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. (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. (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. 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.
4.2 Within [*] prior to the launch of Theravance’s formulated Product, Theravance shall provide ScinoPharm/BSP with an initial forecast (as set forth in Exhibit B) of purchases of Product for [*] following launch. Such [*] forecast shall be updated at least once a quarter. In case the ordered quarterly quantity increases over [*] against the forecasted quarterly quantity, the delivery date is to be negotiated between ScinoPharm and Theravance. Forecasts are estimates only and firm purchase orders shall be placed by Theravance at least [*] prior to the delivery date set forth therein. ScinoPharm shall be deemed to have accepted any Theravance purchase order as a firm order unless it notifies Theravance in writing within [*] of receipt that it cannot accept the order. ScinoPharm must accept any Theravance purchase order if the amount of Product requested is within ScinoPharm’s production capacity. All terms and conditions of Theravance’s purchase order shall apply. In the event of a conflict between the purchase orders and this Agreement, the terms of this Agreement shall prevail.
4.3 Should Theravance’s requirements for Product increase during any given calendar year, ScinoPharm agrees to use its best efforts to increase Production up to its maximum annual capacity in order to satisfy Theravance’s increased demand for the Product upon the same terms and conditions as set forth in this Agreement and upon the same or better price terms as set forth in Exhibit A.
4.4 Either Party may cancel or modify without penalty any purchase orders for Product if the other Party does not materially comply with the terms of this Agreement; provided, however, the Party alleged to be in default shall have [*] to remedy such default after receiving written notice of the alleged default.
Manufacturing Obligations. 7.2.1 The Product shall be manufactured in accordance with cGMPs promulgated by the FDA, the Product Specifications and in accordance with the regulatory specifications and methods described and approved in the Registration.
7.2.2 For quality control, Skye shall conduct in-process and final controls in accordance with the Testing Methods. Skye shall be responsible for the validation of all manufacturing processes and processing systems and shall maintain its programs for change control for the validated process, systems, and computer systems.
7.2.3 Skye shall store for each shipment of manufactured Product the respective documentation as well as retain a sample for one (1) year beyond expiration of the Product. Skye shall provide quality control examination of the retained sample representing the beginning, middle and end of the packaging operation prior to release to assure the Product’s packaging is in accordance with the Product Specifications.
7.2.4 Skye shall provide a certificate of analysis to Enzon for each batch of the Product delivered hereunder.
7.2.5 Skye will provide final reports, including recommendation for the Product disposition for all investigations involving:
7.2.5.1 foreign matter/particulate contamination;
7.2.5.2 initial sterility test failure (if applicable); and
