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 (a) Each Party shall keep 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 other Party informed on an ongoing basis regarding any of MorphoSys its (or its Affiliate’s or Sublicenseesublicensee’s) Licensed Antibody and/or regulatory strategy, planned regulatory submissions and material communications with Regulatory Authorities with respect to all Licensed Products. Partner shall not communicate with Regulatory Authorities in the AVEO Territory regarding any Licensed Compound or Licensed Product without AVEO’s advance written consent, such consent not to be unreasonably withheld, delayed or conditioned. Partner shall not communicate with Regulatory Authorities in the KHK Territory regarding any Licensed Compound or Licensed Product without KHK’s advance written consent, which AVEO shall seek upon Partner’s request and which shall not be unreasonably withheld, delayed or conditioned. In addition, Xencor Partner shall promptly furnish to MorphoSys AVEO copies of all correspondence that Xencor Partner (or its AffiliateAffiliate or Sublicensee) 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 Partner shall also provide to MorphoSys AVEO any meeting minutes that reflect material communications with any Regulatory Authority regarding a Licensed Antibody and/or Product. (b) AVEO shall not communicate with Regulatory Authorities inside of the Partner Territory regarding any Licensed Compound or Licensed Product without Partner’s advance written consent, such consent not to be unreasonably withheld, delayed or conditioned. In addition, AVEO shall promptly furnish to Partner copies of all correspondence that AVEO (or its Affiliate or Other Licensee) receives from, or submits to, any Regulatory Authority (including contact reports concerning conversations or substantive meetings) relating to any Licensed Product. AVEO shall also provide to Partner any meeting minutes that reflect material communications with any Regulatory Authority regarding a Licensed Product. (c) Subject to Partner’s agreement to the provisions scope and location of any clinical trials to be conducted by AVEO in the Field in the Partner Territory in accordance with Section 2.2(c)(ii2.3(c), MorphoSys AVEO shall provide in its MorphoSys Annual Development Reports not be required to Xencor, and through JDC discussion, information regarding its (or its Affiliateobtain Partner’s or, consent to the extent permitted by the Sublicense, Sublicensee’s) interactions communicate with Regulatory Authorities with respect to all Licensed Antibodies and/or Licensed Products such clinical trials, and notwithstanding the provisions of Section 2.2(a), Partner shall have no responsibility or decision making authority for activities and decisions of AVEO with respect to such clinical trials conducted by AVEO in its respective the Partner Territory. In addition, . (d) Subject to AVEO’s agreement to the extent permitted scope and location of any clinical trials to be conducted by law and subject to Partner in the Field in the AVEO Territory in accordance with Section 3.62.3(d), 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 Partner shall not be required to share obtain AVEO’s consent to communicate with Xencor Regulatory Authorities with respect to such clinical trials, and notwithstanding the provisions of Section 2.2(a), AVEO shall have no responsibility or decision making authority for activities and decisions of Partner with respect to such clinical trials conducted by Partner in the AVEO Territory. (e) Partner acknowledges that KHK has the right to attend and observe (but not participate actively in) any information which MorphoSys is not permitted to share material meeting or material conference call between Partner and any Regulatory Authority regarding Licensed Products in the Partner Territory and, if requested by AVEO, Partner shall reasonably cooperate with Xencor under AVEO in coordinating the applicable laws logistics of any such attendance or regulations of the Securities & Exchange Commission or other regulatory body of the US or elsewhereobservation by KHK.

