Common use of Communications with Regulatory Authorities Clause in Contracts

Communications with Regulatory Authorities. During the Collaboration Term, Xencor shall provide MorphoSys with reasonable advance notice of any meeting or substantive telephone conference with any Regulatory Authority relating to any Licensed Antibody and/or Licensed Product. MorphoSys shall have the right to attend and observe (but not participate actively in) any material meeting or material conference call with any Regulatory Authority regarding any of MorphoSys (or its Affiliate’s or Sublicensee’s) Licensed Antibody and/or Licensed Products. In addition, Xencor shall promptly furnish to MorphoSys copies of all correspondence that Xencor (or its Affiliate) receives from, or submits to, any Regulatory Authority (including contact reports concerning conversations or substantive meetings) relating to any Licensed Antibody and/or Licensed Product. Xencor shall also provide to MorphoSys any meeting minutes that reflect material communications with any Regulatory Authority regarding a Licensed Antibody and/or Licensed Product. Subject to the provisions of Section 2.2(c)(ii), MorphoSys shall provide in its MorphoSys Annual Development Reports to Xencor, and through JDC discussion, information regarding its (or its Affiliate’s or, to the extent permitted by the Sublicense, Sublicensee’s) interactions with Regulatory Authorities with respect to all Licensed Antibodies and/or Licensed Products in its respective Territory. In addition, to the extent permitted by law and subject to Section 3.6, Xencor may participate in communications and meetings with any Regulatory Authority to the extent the name and/or then-current Xencor logo is used on the drug product label and such labeling is being discussed in such communication or meeting. Notwithstanding MorphoSys’ obligations under this Article 3, MorphoSys shall not be required to share with Xencor any information which MorphoSys is not permitted to share with Xencor under the applicable laws or regulations of the Securities & Exchange Commission or other regulatory body of the US or elsewhere.

Communications with Regulatory Authorities. During the Collaboration TermTrials, Xencor OPKO shall promptly provide MorphoSys with reasonable advance notice Pfizer access to a copy of any meeting written communication received by OPKO or substantive telephone conference with its representatives from any Regulatory Authority relating with respect to any Licensed Antibody and/or Compound or Licensed Product. MorphoSys OPKO will have primary responsibility to respond to such communications; however, if any planed written responses or meetings with Regulatory Authorities relates to information that may affect any of the timelines set forth in the Development Plan or that may have a material impact on the success of any BLA submission by Pfizer, then OPKO shall have also notify Pfizer in advance of all such responses or meetings with the right Regulatory Authorities, whether in person or by telephone or videoconference and Pfizer shall be entitled to attend and, if appropriate and observe (but not permitted under Applicable Law, participate actively in) any material meeting in all such meetings with Regulatory Authorities, whether in person or material conference call with any Regulatory Authority regarding any by means of MorphoSys (or its Affiliate’s or Sublicensee’s) Licensed Antibody and/or Licensed Productstelecommunication; further provided, however, that where such communications concern the CMC Information, Pfizer will have primary responsibility to prepare responses to such communications as described further in this Section 3.3.1. In addition, Xencor shall promptly furnish to MorphoSys copies During the preparation and submission of all correspondence that Xencor (or its Affiliate) receives from, or submits to, any Regulatory Authority (including contact reports concerning conversations or substantive meetings) relating to any Licensed Antibody and/or Licensed Product. Xencor shall also provide to MorphoSys any meeting minutes that reflect material communications with any Regulatory Authority regarding a Licensed Antibody and/or Licensed Product. Subject to the provisions of Section 2.2(c)(ii), MorphoSys shall provide in its MorphoSys Annual Development Reports to Xencor, and through JDC discussion, information regarding its (or its Affiliate’s orBLAs, to the extent permitted practical, and provided that Pfizer will not be required to incur a substantive delay, OPKO shall be provided with prior notice as reasonably practicable of all proposed communications and meetings by the Sublicense, Sublicensee’s) interactions Pfizer with Regulatory Authorities and afforded the opportunity to promptly comment on such communications (and Pfizer shall reasonably take into account such comments) and attend such meetings (unless the Parties shall reasonably determine that such participation would decrease the likelihood of obtaining any requisite Regulatory Approval); provided, further, that notwithstanding anything set forth above, Pfizer will have the sole decision making authority and responsibility with respect to all Licensed Antibodies and/or Licensed Products in its respective Territory. In addition, to the extent permitted by law and subject to Section 3.6, Xencor may participate in any such communications and meetings with Regulatory Authorities. During the preparation and submissions of BLAs, OPKO will provide