Disclosure Process. Each Party will each nominate a “Disclosure Representative” to oversee and coordinate the Disclosure Process. The Disclosure Representatives will meet regularly, on a timetable that they will agree, to facilitate disclosure and ensure that the licensed Technology is transferred to Orchard in a timely fashion. Within [***] of the Effective Date, Orchard will present to UCLB and UCLA (as applicable) a list of high-priority items to be disclosed, and the Disclosure Representatives will arrange for such items to be disclosed within [***] of UCLB or UCLA (as applicable) receiving the list, or on a timetable to be reasonably agreed between the Disclosure Representatives as dictated by the business needs of Orchard. Orchard may make additional requests from time to time for items to be disclosed, for which a similar procedure will be followed, managed by the Disclosure Representatives. The Disclosure Representatives will collaborate with the intention of completing the initial Disclosure Process as soon as possible and within [***] of the Effective Date. [***] from the Effective Date, the Disclosure Representatives will meet to determine which items, if any, have not been disclosed and will agree a timetable and process for completion of the initial Disclosure Process. While the intention is to complete the initial Disclosure Process within [***], Orchard shall have the right to seek additional disclosure beyond the [***] Disclosure Process, as described in Clause 3. Notwithstanding the foregoing, with respect to disclosure of the Joint Clinical Data the following principles shall apply: • An independent third party data management company shall be appointed to manage and undertake the identification, collection, storage and verification of the Joint Clinical Data on behalf of Orchard; • The independent third party data management company shall be paid by Orchard; • UCLB and UCLA shall work with, assist and co-operate with the independent third party data management company to facilitate the collection of all the Joint Clinical Data and to build/create a database of the Joint Clinical Data, that meets all necessary regulatory, quality and security standards as required by the FDA and/or EMA. • It is anticipate that this data collection process will take longer than [***], but that it shall be started upon notice from Orchard.
Appears in 2 contracts
Sources: License Agreement (Orchard Rx LTD), License Agreement (Orchard Rx LTD)