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)...
Sample 1Sample 2
AutoNDA by SimpleDocs
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.
Sample 1
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 [***].
Sample 1

Related to Expanded Access Program

  • Originating Switched Access Detail Usage Data A category 1101XX record as defined in the EMI Telcordia Practice BR-010-200- 010.

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

  • EU Access SAP will use only European Subprocessors to provide support requiring access to Personal Data in the Cloud Service and SAP shall not export Personal Data outside of the EEA or Switzerland unless expressly authorized by Customer in writing (e-mail permitted) on a case by case basis; or as excluded under Section 9.4.

  • Service Level Agreement 6.1 NCR Voyix will use commercially reasonable efforts to make the Service available to you at or above the Availability Rate set forth at xxxxx://xxx.xxx.xxx/support/aloha-sla. If NCR Voyix does not meet the Availability Rate, you are entitled to request a service-level credit subject to the terms of this Agreement. This credit is calculated as a percentage of the monthly recurring bill (or monthly pro rata share of billing, if billing does not occur monthly) for the Service for the month in which the Availability Rate was not met. The Availability Rate is determined by: (a) dividing the total number of valid outage minutes in a calendar month by the total number of minutes in that month; (b) subtracting that quotient from 1.00; (c) multiplying that difference by 100; and (d) rounding that result to two decimal places in accordance with standard rounding conventions. The number of outage minutes per day for a given service is determined by the lesser of the number of outage minutes. 6.2 Unavailability due to other conditions or caused by factors outside of NCR Voyix’s reasonable control will not be included in the calculation of the Availability Rate. Further, the following are expressly excluded from the calculation of the Availability Rate: (a) service unavailability affecting services or application program interfaces that are not used by you; (b) cases where fail-over to another data center is available but not utilized; (c) transient time-outs, required re-tries, or slower-than-normal response caused by factors outside of NCR Voyix’s reasonable control; (d) Scheduled Downtime, including maintenance and upgrades; (e) force majeure; (f) transmission or communications outages outside the NCR Voyix- controlled environment; (g) store-level down-time caused by factors outside of NCR Voyix’s reasonable control; (h) outages attributable to services, hardware, or software not provided by NCR Voyix, including, but not limited to, issues resulting from inadequate bandwidth or related to third-party software or services; (i) use of the Service in a manner inconsistent with the documentation for the application program interface or the NCR Voyix Product; (j) your Point of Sale (“POS”) failure or the failure to properly maintain the POS environment, including updating the POS firmware or version of the software running on the POS as recommended by either NCR Voyix, a third-party POS reseller or servicer; and (k) issues related to third party domain name system (“DNS”) errors or failures. 6.3 To obtain a service-level credit, you must submit a claim by contacting NCR Voyix through the website at xxxxx://xxx.xxx.xxx/support/aloha-sla Your failure to provide the claim and other information will disqualify you from receiving a credit. NCR Voyix must receive claims within 60 days from the last day of the impacted month. After that date, claims are considered waived and will be refused. You must be in compliance with the Agreement in order to be eligible for a service-level credit. You may not unilaterally offset for any performance or availability issues any amount owed to NCR Voyix. If multiple Services experience an outage in a given month, the total credit for that month will be the highest credit allowed for any single Service which failed; there is no stacking of credits. 6.4 The remedies set forth in the Section are your sole and exclusive remedies for performance or availability issues affecting the Services, including any failure by NCR Voyix to achieve the Availability Rate.

  • Terms of Use The Clean Energy Council Limited (CEC) owns all intellectual property rights in the Solar PV Sale and Installation Agreement (Agreement).

  • Limited Access If necessary for the fulfillment of the Agreement, NBU may provide the Professional with non-exclusive, limited access to NBU’s information technology infrastructure. The Professional understands and agrees to abide by NBU policies, standards, regulations and restrictions regarding access and usage of NBU’s information technology infrastructure. The Professional shall reasonably enforce such policies, standards, regulations and restrictions with all the Professional’s employees, agents or any tier of subcontractor granted access in the performance of this Agreement, and shall be granted and authorize only such access as may be necessary for the purpose of fulfilling the requirements of the Agreement. The Professional’s employees, agents and subcontractors must receive prior, written approval from NBU before being granted access to NBU’s information technology infrastructure and data and NBU, in its sole determination, shall determine accessibility and limitations thereto. The Professional agrees that the requirements of this Section shall be incorporated into all subcontractor agreements entered into by the Professional. It is further agreed that a violation of this Section shall be deemed to cause irreparable harm that justifies injunctive relief in court. A violation of this Section may result in immediate termination of this Agreement without notice.

  • Data Access Access to Contract and State Data The Contractor shall provide to the Client Agency access to any data, as defined in Conn. Gen Stat. Sec. 4e-1, concerning the Contract and the Client Agency that are in the possession or control of the Contractor upon demand and shall provide the data to the Client Agency in a format prescribed by the Client Agency and the State Auditors of Public Accounts at no additional cost.

  • Authorized Access Transfer Agent shall have controls that are designed to maintain the logical separation such that access to systems hosting Fund Data and/or being used to provide services to Fund will uniquely identify each individual requiring access, grant access only to authorized personnel based on the principle of least privileges, and prevent unauthorized access to Fund Data.

  • 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.

  • Restricted Access (a) Buyer agrees that the Facilities themselves contain Seller’s valuable trade secrets. Buyer agrees (i) to restrict the use of such information to matters relating to the Facilities, and (ii) to restrict access to such information as provided in Section 10.3(b). (b) Seller’s Confidential Information will not be reproduced without Seller’s prior written consent, and following termination of this Agreement all copies of such written information will be returned to Seller upon written request (not to be made while materials are still of use to the operation of a Facility and no Buyer Default has occurred and is continuing), unless otherwise agreed by the Parties. Buyer’s Confidential Information will not be reproduced by Seller without Buyer’s prior written consent, and following termination of this Agreement all copies of such written information will be returned to Buyer upon written request or shall be certified by Seller as having been destroyed. (c) Subject to ARTICLE XI and Section 10.2(a) and (b) hereof, the Facilities are offered for sale and are sold by Seller subject to the condition that such sale does not convey any license, expressly or by implication, to manufacture, reverse engineer, duplicate or otherwise copy or reproduce any part of the Facilities, documentation or Software without Seller’s express advance written permission. Subject to ARTICLE XI hereof, Buyer agrees not to remove the covering, not to access the interior or to reverse engineer, or cause or knowingly allow any third party to open, access the interior or reverse engineer any Facility or Software provided by Seller. Subject to ARTICLE XI hereof, and anything contemplated pursuant to this Agreement, only Seller or its authorized representatives may open or access the interior of a Facility. Notwithstanding the foregoing or anything else herein to the contrary, and without limitation of the rights set forth in ARTICLE XI hereof, if any Facility is no longer covered by this Agreement or another agreement between Buyer and Seller (or any Affiliate of Seller) regarding the operation and maintenance of such Facility, Buyer shall be entitled to maintain, or cause a third party to maintain, such Facility, including replacing parts or components as needed or desired; provided that Buyer shall use commercially reasonable efforts to engage a third party to provide such maintenance that is not a competitor of Seller or its Affiliates and is not in litigation or other material dispute with Seller.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!