Clinical Trial Registration Sample Clauses

Clinical Trial Registration. Notwithstanding the foregoing, in all cases, Merck shall have the right to register clinical trials and publish the results or summaries of results of any clinical trials conducted hereunder with respect to Compound or Product on xxxxxxxxxxxxxx.xxx or other similar registry.
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Clinical Trial Registration. This clinical trial will be registered on the “xxxxxxxxxxxxxx.xxx” clinical trial registry website as required by 42 USC 282(j).
Clinical Trial Registration. CHINA This is the process of assembling, summarizing and translating all pre-clinical and clinical information relating to work that has been completed with the device to date by NexMed as well as any related devices on the market in the US or in China. The strategy will be to equate this herpes device with already marketed TENS devices which will make the clinical registration process much easier and quicker. Innapharma China will then submit this package to the Ministry of Public Health. Upon review of this package, the Ministry will issue Clinical Trial Registration Approval allowing the trial to begin or advise us as to the proper pathway. The assumption has been made that this clinical trial will be conducted under U.S. Good Clinical Practice conditions and the data from the trial will be submitable worldwide to augment other submissions
Clinical Trial Registration. CHINA This is the process of assembling, summarizing and translating all pre-clinical and clinical information relating to prostaglandin E-1 from the literature as well as from NexMed's trials and submitting this package to the Ministry of Health. Upon review of this package, the Ministry will issue Clinical Trial Registration Approval allowing the trial to Commence or advise us as to the proper pathway. The assumption has been made that this clinical trial will be conducted under U.S. Good Clinical Practice conditions and the data from the trial will be able to be used worldwide to augment other submissions All work both in US and in China to prepare this package is covered by one charge as indicated in Exhibit B and listed as "Clinical Trial Registration Process". II. PREPARATION OF STUDY MATERIALS INNAPHARMA assumes that there will be further modifications to the protocol submitted to the Chinese regulatory authorities. Innapharma will work with the Chinese regulatory authorities to produce a final Protocol that satisfies all parties. Innapharma will develop and design the case report forms (annotated in Chinese). It has been assumed that the clinical supplies will be produced, packaged and shipped to investigative sites by NexMed. III. INITIATION OF STUDY Innapharma will work with the Ministry of Health to select the most qualified and experienced investigative sites for this study. Innapharma will negotiate all investigator grants and provide a duly constituted local IRB. Innapharma will conduct pre-study qualification visits to all sites. Upon satisfactory approval each site will be shipped a pre-study package of documents to prepare and submit to Innapharma as per GCP. INITIATION VISITS I SITE COORDINATOR TRAINING During the initiation visits study coordination training sessions to review protocol / CRFs will be developed and conducted by INNAPHARMA personnel at study initiation visits for all investigative sites involved in the clinical trial. IV. CONDUCT OF STUDY PATIENT GRANTS Innapharma will manage grant payments to all investigators. STUDY MONITORING INNAPHARMA will select study monitors from the Innapharma China Monitor Network. All monitors are medical doctors. Monitors will be chosen based on therapeutic experience as well as location. INNAPHARMA will utilize local monitors whenever possible to minimize travel time and costs. ONGOING REPORTS SERIOUS ADVERSE EVENTS Serious adverse event reports will be forwarded to the sponsor within 24 hours...
Clinical Trial Registration. MEMORY shall register each clinical trial to be conducted pursuant to the Development Program with (i) SMRI’s quarterly trial reporting system and (ii) if and to the extent required by law, the US FDA’s xxx.XxxxxxxxXxxxx.xxx website.
Clinical Trial Registration. Prior to the initiation of Study enrollment, Sponsor shall be responsible for posting the Study on a clinical trial registry which meets the criteria and contains the information required by the International Committee of Medical Journal Editors (“ICMJE”) for publication and meets the requirements of the Food and Drug Administration (“FDA”) and any other state or federal law pertaining to registration of the Study. Sponsor shall be responsible for updating such registration as required to comply with updates to any such ICMJE, FDA, and/or legal requirements.

