Function and Powers of the JDC Sample Clauses

Function and Powers of the JDC. During the Merck Participation Term for a given Program, without limiting the generality of this Section 2.5, the JDC shall oversee and facilitate the conduct of the Development of Collaboration Products during the Merck Participation Term for such Program, including to: (i) monitor and oversee the Development activities under the Development Plan, including timely sharing and discussion of any material results or events relating to such Development activities and discussion of any anticipated cost overruns; (ii) oversee the conduct of and monitor progress of any Clinical Studies under the Joint Development Plan and Budget for such Program; (iii) decide whether and when to initiate or discontinue any Clinical Study under the Joint Development Plan and Budget for such Program; (iv) facilitate the flow of information between the Parties with respect to the Development of Collaboration Products for such Program; (v) discuss and review the overall strategy regarding Regulatory Approval of Collaboration Products in the Territory for such Program; (vi) provide a forum for discussion of any regulatory related activities and maintenance of INDs or CTAs for Collaboration Products and initial Regulatory Approvals for Collaboration Products for such Program; (vii) review the Development Transition Plans for such Program; (viii) coordinate with the JMC regarding enrollment for Clinical Studies for Collaboration Products, including the forecast for Manufacturing capacity and the applicable enrollment rate; (ix) discuss any Additional Study(ies) proposed by either Party for such Program; and (x) until the formation of the JCC, discuss, when available to Merck, the applicable and relevant components of the initial Global Commercialization Plan for such Program; provided that for clarity, the JDC will not oversee the Commercialization activities with respect to Collaboration Products, and such Commercialization activities shall be under the purview of the JCC, as, and to the extent, applicable.
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Function and Powers of the JDC. The JDC will: (i) provide input and advise on the Development Plan (including making recommendations with respect to the remediation of any issues that arise in the conduct of the Development activities by Scynexis or any of its Affiliates pursuant thereto); (ii) oversee the implementation, progress under, and execution of the Development Plan; (iii) review the results of the activities being carried out under the Development Plan; (iv) review, discuss and oversee the exchange of Adverse Event and other safety related information (e.g., Serious Adverse Events and emerging safety issues) between the Parties with respect to Products (A) prior to the effectiveness of the Pharmacovigilance Agreement and (B) for so long as the JDC exists pursuant to Section ‎3.2(a), through the data safety monitoring subcommittee; (v) review, discuss, decide whether to approve and, if approved, implement potential amendments to the then-current Development Plan, including any modifications that are required as a result of any request or requirement of the FDA or any other Regulatory Authority in the GSK Territory, subject to Section ‎4.1(a)(i); (vi) establish subcommittees, direct and oversee any operating subcommittee on all significant issues, and resolve disputed matters that may arise at the subcommittees; (vii) establish an appropriate mechanism for the ongoing transfer from Scynexis to GSK of results, data, and information arising from the Development activities performed by or on behalf of Xxxxxxxx as contemplated by Section ‎4.1(c); (viii) perform any and all tasks and responsibilities that are expressly attributed to the JDC under this Agreement or as otherwise agreed by the Parties in writing; and (ix) discuss and coordinate activities under the Technology Transfer Plan and Commercialization Transition Plan; provided, that, the JDC will not have the ability to amend any such plans without mutual consent of the Parties.
Function and Powers of the JDC. Subject to the Parties’ respective final decision-making rights, the JDC shall oversee the Development of Compound, Product and the Companion Diagnostic, including but not limited to: (i) Review and approval of the Product Development Plan and Companion Diagnostic Development Plan, including amendments thereto, including proposed updates to the Endocyte Development Budget; (ii) Monitoring the Development activities under the Product Development Plan and Companion Diagnostic Development Plan, including any changes thereto between updates or amendments as provided in this Agreement; (iii) Discussing any additional studies proposed by either Party for inclusion in the Product Development Plan; (iv) Discussing any anticipated Development Cost overruns related to the PROC Clinical Trial; (v) Coordinate and collaborate with respect to the pre-Product Approval Medical Affairs Activities in support of Products and the Companion Diagnostic in the Territory; and (vi) Resolution of any disputes within the purview of the JDC, subject to the Parties’ final decision-making rights and Section 3.3.2. 1. 128.2 The Global Regulatory Steering Team or GRST. [ * ] = 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.

Related to Function and Powers of the JDC

  • Purpose and Powers of the Company The Company is organized for the purpose of carrying on any lawful activity for which limited liability companies may be formed under the Act. The Company shall possess and may exercise all of the powers and privileges granted by the Act or by any other law or by this Agreement, together with any powers incidental thereto, so far as such powers and privileges are necessary or convenient to the conduct, promotion or attainment of the business purposes or activities of the Company contemplated by this Agreement.

