Filing of IND Sample Clauses

Filing of IND. Bio-Management, its licensees or sublicensees shall file an IND with the U.S. FDA for one or more Products under this Agreement within five (5) years of the Effective Date. After the filing of an IND for a Product, Bio-Management, its licensees or sublicensees, shall be required to have an active IND and to be actively and diligently conducting clinical trials in pursuit of regulatory approval for such Product in the U. S. until such Product may be sold commercially in the U.S.
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Filing of IND. The work here relates to completing the pre-clinical development of EPI-506 and then filing an IND based on that work. Also included is the required preparatory work for commencing clinical studies.
Filing of IND. Cell-Matrix, its licensees or sublicensees shall file an IND with the U.S. FDA for one or more Products under this Agreement no later than February 28, 2006. Cell-Matrix shall use its best efforts to obtain FDA approval of the IND within [***]. Within [***] after the non-conditional approval of the IND for a Product, Cell-Matrix, its licensees or sublicensees, shall be required to have an active IND and to be actively and diligently conducting clinical trials in pursuit of regulatory approval for such Product in the U. S. until such Product may be sold commercially in the U.S.
Filing of IND. Without limiting Section 5.1 above, AVI or its Sublicensee shall file an IND with the U.S. FDA for one or more Products under this Agreement [*]; provided, however, prior to the expiration of such [*], if AVI requests in writing that ABX extend such time period, and provides ABX with reasonably satisfactory evidence that AVI has diligently endeavored to file such an IND within such [*], and pays to ABX the [*], then ABX shall extend such time period for an additional [*]. If AVI pays such extension fee to ABX as set forth above, AVI shall have the right to [*]. After the filing of an IND for a Product, AVI, or its Sublicensee, shall be required to have an active IND and to be actively and diligently conducting clinical trials in pursuit of regulatory approval ------------------ * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. for the Product in the United States until such Product may be sold commercially in the United States.
Filing of IND. Unless otherwise agreed to by Cira, xxthin one hundred twenty (120) days after receipt of the final written report from Dr. Xxxxxx xxxcribed in Section 6.01, Neoprobe shall file information and data with the FDA sufficient to support an IND and a Protocol for the next appropriate clinical study. Unless otherwise agreed to by Cira, Xxoprobe shall initiate the next study Protocol within one hundred twenty (120) days after approval of such study Protocol by the FDA.
Filing of IND. Without limiting Section 5.1 above, MBio, its Affiliate or Sublicensee shall file an IND with the U.S. FDA for one or more Products under this Agreement [*]; provided, however, if MBio, its Affiliate or Sublicensee has failed to file an IND with the U.S. FDA for one or more Products under this Agreement [*], such failure shall not constitute a material breach under Section 10.2 below if, and (except as provided below) for so long as, MBio, its Affiliate or Sublicensee then uses and thereafter continues to use its best efforts to file an IND with the U.S. FDA for one or more Products under this Agreement [*]; provided, further, in any event, MBio, its Affiliate or Sublicensee shall file an IND with the U.S. FDA for one or more Products under this Agreement [*] of the date of the XT-ABX Product License regarding the Product Antigen. After the filing of an IND for a Product, MBio, its Affiliate or Sublicensee shall be required to have an active IND and to be actively and diligently conducting clinical trials in pursuit of regulatory approval for the Product in the United States until such Product may be sold commercially in the United States.

Related to Filing of IND

  • Filing of Agreement Upon execution of this Agreement, it shall be filed with the appropriate state regulatory agency pursuant to the requirements of Section 252 of the Act. If the regulatory agency imposes any filing or public notice fees regarding the filing or approval of the Agreement, Carrier shall be responsible for publishing the required notice and the publication and/or notice costs shall be borne by Carrier.

  • Recording of Indenture If this Indenture is subject to recording in any appropriate public recording offices, such recording is to be effected by the Issuer and at its expense accompanied by an Opinion of Counsel (which may be counsel to the Indenture Trustee or any other counsel reasonably acceptable to the Indenture Trustee) to the effect that such recording is necessary either for the protection of the Noteholders or any other Person secured hereunder or for the enforcement of any right or remedy granted to the Indenture Trustee under this Indenture.

  • Filing of Amendments The Company will give the Representatives notice of its intention to file or prepare any amendment to the Registration Statement (including any filing under Rule 462(b)), any Term Sheet or any amendment, supplement or revision to either the prospectus included in the Registration Statement at the time it became effective or to the Prospectus, whether pursuant to the 1933 Act, the 1934 Act or otherwise, will furnish the Representatives with copies of any such documents a reasonable amount of time prior to such proposed filing or use, as the case may be, and will not file or use any such document to which the Representatives or counsel for the Underwriters shall object.

  • CLOSING OF IPO 38 8.10 Secretary's Certificate.........................................38 8.11 Employment Agreements...........................................38 8.12

