Development and Regulatory Responsibilities Sample Clauses

The 'Development and Regulatory Responsibilities' clause defines the obligations of each party regarding the development of a product and compliance with applicable regulatory requirements. It typically outlines which party is responsible for conducting research, obtaining necessary approvals, and maintaining records to meet legal and industry standards. This clause ensures that both parties clearly understand their roles in product development and regulatory compliance, thereby reducing the risk of misunderstandings or non-compliance with laws.
Development and Regulatory Responsibilities. 2.1. Section 2.1 of the Agreement is hereby amended by the addition of the following as a new second paragraph thereto: "Notwithstanding the preceding, Mylan retains the right on a co-exclusive basis with Forest (i.e., an exclusive right subject only to the rights granted to Forest hereunder) under the Licensed Patents and Licensed Know-How in the Territory for the limited purpose of Developing and Commercializing the Product (as defined in subsection (a) of Section 1.26) for the indication of [***] (the "Reserved Indication"). Such right shall not be assignable or sublicensable by Mylan and, with respect to Commercialization, may only be used for the Commercialization of Product in such dosage forms and strengths as are not reasonably likely to be substituted for dosage forms and strengths being Commercialized or Developed by Forest. In the event that sales of a Product by Mylan authorized by this paragraph are being made for indications other than the Reserved Indication during the Term ("Unauthorized Sales") as indicated by generally recognized Third Party data sources, Mylan agrees to pay Forest an amount equal to the Net Sales which Forest would have achieved if the Unauthorized Sales had been sales by Forest of the Product." 2.2. From and after the Amendment Effective Date, Forest will have the sole authority, discretion and responsibility, at Forest’s sole cost and expense, for all further Development activities, including, without limitation, all studies currently underway (including NEB310 and NEB323), all interactions with Regulatory Authorities with respect to Regulatory Approval (including labeling discussions and finalization) and other matters relating to the Product and with respect to the conduct of any further Development activities. From and after the Amendment Effective Date, Forest will have the sole responsibility and authority for formulating and preparing the submission strategy for any further Development required for all future indications for which Regulatory Approval may be sought, including, without limitation, for the treatment of congestive heart failure. From and after the Amendment Effective Date, Mylan shall not perform any Development activities, provided that Mylan shall cooperate with Forest in obtaining any consent required by ▇▇▇▇▇▇▇ under the ▇▇▇▇▇▇▇ Agreement to Development plans or activities proposed to be conducted by Forest. 2.3. In accordance with the assignment of authority and responsibility for future Develop...
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Development and Regulatory Responsibilities. Subject to Section 3.1(c), the SCJ shall: (1) approve the Development and regulatory strategy for the Final Product, (2) provide a forum for coordination of the Parties’ Development and regulatory activities under this Agreement, and (3) as applicable, review, comment on, approve, and seek to resolve disputes with respect to, Development plans and budgets for, and the implementation of, the Development and regulatory strategy for, the Final Product. The Long-Term Development Plan, as of the Restatement Effective Date, is as set forth in Exhibit 3.1(a) hereto. The SCJ may amend or supplement the Long-Term Development Plan, and make any decision necessary to fulfill the Long-Term Development Plan in accordance with this Agreement. In particular, the SCJ shall have the following specific responsibilities with respect to the Development and registration of the Final Product in Japan: (i) subject to Section 3.1(c), review and approve all Annual Development Plans and Budgets, and all updates, amendments and modifications to, and waivers of provisions of, each Annual Development Plan and Budget and the Long-Term Development Plan, including whether to pursue the Development of an additional Indication (or a new line of therapy within an existing approved Indication), the termination of an Indication (or line of therapy) then being developed, or the initiation or cessation of other additional Development activities; (ii) review and approve each Annual Development Plan and Budget or any changes thereto approved by the JJDC, and resolve any disputes at the JJDC with respect to the Annual Development Plan and Budget or any changes thereto; (iii) monitor progress of the ongoing Clinical Trials and any future Clinical Trials added to the binding and non-binding sections of the Long-Term Development Plan, identify issues and provide necessary resources, tools and ideas to solve such issues; (iv) establish and develop common working structures (e.g., use of common databases, investigator brochures, exchange of safety information); (v) review and comment upon interactions with the Japanese Regulatory Authorities pursuant to Article 3 hereof; (vi) review, modify and approve, and ensure consistency between, draft JNDAs for Cetuximab proposed by BMKK, as agent for ImClone, and MJ; Confidential Treatment has been requested by ImClone Systems Incorporated for portions of this document. (vii) create, monitor, oversee and direct working groups as necessary or useful to carry out ...
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Development and Regulatory Responsibilities. Unless the Parties otherwise mutually agree in writing, (a) Serendex will have control of all activities and responsibilities bearing on the development and/or testing of the Drug Product and seeking Marketing Approval and/or Regulatory Approval for the Drug Product, and (b) PARI will have control of all activities and responsibilities bearing on the development and/or testing of the Device and seeking Marketing Approval and/or Regulatory Approval for the Device. Notwithstanding the foregoing, the Parties will closely collaborate and support each other in obtaining reimbursement for the Device and PARI has to approve all documents on reimbursement for the Device prior to the submission to any third party. If any drug/device combination filing for a Product is requested by any Regulatory Authority, including any ▇▇▇▇ on Product: (i) PARI will support Serendex in making and prosecuting such filing, including with respect to the preparation, provision and filing of Device documentation, provided, however, that no documentation relating directly to the Device will be filed without PARI’s prior written approval, which approval shall not be unreasonably withheld or delayed, (ii) PARI shall at all times control the marking, labeling, CE conformity declaration and technical documentation with respect to the Device, (iii) PARI will have the right to review and comment upon any portion of such filings bearing on the Device prior to such filing, and (iv) PARI will have the right to have one of its representatives participate in any material discussions or meetings with such Regulatory Authority bearing on the Device. If Regulatory Authorities require the Device or any Product to be included under the MAA, (y) Serendex will support PARI in accommodating such requirement; and (z) the Parties will work in good faith to allow for PARI to implement any necessary changes to the Device or any Product accordingly.
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Development and Regulatory Responsibilities 
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Related to Development and Regulatory Responsibilities

