Development Records; Reports Sample Clauses

Development Records; Reports. 5.3.1. Salix shall maintain records of the development process (including clinical development) of the Licensed Products in such detail and in good scientific manner as is generally practiced for similar products and in accordance with standard industry practice. 5.3.2. Within thirty (30) days following the end of each Calendar Quarter during the Term, Salix shall provide RedHill with an informal report, which may be either written or oral (including by telephone), regarding the Development (including clinical Development) of the Licensed Products and Salix’s reasonably fixed future plans for the Licensed Products, which report shall cover those topics set out in Schedule 5.3.2; provided, however, that in the event of a Change in Control or Acquisition of or by RedHill that results in RedHill being under the control of, under common control with, or controlling (as such terms are used in Section ‎1.13) a Competitor, Salix shall have no further obligation to provide any such reports to RedHill, its Affiliates, successors or assigns; provided, however, that the foregoing shall not be applicable in the event of a Change in Control or Acquisition by RedHill that results in RedHill controlling (as such term is used in Section ‎1.13) a direct or indirect subsidiary of a Competitor that is not, by itself following such Change in Control or Acquisition by RedHill, engaged in the business of [****]. 5.3.3. Without limiting the provisions of Section ‎5.3.2, Salix shall, within thirty (30) days following the end of each Calendar Quarter ending during the period beginning six (6) months following the Effective Date and ending on the date on which both milestones contemplated by Section ‎6.2 have been paid by Salix to RedHill, provide RedHill with information in respect of Salix’s Development of the Licensed Products sufficient to permit RedHill to make determinations relevant to the exercise its rights under Section ‎12.3, including a one-page summary report of such information.
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Development Records; Reports. Each Party will maintain complete and accurate records (in the form of technical notebooks or electronic files where appropriate) of all work conducted by it with respect to the Development of the Products and all information resulting from such Development work. Such records, including any electronic files where such information may also be contained, will fully and properly reflect all Development work done and results achieved in the Development of the Product in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes. Periodically, but no less frequently than [**], to the extent that a Party has conducted any Development activities over such [**], such Party will deliver to the JSC a report (each, a “Development Report”) containing reasonably detailed information regarding its progress with respect to the Development of the Product in such Party’s Territory, which will include a summary of (a) all Development activities conducted and results obtained with respect to each Product, (b) any Significant Development Events applicable to any Product, (c) a summary of all (i) Know-How conceived or reduced to practice over such period and (ii) Clinical Data, including Safety Data and CMC Data, generated by such Party over such period and (d) with respect to CANbridge, (i) reasonable evidence of its satisfaction of the minimum requirements set forth in Section 12.2.3 (Termination by AVEO) and (ii) a non-binding estimate of the expected timing of any Development Milestone Event and Sales Milestone Event to be achieved with respect to each Product.

Related to Development Records; Reports

  • Records Reports To maintain records and to prepare and file reports required by law to be filed by the Trustee or required by agreement with the Company;

  • Development Reports Beginning six months after Effective Date and ending on the date of first commercial sale of a Licensed Product in the United States, LICENSEE shall report to Cornell progress covering LICENSEE's (and Affiliate's and Sublicensee's) activities and efforts in the development of rights granted to LICENSEE under this Agreement for the preceding six months. The report shall include, but not be limited to, activities and efforts to develop and test all Licensed Products and obtain governmental approvals necessary for marketing the same. Such semi-annual reports shall be due within sixty days (60) of the reporting period and shall use the form as provided herein as Appendix C.

  • Development Records Each Party shall maintain complete, current and accurate records of all Development activities conducted by it hereunder, and all data and other information resulting from such activities. Such records shall fully and properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory and patent purposes. Each Party shall document all non-clinical studies and Clinical Trials in formal written study reports according to Applicable Laws and national and international guidelines (e.g., ICH, cGCP, cGLP, and cGMP).

