Common use of Regulatory Information Sharing Clause in Contracts

Regulatory Information Sharing. Each Party shall, upon the other Party’s reasonable request, promptly provide the other Party (but in no event more than [ * ]) with copies of any Regulatory Filings prepared (including any drafts), submitted or received by such Party in the U.S. and the Licensee Territory pertaining to the Compound and Products, and such other Party shall have the right to review and comment on drafts of such Regulatory Filings, provided that such review and comment shall not delay the submission of any Regulatory Filings. The sharing of Regulatory Filings shall, as applicable, be the following communications/correspondence with the Regulatory Authority: (i) summary of contact reports either Party receives concerning substantive conversations or substantive meetings in its respective territory with the FDA, EMA, CFDA and PMDA with respect to the Product or if contacts with those Regulatory Authorities are made orally, to be reduced in writing, (ii) documents related to regulatory milestones and dates (e.g., submission, validations, agency review questions, CHMP opinion and FDA complete response letter and their equivalent), (iii) IND annual reports and cover letters of all agency submissions relating to the Compound or any Product. If any Regulatory Filing to be provided under this Section 5.3 was originally created in a language other than the English language, then at the receiving Party’s request and to the extent already existing and readily available, the providing Party shall provide an English translation along with the original document to the receiving Party. The Parties acknowledge that it is their intent to collaborate in good faith in the exchange of such Regulatory communications including with any Sublicensee or Future Exelixis Licensee. Each of Licensee and Exelixis shall use Commercially Reasonable Efforts to grant the other Party access and rights to use any such communications with any Regulatory Authority generated by or on behalf of any Sublicensee or Future Exelixis Licensee, respectively. Should either Party fail to obtain such access and rights from any Sublicensee or Future Exelixis Licensee, such Party shall not have the right to grant access or rights to such Sublicensee or Future Exelixis Licensee to any such communications with any Regulatory Authority generated by or on behalf of the other Party.

Regulatory Information Sharing. Each To the extent that such Regulatory Filings that relate to the activities in the requesting Party’s territory, each Party shall, upon the other Party’s reasonable request, promptly provide the other Party (but in no event more than [ * ]) with copies of any Regulatory Filings prepared (including any draftsdrafts and supporting information), submitted or received by such Party in the Exelixis Territory including the U.S. and the Licensee Collaborator Territory pertaining to the Compound and Products, and such other Party shall have the right to review and comment on drafts of such Regulatory Filings, provided that such review and comment shall not delay the submission of any Regulatory Filings. The sharing of Regulatory Filings shall, as applicable, be the following shall include any communications/correspondence with the Regulatory Authority: (i) summary of contact Authority regarding label changes, IND annual reports either Party receives concerning substantive conversations or substantive meetings in its respective territory with the FDAand cover letters, EMA, CFDA and PMDA with respect to the Product or if contacts with those Regulatory Authorities are made orally, to be reduced in writing, (ii) documents related to regulatory milestones and dates (e.g., submission, submissions and validations, agency review questions, CHMP opinion and FDA complete response letter and their equivalent), (iii) IND annual reports and cover letters of all agency submissions relating to the Compound or any Product. If any Regulatory Filing to be provided under this Section 5.3 5.2 was originally created in a language other than the English language, then at the receiving Party’s request and to the extent already existing and readily available, the providing Party shall provide an English translation along with the original document to the receiving Party. The Parties acknowledge that it is their intent to collaborate in good faith in the exchange of such Regulatory communications including with any Sublicensee or Future other Exelixis Licenseelicensee. Each of Licensee Collaborator and Exelixis shall use Commercially Reasonable Efforts reasonably endeavor to grant access and rights for the other Party access and rights to use any such communications with any Regulatory Authority generated by or on behalf of any Sublicensee or Future other Exelixis Licenseelicensee, respectively. For clarity, a Party’s provision to the other Party of copies of Regulatory Filings prepared, submitted, or received in each Party’s territory is expressly conditioned upon the receiving Party granting to the providing Party the right to share with the providing Party’s own licensee for its territory copies of any and all Regulatory Filings prepared, submitted, or received by the receiving Party in its territory. Should either Party fail to obtain such access and rights from any Sublicensee or Future Exelixis Licenseelicensee, such Party shall not have the right to grant access or rights to such Sublicensee or Future other Exelixis Licensee licensee to any such communications with any Regulatory Authority generated by or on behalf of the other Party.

