Expanded Access Program Sample Clauses

Expanded Access Program. At such time as Foundation and Roche mutually agree, or the SMAF Clinical Trials Advisory Committee in its sole discretion determines, that results from clinical trials and other development activities with respect to the applicable SRA Development Candidate or SRA Product support expanded access to such SRA Development Candidate or SRA Product for patients with SMA, then Roche and Foundation shall cooperate to establish such an expanded access program in which at least [**] SMA patients identified by Foundation who do not meet the enrollment criteria for a particular clinical trial (whether or not such clinical trial is directed to SMA patients) for such SRA Development Candidate or SRA Product (such patients, the “Patients”) may gain access to such SRA Development Candidate or SRA Product. Roche agrees that at its earliest reasonable opportunity following the commencement of such cooperation (e.g., at a meeting with the FDA), Roche will inquire about the feasibility of an expanded access protocol for such SRA Development Candidate or SRA Product for SMA purposes and will invite a designee of Foundation with appropriate medical or regulatory experience to participate in discussions with the FDA regarding the establishment and maintenance of such expanded access program. In connection with such expanded access program, at Foundation’s request and consistent with any recommendations made by the SMAF Clinical Trials Advisory Committee, Roche will either (i) submit to the FDA a protocol that is reasonably acceptable to Foundation and calls for administering such SRA Development Candidate or SRA Product to the Patients or (ii) notify Foundation that it will not be making such a submission and facilitate the submission and approval of such a protocol by the Foundation or its designee. If Roche chooses option (i) above, then it shall use Commercially Reasonable Efforts to obtain approval of such protocol and, upon receipt of such approval, it shall provide such SRA Development Candidate or SRA Product to the Patients in accordance with the approved protocol; provided, that Roche and Foundation shall engage in good faith negotiations with respect to [**]. If Roche chooses option (ii) above, then Roche shall facilitate Foundation’s efforts to arrange for such expanded access program for such SRA Development Candidate or SRA Product for the Patients by taking all reasonable actions requested by Foundation, in each case [**], including without limitation: either (1)...
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Expanded Access Program. Jazz acknowledges that PharmaMar has entered into a master service agreement and a related work order with [***] effective on [***], a copy of which has been provided to Jazz prior to the Effective Date of this Agreement, under which [***] is providing PharmaMar with services related to the set up and delivery of an EAP for the Licensed Product in the Jazz Territory in the SCLC Indication (“EAP Agreement”). Jazz shall have the right to choose between: (i) having the EAP Agreement assigned by PharmaMar to Jazz; in which case, Jazz shall assume PharmaMar´s post-assignment obligations under the EAP Agreement, including payment of any service fees and other expenses due to Bionical Inc. after the assignment date; provided however that PharmaMar would remain responsible for the supply of the Licensed Product under the EAP Agreement at Jazz´s expense solely until the time Jazz is able to supply the Licensed Product for EAP itself or (ii) having PharmaMar terminate the EAP Agreement in accordance with the EAP Agreement provisions, in which case PharmaMar shall retain all obligations under the EAP Agreement. Jazz shall notify PharmaMar of its decision regarding the EAP Agreement within [***] from the HSR Clearance Date. For clarity, Jazz acknowledges and agrees that the existence of EAP Agreement shall not, by itself, be deemed a breach by PharmaMar of the exclusive rights and licenses granted to Jazz pursuant to this Agreement or of any representation, covenant or any other provision of this Agreement.
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Expanded Access Program. Jazz acknowledges that PharmaMar has entered into a master service agreement and a related work order with [***] effective on [***], a copy of which has been provided to Jazz prior to the Effective Date, under which [***] was providing PharmaMar with services related to the set up and delivery of an EAP for the Licensed Product in the Jazz Territory in the SCLC Indication (“EAP Agreement”). Upon Jazz´s election under the Original License Agreement, the Parties acknowledge that the EAP Agreement was effectively assigned by PharmaMar to Jazz on [***].
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Related to Expanded Access Program

  • REMOTE ACCESS SERVICES ADDENDUM The Custodian and each Fund agree to be bound by the terms of the Remote Access Services Addendum hereto.

  • 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.

  • DATA ACCESS SERVICES ADDENDUM TO CUSTODIAN AGREEMENT Addendum to the Custodian Agreement (as defined below) between each fund listed on Appendix A to the Custodian Agreement, as such Appendix A is amended from time to time (each such fund listed on Appendix A shall be individually referred to herein as the “Fund”), and State Street Bank and Trust Company (“State Street”).

  • 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.

