Early Access Programs Clause Samples

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Early Access Programs. The Parties shall discuss at the Steering Committee the appropriate mechanism for considering, approving, providing for supply of Licensed Product in respect of, and otherwise administering, any Early Access Programs [***].
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Early Access Programs. Pharmacyclics shall be permitted to undertake Early Access Programs for the Products in the Field in the United States and JBI shall be permitted to undertake Early Access Programs for the Products in the Field in the License Territory. If either Party desires to undertake an Early Access Program in accordance with this Section 5.12, such Party shall submit to the JDC a proposal for such Early Access Program, which proposal shall include the clinical methodology, monitoring requirements and funding budget for such Early Access Program. If the JDC agrees to an Early Access Program proposal, such proposal shall be submitted to the JSC for review and approval. The JSC shall approve such Early Access Program proposal unless the JSC determines in good faith that the proposed Early Access Program could adversely affect the Development or Commercialization of the Products in the Field in the United States or the License Territory. The Parties’ costs and expenses incurred in performing Early Access Programs that have been approved by the JSC in accordance with this Section 5.12 shall be taken into account in determining Pre-Tax Profit or Loss as, and to the extent, provided for as EAP Expenses in the Financial Exhibit.
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Early Access Programs. Atara shall be responsible, at its sole cost and expense, for operationally managing and conducting the Early Access Programs for Product outside the Territory. Atara shall have the right, but not the obligation (unless required under applicable Law in any country, region or jurisdiction, as applicable, in the Territory), to conduct the Atara 902 EAP Observational Study and/or the Atara EU EAP/SPU Program in the Territory. With respect to the EU or the UK, as applicable, and unless otherwise agreed between the Parties through the JSC, Atara shall be responsible for operationally managing and conducting the Atara 902 EAP Observational Study and/or the Atara EU EAP/SPU Program in Europe or the UK, as applicable, [***]. Partner shall be responsible, at its sole cost and expense, for any other Early Access Programs for Product in the Territory after the Effective Date, provided, however, Partner may not initiate or conduct any Early Access Program activities relating to (a) the Primary Indication prior to obtaining Marketing Authorization for the Product for the Primary Indication in the European Territory or (b) for a Multi-Cohort Indication prior to obtaining Marketing Authorization for a Multi-Cohort Indication in the European Territory, in each case, without the prior written consent of Atara.
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Early Access Programs. 6.7.1 As soon as practical the MAG shall establish the EAC which shall be responsible for approving all Early Access Programs. The EAC shall include an equal number of Medical Affairs and clinical Development representatives from each Kite and Arcellx. In conducting its activities, the EAC shall operate and make its decisions consistent with the terms of this Agreement. 6.7.2 Kite shall be permitted to undertake Early Access Programs for all Licensed Products in the Field. If Kite desires to undertake an Early Access Program in accordance with this Section 6.7, Kite shall submit to the EAC a proposal for such Early Access Program, which proposal shall include the clinical methodology, monitoring requirements and funding budget for such Early Access Program. If the EAC agrees to an Early Access Program proposal, such proposal shall be submitted to the JSC for review and approval. The JSC shall approve such Early Access Program proposal unless the JSC determines in good faith that the proposed Early Access Program could adversely affect the Development or Commercialization of the Licensed Products in the Field. The Parties’ costs and expenses incurred in performing Early Access Programs for Co-Promote Products in the United States that have been approved by the JSC in accordance with this Section 6.7 shall be taken into account in determining Pre-Tax Profit or Loss as, and to the extent, provided for as EAP Expenses in the Financial Exhibit.
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Early Access Programs. Nippon Shinyaku shall be permitted to undertake Early Access Programs for the Licensed Products in the Licensed Field in the Territory and REGENX shall be permitted to undertake Early Access Programs for the Licensed Products in the Licensed Field outside of the Territory.
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Early Access Programs. *** Certain information has been excluded from this agreement because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. [***]. If [***] desires to undertake an Early Access Program with respect to a Cost Profit Sharing Product in the United States, such Party shall submit (a) [***] (b) [***]. If the JDC and JMC agree to an Early Access Program proposal, such proposal shall be submitted to the JSC for review and approval. The JSC shall approve such Early Access Program proposal unless the JSC determines in good faith that the proposed Early Access Program [***]. Any Early Access Program conducted by either Party for the Cost Licensed Products shall be in accordance with the plan therefor to the extent established by the JDC. [***].
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Early Access Programs. The parties shall discuss at the Steering Committee the appropriate mechanism for transferring control of all Early Access Programs from Protalix to Pfizer with the goal of transferring such control as soon as reasonably practicable after the Effective Date.
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Early Access Programs. Atara shall use Commercially Reasonable Efforts to continue conducting (and shall continue to conduct when required under applicable Law in any country, region or jurisdiction, as applicable, in the Territory), the Atara 902 EAP Observational Study in the Territory during the R&D Pre-Transfer Period. Unless otherwise agreed between the Parties through the JSC, Atara shall be responsible for operationally managing and conducting the Atara 902 EAP Observational Study throughout the Territory, [***]. Partner shall be responsible, at its sole cost and expense, for continuing to conduct the Atara 902 EAP Observational Study during the R&D Post-Transfer Period, if applicable, and any other Early Access Programs for Product in the Territory after the Effective Date, provided, however, Partner may not initiate or conduct any Early Access Program activities relating to the Primary Indication in the United States prior to obtaining Marketing Authorization for the Product for the Primary Indication in the United States.
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Early Access Programs. (a) Day One shall be responsible, at its sole cost and expense and for its benefit, for operationally managing and conducting the Early Access Programs for the Licensed Product: [*] (“Existing Early Access Programs”) [*]. (b) Licensee shall be responsible[*] for any other Early Access Programs for the Licensed Product in the Licensee Territory after the Effective Date that are not Existing Early Access Programs (“New Early Access Programs”) and shall [*].
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Related to Early Access Programs