  • Books and Records Reports (a) The Trustees shall keep a certified copy or duplicate original of this Trust Agreement on file at the office of the Trust and the office of the Administrator available for inspection at all reasonable times during its usual business hours by any Holder. The Trustees shall keep proper books of record and account for all the transactions under this Trust Agreement at the office of the Trust and the office of the Administrator, and such books and records shall be open to inspection by any Holder at all reasonable times during usual business hours. The Trustees shall retain all books and records in compliance with Section 31 of the Investment Company Act and the rules and regulations thereunder. (b) With each payment to Holders the Paying Agent shall set forth, either in the instruments by means of which payment is made or in a separate statement, the amount being paid from the Trust Account expressed as a dollar amount per STRYPES and the other information required under Section 19 of the Investment Company Act and the rules and regulations thereunder. The Trustees shall prepare and file or distribute reports as required by Section 30 of the Investment Company Act and the rules and regulations thereunder. The Trustees shall prepare and file such reports as may from time to time be required to be filed or distributed to Holders under any applicable state or Federal statute or rule or regulation thereunder, and shall file such tax returns as may from time to time be required under any applicable state or Federal statute or rule or regulation thereunder. One of the Trustees shall be designated by resolution of the Trustees to make the filings and give the notices required by Rule 17g-1 under the Investment Company Act. (c) In calculating the net asset value of the Trust as required by the Investment Company Act, (i) the U.S. Treasury Securities will be valued at the mean between the last current bid and asked prices or, if quotations are not available, as determined in good faith by the Trustees, (ii) short-term investments having a maturity of 60 days or less will be valued at cost with accrued interest or discount earned included in interest receivable and (iii) the Contract will be valued at the mean of the bid prices received by the Administrator from at least three independent broker-dealer firms unaffiliated with the Trust to be named by the Trustees who are in the business of making bids on financial instruments similar to the Contract and with terms comparable thereto.

  • Records, Audits and Reports The Company shall maintain at its principal office the Company’s records and accounts of all operations and expenditures of the Company including the following: 9.1 A current list in alphabetical order of the full name and last known business or resident address of the Member, together with the Capital Contribution and the share in profits and losses of the Member; 9.2 A copy of the Certificate of Formation and all amendments thereto, together with any powers of attorney pursuant to which the Certificate of Formation or any amendments thereto were executed; 9.3 Copies of the Company’s Federal, state, and local income tax or information returns and reports, if any, for the six most recent taxable years; 9.4 Copies of this Agreement and any amendments thereto together with any powers of attorney pursuant to which any written accounting or any amendments thereto were executed; 9.5 Copies of any financial statements of the Company, if any, for the six most recent years; and 9.6 The Company’s books and records as they relate to the internal affairs of the Company for at least the current and past four fiscal years.

  • Research Reports Distributor acknowledges that Dealer may prepare research reports relating to the Fund that are not to be used for marketing purposes (“Research Reports”). Distributor hereby authorizes Dealer to use the name of the Fund, Distributor and BREDS in Research Reports.

  • Progress Reports The Recipient shall submit to the OPWC, at the OPWC's request, summary reports detailing the progress of the Project pursuant to this Agreement and any additional reports containing such information as the OPWC may reasonably require.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • Project Records Borrower shall: Make and keep books, records, and accounts, in such reasonable detail, so as to fully, accurately, and fairly reflect the activities of Borrower. Record the Project’s assets, liabilities, revenues, expenses, receipts and disbursements in separate accounts from any other assets, liabilities, revenues, expenses, receipts and disbursements of Borrower so as to permit the production of a Statement of Financial Position, a Statement of Profit and Loss (Statement of Activities), and a Statement of Cash Flows for Borrower in which the activities of Borrower are separately identifiable from the activities of the Operator, unless Borrower is also Operator. Devise and maintain a system of internal accounting controls sufficient to provide reasonable assurances that: Transactions are executed, and access to assets is permitted, only in accordance with Xxxxxxxx’s authorization; Transactions are accurately and timely recorded to permit the preparation of quarterly and annual financial reports in conformity with applicable Program Obligations; Transactions are timely recorded in sufficient detail so as to permit an efficient audit of the Borrower’s books and records in accordance with Generally Accepted Auditing Standards (GAAS), Generally Accepted Government Auditing Standards (GAGAS), and other applicable Program Obligations; and Transactions are timely recorded in sufficient detail so as to maintain accountability of the Borrower’s assets. The recorded accountability for assets shall be compared with the existing assets at reasonable intervals, but not less than annually, and appropriate action shall be taken with respect to any differences. Make the books, records and accounts of Borrower available for inspection by HUD or its authorized representatives, after reasonable prior notice, during normal business hours, at the Project or other mutually agreeable location or, at HUD’s request, shall provide legible copies of such documents to HUD or its authorized representatives within a reasonable time after HUD or its authorized representative makes a request for such documents. Include as a requirement in any operating or management contract that the books, records, and accounts of any agent of Borrower, as they pertain to the operations of the Project, shall be kept in accordance with the requirements of this Section 19 and be available for examination by HUD or its authorized representatives after reasonable prior notice during customary business hours at the Project or other mutually agreeable location or, at HUD’s request, the Management Agent shall provide legible copies of such documents to HUD or its authorized representatives within a reasonable time after HUD or its authorized representative makes the request.

  • Project Reports The Recipient shall monitor and evaluate the progress of the Project and prepare Project Reports in accordance with the provisions of Section 4.08 of the General Conditions and on the basis of the indicators agreed with the Association. Each Project Report shall cover the period of one calendar semester, and shall be furnished to the Association not later than one month after the end of the period covered by such report.

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