Quality Agreement. At an appropriate time after the Effective Date, the Parties shall enter into a quality agreement (the “Quality Agreement”) setting forth in detail the quality assurance arrangements and procedures with respect to the manufacture and supply of the Product under this Agreement, which Quality Agreement shall be incorporated herein by reference following its execution by both Parties. To the extent that the terms of this Agreement and those of the Quality Agreement are in conflict, the terms of this Agreement shall control except with respect to quality issues, which shall be governed by the Quality Agreement.
Appears in 3 contracts
Samples: Supply Agreement, Supply Agreement (DiaMedica Therapeutics Inc.), Supply Agreement (DiaMedica Therapeutics Inc.)
Quality Agreement. At an appropriate time after the Effective Date, the The Parties shall intend to enter into a quality agreement acceptable to both Parties (the “Quality Agreement”) setting forth in as soon as practicable after the Effective Date. The Quality Agreement will detail the quality assurance arrangements and procedures regulatory obligations and responsibilities of the Parties with respect to the manufacture Products to the extent these obligations and supply of the Product under responsibilities are not fully covered in this Agreement; provided, which Quality Agreement shall be incorporated herein by reference following its execution by both Parties. To however, that in the extent that event of conflict between the terms of this Agreement and those the Quality Agreement, (i) the provisions of the Quality Agreement are will prevail with respect to all matters pertaining to, or governed by, GMP and (ii) in conflictall other respects, the terms provisions of this Agreement shall control except with respect to quality issues, which shall be governed by the Quality Agreementwill prevail.
Appears in 3 contracts
Samples: Commercial Manufacturing Agreement (PTC Therapeutics, Inc.), Commercial Manufacturing Agreement (Corcept Therapeutics Inc), Commercial Manufacturing Agreement (Corcept Therapeutics Inc)
Quality Agreement. At an appropriate time The Parties shall negotiate in good faith and use commercially reasonable efforts to enter into the Quality Agreement promptly after the Effective Date. The Quality Agreement will set out the policies, procedures and standards by which the Parties shall enter into a quality agreement (will coordinate and implement the “Quality Agreement”) setting forth in detail the operation and quality assurance arrangements activities and procedures regulatory compliance objectives contemplated under this Agreement with respect to the manufacture and supply of the Product under this Agreement, which Quality Agreement shall be incorporated herein by reference following its execution by both PartiesProduct. To the extent that the terms of there are any inconsistencies or conflicts between this Agreement and those of the Quality Agreement are in conflictAgreement, the terms and conditions of this Agreement shall control except with respect to quality issues, which shall be governed by unless the Quality AgreementParties specifically agreed otherwise in writing.
Appears in 2 contracts
Samples: And Distribution Agreement (CytoDyn Inc.), And Distribution Agreement (CytoDyn Inc.)
Quality Agreement. At an appropriate time The Parties shall use commercially reasonable efforts to enter into a Quality Agreement within [***] after the Effective Date, the Parties shall enter into a quality agreement Date (the “Quality Agreement”) setting forth in detail ). In the quality assurance arrangements and procedures with respect to the manufacture and supply event of a conflict between any of the Product under this Agreement, which Quality Agreement shall be incorporated herein by reference following its execution by both Parties. To the extent that the terms provisions of this Agreement and those of the Quality Agreement are in conflictAgreement, the terms provisions of this Agreement shall control except with respect to quality issues, which shall be governed by the Quality Agreementgovern.
Appears in 2 contracts
Samples: Api Supply Agreement, Api Supply Agreement (Amarin Corp Plc\uk)
Quality Agreement. At an appropriate time after the Effective Date, the The Parties shall intend to enter into a quality agreement acceptable to both Parties (the “Quality Agreement”) setting forth in as soon as practicable after the Effective Date. The Quality Agreement will detail the quality assurance arrangements obligations and procedures responsibilities of the Parties with respect to quality assurance, quality control and regulatory compliance aspects of the manufacture and supply of Product; provided, however, that in the Product under this Agreement, which Quality Agreement shall be incorporated herein by reference following its execution by both Parties. To the extent that event of conflict between the terms of this Agreement and those the Quality Agreement, (i) the provisions of the Quality Agreement are will prevail with respect to all matters pertaining to, or governed by, GMP and (ii) in conflictall other respects, the terms provisions of this Agreement shall control except with respect to quality issues, which shall be governed by the Quality Agreementwill prevail.
