foregoing, MD Anderson may publish the Data and Study results individually in accordance with Section
11.1 upon the first occurrence of one of the following: (a) multi-center Publication is published; (b) no multi-center Publication is submitted within eighteen (18) months after the earlier of the conclusion, abandonment, or termination of the Study at all sites, or (c) Company notifies MD Anderson that there will be no multi-site Publication. If MD Anderson, through its Principal Investigator, is identified to participate in the multi-center Publication: (i) MD Anderson will have the opportunity to review the aggregate multi- center Data, upon request; and (ii) consistent with the International Committee of Medical Journal Editors (ICMJE) regulations, MD Anderson will have adequate opportunity to review and provide input on any abstract or manuscript prior to its submission for Publication. MD Anderson also retains the right, on behalf of its Principal Investigator, to decline to be an author on any Publication.
11.3MD Anderson and/or Principal Investigator shall give Company acknowledgment for its sponsorship of a Study in all applicable Study publications. Authorship and acknowledgements for Study publications shall be determined by MD Anderson.
11.4The “sponsor” of a Study, within the regulatory meaning of such term, shall register the Study if required by, and in accordance with, Section 801 of the Food and Drug Administration Amendments Act of 2007 on www.clinicaltrials.gov and on any other database required by laws or regulations in accordance with applicable standards regarding scope, form and content and in accordance with ICMJE guidelines such that the Study will be eligible for publication in those publications.
12.Use of Name/Public Statements/Disclosure
12.1Except as expressly set forth in this Agreement, each Party agrees that it will not at any time during the term of this Agreement or following termination of this Agreement use any name of the other Party or any other names, insignia, mark(s), symbol(s), or logotypes associated with the other Party or any variant or variants thereof in any advertising, or promotional materials without the prior written consent of the other Party.
12.2Except as expressly set forth in this Agreement, to the extent required by law or regulation, or to the extent necessary for MD Anderson for the recruitment of subjects to any Study hereunder, the Parties agree to make no public presentations about any Study Drug, Study Device or any Study conducted under this Agreement, and to issue no news releases about any Study Drug, Study Device or any Study. Any advertisements directed at recruitment of study subjects for a Study must comply with all applicable laws, rules and regulations (including the need for IRB review), the confidentiality obligations herein, and shall not include the trademarked insignia, symbol(s), or logotypes, or any variant or variants thereof, of the other Party. Except as required by law or for regulatory purposes, neither Party will use the name (including trademark or other identifier) of the other Party or such other Party’s employee or staff member (except in an acknowledgment of sponsorship) in publications, advertising, press releases or for any other commercial purpose without the written approval of the other Party. Company will not state or imply in any publication, advertisement, or other medium that any product or service bearing any of Company’s names or trademarks and/or manufactured, sold or distributed by Company has been tested, approved, or endorsed by MD Anderson. Notwithstanding any other provision of this Agreement, each Party and its researchers and employees will have the right, without the other Party’s approval, to acknowledge the other Party and the other Party’s involvement with a Study in academic publications and communications describing the Study or reporting the results of the Study.
12.3Either Party may use the name of the other Party in any document filed with any governmental authority or regulatory agency applicable to a Study, and to comply with any applicable legal or regulatory requirements. Further, each Party is permitted to disclose the other Party’s name, the title of the Study, the name of the Principal Investigator, and an overall Study budget amount projected to be paid/actual total