Provision Language
4. TECHNICAL ASSISTANCE
4.2 Technical Transfer Package and Technical Transfer
(a) GARDP shall transfer, or in accordance with the Shionogi License Agreement request that Shionogi transfer, to the Sublicensee one set of electronic copies of a package of documentation prepared by Shionogi of the technical information owned or controlled by Shionogi that Shionogi reasonably believes is necessary for the effective transfer to the Sublicensee of the Manufacturing process used to Manufacture the Licensed Compound and Licensed Product in the same manner that such were Manufactured on the effective date of the Shionogi License Agreement (the “Technical Transfer Package”). The Technical Transfer Package and all information and materials provided by or on behalf of Shionogi in connection with the technical transfer process contemplated by this Section 4.2 are trade secrets of Shionogi, subject to the confidentiality and restricted use obligations of this Sublicense Agreement applicable to Confidential Information received by the Sublicensee.
(b) If requested by the Sublicensee, GARDP shall in accordance with the Shionogi License Agreement request that Shionogi, its Affiliates and/or its contractors conduct a technical transfer process (the “Technical Transfer”) to provide reasonable assistance to enable the Sublicensee (and if applicable a Sublicensee Contractor) to understand and implement the Sublicensed Manufacturing Know-How. Each party involved in the Technical Transfer shall be responsible for all its own costs (including the costs of its personnel, travel and lodging) incurred in connection therewith, including those of its respective Affiliates and contractors. For clarity, the Sublicensee shall thereafter be responsible for all its Manufacturing Development costs and the costs incurred to obtain Manufacturing Approvals. If requested by Shionogi, the Sublicensee (and if applicable any Sublicensee Contractor involved in any such technical transfer process) shall enter into a separate agreement with Shionogi to govern the terms and conditions of such technical transfer process, which agreement shall be consistent with all the relevant terms and conditions of this Sublicense Agreement. If requested by GARDP, the Sublicensee shall permit representatives of GARDP to participate in the technical transfer process and shall share with GARDP one electronic copy of all information received from Shionogi or its contractors in connection with such technical transfer.
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4.4 Technical Transfer to Other Manufacturer
(a) GARDP may at any time request that the Sublicensee perform a technical transfer of the Manufacturing processes used by Sublicensee to Manufacture Licensed Compound and/or Licensed Product to a Third Party manufacturer. This technical transfer shall include a transfer to the Third Party manufacturer of a copy of all relevant documentation in the Sublicensee’s [or its contractor’s] possession or control describing the relevant Manufacturing processes, and if applicable the right for the Third Party manufacturer to access and/or refer to the Sublicensee’s Manufacturing Approvals. The Sublicensee shall assign qualified personnel of the Sublicensee [and/or its contractors] to diligently and in good faith perform the technical transfer to the Third Party manufacturer, including if applicable by training Third Party manufacturer personnel at its or its contractor’s facility(ies) or at the Third Party’s manufacturing facility, and generally providing reasonable assistance to enable the Third Party to understand and implement at their facility(ies) the Manufacturing processes used by or for the Sublicensee to Manufacture Licensed Compound and Licensed Product. The technical transfer to the Third Party shall include a non-exclusive, fully paid-up license to use and practice the transferred processes and any intellectual property (including know-how and trade secret and if applicable patent rights) the Sublicensee may have in or to the transferred processes, solely for the purposes of the Licensed Compound and Licensed Product licenses granted to the Third Party by GARDP and/or Shionogi. If requested by the Sublicensee, the Third-Party manufacturer shall enter into a written agreement with the Sublicensee undertaking to protect the confidentiality of the transferred processes and to use them solely for the purposes for which it has obtained a license from GARDP and/or Shionogi.
(b) GARDP shall compensate the Sublicensee for the time spent performing the technical transfer services contemplated in paragraph (a) above based on a reasonable fee agreed by the Parties and shall reimburse the Sublicensee for any reasonable out of pocket expenses engaged to give effect to the technical transfer. Notwithstanding the preceding sentence, the Sublicensee’s conduct of any such technical transfer shall be at its entire cost if the technical transfer is requested by GARDP following a breach by the Sublicensee of its obligations under this Sublicense Agreement and/or if the technical transfer is required because the Sublicensee has not successfully implemented an Access Action Plan agreed by the Parties pursuant to Section 3.3 above or a Manufacturing Action Plan agreed by the Parties pursuant to Section 5.3 below.