Manufacturing Obligations. Licensee agrees that it will manufacture the Compound, Product and Licensed Product in a manner consistent with (a) WHO Prequalification standards; or (b) the standards of any SRA. Licensee will manufacture and sell the Compound, Product and Licensed Products in accordance with all laws and regulations relevant to the manufacture and sale of the Compound, Product and Licensed Product, including cGMP, and in accordance with good industry practice. Licensee will not sell any Licensed Product without WHO Prequalification or SRA approval, or through any provisional or emergency use authorizations available through WHO or an SRA and will comply with applicable regulatory requirements in the country of manufacturing and the country of sale.
Manufacturing Obligations. Licensee agrees that it will manufacture the Compound and Licensed Product in a manner consistent with (a) WHO Prequalification standards; or (b) the standards of any SRA. Licensee will manufacture and sell the Compound and Licensed Products in accordance with all laws and regulations relevant to the manufacture and sale of the Compound and Licensed Product, including cGMP, and in accordance with good industry practice. Licensee agrees that it: (a) subject to Section 3.8, will not sell any Licensed Product without WHO Prequalification or SRA approval, or through any provisional or emergency use authorizations available through WHO or an SRA; and (b) will comply with applicable regulatory requirements in the country of manufacture and the country of sale.
Manufacturing Obligations. Osiris shall Process for and supply to NuVasive Product in accordance with the terms of this Agreement. Osiris shall Process and supply the Product to NuVasive hereunder in conformity with the Specifications and in compliance with cGTP and all applicable Laws. If either party seeks a change to the Specifications or there is a change in applicable Laws that would necessitate a change in the Specifications, the parties will meet and confer in good faith to determine whether and what changes (if any) should be made thereto. Any and all amendments or modifications in the Specifications must be agreed upon in writing by both parties.
Manufacturing Obligations. Regulus shall [...***...] use its Diligent Efforts to manufacture pre-clinical supplies and clinical supplies of Collaboration Compounds, including all bulk drug substance, for all Pre-Clinical Studies and Clinical Studies, including process development and scale-up, conducted by Regulus under such Program during the Program Term for such Program. At GSK’s request, Regulus shall also supply to GSK reasonable (as determined by the Joint Steering Committee) quantities of bulk drug substance for Collaboration Compounds as reasonably required by GSK for certain supplemental Enabling Studies which GSK may from time to time undertake pursuant to Section 3.8, unless Regulus is unable to do so due to [...***...], provided, that the determination of whether [...***...] shall not take into account [...***...]. Regulus shall carry out its manufacturing obligations consistent with Regulus’ reasonable internal practices, industry standards, cGMP requirements, and all applicable laws and regulations. For purposes of clarity, upon GSK’s exercise of its Program Option for a Program, GSK will thereafter be responsible for manufacturing, [...***...] all pre-clinical, clinical and commercial supplies of the Option Compounds and related Licensed Products under such Program, as set forth in Section 4.4.2. The Parties shall discuss in good faith at the JSC the manufacturing process as then being used or planned to be used by Regulus for Collaboration Compounds under each Program well in advance of the Program reaching the Candidate Selection Stage, in order that, wherever practical, (a) the Parties can plan together to minimize [...***...], and (b) the Parties can [...***...] for Commercialization by GSK in the event that GSK exercises its Program Option.
Manufacturing Obligations. 5.1 NSGT shall perform the Services for the Products on a turnkey basis in strict compliance with the Specifications and the work instructions agreed between Xtera and NSGT for each Product. NSGT will use only ISO 9002 manufacturing sites to perform Services under this Agreement. Xtera will consign the test equipment to support production and provide technical assistance as reasonably required for operation of such test equipment. All such Xtera provided equipment (as set out in Exhibit A, Xtera Provided Equipment) and as modified by Xtera from time to time, upon written notice to NSGT will remain the property of Xtera and shall be returned to Xtera or its designee (as requested by Xtera) upon any termination or expiration of this Agreement. Xtera will be responsible for the initial set up and configuration of the Xtera Provided Equipment, with NSGT’s reasonable cooperation. Except as expressly set forth herein, NSGT will provide all manufacturing technology, standard and common equipment, labor, materials and facilities necessary to perform the Services.
