Regulatory Matters; Right of Reference Sample Clauses

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Regulatory Matters; Right of Reference. LICENSEE shall control all regulatory interactions and decisions relating to the Licensed Product in the Territory and shall hold the NDA and other regulatory approvals for the Licensed Product in the Territory. LICENSEE shall have the exclusive right to reference and use all information, know‐how, and data generated in LICENSOR’s prior and future depression clinical trials and other development activities related to Licensed Product conducted by LICENSOR prior to and following the Effective Date of the Agreement in support of regulatory filings and regulatory approvals for the Licensed Product in the Territory.
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Regulatory Matters; Right of Reference. LICENSOR will, within 30 days after notice from LICENSEE and at LICENSEE’s expense, (a) transfer ownership of and rights under its IND for the Licensed Product to LICENSEE, and (b) with input and direction from LICENSEE, complete all relevant activities related to such IND, including the submission of relevant notices to the FDA, in form and substance satisfactory to LICENSEE, as required for LICENSEE to assume such ownership and rights, as applicable. Promptly after the Effective Date, if requested by LICENSEE, LICENSOR will also (i) send letters (in form and substance satisfactory to LICENSEE) to the FDA and other Regulatory Authorities in the Territory indicating that any other Regulatory Documents are transferred to LICENSEE and that LICENSEE is the new owner of the Regulatory ___________________ ***** VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND EXCHANGE COMMISSION. Documents as of the Effective Date, (ii) send letters to all applicable IRBs or other relevant entities and similar committees to direct product-related communications to LICENSEE commencing on the Effective Date, and (iii) provide to LICENSEE a copy of such letters. LICENSEE shall control all regulatory interactions and decisions relating to the Licensed Product in the Territory and shall hold the NDA and other regulatory approvals for the Licensed Product in the Territory. LICENSEE shall have the exclusive right to reference and use all information, know‐how, and data generated in LICENSOR’s prior and future SAD clinical trials and other development activities related to Licensed Product conducted by LICENSOR prior to and following the Effective Date of the Agreement in support of regulatory filings and regulatory approvals for the Licensed Product in the Territory.
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Regulatory Matters; Right of Reference. Sucampo shall control regulatory interactions and decisions relating to the Product in the Territory and shall hold the NDA and other Regulatory Approvals for the Product in the Territory. Sucampo would have the exclusive right to reference and use all information, know-how, and data generated in the FAP Pivotal Trial (as defined in the Option Agreement) and other Product development activities conducted by CPP in support of Regulatory Filings and Regulatory Approvals for the Product in the Territory. Product Rights Subject to the Excepted Matters, Sucampo would be responsible for and control the development, manufacture and commercialization of the Product in the Field and Territory at its own expense. Diligence Sucampo would use commercially reasonable efforts to develop, manufacture and commercialize the Product in the Field in the Territory, including in FAP and in indications in the Field other that FAP that are (i) Sucampo-Approved Indications or (ii) granted Regulatory Approval in the Territory. Exclusivity Except for the Product, CPP would not develop or commercialize in the Territory (i) any product with both of the Active Ingredients (or where both Active Ingredients are co-packaged or co-marketed) for use in the Field, or (ii) any product that uses any Active Ingredient (whether both or a single Active Ingredient) for the treatment of FAP. License Fee Payable upon execution of the license agreement if the option was exercised prior to the completion (i.e., database lock and completion of analyses) of the FAP trial $5 million Payable upon execution of the license agreement if the option was exercised after the completion of the FAP trial $10 million Milestone Payments NDA approval for FAP [*****] First dosing in pivotal trial in each of up to three additional indications (i.e., other than FAP) [*****] NDA approval for second indication [*****] NDA approval for third indication [*****] NDA approval for fourth indication [*****] First time annual net sales of the Product in the Territory > $100M [*****] First time annual net sales of the Product in the Territory > $250M [*****] First time annual net sales of the Product in the Territory > $500M [*****] First time annual net sales of the Product in the Territory > $750M [*****]
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Related to Regulatory Matters; Right of Reference

  • Right of Reference Section 1: If the two Parties fail to agree upon an interpretation of the Agreement, either Party shall have the right to refer the matter to the Joint Industry Committee, hereinafter provided, and if either party does make such reference, the other Party must accept the reference. Section 2: The Joint Industry Committee shall consist of three (3) representatives selected by the USW. Negotiating Committee and three (3) representatives selected by the Employers represented in the negotiations of this Agreement, and the two (2) committees may be represented by one (1) or more Parties selected by them. Section 3: When an interpretation of the Agreement has been referred to the Joint Committee, this reference shall be for the period of forty-eight (48) hours or longer by mutual consent of the Parties to this Agreement. In case the Joint Committee agrees upon a recommendation or interpretation, this shall be furnished in writing to the Union involved and to the Employer. Section 4: In the event the Joint Committee members disagree, all the facts in the case as found by the Union and Union members of the Joint Committee shall be placed in writing by the Union representatives and submitted to the Employer and to the Union Members involved. The facts in the case as found by the Employer and the employer members of the Joint Committee shall be placed in writing and given to the Union member employees for their information. Section 5: If a satisfactory interpretation of the point in question is not reached, either Party may refer the question to arbitration as hereinafter provided.

  • Waiver of Appraisal and Dissenters’ Rights and Actions Stockholder hereby (i) waives and agrees not to exercise any rights (including under Section 262 of the General Corporation Law of the State of Delaware) to demand appraisal of any Company Shares Beneficially Owned by Stockholder or rights to dissent from the Merger which may arise with respect to the Merger and (ii) agrees not to commence or participate in, and to take all actions necessary to opt out of any class in any class action with respect to, any claim, derivative or other Proceeding, against Parent, Acquisition Sub, the Company or any of their respective successors relating to the negotiation, execution or delivery of this Agreement or the Merger Agreement or the making or consummation of the Offer or consummation of the Merger, including any Proceeding (x) challenging the validity of, or seeking to enjoin the operation of, any provision of this Agreement or (y) alleging a breach of any fiduciary duty of the Board of Directors of the Company in connection with the Merger Agreement or the transactions contemplated thereby.

  • Rights of Reference Upon mutual agreement, Regeneron will grant to the Government a right of reference to any Regulatory Application submitted in support of this Project Agreement, solely for the purpose of the Government conducting a clinical trial with the drug product supplied under this Project Agreement under a protocol approved by Regeneron for performance by the Government. In such a case, Regeneron agrees to provide a letter of cross-reference to the Government and file such letter with the appropriate FDA office. Nothing in this paragraph reduces the Government’s data rights as articulated in other provisions of this award.

  • STUDENT’S RIGHT TO CANCEL You have the right to cancel this agreement and obtain a refund of charges paid through the attendance at the first class session, or the seventh day after enrollment, whichever is later.

  • Retention of Records, Right to Monitor and Audit (a) CONTRACTOR shall maintain all required records for three (3) years after the COUNTY makes final payment and all other pending matters are closed, and shall be subject to the examination and/or audit of the County, a Federal grantor agency, and the State of California.