Right of Reference; Samples Sample Clauses

Right of Reference; Samples. Each Party has right to reference and receive access to all Regulatory Materials for the Compound (and any chemical alteration or improvement of the Compound (e.g. pursuant to Section 8.3)) that are Controlled by the other Party, its Affiliates, or its sublicensees, whether existing as of the Effective Date, generated from any activities of the Parties in connection with this Agreement, solely for the purposes set forth in this Agreement, or otherwise existing after the Effective Date. Elanco will provide Tarsus with reasonable samples of (a) Elanco’s chemical alterations or improvements of the Compound, (b) the Compound’s related substances, and/or (c) reference standards for the Compound, in each case, after Tarsus’s request(s) from time to time. Tarsus shall pay Elanco for such samples at an amount equal to [***] paid by Elanco for such samples plus [***]% thereof.
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Right of Reference; Samples. Each Party has right to reference and receive access to all Regulatory Materials for the Compound (and any chemical alteration or improvement of the Compound (e.g. pursuant to Section 8.3)) that are Controlled by the other Party, its Affiliates, or its sublicensees, whether existing as of the Effective Date, generated from any activities of the Parties in connection with this Agreement, solely for the purposes set forth in this Agreement, or otherwise existing after the Effective Date. Elanco will provide Tarsus with reasonable samples of (a) Elanco’s chemical alterations

Related to Right of Reference; Samples

  • Right of Reference Each Party hereby grants to the other Party, and at the request of the other Party will grant to the other Party’s Related Parties, a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) (or any successor rule or analogous Law recognized outside of the United States), to, and a right to copy, access, and otherwise use, all information and data (including all CMC information as well as data made, collected or otherwise generated in the conduct of any Clinical Studies or upon exercise of the Additional Development Opt-In Right, Supplemental Studies or Regional [***] Activities, or early access/named patient programs for the Regional Licensed Products) included in or used in support of any regulatory filing, Regulatory Approval, drug master file or other regulatory documentation (including orphan drug applications and designations) maintained on behalf of such Party (or its Related Parties) that relates to any Regional Licensed Product, to the extent necessary or useful to obtain Regulatory Approval of a Regional Licensed Product in the Novartis Territory or the Surface Territory, as applicable, and such Party will provide a signed statement to this CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. effect, if requested by the other Party, in accordance with 21 C.F.R. § 314.50(g)(3) (or any successor or analogous Law outside of the United States). In addition, upon reasonable request of either Party (on behalf of itself or a Sublicensee), the other Party will obtain and provide to the requesting Party certificates or other formal or official attestations concerning the regulatory status of the Regional Licensed Products in the Novartis Territory or the Surface Territory, as applicable (e.g., Certificates of Free Sale, Certificates for Export, Certificates to Foreign Governments), at the requesting Party’s request, and provided further that such attestations are reasonably necessary for the requesting Party to exercise its rights under this Agreement. Notwithstanding anything to the contrary in this Agreement other than for Safety Concerns, neither Party will withdraw or inactivate any regulatory filing that the other Party references or otherwise uses pursuant to this Section 7.2.3. For clarity, the benefit of any regulatory vouchers [***]

  • Right of Review Once Lessor shall have finally determined said Operating, Utility and Energy or Real Estate Tax Costs at the expiration of a Lease Year, then as to the item so established, Lessee shall only be entitled to dispute said charge as finally established for a period of six (6) months after such charge is finally established, and Lessee specifically waives any right to dispute any such charge at the expiration of said six (6) month period.

  • Rights of Reference Upon mutual agreement, Regeneron will grant to the Government a right of reference to any Regulatory Application submitted in support of this Project Agreement, solely for the purpose of the Government conducting a clinical trial with the drug product supplied under this Project Agreement under a protocol approved by Regeneron for performance by the Government. In such a case, Regeneron agrees to provide a letter of cross-reference to the Government and file such letter with the appropriate FDA office. Nothing in this paragraph reduces the Government’s data rights as articulated in other provisions of this award.

  • Right of Refusal Provided the Lease is in full force and effect and no event of default shall exist under the Lease at the time, Tenant shall have a Right of Refusal to lease any space on the second floor (the “RoR Space”) as such space becomes available for rent. Such Right of Refusal shall be subject to and subordinate to all options and rights of existing tenants of the Building, including but not limited to existing renewal and existing expansion options and rights. Landlord shall notify Tenant in writing promptly upon receipt of an offer acceptable to Landlord to lease the RoR Space, and such written notice shall include a summary of all material economic terms of the lease offer. Within five (5) business days after such notice, time being of the essence, Tenant shall give Landlord a written notice that it either will or will not enter into a lease with Landlord for the RoR Space. In the event that Tenant’s notice provides that it will not enter into a lease for the RoR Space or if Tenant fails to give Landlord the notice of its desires respecting the RoR Space within the above-stated five (5) business day period, then Landlord shall be entitled to proceed to lease the RoR Space to the third party free and clear of Tenant’s Right of Refusal and such right shall be deemed forever terminated with respect to the RoR Space described in the notice from Landlord. In the event that Tenant gives Landlord a notice as required above that Tenant wishes to lease the RoR Space from Landlord, then Tenant shall have five (5) business days from the date of Tenant’s notice, and Landlord shall have fifteen (15) business days from the date of Tenant’s notice, within which to sign a mutually acceptable new lease covering the RoR Space or to amend this Lease in a mutually acceptable manner by adding the RoR Space. All space taken under the terms of the Right of Refusal shall be on identical economic terms and conditions to those of the then proposed lease offer, including square footage, length of term, rental rate, operating cost base year or expense stop, and tenant build-out allowance.

