Takeda Responsibilities Sample Clauses

Takeda Responsibilities. Subject to Applicable Law and this Section 6.2 (Regulatory Cooperation), Takeda will, at is sole expense, oversee, monitor, and manage all regulatory interactions, communications, and filings with, and submissions to, the PMDA with respect to the TAK-385 Licensed Compound and TAK-385 Licensed Products in the Field in the Takeda Territory; provided that Takeda will provide Licensee with a copy of all proposed material Regulatory Materials filed with or submitted to any Regulatory Authority for Licensee’s review and comment sufficiently in advance of Takeda’s filing or submission thereof, and Takeda will reasonably consider incorporating any reasonable comments received from Licensee into such Regulatory Materials. Subject to Section 6.5 (Labeling Information Exchange), Takeda will have final decision making authority regarding all regulatory activities, including the Labeling strategy and the content of submissions within the Takeda Territory, subject to the terms and conditions of this Agreement. For the avoidance of doubt, to the extent any such Regulatory Materials are not prepared in English by Takeda in the normal course of business, Takeda shall not be required to translate any such Regulatory Materials into English for the purposes of this Section 6.2.2 (Takeda Responsibilities).
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Takeda Responsibilities. During the Research Program Term, TAKEDA shall: (a) provide ARCHEMIX with such TAKEDA Background Technology, and conduct such TAKEDA Research Activities, if any, as may be necessary or useful to further the objectives of the Research Program or as otherwise may be set forth in any Annual Research Plan; (b) pay ARCHEMIX each Quarterly FTE Payment in accordance with Section 5.2.1 and the R&D Funding to the extent the R&D Funding exceeds the Quarterly FTE Payments; (c) give ARCHEMIX not less than [***] days’ written notice in the event that TAKEDA requires a number of FTEs above [***] FTEs in any Fiscal Year; (d) commit such resources as are reasonably necessary to conduct the TAKEDA Research Activities, if any, set forth in any Annual Research Plan; and (e) use Commercially Reasonable Efforts to conduct the TAKEDA Research Activities, if any, set forth in any Annual Research Plan.
Takeda Responsibilities. Takeda shall use reasonable efforts to promptly screen Compounds provided by Array against the [***]. In addition, Takeda shall provide Array with such support and assistance as Array may reasonably request, including without limitation, providing Array with SAR Information and other Takeda Technology.
Takeda Responsibilities. (i) Takeda shall undertake the responsibilities allocated to Takeda in the Joint Development Plan and the Joint Commercialization Plan under the direction and oversight of the SPC, with the understanding that Takeda shall be the lead Party and have primary responsibility for such activities; (ii) Takeda shall prepare and submit regulatory applications to Regulatory Authorities in order to obtain the Regulatory Approvals with respect to the Shared Product and shall own and maintain all Regulatory Approvals and communicate with Regulatory Authorities with respect to Shared Product and share with Alnylam material written communication it receives from Regulatory Authorities; (iii) Takeda shall Co-Promote the Shared Product in the U.S. in accordance with the Joint Commercialization Plan and under the direction and oversight of the SPC. Takeda shall employ an appropriate management infrastructure to supervise the sales representatives required to oversee Takeda’s obligations to perform its Detail Requirements and marketing staff of sufficient size and adequate experience to establish, maintain and implement the Joint Commercialization Plan for the Shared Product(s); (iv) Takeda shall have the sole right and responsibility to record and collect payment for sales of Shared Products throughout the U.S. Takeda shall be responsible for distribution, invoicing and collection with respect to sales of Shared Products in the U.S. and shall book such sales (it being understood that Takeda shall be solely and exclusively responsible for its own revenue recognition with respect to Shared Products, and Alnylam shall have no responsibility therefor); (v) Takeda shall use Commercially Reasonable Efforts to build and maintain an appropriate pharmacovigilence infrastructure, including to maintain a global safety database with respect to the Shared Product, in connection with which the Parties shall enter into a pharmacovigilence agreement; (vi) Takeda shall have the sole right to Manufacture the Shared Product or contract a Third Party to Manufacture the Shared Product, in either case, in a commercially reasonable manner, including, managing raw material supply for Manufacturing the Shared Product, warehousing and distributing the Shared Product; and (vii) Takeda shall have the sole right to select, register, maintain, enforce and defend the Product Trademark for the Shared Product and own such Product Trademark.
Takeda Responsibilities. Subject to Applicable Law, Section 9.4 and this Section 4.8(c), Takeda will, at its sole expense, oversee, monitor, and manage all regulatory interactions, communications, and filings with, and submissions to, Regulatory Authorities with respect to the Takeda Products and the Compound for use in the Manufacture of Takeda Products in the Takeda Field in the Territory; provided that Takeda will provide Day One with a copy of all proposed material Regulatory Submissions filed with or submitted to any Regulatory Authority for Day One’s review and comment sufficiently in advance of Takeda’s filing or submission thereof, and Takeda will reasonably consider in good faith incorporating comments received from Day One into such Regulatory Submissions. Subject to Section 4.11 and Section 9.4, Takeda will have final decision making authority regarding all regulatory activities, including the Labeling strategy and the content of submissions with respect to the Takeda Products and the Compound for the use in the Manufacture of Takeda Products in the Takeda Field, subject to the terms and conditions of this Agreement. Notwithstanding any provision to the contrary set forth in this Agreement, Takeda shall have sole control over and decision making authority with respect to the IO Combo Study and any Regulatory Submissions relating thereto, provided that Takeda will provide to Day One a copy of the final clinical study report for the IO Combo Study, which report Takeda may redact to the extent not related to TAK-580.

