Delay of Grant of First Regulatory Approval Sample Clauses

Delay of Grant of First Regulatory Approval. In the event that the grant of the first Regulatory Approval of the NDA for the Original Product in the Field and in the Territory, regardless of its scope, should occur after [***], then, for each complete month of delay after [***] and always subject to Section 3.3.3.1, the Development Milestone Fee shall be reduced by an amount of US dollars [***] for each such month of delay, pro-rated for a partial month of delay.
Sample 1
AutoNDA by SimpleDocs
Delay of Grant of First Regulatory Approval. In the event that the grant of the first Regulatory Approval of the NDA for the Original Product in the Field and in the Territory, regardless of its scope, will occur after [***], which right may only be exercised (i) within [***] from a formal communication from the FDA in respect of such Regulatory Approval, or (ii) if following such communication Partner undertakes Development or regulatory activities to address such communication, under a Clinical Development Plan that has been coordinated and approved by the JDC in accordance with Sections 6.2.2 and 6.2.3 and Article 4, within [***] from receipt of results of such activities or from a formal communication from the FDA relating to such results. Promptly following the FDA communication referenced in the preceding clause (i), Partner shall notify Nycomed whether it intends to undertake such Development or regulatory activities. If Partner determines to undertake such activities, then Partner shall submit such Clinical Development Plan in respect thereof to the JDC, and the JDC shall review and approve such plan [***] so that Partner may comply with the [***] period referenced in the preceding clause (i).
Sample 1

Related to Delay of Grant of First Regulatory Approval

  • Grant of Right of First Refusal Except as provided in Section 12.7 below, in the event the Optionee, the Optionee's legal representative, or other holder of shares acquired upon exercise of the Option proposes to sell, exchange, transfer, pledge, or otherwise dispose of any Vested Shares (the "TRANSFER SHARES") to any person or entity, including, without limitation, any shareholder of the Participating Company Group, the Company shall have the right to repurchase the Transfer Shares under the terms and subject to the conditions set forth in this Section 12 (the "RIGHT OF FIRST REFUSAL").

  • Registration Compliance; No Stop Order No order suspending the effectiveness of the Registration Statement shall be in effect, and no proceeding for such purpose or pursuant to Section 8A under the Securities Act shall be pending before or threatened by the Commission; the Prospectus and each Issuer Free Writing Prospectus shall have been timely filed with the Commission under the Securities Act (in the case of an Issuer Free Writing Prospectus, to the extent required by Rule 433 under the Securities Act) and in accordance with Section 4(a) hereof; and all requests by the Commission for additional information shall have been complied with to the reasonable satisfaction of the Representatives.

  • Termination of Right of First Refusal The Right of First Refusal shall terminate as to any Shares upon the earlier of (i) the first sale of Common Stock of the Company to the general public, or (ii) a Change in Control in which the successor corporation has equity securities that are publicly traded.

  • Registration of the Shares Compliance with the Securities Act. --------------------------------------------------------------

  • Right of First Refusal to Purchase TENANT shall have the right of first refusal to purchase the demised premises as hereinafter set forth. If at any time during the term as extended, LANDLORD shall receive a bona fide offer from a third person for the purchase of the demised premises, which offer LANDLORD shall desire to accept, LANDLORD shall promptly deliver to TENANT a copy of such offer, and TENANT may, within fifteen (15) days thereafter, elect to purchase the demised premises on the same terms as those set forth in such offer, excepting that TENANT shall be credited against the purchase price to be paid by TENANT, with a sum equal to the amount of any brokerage commissions, if any, which LANDLORD shall save by a sale to TENANT. If LANDLORD shall receive an offer for the purchase of the demised premises, which is not consummated by delivering a deed to the offerer, the TENANT'S right of first refusal to purchase shall remain applicable to subsequent offers. If LANDLORD shall sell the demised premises after a failure of TENANT to exercise its right of first refusal, such shall be subject to the Lease and shall continue to be applicable to subsequent sales of the demised premises. Notwithstanding the foregoing, TENANT'S right of first refusal shall not apply or extend to any sales or transfers between LANDLORD and any affiliates in which the principals of the LANDLORD are the majority shareholders to any family trusts or to the heirs of the principals of LANDLORD. LANDLORD shall be entitled to net the same amount under any right of first refusal exercise.

  • Registration Compliance; No Stop Orders The Registration Statement has become effective under the Securities Act, and no stop order suspending the effectiveness of the Registration Statement or any part thereof, preventing or suspending the use of any Preliminary Prospectus, the Prospectus or any Permitted Free Writing Prospectus or any part thereof shall have been issued and no proceedings for that purpose or pursuant to Section 8A under the Securities Act shall have been initiated or threatened by the Commission, and all requests for additional information on the part of the Commission (to be included in the Registration Statement or the Prospectus or otherwise) shall have been complied with to the reasonable satisfaction of the Representative; the Rule 462(b) Registration Statement, if any, and the Prospectus shall have been filed with the Commission within the applicable time period prescribed for such filing by, and in compliance with, the Rules and Regulations and in accordance with Section 4(a) of this Agreement, and the Rule 462(b) Registration Statement, if any, shall have become effective immediately upon its filing with the Commission; and FINRA shall have raised no unresolved objection to the fairness and reasonableness of the terms of this Agreement or the transactions contemplated hereby.

  • Exercise of Right of First Refusal At any time within thirty (30) days after receipt of the Notice, the Company and/or its assignee(s) may, by giving written notice to the Holder, elect to purchase all, but not less than all, of the Shares proposed to be transferred to any one or more of the Proposed Transferees, at the purchase price determined in accordance with subsection (c) below.

  • AMENDMENT OF REGISTRATION RIGHTS Provisions of this Agreement may be amended and the observance thereof may be waived (either generally or in a particular instance and either retroactively or prospectively), only by a written agreement between the Company and the Investor. Any amendment or waiver effected in accordance with this Section 9 shall be binding upon the Investor and the Company. No consideration shall be offered or paid to any Person to amend or consent to a waiver or modification of any provision of any of this Agreement unless the same consideration also is offered to all of the parties to this Agreement.

  • Assignment of Right of First Refusal The Company shall have the right to assign the Right of First Refusal at any time, whether or not there has been an attempted transfer, to one or more persons as may be selected by the Company.

  • CERTAIN RIGHTS RESERVED TO LANDLORD Landlord reserves the following rights:

Time is Money Join Law Insider Premium to draft better contracts faster.