Development Committee Responsibilities Sample Clauses

Development Committee Responsibilities. The Development Committee shall be responsible for: (i) implementing the Development, Commercialization and Manufacturing strategy for Products in the Field in the Territory as determined by the JMC; (ii) establishing the Development Plan and the personnel, facilities, expertise and other resources of each Party to be used in the performance of the Collaboration; and (iii) performing such other activities as are contemplated for the Development Committee under this Agreement.
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Development Committee Responsibilities. The Development Committee shall perform the following functions: (1) oversee and manage the work under, monitor the progress of, and implement the Development Plan, the Manufacturing Plan and the Technology Transfer Plan, including compliance with budget and timelines; (2) develop an overall strategy and detailed plans for the Development and Manufacturing of Licensed Product for review by the JSC; (3) formulate any Substantive Amendments to the Development Plan (including allocation of Development activities between the Parties) and the budget for review and approval by the JSC; (4) make recommendations for further Development of Licensed Product, including Development of Licensed Product for indications that are not contemplated in the Development Plan as of the Execution Date; (5) review forecasts of Clinical Supplies requirements for Development of Licensed Product, review the supply of Licensed Product for Development, and formulate any Substantive Amendments to the Manufacturing Plan (including allocation of Manufacturing activities between the Parties) for review and approval by the JSC; (6) discuss and approve any Non-Substantive Amendments (as defined in Clause 5.1(C)) to the Development Plan and the Manufacturing Plan that involve performance by Genmab; (7) discuss and exchange information regarding the conduct of ongoing Clinical Studies; (8) exchange information regarding Licensed Product and facilitate cooperation and coordination between the Parties relating to Development and Manufacture of Licensed Product as they exercise their respective rights and meet their respective obligations under the Development Plan, the Manufacturing Plan and this Agreement; (9) provide status updates to the JSC regarding Development and Manufacturing activities; and (10) perform such other functions as appropriate to further the purposes of this Agreement as determined by the Parties.
Development Committee Responsibilities. The Development Committee shall be responsible for overseeing the development and Regulatory Approval of Product in the Xxxxxx Territory and/or Joint Territory, including review and approval of all clinical protocols, regulatory progress and regulatory strategy, drafts of submissions of Product prescribing information and other regulatory correspondence and proposed responses thereto.
Development Committee Responsibilities. The Development Committee shall be responsible for: (i) proposing and overseeing the implementation of the Development strategy for Products in the Field in the Territory as determined by the Steering Committee; (ii) establishing the Development Plan to be submitted to the Steering Committee for approval; (iii) overseeing preclinical studies of Products, including toxicological and pharmacokinetic studies; (iv) overseeing the filing of INDs with Regulatory Authorities throughout the Territory by the designated Party pursuant to Section 4.5(a); (v) approving the protocol of any clinical studies of the Products throughout the Territory; (vi) overseeing clinical studies of Products throughout the Territory; (vii) overseeing the filing of BLAs with Regulatory Authorities throughout the Territory by the designated Party pursuant to Section 4.5(a); (viii) overseeing the activities of the Parties with respect to the Development of Products in the Territory; (ix) confirming the annual adjustments for inflation to the FTE Rate, as provided in the definition thereof; (x) assuring comparable methodologies in calculating FTE Costs; (xi) determining whether licenses from Third Parties are required or beneficial for the Development or Commercialization of a Product in the Field, as reflected in Section 4.7(b), and making proposals to the Steering Committee with respect thereto; (xii) establishing, as appropriate, one or more advisory committees comprised of scientific, medical and/or other appropriate experts not affiliated with either Party, which committee(s) shall be responsible for advising the Development Committee on scientific, medical and other matters related to a Product or Target Antigen, including without limitation by making recommendations as to size and design of clinical trials, which recommendations shall be considered in good faith by the Development Committee but shall not be binding on the Parties; (xiii) providing all appropriate information regarding the progress of the Development Program to the Steering Committee in advance of its quarterly meetings or as otherwise requested by the Steering Committee; and (xiv) performing such other activities as are contemplated for the Development Committee under this Agreement.

