Common use of Transition Plan; Transition of Extension Study Clause in Contracts

Transition Plan; Transition of Extension Study. (a) Within [***] days following the Effective Date, the Transition Committee shall discuss and agree an initial transition plan describing in reasonable detail the activities to be carried out by each Party, in order to facilitate, the prompt and orderly transfer to Pharming or its designee the Licensed Know-How and all Development, regulatory and manufacturing activities undertaken by or on behalf of Novartis or its Affiliates as of the Effective Date with respect to CDZ173 and the Lead Product (other than the Ongoing Trial) and allow Pharming to assume responsibility for such activities. Without limiting the foregoing, such transition plan shall set out in reasonable detail a process for (i) the transition of the Extension Study from Novartis to Pharming, (ii) the delivery to Pharming or its designee of any Licensed Know-How not previously delivered, and (iii) the technology transfer contemplated by Section 6.7, in each case ((i) through (iii)), in accordance with the terms of this Agreement and Applicable Laws, including the timing and sequence for the transition of the Extension Study on a country-by-country or trial site-by-trial site basis, the Third Party agreements to be transferred to Pharming or its designee pursuant to the Ancillary Agreement in connection with the transition of the Extension Study, and the other transition activities to be undertaken by the Parties and the timing therefor. In agreeing on the Transition Plan, the Transition Committee shall incorporate the Joint Trial Plan and the Technology Transfer Plan as discussed and agreed by the applicable Subcommittee. Such plan, as approved by the Transition Committee, in whole or in part, is referred to herein as the “Transition Plan.” The Transition Committee may review and approve any portion or component of such plan independently, and once approved by the Transition Committee, each such portion or component shall be regarded as part of the “Transition Plan” hereunder. Once approved, the Transition Plan may only be amended by mutual agreement of the Parties through the Transition Committee (or, with respect to the Joint Trial Plan and Technology Transfer Plan, the applicable Subcommittee). Each Party shall use Commercially Reasonable Efforts to perform their respective activities under the Transition Plan in accordance with the schedules and timetables thereunder. No breach or alleged breach by a Party of its obligations under the Transition Plan shall excuse the performance by the other Party of its obligations under the Transition Plan to the extent such obligations may be performed in accordance with the material terms and conditions of this Agreement and Applicable Law. (b) Within [***] days following the applicable Regulatory Filing Transfer, the Parties shall transition the Extension Study from Novartis to Pharming, including with respect to the applicable Site Agreement and by transferring sponsorship and operational control with respect to the relevant trial site, on a country-by- country or trial site-by-trial site basis as of the applicable Extension Study Transition Date in accordance with the Transition Plan, standard industry practice and Applicable Law. Such transition shall be mutually agreed by and subject to the oversight and input of the Alliance Managers and the JCT. From and after the Extension Study Transition Date on a country-by-country or trial site-by-trial site basis, Pharming (i) shall be the sponsor of the Extension Study, and (ii) shall, at its own cost and expense, manage, conduct, and perform the Extension Study in a good scientific manner and in compliance with Applicable Law until at least the date of the First Commercial Sale of Licensed Product in the relevant country and the completion of the Extension Study as defined in the Extension Study Protocol. (c) Within [***] days following the Extension Study Transition Date on a country-by-country or trial site-by-trial site basis, as mutually agreed by the JCT, Novartis shall provide or cause to be provided to Pharming subject to Section 4.1 a copy (in electronic format if available in electronic format, or hard copy if not available in electronic format) of any Trial Data not previously provided to Pharming.