Early Access Programs Sample Clauses

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.
Sample 1
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.
Sample 1
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.
Sample 1
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.
Sample 1
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.
Sample 1
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. [***].
Sample 1
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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 [*].
Sample 1

Related to Early Access Programs

  • Early Access Subject to Tenant’s delivery of an executed original of this Lease, the prepaid Base Rent and the Letter of Credit as required elsewhere in this Lease, and the insurance certificates evidencing Tenant’s insurance policies required under this Lease, Landlord shall provide Tenant with early access to the Premises on the latest to occur of (i) the first (1st) Business Day following the date of mutual execution and delivery of this Lease, (ii) the first (1st) Business Day following the date on which Landlord determines the Premises is free and clear of any existing tenancy, and (iii) fifteen (15) days prior to Landlord’s then-estimated date of delivery of the Premises (in any case, the “Access Date”). Such period of early access shall commence on the Access Date and continue through the date immediately preceding the Commencement Date (the “Early Access Period”), and Tenant’s access during the Early Access Period shall be subject to all of the terms and conditions of this Lease, except for Tenant’s obligation to pay Rent (which obligation shall commence upon the Commencement Date, subject to the abatement of Base Rent provided in the Basic Lease Information). Notwithstanding the foregoing, the conduct of business in the Premises shall cause an immediate acceleration of the Commencement Date to the date of Tenant’s initial conduct of business in the Premises. During the Early Access Period, Tenant may enter the Premises (but not any other portion of the Building or the Project other than for ingress and egress) for the sole purpose of installing cabling, furniture, fixtures and equipment, provided that Tenant shall be solely responsible for all of the foregoing and for any loss or damage thereto from any cause whatsoever. Such early access and installation shall be permitted only to the extent that such early access and installation activities will not interfere with the access, use and occupancy of the Building or the Project by Landlord or any other tenant or occupant and/or Landlord’s performance of the Work and/or otherwise delay Landlord’s delivery of possession of the Premises to Tenant in the condition required under this Lease. The provisions of Sections 8(a) and 11 of this Lease shall apply in full during the Early Access Period, and Tenant shall (x) provide certificates of insurance evidencing the existence and amounts of liability insurance carried by Tenant and its agents and contractors, reasonably satisfactory to Landlord, prior to and as a condition to such early access, and (y) comply with all Laws applicable to such early access work in the Premises. If Landlord reasonably determines that Tenant’s early access is interfering in any material way with Landlord’s ability to deliver possession of the Premises in the condition required under this Lease and/or to complete the Work, then Landlord shall have the right to limit or otherwise restrict Tenant’s access during the Early Access Period without any liability.

  • Wellness Program Nothing in this Agreement shall prevent a department or agency from recommending experimental “fitness” type programs and reward programs involving wellness promotion activities. Any such activities shall be funded from the department’s separate appropriation, after review by the Benefits Advisory Committee and approval by the Secretary of Administration, or designee.

  • 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.

  • Payment Terms and Billing (1) Payment shall be made only after the Client Agency receives and accepts the Goods or Services and after it receives a properly completed invoice. Unless otherwise specified in the Contract, payment for all accepted Goods or Services shall be due within forty-five (45) days after acceptance of the Goods or Services, or thirty (30) days if the Contractor is a certified small contractor or minority business enterprise as defined in Conn. Gen.

  • Pilot Programs The Employer may develop voluntary pilot programs to test the acceptability of various risk management programs. Incentives for participation in such programs may include limited short-term improvements to the benefits outlined in this Article. Implementation of such pilot programs is subject to the review and approval of the Joint Labor-Management Committee on Health Plans.

  • 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.

  • 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

  • Technology Access Fee After the Effective Date, within [***] days after receipt of the corresponding invoice from Mersana, Merck will pay to Mersana, a one-time, non-refundable, non-creditable, upfront fee of Twelve Million Dollars ($12,000,000.00) (the “Technology Access Fee”). Payment of the Technology Access Fee shall be subject to any withholding Tax obligations set forth in Section 6.9.1.

  • 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.

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