Manufacturing and Supply Agreements Sample Clauses

Manufacturing and Supply Agreements. 8.3.3.1. The terms under which Novartis will Manufacture and supply Regional Antibody Candidates and Regional Licensed Products to Novartis pursuant to Section 8.3 will be set forth in a supply agreement to be entered into between the Parties (the “RLP Supply Agreement”) within [***] of either Party’s written request. The RLP Supply Agreement will contain customary terms and conditions, including quality, and otherwise be consistent with this Agreement and Novartis quality standards. 8.3.3.2. Subject to Section 8.2.3, Surface will, at such time as determined by the JSC, use Commercially Reasonable Efforts to assign to Novartis or its designee all then-existing Manufacturing contracts with Third Party contract manufacturers that are solely related to the Manufacture of any Regional Antibody Candidates or Regional Licensed Products and that Novartis agrees to assume.
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Manufacturing and Supply Agreements. Within six (6) months after the Effective Date, the Parties shall negotiate in good faith and enter into a definitive written clinical supply agreement, which will specify the terms of the Manufacturing and supply of Products by BioGenerics to Licensee or its designee to be used in non-clinical and Clinical Trials. The Parties shall negotiate in good faith and enter into a definitive written commercial supply agreement[***], which will specify the terms of the Manufacturing and supply of Products by BioGenerics to Licensee or its designee for commercial use (together with the clinical supply agreement, the “Manufacturing and Supply Agreements”). The Manufacturing and Supply Agreements shall be consistent with all of the terms and conditions in this Section 5.1, Exhibit 5.1 (Manufacturing and Supply by BioGenerics), and all other relevant provisions of this Agreement, and shall be agreements to supply all of Licensee’s, its Affiliates’ and Sublicensees’ requirements for the Products in the Territory and contain customary market terms including, without limitation, [***].
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Manufacturing and Supply Agreements. Nanogen and Becton shall enter into Manufacturing and Supply Agreements for, respectively, the United States and outside of the United States (collectively, the "Manufacturing and Supply Agreements"). The Manufacturing and Supply Agreements shall provide for the following: ***CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION. (i) Nanogen shall supply Components to Becton for sale by Becton to third parties in the United States, and for sale by Becton to its Affiliates for sale to third parties outside the United States. The prices at which, or procedures for determining the prices at which, Components are to be supplied to Becton under the Manufacturing and Supply Agreement for the United States shall be established in said Manufacturing and Supply Agreement in such manner that as a result of such pricing, the applicable Profit or Loss (as defined in Section 2.3(c)(ii)) relating to the United States market is shared *** by Nanogen and *** by Becton. In the case of the sale of Components and the sale or provision of use of Instruments by Becton Affiliates outside the United States, the Profit or Loss relating to foreign markets also shall be shared *** by Nanogen and *** by Becton, and such sharing shall be achieved by (A) the pricing of Components to Becton under the Manufacturing and Supply Agreement for outside the United States, (B) special allocations of Partnership profit, loss, distributions and contributions or (C) combinations of such pricing and Partnership allocations, as agreed by Becton and Nanogen as part of the negotiation of such Manufacturing and Supply Agreement. Becton shall consult in good faith with Nanogen regarding the prices and amounts of any royalties to be charged by Becton to its Affiliates for sales of Components and sale or provision of the use of Instruments *** and the terms of any sales and any license agreements between Becton and its Affiliates relating to such sales of Components or sale or provision of the use of such Instruments; provided, ***CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION. however, that ***, under the Manufacturing and Supply Agreement for ***, to determine such prices, royalties and terms. (ii) Under the Manufacturing and Supply Agreements, the applicable Profit or Loss shall be computed quarterly and any adjustments to such prices needed to, and payments to be made to, achieve such sharing of such quarterly applicable Profit or Loss shall be made promptly...
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Manufacturing and Supply Agreements. The Buyer Manufacturing and Supply Agreements and the Sellers Manufacturing and Supply Agreements, duly executed by the applicable Seller or its Affiliate;
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Manufacturing and Supply Agreements. 5.3.1 In the event that the requirements of Section 5.2 have been met such that Livzon will be Epirus’s Preferred Supplier, the Parties shall negotiate in good faith and use their respective Commercially Reasonable Efforts to enter into a definitive written pre-clinical and clinical supply agreement, [***], which will specify the terms of the Manufacture and supply of Collaboration Compounds and/or Collaboration Products for Epirus’s use in Pre-Clinical Development and Clinical Development activities in Epirus Territory [***] (each a “Clinical Supply Agreement”). 5.3.2 In the event that the requirements of Section 5.2 have been met such that Livzon will be Epirus’s Preferred Supplier, the Parties shall negotiate in good faith and use their respective Commercially Reasonable Efforts to enter into a definitive written commercial supply [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. agreement, [***], which will specify the terms of the Manufacturing and supply of Collaboration Products by Livzon for Commercialization by Epirus in the Epirus Territory [***] (each a “Commercial Supply Agreement”). 5.3.3 Each Clinical Supply Agreement and Commercial Supply Agreement shall be consistent with all of the terms and conditions in this Section 5.3 and all other relevant provisions of this Agreement, and shall contain customary market terms including, without limitation, (a) plans and timelines for material supply, (b) Commercially Reasonable Efforts to supply, including appropriate remedies for supply delays or shortfalls, (c) forecasting mechanisms, including limits on forecast increases and orders, (d) audit rights, and (e) quality and specifications.
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Manufacturing and Supply Agreements. On or prior to the Effective Date, ALZA and Menarini will, except in the event a Section 2.1 Closing does not occur by the Final Section 2.1 Closing Date, execute a mutually acceptable Non-Group E Market Manufacturing Agreement. Except in the event a Section 2.1 Closing does not occur by the Final Section 2.1 Closing Date, ALZA and GENUPRO agree to negotiate in good faith and execute a mutually acceptable Group E Market Manufacturing Agreement which shall provide for the supply of Agreement Product to GENUPRO for at least one year following Regulatory Approval in the US. In the event a Section 2.1 Closing does not occur by the Final Section 2.1 Closing Date, the Non-Group E Market Manufacturing Agreement and the Group E Market Manufacturing Agreement shall be of no effect and, subject to Section 14.2.2.2, ALZA and GENUPRO shall negotiate in good faith a GENUPRO Manufacturing Agreement and GENUPRO Quality Agreement under which ALZA will supply Agreement Product to GENUPRO for a limited time in those Group A Market, Group B Market, Group C Market and Group E Market countries where GENUPRO intends to use or sell Agreement Product.
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Manufacturing and Supply Agreements. At or prior to the Closing, (i) Purchaser and J&J shall enter into, execute and deliver a manufacturing and supply agreement substantially to the effect set forth in Exhibit D (the "J&J Manufacturing and Supply Agreement") and (ii) Purchaser and Pfizer shall enter into, execute and deliver a manufacturing and supply agreement substantially to the effect set forth in Exhibit D (the "Pfizer Manufacturing and Supply Agreement").
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Manufacturing and Supply Agreements. Drug Substance and Validation and Supply Agreement between SuperGen, Inc. and Ferro Pfanstiehl Laboratories, Inc. and its affiliates, effective as of July 2, 2003 and Amendments 1, 2, 3, 4, 5, and 6 thereto
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Related to Manufacturing and Supply Agreements