Communications with Regulatory Authorities. During the 7.3.1 On a Collaboration TermTarget-by-Collaboration Target basis, Xencor shall provide MorphoSys (a) Kymera, as Regulatory Lead, with reasonable advance notice of any meeting or substantive telephone conference respect to Material Communications with any a Regulatory Authority relating in the Territory, and (b) Sanofi, as Regulatory Lead prior to any Licensed Antibody and/or Licensed Product. MorphoSys shall have and during the right Opt-In Period, with respect to attend and observe (but not participate actively in) any material meeting or material conference call Material Communications with any a Regulatory Authority regarding any of MorphoSys in the Major Market Countries, as applicable, will: (a) provide the JSC (or a Committee or Subcommittee to which the JSC has delegated responsibility) for its Affiliate’s or Sublicensee’s) Licensed Antibody and/or Licensed Products. In addition, Xencor shall promptly furnish to MorphoSys copies review and discussion with a brief description in English 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 principal issues raised 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 each Material Communication with Regulatory Authorities with respect to all Licensed Antibodies and/or any Collaboration Candidates or Licensed Products in Directed Against such Collaboration Target for which such Party is the Regulatory Lead, including any communications with a Regulatory Authority with respect to any audit or inspection of such Party or any of its respective Territory. In addition, Affiliates or Subcontractors conducted by a Regulatory Authority and related findings thereunder to the extent permitted such audit or inspection relates to the activities conducted under this Agreement; (b) provide such descriptions of such Material Communications to the JSC as part of the quarterly updates regarding Development and Commercialization activities with respect to such Collaboration Target, if related to any Collaboration Candidates or Licensed Products Directed Against such Collaboration Target (except, solely with respect to the U.S., within [***] after receipt thereof), if related to any Collaboration Candidates or Licensed Products Directed Against such Collaboration Target; and (c) allow the other Party a reasonable opportunity to review and comment on such Regulatory Lead’s proposed response to such Material Communication in advance of the transmission of such response, and the Regulatory Lead will reasonably consider all comments timely provided by law and subject such other Party in connection therewith; provided that Sanofi will not be obligated to provide Kymera the right to review or comment on Sanofi’s proposed response to a Material Communication to a Major Market Country other than the U.S., even during the Opt-In Period. 7.3.2 Subject to Section 3.67.3.1, Xencor may participate in communications Sanofi, as Regulatory Lead, will keep Kymera reasonably informed of its progress with Regulatory Authorities with respect to Collaboration Candidates and meetings with any Regulatory Authority Licensed Products pursuant to the extent the name and/or then-current Xencor logo is used on the drug product label Late Development Plan 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 JSC as part of the Securities & Exchange Commission or other regulatory body of the US or elsewherequarterly updates regarding Development and Commercialization activities with respect to such Collaboration Candidates and Licensed Products.

Communications with Regulatory Authorities. During (a) Except to the Collaboration extent set forth in Section 5.4(b), all communications with Government Authorities concerning the Product shall be the sole responsibility of Zogenix. Zogenix shall within [***] provide Astellas with copies of all such communications (including summaries of all relevant verbal communications) related to Promotional Materials and Serious Adverse Drug Experiences (except that routine communications as to such matters (e.g., FDA 2253 correspondence) may be forwarded to Astellas within [***]) and shall reasonably respond to all inquiries by Astellas relating thereto. Zogenix will reasonably consult with Astellas concerning Adverse Drug Experience reporting to the FDA and communications related to Promotional matters with the FDA or other Governmental Authorities that could reasonably be considered to be material to the Product, including regulatory responses to follow up inquiries regarding Adverse Drug Experiences. Zogenix will provide to Astellas a copy of all draft responses related to such matters [***] and will endeavor to provide such responses at least [***] in advance of their submission (to the extent allowable under Legal Requirements), and will consider in good faith any comments provided to Zogenix by Astellas. (b) Astellas shall not, without the consent of Zogenix, correspond or communicate with the FDA or with any other Governmental Authority, whether within the Territory or otherwise, concerning the Product, or otherwise take any action concerning any Regulatory Approval under which the Product is sold or any application for Regulatory Approval of the Product; provided that during the 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 Astellas shall have the right to attend and observe do so: (but not participate actively ini) if Astellas believes in good faith that it is necessary to do so to comply with the terms of this Agreement or any material meeting Legal Requirement (including without limitation state or material conference call with any Regulatory Authority regarding any of MorphoSys (local Legal Requirements related to marketing activities undertaken by Astellas 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 fromthe Astellas Sales Force), or submits to, any Regulatory (ii) at the request of a Governmental Authority (including contact reports concerning conversations or substantive meetings) relating to any Licensed Antibody and/or Licensed Product. Xencor provided that, where practicable, Astellas shall also provide to MorphoSys any meeting minutes have requested