Compassionate Use Programs Sample Clauses

Compassionate Use Programs costs associated with any program to provide patients with products free of charge. These costs include compassionate use programs, provided however that any compassionate use programs prior to Marketing Approval shall be mutually agreed upon by the Parties in advance.
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Compassionate Use Programs. ViroPharma shall not make Compounds or Products available under its compassionate use programs, or initiate any new compassionate use programs, in the Territory for any indications other than the ViroPharma Compassionate Use Indications, without Schering’s prior written approval. In addition, Schering shall have the right, exercisable at its sole discretion at any time during the term of the License Agreement, to instruct ViroPharma to discontinue its compassionate use programs and/or to assume control over all of ViroPharma’s compassionate use programs in the Territory under which patients are being provided access to the Compound and/or Products. Schering shall notify ViroPharma in writing in the event that Schering decides to exercise its right to terminate or take control of such compassionate use programs. Promptly following such notice, ViroPharma shall fully cooperate with Schering and otherwise undertake any actions reasonably requested by Schering to terminate or to transfer control over the compassionate use programs to Schering or its designated Affiliate. A-4 COMMERCIALIZATION
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Compassionate Use Programs. Following the transfer of the Compassionate Use Programs from the Sellers to the Buyer pursuant to Section 6.1(d), the Buyer shall take over and assume (a) all of the Sellers’ duties and responsibilities related to the ongoing conduct of the Compassionate Use Programs from and after such transfer in accordance with the protocols therefore and (b) the related Liabilities described in Section 2.3(c).
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Compassionate Use Programs. With respect to each Collaboration Product, the Parties shall, through the JRDC and the JSC, discuss and agree on [***].
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Related to Compassionate Use Programs

  • Regulatory Assistance Provider will permit regulators with jurisdiction over BFA or any BFA Recipient to examine Provider’s activities relating to its performance under this Agreement and the Services. Subject to Section 17.6, Provider will cooperate and provide all information reasonably requested by the regulator in connection with any such examination and provide reasonable assistance and access to all equipment, records, and systems requested by the regulator relating to the Services.

  • Anti-Money Laundering Program Services BNYM will perform one or more of the services described in subsections (1) through (7) of this Section 3(b) if requested by the Fund and the Fund agrees to pay the fees applicable to the service as set forth in the Fee Agreement (“AML Services”).

  • Collaboration Management Promptly after the Effective Date, each Party will appoint a person who will oversee day-to-day contact between the Parties for all matters related to the management of the Collaboration Activities in between meetings of the JSC and will have such other responsibilities as the Parties may agree in writing after the Effective Date. One person will be designated by Merck (the “Merck Program Director”) and one person will be designated by Moderna (the “Moderna Program Director,”) together will be the “Program Directors”. Each Party may replace its Program Director at any time by notice in writing to the other Party. Any Program Director may designate a substitute to temporarily perform the functions of that Program Director by written notice to the other Party. The initial Program Directors will be: For Moderna: [***] For Merck: [***]

  • Program Management (WBS 1.1) All components of the Project Management Plan as implemented for the Base Contract and Options 1-4 will be reviewed and amended to reflect specific needs for Option 5 and the outcome of continuous process improvement evaluations.

  • Use of Immobilization Programs Provided (i) the Bank has received a certified copy of a resolution of the Board specifically approving the maintenance of Portfolio Securities in an immobilization program operated by a bank which meets the requirements of Section 26(a)(1) of the 1940 Act, and (ii) for each year following such approval the Board has reviewed and approved the arrangement and has not delivered an Officer's Certificate to the Bank indicating that the Board has withdrawn its approval, the Bank shall enter into such immobilization program with such bank acting as a subcustodian hereunder.

  • REGULATORY ADMINISTRATION SERVICES BNY Mellon shall provide the following regulatory administration services for each Fund and Series:  Assist the Fund in responding to SEC examination requests by providing requested documents in the possession of BNY Mellon that are on the SEC examination request list and by making employees responsible for providing services available to regulatory authorities having jurisdiction over the performance of such services as may be required or reasonably requested by such regulatory authorities;  Assist with and/or coordinate such other filings, notices and regulatory matters and other due diligence requests or requests for proposal on such terms and conditions as BNY Mellon and the applicable Fund on behalf of itself and its Series may mutually agree upon in writing from time to time; and

  • Customer Service As between Fig and Developer, Developer shall be solely responsible for providing and maintaining customer service and technical support in the Territory to Distributors and end users with respect to the Licensed Game (including, for the avoidance of doubt, any Distributors and end-users of Fig pursuant to Fig Sales (as defined below)). Such customer service and technical support shall be of a quality that is comparable to such customer service and technical support as Developer provides for its other “top-tier” titles. For the purposes of this Section, “customer service” means the resolution of issues pertaining to the Licensed Game in the following general categories: payment processing, order inquiries, replacements and refunds, and technical support.

  • Maintenance Program LESSEE's Maintenance Program

  • Review Systems; Personnel It will maintain business process management and/or other systems necessary to ensure that it can perform each Test and, on execution of this Agreement, will load each Test into these systems. The Asset Representations Reviewer will ensure that these systems allow for each Review Receivable and the related Review Materials to be individually tracked and stored as contemplated by this Agreement. The Asset Representations Reviewer will maintain adequate staff that is properly trained to conduct Reviews as required by this Agreement.

  • USE OF THIRD PARTY SYSTEMS-LEVEL SOFTWARE State Street and the Fund acknowledge that in connection with the Data Access Services provided under this Addendum, the Fund will have access, through the Data Access Services, to Fund Data and to functions of State Street’s proprietary systems; provided, however that in no event will the Fund have direct access to any third party systems-level software that retrieves data for, stores data from, or otherwise supports the System.

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