Related to Takeda Responsibilities

  • 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.

  • IRO Responsibilities The IRO shall: 1. perform each Claims Review in accordance with the specific requirements of the CIA;

  • 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.

  • Our Responsibilities This notice describes how medical information about you may be used and disclosed and how you can get access to this information. This notice took effect on September 23, 2013. We are required to maintain the privacy of your protected health information and we will follow the terms of this notice while it is in effect. • Your past, present, or future physical or mental health or condition • Providing you health care • The past, present, or future payment for providing you health care We collect your information as necessary to provide you with health insurance products and services and to administer our business. We may also disclose this information to nonaffiliated third parties as described in this notice. The types of information we may collect and disclose include: • Information you or your employer provide on applications and other forms, such as names, addresses, social security numbers, and dates of birth • Information about your interactions with us or others (such as providers) regarding your medical information or claims • Information you provide in person, by phone, in email, or through visits to our website • You can ask to see or get a copy of your health and claims records and other health information we have about you. • We will provide a copy or a summary of your health and claims records, usually within 30 days of your request. We may charge a reasonable, cost-based fee. • We may ask that you submit your request in writing. Please note, if you want to obtain copies of your medical records, you should contact the practitioner or facility. We do not generate, modify, or maintain complete medical records. • You may also request that we send a copy of your information to a third party. We may ask that you submit a written, signed authorization form permitting us to do so and we may charge a reasonable fee for copying and mailing your personal information. • You can ask us to correct your health and claims records if you think they are incorrect or incomplete. • We may say no to your request, but we’ll tell you why in writing within 60 days. • You can ask us to contact you in a specific way (for example, home or office phone) or to send mail to a different address. • We will consider all reasonable requests, and must say “yes” if you tell us you would be in danger if we do not. • All requests should be made in writing. • It may take a short period of time for us to implement your request. • We will comply with your request if it is reasonable and continues to permit us to collect premiums and pay claims under your policy, including issuing certain explanations of benefits and policy information to the BlueShield of Northeastern New York is a division of HealthNow New York Inc., an independent licensee of the BlueCross BlueShield Association. 15049R_NENY_12_19 f11011 subscriber of the policy. For example, even if you request confidential communications: ο We will mail the check for services you receive from a nonparticipating provider to you but made payable to the subscriber ο Accumulated payment information such as deductibles (in which your information might appear), will continue to appear on explanations of benefits sent to the subscriber ο We may disclose to the subscriber, as the contract holder, policy details such as eligibility status or certificates of coverage • You can ask us not to use or share certain health information for treatment, payment, or our operations. • We are not required to agree to your request, but if we do, we will abide by our agreement (except when necessary for treatment in an emergency). • You have the right to authorize individuals to act on your behalf with respect to your information. You must identify your authorized representatives on a HIPAA-compliant authorization form (available on our website) and explain what type of information they may receive. • You have the right to revoke an authorization except for actions already taken based on your authorization. • You can complain if you feel we have violated your rights by contacting us using the information listed on page 4. • You can file a complaint with the U.S. Department of Health and Human Services Office for Civil Rights. • We will not retaliate against you for filing a complaint. • With your family, close friends, or others involved with your health care or payment for your care when you are present and have given us permission to do so. If you are not present, if it is an emergency, or you are not able to give us permission, we may give your information to a family member, friend, or other person if sharing your information is in your best interest. In these cases, the person requesting your information must accurately verify details about you (e.g., name, identification number, date of birth, etc.) and prove involvement with your health care or payment for your health care by providing details relevant to the information requested. For example, if a family member calls us with prior knowledge of a claim (e.g., provider’s name, date of service, etc.), we may confirm the claim’s status, patient responsibility, etc. We will only disclose information directly relevant to that person’s involvement with your health care or payment for your health care. • In a disaster relief situation. In these cases we never share your information unless you give us written permission: • Marketing purposes • Sale of your information • Disclose your psychotherapy notes • Make certain disclosures of information considered sensitive in nature, such as HIV/AIDS, mental health, alcohol or drug dependency, and sexually transmitted diseases. Certain federal and state laws require that we limit how we disclose this information. In general, unless we obtain your written authorization, we will only disclose such information as provided for in applicable laws. We typically use or share your health information in the following ways: • We can use your health information and share it with professionals who are treating you.