  • Early Access (i) Subject to receipt of Master Landlord’s Consent, Subtenant shall have early access to the portion of the Subleased Premises consisting of approximately 9,789 rentable square feet as shown on Exhibit D hereto and identified therein as “Initial ConforMIS Space” (the “Early Access Area”) for the period commencing on June 15, 2012, or such earlier date as Sublandlord may determine in its sole discretion (the “Early Access Date”) until the Sublease Commencement Date (the “Early Access Period”), for the purposes of installing its telecommunications equipment, validating business equipment and operating any such validated equipment in support of Subtenant’s standard business operations (the “Early Access Work”). All Early Access Work shall be performed in accordance with the terms of the Master Lease, including but not limited to Section 6 thereof. In the event of a conflict between the terms and conditions of the Master Lease and the terms and conditions of this Section 2(d), the Master Lease shall control. (ii) Subtenant’s early access rights granted herein shall be subject to all the terms and conditions of this Sublease, including without limitation all insurance and maintenance obligations, except that no Base Rent or Additional Rent under Section 4(d) herein will be charged to Subtenant during the Early Access Period. Notwithstanding the foregoing, Subtenant will be responsible for paying the Estimated Electricity Usage Charge during the Early Access Period based only on the 1st floor portion of the Early Access Area, as provided for in Section 5(a) below. (iii) Prior to the Early Access Date, Sublandlord will, at its sole cost and expense, construct such demising partitions as may be necessary in Sublandlord’s sole discretion to separate the Early Access Area from the remainder of the Subleased Premises. Sublandlord shall remove such demising partitions at Sublandlord’s expense at the end of the Early Access Period and repair any damage caused by the removal of the partitions and restore to its previous condition. (iv) Subtenant agrees that (i) it will use commercially reasonable efforts to not interfere with Sublandlord’s use of or access to the remainder of the Subleased Premises during the Early Access Period, (ii) Subtenant and its contractors shall conduct the Early Access Work in a manner that shall minimize disruption and inconvenience to other tenants and occupants of the Building, and (iii) Sublandlord’s representative shall have the right to inspect any work performed by Subtenant or its contractor during the normal hours of operation of the Building or such other hours as Sublandlord may reasonably request. (v) Sublandlord makes no representation or warranty that the Early Access Area will be adequate to satisfy Subtenant’s needs with respect to the Early Access Work. Subtenant has previously inspected the Early Access Area and has satisfied itself as to the adequacy of such space. Notwithstanding the foregoing, Sublandlord agrees to cooperate with Subtenant and allow Subtenant reasonable access to other portions of the Subleased Premises to the extent reasonably necessary to perform the Early Access Work, which access (i) shall be requested (in writing, if commercially practicable, otherwise orally) at least twenty-four (24) hours in advance and (ii) may require, at Sublandord’s sole discretion, continuous escort by authorized personnel of Sublandlord. (vi) Subtenant agrees to comply with the following terms and conditions during the performance of the Early Access Work: (A) Subtenant shall keep all public and common areas of the Building where such work is being performed neat and clean at all times and Subtenant shall remove or cause all debris to be removed from the Building at the end of each work day. (B) Subtenant shall promptly repair, at its sole cost and expense, any damage done to the Building or to the premises of any other tenant in the Building and to any existing heating, ventilating and air conditioning system (“HVAC”), electrical, plumbing, fire alarm, sprinkler and lighting systems serving the Building or other common areas appurtenant to the Building that are caused by or arise out of any work performed by Subtenant or its contractor pursuant to this Section. (C) Any contractor performing such Early Access Work shall be subject to the prior written approval of Sublandlord, which approval shall not be unreasonably withheld, conditioned or delayed, and Master Landlord if required pursuant to the terms and conditions of the Master Lease. (D) In performing such work, Subtenant and its contractor shall observe Master Landlord’s and Sublandlord’s commercially reasonable rules and regulations regarding the construction, installation, and removal of tenant improvements in the Building, which rules and regulations, together with any modifications thereto, shall be provided to Subtenant, in writing, prior to enforcement. (E) Subtenant shall be solely responsible at its sole cost and expense to correct and to repair any work or materials installed by Subtenant or Subtenant’s contractor, and Sublandlord shall have no liability to Subtenant whatsoever on account of any work performed or material provided by Subtenant or its contractor. (F) All work done and materials furnished by Subtenant and/or its contractor shall be of such quality, shall be performed in such manner and in accordance and compliance with such Laws (as hereinafter defined) as required for work done and materials furnished by Sublandlord and/or its contractor pursuant to the Master Lease.