reasonable support in the preparation of the relevant sections related to OPKOs clinical activities (including Modules 1 and 2) and provide support to the rapid response team for queries. Each Party will promptly provide the JDC with access to copies of all regulatory communications, and in circumstances during the Trial where such communications require a response that pertains to the CMC Information, OPKO will provide Pfizer with a copy of such communication promptly (and in no event more than *** Business Days) following receipt thereof so that, after having considered any OPKO comments thereto, at Pfizer’s discretion, Pfizer can provide OPKO with the relevant response, which OPKO will submit *** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment. An unredacted version of this exhibit has been filed separately with the Commission. Execution Version to the applicable Regulatory Authority in whole without any changes, additions or deletions, except with respect to translations to local language required by Applicable Law or with Pfizer’s consent, not to be unreasonably withheld. For clarity, during preparation and submission of the BLAs, if Pfizer receives any correspondence from any Regulatory Authority Authorities, including that relates to the extent the name and/or then-current Xencor logo is used on the drug product label CMC Information, Pfizer will provide OPKO a full and complete copy, of such labeling is being discussed in such communication or meeting. Notwithstanding MorphoSys’ obligations under this Article 3, MorphoSys shall not be required to share with Xencor any information which MorphoSys is not permitted to share with Xencor under the applicable laws or regulations of the Securities & Exchange Commission or other regulatory body of the US or elsewherecommunication.

Communications with Regulatory Authorities. Except as required by applicable law, Genta shall have the sole right to communicate with Regulatory Authorities concerning Products, including conducting meetings and holding telephone discussions with such Regulatory Authorities, provided that the foregoing prohibition shall not apply to Emisphere’s filings and filing-related communications with Regulatory Authorities relating solely to the Program Carrier (in which event Emisphere shall consult with Genta prior to such communication and consider Genta’s input in good faith) or to combinations of the Program Carrier with any API other than a Gallium Compound (in which event no consultation with Genta will be required). During the Collaboration Development Term, Xencor Emisphere will assist Genta, at Genta’s reasonable request, in preparing for any such communications or meetings, Genta shall provide MorphoSys notify Emisphere prior to scheduling any such meetings with reasonable advance notice of any meeting or substantive telephone conference with any Regulatory Authority relating the FDA to any Licensed Antibody and/or Licensed Product. MorphoSys enable Emisphere to participate in such meetings, and Emisphere shall have the right to have a representative of Emisphere attend with Genta to observe any meeting with the FDA pertaining to Products, provided Emisphere gives Genta reasonable advance notice of its desire to attend such meeting, Emisphere participates with Genta in Genta’s preparation for the meeting, and observe (but the FDA does not participate actively in) any material meeting object to Emisphere’s attendance or material conference call participation. Emisphere’s participation in communications with any Regulatory Authority regarding any of MorphoSys (or its AffiliateAuthorities concerning Products shall be subject to Genta’s or Sublicensee’s) Licensed Antibody and/or Licensed Productsreasonable discretion. In addition, Xencor shall promptly furnish to MorphoSys copies of all correspondence that Xencor (or its Affiliate) receives from, or submits to, any Regulatory Authority (including contact reports concerning conversations or substantive meetings) relating to any Licensed Antibody and/or Licensed Product. Xencor Genta shall also provide to MorphoSys any Emisphere copies of all meeting minutes that reflect are kept for Genta interactions during the Development Term with the FDA in respect of Products. * denotes material communications omitted pursuant to a Confidential Treatment Request and filed separately with any Regulatory Authority regarding a Licensed Antibody and/or Licensed Product. Subject to the provisions of Section 2.2(c)(ii), MorphoSys shall provide in its MorphoSys Annual Development Reports to Xencor, and through JDC discussion, information regarding its (or its Affiliate’s or, to the extent permitted by the Sublicense, Sublicensee’s) interactions with Regulatory Authorities with respect to all Licensed Antibodies and/or Licensed Products in its respective Territory. In addition, to the extent permitted by law and subject to Section 3.6, Xencor may participate in communications and meetings with any Regulatory Authority to the extent the name and/or then-current Xencor logo is used on the drug product label and such labeling is being discussed in such communication or meeting. Notwithstanding MorphoSys’ obligations under this Article 3, MorphoSys shall not be required to share with Xencor any information which MorphoSys is not permitted to share with Xencor under the applicable laws or regulations of the Securities & and Exchange Commission or other regulatory body of the US or elsewhereCommission.

