Product Registration Application Sample Clauses

Product Registration Application. Ownership Cadence shall be the sole owner of all NDA and other registration applications submitted to Regulatory Authorities for the Drug Product. Cadence shall have responsibility for the documentation and submission of the registration applications to Regulatory Authorities for the Drug Product and for completing the FDA Annual Report and similar reports required by other Regulatory Authorities for Drug Product, with support from Solvay in providing any information required from Solvay in order to complete such reports.
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Related to Product Registration Application

  • Listing Application If shares of any class of stock of the Company shall be listed on a national securities exchange, the Company shall, at its expense, include in its listing application all of the shares of the listed class then owned by any Investor.

  • Regulatory Applications (a) Sky and Metropolitan and their respective Subsidiaries shall cooperate and use their respective reasonable best efforts to prepare, within 45 days of the execution of this Agreement, all documentation and requests for regulatory approval, to timely effect all filings and to obtain all permits, consents, approvals and authorizations of all third parties and Governmental Authorities and Regulatory Authorities necessary to consummate the transactions contemplated by this Agreement. Each of Sky and Metropolitan shall have the right to review in advance, and to the extent practicable each will consult with the other, in each case subject to applicable laws relating to the exchange of information, with respect to, and shall be provided in advance so as to reasonably exercise its right to review in advance, all material written information submitted to any third party or any Governmental Authority or Regulatory Authority in connection with the transactions contemplated by this Agreement. In exercising the foregoing right, each of the parties hereto agrees to act reasonably and as promptly as practicable. Each party hereto agrees that it will consult with the other party hereto with respect to the obtaining of all material permits, consents, approvals and authorizations of all third parties and Governmental Authorities or Regulatory Authorities necessary or advisable to consummate the transactions contemplated by this Agreement and each party will keep the other party apprised of the status of material matters relating to completion of the transactions contemplated hereby.

  • 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.

  • 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 National Institutes of Health, 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.

  • Additional Registration Procedures In connection with any Shelf Registration Statement and, to the extent applicable, any Exchange Offer Registration Statement, the following provisions shall apply.

  • Regulatory Materials (a) Alvogen shall have the sole right to control filing or submission of Regulatory Materials with the Regulatory Agencies in the Territory with respect to Product including the MAA Approval for Product and Regulatory Approvals in the Territory, subject to Section 3.2 and the oversight of and in consultation with the Executive Steering Committee, and [***]Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. shall be responsible for managing all communications and interactions with the Regulatory Agencies in the Territory with respect to Product in the Territory. In all cases, prior to the filing of any Regulatory Materials (including the MAA for Product) for Product with the applicable Regulatory Agency, Alvogen shall provide a copy thereof to Pfenex (through the Executive Steering Committee) for its review and comment. Pfenex shall have fifteen (15) Business Days from the date it receives a copy of any Regulatory Materials with respect to the Product to provide Alvogen with comments regarding such Regulatory Materials, unless the Regulatory Agencies in the Territory or Applicable Law requires that such Regulatory Material(s) be filed on a timeline that does not reasonably permit such advanced notice, in which case Pfenex shall have as much time as is reasonably practicable to provide Alvogen with comments. Alvogen shall consider all such comments in good faith. Alvogen shall, to the extent permitted by Applicable Law, provide Pfenex with (i) reasonable advanced notice (and in no event less than fifteen (15) Business Days’ advance notice whenever feasible) of substantive meetings with any Regulatory Agency in the Territory that are either scheduled with or initiated by or on behalf of Alvogen or its Affiliates, (ii) an opportunity to have a reasonable number (but at least two (2)) representatives participate in all substantive meetings with the Regulatory Agencies in the Territory with respect to Product, and in any case keep Pfenex informed as to all material interactions with the Regulatory Agencies in the Territory with respect to Product, and (iii) a copy of any material documents, information and correspondence submitted to or received from the Regulatory Agencies in the Territory with respect to Product as soon as reasonably practicable.