  • Site Access The Buyer agrees to RELEASE, INDEMNIFY AND HOLD HARMLESS the Seller Indemnitees from and against the entirety of any Adverse Consequences that are suffered by the Seller Indemnitees arising out of, resulting from or relating to any field visit or other due diligence activities relating to any performance of the Diligence Activities to the extent caused by acts or omissions of any Buyer Party or Buyer Diligence Representative, even if such Adverse Consequences arise out of or result from, solely or in part, the sole, active, passive, concurrent or comparative negligence, strict liability or other fault or violation of Law of or by the Seller Indemnitees, except Adverse Consequences to the extent resulting from the gross negligence or willful misconduct of the Seller Indemnitees.

  • Early Access Sublandlord agrees to cooperate with Subtenant to allow Subtenant access to the Initial Premises from the day following the Consent Date to the Delivery Date and deliver exclusive possession of the Initial Premises, including the Data Room (but excluding the Lab Space), on the Delivery Date, for design and construction purposes and for the purposes of the installation of furniture, fixtures and equipment and preparing the Initial Premises for occupancy (the “Early Access Activities”), provided that Subtenant has first given Sublandlord at least one (1) business day’s prior notice of any such access (for access prior to the Delivery Date only) and has first delivered to Sublandlord a certificate of insurance evidencing compliance with the insurance obligations herein. Such access (a) shall be solely for the Early Access Activities and not for the purposes of occupancy or possession of the Initial Premises, or of conducting business therein, and (b) shall be subject to and upon all the terms and conditions of this Sublease (including without limitation Section 11 hereof), except that Subtenant shall have no obligation to pay Base Rent or Additional Rent for the period prior to the Initial Premises Commencement Date; provided, however, that if Subtenant’s pursuit of the Early Access Activities causes an increase of more than ten percent (10%) in the cost of utilities (including without limitation water, electricity, heat or air conditioning) allocable to the Initial Premises on a square-foot basis (as compared to the average cost for such utilities over the prior three (3) months), Subtenant shall reimburse Sublandlord for such increase in the cost of utilities within thirty (30) days following Sublandlord’s presentation of an invoice therefor (including reasonable supporting documentation), which invoice shall be presented to Subtenant within fifteen (15) days following each month of such Early Access Activities. The Early Access Activities shall be performed between the hours of 6:00 a.m. and 5:00 p.m. on business days, and shall be coordinated with Sublandlord. Subtenant’s early access shall not affect or alter the Initial Premises Commencement Date, the Expansion Premises Commencement Date, the Expiration Date, or the Term.

  • Data Access Services State Street agrees to make available to the Fund the Data Access Services subject to the terms and conditions of this Addendum and such data access operating standards and procedures as may be issued by State Street from time to time. The Fund shall be able to access the System to (i) originate electronic instructions to State Street in order to (a) effect the transfer or movement of cash or securities held under custody by State Street or (b) transmit accounting or other information (the transactions described in (i)(a) and (i)(b) above are referred to herein as “Client Originated Electronic Financial Instructions”), and (ii) access data for the purpose of reporting and analysis, which shall all be deemed to be Data Access Services for purposes of this Addendum.

  • IMPORTANT INFORMATION ABOUT PROCEDURES FOR OPENING A NEW ACCOUNT To help the government fight the funding of terrorism and money laundering activities, Federal law requires all financial institutions to obtain, verify, and record information that identifies each person who opens an Account. When the Company opens an Account the Bank will ask for the depositor's name, address and other information that will allow the Bank to identify the depositor. The Bank may also ask to see other documents that substantiate the depositor's identity.

  • 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.

  • Network Access Control The VISION Web Site and the Distribution Support Services Web Site (the “DST Web Sites”) are protected through multiple levels of network controls. The first defense is a border router which exists at the boundary between the DST Web Sites and the Internet Service Provider. The border router provides basic protections including anti-spoofing controls. Next is a highly available pair of stateful firewalls that allow only HTTPS traffic destined to the DST Web Sites. The third network control is a highly available pair of load balancers that terminate the HTTPS connections and then forward the traffic on to one of several available web servers. In addition, a second highly available pair of stateful firewalls enforce network controls between the web servers and any back-end application servers. No Internet traffic is allowed directly to the back-end application servers. The DST Web Sites equipment is located and administered at DST’s Winchester data center. Changes to the systems residing on this computer are submitted through the DST change control process. All services and functions within the DST Web Sites are deactivated with the exception of services and functions which support the transfer of files. All ports on the DST Web Sites are disabled, except those ports required to transfer files. All “listeners,” other than listeners required for inbound connections from the load balancers, are deactivated. Directory structures are “hidden” from the user. Services which provide directory information are also deactivated.

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