Secondary Supply Sample Clauses

Secondary Supply. If LM does not receive FDA approval by June 30, 2019 or if ETON believes LM will have issues meeting Product demand, ETON shall have the right to transfer manufacturing of the Product to an alternate manufacturer of its sole and exclusive choosing, however LMW will be informed about this within appropriate time. Any costs incurred by ETON for the qualification of a manufacturer pursuant to this section shall be deducted from any profit share or milestone payment owed to LMW pursuant to this Agreement.
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Secondary Supply. COR shall have the right to establish a Secondary Source for the manufacture of Bulk Product by the Licensed Process for COR. The Secondary Source shall be [*]. COR and Solvay agree that a [*], would be acceptable as the Secondary Source. COR will notify Solvay of the establishment of the Secondary Source. In the event
Sample 1
Secondary Supply. COR shall have the right to establish a Secondary Source for the manufacture of Bulk Product by the Licensed Process for COR The Secondary Source shall be selected from the list of specific potential secondary sources acceptable to COR and to Solvay which is attached hereto as Exhibit C; this list may be amended from time to time upon agreement of COR and Solvay, such agreement not to be unreasonably withheld, and without any additional fee. COR and Solvay agree that a potential corporate partner, such as one of those exemplified in Exhibit C, would be acceptable as the Secondary Source. COR will notify Solvay of the establishment of the Secondary Source. In the event COR terminates a supply arrangement with a Secondary Source, COR may establish an alternate Secondary Source. COR shall notify Solvay [**] of such a termination of supply arrangements with a Secondary Source. Further, after the Secondary Source is established, COR may use [**] for the manufacture of Bulk Product starting from Step One Intermediates supplied by Solvay to [**]. COR's future requirements for Bulk Product cannot be ascertained with certainty at the present time, however, COR wants to entertain certain minimum purchase obligations. Therefore, after the Secondary Source is established, COR shall be required to purchase from Solvay a share of at least [**] percent ([**]%) of its total, worldwide requirements for Bulk Product on a year-to-year basis (to the extent that such share does not exceed the manufacturing capacity planned by Solvay to produce Bulk Product) for the time period during which royalties are payable under this Agreement, except to the extent the parties have agreed otherwise in writing. For purposes of the preceding sentence, such planned capacity shall be determined for a particular calendar year X on the [**]. Notwithstanding the above however, COR may purchase from such Secondary Source and/or [**] percent ([**]%) of its requirements in the event of any breach or default of Solvay of any supply arrangement between COR and Solvay for so long as the breach or default remains uncured. In the event Solvay assigns or transfers to a third party the Licensed Process, this Agreement, the Supply Agreement or the Long Term Supply Agreement, inconsistently with the terms of these Agreements, COR may establish and additional, "Back-up" Secondary Source for the manufacture of Bulk Product. In the event that COR wishes to establish COR itself either as the Secondary Source or...
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Secondary Supply. If LM does not receive FDA approval by December 31, 2020 or if ETON believes LM will have issues meeting Product demand, ETON shall have the right to transfer manufacturing of the Product to an alternate manufacturer of its sole and exclusive choosing, however LMW will be informed about this within appropriate time. Any costs incurred by ETON for the qualification of a manufacturer pursuant to this section shall be deducted from any profit share or milestone payment owed to LMW pursuant to this Agreement. In such an event, LMW and LW shall provide the appropriate rights and licenses to the Product and any LMW Background Intellectual Property for the manufacture and supply of the Product by the alternate manufacturer to ETON for sale and marketing in the Territory.
Sample 1
Secondary Supply. VBL shall use Commercially Reasonable Efforts to establish, at its own cost and expense, a second source of supply for the Finished Product at a facility that is separate from VBL’s Facility at Modiin, Israel, which may be an additional VBL manufacturing site or a Third Party, and which is capable of Manufacturing the Finished Product pursuant to the specifications and requirements set forth in this Agreement and the Quality Agreements (“Secondary Source”). In the event that VBL is unable to fulfill Licensee’s requirements for the Finished Product through VBL’s own Manufacturing capacity, VBL shall engage the Secondary Source to Manufacture the Finished Product to fulfill Licensee’s requirements thereof. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,AS AMENDED.
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Secondary Supply. Within [**] days after the Effective Date, XXXXXX shall elect, and notify MERRIMACK of such election, either (a) to commit to establishing commercial scale manufacturing capabilities for Drug Product either directly or through a Third Party and, if XXXXXX elects, Licensed Product, or (b) not to commit to establishing such capabilities. If XXXXXX makes the election set forth in the foregoing clause (a), XXXXXX shall thereafter use Commercially Reasonable Efforts to establish such capabilities at XXXXXX’x sole expense and XXXXXX and MERRIMACK shall enter into a supply agreement (the “XXXXXX Supply Agreement”) pursuant to which XXXXXX will supply Drug Product to MERRIMACK. The terms of such XXXXXX Supply Agreement shall be negotiated in good faith by the Parties and will contain customary terms and conditions that are consistent with this Agreement and the agreed-upon terms attached hereto as Exhibit D. If XXXXXX makes the election set forth in the foregoing clause (b), MERRIMACK will develop a plan for the construction of a facility to serve
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Related to Secondary Supply

