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.
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.
Leave With Pay for Family-Related Responsibilities (a) For the purpose of this clause, “family” is defined as:
(i) spouse (including common law spouse resident with the employee);
(ii) children (including xxxxxx children, children of legal or common-law partner and xxxx of the employee);
(iii) parents (including step-parents or xxxxxx parents), father-in-law, mother-in-law;
(iv) brother, sister, step-brother, step-sister;
(v) grandparents and grandchildren of the employee;
(vi) any relative, residing in the employee’s household or with whom the employee permanently resides; or
(vii) any relative for whom the employee has a duty of care, irrespective of whether they reside with the employee.
(b) The total leave with pay which may be granted under this clause shall not exceed thirty-seven decimal five (37.5) hours in a fiscal year.
(c) At the request of an employee, leave with pay for family related responsibilities may be granted as follows:
(i) to take a dependent family member for medical or dental appointments, or for appointments with school authorities or adoption agencies; the employee who requests a leave pursuant to this clause should make every reasonable effort to schedule these appointments to minimize or preclude his or her absence from work;
(ii) for the temporary care of a sick member of the employee's family and to provide the employee with time to make alternate care arrangements where the illness is of a longer duration;
(iii) for needs directly related to the birth or adoption of his or her child;
(iv) to attend school functions, if the supervisor was notified of the functions as far in advance as possible;
(v) to provide for the employee’s child in the case of an unforeseeable closure of the school or daycare facility;
(vi) seven decimal five (7.5) hours out of the thirty-seven decimal five (37.5) hours stipulated in paragraph (b) above may be used to attend an appointment with a legal or paralegal representative for non-employment related matters, or with a financial or other professional representative, if the supervisor was notified of the appointment as far in advance as possible.
Allocation of Responsibilities The persons responsible for the Plan and the duties and responsibilities allocated to each are as follows:
Monitoring Responsibilities The Custodian shall furnish annually to the Fund, during the month of June, information concerning the foreign sub-custodians employed by the Custodian. Such information shall be similar in kind and scope to that furnished to the Fund in connection with the initial approval of this Contract. In addition, the Custodian will promptly inform the Fund in the event that the Custodian learns of a material adverse change in the financial condition of a foreign sub-custodian or any material loss of the assets of the Fund or in the case of any foreign sub-custodian not the subject of an exemptive order from the Securities and Exchange Commission is notified by such foreign sub-custodian that there appears to be a substantial likelihood that its shareholders' equity will decline below $200 million (U.S. dollars or the equivalent thereof) or that its shareholders' equity has declined below $200 million (in each case computed in accordance with generally accepted U.S. accounting principles).
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.
Resident Responsibilities The Resident agrees to pay all fees specified, to observe all rules and regulations of the University of Connecticut and to abide by the Responsibilities of Community Life: The Student Code, this contract and any addendum, as well as other University publications/policies. Residents assume total responsibility for their room/suite/apartment/house and for the behavior and activities which occur within all assigned living areas. Applicants and/or residents cannot exchange money or favors for a room assignment. Failure to fulfill the terms of the above may lead to termination of this contract, removal from on-campus housing, and a community standards process resulting in a sanction, including but not limited to expulsion.
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.
District Responsibilities With respect to all sums deducted by the District pursuant to authorization of the employee, whether for membership dues or equivalent fees, the District agrees promptly to remit such monies to the Association together with an alphabetical list of unit members for who such deductions have been made, categorizing them as to membership or non-membership in the Association, and indicating any changes in personnel from the list previously furnished.