Manufacturing Obligations. MANUFACTURING OF PRODUCT Precision shall supply to Baxalta formulated Licensed Product Candidates or Licensed Product (as applicable, the “Product”) for use by Baxalta in Phase II Clinical Trials. Prior to manufacture by Precision of any Product for use in Phase I or Phase II Clinical Trials, the Parties will establish (and the JSC shall approve) a written specification for each Product, setting forth Product attributes and the corresponding test methods and quality systems adequate to ensure quality and consistency of the Product (the “Specification”). Precision shall manufacture all Product for Clinical Trial use in accordance with cGMP, the Specification and the Quality Agreement. Precision may not make any material changes to the manufacturing process for Product without JSC approval. Precision shall label Product in accordance with the JSC’s instructions in a manner appropriate for clinical use. Precision shall ensure that all Product supplied to Baxalta has the minimum shelf life specified in the Specification for the applicable Product. All manufacturers and suppliers of materials to manufacture Product shall be Baxalta certified and approved prior to the initiation of manufacture. [***] Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commission. [***] FORECASTS AND ORDERS The quantity of the Phase II Ready Batch shall be established for each Product by the JSC in accordance with the Agreement. Baxalta shall deliver a binding order for the Phase II Ready Batch not less than [***] before its requested delivery date. If Baxalta determines that it requires additional quantities of Product for use in Phase II Clinical Trials after supply of the Phase II Ready Batch, Baxalta shall provide Precision with a non-binding forecast of its requirements as soon as practicable after making such determination and shall adjust its forecast from time to time as its expected requirements of such additional Product change. Baxalta shall issue a binding order of its requirements of Product not less than [***] before its requested delivery date. The Supply Agreement will acknowledge that the process for manufacture of the Products has variable yields and will provide appropriate accommodation parameters regarding ordered and delivered quantities of Products. CERTIFICATE OF ANALYSIS In conjunction with each delivery of Product, Precisi...
Manufacturing Obligations. (a) AVID shall maintain sufficient raw materials or in-process inventory and maintain open manufacturing slots to perform, and shall perform, each manufacturing run forecasted in the *** of each Forecast and for each subsequent manufacturing run for which HALOZYME has paid a Slot Reservation Fee, up to a maximum of twenty (20) runs in a period of four (4) consecutive calendar quarters, and to sell to HALOZYME all BDS produced thereby; provided, however, if HALOZYME requests additional manufacturing runs in excess of those on the most recent Forecast, AVID shall use commercially reasonable efforts to perform such additional manufacturing runs and shall sell to HALOZYME all BDS produced thereby. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commission. (b) AVID shall provide HALOZYME with a right of first refusal for manufacturing slots to perform the subsequent manufacturing runs that are forecasted for the *** of each Forecast for which HALOZYME has not yet paid a Slot Reservation Fee. Should another external customer request to use any such slot, then AVID shall inform HALOZYME in writing of such request and HALOZYME shall have the right of first refusal for such slot. If HALOZYME desires to reserve such slot, HALOZYME shall inform AVID in writing within three (3) business days after its receipt of such notice. If (i) such customer has responded to a bona fide project proposal sent by AVID, (ii) such customer in good faith agrees to pay, promptly upon reservation of such slot, not less than the same nonrefundable slot reservation fee as HALOZYME hereunder for such slot, and (iii) such notice expressly states so, then HALOZYME shall pay the applicable Slot Reservation Fee for such slot within three (3) business days after its receipt of such notice, and such Slot Reservation Fee shall be non-refundable; provided, however, in such case, if payment for the Slot Reservation Fee is not received within such three (3) business day period, then AVID shall have no obligation to reserve the said slot for HALOZYME.
Manufacturing Obligations. 4.1 ScinoPharm shall manufacture and deliver to Theravance through BSP, batches of Product in such quantities of up to [*] at commercial scale as the Parties shall agree upon and at such times as Theravance may request.
Manufacturing Obligations. Company shall manufacture, or have manufactured (by such Third Party manufacturer as may be mutually agreed upon from time to time by the Parties; any such Third Party manufacturer, a “Contract Manufacturer”), and sell to Distributor, and Distributor shall purchase from Company, those quantities of Product ordered by Distributor pursuant to purchase orders submitted from time to time in accordance with this Agreement. If Company uses a Contract Manufacturer to supply Product to Distributor under this Agreement, such Contract Manufacturer shall be required to agree in writing for the benefit of Distributor as a third party beneficiary to be bound by the applicable terms and conditions of this Agreement relating to the manufacture and supply of Product, including without limitation Sections 2.3, 4, 6 and 8. No arrangement with any Contract Manufacturer shall relieve Company of any obligation it otherwise would have under this Agreement, including Company’s obligation to supply Product to Distributor, and Company shall be responsible and liable to Distributor for any breach of any such obligations by Company or any Contract Manufacturer.
Manufacturing Obligations. In accordance with the provisions of this Agreement and all applicable Legal Requirements, Horizon shall, at its cost and expense, use […***…] efforts to perform or cause to be performed all manufacture, labeling, packaging, warehousing, distribution and return, order entry, invoicing payment processing, customer services and all other activities required to supply and distribute the Product in the Territory as necessary or appropriate to enable Mallinckrodt to perform its obligations and to secure its rights under or as contemplated by this Agreement. Horizon shall use […***…] efforts to ensure timely supply of the Product to customers and Product samples ordered by Mallinckrodt in accordance with Section 6.3. In the event that, for any period of time during the Term, there is a shortage of or a failure to supply Product in a quantity sufficient timely to meet existing or forecasted orders for the Product, Horizon shall (i) immediately notify Mallinckrodt in writing of the nature of any such event, its expected duration, and the percentage of normal trade demand for the Product affected by any such event and (ii) shall use […***…] efforts to rectify any such failure to supply or shortage as soon as possible.
