Communications and Cooperation. Karyopharm shall cooperate in good faith with Ono pertaining to Ono’s Development activities and regulatory affairs with respect to each Licensed Product in the Field in the Ono Territory at Ono’s sole cost and expense. Ono will, as to each Licensed Product in the Field in the Ono Territory, (a) notify Karyopharm in writing of all material communications from a Regulatory Authority within [**] after receipt thereof, including a brief description in English of the principal issues raised, (b) provide Karyopharm with a summary translation of such material communications in English as soon as reasonably possible, and (c) provide the complete copies of the original correspondence in its original language to Karyopharm upon request. Ono shall provide Karyopharm with reasonable advance notice of all substantive meetings with the Regulatory Authorities in the Ono Territory pertaining to each Licensed Product in the Field, or with as much advance notice as practicable under the circumstances. Karyopharm may, at its own cost, attend such meetings with Regulatory Authorities as an observer upon reasonable advance notice to Ono, subject to Ono’s prior written consent and receipt of any required permissions of such Regulatory Authorities. Karyopharm will, as to each Licensed Product in the Field in the Karyopharm Territory, (a) notify Ono in writing of all material communications from a Regulatory Authority within [**] after receipt thereof, including a brief description in English of the principal issues raised, (b) provide Ono with a summary translation of such material communications in English as soon as reasonably possible, and (c) provide the complete copies of the original correspondence in its original language to Ono upon request. Karyopharm shall provide Ono with reasonable advance notice of all substantive meetings with the Regulatory Authorities in the Karyopharm Territory pertaining to each Licensed Product in the Field, or with as much advance notice as practicable under the circumstances. Ono may, at its own cost, attend such meetings with Regulatory Authorities as an observer upon reasonable advance notice to Karyopharm subject to Karyopharm’s prior written consent and receipt of any required permissions of such Regulatory Authorities.
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Communications and Cooperation. Karyopharm shall cooperate in good faith with Ono Antengene pertaining to OnoAntengene’s Development activities and regulatory affairs with respect to each Licensed Product in the Field in the Ono Antengene Territory at OnoAntengene’s sole cost and expense. Ono Antengene will, as to each Licensed Product in the Field in the Ono Antengene Territory, (a) notify Karyopharm in writing of all material communications from a Regulatory Authority within [**] after receipt thereof, including a brief description in English of the principal issues raised, (b) provide Karyopharm with a summary translation of such material communications in English as soon as reasonably possible, and (c) provide the complete copies of the original correspondence in its original language to Karyopharm upon request. Ono Antengene shall provide Karyopharm with reasonable advance notice of all substantive meetings with the Regulatory Authorities in the Ono Antengene Territory pertaining to each Licensed Product in the Field, or with as much advance notice as practicable under the circumstances, but not less than [**]. Karyopharm may, at its own cost, attend such meetings with Regulatory Authorities as an observer upon reasonable advance notice to OnoAntengene, subject to Ono’s prior written consent and receipt of any required permissions of such Regulatory Authorities. Karyopharm will, as to each Licensed Product in the Field in the Karyopharm Territory, (a) notify Ono Antengene in writing of all material communications from a Regulatory Authority that concern the safety or efficacy of a Licensed Compound within [**] after receipt thereof, including a brief description in English of the principal issues raised, (b) provide Ono Antengene with a summary translation of such material communications in English as soon as reasonably possible, and (c) provide the complete copies of the original correspondence in its original language to Ono Antengene upon request. Karyopharm shall provide Ono Antengene with reasonable advance notice of all substantive meetings with the Regulatory Authorities in the Karyopharm Territory pertaining to each Licensed Product in the Field, or with as much advance notice as practicable under the circumstances, but not less than [**]. Ono mayFor the purposes of this Section 3, at its own cost“material communications” includes but is not limited to all communications related to or impacting the Development of the Licensed Compounds or Licensed Products, attend such meetings with Regulatory Authorities as an observer upon reasonable advance notice to Karyopharm study endpoints, study design, clinical trial subject to Karyopharm’s prior written consent numbers, clinical study timelines, and receipt safety or efficacy of any required permissions of such Regulatory Authoritiesa Licensed Compound.
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