Progress Reports and Pre-IND Studies Sample Clauses

Progress Reports and Pre-IND Studies. Promptly after the Effective Date, the Parties shall meet to review and discuss generally (i) Targacept’s Option Compound research strategy and [********] IND-Ready Option Compounds [********] in each case if any, including discussion of screening and pre-clinical development strategies, (ii) the expected target profile for each IND-Ready Option Compound for any such indication, taking into consideration scientific, clinical and commercial inputs if and as available, and (iii) [********] Option Compound updates, and thereafter shall meet [********] to discuss generally any updates with respect thereto; provided that, for purposes of clarity, it is not contemplated that the Parties will discuss chemical structures or structure-activity relationships at any such meeting (and that similarly no such information will be included in any Preliminary IND Notice or update thereto as provided below). With respect to each Compound in respect of which Targacept expects to submit an IND-Ready Notice (each, a “Potential Option Compound”), Targacept shall provide AstraZeneca a written notice (each, a “Preliminary IND Notice”) at least [********] the date Targacept expects to provide AstraZeneca with an IND-Ready Notice therefor. Each Preliminary IND Notice shall identify the specific anticipated Option Indication (each, a “Potential Option Indication”) for which Targacept intends to develop and commercialize such Potential Option Compound, include a summary of the results of the studies and assessments with respect to such Potential Option Compound completed by or on behalf of Targacept (which shall include, at a minimum, those studies and assessments identified as [********] studies on Schedule 1.148, as such Schedule may be amended by the Parties from time to time with respect to a particular Potential Option Compound) and specify the research and development activities to be conducted by or on behalf of Targacept with respect thereto, in each case with sufficient detail for AstraZeneca to interpret such results and [********] such tests or studies or expected research and development activities; provided, however, that Targacept shall not have any obligation to offer such Potential Option Compound for the Potential Option Indication identified in the Preliminary IND Notice or to offer such Potential Option Compound as an Option Compound at all. If AstraZeneca reasonably believes that additional data beyond what has been provided, or that will result from the activitie...
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Related to Progress Reports and Pre-IND Studies

  • 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.

  • Progress Reports and Invoices The goals of this subtask are to: (1) periodically verify that satisfactory and continued progress is made towards achieving the project objectives of this Agreement; and (2) ensure that invoices contain all required information and are submitted in the appropriate format. • Submit a monthly Progress Report to the CAM. Each progress report must: o Summarize progress made on all Agreement activities as specified in the scope of work for the preceding month, including accomplishments, problems, milestones, products, schedule, fiscal status, and an assessment of the ability to complete the Agreement within the current budget and any anticipated cost overruns. See the Progress Report Format Attachment for the recommended specifications. • Submit a monthly or quarterly Invoice that follows the instructions in the “Payment of Funds” section of the terms and conditions, including a financial report on Match Fund and in-state expenditures. • Progress Reports • Invoices

  • 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.

  • Progress Report By March 1 of each year, ***** will submit a written annual report to Stanford covering the preceding calendar year. The report will include information sufficient to enable Stanford to satisfy reporting requirements of the U.S. Government and for Stanford to ascertain progress by ***** toward meeting this Agreement’s diligence requirements. Each report will describe, where relevant: *****’s progress toward commercialization of Licensed Product, including work completed, key scientific discoveries, summary of work-in-progress, current schedule of anticipated events or milestones, market plans for introduction of Licensed Product, and significant corporate transactions involving Licensed Product. ***** will specifically describe how each Licensed Product is related to each Licensed Patent.

  • Quarterly Progress Reports The goal of this task is to periodically verify that satisfactory and continued progress is made towards achieving the objectives of this Agreement on time and within budget. The objectives of this task are to summarize activities performed during the reporting period, to identify activities planned for the next reporting period, to identify issues that may affect performance and expenditures, and to form the basis for determining whether invoices are consistent with work performed. • Prepare a Quarterly Progress Report which summarizes all Agreement activities conducted by the Recipient for the reporting period, including an assessment of the ability to complete the Agreement within the current budget and any anticipated cost overruns. Progress reports are due to the CAM the 10th day of each January, April, July, and October. The Quarterly Progress Report template can be found on the ECAMS Resources webpage available at xxxxx://xxx.xxxxxx.xx.xxx/media/4691. • Quarterly Progress Reports

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • 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.

  • Progress Reporting 5. The IP will submit to UNICEF narrative progress reports against the planned activities contained in the Programme Document, using the PDPR. Unless otherwise agreed between the Parties in writing, these reports will be submitted at the end of every Quarter. The final report will be submitted no later than thirty (30) calendar days after the end the Programme and will be provided together with the FACE form.

  • Monthly Progress Reports During the Construction Period, the Concessionaire shall, no later than 7 (seven) days after the close of each month, furnish to the Authority and the Independent Engineer a monthly report on progress of the Construction Works and shall promptly give such other relevant information as may be required by the Independent Engineer.

  • Environmental Studies Promptly conduct and complete, at Borrower’s expense, all such investigations, studies, samplings and testings as may be requested by Lender or any governmental authority relative to any substance, or any waste or by-product of any substance defined as toxic or a hazardous substance under applicable federal, state, or local law, rule, regulation, order or directive, at or affecting any property or any facility owned, leased or used by Borrower.

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