Supply and Quality Agreement Sample Clauses

Supply and Quality Agreement. At a time agreed by the Parties that is reasonably sufficiently early enough to meet the objectives under this Section 6.5, the Parties will negotiate in good faith and enter into separate supply and quality agreements governing the commercial supply of finished product from FibroGen WFOE to AstraZeneca (the “Supply and Quality Agreement”). Such agreements will reflect the terms and conditions set forth on Exhibit K of the U.S. and RoW Agreement and contain such further commercially reasonable terms governing similar supply arrangements and other terms as the Parties may agree, including appropriate forecasting and firm purchase order lead times, taking into consideration the reasonable notice requirements of FibroGen WFOE and its Third Party manufacturers as well as any other terms set forth in this Article 6. In the event of any inconsistency between the Supply and Quality Agreement and Article 6 of this Agreement with regard to matters relating to supply, quality control and quality assurance, the terms of the Supply and Quality Agreement shall prevail.
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Supply and Quality Agreement. Kite shall be responsible for manufacturing and supplying, itself or through a mutually selected contract manufacturing organization (a “Kite CMO”), Amgen’s requirements for Amgen Products, subject to the limitation set forth in Section 5.1.1 (Kite or Kite CMO Manufacturer), pursuant to a supply agreement and quality agreement, to be negotiated in good faith and entered into by the Parties within […***…] after the Effective Date. The terms of such supply agreement shall be consistent with this Article 5 (Supply) and Exhibit E (Supply Agreement) in all material respects. Pursuant to the foregoing, upon approval by the JSC of the first Preclinical Development Plan for an Amgen Target, Kite shall elect to either itself serve or have a Kite CMO serve as the manufacturer of Amgen Products directed against such Amgen Target. To the extent a Kite CMO serves as the manufacturer of Amgen Products, Kite shall have no responsibility for the performance of the Kite CMO, other than to enforce Kite’s contractual rights against the Kite CMO for the benefit of Amgen. For clarity, Kite shall be responsible for the management and oversight of the activities of the Kite CMO with respect to the manufacture of the Amgen Products. Additionally, Amgen shall have the right to transition such manufacturing to Amgen (or a mutually agreed upon designee of Amgen) at any time upon […***…] prior written notice, subject to Section 5.1.2 (Kite Future Manufacture).
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Supply and Quality Agreement. If during the Term, a Party (“Non-Manufacturing Party”) requires a Licensed Product for the conduct of activities under the GDP for such Licensed Product and at such time the other Party (“Manufacturing Party”) is responsible for Manufacturing such Licensed Product, then, upon either Party’s request, the Parties shall enter into separate supply and associated quality agreements (each, a “Supply and Quality Agreement”) covering the terms of supply to such Party for such activities (and to the extent requested by the Party receiving such supply, such quality agreement shall be entered into prior to such supply). The Supply and Quality Agreement will contain terms and conditions that are reasonable and customary for agreements of such nature and in all respects consistent with the terms and conditions of this Agreement. If the Parties are unable to reach agreement on such provisions of the Supply and Quality Agreement within [***] calendar days of a request by either Party to enter into the Supply and Quality Agreement (which [***]-day period may be extended upon the mutual agreement of the Parties), upon request by either Party, the same shall be determined pursuant to Section 14.3.2. The terms of any such Supply and Quality Agreement, including the Manufacturing Party’s and the Non-Manufacturing Party’s respective rights and obligations under such Supply and Quality Agreement, shall be consistent with, and limited by, rights and obligations of the Manufacturing Party under any applicable Manufacturing Subcontract.
Sample 1
Supply and Quality Agreement. The Other Party shall supply its Compound to the Sponsoring Party in accordance with such supply and quality addenda or agreement(s) as the Parties may agree (the “Supply and Quality Documentation”). The Parties shall finalize and execute the Supply and Quality Documentation in no event later than the date on which the first shipment of the Other Party’s Compound is supplied for use in the Combined Therapy Study. The Supply and Quality Documentation shall outline the additional roles and responsibilities relative to the quality of each Party’s Compound in support of the Combined Therapy Study. It shall include the responsibility for quality elements as well as exchanged GMP documents and certifications required to release the Other Party’s Compound for the Combined Therapy Study. In addition, the Supply and Quality Documentation shall detail the documentation required for each shipment of the Other Party’s Compound supplied.
