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. 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.
5.2 Both parties hereby acknowledge that Subcontractors will be used by NSGT to render Services for Phase 1 and potentially in Phase 2 of the Orders with NSGT. Except as expressly set forth herein, in no event shall NSGT be relieved of its obligations under this Agreement as a result of its use of any Subcontractors and NSGT shall supervise the activities and performance of each Subcontractor and shall be liable with each such Subcontractor for any act or failure to act by such Subcontractor. NSGT shall require Subcontractors (i) to follow NSGT policies and procedures, and (ii) to execute a written agreement with NSGT (the “Subcontractor Agreement”) that is no less protective of Xtera’s rights in this Agreement, including without limitation the assignment of Developments and protection of Xtera’s Confidential Information as set forth herein. NSGT shall immediately notify Xtera in writing if the Subcontractor breaches any provision of the Subcontractor Agreement or any act or omission, which if were an act or omission of NSGT would be deemed a breach of this Agreement, and shall describe the particulars of any such breach. Notwithstanding Xtera’ third party status and without limiting any of Xtera’ rights and remedies under this Agreement, NSGT shall vigorously enforce the provisions of the Subcontractor Agreement against Subcontractor at NSGT’s sole cost and shall ensure compliance with the terms of this ...
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, Precision sha...
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 [...***...
Manufacturing Obligations. All references to CYMER in Section 5.3 shall be deleted and replaced with CJI.
Manufacturing Obligations. (a) Subject to the terms and conditions of this Agreement, Roquette agrees to Manufacture, package, label and store such quantities of Products as the Company may order from time to time pursuant to Section 2.4. Roquette agrees to ship such Products to the Company, or to such customers of the Company as shall be designated by the Company in the applicable Purchase Order. For the purposes of this Agreement such customers shall be referred to as the Company’s designees.
(b) Roquette shall Manufacture the Products in strict accordance with the Technologies and Processes to be subsequently agreed by Roquette and the Company. Once approved, Roquette shall not deviate from such instructions without the Company’s express prior written consent.
(c) Roquette shall be entitled to retain a copy of the Technologies and Processes solely for the purpose of Manufacturing the Products for the Company.
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.
(c) Within ten (10) days following the receipt of each Forecast, AVID shall supply HALOZYME in writing with an amended Manufacturing Schedule that includes each manufacturing run forecasted for the *** of such Forecast and for each additional manufacturing run thereafter for which HALOZYME pays the Slot Reservation Deposit.
3.7.1 Subject to the terms and conditions of this Agreement,...
Manufacturing Obligations. Hisense shall manufacture for, and deliver to or on the instruction of, ForeFront that number of units of the Product required or requested by ForeFront for resale or other uses. The parties recognize and acknowledge that such forecast is an estimate only, and the actual requirements or requests of ForeFront may be below or exceed such forecast. Such excess or shortfall will not relieve Hisense of its obligations hereunder to provide the requirements or requests of Products of ForeFront. The manufacture of any and all Products by Hisense for ForeFront shall be pursuant to and in accordance with specifications provided by ForeFront. Hisense shall not allow or authorize any other entity, including any parent, subsidiary or affiliated entity or corporation of Hisense, or any subcontractor, to manufacture, build or in any way produce, in whole or in part, any Product without the prior express written consent of ForeFront, except to meeting orders placed by ForeFront.
