Specific Responsibilities. The JDC shall meet at least semi-annually, or as otherwise agreed to by the Parties, and such meetings may be conducted by telephone, video-conference or in person as determined by the JDC members, provided that with respect to in person meetings, unless otherwise agreed the location of such meetings shall alternate between locations designated by Licensor and locations designated by AbbVie. The JDC shall develop the strategies for and oversee the Development of the Licensed Antibodies or Licensed Products in the Territory, and shall serve as a forum for the coordination of Development activities for the Licensed Antibodies or Licensed Products for the Territory. In particular, the JDC shall:
(a) periodically (no less often than annually) review and serve as a forum for discussing each Pre Exercise Development Plan and Budget, and review and approve amendments thereto, which approval will be reflected in the applicable minutes of the JDC meeting; *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
(b) serve as a forum for discussing and oversee the conduct of Pre Exercise Development Activities;
(c) periodically (no less often than annually) review and approve each Post Exercise Development Plan and Budget, and review and approve amendments thereto, which approval will be reflected in the applicable minutes of the JDC meeting;
(d) serve as a forum for discussing the conduct of the applicable Country-Specific Development Activities;
(e) serve as a forum for discussing and oversee the conduct of Additional Licensor Development Activities;
(f) serve as a forum for reviewing and approving strategies for obtaining Regulatory Approvals including approving use of consultants, key opinion leaders or any other experts to seek advice on strategies for seeking Regulatory Approvals for the Licensed Products in the Territory;
(g) establish secure access methods (such as secure databases) for each Party to access Regulatory Documentation and other JDC related Information as contemplated under this Agreement; and
(h) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.
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.
Specific Responsibilities. The Manager will, for each Fund:
1. Maintain office facilities for the Fund.
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 filed with the SEC (on Form N-1A or any successor form).
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 the Fund in accordance with the Prospectus, resolutions of the Trust’s Board of Trustees, and the valuation procedures of the Trust as in effect from time to time. The Manager may rely in good faith upon information prepared by or furnished to it or the Trust by any accounting or sub-accounting agent, and broker, dealer, or pricing or valuation service, or other usual or customary source of financial, accounting, or valuation information, and the Manager shall not be responsible for any loss occasioned by or resulting directly or indirectly from such reliance.
8. Keep and maintain the financial accounts and records of the Fund and provide the Trust with certain reports, as needed or reasonably 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 A: Fund Accounting Functions.
11. Implement the Funds’ policies and procedures with respect to market timing, late trading, anti-money laundering, customer identification, privacy, sales load breakpoints, and redemption fees, to the extent implementation of those policies and procedures have not been delegated to another service provider of the Funds.
12. Generally take steps to provide for shareholder servicing, recordkeeping services for direct and indirect investors in the Fund (“Shareholders Services”), and such other related services as the Manager may from time to time consider appropriate, and to pay such amounts to third parties (who may be affiliates of the Manager) in respect of ...
Specific Responsibilities. The JCC will, subject to the escalation, final decision-making authority and dispute resolution procedures in Section 9.9:
(a) review, discuss and approve the FTE Rate with respect to Co-Promote activities;
(b) ensure that each Co-Promotion Plan allocates to the Designated Sales Force a pro rata portion of centers of excellence and high prescribing physicians for the Opt-In Product(s);
(c) upon request of a Party, discuss the appropriate level of detail to include in a Co-Commercialization Budget;
(d) review, discuss and approve each proposed Co-Commercialization Plan; while endeavoring to approve each such Co-Commercialization Plan no later than [***] of each relevant Calendar Year;
(e) review, discuss and approve proposed updates or amendments to a Co-Commercialization Plan;
(f) review and discuss reports provided pursuant to Section 6.8 or a Co-Promotion Agreement;
(g) review, discuss and provide comments with respect to any promotional materials for the Co-Promotion of Opt-In Products;
(h) discuss notification from Kymera that Kymera wishes to decrease its then-allocated percentage of Detailing;
(i) oversee the Parties’ joint promotional efforts;
(j) specify which commercial functional area experts (other than managed care) of Sanofi the Designated Sales Force will have access to;
(k) review and discuss the engagement by Sanofi of a commercial advertising agency to be used in connection with Detailing of the Opt-In Products, including the identity of such agency and the material terms of such engagement;
(l) establish the value of secondary position details, consistent with Sanofi’s then-current standard operating procedures;
(m) establish benchmarks for the content and effectiveness of the principal promotional messages that are used by the Parties to promote the relevant Opt-In Product(s);
(n) develop a Corrective Plan in the event market research indicates that a Party’s delivery of the principal promotional messages for an Opt-In Product set forth in the applicable Co-Promotion Plan is not effective and not conveying the corresponding underlying promotional message;
(o) establish the PDE Cost;
(p) determine the anticipated commercial launch date of each Opt-In Product; and
(q) perform such other functions as are set forth in this Agreement, or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement. Any failure of the Parties to agree on matters within the purview of the JCC as set forth in this S...
