Technical Dispute Resolution. If a dispute arises (other than disputes under Sections 6.1(b) or 12.1) between the Parties that is exclusively related to technical aspects of the manufacturing, packaging, labelling, quality control testing, handling, storage, or other activities under this Agreement (a "Technical Dispute"), the Parties will make all reasonable efforts to resolve the dispute by amicable negotiations. In that regard, senior representatives of each Party will, as soon as possible and in any event no later than […***…] Business Days after a written request from either Party to the other, meet in good faith to resolve any Technical Dispute. If, despite this meeting, the Parties are unable to resolve a Technical Dispute within a reasonable time, and in any event within […***…] Business Days of the written request, the Technical Dispute will, at the request of either Party, be referred for determination to an expert in accordance with Exhibit A. If the Parties cannot agree that a dispute is a Technical Dispute, Section 12.1 will prevail. For greater clarity, the Parties agree that the release of the Products for sale or distribution under the applicable marketing approval for the Products will not by itself indicate compliance by Patheon with its obligations for the Manufacturing Services and further that nothing in this Agreement (including Exhibit A) will remove or limit the authority of the relevant qualified person (as specified by the Quality Agreement) to determine whether the Products are to be released for sale or distribution.
Appears in 2 contracts
Sources: Master Manufacturing Services Agreement (Acadia Pharmaceuticals Inc), Master Manufacturing Services Agreement (Acadia Pharmaceuticals Inc)
Technical Dispute Resolution. If a dispute arises (other than disputes under Sections 6.1(b) or 12.1) between the Parties parties that is exclusively related to technical aspects of the manufacturing, packaging, labelling, quality control testing, handling, storage, or other activities under this Agreement (a "“Technical Dispute"”), the Parties parties will make all reasonable efforts to resolve the dispute by amicable negotiations. In that regard, senior representatives of each Party party will, as soon as possible practicable and in any event no later than […***…] Business Days after a written request from either Party party to the other, meet in good faith to resolve any Technical Dispute. If, despite this meeting, the Parties parties are unable to resolve a Technical Dispute within a reasonable time, and in any event within […***…] Business Days of the written request, the Technical Dispute will, at the request of either Partyparty, be referred for determination to an expert in accordance with Exhibit A. Schedule E. If the Parties parties cannot agree that a dispute is a Technical Dispute, Section 12.1 will prevail. For greater claritycertainty, the Parties parties agree that the release of the Products for sale or distribution under the applicable marketing approval for the Products will not by itself indicate compliance by Patheon with its obligations for the Manufacturing Services and further that nothing in this Agreement (including Exhibit ASchedule E) will *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. remove or limit the authority of the relevant qualified person (as specified by the Quality Agreement) to determine whether the Products are to be released for sale or distribution.
Appears in 2 contracts
Sources: Manufacturing Services Agreement (Santarus Inc), Manufacturing Services Agreement (Santarus Inc)
Technical Dispute Resolution. If a dispute arises (other than disputes under Sections 6.1(b) or 12.1) between the Parties parties that is exclusively related to technical aspects of the manufacturing, packaging, labelling, quality control testing, handling, storage, or other activities under this Agreement (a "“Technical Dispute"”), the Parties parties will make all reasonable efforts to resolve the dispute by amicable negotiations. In that regard, senior representatives of each Party party will, as soon as possible and in any event no later than […***…] Business Days after a written request from either Party party to the other, meet in good faith to resolve any Technical Dispute. If, despite this meeting, the Parties parties are unable to resolve a Technical Dispute within a reasonable time, and in any event within […***…] Business Days of the written request, the Technical Dispute will, at the request of either Partyparty, be referred for determination to an expert in accordance with Exhibit A. If the Parties parties cannot agree that a dispute is a Technical Dispute, Section 12.1 will prevail. For greater claritycertainty, the Parties parties agree that the release of the Products for sale or distribution under the applicable marketing approval for the Products will not by itself indicate compliance by Patheon with its obligations for the Manufacturing Services and further that nothing in this Agreement (including Exhibit A) will remove or limit the authority of the relevant qualified person (as specified by the Quality Agreement) to determine whether the Products are to be released for sale or distribution.
Appears in 2 contracts
Sources: Master Manufacturing Services Agreement (Horizon Pharma, Inc.), Master Manufacturing Services Agreement (Horizon Pharma, Inc.)
