Pacira shall use commercially reasonable efforts to provide replacement Bulk Product for the quantity of Bulk Product rejected by Aratana in the original shipment as soon as reasonably possible but no later than [**] days after the date of receipt of the notice of rejection. Aratana shall remain responsible for the purchase price for the allegedly nonconforming or noncomplying Bulk Product; provided, however, if the Bulk Product rejected by Aratana from such original shipment ultimately is found to be nonconforming or noncomplying (whether pursuant to Section 4.3(a) or if Aratana acknowledges such in writing), Pacira shall bear all costs and expenses of such replacement Bulk Product (including the purchase price thereof and/or disposal charges for such nonconforming or noncomplying Bulk Product). If it is determined subsequently that such Bulk Product was in fact conforming (whether pursuant to Section 4.3(a) or if Aratana acknowledges such in writing), then Aratana shall be responsible for the purchase price for the allegedly nonconforming Bulk Product, as well as, upon receipt and acceptance by Aratana in accordance with the procedures set forth herein, the replacement Bulk Product, which shall be purchased at the then-effective purchase price for such Bulk Product. Replacement shipments shall also be subject to the procedures contained in this Section 4.3(b). Pacira shall be under no obligation to accept a return of Bulk Product except as provided for in this Section 4.3. (c) If Pacira disagrees with any alleged nonconformity or noncompliance, then the Parties shall have [**] days from the date of Pacira’s receipt of Aratana’s notification pursuant to Section 4.2(a) to resolve any such dispute. If such dispute is not resolved in the [**] day period then an independent cGMP-certified laboratory (or other expert or consultant) of recognized repute (the “Laboratory”), selected by Pacira and reasonably acceptable to Aratana, shall analyze an aliquot sample or such other portions of a shipment, furnished by Aratana from the shipment received and rejected by Aratana, as may be necessary to substantiate whether the shipment rejected by Aratana conformed in all material respects to the Specification at the time of Delivery to, which analysis shall be performed in compliance with applicable FDA regulations for re-testing of pharmaceutical products. The Parties agree to cooperate with the Laboratory’s reasonable requests for assistance in connection with its analysis hereunder. The Parties shall be bound by the Laboratory’s results of analysis, which, absent manifest error, shall be deemed final as to any dispute over compliance of the Bulk Product in all material respects with the Specification at the time of Delivery. The fees and expenses of the Laboratory making such determination shall be by the Party against which the determination is made, or if the Laboratory cannot place the fault noticed and complained about, then the Parties shall share equally such costs. (d) If Pacira accepts rejection of any shipment due to nonconformity or noncompliance (or if not, then following the decision of the Laboratory that the shipment was nonconforming), Pacira shall promptly (and in any case within [**] Business Days thereafter) make arrangements for the return, reworking or disposal, at Pacira’s option, of any nonconforming or noncomplying Bulk Product. If Pacira requests that Aratana dispose of such nonconforming or noncomplying Bulk Product, Pacira shall give Aratana written instructions as to how Aratana or its agent should dispose of such nonconforming or noncomplying Bulk Product, and Aratana shall provide Pacira with written certification of such destruction. Pacira shall pay (or reimburse Aratana) for any reasonable return shipping charges or out-of-pocket costs or expenses incurred by Aratana for such return shipment or lawful disposal of such nonconforming or noncomplying Bulk Product.

Appears in 1 contract

Samples: Supply Agreement (Pacira Pharmaceuticals, Inc.)

