Cooperation in Investigations; Disposition of Non-Conforming Product. If Helix desires to make a claim against BioVectra with respect to and causing the rejection of a Batch of Non-Conforming Product pursuant to Section 8.1, Helix agrees that it shall not dispose of or allow such Product to be disposed of without written authorization and instructions from BioVectra either to dispose of or return to BioVectra such Non-Conforming Product. Upon written request by Helix, BioVectra agrees promptly to give Helix such authorization and instructions within a reasonable period of time. Each Party shall act in good faith and shall cooperate with the other Party and with any Third Party or arbitrator appointed pursuant to Section 8.5 in connection with an investigation as to the existence of or source of any Non-Conforming Product supplied under this Agreement. At the request of Helix, BioVectra will provide all Non-Conforming Product to Helix at a price (including shipping and delivery expenses) to be agreed upon between the Parties and in accordance with the delivery terms set forth in Section 4 hereof. Helix may make whatever further use of such Non-Conforming Product as it shall determine; provided, however, that Helix agrees that: (a) such Non-Conforming Product shall not be used in humans, and (b) the warranties provided in Sections 11.1 and 11.2 of this Agreement shall not apply to such Non-Conforming Product. BioVectra shall dispose of any Non-Conforming Product returned by Helix in accordance with all relevant Regulatory Requirements for such disposal, at BioVectra's expense, if BioVectra was liable for such Non-Conforming Product in accordance with Section 8.3 and at Helix's expense if BioVectra was not liable for such Non-Conforming Product in accordance with Section 8.2.
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Samples: CGMP Process Development, Scale Up and Clinical Supplies Manufacturing Agreement (Helix BioPharma Corp), CGMP Process Development, Scale Up and Clinical Supplies Manufacturing Agreement (Helix BioPharma Corp), CGMP Process Development, Scale Up and Clinical Supplies Manufacturing Agreement (Helix BioPharma Corp)
Cooperation in Investigations; Disposition of Non-Conforming Product. If Helix desires to make a claim against BioVectra CPL with respect to and causing the rejection of a Batch of Non-Conforming Product pursuant to Section 8.1, Helix agrees that it shall not dispose of or allow such Product to be disposed of without written authorization and instructions from BioVectra CPL either to dispose of or return to BioVectra CPL such Non-Conforming Product. Upon written request by Helix, BioVectra CPL agrees promptly to give Helix such authorization and instructions within a reasonable period of time. Each Party shall act in good faith and shall cooperate with the other Party and with any Third Party or arbitrator appointed pursuant to Section 8.5 in connection with an investigation as to the existence of or source of any Non-Conforming Product supplied under this Agreement. At the request of Helix, BioVectra CPL will provide all Non-Conforming Product to Helix at a price (including shipping and delivery expenses) to be agreed upon between the Parties and in accordance with the delivery terms set forth in Section 4 3 hereof. Helix may make whatever further use of such Non-Conforming Product as it shall determine; provided, however, that Helix agrees that:
(a) such Non-Conforming Product shall not be used in humans, and
(b) the warranties provided in Sections 11.1 and 11.2 of this Agreement shall not apply to such Non-Conforming Product. BioVectra CPL shall dispose of any Non-Conforming Product returned by Helix in accordance with all relevant Regulatory Requirements for such disposal, at BioVectraCPL's expense, if BioVectra CPL was liable for such Non-Conforming Product in accordance with Section 8.3 and at Helix's expense if BioVectra CPL was not liable for such Non-Conforming Product in accordance with Section 8.2.