Technical Dispute Resolution. If In the event of a dispute arises (other than disputes under in relation to the matters set out in Sections 6.1(b) or and 12.1) between the Parties that is exclusively related to technical aspects of the manufacturing, packaging, labelling, quality control testing, handling, storage, storage or other activities under this Agreement (a "“Technical Dispute"”), the Parties will shall make all reasonable efforts to resolve the dispute by amicable negotiations. In that this regard, senior representatives of each Party willshall, as soon as possible practicable and in any event no later than […***…] Business Days after a written request from either Party to the other, meet in good faith to resolve any Technical Dispute. If, despite this such meeting, the Parties are unable to resolve a Technical Dispute within a reasonable time, and in any event within […***…] Business Days of the such written request, the Technical Dispute willshall, at the request of either Party, be referred for determination to an expert in accordance with Exhibit A. If the provisions of Schedule F. In the event that the Parties cannot agree that [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. whether a dispute is a Technical Dispute, the dispute shall be considered a commercial dispute and its resolution shall be governed by the terms of Section 12.1 will prevailabove. For greater claritycertainty, the Parties agree that the release of the Products for sale or distribution under pursuant to the applicable marketing approval for the such Products will shall not by itself indicate compliance by Patheon with its obligations for in respect of the Manufacturing Services and further that nothing in this Agreement (including Exhibit ASchedule F) will shall remove or limit the authority of the relevant qualified person (as specified by the Quality AgreementAgreement(s)) to determine whether the Products are to be released for sale or distribution.
Appears in 1 contract
Sources: Manufacturing Services Agreement (Transcept Pharmaceuticals Inc)
Technical Dispute Resolution. If a dispute arises (other than disputes under about the matters set out in Sections 6.1(b) or and 12.1) between the Parties parties that is exclusively related to technical aspects of the manufacturing, packaging, labelling, quality control testing, handling, storage, storage or other activities under this Agreement (a "Technical Dispute"), the Parties parties will make all reasonable efforts to resolve the dispute by amicable negotiations. In that this regard, senior representatives of each Party party will, as soon as possible practicable and in any event no later than […***…**] Business Days after a written request from either Party party to the other, meet in good faith to resolve any Technical Dispute. If, despite this meeting, the Parties parties are unable to resolve a Technical Dispute within a reasonable time, and in any event within […***…**] Business Days of the written request, the Technical Dispute will, at the request of either Partyparty, be referred for determination to an expert in accordance with Exhibit A. the Schedule F. If the Parties parties cannot agree that a dispute is a Technical Dispute, Section 12.1 will prevail. For greater claritycertainty, the Parties parties agree that the release of the Products for sale or distribution under the applicable marketing approval for the Products will not by itself indicate compliance by Patheon with its obligations for the Manufacturing Services and further that nothing in this Agreement (including Exhibit ASchedule F) will remove or limit the authority of the relevant qualified person (as specified by the Quality Agreement) to determine whether the Products are to be released for sale or distribution.
Appears in 1 contract
Sources: Manufacturing Services Agreement (Acorda Therapeutics Inc)
Technical Dispute Resolution. If a dispute arises (other than disputes under Sections 6.1(b) or 12.1) between the Parties that is exclusively related to technical aspects of the manufacturing, packaging, labelling, quality control testing, handling, storage, or other activities under this Agreement (a "“Technical Dispute"”), the Parties will make all reasonable efforts to resolve the dispute by amicable negotiations. In that regard, senior representatives of each Party will, as soon as possible and in any event no later than […***…] Business Days after a written request from either Party to the other, meet in good faith to resolve any Technical Dispute. If, despite this meeting, the Parties are unable to resolve a Technical Dispute within a reasonable time, and in any event within […***…] Business Days of the written request, the Technical Dispute will, at the request of either Party, be referred for determination to an expert in accordance with Exhibit A. If the Parties cannot agree that a dispute is a Technical Dispute, Section 12.1 will prevail. For greater clarity, the Parties agree that the release of the Products for sale or distribution under the applicable marketing approval for the Products will not by itself indicate compliance by Patheon with its obligations for the Manufacturing Services and further that nothing in this Agreement (including Exhibit A) will remove or limit the authority of the relevant qualified person (as specified by the Quality Agreement) to determine whether the Products are to be released for sale or distribution.