Sample 1
Supply and Quality Agreement. The Other Party shall supply its Compound to the Sponsoring Party in accordance with such supply and quality addenda or agreement(s) as the Parties may agree (the “Supply and Quality Documentation”). The Parties shall finalize and execute the Supply and Quality Documentation within forty-five (45) calendar days of the Effective Date, but in no event later than the date on which the first shipment of the Other Party’s Compound is supplied for use in the Combined Therapy Study. The Supply and Quality Documentation shall outline the additional roles and responsibilities relative to the quality of each Party’s Compound in support of the Combined Therapy Study. It shall include the responsibility for quality elements as well as exchanged GMP documents and certifications required to release the Other Party’s Compound for the Combined Therapy Study. In addition, the Supply and Quality Documentation shall detail the documentation required for each shipment of the Other Party’s Compound supplied to the Sponsoring Party or its designee for use in the Combined Therapy Study.
Sample 1
Supply and Quality Agreement. Within [***] ([***]) days following the Effective Date, the Parties will also enter into a Supply and Quality Agreement in a substantially similar form as Exhibit F attached hereto, solely with respect to the inventory transferred pursuant to Section 4.4.2. The terms and conditions of the Supply and Quality Agreement shall be negotiated by the Parties prior to the transfer of inventory contemplated by Section 4.4.2.
Sample 1
Supply and Quality Agreement. If during the Term, a Party (“Non-Manufacturing Party”) requires Licensed Antibody or Licensed Product for the conduct of activities under the GDP (or in the case of Alector, any Independent ADA or is requested pursuant to Section 6.1.2(b)) and at such time the other Party (“Manufacturing Party”) is responsible for Manufacturing such Licensed Antibody or Licensed Product, then the Manufacturing Party shall supply such Licensed Antibody or Licensed Product to the Non-Manufacturing Party at Supply Cost and, upon either Party’s request, the Parties shall enter into separate supply and associated quality agreements (each, a “Supply and Quality Agreement”) covering the terms of such supply to such Party for such activities (and to the extent requested by the Party receiving such supply, (a) the Manufacturing Party shall cooperate to enter into such quality agreement on reasonably and customary terms for a quality agreement and (b) such quality agreement shall be entered into prior to such supply). The Supply and Quality Agreement will contain terms and conditions that are reasonable and customary for agreements of such nature. The terms of any such Supply and Quality Agreement, including the Manufacturing Party’s and the Non-Manufacturing Party’s respective rights and obligations under such Supply and Quality Agreement, shall be consistent with, and limited by, rights and obligations of the Manufacturing Party under any applicable Manufacturing Subcontract.
Sample 1
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Supply and Quality Agreement. As soon as reasonably practicable after the Effective Date, the Parties shall negotiate and execute a separate supply agreement and related quality agreement (collectively, the “Supply and Quality Agreement”) setting forth the mutually agreed terms for the Manufacture and supply of the Products to NewCo for Development and Commercialization use in the Territory. The Supply and Quality Agreement shall be consistent with the terms and conditions of this Agreement and shall include NewCo’s good faith estimate of its and its Affiliates’ and sublicensees’ requirements for the Products for the following [**] months. In addition, NewCo shall supply ADCT with a [**] year rolling forecast of its and its Affiliates’ and sublicensees’ requirements for the Products, which forecast shall be updated [**]. The Supply and Quality Agreement shall also include, among other things, comprehensive and commercially reasonable terms regarding: allocation of Products (and/or consideration of any supplemental Manufacturing arrangements) if supply becomes constrained; ADCT’s commitments regarding compliance with Applicable Laws in the Territory related to the manufacture and quality of the Products (including Product registration specifications, manufacturing and testing protocols, and monograph requirements); NewCo or its designee’s right to inspect and audit the sites where Products are Manufactured and to audit Manufacturing Costs; change controls related to Products and labeling; the supply to NewCo of Regulatory Materials; and the provision by ADCT of reasonable cooperation, information, and assistance with any inspection of ADCT, its Affiliates, sublicensees or subcontractors outside the Territory (including without limitation, Clinical Trial and Manufacturing sites) that is ordered by any Regulatory Authority inside the Territory but only to the extent permitted under and in accordance with the terms of any agreement between ADCT and its sublicensees or subcontractors.
Sample 1