Regulatory Information Sharing. Each Party shall, upon the other Party’s reasonable request, promptly provide the other Party (but in no event more than [ * ]) with copies of any Regulatory Filings prepared (including any drafts), submitted or received by such Party in the U.S. and the Licensee Territory pertaining to the Compound and Products, and such other Party shall have the right to review and comment on drafts of such Regulatory Filings, provided that such review and comment shall not delay the submission of any Regulatory Filings. The sharing of Regulatory Filings shall, as applicable, be the following communications/correspondence with the Regulatory Authority: (i) summary of contact reports either Party receives concerning substantive conversations or substantive meetings in its respective territory with the FDA, EMA, CFDA and PMDA with respect to the Product or if contacts with those Regulatory Authorities are made orally, to be reduced in writing, (ii) documents related to regulatory milestones and dates (e.g., submission, validations, agency review questions, CHMP opinion and FDA complete response letter and their equivalent), (iii) IND annual reports and cover letters of all agency submissions relating to the Compound or any Product. If any Regulatory Filing to be provided under this Section 5.3 was originally created in a language other than the English language, then at the receiving Party’s request and to the extent already existing and readily available, the providing Party shall provide an English translation along with the original document to the receiving Party. The Parties acknowledge that it is their intent to collaborate in good faith in the exchange of such Regulatory communications including with any Sublicensee or Future Exelixis Licensee. Each of Licensee and Exelixis shall use Commercially Reasonable Efforts to grant the other Party access and rights to use any such communications with any Regulatory Authority generated by or on behalf of any Sublicensee or Future Exelixis Licensee, respectively. Should either Party fail to obtain such access and rights from any Sublicensee or Future Exelixis Licensee, such Party shall not have the right to grant access or rights to such Sublicensee or Future Exelixis Licensee to any such communications with any Regulatory Authority generated by or on behalf of the other Party. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

Regulatory Information Sharing. Each Party shall, upon the other Party’s reasonable request, promptly provide the other Party (but in no event more than [ * ]) with copies of any Regulatory Filings prepared (including any drafts), submitted or received by such Party in the U.S. and the Licensee Territory pertaining to the Compound and Products, and such other Party shall have the right to review and comment on drafts of such Regulatory Filings, provided that such review and comment shall not delay the submission of any Regulatory Filings. The sharing of Regulatory Filings shall, as applicable, be the following communications/correspondence with the Regulatory Authority: (i) summary of contact reports either Party receives concerning substantive conversations or substantive meetings in its respective territory with the FDA, EMA, CFDA and PMDA with respect to the Product or if contacts with those Regulatory Authorities are made orally, to be reduced in writing, (ii) documents related to regulatory milestones and dates (e.g., submission, validations, agency review questions, CHMP opinion and FDA complete response letter and their equivalent), (iii) IND annual reports and cover letters of all agency submissions relating to the Compound or any Product. If any Regulatory Filing to be provided under this Section 5.3 was originally created in a language other than the English language, then at the receiving Party’s request and to the extent already existing and readily available, the providing Party shall provide an English translation along with the original document to the receiving Party. The Parties acknowledge that it is their intent to collaborate in good faith in the exchange of such Regulatory communications including with any Sublicensee or Future Exelixis Licensee. Each of Licensee and Exelixis shall use Commercially Reasonable Efforts to grant the other Party access and rights to use any such communications with any Regulatory Authority generated by or on behalf of any Sublicensee or Future Exelixis Licensee, respectively. Should either Party fail to obtain such access and rights from any Sublicensee or Future Exelixis Licensee, such Party shall not have the right to grant access or rights to such Sublicensee or Future Exelixis Licensee to any such communications with any Regulatory Authority generated by or on behalf of the other Party.. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 5.4

Regulatory Information Sharing. Each To the extent that such Regulatory Filings that relate to the activities in the requesting Party’s territory, each Party shall, upon the other Party’s reasonable request, promptly provide the other Party (but in no event more than [ * ]) with copies of any Regulatory Filings prepared (including any draftsdrafts and supporting information), submitted or received by such Party in the Exelixis Territory including the U.S. and the Licensee [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. Collaborator Territory pertaining to the Compound and Products, and such other Party shall have the right to review and comment on drafts of such Regulatory Filings, provided that such review and comment shall not delay the submission of any Regulatory Filings. The sharing of Regulatory Filings shall, as applicable, be the following shall include any communications/correspondence with the Regulatory Authority: (i) summary of contact Authority regarding label changes, IND annual reports either Party receives concerning substantive conversations or substantive meetings in its respective territory with the FDAand cover letters, EMA, CFDA and PMDA with respect to the Product or if contacts with those Regulatory Authorities are made orally, to be reduced in writing, (ii) documents related to regulatory milestones and dates (e.g., submission, submissions and validations, agency review questions, CHMP opinion and FDA complete response letter and their equivalent), (iii) IND annual reports and cover letters of all agency submissions relating to the Compound or any Product. If any Regulatory Filing to be provided under this Section 5.3 5.2 was originally created in a language other than the English language, then at the receiving Party’s request and to the extent already existing and readily available, the providing Party shall provide an English translation along with the original document to the receiving Party. The Parties acknowledge that it is their intent to collaborate in good faith in the exchange of such Regulatory communications including with any Sublicensee or Future other Exelixis Licenseelicensee. Each of Licensee Collaborator and Exelixis shall use Commercially Reasonable Efforts reasonably endeavor to grant access and rights for the other Party access and rights to use any such communications with any Regulatory Authority generated by or on behalf of any Sublicensee or Future other Exelixis Licenseelicensee, respectively. For clarity, a Party’s provision to the other Party of copies of Regulatory Filings prepared, submitted, or received in each Party’s territory is expressly conditioned upon the receiving Party granting to the providing Party the right to share with the providing Party’s own licensee for its territory copies of any and all Regulatory Filings prepared, submitted, or received by the receiving Party in its territory. Should either Party fail to obtain such access and rights from any Sublicensee or Future Exelixis Licenseelicensee, such Party shall not have the right to grant access or rights to such Sublicensee or Future other Exelixis Licensee licensee to any such communications with any Regulatory Authority generated by or on behalf of the other Party.