Sigma-Tau's Obligations Sample Clauses

Sigma-Tau's Obligations. (a) Subject to (1) the availability of Licensed Product and the alpha interferon product, (2) the parties' mutual agreement on the clinical protocol, (3) regulatory authorization, if needed, to commence the clinical trial described below, and (4) other necessary authorizations and procedures customary and normal to the conduct of a clinical trial in the Territory in accordance with ICH Guidelines, Sigma-Tau shall use its reasonable best efforts to perform at least one (1) pivotal phase 3 clinical trial in the Territory either (i) in accordance with ICH Guidelines or (ii) in accordance with regulatory requirements of a rapporteur country, which country shall be mutually agreeable to SPIL and Sigma-Tau, and in each case involving the Licensed Product in combination with alpha interferon for the treatment of Hepatitis C (the "Hepatitis C Trial") with the primary objective of obtaining for the Licensed Product either (a) EMEA marketing approval in the Territory or (b) rapporteur country marketing approval followed by marketing approval in each country in the Territory, at the most satisfactory governmentally reimbursable price and in the fastest manner possible. Subject to the foregoing conditions, unless otherwise agreed by the parties in writing, Sigma-Tau agrees to the following development obligations with respect to the Hepatitis C Trial: (i) to submit an application to the Principal Ethical Committee on or before June 30, 2000; (ii) to administer the first dose to the first patient in the Hepatitis C Trial on or before September 30, 2000; (iii) to administer the first dose to the last patient in the Hepatitis C Trial on or before July 1, 2001; and (iv) to administer the last dose to the last patient in the Hepatitis C Trial on or before July 1, 2002. The Hepatitis C Trial must be designed, implemented and monitored according to either ICH Guidelines or regulatory approval requirements of a mutually agreeable rapporteur country in the Territory. SPIL and Sigma-Tau shall agree in good faith on the contents and targets of the Hepatitis C Trial in the Territory. In furtherance of the Hepatitis C Trial, SPIL shall supply [****] to Sigma-Tau (i) the Licensed Product needed for the Hepatitis C Trial and (ii) the preclinical and clinical data on the Licensed Product in SPIL's possession which SPIL determines, based on ICH Guidelines, to be relevant to the Hepatitis C Trial. (b) Upon execution of this Agreement, Sigma-Tau agrees to use reasonable best efforts to ...
Sample 1
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Sigma-Tau's Obligations. (A) Subject to (1) the availability of Licensed Product, (2) the parties' mutual agreement on the design and objectives of the clinical program and the clinical protocol, (3) regulatory authorization, if needed, to commence the clinical trial described below, and (4) other necessary authorizations and procedures customary and normal to the conduct of a clinical trial in the Territory in accordance with ICH Guidelines, Sigma-Tau shall use its reasonable best efforts to perform at least one (1) comprehensive clinical program including a pivotal phase 3 clinical trial in the Territory designed, implemented and monitored according to ICH Guidelines involving the Licensed Product in the treatment of malignant melanoma with the primary objective of obtaining for the Licensed Product an EMEA marketing approval in the Territory [****]. Subject to the foregoing conditions, unless otherwise agreed by the parties in writing, Sigma-Tau agrees to the following development obligations with respect to the malignant melanoma clinical program: * Certain information on this page has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portions. (i) to enroll the first patient in the phase 2 malignant melanoma clinical trial [****]; (ii) to enroll the first patient in the phase 3 pivotal malignant melanoma clinical trial [****] of the enrolment of the first patient in the phase 2 malignant melanoma clinical trial provided that such phase 2 malignant melanoma clinical trial had shown positive results so that the parties agree in good faith to proceed with the phase 3 pivotal malignant melanoma clinical trial; (iii) in the event the parties do not agree to proceed with the phase 3 pivotal malignant melanoma clinical trial described under 5.1 (a) (ii) above, Sigma Tau commits to replace this clinical trial, in a manner and time frame mutually acceptable to the parties, with other clinical trial(s) to study the use of the Licensed Product in other indications. Sigma Tau's costs to conduct such other trials will be at the minimum comparable to the costs that Sigma Tau would have borne had the phase 3 pivotal malignant melanoma trial been conducted; (iv) to fund up to US$ 50,000 (US Dollars fifty thousand) of the development costs [****]. The US$ 50,000 will be paid as and when the costs are incurred and properly documented. The development program is intended to be conducted by SPIL in Italy and completed [**...
Sample 1

Related to Sigma-Tau's Obligations

  • Valid Obligations The execution, delivery and performance of the Loan Documents have been duly authorized by all necessary corporate action and each represents a legal, valid and binding obligation of Borrower and is fully enforceable according to its terms, except as limited by laws relating to the enforcement of creditors' rights.

  • TRANSNET’S OBLIGATIONS 8.1 Transnet undertakes to promptly comply with any reasonable request by the Supplier/Service Provider for information, including information concerning Transnet's operations and activities, that relates to the Goods/Services as may be necessary for the Supplier/Service Provider to provide the Goods/Services, but for no other purpose. However, Transnet's compliance with any request for information is subject to any internal security rules and requirements and subject to the observance by the Supplier/Service Provider of its confidentiality obligations under this Agreement. 8.2 The Supplier/Service Provider shall give Transnet reasonable notice of any information it requires. 8.3 Transnet agrees to provide the Supplier/Service Provider or its Personnel such access to and use of its facilities as is necessary to allow the Supplier/Service Provider to perform its obligations under this Agreement.

