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 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 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 Schedule E. If the parties cannot agree that a dispute is a Technical Dispute, Section 12.1 will prevail. For greater certainty, 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 Schedule 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
Samples: 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 practicable 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 Schedule E. Exhibit A. If the parties Parties cannot agree that a dispute is a Technical Dispute, Section 12.1 will prevail. For greater certaintyclarity, 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 Schedule EExhibit A) 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
Samples: 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 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 practicable 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 Schedule E. Exhibit A. If the parties cannot agree that a dispute is a Technical Dispute, Section 12.1 will prevail. For greater certainty, 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 Schedule EExhibit A) 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
Samples: Master Manufacturing Services Agreement (Horizon Pharma, Inc.), Master Manufacturing Services Agreement (Horizon Pharma, Inc.)
Technical Dispute Resolution. If a dispute arises (other than disputes under about the matters set out in Sections 6.1(b6.2(b) or and 12.1) between the parties Parties that is exclusively related to technical aspects of the manufacturing, packaging, labellinglabeling, 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 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 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 this written request, the Technical Dispute will, at the request of either partyParty, be referred for determination to an expert in accordance with Schedule E. D. If the parties Parties cannot agree that whether a dispute is a Technical Dispute, Section 12.1 will prevail. For greater certainty, 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 NPI with its obligations for the Manufacturing Services and further that nothing in this Agreement (including Schedule ED) 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 1 contract
Samples: Manufacturing Services Agreement (Keryx Biopharmaceuticals 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 practicable 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 Schedule E. Exhibit A. If the parties cannot agree that a dispute is a Technical Dispute, Section 12.1 will prevail. For greater certainty, 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 Schedule EExhibit A) 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 1 contract
Samples: 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 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 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 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 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 after the written request, the Technical Dispute will, at the request of either partyParty, be referred for determination to an expert in accordance with Schedule E. F. If the parties Parties cannot agree that a dispute is a Technical Dispute, Section 12.1 will prevail. For greater certainty, 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 Schedule EF) 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 1 contract
Samples: Manufacturing Services Agreement (Penwest Pharmaceuticals Co)
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 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 make all reasonable efforts to resolve the dispute by amicable negotiations. In that this regard, senior representatives of each party will, as soon as 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 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 the Schedule E. F. If the parties cannot agree that a dispute is a Technical Dispute, Section 12.1 will prevail. For greater certainty, 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 Schedule EF) 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 1 contract
Samples: 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 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 practicable 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 Schedule E. Exhibit A. If the parties Parties cannot agree that a dispute is a Technical Dispute, Section 12.1 will prevail. For greater certaintyclarity, 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 Schedule EExhibit A) 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 1 contract
Samples: Master Manufacturing Services Agreement (Acadia Pharmaceuticals Inc)
Technical Dispute Resolution. If a dispute arises (other than disputes under Sections 6.1(b) or Section 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 negotiationsgood faith negotiations in the Supply and Quality Committee. In that regard, senior representatives of each party the Supply and Quality Committee will, as soon as practicable 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 Schedule E. Exhibit A. If the parties Parties cannot agree using good faith efforts that a dispute is a Technical Dispute, Section 12.1 will prevail. For greater certainty, 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 Schedule EExhibit A) 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 1 contract
Samples: Master Manufacturing Services Agreement (Paratek Pharmaceuticals, Inc.)