Manufacturing and Supply Committee Sample Clauses

Manufacturing and Supply Committee. The Process Science/Clinical Manufacture Agreement shall include a Manufacturing and Supply Committee consisting of an equal number of representatives from each Party, with the responsibility to oversee the manufacturing and supply process during each Process Development Program and to assist the Development Management Committee to (a) establish criteria and timelines for implementation of process development, manufacturing and supply of Candidate Drugs and Licensed Products; (b) oversee the planning and resourcing for an approved manufacturing program; (c) decide on the use of the AZ ABL facility in the manufacturing and supply of Candidate Drugs and Licensed Products; (d) recommend Third Party support, as appropriate; and (e) take such other actions as are set forth in this Article 7 or in the Process Science/Clinical Manufacture Agreement or the Manufacturing and Supply Agreement. The Development Management Committee shall have oversight over the Manufacturing and Supply Committee and each Process Development Program. Any disputes or disagreements arising in the Manufacturing and Supply Committee that cannot be resolved by the members of the Manufacturing and Supply Committee shall be referred to the Chief Executive Officer of ABX and the Executive Vice President of Operations of AZ (or one of his or her direct reports) for resolution. If any such dispute (other than disputes relating to a Party’s interpretation of, or any allegation of breach of, this Agreement, the Process Science/Clinical Manufacture Agreement or the Manufacturing and Supply Agreement) is unable to be resolved, then AZ shall have the final deciding vote; provided, however, that, subject to the relevant provisions of this Article 7, (x) neither Party shall be obligated to perform any activities under a Process Development Program that are not set forth in the applicable Process Development and Manufacturing Plan and any changes to a Process Development and Manufacturing Plan that result in changes to the applicable Program Budget shall require that ABX submit a revised Program Budget proposal pursuant to Section 7.13, and (y) certain technical disputes under the Process Science/Clinical Manufacture Agreement or the Manufacturing and Supply Agreement, such as whether a particular Candidate Drug or Licensed Product conforms to the applicable specifications, shall be referred to an independent testing laboratory for resolution. The Parties acknowledge and agree that, subject to the provi...

Manufacturing and Supply Committee. Within [**] after the Effective Date, the Parties shall establish a joint manufacturing and supply committee (the “Manufacturing and Supply Committee” or “MSC”), which shall include appropriate representation of each Party (which such representation need not be equal), and each representative shall possess the requisite experience and seniority to enable such person to make decisions on behalf of the applicable Party with respect to the issues falling within the jurisdiction of the MSC. From time to time, each Party may substitute one or more of its representatives to the MSC on written notice to the other Party. Sanofi shall select from its representatives the chairperson for the MSC, which chairperson may be changed from time to time, on written notice to Lexicon. On the MSC, Lexicon shall have an advisory role only, and for clarity, any Dispute arising within the MSC shall not be resolved through the dispute resolution procedures in Section 13.5.2, but instead shall be decided by Sanofi’s MSC representatives. The MSC shall: 5.3.1. periodically serve as a forum for discussing Manufacturing and supply of Licensed Products in the Territory hereunder or under any Supply Agreement;

Manufacturing and Supply Committee. (i) The MSC shall consist of members from each of Organon and Pfizer, each of which shall confirm to the other its designees. Consistent with the Production Agreements, the MSC shall be responsible for: (a) Overseeing manufacturing activities underway as of the Effective Date, including stability studies and management of clinical supplies of the Product; (b) Establish the adequacy of, and periodically (no less than once per Calendar Quarter) review and monitor, all development plans relating to manufacture of the Intermediate and the Compound; establish the adequacy of, and periodically (no less than once per Calendar Quarter) review and monitor, all development plans relating to manufacture of the Intermediate and the Compound, including the First Generation Process Plan and Second Generation Process Plan; Overseeing the manufacturing of registration batches of Product; reviewing the CMC section of the NDA for the Product; reviewing and approving Specifications for purposes of the NDA and other Applications for Regulatory Approval and for Launch; overseeing the preparation for and execution of any pre-approval inspections of the Product manufacturing sites; and monitoring the manufacture of validation lots; (c) Monitoring worldwide quality assurance efforts and ensuring that the Intermediate, the Compound, and all Products are manufactured in accordance with the Parties' quality standards; and overseeing any routine or non-routine inspections by FDA and other Regulatory Authorities and ensuring adherence to compliance standards following Product approval; (d) Monitoring the manufacture of the Intermediate, the Compound and the Product; (e) Determining methods of obtaining cost efficiency, including by developing more efficient manufacturing processes, and reviewing sourcing alternatives of Product components; (f) Coordinating with the GCC and CDRC as appropriate; (g) Evaluating the forecasts provided in each Global Marketing Plan as well as inventory levels for the Intermediate, the Compound and the Product; (h) Establish a method for measuring the Parties' respective manufacturing capacity for the Intermediate, the Compound and the Product, and periodically review and monitor all capacity expansion plans; overseeing the Capacity Plan; and (i) Providing updates on the MSC's activities and achievements to the JOC. (ii) The MSC shall establish, at a minimum, the following subcommittees: (a) Supply Chain Subcommittee, (b) Quality Subcommittee, (c) Technical...

