Ongoing Single Patient Expanded Access Sample Clauses

Ongoing Single Patient Expanded Access. As of the Effective Date, a single patient is being treated with the Compound in combination with Licensor’s proprietary compound known as avelumab at the [***] (“[***]”), under a single patient expanded access arrangement and a single patient IND, which IND is not controlled by Licensor but is understood to be cross-referencing Licensor’s IND #1311384. A redacted version of the underlying physician’s agreement has been made available to Company prior to the Effective Date. Licensor has informed Company that on or about the date hereof it has or it will supply to the [***]. As soon as practicable after the Effective Date, the Parties will work together in good faith and with the [***], as may be required, to enable provision of the Compound by Company, and of avelumab by Licensor, to the [***] for its treatment of the single patient for as long as such treatment is medically appropriate and in accordance with Applicable Law.
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Related to Ongoing Single Patient Expanded Access

  • Technology Access Fee In consideration of the licenses and rights granted to Regado herein, Regado shall, as of the date immediately preceding the closing (the “Closing”) of the first equity financing of Regado in which Regado is assigned a pre-money valuation of not less than [***] dollars ($[***]), issue to Archemix fully-paid and non-assessable shares of common stock of Regado equal to [***] percent ([***]%) of the total number of equity shares of Regado, on a fully diluted basis, immediately prior to the issuance of shares at the Closing. Regado shall deliver written notice of the Closing to Archemix at least [***] business days prior to such Closing in accordance with the notice provisions contained in Section 14.1 of this Agreement. Archemix and Regado shall enter into such agreements relating to the issuance of the common stock as are customary under such circumstances. For the purpose of this Agreement, “fully diluted basis” shall mean the aggregate of (a) the number of shares of common stock issued and outstanding on the determination date, (b) the number of shares of common stock issuable upon exercise, exchange or conversion of all exercisable, exchangeable or convertible securities outstanding on the determination date, assuming such securities were exercised, exchanged or converted on the determination date (without regard to whether such securities are actually exercisable, exchangeable or convertible on the determination date) and (c) the number of shares of common stock issuable pursuant to any other obligation or agreement of, or right granted by, Regado, whether vested or unvested, contingent or otherwise.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Service Level Agreement Subject to the terms and conditions of this Agreement, Bank agrees to perform the custody services provided for under this Agreement in a manner that meets or exceeds any service levels as may be agreed upon by the parties from time to time in a written document that is executed by both parties on or after the date of this Agreement, unless that written document specifically states that it is not contractually binding. For the avoidance of doubt, Bank’s Service Directory shall not be deemed to be such a written document.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • User Access Transfer Agent shall have a process to promptly disable access to Fund Data by any Transfer Agent personnel who no longer requires such access. Transfer Agent will also promptly remove access of Fund personnel upon receipt of notification from Fund.

  • License; Use Upon delivery to an Authorized Person or a person reasonably believed by Custodian to be an Authorized Person of the Fund of software enabling the Fund to obtain access to the System (the “Software”), Custodian grants to the Fund a personal, nontransferable and nonexclusive license to use the Software solely for the purpose of transmitting Written Instructions, receiving reports, making inquiries or otherwise communicating with Custodian in connection with the Account(s). The Fund shall use the Software solely for its own internal and proper business purposes and not in the operation of a service bureau. Except as set forth herein, no license or right of any kind is granted to the Fund with respect to the Software. The Fund acknowledges that Custodian and its suppliers retain and have title and exclusive proprietary rights to the Software, including any trade secrets or other ideas, concepts, know-how, methodologies, or information incorporated therein and the exclusive rights to any copyrights, trademarks and patents (including registrations and applications for registration of either), or other statutory or legal protections available in respect thereof. The Fund further acknowledges that all or a part of the Software may be copyrighted or trademarked (or a registration or claim made therefor) by Custodian or its suppliers. The Fund shall not take any action with respect tot the Software inconsistent with the foregoing acknowledgement, nor shall the Fund attempt to decompile, reverse engineer or modify the Software. The Fund may not xxx, sell, lease or provide, directly or indirectly, any of the Software of any portion thereof to any other person or entity without Custodian’s prior written consent. The Fund may not remove any statutory copyright notice or other notice included in the Software or on any media containing the Software. The Fund shall reproduce any such notice on any reproduction of the Software and shall add any statutory copyright notice or other notice to the Software or media upon Custodian’s request.

  • Software License Agreement McDATA agrees that all Licensed Software will be distributed to Customers subject to a Software License Agreement (including warranty statement), along with a McDATA Manual, in a manner which is (a) no less protective of BROCADE's Intellectual Property Rights in the Licensed Software than the form attached hereto as Exhibit D, and (b) legally enforceable in the jurisdictions in which the Licensed Software, as incorporated into the McDATA Products, is distributed.

  • SERVICE XXXX USE A. Controlled Affiliate recognizes the importance of a comprehensive national network of independent BCBSA licensees which are committed to strengthening the Licensed Marks and Name. The Controlled Affiliate further recognizes that its actions within its Service Area may affect the value of the Licensed Marks and Name nationwide.

  • Non-Exclusivity of Services The Manager is free to act for its own account and to provide investment management services to others. The Fund acknowledges that the Manager and its officers and employees, and the Manager's other funds, may at any time have, acquire, increase, decrease or dispose of positions in the same investments which are at the same time being held, acquired or disposed of under this Agreement for the Fund. Neither the Manager nor any of its officers or employees shall have any obligation to effect a transaction under this Agreement simply because such a transaction is effected for his or its own account or for the account of another fund. Fund agrees that the Manager may refrain from providing any advice or services concerning securities of companies for which any officers, directors, partners or employees of the Manager or any of the Manager's affiliates act as financial adviser, investment manager or in any capacity that the Manager deems confidential, unless the Manager determines in its sole discretion that it may appropriately do so. The Fund appreciates that, for good commercial and legal reasons, material nonpublic information which becomes available to affiliates of the Manager through these relationships cannot be passed on to Fund.

  • License Fee Controlled Affiliate will pay to BCBSA a fee for this License determined pursuant to the formula(s) set forth in Exhibit B.

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