Regulatory Activities a) As between the Parties, Xynomic shall have the sole responsibility and discretion for preparing, obtaining, and maintaining Drug Approval Applications (including the setting of the overall regulatory strategy therefor), other Regulatory Approvals and other submissions, and for conducting communications with the Regulatory Authorities, for Licensed Compounds or Licensed Products in the Territory (which shall include filings of or with respect to INDs and other filings or communications with the Regulatory Authorities). All Regulatory Approvals relating to the Licensed Compounds or Licensed Products with respect to the Territory shall be owned by, and shall be the sole property and held in the name of, Xynomic or its designated Affiliate. Pharmacyclics hereby assigns to Xynomic all of Pharmacyclics’ (or its Affiliates’) right, title, and interest in and to all Regulatory Documentation owned by Pharmacyclics (or its Affiliates) and held in Pharmacyclics’ name (or its Affiliates) as of the Effective Date or generated in the “winding up” activities after the Effective Date and shall deliver all Regulatory Documentation as well as embodiments of all Regulatory Documentation to Xynomic within sixty (60) days after the Effective Date. b) Xynomic shall notify the Pharmacyclics Alliance Manager promptly (but in no event later than forty-eight (48) hours) following its determination that any event, incident, or circumstance has occurred that may result in the need for a recall, market suspension, or market withdrawal of a Licensed Compound or Licensed Product in the Territory, and shall include in such notice the reasoning behind such determination, and any supporting facts. Xynomic (or its Sublicensee) shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension, or market withdrawal in the Territory; provided that prior to any implementation of such a recall, market suspension, or market withdrawal, Xynomic shall consult with Pharmacyclics and shall consider Pharmacyclics’ comments in good faith. If a recall, market suspension, or market withdrawal is mandated by a Regulatory Authority in the Territory, Xynomic (or its Sublicensee) shall initiate such a recall, market suspension, or market withdrawal in compliance with Applicable Law. For all recalls, market suspensions, or market withdrawals undertaken pursuant to this Section 2.2.1.b), Xynomic (or its Sublicensee) shall be solely responsible for the execution and all costs thereof.
Services to Other Clients; Certain Affiliated Activities (a) The relationship between the Asset Manager and the Series is as described in this Agreement and nothing in this Agreement, none of the services to be provided pursuant to this Agreement, nor any other matter, shall oblige the Asset Manager to accept responsibilities that are more extensive than those set forth in this Agreement. (b) The Asset Manager’s services to the Series are not exclusive. The Asset Manager may engage in other activities on behalf of itself, any other Managing Party and other clients (which, for the avoidance of doubt, may include other series of the Company). The Series acknowledges and agrees that the Asset Manager may, without prior notice to the Series, give advice to such other clients. The Asset Manager shall not be liable to account to the Series for any profits, commission or remuneration made or received in respect of transactions effected pursuant to the Asset Manager’s advice to another client and nor will the Asset Manager’s fees be abated as a result.
Requester and Approved User Responsibilities The Requester agrees through the submission of the DAR that the PI named has reviewed and understands the principles for responsible research use and data management of the genomic datasets as defined in the NIH Security Best Practices for Controlled-Access Data Subject to the GDS Policy. The Requester and Approved Users further acknowledge that they are responsible for ensuring that all uses of the data are consistent with national, tribal, and state laws and regulations, as appropriate, as well as relevant institutional policies and procedures for managing sensitive genomic and phenotypic data. The Requester certifies that the PI is in good standing (i.e., no known sanctions) with the institution, relevant funding agencies, and regulatory agencies and is eligible to conduct independent research (i.e., is not a postdoctoral fellow, student, or trainee). The Requester and any Approved Users may use the dataset(s) only in accordance with the parameters described on the study page and in the 1 If contractor services are to be utilized, PI requesting the data must provide a brief description of the services that the contractor will perform for the PI (e.g., data cleaning services) in the research use statement of the DAR. Additionally, the Key Personnel section of the DAR must include the name of the contractor’s employee(s) who will conduct the work. These requirements apply whether the contractor carries out the work at the PI’s facility or at the contractor’s facility. In addition, the PI is expected to include in any contract agreement requirements to ensure that any of the contractor’s employees who have access to the data adhere to the NIH GDS Policy, this Data Use Certification Agreement, and the NIH Security Best Practices for Controlled-Access Data Subject to the GDS Policy. Note that any scientific collaborators, including contractors, who are not at the Requester must submit their own DAR. Addendum to this Agreement for the appropriate research use, as well as any limitations on such use, of the dataset(s), as described in the DAR, and as required by law. Through the submission of this DAR, the Requester and Approved Users acknowledge receiving and reviewing a copy of the Addendum which includes Data Use Limitation(s) for each dataset requested. The Requester and Approved Users agree to comply with the terms listed in the Addendum. Through submission of the DAR, the PI and Requester agree to submit a Project Renewal or Project Close-out prior to the expiration date of the one (1) year data access period. The PI also agrees to submit an annual Progress Update prior to the one (1) year anniversary2 of the project, as described under Research Use Reporting (Term 10) below. By approving and submitting the attached DAR, the Institutional Signing Official provides assurance that relevant institutional policies and applicable local, state, tribal, and federal laws and regulations, as applicable, have been followed, including IRB approval, if required. Approved Users may be required to have IRB approval if they have access to personal identifying information for research participants in the original study at their institution, or through their collaborators. The Institutional Signing Official also assures, through the approval of the DAR, that other institutional departments with relevant authorities (e.g., those overseeing human subjects research, information technology, technology transfer) have reviewed the relevant sections of the NIH GDS Policy and the associated procedures and are in agreement with the principles defined. The Requester acknowledges that controlled-access datasets subject to the NIH GDS Policy may be updated to exclude or include additional information. Unless otherwise indicated, all statements herein are presumed to be true and applicable to the access and use of all versions of these datasets.
Conflict of Interest Contractor Personnel 2.5.1 The A-E shall exercise reasonable care and diligence to prevent any actions or conditions that could result in a conflict with the best interests of the COUNTY. This obligation shall apply to the A-E; the A-E’s employees, agents, and relatives; sub-tier contractors; and third parties associated with accomplishing work and PROJECTS/SERVICES hereunder. 2.5.2 A-E’s efforts shall include, but not be limited to establishing precautions to prevent its employees or agents from: making, receiving, providing or offering gifts, entertainment, payments, loans or other considerations which could be deemed to appear to influence individuals to act contrary to the best interests of the COUNTY.
Connecting Transmission Owner’s Scope of Work and Responsibilities The Connecting Transmission Owner will design, construct, own, operate and maintain all Connecting Transmission Owner’s Interconnection Facilities, except as otherwise stated above and in the Project Specific Specifications. The Connecting Transmission Owner will complete all engineering reviews, field verifications and witness testing, etc. in accordance with the ESBs and the Project Specific Specifications. Connecting Transmission Owner shall provide the revenue metering CT/PT units and meter socket enclosure. The Connecting Transmission Owner shall: • provide, run, and wire both ends of the color-coded cable for the revenue metering instrument transformer secondary wiring; • perform all terminations; and • supply and install the meter. The revenue meter may require a communications link to the RTU. The Connecting Transmission Owner will specify and run those communications cables. The Connecting Transmission Owner shall complete all wiring, testing and commissioning of the RTU.