Responsibilities of the Joint Development Committee Sample Clauses

Responsibilities of the Joint Development Committee. The JDC shall be responsible for (a) receiving and reviewing all safety data, relevant regulatory information and other related information obtained by either Party in connection with the Development, Manufacture, use and Commercialization of Licensed Products; (b) facilitating communication between the Parties, (c) resolving Disputes between the Parties, such as Disputes about interpretation of this Agreement, understanding that CytomX has sole authority over the Development, Manufacturing, use and Commercialization of Licensed Products; and (d) such other functions as expressly specified hereunder or as agreed by the Parties. At the time that the first Licensed Product enters a clinical trial, the Parties shall negotiate in good faith the terms of a separate written safety data exchange agreement that, among other things, will govern the exchange of pharmacovigilance information.
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Responsibilities of the Joint Development Committee. Each Party shall keep the JDC informed about activities performed by that Party hereunder. Except as otherwise provided in the last sentence of this Section 2.4 with respect to Sponsor-Funded Studies, the JDC shall be responsible for the following with respect to each Combined Therapy Study, and for clarity will have no authority with respect to any aspect of the following relating solely to the Monotherapy Arm of the CGEN Phase 1 Study: (a) establishing and approving each Study Plan, including any amendments to such Study Plan, in accordance with Section 2.1(a); (b) overseeing the activities of the Parties with respect to a Combined Therapy Study, and providing a forum for the Parties to discuss, monitor and coordinate all activities and communications regarding the Combined Therapy Study; (c) approving a Budget for the Study Costs in connection with Jointly-Funded Studies (or any changes to the Budget), provided that if the proposed total Budget amount (or any proposed changes to the Budget) exceeds [*] of the applicable Preliminary Budget, such Budget (or changes to the Budget) must be expressly approved in writing by authorized representatives of each Party; (d) reviewing the progress of each Combined Therapy Study, and reviewing the strategy for and results of medical monitoring and site audits; (e) reviewing and approving the Protocol and any proposed amendments to the Protocol (including any changes in the dosage and/or dosage regimen for the BMS Compound and/or Compugen Compound (and/or other therapeutic agent or therapy, as applicable), and amendments that have an impact on the Budget, timelines, patient safety and any changes to the study design, dosage or administration of Compound, collection of patient samples or indications to be explored) (with such review to be completed within [*] following presentation of the proposed amendment to the JDC for review); (f) approving any immunogenicity analysis for the Combined Therapy, including the protocol and entity to do the analysis; (g) approving the Bioanalysis Plan and any amendments to the Bioanalysis Plan; [*] = 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. (h) reviewing substantive proposed communication strategies and substantive communications with any Regulatory Authority regarding the conduct of the Com...
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Responsibilities of the Joint Development Committee. The JDC shall agree on the initial Development Plan, shall exercise oversight of the implementation of the Development Plan, and shall approve all modifications and addenda to the Development Plan. To satisfy its responsibilities, the JDC shall prepare and submit to the Parties, by the first day of each calendar year, an updated Development Plan that includes a detailed description of all development anticipated to be performed during the following calendar year.
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Responsibilities of the Joint Development Committee. The JDC will: (a) review and report on the progress of the Project including individual Milestones, and ensure that the Project proceeds according to the Project Agreement; (b) ensure the cooperation and participation of the Parties in the performance of the Project and review the recommendations, plans and other activities in support of the Project; (c) coordinate the activities of the Parties to assure that the Project is aligned with Arno’s intended use of the Deliverables; (d) in the case of an Approval Delay, cooperate to resolve such Approval Delay; and (e) approve amendments to the applicable Project Agreement (including the applicable SOW) and oversee regulatory activities with respect to the Product as described further below. The following decisions require approval of the JDC (which approval will not be unreasonably withheld): (i) approval of the Assay User Requirements for the Deliverables (as applicable); (ii) selection of the primary antibody or reagents (as applicable) for the Deliverables and any standards for the Deliverables; (iii) the Labeling (including but not limited to the “Indication for Use” statement) to be submitted in a Regulatory Submission or otherwise to be presented to a Regulatory Authority for the Product (as applicable); (iv) approval of the Regulatory Submission for the Deliverables (including any such modules thereof) that relate to the Intended Use or Indication, or that relate or refer to the Drug) (as applicable); (v) approval of Other Product Development Costs; and (vi) any changes to the SOW including any changes to the Project Agreement (and corresponding FTE Payments or Milestone Fees, as applicable). If the JDC, JSC and Alliance Managers are unable to reach an agreement regarding the Approval Application or Labeling, if applicable, then LBS shall have final authority with respect to such decision.
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Related to Responsibilities of the Joint Development Committee

  • Joint Development Committee (a) The Parties shall establish a Joint Development Committee (the “Joint Development Committee” or “JDC”), comprised of [**] representatives of Ikaria and [**] representatives of BioLineRx, to oversee the Development of Products. Each Party shall make its initial designation of its representatives not later than [**] days after the Effective Date. Each Party may change any one or more of its representatives to the Joint Development Committee at any time upon notice to the other Party. (b) The JDC shall meet at least [**] during the Development Term or more or less frequently as the JDC may agree. The JDC may meet in person or by means of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunder.

