Limitations on JSC Responsibility after the Commercial Option Exercise Date; Annual Reports Sample Clauses

This clause defines the extent of the Joint Steering Committee's (JSC) responsibilities after the Commercial Option Exercise Date and outlines requirements for annual reporting. After this date, the JSC's authority or obligations may be reduced or altered, often shifting decision-making or oversight to another party, such as the licensee or commercial partner. Additionally, the clause typically requires the submission of annual reports detailing progress, compliance, or other relevant information. Its core function is to clarify the transition of responsibilities and maintain accountability through regular reporting, thereby ensuring a smooth handover and ongoing transparency.
Limitations on JSC Responsibility after the Commercial Option Exercise Date; Annual Reports. (a) With respect to each Licensed Product for which Precision has not exercised the CDCP Option, from and after the Commercial Option Exercise Date with respect to such Licensed Product Candidate, the JSC’s responsibility with respect to the corresponding Licensed Product shall be limited as follows: (i) the JSC will not have any decision making or oversight rights with respect to such Licensed Product; and (ii) the JSC’s role shall be limited to reviewing and discussing reports provided by Baxalta as set forth in the following sentence. On an annual basis, Baxalta will be obligated to (x) deliver to Precision a report describing the status of the Development and Commercialization efforts with respect to such Licensed Product, for informational purposes only (but sufficient to establish Baxalta’s compliance with its Development and Commercialization obligations under this Agreement and for Precision to comply with its disclosure obligations (if any) under any Law applicable to the public sale of securities or status as a public or listed company, provided that Precision has provided Baxalta a written request describing the type of information it needs in order to fulfill such disclosure obligations), and (y) upon Precision’s request, meet with Precision through the JSC to discuss such report. In addition, within [***] after Baxalta’s completion of any Phase II Clinical Trial with respect to a particular Licensed Product, Baxalta shall notify Precision of Baxalta’s determination of whether such Licensed Product has an acceptable safety profile to proceed to Phase III Clinical Trials. (b) With respect to each Licensed Product for which Precision has exercised the CDCP Option, a separate joint co-development and co-promotion committee will be established for each such Licensed Product to oversee clinical Development, manufacturing, registration, Commercialization and marketing in the U.S. pursuant to the CDCP Agreement, and the JSC under this Agreement will have no role with respect to any such Licensed Product. [***] Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commission.
View SourceView Similar (2)

Related to Limitations on JSC Responsibility after the Commercial Option Exercise Date; Annual Reports

  • Venue Limitation for TIPS Sales Vendor agrees that if any "Venue" provision is included in any TIPS Sale Agreement/contract between Vendor and a TIPS Member, that clause must provide that the "Venue" for any litigation or alternative dispute resolution shall be in the state and county where the TIPS Member operates unless the TIPS Member expressly agrees otherwise. Any TIPS Sale Supplemental Agreement containing a “Venue” clause that conflicts with these terms is rendered void and unenforceable.

  • HHS Single Audit Unit will notify Grantee to complete the Single Audit Determination Form If Grantee fails to complete the form within thirty (30) calendar days after receipt of notice, Grantee maybe subject to sanctions and remedies for non-compliance.

  • Please see the current Washtenaw Community College catalog for up-to-date program requirements Conditions & Requirements

  • Plan Annual Reports Promptly and in any event within 30 days after the filing thereof with the Internal Revenue Service, copies of each Schedule B (Actuarial Information) to the annual report (Form 5500 Series) with respect to each Plan.

  • Certification of Meeting or Exceeding Tobacco-Free Workplace Policy Minimum Standards A. Grantee certifies that it has adopted and enforces a Tobacco-Free Workplace Policy that meets or exceeds all of the following minimum standards of: i. Prohibiting the use of all forms of tobacco products, including but not limited to cigarettes, cigars, pipes, water pipes (hookah), bidis, kreteks, electronic cigarettes, smokeless tobacco, snuff and chewing tobacco; ii. Designating the property to which this Policy applies as a "designated area,” which must at least comprise all buildings and structures where activities funded under this Grant Agreement are taking place, as well as Grantee owned, leased, or controlled sidewalks, parking lots, walkways, and attached parking structures immediately adjacent to this designated area; iii. Applying to all employees and visitors in this designated area; and iv. Providing for or referring its employees to tobacco use cessation services. B. If Grantee cannot meet these minimum standards, it must obtain a waiver from the System Agency.