Related to Clinical Trial Registration

  • Initial Registration The Company shall file a Registration Statement under the Securities Act promptly, but in any event within thirty (30) days following the Closing, to permit the public resale of all the Registrable Securities held by the Holders from time to time as permitted by Rule 415 under the Securities Act (or any successor or similar provision adopted by the Commission then in effect) (“Rule 415”) on the terms and conditions specified in this subsection 2.1.1 and shall use its commercially reasonable efforts to cause such Registration Statement to be declared effective as soon as practicable after the filing thereof, but in no event later than sixty (60) days following the filing deadline (the “Effectiveness Deadline”); provided, that the Effectiveness Deadline shall be extended to ninety (90) days after the filing deadline if the Registration Statement is reviewed by, and receives comments from, the Commission. The Registration Statement filed with the Commission pursuant to this subsection 2.1.1 shall be a shelf registration statement on Form S-1 (a “Form S-1”) or such other form of registration statement as is then available to effect a registration for resale of such Registrable Securities, covering such Registrable Securities, and shall contain a Prospectus in such form as to permit any Holder to sell such Registrable Securities pursuant to Rule 415 at any time beginning on the effective date for such Registration Statement. A Registration Statement filed pursuant to this subsection 2.1.1 shall provide for the resale pursuant to any method or combination of methods legally available to, and requested by, the Holders. The Company shall use its commercially reasonable efforts to cause a Registration Statement filed pursuant to this subsection 2.1.1 to remain effective, and to be supplemented and amended to the extent necessary to ensure that such Registration Statement is available or, if not available, that another Registration Statement is available, for the resale of all the Registrable Securities held by the Holders until all such Registrable Securities have ceased to be Registrable Securities. As soon as practicable following the effective date of a Registration Statement filed pursuant to this subsection 2.1.1, but in any event within two (2) business days of such date, the Company shall notify the Holders of the effectiveness of such Registration Statement. When effective, a Registration Statement filed pursuant to this subsection 2.1.1 (including the documents incorporated therein by reference) will comply as to form in all material respects with all applicable requirements of the Securities Act and the Exchange Act and will not contain a Misstatement.

  • Initial Registration Statement Promptly following the closing of the Merger Agreement and Plan of Reorganization dated as of January ____, 2007, among the Corporation, Elite FX, Inc., and other parties named therein (the "Closing Date") (but no later than one hundred and eight (180) days after the Closing Date), the Corporation shall use its reasonable best efforts to cause to be filed and declared effective as soon as reasonably practicable (but in no event later than 30 days after the SEC issues a no review letter) a registration statement under the Securities Act of 1933 and the rules promulgated thereunder (the "1933 Act"), covering the resale of the Registrable Securities held by the Subscribers, Nugent, Baudanza, Horn and Investa, if any, plus the number of shares of Common Stock necessary to permit the exercise in full of the Penalty Warrants outstanding or issuable on the date of filing. At the time the Registration Statement is declared effective, the Registration Statement shall include all shares of Common Stock exercisable under all Penalty Warrants outstanding or issuable at such time, if any. Such Registration Statement also shall cover, to the extent allowable under the 1933 Act (including Rule 416), such indeterminate number of additional shares of Common Stock resulting from stock splits, stock dividends or similar transactions with respect to the Registrable Securities. No securities held by a third party shall be included in such Registration Statement without the consent of the Subscribers. The Registration Statement (and each amendment or supplement thereto, and each request for acceleration of effectiveness thereof) shall be provided in accordance with Section 3(c) hereof to the Subscribers and their counsel prior to its filing or other submission. If a Registration Statement covering the Registrable Securities is not filed with the SEC within one hundred and eighty (180) days of the Closing Date (the "Registration Date"), except as excused pursuant to Section 2(d) below, for each 30-day period (or pro rata for any portion thereof) following the Registration Date during which no Registration Statement is filed with respect to the Registrable Securities, the Corporation will issue Penalty Warrants as set forth in Section 8 below in respect of any Registrable Shares still held by any Subscriber, Nugent, Baudanza, Horn or Investa, if any; provided, however, that no Penalty Warrants shall be issuable to any Subscriber, Nugent, Baudanza, Horn or to Investa in the event such party does not hold or no longer holds Registrable Securities at the time any Penalty Warrants are to be issued.