Specific Responsibilities. In addition to its overall responsibility for monitoring and providing strategic oversight with respect to the Parties’ activities under this Agreement, the JSC will in particular have the following responsibilities:
2.2.3.1. review and discuss the Research by the Parties with respect to the T1 Antibody Candidates and Option Target Antibody Candidates, including whether a Technical Failure has occurred with respect to Option Target Antibody Candidates; CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
2.2.3.2. review and discuss the Development of Regional Antibody Candidates;
2.2.3.3. review and discuss the Commercialization of Regional Licensed Products and any other ongoing related activities;
2.2.3.4. review, discuss and oversee Manufacturing for the T1 Antibody Candidates and Option Antibody Candidates, including the supply chain for Antibody Candidates;
2.2.3.5. facilitate the flow of information between the Parties with respect to T1 Antibody Candidates, Regional Antibody Candidates, Global Antibody Candidates and Licensed Products;
2.2.3.6. review and discuss reports from the JRC, JDC and JCC, and provide guidance thereto and direct the activities of such Committees, and review and approve all Research Plans and each RLP Development Plan, and, in each case, all amendments thereto;
2.2.3.7. review and discuss the entry of any Collaboration In-Licenses with respect to the Research, Development, Manufacture or Commercialization of any Antibody Candidates or Licensed Products;
2.2.3.8. review, discuss and coordinate the Parties’ scientific presentation and publication strategy relating to the Regional Licensed Products in the Territory;
2.2.3.9. review and facilitate discussion of proposed publications and resolve disputes with respect thereto taking into consideration Section 11.2.1;
2.2.3.10. attempt to resolve issues presented to it by, and disputes within, the JRC, JDC or JCC, or any other subcommittee;
2.2.3.11. establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; and
2.2.3.12. perform such other functions as appropriate, and direct each other Committee to perform such other functions ...
Specific Responsibilities a. Provide information service for faculty, staff, students and community.
b. Select materials of the various types necessary for the collection: books, periodicals, manuscripts, newspapers, tapes, films, maps, charts, posters, etc.
c. Coordinate reference service with other resource center services.
d. Make appropriate utilization of the resources of other libraries, either through referral or interlibrary loan.
e. Facilitate access to materials by developing bibliographic aids designed for the needs of the patrons.
f. Assist the appropriate administrator in preparing the annual budget.
g. Provide instruction in use of the resource center and its materials and services informally on a one-to-one basis between the librarian and the patron at the time of a patron’s needs; by formal instruction in the classroom at the request of a faculty member; by formal instruction in the classroom in the library course designed to accomplish this purpose. When in this capacity, librarians shall perform the duties and responsibilities of faculty as set out in Section K, above.
h. Tenured librarians will assist, when appropriate, in recruiting and interviewing prospective faculty.
i. Submit requests for supplies and equipment.
j. Supervise library staff and student help assigned to reference or circulation.
k. Coordinate access to information and materials available through regional and national databases and stay abreast of developing library and information technologies.
l. Keep current with changes in the field, through reading and attending in-service and professional development activities. Each librarian shall have on file with the appropriate administrator an agreed upon professional improvement plan.
m. Teach classes as assigned. If these classes are in addition to regular workload, the class be paid as an overload.