  • Product Supply The Parties shall reasonably cooperate and assist each other in transferring ownership of Product drug product and/or Product drug substance (such material, CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. collectively, the “Product Lots”) set forth in Exhibit A attached hereto as promptly as reasonably practicable following the Effective Date; provided, however, that neither Party shall be required to pay money to any Third Party, commence any litigation with, or offer or grant any accommodation (financial or otherwise) to any Third Party. Such Product Lots shall be delivered EXW (Ex Works) (Incoterms 2010) AMGEN, Thousand Oaks, California. Any expense for shipment shall be borne by AKERO (including any import or export duties or taxes). Subject to the terms of this Section 5.4 and Section 6.2 (Additional AMGEN Warranties), AMGEN transfers the Product Lots to AKERO “as is”, and makes no other representation to AKERO in connection therewith. The Parties have entered into a Quality Agreement substantially in the form attached hereto as Exhibit F, dated as of the date hereof, governing the quality of the Product Lots to be supplied pursuant to this Section 5.4. For the avoidance of doubt, Product Lots consisting of drug product as set forth in Exhibit A supplied pursuant to this Section 5.4 shall be labeled for their intended clinical use as set forth in Exhibit A and the labeling of any Product drug product manufactured after the Effective Date shall be the responsibility of AKERO. Except for the Licensed Materials and such Product Lots to be transferred to AKERO, AKERO shall be responsible for, and shall bear the cost of, obtaining (whether by manufacturing or causing to be manufactured) research, clinical and commercial supplies of the Product. From and after the Effective Date, AKERO shall be responsible for all costs and expenses in connection with the storage of, and any stability studies performed on, the Product Lots.

  • Manufacturing and Supply Genentech shall be responsible for manufacturing and supplying Licensed Products for clinical use and commercial sale in the Genentech Field.

  • Clinical Supply Takeda will provide to Licensee[***] the amount of TAK-385 Licensed Compound or TAK-385 Licensed Products needed by Licensee to complete all Clinical Trials contemplated by the TAK-385 Development Plan (estimated by Licensee as of the Effective Date to be [***]), solely to the extent that Takeda can supply such TAK-385 [***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406. Licensed Compound or TAK-385 Licensed Products (a) from its supply of TAK-385 Licensed Compound or TAK-385 Licensed Products in existence as of the Effective Date and which supply can be used for its intended purposes without further re-processing (the “Initial Clinical Supply”) and (b) after retaining the amount needed by Takeda for Clinical Trials in the Takeda Territory. Takeda will also provide to Licensee, at [***] any additional supplies of TAK-385 Licensed Compound or TAK-385 Licensed Products in excess of the Initial Clinical Supply needed by Licensee to complete all Clinical Trials contemplated by the TAK-385 Development Plan. Within [***] days after the Effective Date, the Parties will enter into a manufacturing and supply agreement (the “Takeda Clinical Manufacturing and Supply Agreement”), which will govern the terms and conditions of the Manufacturing and supply of the TAK-385 Licensed Compound and TAK-385 Licensed Products (including the Initial Clinical Supply) by Takeda to Licensee for Development purposes, including the exact quantities and the timelines for delivery. The Parties will negotiate the terms and conditions of such Takeda Clinical Manufacturing and Supply Agreement in good faith for a period of [***] days (as may be extended upon agreement of the Parties). As part of the negotiation related to the Takeda Clinical Manufacturing and Supply Agreement, the Parties shall discuss in good faith the ability of Takeda to supply to Licensee [***]. If the Parties have not entered into a definitive agreement within such negotiation period, then the final terms and conditions of such agreement will be resolved in accordance with Section 8.2 (Arbitration for Failure to Agree).

  • Commercial Supply Celgene shall Manufacture and supply all Commercial Supplies.

  • Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].

  • 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.

  • Product Support a. In the event that any goods delivered under this contract become defective or malfunction for any reason and at any time (even after the applicable warranty period has expired), including while “in-orbit” if integrated into a satellite, Seller shall promptly perform a failure verification or analysis and determine the appropriate corrective action at no additional cost to Buyer. Seller shall take the appropriate measures to correct all defects, determined to be Seller's responsibility, in all applicable documentation, undelivered goods, and delivered un-launched goods, as required by Buyer.

  • Supply Agreement The Supply Agreement shall have been executed on behalf of the Seller and delivered to the Purchaser.

  • API If the Software offers integration capabilities via an API, your use of the API may be subject to additional costs or Sage specific policies and terms and conditions (which shall prevail in relation to your use of the API). You may not access or use the API in any way that could cause damage to us or the Software, or in contravention of any applicable laws. We reserve the right in our sole discretion, to: (i) update any API from time to time; (ii) place limitations around your use of any API; and (iii) deny you access to any API in the event of misuse by you or to otherwise protect our legitimate interests.

  • Manufacturing Agreement Each of the Sellers (as applicable) shall have executed and delivered to the Buyer the Manufacturing Agreement with respect to the portion of the Business conducted at the applicable Facility.

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