After FDA approval or the Sample Clauses

After FDA approval or the first commercial exploitation of the Assigned Patents whichever occurs first, during each calendar quarter this Agreement is in effect (January through March being the First Quarter, April through June being the Second Quarter, July through September being the Third Quarter and October through December being the Fourth Quarter) commencing with the end of the first calendar quarter after the date of first commercial sale of any product sold by Odyssey that contains the Assigned Patents. Odyssey shall deliver to De Luca and MCP, within thirty (30) days from the last day of the calendar quarter, an accurate and complete written statement setting forth Odyssey’s calculations of all Royalty payments due De Luca and MCP from net profits accounted during such calendar quarter, including all amounts of net profits accounted from whatever sources related to the Royalty during the quarter, certified as to accuracy by an appropriate representative of Odyssey. Time is of the essence of this provision. Odyssey hereby grants De Luca the right to audit and inspect Odyssey’s records and operations relating to the Royalty (including the right to access Odyssey’s proprietary or confidential business information to the extent reasonably necessary, provided that De Luca agrees to keep all such information confidential when identified as such by Odyssey), one time per year and upon reasonable notice, to insure the amount of the Royalty paid to De Luca under the terms of this Agreement is accurate and appropriate. The costs of the audit will be at De Luca’s expense. However, in the event that the audit reveals an underpayment of a royalty by Odyssey, Odyssey shall pay any undisputed difference within fifteen (15) calendar days following written notice of the underpayment. If the underpayment is in excess of three percent of the royalty due De Luca and MCP, then Odyssey shall reimburse De Luca and MCP for the reasonable, actual and documented cost of the audit.
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Related to After FDA approval or the

  • Regulatory Approval 25.1 The Parties understand and agree that this Agreement and any amendment or modification hereto will be filed with the Commission for approval in accordance with Section 252 of the Act and may thereafter be filed with the FCC. The Parties believe in good faith and agree that the services to be provided under this Agreement are in the public interest. Each Party covenants and agrees to fully support approval of this Agreement by the Commission or the FCC under Section 252 of the Act without modification.

  • GOVERNMENT APPROVAL OR REGISTRATION If this Agreement or any associated transaction is required by the law of any nation to be either approved or registered with any governmental agency, the Licensee will assume all legal obligations to do so. The Licensee will notify The Regents if it becomes aware that this Agreement is subject to a United States or foreign government reporting or approval requirement. The Licensee will make all necessary filings and pay all costs including fees, penalties and all other out-of-pocket costs associated with such reporting or approval process.

  • Commercial or Marketing Use Prohibition Contractor agrees that it will not sell PII or use or disclose PII for a Commercial or Marketing Purpose.

  • No Regulatory Approval By the Company or Parent, if its Board of Directors so determines by a vote of a majority of the members of its entire Board, in the event any Requisite Regulatory Approval shall have been denied by final, nonappealable action by such Governmental Authority or a Governmental Authority shall have requested the permanent withdrawal of an application therefor.

  • Required Regulatory Approvals (a) The obligations of each Party under this Agreement are expressly contingent upon (i) each Party receiving all licenses, permits, permissions, certificates, approvals, authorizations, consents, franchises and releases from any local, state, or federal regulatory agency or other governmental agency or authority (which may include, without limitation and as applicable, the NYISO and the PSC) or any other third party that may be required for such Party in connection with the performance of such Party’s obligations under or in connection with this Agreement (the “Required Approvals”), (ii) each Required Approval being granted without the imposition of any modification or condition of the terms of this Agreement or the subject transactions, unless such modification(s) or condition(s) are agreed to by both Parties in their respective sole discretion, and (iii) all applicable appeal periods with respect to the Required Approvals having expired without any appeal having been made or, if such an appeal has been made, a full, final and non-appealable determination having been made regarding same by a court or other administrative body of competent jurisdiction, which determination disposes of or otherwise resolves such appeal (or appeals) to the satisfaction of both Parties in their respective sole discretion. (b) If any application or request is made in connection with seeking any Required Approval and is denied, or is granted in a form, or subject to conditions, that either Party rejects, in its sole discretion, as unacceptable, this Agreement shall terminate as of the date that a Party notifies the other Party of such denial or rejection, in which event the obligations of the Parties under this Agreement shall cease as of such date and this Agreement shall terminate, subject to NYSEG’s obligation to pay National Grid in accordance with the terms of this Agreement (including, without limitation, Section 10.3 above) for all Reimbursable Costs. All of National Grid’s actual costs in connection with seeking Required Approvals shall be included within the meaning of the term Reimbursable Costs and shall be paid for by NYSEG.

  • Preliminary Approval Order “Preliminary Approval Order” means the order of the Court preliminarily approving this Settlement Agreement.

