Common use of Review of Regulatory Submissions Clause in Contracts

Review of Regulatory Submissions. (a) BeiGene shall provide to AssemblyBio all Regulatory Submissions (including certified English translations thereof) prepared by or on behalf of BeiGene at least [* * *] prior to submission and shall consider in good faith any reasonable comments received from AssemblyBio with respect thereto. AssemblyBio shall provide BeiGene with copies of all Clinical Trial Applications for the Licensed ABI-H0731 Products in the Territory (including certified English translations thereof) prepared by or on behalf of AssemblyBio. (b) In addition, each Party shall notify the other Party of any comments or other material correspondence regarding any Regulatory Submissions that are received from any Regulatory Authority in the Territory or, with respect to Clinical Trials conducted pursuant to the Global Development Plan, outside the Territory, and shall provide the other Party with copies thereof as soon as reasonably practicable, but in all events within [* * *] of receipt (or such longer time period as may be necessary to obtain translations thereof). Each Party will provide quarterly updates, at each JDC meeting, regarding its activities and progress with respect to all Clinical Trials conducted pursuant to the Global Development Plan or the Territory Development Plan. (c) Each Party shall keep the other Party reasonably informed of regulatory developments related to Licensed Products in the Field in the Territory and outside the Territory of which it becomes aware and shall promptly notify the other Party in writing of any material decision by any Regulatory Authority in the Field, in the Territory and outside the Territory, of which it becomes aware regarding any Licensed Product. (d) Each Party shall provide the other Party with notice no later than [* * *] after receiving notice of any material meeting or substantive communication with any Regulatory Authority in the Territory related to any Licensed Product in the Field. Each Party shall provide the other Party with a written summary of each such meeting or substantive communication in English promptly following such meeting or discussion. AssemblyBio or its designee will have the right, but not the obligation, to attend and observe any such meeting or discussion with Regulatory Authorities in the Territory unless prohibited or restricted by Applicable Law or the Regulatory Authorities; provided that BeiGene shall not be obligated to schedule such meetings to specifically enable AssemblyBio’s or its designee’s attendance. Without limiting the generality of the foregoing, with respect to ABI-H0731 and Licensed ABI-H0731 Products, (i) until the study protocols of the Phase 3 Clinical Trials for the Licensed ABI-H0731 Products are approved by the applicable Regulatory Authorities in the Territory, AssemblyBio shall be the leading Party for the discussion and interactions with Regulatory Authorities in the Territory with respect to the Licensed ABI-H0731 Products, taking into account in good faith comments and input from BeiGene related thereto; (ii) after the study protocols of the Phase 3 Clinical Trials for the Licensed ABI-H0731 Products are approved by the applicable Regulatory Authorities in the Territory, BeiGene shall be the leading Party for the discussion and interactions with Regulatory Authorities in the Territory with respect to the Licensed ABI-H0731 Products, taking into account in good faith comments and input from AssemblyBio related thereto; and (iii) BeiGene shall have the right to participate in any meeting between AssemblyBio and Regulatory Authorities in the Territory regarding the Clinical Trials for ABI-H0731 and Licensed ABI-H0731 Products unless prohibited or restricted by Applicable Law or the Regulatory Authorities, provided that AssemblyBio shall not be obligated to schedule such meetings to specifically enable BeiGene’s or its designee’s attendance.