  • Registration Procedures In connection with the Company’s registration obligations hereunder, the Company shall:

  • Patent Applications It is understood by the parties that, pursuant to the Baylor Technology Transfer Agreement, MAS has the initial responsibility for filing, prosecution and maintenance of Patents and Patent Applications covering the Baylor Technology. The parties agree that, as between MAS and CTI, MAS shall be responsible for deciding whether and how to file, prosecute and maintain the Patents and Patent Applications, provided that:

  • Registration Procedure Unless such Redemption Shares have been included in the filing of an Issuer Registration Statement as provided in Section 2 hereof, then, subject to Sections 3.1(c) and 3.2 hereof, the Holder may deliver to the Company, at any time after the last date on which an Issuer Registration Statement may be filed as provided in Section 2 hereof, a written notice (a "REGISTRATION NOTICE") informing the Company of its desire to have the Redemption Shares underlying its Units registered for sale (such Redemption Shares, together with all additional shares of Common Stock which may be issued in the future upon redemption of any remaining Units held by Holder, referred to herein as the "REGISTRABLE SECURITIES"); provided, however, that if the Redemption Shares have been included in the Issuer Registration Statement and the Issuer Registration Statement has not been declared effective by the SEC within ninety (90) days after the original filing date or the Company is unable to keep such Issuer Registration Statement effective until such time as the Holder no longer owns any Units, the Holder shall be entitled to exercise the rights provided under this Section 3.1. Upon receipt of the Registration Notice, if the Company has not already caused the Registrable Securities to be included as part of an existing shelf registration statement and related prospectus that the Company then has on file with, and has been declared effective by, the Commission and which remains in effect and not subject to any stop order, injunction or other order or requirement of the Commission (the "SHELF REGISTRATION STATEMENT") (in which event the Company shall be deemed to have satisfied its registration obligation under this Section 3), then the Company will cause to be filed with the Commission as soon as reasonably practicable after receiving the Registration Notice, but in no event more than sixty (60) days following receipt of such notice, a new registration statement and related prospectus (the "NEW REGISTRATION STATEMENT") that complies as to form in all material respects with applicable Commission rules providing for the sale by the Holder of the Registrable Securities, and agrees (subject to Section 3.2 hereof) to use commercially reasonable efforts to cause the New Registration Statement to be declared effective by the Commission as soon as practicable. (As used herein, "REGISTRATION STATEMENT" and "PROSPECTUS" refer to the Shelf Registration Statement and related prospectus (including any preliminary prospectus) or the New Registration Statement and related prospectus (including any preliminary prospectus), whichever is utilized by the Company to satisfy Holder's Registration Rights pursuant to this Section 3, including, in each case, any documents incorporated therein by reference.) Subject to Section 3.2 hereof, the Company agrees to use commercially reasonable efforts to keep the Registration Statement continuously effective (including the preparation and filing of any amendments and supplements necessary for that purpose) until the earlier of (i) the date that is two (2) years after the date of effectiveness of the Registration Statement, (ii) the date on which all of the Redemption Shares held by the Holder are eligible for immediate sale pursuant to Rule 144(k) (or any successor provision) or in a single transaction under Rule 144(e) (or any successor provision) under the Securities Act of 1933, as amended (the "SECURITIES ACT"), or (iii) the date on which the Holder consummates the sale of all of the Redemption Shares. Notwithstanding the foregoing, the Company may at any time, in its sole discretion and prior to receiving a Registration Notice from the Holder, include all of the Holder's Redemption Shares or any portion thereof in any shelf Registration Statement (in which event the Company shall be deemed to have satisfied its registration obligation under this Section 3.1(a) so long as such shelf Registration Statement remains effective and not the subject of any stop order, injunction or other order of the Commission).

  • Prosecution of Patent Applications At its own expense, each Assignor shall diligently prosecute all material applications for (i) United States Patents listed in Annex F hereto and (ii) Copyrights listed on Annex G hereto, in each case for such Assignor and shall not abandon any such application prior to exhaustion of all administrative and judicial remedies (other than applications deemed by such Assignor to be no longer prudent to pursue), absent written consent of the Collateral Agent.

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