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Receipt of Product; Acceptance. 2.6.1 WC (a) Promptly after each Delivery Date, and prior to the labeling and packaging of such Bulk Product, Aratana shall conduct (i) a visual inspection of the Bulk Product for defects or damages and (ii) an inspection of all associated quality assurance documents, including, without limitation, the Certificate of Analysis delivered in accordance with Section 4.1. Aratana shall be entitled to reject and return any portion or all of any shipment of Products Bulk Product that does not conform to the Certificate of Analysis Specification or otherwise fails to comply with the representations and warranties warranty set forth in Section 5.2.1 7.2(b) (unless such non-conformity was nonconformity or noncompliance is attributable to an act or omission of WC or Aratana after the common carrier once the time such Bulk Product was delivered Delivered by BMSLC to such common carrier provided that the Products were packaged for shipment in accordance with Section 2.5Pacira); provided provided, that (a) WC shall notify BMSLC within fifteen (15) business days after receipt Aratana provides notice of non-conformance discovered by Aratana based on such shipment if it is rejecting a shipment due to obvious physical damage or quantity discrepancies that are evident upon visual inspection and inspection of the packaged Products as shipped by BMSLC, and (bassociated quality assurance document or any other non-conformance to the warranties provided in Section 7.2(b) in the case of Products having defects other than those obvious defects, WC shall notify BMSLC within fifteen (15) business [***] calendar days after WC becomes aware Delivery of such defectBulk Product. Notwithstanding anything contained herein, WC shall have no obligation to inspect the Products beyond a visual inspection of each shipment for obvious physical damage or quantity discrepancies that are evident upon visual inspection of the packaged Products as shipped by BMSLC. Without in any way limiting BMSLC's indemnity obligation as set forth in Section 6.1, if If no notice is provided by WC Aratana within such time periods (i.e., fifteen (15) business days)period, then WC Aratana shall be deemed to have accepted the shipmentshipment and all such Bulk Product Delivered to Aratana shall be deemed to materially conform with the Specification. Any notice of rejection by WC Aratana shall specify the shipment and Purchase Order number and shall be accompanied by a reasonably detailed statement of its Aratana’s exact reasons for rejection and along with reasonable evidence of the alleged nonconformity or noncompliance (including a sample of the Bulk Product from the shipment tested) and, if applicable, a report of any pertinent analysis performed by WC Aratana on the allegedly nonconforming or noncomplying Bulk Product, together with the methods and procedures usedused to determine such non-conformity. BMSLC Pacira shall notify WC Aratana in writing as promptly as reasonably possiblepracticable, but in any event within ten (10) days [***] Business Days after receipt of such notice of rejection, whether it Pacira accepts WC's Aratana’s assertions of nonconformitynonconformity or noncompliance. (b) Whether or not Pacira accepts Aratana’s assertion of nonconformity or noncompliance, promptly upon receipt of a notice of rejection, Pacira shall use commercially reasonable efforts to provide replacement Bulk Product for the quantity of Bulk Product rejected by Aratana in the original shipment as soon as reasonably possible but no later than [***] days after the date of receipt of the notice of rejection. Aratana shall remain responsible for the purchase price for the allegedly nonconforming or noncomplying Bulk Product; provided, however, if the Bulk Product rejected by Aratana from such original shipment ultimately is found to be nonconforming or noncomplying (whether pursuant to Section 4.3(a) or if Aratana acknowledges such in writing), Pacira shall bear all costs and expenses of such replacement Bulk Product (including the purchase price thereof and/or disposal charges for such nonconforming or noncomplying Bulk Product). If it is determined subsequently that such Bulk Product was in fact conforming (whether pursuant to Section 4.3(a) or if Aratana acknowledges such in writing), then Aratana shall be responsible for the purchase price for the allegedly nonconforming Bulk Product, as well as, upon receipt and acceptance by Aratana in accordance with the procedures set forth herein, the replacement Bulk Product, which shall be purchased at the then-effective purchase price for such Bulk Product. Replacement shipments shall also be subject to the procedures contained in this Section 4.3(b). Pacira shall be under no obligation to accept a return of Bulk Product except as provided for in this Section 4.3. (c) If Pacira disagrees with any alleged nonconformity or noncompliance, then the Parties shall have [***] days from the date of Pacira’s receipt of Aratana’s notification pursuant to Section 4.2(a) to resolve any such dispute. If such dispute is not resolved in the [***] day period then an independent cGMP-certified laboratory (or other expert or consultant) of recognized repute (the “Laboratory”), selected by Pacira and reasonably acceptable to Aratana, shall analyze an aliquot sample or such other portions of a shipment, furnished by Aratana from the shipment received and rejected by Aratana, as may be necessary to substantiate whether the shipment rejected by Aratana conformed in all material respects to the Specification at the time of Delivery to, which analysis shall be performed in compliance with applicable FDA regulations for re-testing of pharmaceutical products. The Parties agree to cooperate with the Laboratory’s reasonable requests for assistance in connection with its analysis hereunder. The Parties shall be bound by the Laboratory’s results of analysis, which, absent manifest error, shall be deemed final as to any dispute over compliance of the Bulk Product in all material respects with the Specification at the time of Delivery. The fees and expenses of the Laboratory making such determination shall be by the Party against which the determination is made, or if the Laboratory cannot place the fault noticed and complained about, then the Parties shall share equally such costs. (d) If Pacira accepts rejection of any shipment due to nonconformity or noncompliance (or if not, then following the decision of the Laboratory that the shipment was nonconforming), Pacira shall promptly (and in any case within [***] Business Days thereafter) make arrangements for the return, reworking or disposal, at Pacira’s option, of any nonconforming or noncomplying Bulk Product. If Pacira requests that Aratana dispose of such nonconforming or noncomplying Bulk Product, Pacira shall give Aratana written instructions as to how Aratana or its agent should dispose of such nonconforming or noncomplying Bulk Product, and Aratana shall provide Pacira with written certification of such destruction. Pacira shall pay (or reimburse Aratana) for any reasonable return shipping charges or out-of-pocket costs or expenses incurred by Aratana for such return shipment or lawful disposal of such nonconforming or noncomplying Bulk Product.