Appears in 1 contract
Sources: Master Manufacturing Services Agreement (Acadia Pharmaceuticals Inc)
Technical Dispute Resolution. If In the event of a dispute arises (other than disputes under in relation to the matters set out in Sections 6.1(b) or and 12.1) between the Parties parties that is exclusively related to technical aspects of the manufacturing, packaging, labelling, quality control testing, handling, storage, storage or other activities under this Agreement or any Product Agreement (a "“Technical Dispute"”), the Parties will parties shall make all reasonable efforts to resolve the dispute by amicable negotiations. In that this regard, senior representatives of each Party willparty shall, as soon as possible practicable and in any event no later than […***…] ten (10) Business Days after a written request from either Party party to the other, meet in good faith to resolve any Technical Dispute. If, despite this such meeting, the Parties parties are unable to resolve a Technical Dispute within a reasonable time, and in any event within […***…] thirty (30) Business Days of the such written request, the Technical Dispute willshall, at the request of either Partyparty, be referred for determination to an expert in accordance with the provisions of Exhibit A. If B. In the Parties event that the parties cannot agree that whether a dispute is a Technical Dispute, Section 12.1 will shall prevail. For greater claritycertainty, the Parties parties agree that the release of the Products for sale or distribution under pursuant to the applicable marketing approval for the such Products will shall not by itself indicate compliance by Patheon with its obligations for in respect of the Manufacturing Services and further that nothing in this Agreement nor any Product Agreement (including Exhibit AB (Technical Dispute Resolution)) will shall remove or limit the authority of the relevant qualified person (as specified by the Quality Agreement) to determine whether the Products are to be released for sale or distribution.
Appears in 1 contract
Sources: Master Manufacturing Services Agreement (Avadel Pharmaceuticals PLC)
Technical Dispute Resolution. If a dispute arises (other than disputes under Sections 6.1(b) or 12.1) between the Parties parties that is exclusively related to technical aspects of the manufacturing, packaging, labelling, quality control testing, handling, storage, or other activities under this Agreement (a "Technical Dispute"), the Parties parties will make all reasonable efforts to resolve the dispute by amicable negotiations. In that regard, senior representatives of each Party party will, as soon as possible and in any event no later than […***…] Business Days after a written request from either Party party to the other, meet in good faith to resolve any Technical Dispute. If, despite this meeting, the Parties parties are unable to resolve a Technical Dispute within a reasonable time, and in any event within […***…] Business Days of the written request, the Technical Dispute will, at the request of either Partyparty, be referred for determination to an expert in accordance with Exhibit A. If the Parties parties cannot agree that a dispute is a Technical Dispute, Section 12.1 will prevail. For greater claritycertainty, the Parties parties agree that the release of the Products for sale or distribution under the applicable marketing approval for the Products will not by itself indicate compliance by Patheon with its obligations for the Manufacturing Services and further that nothing in this Agreement (including Exhibit A) will remove or limit the authority of the relevant qualified person (as specified by the Quality Agreement) to determine whether the Products are to be released for sale or distribution.
Appears in 1 contract
Sources: Master Manufacturing Services Agreement (Horizon Therapeutics Public LTD Co)
Technical Dispute Resolution. If a dispute arises (other than disputes under Sections 6.1(b) or 12.1) between the Parties that is exclusively related to technical aspects of the manufacturing, packaging, labelling, quality control testing, handling, storage, handling or other activities storage of Products under this Agreement (a "“Technical Dispute"”), the Parties will make all reasonable efforts to resolve the dispute by amicable negotiations. In that regard, senior representatives of each Party will, as soon as possible practicable and in any event no later than […***…] ten (10) Business Days after a written request from either Party to the other, meet in good faith to resolve any Technical Dispute. If, despite this meeting, the Parties are unable to resolve a Technical Dispute within a reasonable time, and in any event within […***…] thirty (30) Business Days of after the written request, the Technical Dispute will, at the request of either Party, be referred for determination to an expert in accordance with Exhibit A. Schedule F. If the Parties cannot agree that a dispute is a Technical Dispute, Section 12.1 will prevail. For greater claritycertainty, the Parties agree that the release of the Products for sale or distribution under the applicable marketing approval for the Products will not by itself indicate compliance by Patheon with its obligations for the Manufacturing Services and further that nothing in this Agreement (including Exhibit ASchedule F) will remove or limit the authority of the relevant qualified person (as specified by the Quality Agreement) to determine whether the Products are to be released for sale or distribution.
Appears in 1 contract
Sources: Manufacturing Services Agreement (Penwest Pharmaceuticals Co)