ARRY-403 Sample Clauses

ARRY-403. It is understood that, prior to the Effective Date, Array has been proceeding with development activities with respect to ARRY-403, including the filing of an IND (the “Initial IND”), the completion of a Phase I single-rising dose clinical trial (the “403 SAD”), the initiation of a Phase I multiple-rising-dose clinical trial (the “403 MAD”) and the initiation of a bioequivalence trial (the “403 Bioequivalence Trial”). Array shall use Commercially Reasonable Efforts to complete, and be responsible, at its own cost, for completion of, the 403 MAD and the 403 Bioequivalence Trial in compliance with the Global Development Plan, Law and common standards of pharmaceutical practice. Array shall comply with each of the following:
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Related to ARRY-403

  • Category 5 Funds On sales of Class 529-A shares of Funds listed in Category 5 on the attached Schedule A that are accepted by us and for which you are responsible, you will be paid compensation as follows: Compensation as Sales Charge Percentage of as Percentage Purchases Offering Price of Offering Price Less than $100,000 3.50% 4.25% $100,000 but less than $250,000 2.75% 3.50% $250,000 but less than $500,000 2.00% 2.50% $500,000 but less than $750,000 1.60% 2.00% $750,000 but less than $1 million 1.20% 1.50% $1 million or more See below None

  • Category 4 Funds On sales of Class A shares and Class 529-A shares of the Funds listed in Category 4 on the attached Schedule A, no dealer concessions will be paid.

  • Category 2 and Category 5 Funds If you initiate and are responsible for sales of Class A shares and Class 529-A shares, a) amounting to $1 million or more or b) made to certain entities described in the Fund Prospectuses, including employer-sponsored defined contribution-type retirement plans that qualify to invest at net asset value under the terms of the Fund Prospectuses, you will be paid a dealer concession of 1.00% on sales to $10 million, plus 0.50% on amounts over $10 million up to $25 million, plus 0.25% on amounts over $25 million.

  • Development Activities NovaDel shall not be required to commence any Development Activities until Licensee has paid at least twenty-five percent (25%) of the non-refundable License Fee described in Section 4.4.

  • Regulatory Activities Beginning on the Effective Date and to the extent UGNX remains the Lead Development Party with respect to a particular territory, subject to and in accordance with the terms and conditions of this Agreement and the requirements of Applicable Laws, UGNX, shall: (a) use Commercially Reasonable Efforts to file (or have filed) all Regulatory Filings with respect to the Licensed Products in the Field in order to obtain Marketing Approvals in each country in the Territory and the European Territory (or to obtain the European Centralized Approval in the European Core Territory) and in order to obtain Pricing and/or Reimbursement Approvals in the Profit Share Territory; (b) respond in a timely fashion to requests for data and information from Regulatory Authorities with respect to the Licensed Products in the Field in the Territory and the European Territory; and (c) meet with officials of the Regulatory Authorities at such times as may be requested by such Regulatory Authorities with respect to the Core Development Activities (“Regulatory Activities”), provided that KHK will have primary responsibility for obtaining, and UGNX shall provide all assistance reasonably requested by KHK, in relation to Pricing and/or Reimbursement Approvals for the Licensed Products in the Field in the European Territory. For the avoidance of doubt, UGNX will be responsible for obtaining, and KHK will provide all assistance reasonably requested by UGNX, in relation to Pricing and/or Reimbursement Approvals, if any, for the Licensed Products in the Field in the Profit Share Territory as part of the UGNX Core Development Activities, it being understood that the costs incurred by UGNX in connection with such activities will be shared equally (50/50). All such Regulatory Activities will be conducted in a manner consistent with the Core Development Plan and coordinated by the JSC in accordance with Article 3. Without limiting the applicability of the foregoing and the remainder of this Article 5, UGNX shall interface with the applicable Regulatory Authority(ies) and, through the JDC, shall keep KHK reasonably informed of all material events and developments occurring in the course of the Regulatory Activities, including scheduled UGNX regulatory strategy discussions and meetings with Regulatory Authorities in the Territory and the European Territory relating to the Licensed Products in the Field.

  • Category 2 Funds On each purchase order for Class A shares and Class 529-A shares of Funds listed in Category 2 on the attached Schedule A that is accepted by us and for which you are responsible, you will be paid the same compensation indicated above except as follows: Compensation as Sales Charge Percentage of as Percentage Purchases Offering Price of Offering Price Less than $100,000 3.00% 3.75%

  • Category 3 Funds On each purchase order for Class A shares and Class 529-A shares of Funds listed in Category 3 on the attached Schedule A, that are accepted by us and for which you are responsible, you will be paid compensation as follows: Compensation as Sales Charge Percentage of as Percentage Purchases Offering Price of Offering Price Less than $500,000 2.00% 2.50% $500,000 but less than $750,000 1.60% 2.00% $750,000 but less than $1 million 1.20% 1.50% $1 million or more See below None

  • OVERCOLLATERALIZATION INFORMATION Specified Reserve Balance Targeted Credit Enhancement Amount Yield Supplement Overcollateralization Amount Targeted Overcollateralization Amount Actual Overcollateralization Amount (EOP Pool Balance - EOP Note Balance)

  • Product Testing Upon request, Customer shall provide Operator a laboratory report for each Product delivery by Customer or Customer’s supplier. Operator will not be obligated to receive Contaminated Product for throughput through the Pipelines, nor will Operator be obligated to accept Product that fails to meet the applicable quality specifications for the Berths under the BAUTA and any Terminal Service Orders issued thereunder.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials conducted by the Company, and to the knowledge of the Company, the preclinical tests and clinical trials conducted on behalf of or sponsored by the Company, that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures and all applicable laws and regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectuses or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such Permits as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.

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