Review of Regulatory Submissions. (a) BeiGene shall provide to AssemblyBio Zymeworks all Regulatory Submissions (including certified English translations thereof) prepared by or on behalf of BeiGene at least 52 Competitive Information – Commercially Sensitive Terms. 53 Competitive Information – Commercially Sensitive Terms. 54 Competitive Information – Discovery Information and Commercially Sensitive Terms. [* * …***…] prior to submission and shall consider in good faith any reasonable comments received from AssemblyBio Zymeworks with respect thereto. AssemblyBio shall provide BeiGene with copies of all Clinical Trial Applications for the Licensed ABI-H0731 Products in the Territory (including certified English translations thereof) prepared by or on behalf of AssemblyBio.thereto.55 (b) In addition, each Party shall notify the other Party of any comments or other material correspondence regarding any Regulatory Submissions that are received from any Regulatory Authority in the Territory or, with respect to Clinical Trials conducted pursuant to the Global Development Plan, outside the Territory, and shall provide the other Party with copies thereof as soon as reasonably practicable, but in all events within [* * …***…] of receipt (or such longer time period as may be necessary to obtain translations thereof). Each Party will provide quarterly updates, at each JDC JSC meeting, regarding its activities and progress with respect to all Clinical Trials conducted pursuant to the Global Development Plan or the Territory Development Plan.Plan.56 (c) Each Party shall keep the other Party reasonably informed of regulatory developments related to Licensed Products in the Field in the Territory and outside the Territory of which it becomes aware and shall promptly notify the other Party in writing of any material decision by any Regulatory Authority in the Field, in the Territory and outside the Territory, of which it becomes aware regarding any Licensed Product. (d) Each Party shall provide the other Party with notice no later than [* * …***…] after receiving notice of any material meeting or substantive communication discussion with any Regulatory Authority in the Territory related to any Licensed Product in the Field. Each Party shall provide the other Party with a written summary of each such meeting or substantive communication discussion in English promptly following such meeting or discussion. AssemblyBio or its designee will have the right, but not the obligation, to attend and observe any such meeting or discussion with Regulatory Authorities in the Territory unless prohibited or restricted by Applicable Law or the Regulatory Authorities; provided that BeiGene shall not be obligated to schedule such meetings to specifically enable AssemblyBio’s or its designee’s attendance. Without limiting the generality of the foregoing, with respect to ABI-H0731 and Licensed ABI-H0731 Products, (i) until the study protocols of the Phase 3 Clinical Trials for the Licensed ABI-H0731 Products are approved by the applicable Regulatory Authorities in the Territory, AssemblyBio shall be the leading Party for the discussion and interactions with Regulatory Authorities in the Territory with respect to the Licensed ABI-H0731 Products, taking into account in good faith comments and input from BeiGene related thereto; (ii) after the study protocols of the Phase 3 Clinical Trials for the Licensed ABI-H0731 Products are approved by the applicable Regulatory Authorities in the Territory, BeiGene shall be the leading Party for the discussion and interactions with Regulatory Authorities in the Territory with respect to the Licensed ABI-H0731 Products, taking into account in good faith comments and input from AssemblyBio related thereto; and (iii) BeiGene shall have the right to participate in any meeting between AssemblyBio and Regulatory Authorities in the Territory regarding the Clinical Trials for ABI-H0731 and Licensed ABI-H0731 Products unless prohibited or restricted by Applicable Law or the Regulatory Authorities, provided that AssemblyBio shall not be obligated to schedule such meetings to specifically enable BeiGene’s or its designee’s attendance.discussion.57

Review of Regulatory Submissions. (a) BeiGene shall provide to AssemblyBio Leap all Regulatory Submissions (including certified English translations thereof) prepared by or on behalf of BeiGene at least [* * ***] prior to submission and shall consider in good faith any reasonable comments received from AssemblyBio Leap with respect thereto. AssemblyBio shall provide BeiGene with copies of all Clinical Trial Applications for the Licensed ABI-H0731 Products in the Territory (including certified English translations thereof) prepared by or on behalf of AssemblyBio.thereto.48 (b) In addition, each Party shall notify the other Party of any comments or other material correspondence regarding any Regulatory Submissions that are received from any Regulatory Authority in the Territory or, with respect to Multi-Regional Clinical Trials conducted pursuant to the Global Development Plan, outside the Territory, and shall provide the other Party with copies thereof as soon as reasonably practicable, but in all events within [* * ***] of receipt (or such longer time period as may be necessary to obtain translations thereof). Each Party will provide quarterly [***] updates, at each JDC meeting[***], regarding its activities and progress with respect to all Clinical Trials conducted pursuant to of the Global Development Plan or the Territory Development Plan.Licensed Product.49 (c) Each Party shall keep the other Party reasonably informed of regulatory developments related to Licensed Products in the Field in the Territory and outside the Territory of which it becomes aware and shall promptly notify the other Party in writing of any material decision by any Regulatory Authority in the Field, in the Territory and outside the Territory, of which it becomes aware regarding any Licensed Product. 47 Competitive Information – Discovery Information and Commercially Sensitive Terms. 48 Competitive Information – Commercially Sensitive Terms. 