No Patheon Responsibility. Patheon will not assume any responsibility for the accuracy or cost of any application for Regulatory Approval. If a Regulatory Authority, or other governmental body, requires Patheon to incur fees, costs or activities in relation to the Products which Patheon considers unexpected and extraordinary, then Patheon will notify Client in writing and the parties will discuss in good faith appropriate mutually acceptable actions, including fee/cost sharing, or termination of all or any part of this Agreement. Patheon will not be obliged to undertake these activities or to pay for the fees or costs if, in Patheon’s sole discretion, doing so is commercially inadvisable for Patheon.
No Patheon Responsibility. Except as otherwise agreed in the Quality Agreement, Patheon will not assume any responsibility for: (a) the submission, accuracy or cost of any application for Regulatory Approval or related documentation (or the success of those applications); (b) any activity that is required of Client by Applicable Laws for Regulatory Approval (including pharmacovigilance and complaints handling, and preparation and submission of any regular quality or other update); or (c) any dealings with the relevant Regulatory Authority on behalf of Client for Regulatory Approval. If a Regulatory Authority, or other Authority, requires Patheon to incur fees, costs or activities solely with respect to the Products that were not anticipated by the parties under the applicable Product Agreement, then Patheon will notify Client in writing and the parties will discuss appropriate mutually acceptable actions, including fee/cost sharing, or termination of all or any part of this Agreement or a Product Agreement. Patheon will not be obliged to undertake these activities or to pay for the fees or costs until the parties reach agreement on scope and fees for Patheon’s assistance.
No Patheon Responsibility. Other than with respect to information provided by or based upon information provided by Patheon, Patheon will not assume any responsibility for the accuracy or cost of any application for Regulatory Approval.
No Patheon Responsibility. Subject to Section 7.8(e), Patheon will not assume any responsibility for the accuracy of any application for Regulatory Approval. [* * *]
No Patheon Responsibility. Subject to Section 7.8(e), Patheon will not assume any responsibility for the accuracy of any application for Regulatory Approval. If a Regulatory Authority, or other governmental body, requires Patheon to incur fees, costs or activities in relation to the Products which Patheon reasonably considers unexpected and extraordinary and such fees, costs or activities are not otherwise contemplated by this Agreement, then Patheon will notify Client in writing and the Parties will discuss in good faith appropriate mutually acceptable actions, including fee/cost sharing. If, despite reasonable, good faith negotiations between the Parties, agreement cannot be reached as to fee/cost allocation, [* * *].
No Patheon Responsibility. Patheon will provide to Client, its Affiliates and Licensees with reasonable assistance as Client may request in order to assist with obtaining Regulatory Approval for Products, subject to reimbursement of Patheon’s reasonable expenses or third party expenses incurred in connection therewith. Except as otherwise agreed in the Quality Agreement or the Pharmacovigilance Agreement, Patheon will not assume any responsibility for: (a) the submission, accuracy or cost of any application for Regulatory Approval or related documentation (or the success of those applications); (b) any activity that is required by Applicable Laws for Regulatory Approval (including pharmacovigilance and complaints handling, and preparation and submission of any regular quality or other update); or (c) any dealings with the relevant Regulatory Authority on behalf of Client for Regulatory Approval. If a Regulatory Authority, or other Authority, requires Patheon to incur fees, costs or activities in relation to the Product which Patheon reasonably considers unexpected and extraordinary, then Patheon will notify Client in writing and the parties will discuss in good faith appropriate mutually acceptable actions, including fee/cost sharing, or termination of all or any part of this Agreement. Patheon will be not be obliged to undertake these activities or to pay for the fees or costs until the parties reach agreement on scope and fees for Patheon’s assistance.
No Patheon Responsibility. Except as otherwise agreed in the Quality Agreement, Patheon will not assume any responsibility for: (a) the submission, accuracy or cost of any application for Regulatory Approval or related documentation (or the success of those applications); (b) any activity that is required by Applicable Laws for Regulatory Approval (including pharmacovigilance and complaints handling, and preparation and submission of any regular quality or other update), other than those required of Patheon; or (c) any dealings with the relevant Regulatory Authority on behalf of Client for Regulatory Approval. If a Regulatory Authority, or other governmental body, requires Patheon to incur fees, costs or activities in relation to the Products which Patheon considers unexpected and extraordinary, then Patheon will notify Client in writing and the parties will discuss in good faith appropriate mutually acceptable actions, including fee/cost sharing, or termination of this Agreement. Patheon will be not be obliged to undertake these activities or to pay for the fees or costs until the parties reach agreement on scope and fees for Patheon’s assistance. June 28, 2019 Confidential Manufacturing Services Agreement between Patheon and PLx Page 18 of 38 17 CFR 240.24b-2, confidential information has been omitted in places marked “[***]” and has been filed separately with the Securities and Exchange Commission pursuant to a Confidential Treatment Application filed with the Commission.
No Patheon Responsibility. Except as otherwise agreed in the Quality Agreement or otherwise agreed to in writing, Patheon will not assume any responsibility for: (a) the submission, accuracy or cost of any application for Regulatory Approval or related documentation (or the success of those applications) which relates specifically to the Product; (b) any activity that is required by Applicable Laws for Regulatory Approval (including pharmacovigilance and complaints handling, and preparation and submission of any regular quality or other update) which relates to the Product; or (c) any dealings with the relevant Regulatory Authority on behalf of Client for Regulatory Approval. Nothing in this Section 7.5 (e) is intended to limit Patheon’s liability for activities or services in relation to regulatory filings which Patheon has agreed to undertake. If a Regulatory Authority, or other governmental body, requires Patheon to incur fees, costs or activities specifically in relation to the Products which are unexpected and extraordinary, then Patheon will notify Client in writing and the parties will discuss in good faith appropriate mutually acceptable actions, including fee/cost sharing. Patheon will be not be obliged to undertake these activities or to pay for the fees or costs until the parties reach agreement on scope and fees for Patheon’s assistance.