  • COUNTY’S RESPONSIBILITIES A. A County program liaison will monitor the submission of all correspondence required in this Agreement, including, but not limited to: 1. Quarterly Treatment Reports; 2. Financial reports such as annual budgets, cost allocation plans, and cost reports; 3. Incident reports; 4. Outcome data; 5. Monthly XXXXX Reports 6. Other requested reports B. A County program liaison may visit Contractor during the contract term. The visits shall be for the purpose of reviewing any aspect of Contractor’s program operations. The visit may include, but is not limited to: 1. Review all pertinent participant records. 2. Conduct appropriate interviews/discussions with participants served by Contractor. 3. Review and monitor all correspondence and reports submitted by Contractor related to Contractor’s services provided under this Agreement. 4. Meet with appropriate program management and operations staff. 5. Conduct site visit(s) to Contractor’s program(s) at least once during the term of the Agreement to review all aspects of program operations. Site visit(s) may include a review of Contractor’s programmatic and fiscal documentation related to required reports on services specified in the Exhibits. a. Provide a written site review report documenting areas of compliance and any necessary corrective action(s) required. 6. A County program liaison may attend an organized activity of a selected component or selected components of Contractor’s program(s) at least once during the contract term. C. AODS will conduct periodic mandatory treatment provider meetings with representatives of all contracted service providers and appropriate staff. D. Provide ongoing technical assistance as needed. E. AODS shall act as intermediary on behalf of each contracted alcohol and drug service provider in the submission of the California Outcomes Measurement System (CalOMS) data submissions to the State of California. I. GENERAL ADMINISTRATIVE REQUIREMENTS A. Attend each of the following meetings: 1. Contractor shall attend periodic mandatory meetings; and 2. Drug and Alcohol Information System for You (DAISY) User Group meeting. 3. Other meetings as required by the County B. Contractor shall acknowledge the San Mateo County Alcohol and Other Drug Services (AODS) and/or the County of San Mateo as a funding source on newly developed promotional materials. C. Subcontracting requirements: 1. Pursuant to paragraph 12 of the body of this Agreement, Contractor may subcontract for provision of services described in this Agreement with written approval of the Director of the Human Services Agency or her designee. If Contractor subcontracts for any services under this Agreement, Contractor will guarantee that any and all subcontractors have and maintain the same level of insurance coverage required of the Contractor under this Agreement. Contractor and County will be listed as additional insured on all applicable insurance of subcontractor.

  • User Responsibilities i. Users are required to follow good security practices in the selection and use of passwords; ii. Users shall ensure that unattended equipment is protected; and iii. Users shall adopt a clear desk policy for papers and removable storage media and a clear screen policy for information processing facilities.

  • Client’s Responsibilities (a) Client agrees to advise Consultant regarding Client's Project requirements and to provide all relevant information, surveys, data and previous reports accessible to Client which Consultant may reasonably require. (b) Client shall designate a Project Representative to whom all communications from Consultant shall be directed and who shall have limited administrative authority on behalf of Client to receive and transmit information and make decisions with respect to the Project. Said representative shall not, however, have authority to bind Client as to matters of governmental policy or fiscal policy, nor to contract for additions or obligations exceeding a value which is the lesser of $5000 or 5% of the maximum contract price. (c) Client shall examine all documents presented by Consultant, and render decisions pertaining thereto within a reasonable time. The Client's approval of any drawings, specifications, reports, documents or other materials or product furnished hereunder shall not in any way relieve Consultant of responsibility for the professional adequacy of its work. (d) Client shall perform its obligations and render decisions within a reasonable time under the circumstances presented. Based upon the nature of Client and its requirements, a period of 14 days shall be presumed reasonable for any decision not involving policy decision or significant financial impact, when all information reasonably necessary for Client to responsibly render a decision has been furnished. A period of 46 days shall be presumed reasonable for Client to act with respect to any matter involving policy or significant financial impact. The above periods of presumed reasonableness shall be extended where information reasonably required is not within the custody or control of Client but must be procured from others.