  • Purposes and Powers of the Trust The purpose of the trust, as created hereunder, is to engage in the following activities: (a) to sell the Certificates to the Company in exchange for the Mortgage Loans; (b) to enter into and perform its obligations under this Agreement; (c) to engage in those activities that are necessary, suitable or convenient to accomplish the foregoing or are incidental thereto or connected therewith; and (d) subject to compliance with this Agreement, to engage in such other activities as may be required in connection with conservation of the Trust Fund and the making of distributions to the Certificateholders. The trust is hereby authorized to engage in the foregoing activities. Notwithstanding the provisions of Section 11.01, the trust shall not engage in any activity other than in connection with the foregoing or other than as required or authorized by the terms of this Agreement while any Certificate is outstanding, and this Section 2.08 may not be amended, without the consent of the Certificateholders evidencing a majority of the aggregate Voting Rights of the Certificates.

  • Organization and Powers Each Loan Party is a corporation duly organized, validly existing and in good standing under the laws of its jurisdiction of incorporation as specified in Schedule 5.1 annexed hereto. Each Loan Party has all requisite corporate power and authority to own and operate its properties, to carry on its business as now conducted and as proposed to be conducted, to enter into the Loan Documents and Related Agreements to which it is a party and to carry out the transactions contemplated thereby.

  • Appointment and Powers Subject to the terms and conditions hereof, each of the Secured Parties hereby appoints Norwest Bank Minnesota, National Association as the Collateral Agent with respect to the Series 1993-A Collateral and the related Collateral subsequently specified in a Series Supplement, and Norwest Bank Minnesota, National Association hereby accepts such appointment and agrees to act as Collateral Agent with respect to the Series 1993-A Collateral, and upon execution of any Series Supplement, shall be deemed to accept such appointment, and agree to act as Collateral Agent with respect to such Collateral, in each case, for the Secured Parties, to maintain custody and possession of such Collateral (except as otherwise provided hereunder) and to perform the other duties of the Collateral Agent in accordance with the provisions of this Agreement. Each Secured Party hereby authorizes the Collateral Agent to take such action on its behalf, and to exercise such rights, remedies, powers and privileges hereunder, as the Controlling Party may direct and as are specifically authorized to be exercised by the Collateral Agent by the terms hereof, together with such actions, rights, remedies, powers and privileges as are reasonably incidental thereto. The Collateral Agent shall act upon and in compliance with the written instructions of the Controlling Party delivered pursuant to this Agreement promptly following receipt of such written instructions; provided that the Collateral Agent shall not act in accordance with any instructions (i) which are not authorized by, or in violation of the provisions of, this Agreement, (ii) which are in violation of any applicable law, rule or regulation or (iii) for which the Collateral Agent has not received reasonable indemnity. Receipt of such instructions shall not be a condition to the exercise by the Collateral Agent of its express duties hereunder, except where this Agreement provides that the Collateral Agent is permitted to act only following and in accordance with such instructions.

  • Powers of the Advisor Subject to the express limitations set forth in this Agreement and the continuing and exclusive authority of the Board over the management of the Company, the power to direct the management, operation and policies of the Company, including making, financing and disposing of investments, shall be vested in the Advisor, which shall have the power by itself and shall be authorized and empowered on behalf and in the name of the Company to carry out any and all of the objectives and purposes of the Company and to perform all acts and enter into and perform all contracts and other undertakings that it may in its sole discretion deem necessary, advisable or incidental thereto to perform its obligations under this Agreement.

  • Organization and Power The Purchaser is duly organized, validly existing, and in good standing under the laws of the jurisdiction of its formation and has all requisite power and authority to carry on its business as presently conducted and as proposed to be conducted.

  • Authorization and Power Such Subscriber has the requisite power and authority to enter into and perform this Agreement and the other Transaction Documents (as defined herein) and to purchase the Note and Warrants being sold to it hereunder. The execution, delivery and performance of this Agreement and the other Transaction Documents by such Subscriber and the consummation by it of the transactions contemplated hereby and thereby have been duly authorized by all necessary corporate action, and no further consent or authorization of Subscriber or its board of directors or stockholders, if applicable, is required. This Agreement and the other Transaction Documents have been duly authorized, executed and delivered by such Subscriber and constitutes, or shall constitute, when executed and delivered, a valid and binding obligation of such Subscriber, enforceable against Subscriber in accordance with the terms thereof.