Communications with Regulatory Authorities. During Each Party shall keep the Collaboration other Party informed on an ongoing basis at Development Committee meetings regarding its (or its Affiliate’s, Sublicensee’s or Other Licensee’s) regulatory strategy, planned regulatory submissions and material communications with Regulatory Authorities with respect to all Licensed Products and Licensed Product Biomarkers in its respective Territory. Subject to Aveo’s rights under Section 3.1, and Kirin’s rights under Section 3.8, Aveo, its Affiliates and Sublicensees, on the one hand, and Kirin, its Affiliates and Other Licensees on the other hand, shall not, during the Term, Xencor communicate with Regulatory Authorities of the other Party’s Territory regarding any Licensed Compound, Licensed Product or Licensed Product Biomarker without such Party’s advance written consent, such consent not to be unreasonably withheld, delayed or conditioned. However, each Party shall provide MorphoSys the other Party with reasonable advance notice of any meeting or substantive telephone conference with any Regulatory Authority relating to any Licensed Antibody and/or Product or Licensed ProductProduct Biomarker. MorphoSys Each Party shall have the right to attend and observe (but not participate actively in) any material meeting or material conference call with any Regulatory Authority regarding any of MorphoSys the other Party’s (or its Affiliate’s ’s, Sublicensee’s, or SublicenseeOther Licensee’s) Licensed Antibody and/or Products or Licensed ProductsProduct Biomarkers. In addition, Xencor each Party shall promptly furnish to MorphoSys the other Party copies of all correspondence that Xencor the furnishing Party (or its Affiliate, Sublicensee or Other Licensee) receives from, or submits to, any Regulatory Authority (including contact reports concerning conversations or substantive meetings) relating to any Licensed Antibody and/or Product or Licensed ProductProduct Biomarker. Xencor The furnishing Party shall also provide to MorphoSys the other Party any meeting minutes that reflect material communications with any Regulatory Authority regarding a Licensed Antibody and/or Product or Licensed Product. Subject to the provisions of Section 2.2(c)(ii), MorphoSys shall provide in its MorphoSys Annual Development Reports to Xencor, and through JDC discussion, information regarding its (or its Affiliate’s or, to the extent permitted by the Sublicense, Sublicensee’s) interactions with Regulatory Authorities with respect to all Licensed Antibodies and/or Licensed Products in its respective Territory. In addition, to the extent permitted by law and subject to Section 3.6, Xencor may participate in communications and meetings with any Regulatory Authority to the extent the name and/or then-current Xencor logo is used on the drug product label and such labeling is being discussed in such communication or meeting. Notwithstanding MorphoSys’ obligations under this Article 3, MorphoSys shall not be required to share with Xencor any information which MorphoSys is not permitted to share with Xencor under the applicable laws or regulations of the Securities & Exchange Commission or other regulatory body of the US or elsewhereProduct Biomarker.