that reflect material communications such Governmental Authority communicate with any Regulatory Authority regarding a Licensed Antibody and/or Licensed Product. Subject to the provisions of Section 2.2(c)(iiZogenix instead), MorphoSys shall provide and in its MorphoSys Annual Development Reports to Xencoreach such case, and through JDC discussion, information regarding its ((i) or its Affiliate’s or(ii)), to the extent permitted by Legal Requirements and not prohibited by the SublicenseGovernmental Authority, Sublicensee’s) interactions with Regulatory Authorities with respect to all Licensed Antibodies and/or Licensed Products in its respective Territory. In additionAstellas shall give Zogenix notice as soon as reasonably practicable of such communication and, to the extent permitted by law and subject practicable, shall permit Zogenix to Section 3.6accompany Astellas, Xencor may participate take part in any such communications and meetings with receive copies of all such communications. Astellas shall within [***] after receipt of any Regulatory communication from the FDA or from any other Governmental Authority relating to the Product, to the extent so permitted by Legal Requirements and not so prohibited by the name and/or then-current Xencor logo is used on the drug product label and such labeling is being discussed in such communication FDA 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 Governmental Authority, forward a copy of the Securities & Exchange Commission same to Zogenix and reasonably respond to all inquiries by Zogenix relating thereto. If Astellas is required by Legal Requirements to communicate with the FDA or with any other regulatory body Governmental Authority relating to the Product or is requested to do so by the FDA or the Governmental Authority, then Astellas shall so advise Zogenix, to the extent practicable and permitted by Legal Requirements and not prohibited by the FDA or the Governmental Authority, within [***] and shall provide Zogenix in advance with a copy of any proposed written communication, or a written summary of any proposed oral communication with the US FDA or elsewhereany other Governmental Authority. Astellas shall comply with any and all reasonable direction of Zogenix concerning any meeting or written or oral communication with the FDA or any other Governmental Authority relating to the Product unless otherwise required by Legal Requirements or otherwise requested by the FDA or the other Governmental Authority. *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

Communications with Regulatory Authorities. During 4.2.1. ROCHE shall keep SYNTA informed on an ongoing basis through the Collaboration TermJRDC or JSC regarding its (or its Affiliate’s or Sublicensee’s) regulatory strategy, Xencor planned regulatory submissions and material communications with Regulatory Authorities in Major Markets with respect to all Licensed Compounds and Licensed Products. If, and to the extent SYNTA is responsible for the filing of the IND and other regulatory filings with respect to a Licensed Compound pursuant to Section 4.1.1, then the obligations of ROCHE set forth in Sections 4.2.1 above shall apply to SYNTA, mutatis mutandis until such time as Development responsibility is transferred to ROCHE pursuant to Section 2.7.1, except that such obligations shall apply with regard to all countries of the Territory as opposed to just the Major Markets. 4.2.2. In addition, ROCHE shall provide MorphoSys SYNTA with reasonable advance notice of any material meeting or substantive telephone conference with any Regulatory Authority the FDA, MHLW or EMEA relating to any Licensed Antibody and/or Compound or Licensed Product. MorphoSys SYNTA shall have the right to attend and observe (but not participate actively in) any such material meeting or material conference call with any Regulatory Authority the FDA regarding any of MorphoSys Licensed Compound or Licensed Product under Development by ROCHE (or by its Affiliate’s Affiliates or Sublicensee’s) Licensed Antibody and/or Licensed ProductsSublicensees). In addition, Xencor ROCHE shall promptly furnish to MorphoSys copies provide SYNTA with a copy of all material correspondence that Xencor ROCHE (or its AffiliateAffiliate or Sublicensee) receives from, or submits to, any Regulatory Authority in the Major Markets (including contact reports concerning conversations or substantive meetings, contact reports of all Regulatory Authority interactions concerning conversations or substantive meetings, all IND annual reports (including any equivalent filings outside the US), and cover letters of all agency submissions, it being understood that SYNTA may request, and shall then receive, copies of all attachments to any such cover letters) relating to any Licensed Antibody and/or Compound or Licensed Product. Xencor ROCHE shall also provide to MorphoSys SYNTA with any meeting minutes that reflect material communications with any Regulatory Authority in the Major Markets regarding a Licensed Antibody and/or Compound or Licensed Product. 4.2.3. Subject to Notwithstanding the provisions of Section 2.2(c)(ii)foregoing, MorphoSys shall provide in its MorphoSys Annual Development Reports to Xencorif, and through JDC discussion, information regarding its (or its Affiliate’s or, to the extent permitted by SYNTA is responsible for the Sublicense, Sublicensee’s) interactions with Regulatory Authorities filing of the IND and other regulatory filings with respect to all a Licensed Antibodies and/or Licensed Products Compound pursuant to Section 4.1.1, the rights and obligations of ROCHE set forth in its respective TerritorySections 4.2.2 above shall apply to SYNTA, mutatis mutandis until such time as Development responsibility is transferred to ROCHE pursuant to Section 2.7.1. In addition, Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant 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 Company’s application requesting confidential treatment 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 Rule 24b-2 of the Securities & Exchange Commission or other regulatory body Act of the US or elsewhere1934, as amended.