  • Rights Obligations and Powers of the General Partner 6.1 Management of the Partnership. (a) Except as otherwise expressly provided in this Agreement, the General Partner shall have full, complete and exclusive discretion to manage and control the business of the Partnership for the purposes herein stated, and shall make all decisions affecting the business and assets of the Partnership. Subject to the restrictions specifically contained in this Agreement, the powers of the General Partner shall include, without limitation, the authority to take the following actions on behalf of the Partnership: (i) to acquire, purchase, own, operate, lease and dispose of any Investments that the General Partner determines are necessary or appropriate or in the best interests of the business of the Partnership; (ii) to authorize, issue, sell, redeem or otherwise purchase any Partnership Units or any securities (including secured and unsecured debt obligations of the Partnership, debt obligations of the Partnership convertible into any class or series of Partnership Units, or options, rights, warrants or appreciation rights relating to any Partnership Units) of the Partnership; (iii) to borrow or lend money for the Partnership, issue or receive evidences of indebtedness in connection therewith, refinance, increase the amount of, modify, amend or change the terms of, or extend the time for the payment of, any such indebtedness, and secure such indebtedness by mortgage, deed of trust, pledge or other lien on the Partnership’s assets; (iv) to pay, either directly or by reimbursement, for all operating costs and general administrative expenses of the Partnership to third parties or to the General Partner or its Affiliates as set forth in this Agreement; (v) to guarantee or become a co-maker of indebtedness of the General Partner or any Subsidiary thereof, refinance, increase the amount of, modify, amend or change the terms of, or extend the time for the payment of, any such guarantee or indebtedness, and secure such guarantee or indebtedness by mortgage, deed of trust, pledge or other lien on the Partnership’s assets; (vi) to use assets of the Partnership (including, without limitation, cash on hand) for any purpose consistent with this Agreement, including, without limitation, payment, either directly or by reimbursement, of all operating costs and general administrative expenses of the General Partner, the Partnership or any Subsidiary of either, to third parties or to the General Partner as set forth in this Agreement; (vii) to lease all or any portion of any of the Partnership’s assets, whether or not the terms of such leases extend beyond the termination date of the Partnership and whether or not any portion of the Partnership’s assets so leased are to be occupied by the lessee, or, in turn, subleased in whole or in part to others, for such consideration and on such terms as the General Partner may determine; (viii) to prosecute, defend, arbitrate, or compromise any and all claims or liabilities in favor of or against the Partnership, on such terms and in such manner as the General Partner may reasonably determine, and similarly to prosecute, settle or defend litigation with respect to the Partners, the Partnership, or the Partnership’s assets; (ix) to file applications, communicate, and otherwise deal with any and all governmental agencies having jurisdiction over, or in any way affecting, the Partnership’s assets or any other aspect of the Partnership business; (x) to make or revoke any election permitted or required of the Partnership by any taxing authority; (xi) to maintain such insurance coverage for public liability, fire and casualty, and any and all other insurance for the protection of the Partnership, for the conservation of Partnership assets, or for any other purpose convenient or beneficial to the Partnership, in such amounts and such types, as it shall determine from time to time; (xii) to determine whether or not to apply any insurance proceeds for any Property to the restoration of such Property or to distribute the same; (xiii) to establish one or more divisions of the Partnership, to hire and dismiss employees of the Partnership or any division of the Partnership, and to retain legal counsel, accountants, consultants, real estate brokers, and such other persons, as the General Partner may deem necessary or appropriate in connection with the Partnership business and to pay therefor such remuneration as the General Partner may deem reasonable and proper; (xiv) to retain other services of any kind or nature in connection with the Partnership business, and to pay therefor such remuneration as the General Partner may deem reasonable and proper; (xv) to negotiate and conclude agreements on behalf of the Partnership with respect to any of the rights, powers and authority conferred upon the General Partner; (xvi) to maintain accurate accounting records and to file promptly all federal, state and local income tax returns on behalf of the Partnership; (xvii) to distribute Partnership cash or other Partnership assets in accordance with this Agreement; (xviii) to form or acquire an interest in, and contribute Property to, any further limited or general partnerships, joint ventures or other relationships that it deems desirable (including, without limitation, the acquisition of interests in, and the contributions of Property to, its Subsidiaries and any other Person in which it has an equity interest from time to time); (xix) to establish Partnership reserves for working capital, capital expenditures, contingent liabilities, or any other valid Partnership purpose; (xx) to merge, consolidate or combine the Partnership with or into another Person; (xxi) to do any and all acts and things necessary or prudent to ensure that the Partnership will not be classified as a “publicly traded partnership” that is taxable as a corporation under Section 7704 of the Code; and (xxii) to take such other action, execute, acknowledge, swear to or deliver such other documents and instruments, and perform any and all other acts that the General Partner deems necessary or appropriate for the formation, continuation and conduct of the business and affairs of the Partnership (including, without limitation, all actions consistent with allowing the General Partner at all times to qualify as a REIT unless the General Partner voluntarily terminates its REIT status) and to possess and enjoy all of the rights and powers of a general partner as provided by the Act. (b) Except as otherwise provided herein, to the extent the duties of the General Partner require expenditures of funds to be paid to third parties, the General Partner shall not have any obligations hereunder except to the extent that Partnership funds are reasonably available to it for the performance of such duties, and nothing herein contained shall be deemed to authorize or require the General Partner, in its capacity as such, to expend its individual funds for payment to third parties or to undertake any individual liability or obligation on behalf of the Partnership.

  • Powers of the Company The Company shall have the power and authority to take any and all actions necessary, appropriate or advisable to or for the furtherance of the purposes set forth in Section 2.05.

  • Corporate Organization and Power Each of the Borrower and its Subsidiaries (i) is a corporation duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation, (ii) has the full corporate power and authority to execute, deliver and perform the Credit Documents to which it is or will be a party, to own and hold its property and to engage in its business as presently conducted, and (iii) is duly qualified to do business as a foreign corporation and is in good standing in each jurisdiction where the nature of its business or the ownership of its properties requires it to be so qualified, except where the failure to be so qualified would not, individually or in the aggregate, be reasonably likely to have a Material Adverse Effect.

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