Communications with Regulatory Authorities. During From and after the Collaboration TermEffective Date, Xencor except as otherwise set forth in this Agreement, Maruishi shall provide MorphoSys with reasonable advance notice of any meeting or substantive telephone conference with any Regulatory Authority relating to any Licensed Antibody and/or Licensed Product. MorphoSys shall have the right to attend and observe (but not participate actively in) any material meeting or material conference call with any Regulatory Authority regarding any of MorphoSys (or its Affiliate’s or Sublicensee’s) Licensed Antibody and/or Licensed Products. In addition, Xencor shall promptly furnish to MorphoSys copies of be responsible for all correspondence that Xencor (or its Affiliate) receives from, or submits to, any Regulatory Authority (including contact reports concerning conversations or substantive meetings) relating to any Licensed Antibody and/or Licensed Product. Xencor shall also provide to MorphoSys any meeting minutes that reflect material communications with any Regulatory Authority regarding a Licensed Antibody and/or Licensed Product. Subject to the provisions of Section 2.2(c)(ii), MorphoSys shall provide in its MorphoSys Annual Development Reports to Xencor, and through JDC discussion, information regarding its (or its Affiliate’s or, to the extent permitted by the Sublicense, Sublicensee’s) interactions contacts with Regulatory Authorities with respect to all Licensed Antibodies and/or Licensed Products in the Territory within the Field of Use. Maruishi shall have the responsibility, subject to the terms of this Agreement, to prepare and submit (a) all regulatory filings with Regulatory Authorities in the Territory as needed to conduct its respective clinical development of Licensed Products in the Territory in the Field of Use, and (b) all applications to obtain Regulatory Approvals in the Territory. All such regulatory submissions shall be in compliance with all Applicable Laws. Maruishi shall keep Cara fully informed regarding all such regulatory activities, shall provide to Cara copies of all regulatory submissions (including applications for Regulatory Approval) in the Territory and of all responses from Regulatory Authorities, shall provide Cara reasonable advance notice of any meetings or scheduled discussions with Regulatory Authorities in the Territory regarding Licensed Products, and shall update Cara as requested as to all progress and results of all such regulatory filings and meetings. Cara shall have the right to comment on all draft regulatory submissions, and Maruishi shall use reasonable efforts to accommodate all such comments. Maruishi shall use Commercially Reasonable Efforts, including conducting all such activities as needed, to obtain Regulatory Approvals in the Territory as soon as reasonably practicable and feasible. Cara will use reasonable efforts to provide a reasonable level of assistance to Maruishi in its efforts to prepare and to make regulatory submissions leading to Regulatory Approvals in the Territory. Cara shall have the right to use any such regulatory submissions for any of its (or its Affiliates’ or other licensees’) activities involving Licensed Products outside the Territory except upon termination of this Agreement pursuant to Section12.2 At Maruishi’s request, and subject to Cara personnel being available, Cara shall use reasonable efforts to assist and participate in such regulatory discussions, such participation to be paid for by Maruishi at Cara’s standard FTE rate for the applicable personnel (and including payment of all of Cara’s reasonable external expenses, including travel, per diem and lodging, incurred in performing such requested participation). In addition, Cara shall have the right to attend, at its own initiative and cost, meetings with Regulatory Authorities in the Territory regarding Licensed Product (but Cara shall not actively participate in such meetings except to the extent permitted requested by law Maruishi). Maruishi shall disclose and subject provide to Section 3.6Cara all regulatory and related development Information, Xencor may participate in communications and meetings with any including Regulatory Authority communications, protocol submissions, annual reports, and licensing applications in a reasonable timeframe. Cara shall keep Maruishi fully informed regarding all its regulatory activities regarding Licensed Product outside the Territory, shall provide to Maruishi copies of all regulatory submissions (including applications for Regulatory Approval) outside the Territory and of all responses from Regulatory Authorities, all the foregoing to the extent needed by Maruishi for its seeking Regulatory Approval of Licensed Product in the name and/or then-current Xencor logo is used on Territory in the drug product label Field of Use. Cara shall use reasonable efforts to