Specific Responsibilities. To be responsible for the day-to-day operational delivery of Company's performance obligations. To plan, allocate and monitor work undertaken in relation to the Services. To attend review meetings as required by the Agreement. To be responsible for the provision of Reports as required by the Agreement. To ensure that appropriate operational and quality control procedures are in use. To manage and resolve Provider complaints relating to Company's operational activities.
Specific Responsibilities. A. The Fire Chief or his/her designee will:
a. Identify those members where a drug/alcohol screen is required and inform the Director of Public Safety of said status.
b. When necessary, initiate a preliminary investigation to determine the validity of a member's admission that he/she is presently taking prescribed drugs.
i. If the preliminary investigation reveals that the drugs have been legally prescribed and are being consumed according to prescription directions, no further investigation will ensue.
ii. In all other instances, a formal investigation will ensue when the test results disclose positive indicators and/or evidence of drug/alcohol usage by the member.
B. Command level personnel or the Fire Chief shall ensure that members have been properly notified of the date and time of a drug/alcohol screen and that the notification has been properly documented.
C. The member subject to a drug/alcohol screen will:
a. Report on a date and time determined by the Department.
b. Furnish documentation relating to the use of any prescribed drugs to the
Specific Responsibilities. Unless the Parties otherwise agree, the Alliance Managers will attend meetings of the JRC but may not be members of the JRC. The Alliance Managers will serve as the primary contact point between the Parties for the purpose of providing each Party with information regarding the other Parties’ activities pursuant to this Agreement and will have the following responsibilities:
(a) schedule meetings of the JRC and circulate draft written minutes as provided in Section 3.1.3(b);
(b) facilitate the flow of information and otherwise promote communication, coordination and collaboration between the Parties;
(c) provide a single point of communication for seeking consensus both internally within the respective Party’s organization and between the Parties regarding key strategy and planning issues; and
(d) perform such other functions as requested by the JRC.
Specific Responsibilities. In particular, the JDC shall:
(a) oversee and coordinate the on-going transfer, in accordance with the terms of this Agreement, from Infinity to AbbVie of Infinity Know-How, and from AbbVie to Infinity of AbbVie Know-How, related to the Development of Licensed Compounds and Products so that each Party may undertake Development of Licensed Compounds and Products in accordance with the GDP and this Agreement;
(b) coordinate the activities of the Parties under the GDP and oversee the implementation of the GDP;
(c) to the extent necessary, share planning and budgeting information with the JCC and the JMAC and coordinate with the JCC and JMAC in preparing comprehensive planning and budgeting proposals with respect to the Development, Commercialization, Manufacturing and Medical Affairs Activities of Products in the Field, as applicable;
(d) develop and update, on an annual basis, the proposed global regulatory strategy for the Products in the Field in the Territory, and include such proposed strategy in the GDP, for approval by the JSC in accordance with this Agreement;
(e) on an annual basis, update the GDP, including the Development Budget and the allocation of Development responsibilities between the Parties and present to the JSC for approval proposed amendments to the GDP, including the Development Budget, in accordance with Section 4.1.5;
(f) develop and update, on an annual basis, for inclusion in the GDP, the CMC Development plans and the Manufacturing Plans for the pre-clinical and clinical supply of the Licensed Compound and Products in the Territory;
(g) review and comment on Regulatory Filings relating to the Products in the Field in accordance with Section 4.4;
(h) review and comment on the initial Global Publication Strategy and amendments thereto prepared and presented by the JMAC from time to time in accordance with Section 9.4.1;
(i) oversee the Regulatory Working Group, the Pharmacovigilance Working Group, the Manufacturing Working Group, the IP Working Group, the Translational Medicine Working Group and any other Working Groups that reports to the JDC;
(j) monitor progress and performance of Development activities under this Agreement, including a review of actual financial results versus budget or plan; and
(k) perform such other functions as are assigned to it in this Agreement or as are appropriate to further the purposes of this Agreement as agreed in writing by the Parties.