  • Data Access Control Persons entitled to use data processing systems gain access only to the Personal Data that they have a right to access, and Personal Data must not be read, copied, modified or removed without authorization in the course of processing, use and storage.

  • 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.

  • Program Location A. Unless otherwise agreed upon in writing, the parties acknowledge and agree that the Work of this Agreement will be performed at the following Property address: Ktr Address1 Address2

  • Modifications and Updates to the Wire Center List and Subsequent Transition Periods 5.4.6.1 In the event AT&T identifies additional wire centers that meet the criteria set forth in Sections 5.4.2.1 or 5.4.2.2 above, but that were not included in the Master List of Unimpaired Wire Centers or AT&T’s List of Unimpaired Wire Centers, AT&T shall include such additional wire centers in a CNL. Each such list of additional wire centers shall be considered a Subsequent Wire Center List. AT&T will follow any limitations on the frequency with which it may issue such lists and notification procedures set forth in applicable Commission orders. 5.4.6.2 TWTC shall have thirty (30) business days to dispute the additional wire centers listed on AT&T’s CNL. Absent such dispute, effective thirty (30) business days after the date of a AT&T CNL providing a Subsequent Wire Center List, AT&T shall not be required to provide DS1 and DS3 Dedicated Transport, as applicable, in such additional wire center(s), except pursuant to the self-certification process as set forth in Section 1.9.1 of this Attachment. 5.4.6.3 For purposes of Section 5.4.6.1 above, AT&T shall make available DS1 and DS3 Dedicated Transport that were in service for TWTC in a wire center on the Subsequent Wire Center List as of the thirtieth (30th) business day after the date of AT&T’s CNL identifying the Subsequent Wire Center List (Subsequent Embedded Base) until one hundred eighty (180) days after the thirtieth (30th) business day Version: 4Q06 Standard ICA 11/30/06 from the date of AT&T’s CNL identifying the Subsequent Wire Center List (Subsequent Transition Period). 5.4.6.4 The rates set forth in Exhibit B shall apply to the Subsequent Embedded Base during the Subsequent Transition Period. 5.4.6.5 No later than one hundred eighty (180) days from AT&T’s CNL identifying the Subsequent Wire Center List, TWTC shall submit an LSR(s) or spreadsheet(s) as applicable, identifying the Subsequent Embedded Base of circuits to be disconnected or converted to other AT&T services. 5.4.6.5.1 In the case of disconnection, the applicable disconnect charges set forth in this Agreement shall apply. 5.4.6.5.2 If TWTC chooses to convert DS1 and/or DS3 Dedicated Transport to special access circuits in existence as of the Effective Date of this Agreement, AT&T will include such DS1 and/or DS3 Dedicated Transport within TWTC’s total special access circuits, and apply any discounts to which TWTC is entitled from the transition period of 3/11/2006 to the conversion date. Conversions will be subject to the switch-as-is charge set forth in Exhibit A to this Attachment 2. 5.4.6.5.3 AT&T shall not impose disconnect or nonrecurring installation charges when transitioning the Subsequent Embedded Base of DS1 and DS3 Dedicated Transport in existence as of the Effective Date of this Agreement. 5.4.6.6 If TWTC fails to submit the LSR(s) or spreadsheet(s) for all of its Subsequent Embedded Base by one hundred eighty (180) days after the date of AT&T’s CNL identifying the Subsequent Wire Center List, AT&T will identify TWTC’s remaining Subsequent Embedded Base, if any, and will transition such circuits to the equivalent tariffed AT&T service(s), or in the case of Georgia, to the equivalent 271 service(s) set forth in Exhibit 1. In the states of Florida, Kentucky, Mississippi and South Carolina, those circuits identified and transitioned by AT&T shall be subject to the applicable disconnect charges as set forth in this Agreement and the full nonrecurring charges for installation of the equivalent tariffed AT&T service as set forth in AT&T’s tariffs. In the states of Alabama, Georgia, North Carolina and Tennessee, those circuits identified and transitioned by AT&T shall be subject to the applicable switch-as-is rates set forth in Exhibit A of Attachment