  • PRELIMINARY APPROVAL OF SETTLEMENT Promptly upon execution of this Stipulation, Lead Plaintiffs will move for preliminary approval of the Settlement, certification of the Settlement Class for settlement purposes only, and the scheduling of a hearing for consideration of final approval of the Settlement, which motion shall be unopposed by Defendants. Concurrently with the motion for preliminary approval, Lead Plaintiffs shall apply to the Court for, and Defendants shall agree to, entry of the Preliminary Approval Order, substantially in the form attached hereto as Exhibit A.

  • Regulatory Approvals (a) Each Party shall, and shall cause its ultimate parent entity (as such term is defined in the HSR Act) to, use reasonable best efforts to file or otherwise submit, as soon as practicable after the date of this Agreement, all applications, notices, reports, filings and other documents reasonably required to be filed by such Party or its ultimate parent entity with or otherwise submitted by such Party or its ultimate parent entity to any Governmental Body with respect to the Contemplated Transactions, and shall file no later than ten (10) Business Days thereafter the Notification and Report Forms required by the HSR Act. Each Party shall (i) promptly supply the other with any information which may be required in order to effectuate such filings, (ii) submit promptly any additional information which may be reasonably requested by any such Governmental Body, and (iii) coordinate with the other Party in making any such filings or information submissions pursuant to and in connection with the foregoing that may be necessary, proper, or advisable in order to consummate and make effective the Contemplated Transactions. (b) Without limiting the generality of anything contained in this Section 5.4, in connection with its efforts to obtain all requisite approvals and authorizations, and the expiration or termination of all applicable waiting periods for the Contemplated Transactions under any Antitrust Law, each Party hereto shall use its reasonable best efforts to (i) cooperate with the other with respect to any investigation or other inquiry; (ii) promptly provide to the other a copy of all communications received by such Party from, or given by such Party to, any Governmental Body, in each case regarding the Contemplated Transactions; and (iii) to the extent not prohibited under applicable Antitrust Law, permit the other to review in advance any communication given by it to any Governmental Body concerning the Contemplated Transactions, consider in good faith the views of the other in connection with any proposed written communications by such Party to any Governmental Body concerning the Contemplated Transactions, and consult with each other in advance of any meeting or telephone or video conference with, any Governmental Body, and give the other or its outside counsel the opportunity to attend and participate in such meetings and conferences unless prohibited by the applicable Governmental Body; provided, that materials required to be provided pursuant to this Section 5.4(b) may be restricted to outside counsel and redacted to (A) remove references concerning the valuation of either Party, (B) comply with contractual arrangements, and (C) preserve attorney-client privilege. Neither Party shall commit to or agree with any Governmental Body to stay, toll or extend any applicable waiting period under applicable Antitrust Law, or pull and refile under the HSR Act, without the prior written consent of the other. Parent and the Company shall each pay one-half of the filing fee under the HSR Act relating to the HSR filing required for the Merger; provided, however, that each Party shall bear its own legal fees. (c) Except as required by this Agreement, prior to Closing, neither the Company nor Parent shall, and shall cause its Affiliates not to, acquire or agree to acquire by merging or consolidating with, or by purchasing a substantial portion of the assets of or equity in, or by any other manner, any Person or portion thereof, or otherwise acquire or agree to acquire any assets, if the entering into of an agreement relating to or the consummation of such acquisition, merger or consolidation would reasonably be expected to (i) impose any delay in the obtaining of, or significantly increase the risk of not obtaining, any authorizations, consents, orders, declarations or approvals of any Governmental Body necessary to consummate the Contemplated Transactions or the expiration or termination of any applicable waiting period, or (ii) increase the risk of any Governmental Body entering an order prohibiting the consummation of the Contemplated Transactions.

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • Preliminary Approval A. As soon as practicable after this Agreement is fully executed, for settlement purposes only, the Plaintiffs and Co-Lead Counsel shall request the Court to make preliminary findings, enter the Preliminary Approval Order granting conditional certification of the Class, subject to final findings and ratification in the Final Order and Judgment, and appoint the Plaintiffs as class representatives and Co-Lead Counsel as counsel for the Class. Neither Defendant nor Defendant’s Counsel will object to such requests for the purposes of effectuating the Settlement. Such agreement not to object to class certification shall extend only as necessary to effectuate the Settlement. As set forth in the draft Preliminary Approval Order, the Plaintiffs shall request the Court to enter an order: 1. preliminarily approving and finding this Agreement and the Settlement as being fair, reasonable, and adequate; 2. conditionally certifying the Litigation as a settlement class action under Rule 23(b)(3) and (e) of the Federal Rules of Civil Procedure; 3. appointing Plaintiffs as class representatives and Co-Lead Counsel as counsel for the Class; 4. preliminarily approving the form, manner, and content of the Class Notice, as provided herein, and finding that notice is fair, reasonable, and the best notice practicable under the circumstances in connection with notifying the Class Members of their rights and responsibilities under the Settlement and satisfying due process and Rule 23 of the Federal Rules of Civil Procedure; 5. appointing the Settlement Administrator to send Class Notice and administer the Settlement; 6. providing that Class Members will have until a date certain to object to or file a request for exclusion from the Settlement, as provided herein;

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