Related to Development Committee Responsibilities

  • Committee Responsibilities Subject to the provisions of the Plan, the Committee shall have full authority and discretion to take the following actions: (i) To interpret the Plan and to apply its provisions; (ii) To adopt, amend or rescind rules, procedures and forms relating to the Plan; (iii) To adopt, amend or terminate sub-plans established for the purpose of satisfying applicable foreign laws including qualifying for preferred tax treatment under applicable foreign tax laws; (iv) To authorize any person to execute, on behalf of the Company, any instrument required to carry out the purposes of the Plan; (v) To determine when Awards are to be granted under the Plan; (vi) To select the Participants to whom Awards are to be granted; (vii) To determine the type of Award and number of Shares or amount of cash to be made subject to each Award; (viii) To prescribe the terms and conditions of each Award, including (without limitation) the Exercise Price and Purchase Price, and the vesting or duration of the Award (including accelerating the vesting of Awards, either at the time of the Award or thereafter, without the consent of the Participant), to determine whether an Option is to be classified as an ISO or as a Nonstatutory Option, and to specify the provisions of the agreement relating to such Award; (ix) To amend any outstanding Award Agreement, subject to applicable legal restrictions and to the consent of the Participant if the Participant’s rights or obligations would be materially impaired; (x) To prescribe the consideration for the grant of each Award or other right under the Plan and to determine the sufficiency of such consideration; (xi) To determine the disposition of each Award or other right under the Plan in the event of a Participant’s divorce or dissolution of marriage; (xii) To determine whether Awards under the Plan will be granted in replacement of other grants under an incentive or other compensation plan of an acquired business; (xiii) To correct any defect, supply any omission, or reconcile any inconsistency in the Plan or any Award Agreement; (xiv) To establish or verify the extent of satisfaction of any performance goals or other conditions applicable to the grant, issuance, exercisability, vesting and/or ability to retain any Award; and (xv) To take any other actions deemed necessary or advisable for the administration of the Plan. Subject to the requirements of applicable law, the Committee may designate persons other than members of the Committee to carry out its responsibilities and may prescribe such conditions and limitations as it may deem appropriate, except that the Committee may not delegate its authority with regard to the selection for participation of or the granting of Awards under the Plan to persons subject to Section 16 of the Exchange Act. All decisions, interpretations and other actions of the Committee shall be final and binding on all Participants and all persons deriving their rights from a Participant. No member of the Committee shall be liable for any action that he has taken or has failed to take in good faith with respect to the Plan or any Award under the Plan.

  • 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 Responsibilities Licensee is responsible for Licensee’s Users’ compliance with this Agreement. Licensee is responsible for all of Licensee’s uses and accounts. Licensee will be responsible for maintaining the security of Licensee’s accounts, passwords and files. Licensee and Users cannot share Licensee’s accounts or passwords or allow any third party to use Licensee’s accounts or passwords. Licensee will exercise reasonable precautions to prevent unauthorized use of the Software.

  • Joint Responsibilities The relationship between SAE ITC, the Activities and its Members shall be, and at all times, advisory only, and no party shall have the authority to enter into any contract or commitment in the name of, or on behalf of, any other party. Nothing in this Agreement shall be construed to confer upon either party the status of employee, agent, partner, joint venturer or legal representative of the other, it being intended by all parties to remain independent legal entities solely responsible for its own actions.

  • Client Responsibilities You are responsible for (a) assessing each participants’ suitability for the Training, (b) enrollment in the appropriate course(s) and (c) your participants’ attendance at scheduled courses.