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 8.3.1 For so long as it is the Collaboration Termowner of the IND for ADL 5859 or ADL 5747, Xencor Adolor, and after the transfer of the first such IND, Pfizer, shall provide MorphoSys the other Party with reasonable advance notice of all meetings, conferences, and discussions (including without limitation, Advisory Committee meetings or any other meeting or substantive telephone conference of experts convened by the FDA concerning any topic relevant to the Licensed Products) scheduled with the FDA concerning any Regulatory Authority regulatory matters relating to any the Licensed Antibody and/or Products promptly after the scheduling of such meeting, conference, or discussion. The Party that does not, at the time of such meeting, own the IND for the Licensed Product that is the subject of such meeting shall be entitled to have one or more representatives, as appropriate under the circumstance, present at all such meetings. Adolor and Pfizer, through the JDC, shall use all reasonable efforts to agree in advance on the scheduling of such meetings, conferences and discussions and on the objectives to be accomplished at such meetings, conferences and discussions and the agenda for the meetings, conferences and discussions with the FDA, and with respect to Advisory Committee meetings. 8.3.2 For so long as it is the owner of the IND for ADL 5859 or ADL 5747, Adolor will provide Pfizer with copies, which copies may be in draft form, of all material submissions to the FDA relating to a Licensed Product. MorphoSys Adolor will provide Pfizer with such copies sufficiently in advance of such planned submission to the FDA by Adolor, in order to allow Pfizer to provide comments to Adolor regarding such submission. Adolor shall have the right consider Pfizer’s comments in good faith with respect 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 Productssuch submission. In addition, Xencor Adolor shall promptly furnish not make any submissions or other filings to MorphoSys Regulatory Authorities other than the FDA without the prior written consent of Pfizer. After the transfer of the first IND for a Licensed Product, Pfizer will provide Adolor with copies, which copies may be in draft form, of all correspondence that Xencor (material submissions to the FDA or its Affiliate) receives from, or submits to, any Regulatory Authority (including contact reports concerning conversations or substantive meetings) the EMEA relating to any Licensed Antibody and/or a Licensed Product. Xencor shall also Pfizer will provide to MorphoSys any meeting minutes that reflect material communications Adolor with any Regulatory Authority regarding a Licensed Antibody and/or Licensed Product. Subject such copies sufficiently in advance of such planned submission to the provisions of Section 2.2(c)(ii), MorphoSys shall FDA or the EMEA by Pfizer in order to permit Adolor to provide comments regarding such submission. Pfizer will consider Adolor’s comments 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 good faith with respect to all Licensed Antibodies and/or Licensed Products in its respective Territory. In addition, such submission. 8.3.3 Each Party shall provide to the extent permitted by law and subject to Section 3.6other Party, Xencor may participate as soon as reasonably practicable but in communications and meetings with no event more than two (2) Business Days after its receipt, copies of 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 material documents or other regulatory body of material correspondence received from the US FDA or elsewherethe EMEA pertaining to a Licensed Product.

