Audit Feedback. Within thirty (30) days of completing any Audit hereunder, the auditing Party shall submit to the audited Party a written report outlining its findings and/or observations from any such Audit. If deficiencies are discovered during an Audit that could, in the auditing Party’s reasonable opinion, prevent the audited Party from satisfying the requirements of cGMP obligations hereunder, and the audited Party in good faith disputes the observations or conclusions of the auditing Party, then the Parties shall promptly enter into good faith discussions to resolve their differences. If the Parties fail to resolve their differences within thirty (30) days, then the disputed points shall be resolved by submitting same to a mutually agreeable Third Party consultant in the same manner and under parameters similar to those contemplated under Article 9 for disputes related to nonconforming POC Rapid Assays. That is, the Parties shall be bound by the decision of the Third Party consultant and the Party in error shall bear the costs and expenses of the Third Party consultant. If both Parties are in error, they shall share the costs equally. If the audited Party does not, in good faith, dispute the observations made during any Audit it shall promptly correct those deficiencies at its own cost, and shall notify the auditing Party in writing when those deficiencies are corrected.
Audit Feedback. Within thirty (30) days of completing any audit hereunder, Purchaser shall submit to Seller a written report outlining its findings and/or observations from any such audit. If deficiencies are discovered during an audit that could, in Purchaser’s opinion, prevent Seller from satisfying the requirements of cGMP obligations hereunder, and Seller in good faith disputes the observations or conclusions of Purchaser, then the Parties shall promptly enter into good faith discussions to resolve their differences. If the Parties fail to resolve their differences within thirty (30) days after receipt of the audit report, then Seller’s opinion shall prevail; provided, however, that Purchaser shall not be prohibited from taking any action applicable to Purchaser that it is required to take under applicable law. If Seller does not dispute the observations made during any audit it shall use its commercially reasonable efforts to correct those deficiencies at its own cost, and shall notify Purchaser in writing when those deficiencies are corrected.
Audit Feedback. Within thirty (30) days of completing any Audit hereunder, Xxxxxx shall submit to Stellar a written report outlining its findings and/or observations from any such Audit. If deficiencies are discovered during an Audit that could, in Xxxxxx'x opinion, prevent Stellar from satisfying the requirements of cGMP obligations hereunder, and Stellar in good faith disputes the observations or conclusions of Xxxxxx, then the Parties shall promptly enter into good faith discussions to resolve their differences. If the Parties fail to resolve their differences within thirty (30) days, then the disputed points shall be resolved by arbitration in accordance with Article 14. If Stellar does not dispute the observations made during any Audit it shall promptly correct those deficiencies at its own cost, and shall notify Xxxxxx in writing when those deficiencies are corrected.
Audit Feedback. Within thirty (30) days of completing any audit hereunder, Purchaser shall submit to Seller (and the third party manufacturer, if applicable) a written report outlining its findings and/or observations from any such audit. If deficiencies are discovered during an audit that could, in Purchaser’s opinion, prevent Seller or the third party manufacturer from satisfying the requirements of cGMP, and Seller or the third party manufacturer in good faith disputes the observations or conclusions of Purchaser, then the Parties shall promptly enter into good faith discussions to resolve their differences. If the Parties fail to resolve their differences within thirty (30) days after receipt of the audit report, then the parties shall resolve their differences in accordance with Section 17.1 hereto; provided, however, that Purchaser shall not be prohibited from taking any action applicable to Purchaser that it is required to take under applicable law. If Seller (or the third party manufacturer, as the case may be) does not dispute the observations made during any audit it shall use its Commercially Reasonable Efforts to correct those deficiencies at its own cost, and shall notify Purchaser in writing when those deficiencies are corrected.
Audit Feedback. Within thirty (30) days of completing any Audit hereunder, Buyer shall submit to Supplier a written report outlining its findings and/or observations from any such Audit. If deficiencies are discovered during an Audit that could, in Buyer’s opinion, prevent Supplier from satisfying the requirements of Supplier’s or Buyer’s FD&C Act obligations applicable to the Product, and Supplier in good faith disputes the observations or conclusions of Buyer, then the Parties shall promptly enter into good faith discussions to resolve their differences. Within fifteen (15) days of receipt of this audit report, Supplier shall provide Buyer in writing a proposed action plan subject to Buyer’s prior written approval to address the issues described by Buyer in the report. Within fifteen (15) days of receiving the proposed action plan, Buyer will approve or reject the proposed action plan. If the proposed action plan is approved by Buyer, Supplier will execute the actions described in the proposed action plan on the schedule defined by the action plan. If the Parties fail to resolve their differences within thirty (30) days of receipt of the audit report, then the disputed points shall be resolved by submitting same to a mutually agreeable Third Party consultant in the same manner and under parameters similar to those contemplated under Article 6.1 for disputes related to nonconforming Product. That is, the Parties shall be bound by the decision of the Third Party consultant and the Party in error shall bear the costs and expenses of the Third Party consultant. If both Parties are in error, they shall share the costs equally. If Supplier does not, in good faith, dispute the observations made during any Audit it shall promptly correct those deficiencies at its own cost, and shall notify Buyer in writing when those deficiencies are corrected.
Audit Feedback. Within thirty (30) days after completing the results of any Audit hereunder, an auditing Party will submit to the audited Party a written report outlining its findings and/or observations from any such Audit. If deficiencies are discovered during an Audit that could, in the auditing Party’s reasonable opinion, prevent the audited Party from satisfying its obligations under this Agreement, then, provided that the audited Party agrees with the auditing Party’s opinion, the audited Party will promptly correct such deficiencies at its own expense and prior to filling new or outstanding Authorized Orders, and will notify the auditing Party in writing when such deficiencies are corrected. If the audited Party does not agree with the auditing Party’s opinion, the Parties will direct the dispute to the Steering Committee.