  • Manufacturing and Supply (a) Depomed shall supply Product for use in conducting Depomed’s development activities for Product in the Field and in the Territory as set forth in Exhibit D. (b) During the four-year period beginning on the Effective Date (the “Supply Period”), Depomed shall supply and package (or have supplied and packaged) Product pursuant to this Section 4.8. Depomed will use commercially reasonable efforts to enter into a long-term Product supply agreement with [***] days after the Effective Date (the “Depomed Supply Agreement”) that will be freely assignable to Solvay or its Affiliates, successors or assigns at any time. In addition, Depomed and Solvay will negotiate and enter into a Product supply agreement with business terms substantially similar to the Depomed Supply Agreement concurrently with the execution and delivery by Depomed and [***] of the Depomed Supply Agreement (the “Solvay Supply Agreement”, and, together with the Depomed Supply Agreement, the “Supply Agreements”). The Supply Agreements will, together, contain the following provisions (among others mutually agreeable to the Parties): (i) Under the Solvay Supply Agreement, Depomed will agree to supply Solvay with its requirements of finished, packaged Product during the Supply Period; (ii) All manufacturing and records will be performed and maintained in accordance with specifications, cGMP and Applicable Law; (iii) Depomed will provide reasonable assistance to Solvay in the event Solvay wishes to qualify a backup Product manufacturer; (iv) Depomed shall [***]; (v) Solvay will pay Depomed the following amounts in connection with all activities performed by or on behalf of Depomed associated with Product manufacture and supply (other than activities specified on Exhibit D) (A) [***]% of Depomed’s out-of-pocket costs incurred in connection with such manufacture and supply of Product to Solvay, and (B) a labor charge equal to the FTE Charges for all Depomed employees allocated to the manufacture and supply of Product to Solvay, not to exceed FTE Charges for an aggregate of [***] during any given calendar quarter (and Depomed shall provide to Solvay periodic reports detailing the FTE Charges for which Solvay must pay Depomed hereunder);

