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. 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
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. 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. 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
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. Certain information in this Exhibit marked as [***] has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would be competitively harmful if publicly disclosed.
Sample 1
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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

Related to Supply and Quality Agreement

  • 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.

  • Due Incorporation and Qualification Each of the Company and the Significant Guarantors has been duly incorporated and is validly existing as a corporation in good standing under the laws of the jurisdiction of its incorporation, has the corporate power and authority to own, lease and operate its properties and to conduct its business as described in the Disclosure Package (as defined below) and the Prospectus, and is duly qualified to do business and is in good standing in each jurisdiction in which such qualification is required, except where the failure to so qualify or be in good standing would not, individually or in the aggregate, have a material adverse effect on the business, property, financial condition or results of operations of the Company and its consolidated subsidiaries taken as a whole.

  • Formation and Qualification of the Partnership Entities Each of Enterprise Products Holdings LLC, a Delaware limited liability company (the “General Partner”), the Partnership, EPOGP, EPO and their respective subsidiaries listed on Schedule III hereto (each, a “Partnership Entity” and collectively, the “Partnership Entities,” and the subsidiaries of the Partnership listed on Schedule III hereto, the “Subsidiaries”) has been duly formed or incorporated, as the case may be, and is validly existing in good standing under the laws of its jurisdiction of formation or incorporation, as the case may be, with all corporate, limited liability company or partnership, as the case may be, power and authority necessary to own or hold its properties and conduct the businesses in which it is engaged and, in the case of the General Partner and EPOGP, to act as general partner of the Partnership and managing member of EPO, respectively, in each case in all material respects as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus. Each Partnership Entity is duly registered or qualified to do business and is in good standing as a foreign corporation, limited liability company or limited partnership, as the case may be, in each jurisdiction in which its ownership or lease of property or the conduct of its businesses requires such qualification or registration, except where the failure to so qualify or register would not, individually or in the aggregate, have a material adverse effect on the condition (financial or otherwise), results of operations, business or prospects of the Partnership Entities taken as a whole (a “Material Adverse Effect”) or subject the limited partners of the Partnership to any material liability or disability.

  • 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 Parent and each of the Borrowers are duly formed, validly existing and in good standing under the Laws of its jurisdiction of formation. Parent and each of the Borrowers are duly qualified or registered to transact business and is in good standing in 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 would not constitute a Material Adverse Effect. Parent and each of the Borrowers have all requisite corporate or partnership power (as applicable) and authority to conduct their respective business, to own and lease their respective Properties and to execute and deliver each Loan Document to which it is a Party and to perform its Obligations. All outstanding shares of capital stock of Parent and each of the Borrowers are 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 Laws. Parent and each of the Borrowers are in compliance with all Laws and other legal requirements applicable to their respective business, have obtained all authorizations, consents, approvals, orders, licenses and permits from, and have 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 their business, except where the failure so to comply, file, register, qualify or obtain exemptions does not constitute a Material Adverse Effect.

  • Maintenance of Existence and Qualifications Each Restricted Person will maintain and preserve its existence and its rights and franchises in full force and effect and will qualify to do business in all states or jurisdictions where required by applicable Law, except where the failure so to qualify will not cause a Material Adverse Change.

  • Due Organization and Qualification; Subsidiaries (a) Each Loan Party (i) is duly organized and existing and in good standing under the laws of the jurisdiction of its organization, (ii) is qualified to do business in any state where the failure to be so qualified could reasonably be expected to result in a Material Adverse Effect, and (iii) has all requisite power and authority to own and operate its properties, to carry on its business as now conducted and as proposed to be conducted, to enter into the Loan Documents to which it is a party and to carry out the transactions contemplated thereby.

  • Organization and Qualifications Customer and each of its Subsidiaries (i) is a corporation duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation, (ii) has the power and authority to own its properties and assets and to transact the businesses in which it presently is engaged and (iii) is duly qualified and is authorized to do business and is in good standing in each jurisdiction where it presently is engaged in business and is required to be so qualified.

  • Organization and Qualification of the Company The Company is a corporation duly organized, validly existing and in good standing under the Laws of the state of Delaware and has full corporate power and authority to own, operate or lease the properties and assets now owned, operated or leased by it and to carry on its business as it has been and is currently conducted. Section 3.01 of the Disclosure Schedules sets forth each jurisdiction in which the Company is licensed or qualified to do business, and the Company is duly licensed or qualified to do business and is in good standing in each jurisdiction in which the properties owned or leased by it or the operation of its business as currently conducted makes such licensing or qualification necessary.

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