provide Maruishi reasonable advance notice of any meetings or scheduled discussions with Regulatory Authorities outside the Territory regarding Licensed Products, and shall update Maruishi as reasonably requested as to all progress and results of all such labeling is being discussed regulatory filings and meetings. Cara shall use Commercially Reasonable Efforts to obtain CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [*]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Regulatory Approval of Licensed Product in the United States reasonably consistent with the development plan in Exhibit C. Maruishi shall have the right to use any such communication regulatory submissions for any of its (or meetingits Affiliates’ or other licensees’) activities involving Licensed Products in the Territory in the Field of Use except upon termination of this Agreement pursuant to Section12.2. Notwithstanding MorphoSys’ obligations under this Article 3Cara shall use reasonable efforts to disclose and provide to Maruishi in a reasonable timeframe all material regulatory Information, MorphoSys shall not be required including Regulatory Authority communications, protocol submissions, annual reports, and licensing applications, to share with Xencor the extent needed by Maruishi for its seeking Regulatory Approval of Licensed Product in the Territory in the Field of Use. If any information which MorphoSys is not permitted to share with Xencor under the applicable laws or regulations of the Securities & Exchange Commission above-mentioned regulatory activities are conducted by a Cara licensee or other regulatory body of the US or elsewheresublicensee, Cara shall exert a reasonable effort to have such licensee and sublicensee provided such information to Cara as above.

Communications with Regulatory Authorities. During Each of ZKC and Theraclone shall keep the Collaboration Termother party informed on an ongoing basis at Joint Steering Committee meetings regarding its (or its Affiliate’s, Xencor Sublicensee’s or Other Licensee’s) regulatory strategy, planned regulatory submissions and material communications with Regulatory Authorities with respect to all Licensed Antibodies and Licensed Products in its respective territory. Subject to Zenyaku’s rights below in this paragraph, Zenyaku, its Affiliates and Sublicensees, on the one hand, and Theraclone, its Affiliates and Other Licensees on the other hand, shall not, during the term of this Agreement, communicate with Regulatory Authorities of the other party’s territory regarding any Licensed Antibody or Licensed Product without such party’s advance written consent, such consent not to be unreasonably withheld, delayed or conditioned. However, each party shall provide MorphoSys the other party with reasonable advance notice of any meeting or pre-scheduled, material, substantive telephone conference with any Regulatory Authority relating to any Licensed Antibody and/or Product or Licensed ProductAntibody. MorphoSys Each party may request, and, only with permission of the party who is conducting the meeting or teleconference with the Regulatory Authority of its respective territory, shall have the right to attend and observe (but not participate actively in) any material meeting or material conference call with any Regulatory Authority regarding any of MorphoSys the other party’s (or its Affiliate’s ’s, Sublicensee’s, or SublicenseeOther Licensee’s) Licensed Antibody and/or Products or Licensed ProductsAntibody. In addition, Xencor each party shall promptly furnish to MorphoSys the other party copies of all correspondence that Xencor the furnishing party (or its Affiliate, Sublicensee or Other Licensee) receives from, or submits to, any Regulatory Authority (including contact reports concerning conversations or substantive meetings) relating to any Licensed Antibody and/or Product or Licensed ProductAntibody. Xencor The furnishing party shall also provide to MorphoSys the other party any meeting minutes that reflect material communications with any Regulatory Authority regarding a Licensed Antibody and/or Product or Licensed ProductAntibody. Subject Minutes of material communications with the Japanese Regulatory Authority will be translated into English, but materials actually corresponded with the Japanese Regulatory Authority are not required to be translated into English. Each of Theraclone and ZKC shall allow the provisions other to attend all of Section 2.2(c)(ii), MorphoSys shall provide in its MorphoSys Annual Development Reports to Xencortheir clinical investigators’ meetings, and through JDC discussionwill use commercially reasonable efforts in good faith to cause the Other Licensees and Sublicensees, information regarding its (or its Affiliate’s oras appropriate, to allow the extent permitted by parties to attend all of such Other Licensees’ and Sublicensees’, as appropriate, clinical investigators’ meetings. By way of background, it is anticipated that through joint meetings of the SublicenseJSC of this Agreement and the steering committees that each party may have with its Sublicensees and Other Licensees, Sublicensee’s) interactions with Regulatory Authorities with respect to all that the worldwide development program for Licensed Antibodies and/or and Licensed Products in its respective Territory. In addition, to the extent permitted by law and subject to Section 3.6, Xencor may participate in communications and meetings with any Regulatory Authority to the extent the name and/or then-current Xencor logo is used on the drug product label and such labeling is being discussed will be conducted in such communication or meeting. Notwithstanding MorphoSys’ obligations under this Article 3, MorphoSys shall not be required a manner that allows for all developing parties worldwide to share confer with Xencor any information which MorphoSys is not permitted each other and have an opportunity to share with Xencor under the applicable laws or regulations of the Securities & Exchange Commission or other regulatory body of the US or elsewherereach consensus as to clinical development worldwide.

Communications with Regulatory Authorities. During the Collaboration TermWith respect to Trials conducted by OPKO, Xencor OPKO shall promptly provide MorphoSys with reasonable advance notice Pfizer access to a copy of any meeting written communication received by OPKO or substantive telephone conference with its representatives from any Regulatory Authority relating with respect to any Licensed Antibody and/or Compound or Licensed Product. MorphoSys OPKO will have primary responsibility to respond to such communications; however, if any planned written responses or meetings with Regulatory Authorities relates to information that may affect any of the timelines set forth in the Development Plan or that may have a material impact on the success of any BLA submission by Pfizer, then OPKO shall have also notify Pfizer in advance of all such responses or meetings with the right Regulatory Authorities, whether in person or by telephone or videoconference and Pfizer shall be entitled to attend and, if appropriate and observe (but not permitted under Applicable Law, participate actively in) any material meeting in all such meetings with Regulatory Authorities, whether in person or material conference call with any Regulatory Authority regarding any by means of MorphoSys (or its Affiliate’s or Sublicensee’s) Licensed Antibody and/or Licensed Productstelecommunication; further provided, however, that where such communications concern the CMC Information, Pfizer will have primary responsibility to prepare responses to such communications as described further in this Section 3.3.1. In addition, Xencor shall promptly furnish to MorphoSys copies During the preparation and submission of all correspondence that Xencor (or its Affiliate) receives from, or submits to, any Regulatory Authority (including contact reports concerning conversations or substantive meetings) relating to any Licensed Antibody and/or Licensed Product. Xencor shall also provide to MorphoSys any meeting minutes that reflect material communications with any Regulatory Authority regarding a Licensed Antibody and/or Licensed Product. Subject to the provisions of Section 2.2(c)(ii), MorphoSys shall provide in its MorphoSys Annual Development Reports to Xencor, and through JDC discussion, information regarding its (or its Affiliate’s orBLAs, to the extent permitted practical, and provided that Pfizer will not be required to incur a substantive delay, OPKO shall be provided with prior notice as reasonably practicable of all proposed communications and meetings by the Sublicense, Sublicensee’s) interactions Pfizer with Regulatory Authorities and afforded the opportunity to promptly comment on such communications (and Pfizer shall reasonably take into account such comments) and attend such meetings (unless the Parties shall reasonably determine that such participation would decrease the likelihood of obtaining any requisite Regulatory Approval); provided, further, that notwithstanding anything set forth above, Pfizer will have the sole decision making authority and responsibility with respect to all Licensed Antibodies and/or Licensed Products in its respective Territory. In addition, to the extent permitted by law and subject to Section 3.6, Xencor may participate in any such communications and meetings with Regulatory Authorities. During the preparation and submission of BLAs, OPKO will provide reasonable support in the preparation of the relevant sections related to OPKO’s clinical activities (including Modules 1 and 2) and provide support to the rapid response team for queries. Each Party will promptly provide the JDC with access to copies of all regulatory communications and, in circumstances during the