Manufacturing and Supply Committee. Within thirty (30) days after the Effective Date, Auxilium and Asahi agree to establish the Manufacturing and Supply Committee (the “MSC”) as a Committee. The MSC shall consist of up to ten (10) members (or such other number as may be agreed by the Parties in writing), up to five (5) of whom shall be representatives designated by Asahi, and up to five (5) of whom shall be representatives designated by Auxilium. Such representatives shall include individuals who have experience in the manufacturing of pharmaceutical products. The MSC shall be co-chaired by a representative of each of Asahi and Auxilium. One member of the MSC shall serve as secretary of the MSC at each MSC meeting, and the secretary shall alternate from meeting to meeting between an Asahi MSC member and an Auxilium MSC member. The MSC shall advise the JSC with respect to all discussions related to the Manufacture and supply chain for the Product. Meetings of the MSC shall commence at a time to be mutually agreed upon by the Parties and the MSC shall meet at least once every three (3) months, and in any case more or less frequently as Asahi and Auxilium deem appropriate or as reasonably requested by either such Party, on such dates and at such places and times as the Parties shall agree. The MSC may meet either (i) in person alternating between the offices of Asahi and Auxilium, or such other place as the Parties may agree or (ii) by audio or video teleconference. The members of the MSC also may convene or be consulted from time to time by means of telecommunications, video conferences, electronic mail or correspondence, as deemed necessary or appropriate. The MSC shall be a joint forum for the Parties to meet and discuss, with Asahi providing Auxilium reasonable input (which Auxilium shall in good faith consider incorporating into its Manufacturing and supply related decisions), but the MSC shall not be a decision-making body but shall provide regular updates to the JSC on those matters under this Section 3.9 no less frequently than once each calendar quarter after the Effective Date. Additionally, the MSC shall: 3.9.1 Receive quarterly summaries of Drug Substance safety stock levels held at Auxilium’s Facilities; 3.9.2 Be informed of Auxilium’s Manufacturing licensure activities and sourcing strategies in support of the Development and Commercialization of the Product in the Territory, including the strategic aspects of Manufacturing capacity; 3.9.3 Be informed of results of regulatory insp...