  • Maintaining a Registration Statement The Company shall maintain the effectiveness of any Registration Statement that has been declared effective at all times during the Commitment Period, provided, however, that if the Company has received notification pursuant to Section 2.04 that the Investor has completed resales pursuant to the Registration Statement for the full Commitment Amount, then the Company shall be under no further obligation to maintain the effectiveness of the Registration Statement. Notwithstanding anything to the contrary contained in this Agreement, the Company shall ensure that, when filed, each Registration Statement (including, without limitation, all amendments and supplements thereto) and the prospectus (including, without limitation, all amendments and supplements thereto) used in connection with such Registration Statement shall not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein, or necessary to make the statements therein (in the case of prospectuses, in the light of the circumstances in which they were made) not misleading. During the Commitment Period, the Company shall notify the Investor promptly if (i) the Registration Statement shall cease to be effective under the Securities Act, (ii) the Common Shares shall cease to be authorized for listing on the Principal Market, (iii) the Common Shares cease to be registered under Section 12(b) or Section 12(g) of the Exchange Act or (iv) the Company fails to file in a timely manner all reports and other documents required of it as a reporting company under the Exchange Act.

  • Additional Registration Statement To the extent that the Registration Statement is not available for the sales of the Shares as contemplated by this Agreement, the Company shall file a new registration statement with respect to any additional shares of Common Stock necessary to complete such sales of the Shares and shall cause such registration statement to become effective as promptly as practicable. After the effectiveness of any such registration statement, all references to “Registration Statement” included in this Agreement shall be deemed to include such new registration statement, including all documents incorporated by reference therein pursuant to Item 12 of Form S-3, and all references to “Base Prospectus” included in this Agreement shall be deemed to include the final form of prospectus, including all documents incorporated therein by reference, included in any such registration statement at the time such registration statement became effective.

  • Incidental Registration If the Company at any time (other than pursuant to Section 4 or Section 6) proposes to register any of its securities under the Securities Act for sale to the public, whether for its own account or for the account of other securityholders or both (except with respect to registration statements on Forms X-0, X-0 or another form not available for registering the Restricted Stock for sale to the public), each such time the Company will give written notice to all Holders of outstanding Restricted Stock of its intention to do so. Upon the written request of any such Holder received by the Company within 30 days of the giving of any such notice by the Company to register any of such Holder's Restricted Stock (which request shall state the intended method of disposition thereof), the Company will use its reasonable best efforts to cause the Restricted Stock as to which registration shall have been so requested to be included in the securities to be covered by the registration statement proposed to be filed by the Company, all to the extent requisite to permit the sale or other disposition by the Holder (in accordance with such Holder's written request) of such Restricted Stock so registered. In the event that any registration pursuant to this Section 5 shall be, in whole or in part, an underwritten public offering of Common Stock, the number of shares of Restricted Stock to be included in such an underwriting may be reduced if and to the extent that the managing underwriter shall be of the opinion that such inclusion would adversely affect the marketing of the securities to be sold by the Company or the requesting party therein or that such reduction is otherwise advisable, provided, however, that after any shares to be sold by holders that do not have contractual rights to have shares included in such registration have been excluded, shares to be sold by the Holders shall be excluded in such manner that the shares to be excluded shall first be the shares of selling Holders and other requesting holders who, in each case, are not Affiliate Holders and whose shares are then saleable under Rule 144(e) or Rule 144(k) under the Securities Act and then pro rata among them, and if further reduction is necessary, shall next be pro rata among the remaining shares of the selling Holders and other requesting holders who are Affiliate Holders or whose shares are not then saleable under Rule 144(e) or Rule 144(k), unless such registration is pursuant to the exercise of a demand right of another securityholder, in which event such securityholder shall be entitled to include all shares it desires to have so included before any shares of Restricted Stock or shares of any other holder are included therein and provided, however, that, notwithstanding anything in this Agreement to the contrary, in respect of the first underwritten public offering following the date of this Agreement, no reduction shall reduce the number of shares which may be sold by requesting Holders to less than 25% of the shares to be sold in such offering.