Trials conducted by OPKO where such communications require a response that pertains to the CMC Information, OPKO will provide Pfizer with a copy of such communication promptly (and in no event more than *** Business Days) following receipt thereof so that, after having considered any OPKO comments thereto, at Pfizer’s discretion, Pfizer can provide OPKO with the relevant response, which OPKO will submit to the applicable Regulatory Authority in whole without any changes, additions or deletions, except with respect to translations to local language required by Applicable Law or with Pfizer’s consent, not to be unreasonably withheld. For clarity, during preparation and submission of the BLAs, if Pfizer receives any correspondence from any Regulatory Authority Authorities, including that relates to the extent the name and/or then-current Xencor logo is used on the drug product label CMC Information, Pfizer will provide OPKO a full and complete copy, of such labeling is being discussed in such communication or meeting. Notwithstanding MorphoSys’ obligations under this Article 3, MorphoSys shall not be required to share with Xencor any information which MorphoSys is not permitted to share with Xencor under the applicable laws or regulations of the Securities & Exchange Commission or other regulatory body of the US or elsewherecommunication.

Communications with Regulatory Authorities. During Each Party shall keep the Collaboration other Party informed on an ongoing basis at Development Committee meetings regarding its (or its Affiliate’s, Sublicensee’s or Other Licensee’s) regulatory strategy, planned regulatory submissions and material communications with Regulatory Authorities with respect to all Licensed Products and Licensed Product Biomarkers in its respective Territory in the Field. Subject to Aveo’s rights under Section 3.1, and Kirin rights under Section 3.8, Aveo, its Affiliates and Sublicensees, on the one hand, and Kirin, its Affiliates and Other Licensees on the other hand, shall not, during the Term, Xencor communicate with Regulatory Authorities of the other Party’s Territory regarding any Licensed Compound, Licensed Product or Licensed Product Biomarker within the Field without such Party’s advance written consent, such consent not to be unreasonably withheld, delayed or conditioned. However, each Party shall provide MorphoSys the other Party with reasonable advance notice of any meeting or substantive telephone conference with any Regulatory Authority relating to any Licensed Antibody and/or Product or Licensed ProductProduct Biomarker with respect to the Field. MorphoSys Each Party shall have the right to attend and observe (but not participate actively in) any material meeting or material conference call with any Regulatory Authority regarding any of MorphoSys the other Party’s (or its Affiliate’s ’s, Sublicensee’s, or SublicenseeOther Licensee’s) Licensed Antibody and/or Products or Licensed ProductsProduct Biomarkers but shall not have such right to the extent such meeting or conference call does not relate to the Field. In addition, Xencor each Party shall promptly furnish to MorphoSys the other Party copies of all correspondence that Xencor the furnishing Party (or its Affiliate, Sublicensee or Other Licensee) receives from, or submits to, any Regulatory Authority (including contact reports concerning conversations or substantive meetings) relating to any Licensed Antibody and/or Product or Licensed ProductProduct Biomarker within the Field. Xencor The furnishing Party shall also provide to MorphoSys the other Party any meeting minutes that reflect material communications with any Regulatory Authority regarding a Licensed Antibody and/or Product or Licensed Product. Subject to Product Biomarker within the provisions of Section 2.2(c)(ii)Field, MorphoSys shall provide in its MorphoSys Annual Development Reports to Xencor, and through JDC discussion, information regarding its (or its Affiliate’s or, to the extent permitted by the Sublicense, Sublicensee’s) interactions with Regulatory Authorities with respect to all Licensed Antibodies and/or Licensed Products in its respective Territory. In addition, to the extent permitted by law and subject to Section 3.6, Xencor may participate in communications and meetings with any Regulatory Authority to the extent the name and/or then-current Xencor logo is used on the drug product label and such labeling is being discussed in such communication or meeting. Notwithstanding MorphoSys’ obligations under this Article 3, MorphoSys shall but will not be required to share with Xencor provide minutes or portions thereof that relate to communications regarding any information which MorphoSys is not permitted to share with Xencor under product or biomarker outside the applicable laws or regulations of the Securities & Exchange Commission or other regulatory body of the US or elsewhereField.