  • Specific Obligations The HSP: will provide to the Funder, or to such other entity as the Funder may direct, in the form and within the time specified by the Funder, the Reports, other than personal health information as defined in the Enabling Legislation, that the Funder requires for the purposes of exercising its powers and duties under this Agreement, the Accountability Agreement, the Enabling Legislation or for the purposes that are prescribed under any Applicable Law; will fulfil the specific reporting requirements set out in Schedule B; will ensure that every Report is complete, accurate, signed on behalf of the HSP by an authorized signing officer where required and provided in a timely manner and in a form satisfactory to the Funder; agrees that every Report submitted to the Funder by or on behalf of the HSP, will be deemed to have been authorized by the HSP for submission. For certainty, nothing in this section 8.1 or in this Agreement restricts or otherwise limits the Funder’s right to access or to require access to personal health information as defined in the Enabling Legislation, in accordance with Applicable Law for purposes of carrying out the Funder’s statutory objects to achieve the purposes of the Enabling Legislation.

  • Developer Obligations In accordance with applicable NYISO requirements, Developer shall maintain satisfactory operating communications with Connecting Transmission Owner and NYISO. Developer shall provide standard voice line, dedicated voice line and facsimile communications at its Large Generating Facility control room or central dispatch facility through use of either the public telephone system, or a voice communications system that does not rely on the public telephone system. Developer shall also provide the dedicated data circuit(s) necessary to provide Developer data to Connecting Transmission Owner and NYISO as set forth in Appendix D hereto. The data circuit(s) shall extend from the Large Generating Facility to the location(s) specified by Connecting Transmission Owner and NYISO. Any required maintenance of such communications equipment shall be performed by Developer. Operational communications shall be activated and maintained under, but not be limited to, the following events: system paralleling or separation, scheduled and unscheduled shutdowns, equipment clearances, and hourly and daily load data.

  • Seller Obligations Seller shall (A) arrange and pay independently for any and all necessary costs under any Generator Interconnection Agreement with the Participating Transmission Owner; (B) cause the Interconnection Customer’s Interconnection Facilities, including metering facilities, to be maintained; and (C) comply with the procedures set forth in the GIP and applicable agreements or procedures provided under the GIP in order to obtain the applicable Electric System Upgrades and (D) obtain Electric System Upgrades, as needed, in order to ensure the safe and reliable delivery of Energy from the Project up to and including quantities that can be produced utilizing all of the Contract Capacity of the Project.

  • Provider Obligations A. PROVIDER will perform the Services in accordance with the standards of care, skill, and diligence expected of a qualified, competent and experienced professional in the provision of the type of services required under this Agreement. B. PROVIDER will obtain, maintain in effect, and pay the cost for all licenses, permits, or certifications that may be necessary for PROVIDER’s performance of this Agreement. C. PROVIDER represents and warrants that there are no obligations, commitments, third party rights, or impediments of any kind that will limit or prevent PROVIDER’s performance of the Services.

  • Valid Obligation Notes issued on the registration of transfer or exchange of Notes will be the valid obligations of the Issuer, evidencing the same debt, and have the same benefits under this Indenture as the Notes surrendered for registration of transfer or exchange.

  • Buyer Obligations During the Delivery Term, Buyer shall arrange and be responsible for transmission service, including risk of transmission outage or curtailment, from the Delivery Point and bear all risks and costs associated with such transmission service, including, but not limited to, any transmission outages or curtailment. During the Delivery Term, Buyer shall Schedule or arrange for Scheduling Coordinator services with its Transmission Providers to receive the Product at the Delivery Point. During the Delivery Term, Buyer shall be responsible for all CAISO costs and charges, electric transmission losses and congestion from the Delivery Point.

  • Excluded Obligations Notwithstanding anything to the contrary expressed or implied in the Finance Documents, the Security Agent shall not: (a) be bound to enquire as to (i) whether or not any Default has occurred or (ii) the performance, default or any breach by a Transaction Obligor of its obligations under any of the Finance Documents; (b) be bound to account to any other Party for any sum or the profit element of any sum received by it for its own account; (c) be bound to disclose to any other person (including but not limited to any Secured Party) (i) any confidential information or (ii) any other information if disclosure would, or might in its reasonable opinion, constitute a breach of any law or be a breach of fiduciary duty; (d) have or be deemed to have any relationship of trust or agency with, any Obligor.

  • Exit Obligations Upon (a) voluntary or involuntary termination of the Executive’s employment or (b) the Company’s request at any time during the Executive’s employment, the Executive shall (i) provide or return to the Company any and all Company property, including keys, key cards, access cards, identification cards, security devices, employer credit cards, network access devices, computers, cell phones, smartphones, PDAs, pagers, fax machines, equipment, speakers, webcams, manuals, reports, files, books, compilations, work product, email messages, recordings, tapes, disks, thumb drives or other removable information storage devices, hard drives, negatives, and data and all Company documents and materials belonging to the Company and stored in any fashion, including but not limited to those that constitute or contain any Confidential Information or Work Product, that are in the possession or control of the Executive, whether they were provided to the Executive by the Company or any of its business associates or created by the Executive in connection with the Executive’s employment by the Company; and (ii) delete or destroy all copies of any such documents and materials not returned to the Company that remain in the Executive’s possession or control, including those stored on any non-Company devices, networks, storage locations, and media in the Executive’s possession or control.

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