  • Additional Registration Statements Until the Applicable Date (as defined below) and at any time thereafter while any Registration Statement is not effective or the prospectus contained therein is not available for use or any Current Public Information Failure (as defined in the Registration Rights Agreement) exists, the Company shall not file a registration statement or an offering statement under the 1933 Act relating to securities that are not the Registrable Securities (other than a registration statement on Form S-8 or such supplements or amendments to registration statements that are outstanding and have been declared effective by the SEC as of the date hereof (solely to the extent necessary to keep such registration statements effective and available and not with respect to any Subsequent Placement)). “Applicable Date” means the earlier of (x) the first date on which the resale by the Buyers of all the Registrable Securities required to be filed on the initial Registration Statement (as defined in the Registration Rights Agreement) pursuant to the Registration Rights Agreement is declared effective by the SEC (and each prospectus contained therein is available for use on such date) or (y) the first date on which all of the Registrable Securities are eligible to be resold by the Buyers pursuant to Rule 144 (or, if a Current Public Information Failure has occurred and is continuing, such later date after which the Company has cured such Current Public Information Failure).

  • Priority in Incidental Registration If an Incidental Registration involves an Underwritten Offering (on a firm commitment basis), and the sole or the lead managing Underwriter, as the case may be, of such Underwritten Offering shall advise the Company in writing (with a copy to each Holder requesting registration) on or before the date five days prior to the date then scheduled for such offering that, in its opinion, the amount of securities (including Registrable Securities) requested to be included in such registration exceeds the amount which can be sold in such offering without materially adversely affecting the price at which the securities being offered can be sold and/or their ability to successfully market and sell the securities being offered (such writing to state the basis of such opinion and the approximate number of such securities which may be included in such offering without such effect), the Company shall include in such registration, to the extent of the number which the Company is so advised may be included in such offering without such effect, (i) in the case of a registration initiated by the Company, (A) first, the securities that the Company proposes to register for its own account, (B) second, the Registrable Securities requested to be included in such registration by the Holders and any other stockholders having contractual rights to participate in such registration, allocated pro rata in proportion to the number of Registrable Securities requested to be included in such registration by each of them, and (C) third, other securities of the Company to be registered on behalf of any other Person, and (ii) in the case of a registration initiated by a Person other than the Company, (A) first, the securities requested to be included in such registration by any Persons initiating such registration, allocated pro rata in proportion to the number of securities requested to be included in such registration by each of them, (B) second, the Registrable Securities requested to be included in such registration by the Holders and any other stockholders having contractual rights to participate in such registration, allocated pro rata in proportion to the number of Registrable Securities requested to be included in such registration by each of them, (C) third, the securities that the Company proposes to register for its own account, and (D) fourth, other securities of the Company to be registered on behalf of any other Person; provided, however, that in the event the Company will not, by virtue of this Section 2.3(b), include in any such registration all of the Registrable Securities of any Holder requested to be included in such registration, such Holder may, upon written notice to the Company given within three days of the time such Holder first is notified of such matter, reduce the amount of Registrable Securities it desires to have included in such registration, whereupon only the Registrable Securities, if any, it desires to have included will be so included and the Holders not so reducing shall be entitled to a corresponding increase in the amount of Registrable Securities to be included in such registration.

  • SEC Registration The Parties mutually agree to use commercially reasonable efforts to maintain effective registration statements with the Securities and Exchange Commission with respect to the long-term incentive awards to the extent any such registration statement is required by applicable Law.

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