  • Supply Agreements For a period of three years from the consummation of the IPO, Odetics shall not unilaterally terminate or assign its guarantee obligation with respect to any supply agreement pursuant to which it has guaranteed the performance by ATL of ATL's obligations, unless such suppliers have consented to the termination or assignment of such guarantee.

  • Supply Agreement During the period of two (2) years following the Trigger Date (the “Tail Period”), if a member of the Newco Group (the “Newco Purchaser”) reduces in any given six-month period (which period starts at any point of time after the Trigger Date) the GE Sourcing Costs Share with respect to any Seller Good that it purchases from a member of the GE Group (the “GE Supplier”) pursuant to the Supply Agreement by thirty percent (30%) as compared to the GE Sourcing Costs Share with respect to such Seller Good purchased from GE Supplier in the most recently completed calendar year prior to the Trigger Date, and the GE Supplier (a) has available capacity to supply such Seller Good pursuant to the Supply Agreement and (b) is not in material breach of the Supply Agreement (which such breach is incapable of being satisfied or cured by the GE Supplier within thirty (30) calendar days following receipt of written notice from the Newco Purchaser of such breach), then Section 1 shall no longer restrict the GE Supplier from selling such Seller Good during the remainder of the Tail Period. Upon reasonable request from the applicable GE Supplier, Newco shall, or shall cause the applicable Newco Purchaser to, provide to the applicable requesting GE Supplier, in reasonable detail, the GE Sourcing Costs Share with respect to applicable time periods. For purposes of this Section 4, “GE Sourcing Costs Share” means the quotient of (a) the amount of the sourcing costs incurred by the Newco Purchaser with respect to any Seller Good (as defined in the Supply Agreement) purchased by the Newco Purchaser from the GE Supplier in any given period of time divided by (b) the aggregate amount of the sourcing costs incurred by the Newco Group with respect to such Seller Good purchased by the Newco Group from the GE Group and third party suppliers in the same period of time.

  • Quality Agreement Concurrently with execution of this Agreement, the Parties will enter into an agreement that details the quality assurance obligations of each Party with respect to the Manufacture and supply of Supplied Products under this Agreement (the “Quality Agreement”). Each Party shall perform its obligations under the Quality Agreement in accordance with the terms and conditions thereof. In the event of a conflict between the terms of the Quality Agreement and the terms of this Agreement, the provisions of the Quality Agreement shall govern.

