Urovant Right of Reference Sample Clauses

Urovant Right of Reference. Kyorin hereby grants to Urovant (and its Affiliates or its sublicensees) access to, and a right of reference with respect to, all Regulatory Materials Controlled by Kyorin and corresponding documentation, solely for the purposes of (a) Commercializing Vibegron in the Urovant Territory, and (b) Developing Vibegron in the Urovant Territory (including the use for any meeting with or any submission to the relevant Government Authority, itself or through its sublicensees, for the purpose of obtaining any regulatory approvals of Vibegron for any Indication), in each case, in accordance with all Applicable Laws. If Urovant requests Kyorin’s assistance to execute, acknowledge, and deliver any further documents or instruments and to perform all such other acts as may be [***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406. necessary or appropriate in order to effect such right of reference, Urovant shall inform Kyorin of such request, and the Parties shall discuss and agree in writing on the terms and conditions for such assistance; provided, that Kyorin shall, without making any written agreement thereunder, use commercially reasonable efforts to timely answer any questions from Urovant in order to effect the right of reference.
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Related to Urovant Right of Reference

  • 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 [***]

  • 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.

  • 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.

  • 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 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.

  • 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.

  • Grant of Right of First Refusal Except as provided in Section 12.7 below, in the event the Optionee, the Optionee's legal representative, or other holder of shares acquired upon exercise of the Option proposes to sell, exchange, transfer, pledge, or otherwise dispose of any Vested Shares (the "TRANSFER SHARES") to any person or entity, including, without limitation, any shareholder of the Participating Company Group, the Company shall have the right to repurchase the Transfer Shares under the terms and subject to the conditions set forth in this Section 12 (the "RIGHT OF FIRST REFUSAL").

  • Right of Revocation Guarantor understands and agrees that Guarantor may revoke its future obligations under this Guaranty at any time by giving Bank written notice that Guarantor will not be liable hereunder for any indebtedness or obligations of Borrower incurred on or after the effective date of such revocation. Such revocation shall be deemed to be effective on the day following the day Bank receives such notice delivered either by: (a) personal delivery to the address and designated department of Bank identified in subparagraph 1(a) above, or (b) United States mail, registered or certified, return receipt requested, postage prepaid, addressed to Bank at the address shown in subparagraph 1(a) above. Notwithstanding such revocation, Guarantor shall remain liable on its obligations hereunder until payment in full to Bank of (x) all of the Guaranteed Indebtedness that is outstanding on the effective date of such revocation, and any renewals and extensions thereof, and (y) all loans, advances and other extensions of credit made to or for the account of Borrower on or after the effective date of such revocation pursuant to the obligation of Bank under a commitment or agreement made to or with Borrower prior to the effective date of such revocation. The terms and conditions of this Guaranty, including without limitation the consents and waivers set forth in paragraph 7 hereof, shall remain in effect with respect to the Guaranteed Indebtedness described in the preceding sentence in the same manner as if such revocation had not been made by Guarantor.

  • Right of First Negotiation Subject to the terms and conditions of this Agreement, ORGENTEC hereby grants to Proprius the right of first negotiation to obtain a license with respect to one or more Additional Products in the Field in the Territory in accordance with this Section 2.2. If, during the Term, ORGENTEC proposes to introduce (either directly or through an Affiliate or Third Party licensee or distributor) in the Territory any Additional Product, then ORGENTEC shall promptly notify Proprius thereof in writing of such intent and shall provide to Proprius any and all available scientific data, patent filings and other relevant information regarding such Additional Product (“Diligence Information”). At any time during the 30-day period commencing on the date of such notice, provided that all available Diligence Information regarding an Additional Product has been provided within [***] days following such notice (the “Review Period”), Proprius, at its sole discretion, may exercise its right of first negotiation with respect to such Additional Product by delivering written notice of exercise to ORGENTEC. If Proprius exercises such right of first negotiation prior to expiration of the Review Period, the parties shall negotiate in good faith for up to an additional [***] days (the “Negotiation Period”) regarding the terms upon which ORGENTEC would exclusively license such Additional Product to Proprius in the Field in the Territory. Until the expiration of the Negotiation Period with respect to an Additional Product, ORGENTEC shall negotiate exclusively with Proprius regarding the grant of a license with respect to such Additional Product. If Proprius does not exercise its right of first negotiation with respect to an Additional Product prior to expiration of the Review Period, or if Proprius exercises such right of first negotiation with respect to an Additional Product but the Negotiation Period expires without the parties having entered into a definitive written license agreement with respect to such Additional Product, then ORGENTEC shall be free to offer such Additional Product to, and to negotiate and enter into a license with, any Third Party with respect to such Additional Product in the Field in the Territory, except that ORGENTEC shall not license such Additional Product to any Third *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Party on terms more favorable to such Third Party than those offered to Proprius without first offering such license to Proprius on such more favorable terms for a period of at least 30 days.

  • Right of Negotiation (i) If Voyager or any Affiliate, successor, assign thereof decides not to Exploit the Product for any reason, including any such decision by Voyager following a decision by a licensee of Voyager to abandon its rights under a license from Voyager, (which Voyager shall promptly notify DURECT in writing as soon as practicable but no later than thirty (30) days after such decision) or (ii) if DURECT shall have terminated the Agreement pursuant to Section 11.2(c)(ii), DURECT shall have a right of first negotiation to obtain from Voyager an exclusive license, with the right to sublicense, under the Voyager Patents and Project Information and Inventions, and the right to use all regulatory filings, Clinical Trial data and CMC data and all other intellectual property owned by Voyager, in each case to the extent solely related to the Product, and the right to cross-reference any and all regulatory filings with respect to the Product, solely for purposes of Exploiting the Product. No later than twenty (20) days after DURECT's receipt of notice from Voyager under (i) above or the effective date of termination under (ii) above, DURECT shall notify Voyager whether it wishes to exercise its right of first negotiation. If DURECT notifies Voyager that its wishes to exercise its right of first negotiation, then Voyager shall allow DURECT to conduct reasonable diligence including providing to DURECT all information as reasonably requested by DURECT, and the Parties shall negotiate in good faith a definitive agreement covering such license to DURECT for a period not to exceed 180 days from the date of DURECT's notice of exercise. In the event that the Parties have not executed a definitive agreement within such 180-day period, then Voyager shall have no further obligations to DURECT. Prior to the exhaustion of DURECT's right under this Section 8.7, Voyager may not offer nor negotiate with any third Person any license or assignment of subject matter covered by this right of negotiation.

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