  • 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.

  • CITY’S RESPONSIBILITIES 2.1. The CITY shall designate in writing a project coordinator to act as the CITY's representative with respect to the services to be rendered under this Agreement (the "Project Coordinator"). The Project Coordinator shall have authority to transmit instructions, receive information, interpret and define the CITY's policies and decisions with respect to the CONTRACTOR's services for the Project. However, the Project Coordinator is not authorized to issue any verbal or written orders or instructions to the CONTRACTOR that would have the effect, or be interpreted to have the effect, of modifying or changing in any way whatever: (a) The scope of services to be provided and performed by the CONTRACTOR; (b) The time the CONTRACTOR is obligated to commence and complete all such services; or (c) The amount of compensation the CITY is obligated or committed to pay the CONTRACTOR. Any such modifications or changes ((a) (b) or (c)) shall only be made by or upon the authorization of the CITY’s city manager as authorized by city council in the enabling legislation or in the CITY’s procurement policies. 2.2. The Project Coordinator shall: (a) Review and make appropriate recommendations on all requests submitted by the CONTRACTOR for payment for services and work provided and performed in accordance with this Agreement; (b) Arrange for access to and make all provisions for the CONTRACTOR to enter the Project site to perform the services to be provided by the CONTRACTOR under this Agreement; and (c) Provide notice to the CONTRACTOR of any deficiencies or defects discovered by the CITY with respect to the services to be rendered by the CONTRACTOR hereunder. 2.3. The CONTRACTOR acknowledges that access to the Project Site, to be arranged by the CITY for the CONTRACTOR, may be provided during times that are not the normal business hours of the CONTRACTOR.

  • Your Responsibilities 7.1 You are responsible for installing and configuring, and using the Service, Software, and Hardware, including account set up and configuration settings (unless NCR Voyix provides remote support for any of the foregoing as part of your subscription to the Service), compliance with applicable laws and regulations, and establishing any payment processing or other services certified by NCR Voyix for use with the Service (including through NCR Voyix’s wholly owned affiliates). You are solely responsible for reviewing any default or automated settings and configuring applicable settings to meet all legal, regulatory and other requirements applicable to your business. NCR shall have no liability in connection with such settings or configurations. You acknowledge that NCR Voyix does not provide legal, tax or accounting advice. You will provide NCR Voyix access to your network, system, data, and relevant information as reasonably required to perform the Service. You acknowledge that NCR Voyix personnel may require, and you will provide, the ability to access and correct transaction or input data while the Service is being provided to you. NCR Voyix is not responsible for any damage caused by errors or omissions in any information, instructions, data, or scripts you or a third party provides on your behalf in connection with the Service, or any actions NCR Voyix takes at your direction. 7.2 To use the Service, you must maintain internet access at your own expense. NCR VOYIX IS NOT RESPONSIBLE FOR AND DOES NOT WARRANT THE PERFORMANCE OF ANY INTERNET SERVICE OR OTHER PROVIDER OR ITS SERVICES, AND YOU AGREE THAT NCR VOYIX HAS NO LIABILITY TO YOU FOR SUCH PERFORMANCE OR SERVICES. 7.3 Title to hardware, software, systems, documentation, and other intellectual property NCR Voyix uses to provide the Service will remain with NCR Voyix or its licensors, unless otherwise agreed in writing. You will take reasonable actions to protect NCR Voyix’s intellectual property rights. 7.4 You are responsible for complying with all rules, bylaws, programs, and regulations of the payment card networks in connection with your use of the Service, Software and Hardware, as applicable. You will defend and indemnify NCR Voyix against any claim or loss resulting from your failure to fulfill your responsibilities under this Section. 7.5 Certain Services may perform analysis of transaction records designed to identify transaction patterns and activity that may be indicative of fraud. You acknowledge that the indicia reported by such Services may not necessarily be the result of fraudulent activity. You are responsible for performing its own evaluation of any results. NCR Voyix does not guarantee the detection of fraudulent transactions. 7.6 You are responsible for all data, information, materials and instructions (“Customer Instructions”) provided to NCR Voyix by you or on your behalf. NCR Voyix is entitled to rely upon Customer Instructions. In no event will NCR Voyix be liable with respect to any loss, liability, cost, damage, or expense arising out of a claim by you or any third party to the extent that claim arises as a result of NCR Voyix’s compliance with Customer Instructions.

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