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 Pacira shall have the sole right and responsibility and shall bear all costs related 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 government agencies to satisfy their requirements regarding a Licensed Antibody the authorization and/or Licensed Productcontinued authorization to market the Product in commercial quantities in the Territory. 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 To the extent permitted by law, governmental order or regulation and not so prohibited by the Sublicensegovernmental authority, Sublicensee’sDePuy Synthes shall notify Pacira within two (2) interactions business days via facsimile or email of any inquiry or other communication that it receives from the FDA or any other governmental or regulatory authority concerning the Product. Pacira shall handle all communications with Regulatory Authorities the FDA and other governmental and regulatory authorities concerning the Product, including but not limited to post-marketing reports of adverse drug experiences in compliance with 21 CFR §314.80, other post-marketing reports such as those described in 21 CFR §314.81, submission of advertising and promotional labeling to FDA’s Office of Prescription Drug Promotion (OPDP), and responding to any FDA inquiries concerning post-marketing reports and advertising or promotional materials, and shall provide copies of all such communication to DePuy Synthes within five (5) business days via facsimile or email. Notwithstanding the foregoing, DePuy Synthes shall be able to communicate with any such governmental agency regarding the Product to the extent that DePuy Synthes believes in good faith that such communication is necessary to comply with the terms of this Agreement or the requirements of any law, governmental order or regulation or at the request of such governmental agency, provided that DePuy Synthes shall 13 [**] - Indicates certain information has been redacted and filed separately with the U.S. Securities and Exchange Commission. Confidential treatment has been requested with respect to all Licensed Antibodies and/or Licensed Products the redacted portions. within two (2) business days disclose in its respective Territory. In addition, writing to Pacira the nature of any such communication 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 DePuy Synthes 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 elsewherelegally prohibited from making such a disclosure.

Communications with Regulatory Authorities. During 4.3.1 As between the Collaboration TermParties, 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 Salix shall have the right sole responsibility and authority to attend communicate with Regulatory Authorities during the term of this Agreement in relation to Licensed Products in (a) the Human Excluding HIV/AIDS/ID/Pediatric Field in the Salix Human Excluding HIV/AIDS/ID/Pediatric Territory; (b) the HIV/AIDS/Pediatric Field in the Salix HIV/AIDS/Pediatric Territory; and observe (but not participate actively inc) any material meeting or material conference call the ID Field in the Salix ID Territory. Except as necessary to comply with any Regulatory Authority regarding Applicable Law, Napo shall not, nor shall it permit any of MorphoSys (its Affiliates 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 Sublicensees to, initiate 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 concerning the Licensed Antibody and/or Compound or the Licensed ProductProducts without first notifying Salix in writing. Subject The Parties acknowledge and agree that the rights and responsibilities set forth in this Section 4.3.1 shall be subject to Glenmark’s right to prepare and maintain Regulatory Documentation pursuant to Section 4.4(b) of the Glenmark Agreement as in effect as of the Effective Date. 4.3.2 Without limiting the provisions of Section 2.2(c)(ii)4.2 or 4.3.1, MorphoSys Salix shall promptly provide in its MorphoSys Annual Development Reports to Xencor, and through JDC discussion, information regarding its Napo (a) copies of all written or electronic communications received by Salix or its Affiliate’s orAffiliates or Sublicensees from, to the extent permitted or forwarded by the SublicenseSalix or its Affiliates or Sublicensees to, Sublicensee’s) interactions with Regulatory Authorities with respect to all (i) obtaining or maintaining any Approvals or (ii) any other activities relating to the Licensed Antibodies and/or Compound or the Licensed Products regarding such Regulatory Authorities and (b) copies of all contact reports produced by Salix or its Affiliates or Sublicensees, in each case (clause (a) and (b)), within five (5) Business Days of receiving, forwarding or producing any of the foregoing. 4.3.3 Without limiting the provisions of Section 4.2 or 4.3.1, Napo shall promptly provide to Salix (a) copies of all material written or electronic communications received by Napo or its respective Territory. In additionAffiliates or Sublicensees from, or forwarded by Napo or its Affiliates or Sublicensees to, Regulatory Authorities with respect to (i) obtaining or maintaining any Approvals or (ii) any other activities relating to the extent permitted Licensed Compound or the Licensed Products regarding such Regulatory Authorities and (b) copies of all contact reports produced by law Napo or its Affiliates or Sublicensees, in each case (clauses (a) and subject to Section 3.6(b)), Xencor may participate in communications and meetings with within five (5) Business Days of receiving, forwarding or producing 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 elsewhereforegoing.