Communications with Regulatory Authorities. During Except as set forth in this Section 3.2 (Communications with Regulatory Authorities) with respect to the Collaboration TermPre-Approval Clinical Studies to be conducted by Esperion in South Korea and Taiwan in accordance with Section 2.1.2 (Development in South Korea and Taiwan), Xencor DS shall provide MorphoSys be responsible for all communications with reasonable advance notice of any meeting or substantive telephone conference with any the applicable Regulatory Authority relating to the Licens [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED ed Products in the DS Territory. Prior to the date of transfer of the applicable Registration Dossier to DS as set forth in Section 3.1 (Responsibility for Regulatory Matters), Esperion shall be responsible for all communications with the applicable Regulatory Authority in South Korea and Taiwan relating to the Licensed Products. On or following the date of transfer of the applicable Registration Dossier to DS as set forth in Section 3.1 (Responsibility for Regulatory Matters), DS shall be responsible for all communications with the applicable Regulatory Authority in South Korea and Taiwan relating to the Licensed Products. Within [***] business days after receipt of any Material Communication from such Regulatory Authority with respect to a Licensed Antibody and/or Product, the Party responsible for communication with the Regulatory Authority (as described above), shall provide the other Party with a brief written description, in English, of the principal issues raised in such Material Communication with such Regulatory Authority. Upon Esperion’s reasonable request after receiving a notice from DS in accordance with the immediately preceding sentence, DS shall, at its sole cost and expense, translate such Material Communication as soon as practically possible and shall provide to Esperion such translated Material Communication promptly after completion of such translation into English. DS will allow Esperion a reasonable opportunity to review and comment on DS’s proposed response to any Material Communications with such Regulatory Authority with respect to such Licensed Product. MorphoSys Esperion shall have the right send comments on such Material Communication to attend DS in a timely manner and observe (but not participate actively in) any material meeting or material conference call with any Regulatory Authority regarding any of MorphoSys (or its Affiliate’s or Sublicensee’s) Licensed Antibody and/or Licensed Products. In additionDS will reasonably consider all comments timely provided by Esperion in connection therewith; provided, Xencor shall promptly furnish to MorphoSys copies of all correspondence that Xencor (or its Affiliate) receives fromhowever, or submits to, any Regulatory Authority (including contact reports concerning conversations or substantive meetings) relating to any Licensed Antibody and/or Licensed Product. Xencor shall also provide to MorphoSys any meeting minutes that reflect material communications with any Regulatory Authority regarding a Licensed Antibody and/or Licensed Product. Subject to the provisions of Section 2.2(c)(ii), MorphoSys shall provide in its MorphoSys Annual Development Reports to Xencor, and through JDC discussion, information regarding its (or its Affiliate’s or, to the extent permitted by the Sublicense, Sublicensee’s) interactions with Regulatory Authorities with respect to all Licensed Antibodies and/or Licensed Products in its respective Territory. In addition, to the extent permitted by law and subject to Section 3.6, Xencor may participate in communications and meetings with any Regulatory Authority to the extent the name and/or then-current Xencor logo is used on the drug product label and such labeling is being discussed in such communication or meeting. Notwithstanding MorphoSys’ obligations under this Article 3, MorphoSys DS shall not be required to share comply with Xencor the foregoing if to do so would cause DS to fail to meet any information which MorphoSys is not permitted to share with Xencor under deadline requested or required by any Regulatory Authority in the applicable laws or regulations of the Securities & Exchange Commission or other regulatory body of the US or elsewhereDS Territory.