Appears in 3 contracts
Samples: Topical Interferon Alpha 2b GMP Process Development, Scale Up and Clinical Supplies Manufacturing Agreement (Helix BioPharma Corp), GMP Process Development and Manufacturing Agreement (Helix BioPharma Corp), Topical Interferon Alpha 2b GMP Process Development, Scale Up and Clinical Supplies Manufacturing Agreement (Helix BioPharma Corp)
Cooperation in Investigations; Disposition of Non-Conforming Product. If Helix desires to make a claim against BioVectra with respect to and causing the rejection of Client rejects a Batch of as Non-Conforming Product pursuant to Section 8.19.1, Helix agrees that it the Party then in possession of the Batch shall not dispose of or allow such Product to be disposed of without written authorization and instructions from BioVectra the other Party either to dispose of or return to BioVectra such Non-Conforming Product. Upon written request Product or to return it to the other Party, at the receiving Party’s expense, should the other Party wish to have additional testing conducted by Helix, BioVectra agrees promptly to give Helix such authorization and instructions within a reasonable period qualified independent Third-Party laboratory or for purposes of timedisposal. Each Party shall act in good faith and shall cooperate with the other Party and Party, with any Third qualified independent Third-Party or arbitrator appointed pursuant to Section 8.5 laboratory in connection with an investigation investigation, as to the existence of or source of any Non-Conforming Product nonconformity with respect to a Production Batch supplied under this Agreement. At In testing the request of HelixProduction Batch, BioVectra will provide all Nonany independent Third-Conforming Party laboratory shall use analytical testing methods as specified in the Product to Helix at a price (including shipping and delivery expenses) to be agreed upon between the Parties and in accordance with the delivery terms set forth in Section 4 hereof. Helix may make whatever further use of Specifications for such Non-Conforming Product as it shall determine; provided, however, that Helix agrees that:
(a) such Non-Conforming Product shall not be used in humans, and
(b) the warranties provided in Sections 11.1 and 11.2 of this Agreement shall not apply to such Non-Conforming Product. BioVectra The Party in possession shall dispose of any Non-Conforming Product returned by Helix in accordance with all relevant Regulatory Requirements for laws, rules and regulations with respect to such disposal, at BioVectra's expense, Paragon’s cost if BioVectra Paragon was liable for the nonconformity in accordance with Section 9.3 and at Client’s cost if Paragon was not liable for the nonconformity in accordance with Section 9.2, unless Client notifies Paragon in writing that it wishes to retain Non-Conforming Product for evaluation of process development efforts and the Parties agree on payment terms. The Client agrees that at no time shall a Non-Conforming Product be used in pre-clinical GLP studies or clinical studies; provided that if the parties agree to payment terms for any Non-Conforming Product that Client desires to use, then upon payment of such amount, Client shall have the right to use such Non-Conforming Product in accordance and Client shall be solely responsible for all costs, expenses and liabilities associated with Section 8.3 storing, handling, using and at Helix's expense if BioVectra was testing the retained Non-Conforming Product. If the parties cannot liable for such agree on the payment amount within thirty (30) days, the Non-Conforming Product shall be destroyed by the Party in accordance with Section 8.2possessionas provided above.
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Cooperation in Investigations; Disposition of Non-Conforming Product. If Helix desires to make a claim against BioVectra with respect to and causing the rejection of Client rejects a Batch of as Non-Conforming Product pursuant to Section 8.19.1, Helix and the Batch has been received by Client, Client agrees that it shall not dispose of or allow such Product to be disposed of without written authorization and instructions from BioVectra Paragon either to dispose of or return to BioVectra such Non-Conforming Product. Upon written request Product or to return it to Paragon, at Paragon’s expense, should Paragon wish to have additional testing conducted by Helix, BioVectra agrees promptly to give Helix such authorization and instructions within a reasonable period qualified independent Third-Party laboratory or for purposes of timedisposal. Each Party shall act in good faith and shall cooperate with the other Party and Party, with any Third qualified independent Third-Party or arbitrator appointed pursuant to Section 8.5 laboratory in connection with an investigation as to the existence of or source of any Non-Conforming Product nonconformity with respect to a Production Batch supplied under this Agreement. At In testing the request of HelixProduction Batch, BioVectra will provide all Nonany independent Third-Conforming Party laboratory shall use analytical testing methods as specified in the Product to Helix at a price (including shipping and delivery expenses) to be agreed upon between the Parties and in accordance with the delivery terms set forth in Section 4 hereof. Helix may make whatever further use of Specifications for such Non-Conforming Product as it shall determine; provided, however, that Helix agrees that:
(a) such Non-Conforming Product shall not be used in humans, and
(b) the warranties provided in Sections 11.1 and 11.2 of this Agreement shall not apply to such Non-Conforming Product. BioVectra Paragon or Client, pursuant to instructions given by Paragon as described above, shall dispose of any Non-Conforming Product returned by Helix in accordance with all Applicable Laws relevant Regulatory Requirements for to such disposal, at BioVectra's expense, Paragon’s cost if BioVectra Paragon was liable for such the nonconformity in accordance with Section 9.3 and at Client’s cost if Paragon was not liable for the nonconformity in accordance with Section 9.2, unless Client notifies Paragon in writing that it wishes to retain Non-Conforming Product in accordance with Section 8.3 and for evaluation of Process Development efforts. The Client agrees that at Helix's expense if BioVectra was not liable for such no time shall a Non-Conforming Product be used in accordance with Section 8.2pre-clinical GLP studies or clinical studies. [***]. If the Parties cannot agree on the payment amount within [***], the Non-Conforming Product shall be destroyed as provided above.
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