  • Development Committee Arcadia and Xxxxxx shall establish a development committee (the “Development Committee”) comprised of no more than three (3) representatives of each of Arcadia and Xxxxxx. The Development Committee shall be chaired by a member thereof designated from time to time by Arcadia. The Development Committee shall oversee the Research Plan, Milestones and development and production of plants and microorganisms that produce Transgenic Oil in accordance with the Research Plan. The Development Committee may revise the Research Plan and the Milestones as deemed necessary and appropriate by unanimous written consent of all members. Meetings of the Development Committee shall be at least biannual and at such times and places or in such form (e.g., in person, telephonic or video conference) as the members of the Development Committee shall determine. Representatives of both Parties shall be present at any meeting of the Development Committee. Decisions of the Development Committee shall be made by a written consent signed by all six (6) members thereof. The Development Committee shall keep minutes of its deliberations setting forth, among other matters, all proposed actions and all votes thereon. All records of the Development Committee shall at all times be available to both Parties. The Development Committee by unanimous consent may delegate to one Party or to a specific representative the authority to make certain decisions. The Development Committee may revoke such authority by the written consent of four members. All disagreements within the Development Committee shall be subject to the following: (i) The members of the committee will endeavor in good faith for a period of not more than ninety (90) days to attempt to resolve the disagreement; (ii) If the members of the committee are unable to resolve the disagreement by the end of such period, the committee shall promptly present the disagreement to the President of Xxxx Products Division and the President of Arcadia or their respective designees, and the two executives shall endeavor to resolve the disagreement for a period of not more than thirty (30) days; (iii) If the two executives are unable to resolve this disagreement, the disagreement shall be submitted for ADR as provided in Section 12(a).

  • Local Professional Development Committee A. There shall be a Local Professional Development Committee (LPDC) to oversee, review, and approve individual professional development plans (IPDP) for course work, continuing education units and/or other equivalent activities. 1. The LPDC shall be responsible to recommend for the Superintendent’s approval, all in-service activities and workshops offered in the district during the school year for staff professional development. 2. Recommendations for District Workshops and In-Service activities should be submitted to the LPDC for approval and recommendation no later than the last school day of the year prior to the year it will be implemented. 3. The LPDC chair shall review and approve all “Professional Growth Reimbursement Application” forms. B. The LPDC shall consist of three (3) teachers appointed by the Association President and two (2) members appointed by the Superintendent. One of the Superintendent's appointees will be a Principal employed by the district. C. Appointments shall be for two (2) years with half of the committee members being appointed every other year. 1. Appointments shall be made on or before May 1. 2. The Appointments shall be made by each party outlined above, notifying the other of those appointed. 3. In the event of a vacancy, the committee members shall be replaced in accordance with "B." above. 4. The Association shall name a fourth teacher member and the Superintendent shall name a third administrative member to serve as alternates and attend trainings. These two (2) people shall act as substitutes when a committee member is absent. D. This committee shall meet monthly. 1. The committee may also be convened by the request of two sitting members. 2. A quorum shall consist of five (5) members. When administrative licenses/certificates are reviewed, two (2) sitting teacher members will abstain and the decision will be decided by three (3) members. 3. If the committee determines it is needed, they will be provided two (2) professional release days to meet during regular school hours. Substitutes will be provided for the committee members on these release days. 4. Committee members shall be provided an additional annual stipend of $1,000 for meetings beyond the normal work day or year. This stipend shall be paid in two (2) semi-annual payments. Any member who fails to serve the full year shall have the above compensation prorated on a monthly basis for each month served. 5. Decisions of the LPDC will be made by consensus of the committee members present. 6. The committee minutes shall be prepared and maintained in compliance with the laws governing the operation of committees of public bodies.

  • Professional Development Committee There shall be a Professional Development Committee composed of two (2) members of the Association one of whom shall be the Bargaining Unit President or designate and two (2) representatives of the Hospital one of whom shall be the Chief Nursing Officer or designate and one human resources representative.

  • The Joint Committee (a) shall be composed of representatives of the Governments of the Parties; and (b) may establish and delegate its responsibilities to Sub-Committees.

  • 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.