  • Right of Receiver or Corporation to Audit The Receiver or the Corporation, their respective agents, contractors and employees, may (but are not required to) perform an audit to determine the Assuming Institution’s compliance with this Agreement at any time, by providing not less than ten (10) Business Days prior notice. The scope and duration of any such audit shall be at the discretion of the Receiver or the Corporation, as the case may be. The Receiver or the Corporation, as the case may be, shall bear the expense of any such audit. In the event that any corrections are necessary as a result of such an audit, the Assuming Institution and the Receiver shall make such accounting adjustments, payments and withholdings as may be necessary to give retroactive effect to such corrections.

  • Right of Re-Entry Upon the occurrence of a Default, Landlord may elect to terminate this Lease or, without terminating this Lease, terminate Tenant's right to possession of the Premises. Upon any such termination, Tenant shall immediately surrender and vacate the Premises and deliver possession thereof to Landlord. Tenant grants to Landlord the right to enter and repossess the Premises and to expel Tenant and any others who may be occupying the Premises and to remove any and all property therefrom, without being deemed in any manner guilty of trespass and without relinquishing Landlord's rights to Rent or any other right given to Landlord hereunder or by operation of law.

  • First Right of Refusal Subtenant shall have the First Right of Refusal to lease any space that becomes available for lease in the Building. Upon receipt of an acceptable offer to lease available space (the "Acceptable Offer"), Sublessor shall provide Subtenant with notice that it has received such Acceptable Offer. In order to exercise this right, Subtenant must respond, in writing, within fifteen (15) business days, confirming that it will lease said space. Upon exercise, the parties will immediately execute a Sublease Amendment incorporating the expanded space into the original Sublease at a rental rate equal to the lesser of (i) the rate set forth in the Acceptable Offer or (ii) the same rental rates as contained in this Sublease. In the event Subtenant elects to not exercise the above rights with respect to the Acceptable Offer, then Subtenant waives its First Right of Refusal with respect to said Acceptable Offer for the ensuing ninety (90) days. However, after the ninety (90) days or with respect to a different offer or a revision of the Acceptable Offer, Subtenant's expansion rights pursuant to this section of the Sublease shall be reinstated. Notwithstanding anything contained herein to the contrary, Sublessor's negotiations with American Classic Voyagers ("ACV") for the western half of the first floor (as more particularly described on EXHIBIT "D" hereto, the "Exclusion Premises") are excluded from Subtenant's right of first refusal for a period of sixty (60) days after the Lease Commencement Date. If a sublease is not signed with ACV during said sixty (60) day period, any and all rights Subtenant may have with respect to the Exclusion Premises will be reinstated.

  • License Terms 1. The license granted to use and have used the Licensed Marks with respect to, and in conjunction with, the manufacture, offer for sale, sale, importation, exportation, and provision of Licensed Products is non-exclusive, worldwide and royalty-free and includes the right to sublicense to Licensee’s subsidiaries and affiliates.

  • Rights to Work Product The Employee agrees that all work performed by the Employee pursuant hereto shall be the sole and exclusive property of the Company, in whatever stage of development or completion. With respect to any copyrightable works prepared in whole or in part by the Employee pursuant to this Agreement, including compilations of lists or data, the Employee agrees that all such works will be prepared as “work-for-hire” within the meaning of the Copyright Act of 1976, as amended (the “Act”), of which the Company shall be considered the “author” within the meaning of the Act. In the event (and to the extent) that such works or any part or element thereof is found as a matter of law not to be a “work-for-hire” within the meaning of the Act, the Employee hereby assigns to the Company the sole and exclusive right, title and interest in and to all such works, and all copies of any of them, without further consideration, and agrees, to the extent reasonable under the circumstances, to cooperate with the Company to register, and from time to time to enforce, all patents, copyrights and other rights and protections relating to such works in any and all countries. To that end, the Employee agrees to execute and deliver all documents requested by the Company in connection therewith, and the Employee hereby irrevocably designates and appoints the Company as the Employee’s agent and attorney-in-fact to act for and on behalf of the Employee and in the Employee’s stead to execute, register and file any such applications, and to do all other lawfully permitted acts to further the registration, protection and issuance of patents, copyrights or similar protections with the same legal force and effect as if executed by the Employee. The Company shall reimburse the Employee for all reasonable costs and expenses incurred by the Employee pursuant to this Section 11.

  • Captions and Cross References; Incorporation by Reference The various captions (including, without limitation, the table of contents) in this Agreement are included for convenience only and shall not affect the meaning or interpretation of any provision of this Agreement. References in this Agreement to any underscored Section or Exhibit are to such Section or Exhibit of this Agreement, as the case may be. The Exhibits hereto are hereby incorporated by reference into and made a part of this Agreement.

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