Appears in 1 contract

Samples: Supply Agreement (Aratana Therapeutics, Inc.)

Receipt of Product; Acceptance. 2.6.1 WC shall be entitled to reject any portion or all of any shipment of Products that does not conform to the Certificate of Analysis or otherwise fails to comply with the representations and warranties set forth in Section 5.2.1 (unless such non-conformity was attributable to an act or omission of WC or the common carrier once the Product was delivered by BMSLC WSP to such common carrier provided that the Products were packaged for shipment in accordance with Section 2.5); provided that (a) WC shall notify BMSLC WSP within fifteen (15) business days after receipt of such shipment if it is rejecting a shipment due to obvious physical damage or quantity discrepancies that are evident upon visual inspection of the packaged Products as shipped by BMSLCWSP, and (b) in the case of Products having defects other than those obvious defects, WC shall notify BMSLC WSP within fifteen (15) business days after WC becomes aware of such defect. Notwithstanding anything contained herein, WC shall have no obligation to inspect the Products beyond a visual inspection of each shipment for obvious physical damage or quantity discrepancies that are evident upon visual inspection of the packaged Products as shipped by BMSLCWSP. Without in any way limiting BMSLCWSP's indemnity obligation as set forth in Section 6.1, if no notice is provided by WC within such time periods (i.e., fifteen (15) business days), then WC shall be deemed to have accepted the shipment. Any notice of rejection by WC shall be accompanied by a reasonably detailed statement of its reasons for rejection and a report of any pertinent analysis performed by WC on the allegedly nonconforming Product, together with the methods and procedures used. BMSLC WSP shall notify WC as promptly as reasonably possible, but in any event within ten (10) days after receipt of such notice of rejection, whether it accepts WC's assertions of nonconformity.

Appears in 1 contract

Samples: Transitional Support and Supply Agreement (Warner Chilcott Inc)