Related to Supply and Quality Agreement

  • SMHS Governance, Safety and Quality Requirements 4.1 Participates in the maintenance of a safe work environment. 4.2 Participates in an annual performance development review. 4.3 Supports the delivery of safe patient care and the consumers’ experience including participation in continuous quality improvement activities in accordance with the requirements of the National Safety and Quality Health Service Standards and other recognised health standards. 4.4 Completes mandatory training (including safety and quality training) as relevant to role. 4.5 Performs duties in accordance with Government, WA Health, South Metropolitan Health Service and Departmental / Program specific policies and procedures. 4.6 Abides by the WA Health Code of Conduct, Occupational Safety and Health legislation, the Disability Services Act and the Equal Opportunity Act.

  • EMHS Governance, Safety and Quality Requirements 4.1 Participates in the maintenance of a safe work environment. 4.2 Actively participates in the Peak Performance program. 4.3 Supports the delivery of safe patient care and the consumers’ experience including participation in continuous quality improvement activities in accordance with the requirements of the National Safety and Quality Health Service Standards and other recognised health standards. 4.4 Completes mandatory training (including safety and quality training) as relevant to role. 4.5 Performs duties in accordance with the EMHS Vision and Values, WA Health Code of Conduct, Occupational Safety and Health legislation, the Disability Services Act and the Equal Opportunity Act and Government, WA Health, EMHS and Departmental / Program specific policies and procedures.

  • NMHS Governance, Safety and Quality Requirements 2.1 Participates in the maintenance of a safe work environment. 2.2 Participates in an annual performance development review. 2.3 Supports the delivery of safe patient care and the consumers’ experience including participation in continuous quality improvement activities in accordance with the requirements of the National Safety and Quality Health Service Standards and other recognised health standards. 2.4 Completes mandatory training (including safety and quality training) as relevant to role. 2.5 Performs duties in accordance with Government, WA Health, North Metropolitan Health Service and Departmental / Program specific policies and procedures. 2.6 Abides by the WA Health Code of Conduct, Occupational Safety and Health legislation, the Disability Services Act and the Equal Opportunity Act.

  • SHIPPING AND AIR TRANSPORT 1. Profits of an enterprise of a Contracting State from the operation of ships or aircraft in international traffic shall be taxable only in that State. 2. The provisions of paragraph 1 shall also apply to profits from the participation in a pool, a joint business or an international operating agency.

  • Incorporation and Qualification The Company has been duly organized and is validly existing as a Corporation and in good standing under the laws of the State of Colorado with the requisite corporate power and authority to own and use its properties and assets and to carry on its business as currently conducted.

  • Formation and Qualification (a) Each Borrower is duly incorporated and in good standing under the laws of the state listed on Schedule 5.2(a) and is qualified to do business and is in good standing in the states listed on Schedule 5.2(a) which constitute all states in which qualification and good standing are necessary for such Borrower to conduct its business and own its property and where the failure to so qualify could reasonably be expected to have a Material Adverse Effect on such Borrower. Each Borrower has delivered to Agent true and complete copies of its certificate of incorporation and by-laws and will promptly notify Agent of any amendment or changes thereto. (b) The only Subsidiaries of each Borrower are listed on Schedule 5.2(b).

