Clinical Support Services Sample Clauses

Clinical Support Services. From time to time during the Licensed Period, Shionogi may desire for Xxxxx to undertake the performance of certain clinical support activities for the Licensed Products in the Field in the Shionogi Territory in addition to those set forth in the Support Services Plan, including, without limitation, support of IT systems, data analytics, consulting services and regulatory assistance. Xxxxx will not be under any obligation to perform such activities unless mutually agreed by the Parties. Shionogi will bear one hundred percent (100%) of the Development Costs incurred by or on behalf of the Parties in connection with any such mutually agreed Development activities, including any internal and Out-of-Pocket Costs, and will reimburse Xxxxx for any Development Costs incurred by or on behalf of Xxxxx Territory in accordance with the invoicing and payment procedures of Section 7.9.
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Clinical Support Services a) [***]. b) [***]. c) [***]. d) [***]. e) [***]. f) [***]. g) [***]. h) [***]. i) [***]. j) [***]. k) [***]. l) [***]. 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 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. m) [***].
Clinical Support Services. If NWBT requests any services from Cognate relating to the evaluation, preparation, training, initiation and/or support of clinical trial sites for clinical trials of DCVax® Products, NWBT and Cognate will enter into separate agreements for such services (collectively, the “Clinical Support Services”), and each such separate agreement will be attached as part of Exhibit A (Exhibit A-0, X-0, etc.), and incorporated herein by reference. Such Clinical Support Services may include, without limitation, traveling to clinical sites, training various on-site staff in regard to collection, processing, shipping and handling of tumors tissues that are to be used in the production of DCVax® Products by Cognate, as well as scheduling and reserving of manufacturing slots, scheduling and management of delivery of finished DCVax® Products to the hospital’s pharmacy and to the patients, and other clinical matters. Each such separate agreement will include the scope and nature of work, and the payment and cost reimbursement provisions.
Clinical Support Services. During the Term, WHC and WHI may, from time to time, request that Abiomed perform certain clinical support services for WHC or WHI (the “Clinical Support Services”); provided, however, that WHC and WHI are under no obligation to request any Clinical Support Services, or to request any minimum amount of Clinical Support Services during the Term. If Abiomed agrees to perform such Clinical Support Services, the parties shall mutually agree on a written statement of work in the form of Exhibit B hereto (“Clinical Statement of Work”), provided, however, the Parties may mutually agree on variations to such form as required, on a case-by-case basis. Examples of the types of Clinical Support Services that may be provided, upon mutual agreement, include the following: Clinical Support (Clinical Field Specialist level): (a) On-site start-up and ongoing training of a clinical center’s clinical staff responsible for the care and management of LVAS recipients or LVAS hardware. (b) On-site clinical support to clinical centers, including but not limited to direct support at implants. This would include from time-to-time, providing urgent clinical or technical on-site support. (c) Participation in a rotating schedule to provide 24-hour on-call clinical and technical support to clinical centers. (d) Documenting clinical experiences per WHC/WHI’s internal business and regulatory processes. Clinical Trial Support (CRA I level): (e) Conducting study site initiations and close-out visits in compliance with WHC/WHI Clinical Affairs operating procedures and policies. Ensuring collection of required essential documents for study start-up and throughout conduct of study. (f) Conducting study site monitoring visits to ensure that conduct of a Clinical Trial is in compliance with the then-currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirements. Conducting source data/document verification.

Related to Clinical Support Services

  • Technical Support Services 2.1 The technical support services (the "Services"): Party A agrees to provide to Party B the relevant services requested by Party B, which are specified in Exhibit 1 attached hereto ("Exhibit 1").

  • Technical Support State Street will provide technical support to assist the Fund in using the System and the Data Access Services. The total amount of technical support provided by State Street shall not exceed 10 resource days per year. State Street shall provide such additional technical support as is expressly set forth in the fee schedule in effect from time to time between the parties (the “Fee Schedule”). Technical support, including during installation and testing, is subject to the fees and other terms set forth in the Fee Schedule.

  • Support Services Rehabilitation, counselling and EAP’s. Support is strictly non- punitive, and can be accessed at anytime (self-identification of the need for help is strongly encouraged).

  • TAX SUPPORT SERVICES BNY Mellon shall provide the following tax support services for each Fund:  Provide various data and reports as agreed upon in the SLDs to support TRP’s tax reporting and tax filing obligations, including: · Wash sales reporting; · QDI reporting; · DRD reporting; · PFIC analysis; · Straddle analysis; · Paydown adjustments; · Equalization debit adjustments · Tax compliance under §851, §817(h); · Foreign bond sale analysis (§988); · Troubled debt analysis; · Estimation of income for excise tax purposes; · Swap analysis; · Inflation adjustments; · §1256 adjustments; · Market discount analysis; OID adjustments; · CPDI analysis; · Shareholder tax reporting information (e.g. FTC, UGG income, foreign source income by country, exempt income by state);  Provide data, and reports based on such data, maintained by BNY Mellon on its fund accounting platform as reasonably requested by TRP to support TRP’s obligations to comply with requests from tax authorities and TRP’s tax reporting and tax filing obligations.  Assist with other tax-related data needs as mutually agreed upon in writing from time-to-time.

  • Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].

