Common use of Ownership and Use of Data Clause in Contracts

Ownership and Use of Data. 4.6.1 Each Party shall own all data, results, information, developments and documentation generated by activities that were funded solely by it prior to the Date of Agreement. 4.6.2 USL shall own all data, results, information, developments and documentation generated by activities undertaken after the Date of Agreement in connection with or pursuant to the Development Plan, or otherwise undertaken or paid for by USL, provided that USL and Orion shall jointly own all data, results, information, developments and documentation generated by activities after the Date of Agreement to the extent Orion joins USL in funding such activities, and Orion’s funding exceeds the [***] amount specified in Section 4.7(a)(1). Manufacturing process development and validation, manufacturing scale-up, stability testing, or quality assurance/quality control development for the Product shall be performed by Orion, at its expense, and data, information and documentation related thereto (which is not to be reimbursed by USL) shall be Orion’s Proprietary Information owned by Orion, and USL shall have the right to use all such Orion Proprietary Information as provided in this Agreement. 4.6.3 It is understood that the terms of Sections 4.6.1 and 4.6.2 shall apply regardless of whether the activity was conducted directly by a Party or by a Third Party (e.g., a contract research organization) on behalf of such Party. Data, results, information, developments and documentation owned by USL in accordance with this Section 4.6 is referred to as “USL Data” and shall be proprietary and confidential to USL. Orion assigns to USL any right it may have in USL Data, and agrees to execute any documents as USL may reasonably request to document and confirm USL’s ownership of the USL Data. (a) Orion shall make available all data, results, information, development and documentation of Orion that is a part of Orion Proprietary Information for use in connection with USL’s performance of this Agreement regarding the Product in the Territory. USL agrees to share with Orion all pre-clinical and clinical research data and results involving Product which it has developed, develops, or obtains from a Third Party during the Term, as well as correspondence with the FDA and minutes of meetings with the FDA regarding the Product. Such sharing by each Party shall take place as soon as reasonably practicable after such data or results become available, but in no event shall a final study report (“Final Study Report”) for a clinical study involving Product be provided later than twelve (12) months after data base lock for such study, and provided further that any disclosure of information to be shared is not restricted by any Third Party contractual obligations preventing such disclosure by a Party to the other. Each of USL and Orion agrees that it will use commercially reasonable efforts to avoid subjecting itself to such restrictions that would prevent such disclosures to Orion. Such data and results shall be provided to Orion subject to the confidentiality and use restrictions under which each is bound under this Agreement, (it being understood, however, that, with respect to use of such data permitted under Sections 4.6.4 and 4.6.5, such confidentiality and use restrictions shall be observed to the extent permitted by applicable law, and a party shall not be liable for noncompliance with such restrictions in the use of such data under Sections 4.6.4 and 4.6.5 to the extent compliance with such use and confidentiality restrictions is not permitted by applicable law). (b) Each Party shall be entitled to use in the Territory for the purposes of this Agreement, and Orion shall be entitled to use outside the Territory, as it sees appropriate, free-of-charge and without any limitation in time, any and all data and results of any study or other activity, including without limitation the materials identified in Section 4.6.3 (a) above developed or obtained by USL, and any study reports and abstracts, related to Product conducted by or on behalf of either Party in accordance with the provisions of this Section 4. 4.6.4 Each Party shall be entitled to, and shall be provided with access to, all Safety Data of the other Party. “Safety Data” means pre-clinical and clinical data relating to the Product useful for or in connection with demonstrating the safety of the Product for use in humans. Each Party may use Safety Data of the other Party in connection with any regulatory filing, whether or not such filing is mandatory.