  • Reference to and Effect Upon the Credit Agreement (a) The Credit Agreement and the other Loan Documents shall remain in full force and effect, as amended hereby, and are hereby ratified and confirmed. (b) The execution, delivery and effectiveness of this Amendment shall not operate as a waiver of any right, power or remedy of Agent or any Lender under the Credit Agreement or any Loan Document, nor constitute a waiver or amendment of any provision of the Credit Agreement or any Loan Document, except as specifically set forth herein. Upon the effectiveness of this Amendment, each reference in the Credit Agreement to “this Credit Agreement,” “hereunder,” “hereof,” “herein” or words of similar import shall mean and be a reference to the Credit Agreement as amended hereby.

  • Due Incorporation and Qualification The Company has been duly incorporated and is validly existing as a corporation in good standing under the laws of the State of Delaware with corporate power and authority to own, lease and operate its properties and to conduct its business as described in the Pricing Disclosure Package and the Final Supplemented Prospectus and to enter into and perform its obligations under this Agreement, the Indenture and the Securities; and the Company is duly qualified as a foreign corporation to transact business and is in good standing in each jurisdiction in which such qualification is required, whether by reason of the ownership or leasing of property or the conduct of business, except where the failure to so qualify or be in good standing would not have a material adverse effect on the condition, financial or otherwise, or the earnings, business affairs or business prospects of the Company and its subsidiaries considered as one enterprise (a “Material Adverse Effect”).

  • Organization and Qualification The Company and each of the Subsidiaries is an entity duly incorporated or otherwise organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation or organization, with the requisite power and authority to own and use its properties and assets and to carry on its business as currently conducted. Neither the Company nor any Subsidiary is in violation nor default of any of the provisions of its respective certificate or articles of incorporation, bylaws or other organizational or charter documents. Each of the Company and the Subsidiaries is duly qualified to conduct business and is in good standing as a foreign corporation or other entity in each jurisdiction in which the nature of the business conducted or property owned by it makes such qualification necessary, except where the failure to be so qualified or in good standing, as the case may be, could not have or reasonably be expected to result in: (i) a material adverse effect on the legality, validity or enforceability of any Transaction Document, (ii) a material adverse effect on the results of operations, assets, business, prospects or condition (financial or otherwise) of the Company and the Subsidiaries, taken as a whole, or (iii) a material adverse effect on the Company’s ability to perform in any material respect on a timely basis its obligations under any Transaction Document (any of (i), (ii) or (iii), a “Material Adverse Effect”) and no Proceeding has been instituted in any such jurisdiction revoking, limiting or curtailing or seeking to revoke, limit or curtail such power and authority or qualification.

  • Existence and Qualification; Power; Compliance With Laws Borrower is a corporation duly formed, validly existing and in good standing under the Laws of the State of California. Borrower is duly qualified or registered to transact business and is in good standing in the State of California, and each other jurisdiction in which the conduct of its business or the ownership or leasing of its Properties makes such qualification or registration necessary, except where the failure so to qualify or register and to be in good standing could not reasonably be expected to have a Material Adverse Effect. Borrower has all requisite power and authority to conduct its business, to own and lease its Properties and to execute and deliver each Loan Document to which it is a Party and to perform its Obligations. The chief executive offices of Borrower are located in San Dimas, California. All outstanding capital stock of Borrower is duly authorized, validly issued, fully paid and non-assessable, and no holder thereof has any enforceable right of rescission under any applicable state or federal securities or other Laws. Borrower is in compliance with all Laws and other legal requirements applicable to its business, has obtained all authorizations, consents, approvals, orders, licenses and permits from, and has accomplished all filings, registrations and qualifications with, or obtained exemptions from any of the foregoing from, any Governmental Agency that are necessary for the transaction of its business, except where the failure so to comply with Laws and other legal requirements applicable to its business, obtain authorizations, etc., file, register, qualify or obtain exemptions could not reasonably be expected to have a Material Adverse Effect.

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