  • Employer Responsibilities Recognizing the inherent risk(s) in a correctional setting, the Employer is obligated to provide a safe workplace and to educate employees on proper safety procedures and use of protective and safety equipment. The Employer is committed to responding to legitimate safety concerns raised by the Union and employees. The Employer will comply with federal and state safety standards, including requirements relating to first aid training, first aid equipment and the use of protective devices and equipment.

  • GRANTEE RESPONSIBILITIES To participate as a provider under this Contract, the Grantee must: 2.1 Ensure compliance with this Contract, including these Grantee requirements; 2.2 Ensure compliance with all applicable federal and state laws, rules, regulations, standards, guidelines, and policies in effect on the beginning date of this Contract unless amended, including, but not limited to, Texas Health and Safety Code Chapter 31; 2.3 Ensure compliance with all state and federal statutes and regulations, HHSC rules, policies, procedures, and guidelines governing the Program, included but not limited to, TAC Title 25, Part 1 Chapter 39, and - Subchapter A, §39.1 -§39.11. The foregoing rules in TAC Title 25 - as they relate to the Program may be further modified and revised- within their existing title- during the term of the Contract. In the event of such modifications or revision, Grantee shall be required to comply with said rules; 2.4 Ensure compliance at all times with the current Program Policy Manual that is available online and incorporated into this Contract as

  • Student Responsibilities The school provided Chromebook for the student is an important learning tool to be used for educational purposes. In order to use the device each day, the student must be willing to accept the following responsibilities: ● I understand that district officials have the ability to monitor my use of the device AT ALL TIMES IN AND OUT OF SCHOOL and that communications, files, internet search activities, and any other actions using the device are not considered to be private. Note: RCCSD does not have the ability to and will not remotely operate the camera on the device. However, students can cover it when not in use to ensure others are not. ● I understand that the device assigned to me is on loan from Red Clay Consolidated School District. All accounts, programs, and files are subject to inspection at any time without notice. ● I will be responsible for ALL damage or loss of the device due to NEGLECT OR ABUSE including dropping it, getting it wet, and spills of food or drink. ● I will not try to repair my Chromebook. ● At ALL times when using my Chromebook, I will follow the Acceptable Use, Internet Safety Policy, and Student Code of Conduct, and related policies adopted by the Board of Education, and abide by all local, state, and federal laws. ● I will talk with my parent/guardian about their ground rules for going online when not at school. ● I will notify the school principal and my parents of any damage to the device as soon as possible. ● I will charge the Chromebook battery each night and will bring my Chromebook to school every day or be prepared for remote learning. ● I will keep my Chromebook clean. ● I will not lend my device to anyone. This includes family members and friends. Note: I could be held responsible for any inappropriate content on the District issued Chromebook. ● I will keep all passwords assigned to me secure. ● I will only use my account credentials to sign into my Chromebook. ● I am allowed to connect to non-district printers and wireless networks at home and in public places. ● I agree that e-mail or any other computer communication should be used only for appropriate, legitimate, and responsible communication. ● I agree not to share personal information about myself (full name, address, etc.) or about my family, friends or anyone else. ● I agree not to search for, download, display, post, or distribute vulgar, offensive material or images described in applicable district policies. (See the student handbook and/or the district's Acceptable Use Agreement.) ● I agree to abide by all school rules that address electronic device procedures. ● I will return the device when requested, at the end of the school year or upon my withdrawal. ● I agree to not deface or destroy this property in any way. Inappropriate use of the machine may result in the student losing their right to use the Chromebook. ● I understand that identification labels have been placed on the Chromebook. These labels are not to be removed or modified. Additional stickers, labels, tags, or markings of any kind are NOT to be added to the machine.

  • Employee Responsibilities The Employer's policy with respect to employee responsibilities provides for employees:

  • Audit Committee Review Prior to the earlier of the consummation of an initial Business Combination and the Liquidation, the Company’s audit committee will review on a quarterly basis all payments made by the Company to the Sponsor, to the Company’s officers or directors, or to the Company’s or any of such other persons’ respective affiliates.

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