Novartis’ Obligations Regarding Extension Study Sample Clauses

Novartis’ Obligations Regarding Extension Study. (a) Subject to the terms and conditions of this Agreement, including Section 6.2 and Section 8.5, Novartis shall be responsible for the performance of, and shall continue to perform, the Extension Study in accordance with the Extension Study Protocol until, on a country-by-country or trial site-by-trial site basis, as mutually agreed by the Parties, the applicable Extension Study Transition Date. (b) Prior to the Extension Study Transition Date with respect to all trial sites (the “Final Trial Transfer Date”), Novartis shall be permitted to amend the Extension Study Protocol, and following the Final Trial Transfer Date, Pharming shall be permitted to amend the Extension Study Protocol, in each case: (i) to the extent required by Applicable Law or any relevant Regulatory Authority; (ii) to the extent required under the terms of an applicable Site Agreement; (iii) if such Party determines in good faith that any such amendment is necessary or appropriate for health or safety reasons; or (iv) with the prior written consent of the other Party (such consent not to be unreasonably withheld, conditioned, or delayed). Without limiting the foregoing, either Party may propose amendments to the Extension Study Protocol through the JCT, which shall consider any such proposed amendment in good faith. Notwithstanding the foregoing, following the First Commercial Sale of Licensed Product on a country-by-country basis, this Section 5.2(b) will no longer apply to Pharming with respect to the Extension Study Protocol as it relates to Extension Study subjects in such country. (c) At least once every Calendar Quarter following the Effective Date until the Final Trial Transfer Date, Novartis will provide a clinical update regarding the Extension Study to Pharming through the JCT which shall indicate the number of enrolled subjects per trial site and such other information as agreed by the JCT until the Site Agreement for such site has been transferred to Pharming or its designee.
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