  • Responsibilities of the Parties 1.5.1 The Parties shall perform all obligations of this Agreement in accordance with all Applicable Laws and Regulations, Operating Requirements, and

  • Responsibilities of Adviser In carrying out its obligations under this Agreement, the Adviser agrees that it will: (a) Comply with all applicable law, including but not limited to the 1940 Act and the Advisers Act, the rules and regulations of the Commission thereunder, and the conditions of any order affecting the Trust or a Fund issued thereunder; (b) Use the same skill and care in providing such services as it uses in providing services to other fiduciary accounts for which it has investment responsibilities; (c) Not make loans to any person for the purpose of purchasing or carrying Fund shares; (d) Place, or arrange for the placement of, all orders pursuant to its investment determinations for the Funds either directly with the issuer or with any broker or dealer (including any affiliated broker or dealer). In executing portfolio transactions and selecting brokers or dealers, the Adviser will use its best efforts to seek on behalf of each Fund the best overall terms available. In assessing the best overall terms available for any transaction, the Adviser shall consider all factors that it deems relevant, including the breadth of the market in the security, the price of the security, the financial condition and execution capability of the broker or dealer, and the reasonableness of the commission, if any, both for the specific transaction and on a continuing basis. In evaluating the best overall terms available, and in selecting the broker or dealer to execute a particular transaction, the Adviser may also consider whether such broker or dealer furnishes research and other information or services to the Adviser; (e) Adhere to the investment objective, strategies and policies and procedures of the Trust adopted on behalf of each Fund; and (f) Maintain a policy and practice of conducting its investment advisory services hereunder independently of the commercial banking operations of its affiliates. In making investment recommendations for a Fund, the Adviser's investment advisory personnel will not inquire or take into consideration whether the issuers (or related supporting institutions) of securities proposed for purchase or sale for the Fund's account are customers of the commercial departments of its affiliates. In dealing with commercial customers, such commercial departments will not inquire or take into consideration whether securities of those customers are held by the Fund.

  • Labour Management Committee (a) Where the parties mutually agree that there are matters of mutual concern and interest that would be beneficial if discussed at a Labour Management Committee Meeting during the term of this Agreement, the following shall apply. (b) An equal number of representatives of each party as mutually agreed shall meet at a time and place mutually satisfactory. A request for a meeting hereunder will be made in writing prior to the date proposed and accompanied by an agenda of matters proposed to be discussed, which shall not include matters that are properly the subject of grievance or negotiations for the amendment or renewal of this agreement. Any representative(s) attending such meetings during their regularly scheduled hours of work shall not lose regular earnings as a result of such attendance. (c) It is agreed that the topic of a rehabilitation program for drug and alcohol abuse is an appropriate topic for the Labour-Management Committee. It is also agreed that the topic of the utilization of full-time and part-time staff is an appropriate topic for the Labour-Management Committee. The committee shall have access to work schedules and job postings upon request. (d) It is understood that joint meetings with other Labour-Management Committees in the Hospital may be scheduled concerning issues of mutual interest if satisfactory to all concerned. (e) Where two or more agreements exist between a Hospital and CUPE the Committee may be a joint one representing employees under both agreements, unless otherwise agreed.

  • RESPONSIBILITIES OF THE OWNER The Owner agrees to: Provide all documentation, records, and disclosures as required by law or required by the Agent to manage and operate the Property, and immediately notify the Agent if the Owner becomes aware of any change in such documentation, records or disclosures, or any matter affecting the habitability of the Property; Indemnify, defend, and hold harmless the Agent, and all persons in the Agent's firm, regardless of responsibility, from all costs, expenses suits, liabilities, damages, attorneys fees, and claims of every type, including, but not limited to, those arising out of injury or death of any person, or damage to any real or personal property of any person, including the Owner, for: Any repairs performed by the Owner or by others hired directly by the Owner; or Those relating to the management, leasing, rental, security deposit, or operation of the Property by the Agent, or any person in the Agent's company, or the performance or exercise of any of the duties, powers, or authorities granted to the Agent; This sub-section, and all rights to the Agent’s indemnification, shall be considered void if the Agent exemplifies any willful acts of gross negligence; Maintain the Property in a condition fit for human habitation as required by applicable State and local laws; Pay all interest on Tenants’ security deposits if required by applicable laws; Carry and pay for: Public and premises liability insurance in an amount of no less than one-million dollars ($1,000,000.00); and Property damage and worker’s compensation insurance adequate to protect the interests of the Owner and the Agent. The Agent shall be, and the Owner authorizes Agent to be, named as an additional insured party on the Owner’s policies; and Pay any late charges, penalties and/or interest imposed by lenders or other parties for failure to make payment only if the failure is due to insufficient funds in the Agent’s trust account available for such payment. In addition, the Owner agrees to replace any funds required if there are insufficient funds in the Agent’s trust account to cover such responsibilities of the Owner.

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