  • Clinical Supply In connection with the Technology Transfer, Lexicon shall transfer to Sanofi any usable inventory of Licensed Compound or Licensed Product, subject to Lexicon’s retention of reasonable requirements of such Licensed Compound or Licensed Product for its T1DM Development activities no later than [**] (or such other date as is agreed by the Parties), and Lexicon’s Manufacturing Cost paid to Lexicon CMOs for such transferred quantities of inventory shall be treated as Development Costs and borne by the Parties in accordance with Section 7.6. Prior to the completion of the Technology Transfer in accordance with Section 6.2, Lexicon shall, to the extent requested by Sanofi and as mutually agreed by the Parties, supply clinical quantities of the Licensed Products and placebo for use by Sanofi in the Development of Licensed Products for T2DM in accordance with the Development Plan, and Lexicon’s Manufacturing Cost incurred in connection therewith shall be treated as Development Costs. After the Technology Transfer, Sanofi shall supply clinical quantities of the Licensed Products and placebo reasonably required by Lexicon for Lexicon’s use in the Development of Licensed Products for T1DM in accordance with the Development Plan and for its own use in the Development of Licensed Products. Lexicon shall Manufacture (or have Manufactured) all such Licensed Product in accordance with Applicable Law and the applicable specifications therefor, including, to the extent required by Applicable Law, cGMP; provided that Lexicon’s liability arising from a breach by the CMO of its agreement with Lexicon shall be limited to such recoveries as are obtained by Lexicon using Commercially Reasonable Efforts to obtain such recoveries and such other remedies as may be available to Lexicon for such breach under its agreement with such CMO. Otherwise, Sanofi’s sole and exclusive remedy and Lexicon’s sole and exclusive liability to Sanofi for any nonconformity shall be for Lexicon to replace such nonconforming Licensed Compound or Licensed Product with conforming Licensed Compound or Licensed Product within reasonable timelines to be mutually agreed by the Parties in writing, but nothing in this Section 6.1.1 shall limit Lexicon’s liability for Third Party Claims under ARTICLE 11. At either Party’s option, Lexicon and Sanofi shall enter into a clinical supply agreement and a reasonable and customary Quality Agreement that shall set forth the terms and conditions upon which Lexicon and any of its Affiliates will conduct their quality activities in connection with such supply, including (i) a right of Sanofi to audit Lexicon and the Lexicon CMOs, (ii) coordination regarding inspections by Regulatory Authorities and (iii) the exchange of information between the Parties regarding the foregoing and quality issues in general. Such agreements shall be negotiated and agreed by the Parties in good faith.

  • Compliance Support Services Provide compliance policies and procedures related to services provided by BNY Mellon and, if mutually agreed, certain of the BNY Mellon Affiliates; summary procedures thereof; and periodic certification letters. · Such Compliance Support Services are administrative in nature and do not constitute, nor shall they be construed as constituting, legal advice or the provision of legal services for or on behalf of a Fund or any other person, and such services are subject to review and approval by the applicable Fund and by the Fund’s legal counsel. · Provide access to Fund records so as to permit the Fund or TRP to test the performance of BNY Mellon in providing the services under this Agreement. · Such Compliance Support Services performed by BNY Mellon under this Agreement shall be at the request and direction of the Fund and/or its chief compliance officer (the “Fund’s CCO”), as applicable. BNY Mellon disclaims liability to the Fund, and the Fund is solely responsible, for the selection, qualifications and performance of the Fund’s CCO and the adequacy and effectiveness of the Fund’s compliance program.

  • Maintenance and Support Services If this Agreement is for IT goods or services, this section applies: Unless otherwise specified in this Agreement: The Contractor shall promptly provide the Court with all Upgrades, including without limitation: (i) all Upgrades generally made available by Contractor to its other customers; (ii) Upgrades as necessary so that the Work complies with the Specifications and Applicable Law (including changes in Applicable Law); (iii) Upgrades as necessary so that the Work operates under new versions or releases of the Court’s operating system or database platform; and (iv) all on-site services necessary for installation of Upgrades. Without limiting any other obligation of Contractor under this Agreement, Contractor represents and warrants that it will maintain services, equipment, software or any other part of the Work so that they operate in accordance with their Specifications and Documentation; and The Contractor shall respond to the Court within four (4) hours after the Court reports a Technical Support Incident (such hours all occurring during Standard M&S Hours) to Contractor. DELIVERY, ACCEPTANCE, AND PAYMENT Delivery. Contractor shall deliver to the Court the Deliverables in accordance with this Agreement, including the Statement of Work. Unless otherwise specified by this Agreement, Contractor will deliver all goods purchased by the Court “Free on Board Destination Freight Prepaid” to the Court at the address and location specified by the Court. Title to all goods purchased by the Court vests in the Court upon payment of the applicable purchase price. Contractor will bear the risk of loss for any Work being delivered until received by the Court at the proper location. All shipments by Contractor or its Subcontractors must include packing sheets identifying: this Agreement number, the Court’s purchase order number, item number, quantity and unit of measure, part number and description of the goods shipped, and appropriate evidence of inspection, if required. Goods for different Agreements shall be listed on separate packing sheets.

  • Research Support (a) Having regard to the resources reasonably available for such purposes, the Operator will cooperate with AHS to provide such participation by its Staff as may be reasonable in relation to the carrying out of research within the Province. (b) The Operator agrees to promptly notify AHS in the event that it undertakes or agrees to participate in any form of clinical trial, research project, instrument use, or similar activity which in any way relates to the Services provided under this Agreement. The Operator shall, upon request, provide AHS with written evidence of Client disclosure and consent to research.

  • Training Services Training Services may include pre-packaged training Products, and/or the development or customization of training programs as requested, including Live Training, Computer Based/Multi-Media Training which encompasses Internet-Delivered Training, and/or Video Based Training.

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