  • Pharmacovigilance Agreement Subject to the terms of this Agreement, and at a date to be determined by the JDC, Facet and Trubion shall define and finalize the actions the Parties shall employ to protect patients and promote their well-being in a written agreement (hereinafter referred to as the “Pharmacovigilance Agreement”). These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any Collaboration Product. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations to Governmental Authorities. Furthermore, such agreed procedures shall be consistent with relevant ICH guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirements, in which case local reporting requirements shall prevail. The Pharmacovigilance Agreement will provide for a worldwide safety database to be maintained by the Party appointed by the JDC. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement (as the Parties may agree to modify it from time to time) and to cause its Affiliates and permitted sublicensees to comply with such obligations.

  • Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.

  • Manufacture and Supply Zai will be responsible for, and use Commercially Reasonable Efforts to Manufacture, or have Manufactured (pursuant to Section 2.4), Licensed Products, sufficient and solely to meet the Development and Commercialization requirements of a Licensed Product in the Territory, at its sole cost and expense. Zai will undertake such Manufacturing activities of the Licensed Products in accordance with the Product Specifications. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. If [*], Paratek will permit Paratek’s suppliers to provide such supply to Zai and shall reasonably assist Zai to obtain a supply of Licensed Products for the Development and Commercialization activities contemplated hereunder by introducing Zai to suppliers that Paratek utilizes at that time. Zai will ensure that any arrangement between Zai and such suppliers (a) will not alter or affect Paratek’s supply related to the Licensed Product, and (b) Paratek will not have any liability or obligation related to such arrangements. If Zai is required by the CFDA to Commercialize the Licensed Product as an imported product, the Parties will negotiate in good faith the terms of an agreement to address this event (an “Imported Product Agreement”), and such agreement will include, but not be limited to, provisions whereby Zai will indemnify Paratek for any liability (including product liability) related to Paratek’s involvement in the Development, Manufacture or Commercialization of the Licensed Product as an imported product, and Zai will maintain appropriate minimum liability insurance (to be determined in the Imported Product Agreement) levels. For the avoidance of doubt, (y) Paratek will be adequately protected from any liability based on Zai’s activities in the Territory including Zai’s sourcing of the Compound or Licensed Product, and (z) absent the Parties agreement to terms pursuant to an Imported Product Agreement, Paratek will not have any obligation to (i) accommodate the supply (directly or indirectly) of the Compound or Licensed Product to Zai, or (ii) be an applicant on a regulatory application or holder of a regulatory approval related to Zai’s Exploitation of the Licensed Product as an imported product.

  • Sublicense Agreements Sublicenses under this Section 2.3 shall be granted only pursuant to written agreements, which shall be subject to and consistent with the terms and conditions of this Agreement. Such Sublicense agreements shall contain, among other things, provisions to the following effect: 2.3.2.1 all provisions necessary to ensure Licensee’s ability to comply with Licensee’s obligation under or not violate the provisions of Sections 4.4, 4.5, 4.6, 5.1, 5.3, 5.4, 8.1 and 11.1; 2.3.2.2 a section substantially the same as Article 9 (Indemnification), which also shall state that the Indemnitees (as defined in Section 9.1) are intended third party beneficiaries of such Sublicense agreement for the purpose of enforcing such indemnification; 2.3.2.3 in the event of termination of the license set forth in Section 2.1.1 above (in whole or in part (e.g., termination of the license as to a Licensed Product or in a particular country)), any existing Sublicense shall terminate to the extent of such terminated license; provided, however, that, for each Sublicensee, upon termination of the license, if the Sublicensee is not then in breach of the Sublicense agreement such that Licensee would have the right to terminate such Sublicense agreement, such Sublicensee shall have the right to obtain a license from Harvard on the same terms and conditions as set forth herein, which shall not impose any representations, warranties, obligations or liabilities on Harvard that are not included in this Agreement, provided that (a) the scope of the license granted directly by Harvard to such Sublicensee shall be coextensive with the scope of the license granted by Licensee to such Sublicensee, (b) if the Sublicense granted to such Sublicensee was non-exclusive, such Sublicensee shall not have the right to participate in the prosecution or enforcement of the Patent Rights under the license granted to it directly by Harvard and (c) if there are more than one Sublicensee, each Sublicensee that is granted a direct license shall be responsible for a pro rata share of the reimbursement due under Section 6.2.3 of this Agreement (based on the number of direct licenses under the Patent Rights in effect on the date of reimbursement); 2.3.2.4 the Sublicensee shall only be entitled to sublicense its rights under such Sublicense agreement on the terms set forth in this Section 2.3; and 2.3.2.5 the Sublicensee shall not be entitled to assign the Sublicense agreement without the prior written consent of Harvard, except that Sublicensee may assign the Sublicense agreement to a successor in connection with the merger, consolidation or sale of all or substantially all of its assets or that portion of its business to which the Sublicense agreement relates; provided, however, that any permitted assignee agrees in writing in a manner reasonably satisfactory to Harvard to be bound by the terms of such Sublicense agreement.

