Regulatory Ownership. Following the License Commencement Date, (i) OST will be the responsible party for all Regulatory Filings for the Licensed Products in the Field, including Regulatory Approval of the BLA for the First Indication by the FDA and any other Regulatory Authorities, and (ii) OST shall own all Regulatory Filings related to the Licensed Products in the Field. To the extent necessary to seek, obtain or maintain Regulatory Approval, Advaxis hereby grants to OST the right to cross-reference other Advaxis INDs in such Regulatory Filings or for other regulatory purposes as it relates to the Licensed Product. Advaxis shall have the right to charge OST up to Sixty Five Thousand U.S. Dollars ($65,000) for the grant of the cross-reference rights set forth in the immediately preceding sentence, subject to payment in accordance with Section 7.1. Notwithstanding anything to the contrary in the forgoing, OST shall not be permitted and have no authority to include or disclose any information relating to or constituting part of the Advaxis Platform Technology or Advaxis Other Patents in any Regulatory Filing, without Advaxis’s prior written consent which consent shall be given or withheld in Advaxis’s sole discretion. OST hereby grants to Advaxis the right to cross-reference any Regulatory Filings for the Licensed Products in the Field, solely to the extent necessary for Advaxis to seek, obtain or maintain regulatory approval of Advaxis products.
Regulatory Ownership. As between Pieris and BP, BP will exclusively own, maintain and have control over all INDs, XXXx and related regulatory documentation submitted to any Regulatory Authority with respect to any Product Exploited under this Agreement. Responsibility. For the avoidance of doubt, BP (either itself or through its Affiliates, subcontractors and/or Sublicensees) will have sole control over (including the exclusive right, sole responsibility and final decision-making authority for) all aspects of regulatory matters relating to any Product, including (a) overseeing, monitoring and coordinating all regulatory actions, communications and filings with, and submissions to, each Regulatory
Regulatory Ownership. Haemonetics shall be registered as the sole owner of any rights, title and interest to Regulatory Clearances, provided, however, that should any applicable law or regulation require that CoraMed alone be entitled to such ownership rights, the Parties shall promptly discuss and, if approved in writing by Haemonetics, CoraMed shall hold the applicable Regulatory Clearance as trustee for Haemonetics, and CoraMed hereby irrevocably consents to transfer, and does hereby irrevocably transfer, all such Regulatory Clearances to Haemonetics free of charge, or to provide reasonable assistance at Haemonetics’ cost in its efforts to re-obtain the applicable Regulatory Clearances for the benefit of Haemonetics, its Affiliates or a Third Party named by Haemonetics. SCHEDULE D Manufacturing Transition