  • Regulatory Responsibilities 6.6.1 From and after the Closing, subject to the terms of the Transition Services Agreement and except as required by a Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any other Ancillary Agreement, Purchaser shall have the sole right and responsibility for preparing, obtaining and maintaining all Regulatory Approvals necessary for the Product Business, and for conducting communications with Governmental Authorities of competent jurisdiction, for Seller Products. Without limitation of the foregoing, promptly following the Closing, Purchaser shall obtain such FDA approvals as are necessary for Purchaser’s own Product labeling and shall comply with such FDA approvals upon receipt thereof. 6.6.2 Subject to the terms of the Transition Services Agreement from and after the Closing, Seller shall support Purchaser, as may be reasonably necessary and practicable, at Purchaser’s cost and expense, in preparing, obtaining and maintaining all Regulatory Approvals for the Seller Products, including providing necessary documents or other materials required by applicable Law for Purchaser to obtain or maintain such Regulatory Approvals, in each case, in accordance with the terms and conditions of this Agreement. 6.6.3 Except to the extent otherwise provided in the Transition Services Agreement, from and after the Closing, Seller shall provide Purchaser with (i) copies of all written or electronic correspondence relating to any Seller Product received by Seller, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities; and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller with Regulatory Authorities to the extent relating to any Seller Product, including copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, in each case ((i) and (ii)), within ten (10) Business Days after Seller’s receipt, submission or production of the foregoing, as applicable. To the extent applicable, Seller shall provide Purchaser a draft of any written response thereto reasonably in advance (in light of the prevailing circumstances) of submitting such response to the applicable Regulatory Authorities.

  • Development Responsibilities From and after the Effective Date, BMS shall assume sole responsibility for the Development of Compounds and Products in the Field in the Territory during the Term at its own cost and expense (including responsibility for all funding, resourcing and decision-making, subject to Sections 3.3 and 3.4), except with respect to the performance by Ambrx of the Research Program activities assigned to Ambrx pursuant to the Research Plan and as otherwise may be agreed upon by the Parties in writing. BMS, by itself or through its Affiliates and Sublicensees, shall use Diligent Efforts to Develop a Compound or Product in the Field in accordance with the Development Plan for the purpose of obtaining a Regulatory Approval in each Major Market [***]. For clarity, it is understood and acknowledged that Diligent Efforts in the Development of Compounds and Products may include sequential implementation of Clinical Trials and/or intervals between Clinical Trials for data interpretation and clinical program planning and approval.

  • Licensee’s Responsibilities Licensee will be responsible for any and all damage to or relocation of existing facilities. Further, Licensee shall reimburse the City for all costs of replacing or repairing any property of the City, or of others, that is damaged by or on behalf of Licensee as a result of activities under this Agreement.

  • University Responsibilities 4.1 The University will provide a room accommodation to The Resident for a period of one academic year or the portion of the academic year remaining when occupancy begins (limited to the subsequent fall and spring semesters) exclusive of the Winter Recess period unless The Resident is assigned to a facility that remains open during this time or is approved to live on-campus during Winter Recess. Services provided by the University begin on the official check-in dates for the specific area and include access to the assigned building and room. 4.2 In accordance with University policy, the University will provide staff that will help facilitate a living experience that complements the academic mission of the University. 4.3 Exclusive of unanticipated weather events and building system failures that may disrupt service and subject to the availability of applicable resources, the University will provide adequate light, heat, electricity, hot water and telecommunication services (limited to video and internet connection) to residents. Student rooms shall be furnished.

  • Specific Responsibilities Without limiting the responsibilities of the Manager, the Manager will: 1. Maintain office facilities (which may be in the offices of the Manager or a corporate affiliate but shall be in such location as the Trust reasonably determines). 2. Furnish statistical and research data, clerical services and stationery and office supplies. 3. Compile data for, prepare for execution by the Fund and file all the Fund’s federal and state tax returns and required tax filings other than those required by this Agreement to be made by the Fund’s custodian and transfer agent. 4. Prepare compliance filings pursuant to state securities laws with the advice of the Trust’s counsel. 5. Prepare the Trust’s Annual and Semi-Annual Reports to Shareholders and amendments to its Registration Statements (on Form N-1A or any replacement therefor). 6. Compile data for, prepare and file timely Notices to the SEC required pursuant to Rule 24f-2 under the 1940 Act. 7. Determine the daily pricing of the portfolio securities and computation of the net asset value and the net income of Fund in accordance with the Prospectus, resolutions of the Trust’s Board of Trustees, and the procedures set forth in EXHIBIT A: NET ASSET VALUE CALCULATIONS. 8. Keep and maintain the financial accounts and records of the Fund and provide the Trust with certain reports, as needed or requested by the Fund. 9. Provide officers for the Trust as requested by the Trust’s Board of Trustees. 10. Perform fund accounting services for the Fund as set forth in EXHIBIT B: FUND ACCOUNTING FUNCTIONS. 11. Generally assist in all aspects of the operations of the Fund.