Non-Required Development in the Additional Territory Sample Clauses

Non-Required Development in the Additional Territory. (i) If either Party desires to conduct additional clinical trials or other development work on the Initial Product to enhance or expand the Regulatory Approval for the Initial Product in a country in the Additional Territory beyond the scope of the initial Regulatory Approval for the Initial Product in such country (but not for a new Indication), or for the purpose of enhancing scientific knowledge and understanding of the clinical utility of the Initial Product in such country, or for any other appropriate purposes, that are not Pre-Approval Required Additional Territory Development or Post-Approval Required Additional Territory Development (“Non-Required Additional Territory Development”), the Party desiring to conduct such Non-Required Additional Territory Development shall promptly notify the other Party, and the Parties shall promptly meet to discuss in good faith and seek to agree on the terms under which the Parties would conduct such Non-Required Additional Territory Development, including (A) the Parties’ responsibilities for conducting such Non-Required Additional Territory Development and (B) the sharing of Development Expenses with respect to such Non-Required Additional Territory Development and, if the Parties agree on such terms, the Parties shall, through the JDC, establish a Development Plan for such Non-Required Additional Territory Development in the Additional Territory consistent with Section 3.4. For clarity, development of the Initial Formulation for Indications other than the Indications that, as of the Amendment Effective Date, are the subject of the Initial Product NDA shall not be considered Non-Required Additional Territory Development and shall instead, to the extent agreed under Section 3.3, be considered development of an Additional Product; provided that a label expansion or amendment for the Initial Product based on results of the BLOOM-DM Trial or any clinical data specific to the Initial Product existing as of the Amendment Effective Date shall not be considered an Additional Product.
Sample 1
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Related to Non-Required Development in the Additional Territory

  • Compliance with Registration Requirements; No Stop Order; No Objection from NASD For the period from and after effectiveness of this Agreement and prior to the First Closing Date and, with respect to the Optional Common Shares, the Second Closing Date:

  • Compliance with Registration Requirements; No Stop Order; No Objection from FINRA For the period from and after the date of this Agreement and through and including the First Closing Date and, with respect to any Optional Shares purchased after the First Closing Date, each Option Closing Date:

  • Compliance with Registration Requirements; No Stop Order; No Objection from the FINRA Each Prospectus Supplement (in accordance with Rule 424(b)) and “free writing prospectus” (as defined in Rule 405 of the Securities Act), if any, shall have been duly filed with the Commission, as appropriate; no stop order suspending the effectiveness of the Registration Statement or any part thereof shall have been issued and no proceeding for that purpose shall have been initiated or threatened by the Commission; no order preventing or suspending the use of any Prospectus Supplement shall have been issued and no proceeding for that purpose shall have been initiated or threatened by the Commission; no order having the effect of ceasing or suspending the distribution of the Securities or any other securities of the Company shall have been issued by any securities commission, securities regulatory authority or stock exchange and no proceedings for that purpose shall have been instituted or shall be pending or, to the knowledge of the Company, contemplated by any securities commission, securities regulatory authority or stock exchange; all requests for additional information on the part of the Commission shall have been complied with; and the FINRA shall have raised no objection to the fairness and reasonableness of the placement terms and arrangements.

  • Compliance with Registration Requirements; No Stop Order No Objection from the FINRA. Each Prospectus (in accordance with Rule 424(b)) and “free writing prospectus” (as defined in Rule 405 of the Securities Act), if any, shall have been duly filed with the Commission, as appropriate; no stop order suspending the effectiveness of the Registration Statement or any part thereof shall have been issued and no proceeding for that purpose shall have been initiated or threatened by the Commission; no order preventing or suspending the use of any Prospectus shall have been issued and no proceeding for that purpose shall have been initiated or threatened by the Commission; no order having the effect of ceasing or suspending the distribution of the Securities or any other securities of the Company shall have been issued by any securities commission, securities regulatory authority or stock exchange and no proceedings for that purpose shall have been instituted or shall be pending or, to the knowledge of the Company, contemplated by any securities commission, securities regulatory authority or stock exchange; all requests for additional information on the part of the Commission shall have been complied with; and the FINRA shall have raised no objection to the fairness and reasonableness of the placement terms and arrangements.

  • Effectiveness of Registration Statement; Compliance with Registration Requirements; No Stop Order During the period from and after the execution of this Agreement to and including the Closing Date or the Option Closing Date, as applicable:

  • Allocation of Registration Opportunities In any circumstance in which all of the Registrable Securities and other shares of the Company with registration rights (the “Other Shares”) requested to be included in a registration contemplated by Section 2(a) cannot be so included as a result of limitations of the aggregate number of shares of Registrable Securities and Other Shares that may be so included, the number of shares of Registrable Securities and Other Shares that may be so included shall be allocated among the Holders and Other Shareholders requesting inclusion of shares pro rata on the basis of the number of shares of Registrable Securities and Other Shares held by such Holders and Other Shareholders; provided, however, that such allocation shall not operate to reduce the aggregate number of Registrable Securities and Other Shares to be included in such registration, if any Holder or Other Shareholder does not request inclusion of the maximum number of shares of Registrable Securities and Other Shares allocated to such Holder or Other Shareholder pursuant to the above-described procedure, then the remaining portion of such allocation shall be reallocated among those requesting Holders and Other Shareholders whose allocations did not satisfy their requests pro rata on the basis of the number of shares of Registrable Securities and Other Shares which would be held by such Holders and Other Shareholders, assuming conversion, and this procedure shall be repeated until all of the shares of Registrable Securities and Other Shares which may be included in the registration on behalf of the Holders and Other Shareholders have been so allocated.

  • Commercialization Efforts The RECIPIENT shall, including whether through its own efforts or the efforts of a licensee under a License Agreement allowed by the terms of this Attachment, use diligent and commercially reasonable efforts to commercialize at least one Commercial Product or Commercial Service or otherwise bring to practical application the Project Results in accordance with the commercial development plan submitted with the Application and including any changes to such commercial development plan in accordance with Section D3.01. For the avoidance of doubt, partnering or licensing activities shall be considered to be efforts to commercialize.

  • Territory The territorial limits of this Agreement shall be identical with those of the Reinsured Contracts.

  • Additional Termination Requirements ARTICLE X

  • Limitations on Requested Registration The Company shall not be obligated to effect, or to take any action to effect, any such registration pursuant to this Section 2.1:

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