49 Competitive Information – Commercially Sensitive Terms. (d) Each Party shall provide the other Party with notice no later than [* * ***] after receiving notice of any material meeting or substantive communication discussion with any Regulatory Authority in the Territory related to any Licensed Product in the Field. Each Party shall provide the other Party with a written summary of each such meeting or substantive communication discussion in English promptly following such meeting or discussion. AssemblyBio or its designee will have the right, but not the obligation, to attend and observe any such meeting or discussion with Regulatory Authorities in the Territory unless prohibited or restricted by Applicable Law or the Regulatory Authorities; provided that BeiGene shall not be obligated to schedule such meetings to specifically enable AssemblyBio’s or its designee’s attendance. Without limiting the generality of the foregoing, with respect to ABI-H0731 and Licensed ABI-H0731 Products, (i) until the study protocols of the Phase 3 Clinical Trials for the Licensed ABI-H0731 Products are approved by the applicable Regulatory Authorities in the Territory, AssemblyBio shall be the leading Party for the discussion and interactions with Regulatory Authorities in the Territory with respect to the Licensed ABI-H0731 Products, taking into account in good faith comments and input from BeiGene related thereto; (ii) after the study protocols of the Phase 3 Clinical Trials for the Licensed ABI-H0731 Products are approved by the applicable Regulatory Authorities in the Territory, BeiGene shall be the leading Party for the discussion and interactions with Regulatory Authorities in the Territory with respect to the Licensed ABI-H0731 Products, taking into account in good faith comments and input from AssemblyBio related thereto; and (iii) BeiGene shall have the right to participate in any meeting between AssemblyBio and Regulatory Authorities in the Territory regarding the Clinical Trials for ABI-H0731 and Licensed ABI-H0731 Products unless prohibited or restricted by Applicable Law or the Regulatory Authorities, provided that AssemblyBio shall not be obligated to schedule such meetings to specifically enable BeiGene’s or its designee’s attendance.discussion.50

Review of Regulatory Submissions. (a) BeiGene shall provide to AssemblyBio Zymeworks all Regulatory Submissions (including certified English translations thereof) prepared by or on behalf of BeiGene at least [* * …***…] prior to submission and shall consider in good faith any reasonable comments received from AssemblyBio Zymeworks with respect thereto. AssemblyBio shall provide BeiGene with copies of all Clinical Trial Applications for the Licensed ABI-H0731 Products in the Territory (including certified English translations thereof) prepared by or on behalf of AssemblyBio.thereto.55 (b) In addition, each Party shall notify the other Party of any comments or other material correspondence regarding any Regulatory Submissions that are received from any Regulatory Authority in the Territory or, with respect to Clinical Trials conducted pursuant to the Global Development Plan, outside the Territory, and shall provide the other Party with copies thereof as soon as reasonably practicable, but in all events within [* * …***…] of receipt (or such longer time period as may be necessary to obtain translations thereof). Each Party will provide quarterly updates, at each JDC JSC meeting, regarding its activities and progress with respect to all Clinical Trials conducted pursuant to the Global Development Plan or the Territory Development Plan.. 56 (c) Each Party shall keep the other Party reasonably informed of regulatory developments related to Licensed Products in the Field in the Territory and outside the Territory of which it becomes aware and shall promptly notify the other Party in writing of any material decision by any Regulatory Authority in the Field, in the Territory and outside the Territory, of which it becomes aware regarding any Licensed Product. (d) Each Party shall provide the other Party with notice no later than [* * …***…] after receiving notice of any material meeting or substantive communication discussion with any Regulatory Authority in the Territory related to any Licensed Product in the Field. Each Party shall provide the other 54 Competitive Information – Commercially Sensitive Terms. 55 Competitive Information – Commercially Sensitive Terms. 56 Competitive Information – Commercially Sensitive Terms. Party with a written summary of each such meeting or substantive communication discussion in English promptly following such meeting or discussion. AssemblyBio or its designee will have the right, but not the obligation, to attend and observe any such meeting or discussion with Regulatory Authorities in the Territory unless prohibited or restricted by Applicable Law or the Regulatory Authorities; provided that BeiGene shall not be obligated to schedule such meetings to specifically enable AssemblyBio’s or its designee’s attendance. Without limiting the generality of the foregoing, with respect to ABI-H0731 and Licensed ABI-H0731 Products, (i) until the study protocols of the Phase 3 Clinical Trials for the Licensed ABI-H0731 Products are approved by the applicable Regulatory Authorities in the Territory, AssemblyBio shall be the leading Party for the discussion and interactions with Regulatory Authorities in the Territory with respect to the Licensed ABI-H0731 Products, taking into account in good faith comments and input from BeiGene related thereto; (ii) after the study protocols of the Phase 3 Clinical Trials for the Licensed ABI-H0731 Products are approved by the applicable Regulatory Authorities in the Territory, BeiGene shall be the leading Party for the discussion and interactions with Regulatory Authorities in the Territory with respect to the Licensed ABI-H0731 Products, taking into account in good faith comments and input from AssemblyBio related thereto; and (iii) BeiGene shall have the right to participate in any meeting between AssemblyBio and Regulatory Authorities in the Territory regarding the Clinical Trials for ABI-H0731 and Licensed ABI-H0731 Products unless prohibited or restricted by Applicable Law or the Regulatory Authorities, provided that AssemblyBio shall not be obligated to schedule such meetings to specifically enable BeiGene’s or its designee’s attendance.discussion.57