  • License Agreement The Trust shall have the non-exclusive right to use the name "Invesco" to designate any current or future series of shares only so long as Invesco Advisers, Inc. serves as investment manager or adviser to the Trust with respect to such series of shares.

  • License Agreements (a) Except as could not reasonably be expected to have a Material Adverse Effect, Borrower shall (i) promptly and faithfully observe and perform all of the material terms, covenants, conditions and provisions of the material License Agreements to which it is a party to be observed and performed by it, at the times set forth therein, if any, (ii) not do, permit, suffer or refrain from doing anything that could reasonably be expected to result in a default under or breach of any of the terms of any material License Agreement, (iii) not cancel, surrender, modify, amend, waive or release any material License Agreement in any material respect or any term, provision or right of the licensee thereunder in any material respect, or consent to or permit to occur any of the foregoing except as permitted pursuant to Section 9.19(b) below, (iv) give Agent prompt written notice of any material License Agreement (other than Promotional Agreements or licenses by a Borrower, Guarantor or any of their Subsidiaries to a private label manufacturer entered into in the ordinary course of business for the production of Inventory on behalf of a Borrower or “click through” licenses to website hosts or providers in connection with on-line purchasing or licenses to a Borrower by a customer to use such customer’s trademarks or service marks for purposes of goods or services provided by such Borrower to or for such customer or licenses for commercially available off the shelf software) entered into by any Borrower, Guarantor or any of their Subsidiaries after the date hereof, together with (A) either (x) a description of such License Agreement listing the Intellectual Property subject thereto, the name and address of the parties thereto, the term of the license arrangement and the products and territory subject to such license, or (y) a true, correct and complete copy of such License Agreement, and (B) such other information with respect thereto as Agent may reasonably request (subject to any obligation of confidentiality contained therein), (v) give Agent prompt written notice of any notice of default sent to another party to a material License Agreement by Borrower of any material breach of any obligation, or any default, by any party under any material License Agreement, and deliver to Agent (promptly upon the receipt thereof by Borrower in the case of a notice to Borrower and concurrently with the sending thereof in the case of a notice from Borrower) a copy of each notice of default and every other notice and other communication received or delivered by Borrower in connection with any material License Agreement which relates to the right of Borrower to continue to use the property subject to such License Agreement, and (vi) furnish to Agent, promptly upon the request of Agent, such information and evidence as Agent may reasonably require from time to time concerning the observance, performance and compliance by Borrower or the other party or parties thereto with the material terms, covenants or provisions of any material License Agreement. (b) Except as could not reasonably be expected to have a Material Adverse Effect, each Borrower will either exercise any option to renew or extend the term of each material License Agreement to which it is a party in such manner as will cause the term of such material License Agreement to be effectively renewed or extended for the period provided by such option.

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