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 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 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. (a) During the Collaboration Term, Xencor GSK (or one of its Affiliates, licensees or Sublicensees) shall be responsible, and act as the sole point of contact, for communications with Regulatory Authorities in the GSK Territory in connection with the Exploitation of any Compound or any Products in the GSK Territory; provided that, notwithstanding the foregoing, solely with respect to any Regulatory Approvals (including INDs, NDAs and XXXx) granted by any Regulatory Authority in the GSK Territory that are existing as of the date hereof, that are held in the name of, or otherwise Controlled by, Scynexis or any of its Affiliates and that are necessary or useful to Exploit any Compound or any Product in the GSK Territory, from the Effective Date until the date on which Scynexis assigns to GSK all right, title and interest in and to the foregoing in accordance with Section ‎5.2 and the Technology Transfer Plan or Commercialization Transition Plan, Scynexis shall (i) consult with GSK prior to taking any actions that could reasonably be expected to impact such Regulatory Approvals, and (ii) serve as the point of contact for communications with the applicable Regulatory Authorities and shall follow GSK’s reasonable directions with respect to any and all such communications, including promptly submitting any change with respect to such Regulatory Approvals to such Regulatory Authorities as GSK may reasonably request (including, for the avoidance of doubt, any changes required to reflect the regulatory pathway(s) agreed between GSK and Xxxxxxxx). In respect of any such change to a Regulatory Approval, Scynexis shall liaise with GSK in order to determine (x) the classification of the change category, (y) the sections of the relevant dossier impacted and (z) the content of any dossier updates, which matters shall, in each case, be subject to GSK’s final approval and Scynexis shall notify all applicable CMOs involved in the Manufacture of any Compound or any Product of such change. (b) During the Term, Scynexis (or one of its Affiliates, licensees or sublicensees) shall be responsible, and act as the sole point of contact, for communications with Regulatory Authorities in the Excluded Territory in connection with the Exploitation of any Compound or any Products in the Excluded Territory. (c) Neither GSK, with respect to the Excluded Territory, nor Scynexis, with respect to the GSK Territory (except as set forth in Section ‎5.4(a)), shall initiate (or permit any of its respective Affiliates, licensees or sublicensees (including in the case of GSK, Sublicensees) to initiate), with respect to any Product, any meetings or contact with Regulatory Authorities in such Territory, without the other Party’s prior written consent, and to the extent Scynexis or any of its Affiliates receives any written or oral communication from any Regulatory Authority in the GSK Territory concerning Exploitation of any Compound or any Product in the GSK Territory or GSK or any of its Affiliates receives any written or oral communication from any Regulatory Authority in the Excluded Territory concerning Exploitation of any Compound or any Product in the Excluded Territory, to the extent not prohibited by Law, such Party shall (i) refer such Regulatory Authority to the other Party, and (ii) as soon as reasonably practicable (but in any event within [***] ([***]) of receipt of such communication), notify and provide MorphoSys the other Party with a copy of any written communication received by such Party or such Affiliate or, if applicable, complete and accurate minutes of such oral communication. (d) Each Party will provide the other Party with written notice of the submission of any filings or applications for Regulatory Approval of a Product or receipt or denial of any such Regulatory Approval with (i) in the case of GSK as the notifying Party, the FDA, EMA or PMDA, and (ii) in the case of Scynexis as the notifying Party, the Regulatory Authorities in the Excluded Territory to the extent Scynexis is made aware thereof; provided, however, that, unless otherwise required by Law, such notifying Party will inform the other Party of such event prior to public disclosure thereof by such notifying Party or its Affiliates. (e) Each Party will provide the other Party with reasonable advance notice, or with as much advance notice as practicable under the circumstances, of (i) in the case of GSK as the notifying Party, all substantive meetings with the FDA, EMA or PMDA, and (ii) in the case of Scynexis as the notifying Party, all substantive meetings with the Regulatory Authorities in the Excluded Territory to the extent Scynexis is made aware thereof, in each case ((i) or (i)), solely to the extent that (A) such meeting is primarily related to one or more Product(s) in the notifying Party’s respective Territory, and (B) the subject matter of such meeting would reasonably be expected to have a material