  • Filing of Registration Statement The Company has filed with the Commission a registration statement, and an amendment or amendments thereto, on Form F-1 (File No. 333-234654), including any related prospectus or prospectuses, for the registration of the Securities under the Securities Act, which registration statement and amendment or amendments have been prepared by the Company in conformity with the requirements of the Securities Act. Except as the context may otherwise require, such registration statement, as amended, on file with the Commission at the time the registration statement became effective (including the Preliminary Prospectus included in the registration statement, financial statements, schedules, exhibits and all other documents filed as a part thereof or incorporated therein and all information deemed to be a part thereof as of the Effective Date pursuant to paragraph (b) of Rule 430A of the Securities Act (the “Rule 430A Information”), is referred to herein as the “Registration Statement.” If the Company files any registration statement pursuant to Rule 462(b) of the Securities Act, then after such filing, the term “Registration Statement” shall include such registration statement filed pursuant to Rule 462(b). The Registration Statement has been declared effective by the Commission on the date hereof. Each prospectus used prior to the effectiveness of the Registration Statement, and each prospectus that omitted the Rule 430A Information that was used after such effectiveness and prior to the execution and delivery of this Agreement, is herein called a “Preliminary Prospectus.” The Preliminary Prospectus, subject to completion and filed with the Commission on [●], 2020, that was included in the Registration Statement immediately prior to the Applicable Time (as defined below) is hereinafter called the “Pricing Prospectus.” The final prospectus in the form first furnished to the Underwriters for use in the Offering is hereinafter called the “Prospectus.” Any reference to the “most recent Preliminary Prospectus” shall be deemed to refer to the latest Preliminary Prospectus included in the Registration Statement. For purposes of this Agreement:

  • Filing of Reports Title Company shall be solely responsible for the timely filing of any reports or returns required pursuant to the provisions of Section 6045(e) of the Internal Revenue Code of 1986 (and any similar reports or returns required under any state or local laws) in connection with the closing of the transaction contemplated in this Agreement.

  • Filing of Patent Applications Each Party will make timely decisions regarding the filing of Patent Applications on the CRADA Subject Inventions made solely by its employee(s), and will notify the other Party in advance of filing. Collaborator will have the first opportunity to file a Patent Application on joint CRADA Subject Inventions and will notify PHS of its decision within sixty (60) days of an Invention being reported or at least thirty (30) days before any patent filing deadline, whichever occurs sooner. If Collaborator fails to notify PHS of its decision within that time period or notifies PHS of its decision not to file a Patent Application, then PHS has the right to file a Patent Application on the joint CRADA Subject Invention. Neither Party will be obligated to file a Patent Application. Collaborator will place the following statement in any Patent Application it files on a CRADA Subject Invention: “This invention was created in the performance of a Cooperative Research and Development Agreement with the [INSERT into Agency’s model as appropriate: National Institutes of Health, Food and Drug Administration, Centers for Disease Control and Prevention], an Agency of the Department of Health and Human Services. The Government of the United States has certain rights in this invention.” If either Party files a Patent Application on a joint CRADA Subject Invention, then the filing Party will include a statement within the Patent Application that clearly identifies the Parties and states that the joint CRADA Subject Invention was made under this CRADA.

  • Filing of Motions Until the First Priority Obligations Payment Date has occurred, the Second Priority Representative agrees on behalf of itself and the other Second Priority Secured Parties that no Second Priority Secured Party shall, in or in connection with any Insolvency Proceeding, file any pleadings or motions, take any position at any hearing or proceeding of any nature, or otherwise take any action whatsoever, in each case that (a) violates, or is prohibited by, this Section 5 (or, in the absence of an Insolvency Proceeding, otherwise would violate or be prohibited by this Agreement), (b) asserts any right, benefit or privilege that arises in favor of the Second Priority Secured Parties, in whole or in part, as a result of their interest in the Common Collateral (unless the assertion of such right is expressly permitted by this Agreement) or (c) challenges the validity, priority, enforceability or voidability of any Liens or claims held by the First Priority Representative or any other First Priority Secured Party with respect to the Common Collateral, or the extent to which the First Priority Obligations constitute secured claims or the value thereof under Section 506(a) of the Bankruptcy Code or otherwise; provided that the Second Priority Representative may (i) file a proof of claim in an Insolvency Proceeding and (ii) file any necessary responsive or defensive pleadings in opposition to any motion or other pleadings made by any Person objecting to or otherwise seeking the disallowance of any claims of the Second Priority Secured Parties on the Common Collateral, subject to the limitations contained in this Agreement and only if consistent with the terms and the limitations on the Second Priority Representative imposed hereby.

  • Filing of Financing Statements The Depositor will file financing and continuation statements, and amendments to the statements, in the jurisdictions and with the filing offices necessary to perfect the Issuer’s interest in the Sold Property. The Depositor will promptly deliver to the Issuer and the Indenture Trustee file-stamped copies of, or filing receipts for, any financing statement, continuation statement and amendment to a previously filed financing statement.

  • Costs of updating of registration statement If provided for in the Prospectus for a Trust, the Trustee shall pay, or reimburse to the Depositor, the expenses related to the updating of the Trust's registration statement, to the extent of legal fees, typesetting fees, electronic filing expenses and regulatory filing fees. Such expenses shall be paid from the Income Account, or to the extent funds are not available in such Account, from the Capital Account, against an invoice or invoices therefor presented to the Trustee by the Depositor. By presenting such invoice or invoices, the Depositor shall be deemed to certify, upon which certification the Trustee is authorized conclusively to rely, that the amounts claimed therein are properly payable pursuant to this paragraph. The Depositor shall provide the Trustee, from time to time as requested, an estimate of the amount of such expenses, which the Trustee shall use for the purpose of estimating the accrual of Trust expenses. The amount paid by the Trust pursuant to this paragraph in each year shall be separately identified in the annual statement provided to Unit holders. The Depositor shall assure that the Prospectus for the Trust contains such disclosure as shall be necessary to permit payment by the Trust of the expenses contemplated by this paragraph under applicable laws and regulations. The provisions of this paragraph shall not limit the authority of the Trustee to pay, or reimburse to the Depositor or others, such other or additional expenses as may be determined to be payable from the Trust as provided in this Section 6.02.

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