Appears in 1 contract
Samples: Corcept Therapeutics Inc
Quality Agreement. At an appropriate time after Promptly following the Effective Date, the Parties shall will negotiate in good faith to enter into a quality agreement (the “Quality Agreement”) setting forth in detail . The Quality Agreement will specify the respective responsibilities of the quality assurance arrangements and procedures with respect units of the two Parties relating to the manufacture and supply control of the Product under this AgreementProduct, which Quality Agreement shall be incorporated herein by reference following its execution by both Parties. To the extent that the terms or provision of this Agreement and those of the Quality Agreement are service in conflict, the terms of this Agreement shall control except accordance with respect to quality issues, which shall be governed by the Quality AgreementcGMP.
Appears in 1 contract
Quality Agreement. At an appropriate time after On the Effective Date, Date the Parties shall enter have entered into a quality agreement Quality Agreement (the “Quality Agreement”) ), setting forth in detail out the quality assurance arrangements and procedures respective obligations of each Party with respect to quality matters relating to the manufacture and supply Compound. Each Party shall comply with its obligations set forth in the Quality Agreement. The Parties may mutually agree to change the terms of the Product under this Agreement, which Quality Agreement shall be incorporated herein by reference following its execution by both Partiesfrom time to time, as needed. To In the extent that event of a conflict between the terms of the Quality Agreement and the terms of this Agreement and those of the Quality Agreement are in conflictAgreement, the terms of this Agreement shall control control, except with respect to quality issues, which shall be governed by the Quality Agreementmatters.
Appears in 1 contract
Quality Agreement. At an appropriate time after Promptly following the Effective Date, Date the Parties shall will enter into a quality agreement Quality Agreement in substantially the form attached hereto as ANNEX 3 (the “Quality Agreement”) setting forth ). Notwithstanding anything to the contrary in detail this Agreement or in any other document or agreement, in the quality assurance arrangements event of a conflict between this Agreement and procedures the Quality Agreement, the Quality Agreement shall govern and control with respect to the manufacture quality-related matters; and supply of the Product under this Agreement, which Quality Agreement shall be incorporated herein by reference following its execution by both Parties. To the extent that the terms of this Agreement and those of the Quality Agreement are in conflict, the terms of this Agreement shall govern and control except with respect to quality issues, which shall be governed by the Quality Agreementall other matters.
Appears in 1 contract
Quality Agreement. At an appropriate time Within [***] after the Effective Date, the Parties shall enter into a quality agreement an updated Quality Agreement with respect to the Combined Systems (as amended from time to time in accordance with its terms and conditions, the “Quality Agreement”) setting forth in detail the quality assurance arrangements and procedures with respect to the manufacture and supply of the Product under this Agreement, which Quality Agreement shall be incorporated herein by reference following its execution by both Parties). To the extent that there is any conflict between the terms of this Agreement and those conditions of the Quality Agreement are in conflictand this Agreement with respect to quality matters, the terms of Quality Agreement shall control and this Agreement shall control except with respect to quality issues, which shall be governed by the Quality Agreementall other matters.
Appears in 1 contract
Samples: Commercialization Agreement (Tandem Diabetes Care Inc)
Quality Agreement. At an appropriate time Promptly after the Effective Date, the Parties shall enter into a quality agreement (the “separate Quality Agreement”) Agreement setting forth in detail the quality assurance arrangements and procedures with respect to the manufacture and supply of the terms for Product under this Agreement, which quality. Such Quality Agreement shall be incorporated herein by reference following its execution by both Parties. To the extent that the terms of separately appended to this Agreement and those of the Quality Agreement are in conflict, the terms of this Agreement shall control except with respect to quality issues, which shall be governed by the Quality Agreement.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Aduro Biotech, Inc.)