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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);
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.
Commercialization Plan (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] 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. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].
Joint Commercialization Committee As of the Effective Date, the Parties have established a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to Products. The JCC shall in particular: (a) review and recommend the Commercialization Plans and related activities with respect to the Commercialization of Products in the Collaborator Territory, and report to the JEC on all significant Commercialization activities in the Collaborator Territory; (b) provide a forum for and facilitate communications and coordination between the Parties with respect to the Commercialization of Products in the Collaborator Territory and the Exelixis Territory; (c) on an annual basis, discuss and establish Collaborator’s Minimum Commercial Performance thresholds pursuant to Section 6.3(b) and propose recommendation to JEC; [ * ] = 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 24b-2 of the Securities Exchange Act of 1934, as amended. (d) review the status of material Product manufacturing and supply activities and strategies associated with Commercialization; (e) review and discuss the major findings of Collaborator’s market research with respect to any Product in the Collaborator Territory, if any; (f) review and oversee the branding and product positioning strategy for Products in the Collaborator Territory and evaluate Collaborator’s brand strategy for the Product in the Collaborator Territory for consistency with the then-current global brand strategy for the Product; (g) discuss Product list price and status of reimbursement in the Collaborator Territory; and (h) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Commercialization of Products, including endeavoring to resolve any disputes between the Parties arising from the deliberations of the JCC, or as otherwise directed by the JEC.
Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Concession Area, including its abandonment.
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 [***].
Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).
Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.
Development Program RWJPRI shall be [**] and have [**] in consultation with the JDAC, to select LICENSED COMPOUNDS which shall then be designated PRODUCTS for further DEVELOPMENT by RWJPRI and marketing by ORTHO and its AFFILIATES. RWJPRI shall provide KOSAN with written notice of its decision to select a LICENSED COMPOUND for DEVELOPMENT. Once a PRODUCT has been selected for further DEVELOPMENT, RWJPRI, with the advice of the JDAC, shall have the [**] right to develop the PRODUCT through STAGES O, I, II and III and shall have the [**] right to prepare and file, and shall be the owner of, all applications for MARKETING AUTHORIZATION throughout the world. During such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may be mutually agreed, at RWJPRI's expense, in chemical development, formulation development, production of labeled material and production of sufficient quantities of material for STAGE O and initial STAGE I studies. RWJPRI shall exercise diligent efforts, commensurate with the efforts it would normally exercise for products with similar potential sales volume and consistent with its overall business strategy, in developing such PRODUCT in accordance with the DEVELOPMENT PLAN established by RWJPRI. In the course of such efforts RWJPRI shall, either directly or through an AFFILIATE or SUBLICENSEE to which the license shall have been extended, take appropriate steps including the following: (i) in consultation with the JDAC, select certain LICENSED COMPOUNDS for STAGE O DEVELOPMENT; and (ii) establish and maintain a program reasonably designed, funded and resourced to obtain information adequate to enable the preparation and filing with an appropriate and properly empowered national regulatory authority all necessary documentation, data and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. other evidence required for IND non-rejection to commence and conduct human clinical trials of such PRODUCT. (iii) proceed following IND non-rejection to commence PHASE I, II, and III clinical trials, associated studies and such other work which RWJPRI reasonably deems to be required for subsequent inclusion in filings for MARKETING AUTHORIZATION; (iv) after such submissions are filed prosecute such submissions and file all reasonably necessary, reports and respond to all reasonable requests from the pertinent regulatory, authorities for information, data, samples, tests and the like.
Manufacturing Rights (a) If QED fails to supply Product ordered by ViewRay in accordance with the terms of this Agreement regarding the quantity or quality of Products supplied to ViewRay, then QED shall within fifteen (15) Business Days of said failure present ViewRay with a plan to remedy the problem and shall use Commercially Reasonable Efforts to execute such plan and remedy the problem or QED shall secure an alternative source of supply within a reasonable time at no additional cost to ViewRay. Any such alternative source of supply shall be on terms substantially identical with the terms of this Agreement. If QED is unable to provide a plan to remedy the problem or secure an alternative source of supply within [***] after its initial failure to supply, then QED shall consult with ViewRay and the parties shall work together to remedy the problem. If QED is unable to remedy the supply problem after [***] (or longer as agreed in writing by the parties), commencing with the date upon which such failure to supply began, then ViewRay may at its option, and upon notice to QED, manufacture the Products itself or through a third party in accordance with the provisions of Section 3.10(b). [***] 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. (b) If ViewRay notifies QED pursuant to Section 3.10(a), above, that ViewRay will manufacture the Products itself or through a third party, QED shall (i) deliver to ViewRay within thirty (30) days media embodying or disclosing all Program technology and Program proprietary or intellectual property rights necessary to enable ViewRay or its designee to manufacture Products conforming with the Specifications; and (ii) provide ViewRay or its designee, upon request, with reasonable assistance in establishing a back-up manufacturing line. ViewRay shall require any third party ViewRay designates to manufacture Products pursuant to this Section 3.10, to agree in writing to observe the terms of this Agreement relating to confidentiality and the manufacture of Products. Notwithstanding any provision of this Section 3.10 to the contrary, in no case shall QED be required to pay ViewRay in respect of any Products purchased by ViewRay from a third party operating a back-up manufacturing line established pursuant to this Section 3.10 or manufactured by ViewRay or its Affiliates pursuant to this Section 3.10.

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