Receipt of Product; Acceptance. Except as provided in the Xxxxxx Supply Agreement or as specifically provided otherwise in Section 2.11 hereof or in any Related Agreement: 2.6.1 WC On or before the delivery of each shipment of each Product, BMS will provide to DURA a Certificate of Analysis for the shipment being delivered. DURA shall be entitled to reject any portion or all of any such shipment of Products that does not conform to the Certificate of Analysis (other than as a result of damage in transit) or otherwise fails to comply in any material respect with the representations and warranties set forth any other Specifications mutually agreed upon in Section 5.2.1 (unless writing for such non-conformity was attributable to an act or omission of WC or the common carrier once the Product was delivered by BMSLC to such common carrier provided Product; PROVIDED, that the Products were packaged for shipment in accordance with Section 2.5); provided that (a) WC shall DURA will notify BMSLC BMS within fifteen (15) business days after receipt of such the shipment if it as to whether DURA is rejecting a shipment due to obvious physical damage or quantity discrepancies that are evident upon visual inspection of the packaged Products as shipped by BMSLC, and (b) in the case of Products having defects other than those obvious defects, WC shall notify BMSLC within fifteen (15) business days after WC becomes aware of such defectshipment. Notwithstanding anything contained herein, WC shall have If no obligation to inspect the Products beyond a visual inspection of each shipment for obvious physical damage or quantity discrepancies that are evident upon visual inspection of the packaged Products as shipped by BMSLC. Without in any way limiting BMSLC's indemnity obligation as set forth in Section 6.1, if no such notice is provided by WC within such time periods (i.e., fifteen (15) business days)DURA, then WC DURA shall be deemed to have accepted the shipmentshipment ("Acceptance"); provided, that in the case of Products having latent defects which upon diligent examination by DURA upon receipt should not reasonably have been discovered, DURA must give written notice of rejection within twenty (20) days after DURA discovers or should reasonably have discovered such latent defect (and so long as DURA is able to demonstrate that such defect was not attributable to any act or omission of DURA or the common carrier once the Product shall have been delivered by BMS to such common carrier). Any notice of rejection by WC DURA shall be accompanied by a reasonably detailed statement of its reasons for rejection and a report of any pertinent analysis performed by WC DURA on the allegedly nonconforming Product, together with the methods and procedures used. BMSLC BMS shall notify WC DURA as promptly as reasonably possible, but in any event within ten (10) days after receipt of such notice of rejection, whether it accepts WCDURA's assertions of nonconformity. 2.6.2 Whether or not BMS accepts DURA's assertion of nonconformity, promptly on receipt of a notice of rejection, BMS shall use commercially reasonable efforts to provide replacement Product for that rejected by DURA in the original shipment. However, if the Product rejected by DURA from such original shipment ultimately is found to be nonconforming (whether pursuant to Section 2.6.3 or if BMS acknowledges same in writing), BMS shall, to the extent that DURA may previously have paid for such nonconforming Product, bear its own expenses of such replacement Product (including all transportation and/or disposal charges and cost of manufacture for such nonconforming Product), and BMS shall determine if the nonconforming Product shall be destroyed or returned to it. If DURA shall not previously have paid for the allegedly nonconforming Product, and it is determined subsequently that such Product was in fact conforming (whether pursuant to Section 2.6.3 or if DURA acknowledges same in writing), then DURA shall be responsible for the purchase price for the allegedly nonconforming Product (including all transportation charges), as well as, upon receipt and acceptance by DURA in accordance with the procedures (and at the same price charged in the original shipment) set forth herein, the replacement Product. Replacement shipments shall also be subject to the procedures contained in this subparagraph. BMS shall be under no obligation to accept a return of Product except as provided for in this subparagraph. 2.6.3 If BMS disagrees with any alleged nonconformity, then an independent GMP laboratory (or other expert) of recognized repute, selected by BMS and reasonably acceptable to DURA, shall analyze an aliquot sample or such other portions of a shipment, furnished by DURA from the shipment received by DURA, as may be necessary to substantiate whether the shipment rejected by DURA conformed in all material respects to the Certificate of Analysis and/or any other pertinent Specifications. The laboratory (or expert) shall use such procedures and tests as the laboratory may consider necessary or appropriate to reach a conclusion. Both Parties agree to cooperate with the independent laboratory's reasonable requests for assistance in connection with its analysis hereunder. Both Parties shall be bound by the laboratory's results of analysis, which, absent manifest error, shall be deemed final as to any dispute over compliance of the Product in all material respects with the Certificate of Analysis and/or any other pertinent Specifications. The costs incurred by the laboratory shall be borne by the losing Party, or if the laboratory cannot place the fault noticed and complained about, then the Parties shall share equally the expenses connected with the expert. 2.6.4 Where BMS accepts DURA's rejection of nonconformity (or if not, then following the decision of the independent laboratory that the shipment was nonconforming), BMS shall promptly make arrangements (but within 30 days thereafter) for the return or disposal, at BMS's option, of any nonconforming Product. If BMS requests that DURA dispose of such nonconforming Product, DURA shall lawfully destroy such Product promptly, and provide BMS with written certification of such destruction. BMS shall pay (or reimburse DURA for) any reasonable return shipping charges or out-of-pocket costs incurred by DURA for such return shipment or lawful disposal of such nonconforming Product. 2.6.5 All Products sold to DURA hereunder shall be used by DURA in accordance with the terms and conditions of this Agreement and the applicable terms and conditions of any applicable Related Agreement then in force and effect.

Appears in 1 contract

Samples: Supply Agreement (Dura Pharmaceuticals Inc)

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