Existing IND Sample Clauses

The 'Existing IND' clause defines the status and handling of an Investigational New Drug (IND) application that has already been filed with regulatory authorities prior to the agreement. This clause typically specifies which party owns or controls the IND, outlines any obligations regarding its maintenance, and may address how the IND will be referenced or used in connection with the collaboration or project. Its core practical function is to clarify rights and responsibilities related to the pre-existing regulatory filing, thereby preventing disputes over access, use, or ownership of the IND during the course of the agreement.
Existing IND. As of the Effective Date, FivePrime holds an IND for FP-1039 in the U.S. with the IND No. *** (FP-1039) (the “Existing IND”), under which it is conducting the FivePrime-Conducted Trials. As of the Effective Date, FivePrime plans to complete the FP-1039 Phase 1 Trial, and to continue conducting the FP-1039 Endometrial Trial (FP-1039-002) in the U.S. under the same IND and in other countries under INDs to be filed in such other countries that are substantially foreign equivalents of the Existing IND (such future INDs, the “Endometrial Foreign INDs”).
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Existing IND. OGX shall hold, under the direction and control of the JSC, the U.S. IND for Licensed Products that exists as of the Effective Date (“Existing IND”), until such time as either Teva or OGX requests such Existing IND to be transferred to Teva, at which time OGX shall promptly transfer the Existing IND to Teva.
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Existing IND. Array shall retain ownership, and remain the sponsor, of the Initial IND until the last patient visit in the 403 MAD and the 403 Bioequivalence Trial. Array shall notify Amgen within fifteen (15) days after the occurrence of the last patient visit in the 403 MAD and the 403 Bioequivalence Trial. Upon the request of Amgen following such event, Array shall transfer the Initial IND to Amgen or, if directed by Amgen, close or inactivate the Initial IND as soon as reasonably practicable. Array shall complete all relevant clinical trial and Initial IND administrative activities for the 403 MAD and the 403 Bioequivalence Trials and shall promptly, on a regular basis and as requested by Amgen, share all clinical trial data with Amgen. Amgen shall be responsible for the preparation and filing of all subsequent IND(s) or other regulatory filings with respect to any clinical development for ARRY-403 other than the 403 SAD, 403 MAD and 403 Bioequivalence Trial.
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Existing IND. Vical has sufficient legal and/or beneficial title and ownership in the Existing IND sufficient to transfer such Existing IND to Astellas in accordance with Section 4.1; no Regulatory Authority has, to Vical’s knowledge, commenced or threatened to initiate any action or proceeding to refuse to file, reject, not approve, or withdraw the Existing IND, nor has Vical received any notice to such effect; and to Vical’s knowledge, Vical is not in violation of any applicable laws that could reasonably be expected to form the basis for such an action.
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Related to Existing IND

  • Existing Indebtedness (a) Except as described therein, Schedule 5.15 sets forth a complete and correct list of all outstanding Indebtedness of the Company as of the Closing Date after giving effect to the Acquisition (including a description of the obligors and obligees, principal amount outstanding and collateral therefor, if any, and Guaranty thereof, if any), since which date there has been no Material change in the amounts, interest rates, sinking funds, installment payments or maturities of the Indebtedness of the Company. The Company is not in default and no waiver of default is currently in effect, in the payment of any principal or interest on any Indebtedness of the Company and no event or condition exists with respect to any Indebtedness of the Company that would permit (or that with notice or the lapse of time, or both, would permit) one or more Persons to cause such Indebtedness to become due and payable before its stated maturity or before its regularly scheduled dates of payment. (b) The Company is not a party to, or otherwise subject to any provision contained in, any instrument evidencing Indebtedness of the Company, any agreement relating thereto or any other agreement (including, but not limited to, its charter or other organizational document) which limits the amount of, or otherwise imposes restrictions on the incurring of, Indebtedness of the Company, except as specifically indicated in Schedule 5.15 and as provided in the Mortgage.

  • Existing Lock-Up Agreements Except as described in the Registration Statement, the Disclosure Package and the Prospectus, there are no existing agreements between the Company and its security holders that prohibit the sale, transfer, assignment, pledge or hypothecation of any of the Company’s securities. The Company will direct the transfer agent to place stop transfer restrictions upon the securities of the Company that are bound by such “lock-up” agreements for the duration of the periods contemplated therein.

  • Existing Indebtedness; Future Liens (a) Except as described therein, Schedule 5.15 sets forth a complete and correct list of all outstanding Indebtedness of the Parent Guarantor and its Significant Subsidiaries as of March 31, 2018 (including descriptions of the obligors and obligees, principal amounts outstanding, any collateral therefor and any Guarantees thereof, but excluding any intercompany Indebtedness), since which date there has been no Material change in the amounts, interest rates, sinking funds, installment payments or maturities of the Indebtedness of the Parent Guarantor or its Significant Subsidiaries. No Obligor nor any Significant Subsidiary is in default and no waiver of default is currently in effect, in the payment of any principal or interest on any Indebtedness of such Obligor or such Significant Subsidiary and no event or condition exists with respect to any Indebtedness of any Obligor or any Significant Subsidiary that would permit (or that with notice or the lapse of time, or both, would permit) one or more Persons to cause such Indebtedness to become due and payable before its stated maturity or before its regularly scheduled dates of payment. (b) Except as disclosed in Schedule 5.15, no Obligor nor any Significant Subsidiary has agreed or consented to cause or permit any of its property, whether now owned or hereafter acquired, to be subject to a Lien that secures Indebtedness or to cause or permit in the future (upon the happening of a contingency or otherwise) any of its property, whether now owned or hereafter acquired, to be subject to a Lien not permitted by Section 10.5. (c) No Obligor nor any Significant Subsidiary is a party to, or otherwise subject to any provision contained in, any instrument evidencing Indebtedness of such Obligor or such Significant Subsidiary, any agreement relating thereto or any other agreement (including its charter or any other organizational document) which limits the amount of, or otherwise imposes restrictions on the incurring of, Indebtedness of such Obligor, except as disclosed in Schedule 5.15.

  • DESCRIPTION OF EXISTING INDEBTEDNESS AND OBLIGATIONS Among other indebtedness and obligations which may be owing by Borrower to Bank, Borrower is indebted to Bank pursuant to a loan arrangement dated as of June 11, 2003, evidenced by, among other documents, a certain Loan and Security Agreement dated as of June 11, 2003 between Borrower and Bank, as amended from time to time (as amended, the "Loan Agreement"). Capitalized terms used but not otherwise defined herein shall have the same meaning as in the Loan Agreement.

  • Existing Agreements The Executive represents to the Company that he is not subject or a party to any employment or consulting agreement, non-competition covenant or other agreement, covenant or understanding which might prohibit him from executing this Agreement or limit his ability to fulfill his responsibilities hereunder.