“Affected Territory” means the geographic area of any country (i) where there is an Outbreak or (ii) for which there is an Increased Outbreak Preparation Need or (iii) the Parties otherwise agree in writing and in each case, including healthcare workers providing healthcare in such a country regardless of their home country.
“DSMB” means the data safety monitoring board for the Clinical Trial.
“Field” means the disease area relevant for the project.
“Master File” means all drug master files relating to Product in the Field that may be filed with any Regulatory Authority in any country in the Affected Territory or with an Approved Regulatory Authority.
“Similar Product” a pharmaceutical composition which infringes the Foreground Intellectual Property.
“TSC” means the trial steering committee for the Clinical Trial.
4. Records and Standards
4.5 Clinical Trial. For any Clinical Trial:
4.5.1. The Partner shall be the sponsor of the Clinical Trial unless FUNDER otherwise agrees in writing and shall conduct the Clinical Trial in accordance with GCP.
4.5.2 The Partner shall be responsible for obtaining and maintaining all Regulatory Approvals, including Ethical Committee approvals, necessary or reasonably useful for the conduct of the Clinical Trial.
4.5.3. The Partner shall establish a TSC which shall approve the Clinical Trial protocol and monitor the progress of the Clinical Trial, including any changes to the protocol. The TSC shall only include members who are independent of the Partner and who are not otherwise involved in the Clinical Trial.
4.5.4. The Partner shall communicate to FUNDER in writing any data relating to a Product of which it becomes aware which discloses a serious adverse event, promptly (and in any event within forty-eight (48) hours) and where that serious adverse event is a suspected, unexpected, serious adverse reaction or death or raised any other material safety signal, immediately.
4.5.5. The Partner shall inform FUNDER, in writing, of any Product recalls with twenty-four (24) hours of receiving notice of same.
4.5.6. The Partner shall obtain from each subject in the Clinical Trial, prior to enrolment into, and as a condition of that Clinical Trial subject’s participation in, any Clinical Trial, his or her informed consent to: i. Direct access to his or her medical records; ii. The processing of data relating to him or her and to the movement of that data to other countries, including countries outside of the European Economic Area; and iii. The transfer of such data to the Partner, FUNDER and in each case their permitted sub-licensees, and the use of those data in obtaining Regulatory Approvals.
4.6. FUNDER attendance at TSC and DSMB meetings. A FUNDER representative or nominee shall have the right (except for any matters which should remain blinded to FUNDER in the interests of the integrity of the Clinical Trial) to:
4.6.1. attend meetings of the TSC and the DSMB for the Clinical Trial as an observer;
4.6.2 receive all papers that a member of the TSC or DSMB would be entitled to receive ; and
4.6.3. attend TSC or DSMB meetings by telephone or other electronic means rather than in person.
6. Development and Regulatory Activities
6.3 Regulatory. Subject to the provisions of Clauses 9 and 15, the Partner shall be responsible for developing the regulatory strategy for the Product for review and approval by the JMAG. Such strategy shall include the strategy with respect to any data, market or other regulatory exclusivity periods that may be applicable to Product in the Affected Territory or a territory served by an Approved Regulatory Agency. The Partner shall use Reasonable Efforts to file for, obtain and maintain IND or a CTA for the Product in both a territory served by an Approved Regulatory Agency and the Affected Territory, and Marketing Approval for the Product in the Field in such countries in the Affected Territory.
6.4 FUNDER obligations. FUNDER will, where considered useful in FUNDER’s sole discretion, engage with the Partner, applicable Regulatory Authorities and Public Sector Agencies to facilitate the obtaining and maintaining of regulatory approvals.
6.5. Regulatory Filings. The Partner will keep the JMAG updated regarding all Regulatory Filings and provide each Member with copies of the following in a timely manner:
6.5.1. all submissions to Regulatory Authorities relating to the manufacture or of the Marketing Activities of any Product (other than ministerial submissions that do not involve safety or efficacy issues);
6.5.2. all Regulatory Filings and any Data including or referenced therein in respect of Product in the Field;
6.5.3. related documents and information exchanges between any Regulatory Authority and the Partner, including as part of regulatory planning in early stages of development; and
6.5.4. upon request, the Master File.
6.6. The Partner shall invite a FUNDER nominee to observe all interactions between the Partner and Regulatory Authorities which relate to the Project, the Product and the development or protection of the Foreground Intellectual Property. The Partner shall promptly notify FUNDER of its receipt of information from any Regulatory Authority that raises any material concerns regarding safety or efficacy of the Product. At FUNDER’s reasonable request, the Partner will request a meeting with Regulatory Authorities to deal with major unresolved issues. The Parties acknowledge and agree that FUNDER is bound by confidentiality obligations to the Partner pursuant to Clause 13 of this Agreement and therefore Regulatory Authorities’ communications with the Partner should not be limited by the presence of FUNDER nominees at regulatory meetings.
11. Intellectual Property – Management and Exploitation
11.2 Exploitation outside the Field or outside the Affected Territory. Where any proposed exploitation by the Partner is either:
11.2.2 outside the Field and for Development and Marketing Activities directed outside the Affected Territory;
11.2.3 Funder’s consent shall be conditional on the following: (i) the Partner shall be the sponsor of any clinical trial of a pharmaceutical composition which infringes the Foreground Intellectual Property (a “Similar Product”) unless Funder otherwise agrees in writing; (ii) the Partner shall consult with and agree the protocol for such clinical trial with Funder in advance and shall not proceed with any such clinical trial without Funder’s approval, such approval not to be unreasonably withheld, conditioned or delayed; (iii) the Partner shall communicate to Funder in writing any data relating to a Similar Product of which it becomes aware which discloses a serious adverse event, promptly (and in any event within forty-eight (48) hours) and where that serious adverse event is a suspected, unexpected, serious adverse reaction or death or raised any other material safety signal, immediately; (iv) any relevant event under any pharmacovigilance activities and (v) shall grant Funder a right of reference to the regulatory materials relating to any and all Similar Products.