effect on the other Party’s Development or Commercialization of any meeting Compound or substantive telephone conference any Product in such other Party’s respective Territory; provided that, with any Regulatory Authority relating respect to any Licensed Antibody and/or Licensed Product. MorphoSys shall have the right to attend and observe (but not participate actively in) any material such 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 for which notice has been provided pursuant 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 orforegoing, to the extent permitted by Law and the Sublicenseapplicable Regulatory Authority, Sublicensee’sthe Party receiving such notice (or a representative of such Party’s (sub)licensee) interactions with Regulatory Authorities with respect shall have the right to all Licensed Antibodies and/or Licensed Products reasonably request, subject to the notifying Party’s consent and in the case of Xxxxxxxx, the consent of its respective Territory. In additionapplicable licensee, 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 thenattend such meeting as a non-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 elsewhereparticipating observer.

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 any Regulatory Authority 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 extent rapid response team for queries. Each Party will promptly provide the name and/or then-current Xencor logo is used on JDC with access to copies of all regulatory communications, and in circumstances during the drug product label and Trial where such labeling is being discussed in communications require a response that pertains to the CMC Information, OPKO will provide Pfizer with a copy of such communication or meeting. Notwithstanding MorphoSys’ obligations under this Article 3promptly (and in no event more than *** Business Days) following receipt thereof so that, MorphoSys shall not be required to share after having considered any OPKO comments thereto, at Pfizer’s discretion, Pfizer can provide OPKO with Xencor any information the relevant response, 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.OPKO will submit

Communications with Regulatory Authorities. During (i) For so long as [***], Protalix, and after the Collaboration Termassignment and transfer to Chiesi of such regulatory filings pursuant to Section 3.6(c), Xencor Chiesi, shall provide MorphoSys the other Party with reasonable advance notice of all meetings, conferences, and discussions (including advisory committee meetings or any other meeting of experts convened by a Regulatory Authority concerning any topic relevant to the Licensed Product) scheduled with a Regulatory Authority concerning any regulatory matters relating to the Licensed Product in the Field promptly after the scheduling of such meeting, conference, or substantive telephone conference discussion. The Party that does not, at the time of such meeting, own the regulatory filings described in Section 3.6(c) for the Licensed Product shall be entitled to have one or more representatives present at all such meetings to the extent permissible under applicable Law and reasonably practicable under the circumstances. Protalix and Chiesi shall use all reasonable efforts to agree in advance on the scheduling of such meetings, conferences and discussions and on the objectives to be accomplished at such meetings, conferences and discussions and the agenda for the meetings, conferences and discussions with the applicable Regulatory Authority, if any [***]. (ii) For so long [***], Protalix, and after [***], Chiesi, shall provide the other Party with copies, which copies may be in draft form, of all material submissions to any Regulatory Authority in the Territory relating to any the Licensed Antibody and/or Licensed ProductProduct in the Field. MorphoSys Such copies shall have be provided sufficiently in advance of such planned submission to the right to attend and observe (but not participate actively in) any material meeting or material conference call with any applicable Regulatory Authority in order to allow such other Party to provide comments regarding any of MorphoSys (or its Affiliatesuch submission. The Party making the submission shall consider the other Party’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 comments 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 good faith with respect to all Licensed Antibodies and/or Licensed Products in its respective Territory. In addition, such submission [***]. (iii) Each Party shall provide to the extent permitted by law and subject to Section 3.6other Party, Xencor may participate as soon as reasonably practicable but in communications and meetings with no event more than [***] after its receipt, copies of any material documents or other material correspondence received from a Regulatory Authority pertaining to the extent Licensed Product in 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 elsewhereField.

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. 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.