Common use of Regulatory Filings and Interactions Clause in Contracts

Regulatory Filings and Interactions. Alnylam shall be the “Regulatory Lead” with respect to Licensed Products through Phase I Completion and MedCo shall be the Regulatory Lead with respect to Licensed Products thereafter. Except as otherwise provided in the Initial Development Plan or Section 2.6.2, (a) each Party will own the INDs, the NDAs and related regulatory documents submitted to the applicable Regulatory Authorities by it with respect to Licensed Products and (b) the Regulatory Lead will, as to Licensed Products, (i) oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, each Regulatory Authority, (ii) be CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. responsible for interfacing, corresponding and meeting with each Regulatory Authority, and (iii) be responsible for maintaining all regulatory filings. Alnylam will promptly notify the JSC in writing of all material communications received by it from Regulatory Authorities regarding the Licensed Products and of all filings and submissions made by it to Regulatory Authorities regarding the Licensed Products; provided, however, that after Phase I Completion, Alnylam shall not communicate with any Regulatory Authority regarding any Licensed Product without MedCo’s prior written consent, except as required by Law or as requested or required by a Regulatory Authority. MedCo shall provide Alnylam with written notice of (x) all filings and submissions for Regulatory Approval regarding any Licensed Product in the Territory in a timely manner; and (y) all Regulatory Approvals obtained or denied and the filing of any IND for any Licensed Product within fifteen (15) days after such event; provided, however, that in all circumstances except as required by Law, MedCo shall inform Alnylam of such event prior to public disclosure of such event by MedCo.

Regulatory Filings and Interactions. Alnylam Aura shall be the “Regulatory Lead” with respect to responsible at its expense, for preparation and submission of all regulatory filings for Licensed Products through Phase I Completion and MedCo shall be within the Regulatory Lead with respect to Licensed Products thereafterTerritory. Except as otherwise provided in the Initial Development Plan or Section 2.6.2, (a) each Party Aura will own the INDs, the NDAs and related any regulatory documents and applications submitted to the applicable Regulatory Authorities by it in the Territory with respect to the Licensed Products Product, and will be identified as marketing authorization holder in the Territory. Aura shall: (b) the Regulatory Lead will, as to Licensed Products, (ia) oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, each Regulatory Authority, ; (iib) be CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. responsible for interfacing, corresponding and meeting with each Regulatory Authority, ; and (iiic) be responsible for maintaining all regulatory filings. Alnylam will promptly notify the JSC in writing Aura shall provide Clearside with a draft of all material communications regulatory submissions (or portions thereof) that relate to the Clearside Suprachoroidal Microneedle Technology at least ten (10) Business Days prior to submission for review and comment by Clearside, and Aura shall consider in good faith any comments received by it from Regulatory Authorities regarding the Licensed Products Clearside, and of all filings and submissions made by it to Regulatory Authorities regarding the Licensed Products; provided, however, that after Phase I Completion, Alnylam Aura shall not communicate with any Regulatory Authority regarding any Licensed Product submit such regulatory submissions relating to the Clearside Suprachoroidal Microneedle Technology without MedCoreceipt of Clearside’s prior written consent, except as required by Law not to be unreasonably withheld, conditioned or as requested delayed. In addition, Aura shall notify Clearside of any regulatory responses or required by a communications (or portions thereof) relating to the Clearside Microneedle Technology received from any Regulatory Authority. MedCo Authority and shall provide Alnylam Clearside with copies thereof within five (5) days after receipt. Aura shall provide Clearside with prompt written notice of (x) all filings and submissions for any meeting or discussion with any Regulatory Approval regarding any Licensed Product Authority potentially related to the Clearside Microneedle Technology. Aura shall reasonably consider in good faith Clearside’s request to attend such meeting or discussion. Aura shall promptly provide Clearside with unredacted copies of the Territory in a timely manner; and (y) all Regulatory Approvals obtained or denied and the filing portion of any IND for any Licensed Product within fifteen (15) days after such event; provided, however, Regulatory Authority meeting minutes that in all circumstances except as required by Law, MedCo shall inform Alnylam of such event prior pertain to public disclosure of such event by MedCothe Clearside Suprachoroidal Microneedle Technology.

Regulatory Filings and Interactions. Alnylam Each Party shall be the “Regulatory Lead” with respect use Commercially Reasonable Efforts to conduct all regulatory activities relating to Licensed Products through Phase I Completion and MedCo shall be in accordance with the Regulatory Lead with respect to Licensed Products thereafterthen-current Development Plan. Except as otherwise provided in the Initial Development Plan or Section 2.6.2Plan, (a) each Party will own the INDs, the NDAs and related regulatory documents submitted to the applicable Regulatory Authorities by it in its Territory with respect to Licensed Products and (b) the Regulatory Lead each Party will, as to Licensed ProductsProducts in its Territory, (i) oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, each Regulatory Authority, (ii) be CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. responsible for interfacing, corresponding and meeting with each Regulatory Authority, and (iii) be responsible for maintaining all regulatory filings. Alnylam will promptly filings and (iv) notify the JSC in writing writing, including a brief description in English of the principal issues raised, of all material communications received by it from Regulatory Authorities regarding within [**], provide the Licensed Products JSC with a summary translation of such material communications in English as soon as reasonably possible and provide, if appropriate, a full translation of such material communications in English as soon as reasonably possible thereafter. Each Party will provide complete copies of any such original correspondence in their native language to the other Party upon request. Each Party shall provide the other Party with reasonable advance notice of all material, substantive meetings with the Regulatory Authorities in its Territory pertaining to any Licensed Products, or with as much advance notice as practicable under the circumstances. Each Party shall use Commercially Reasonable Efforts, to the extent reasonably practicable, to permit the other Party to have, at the other Party’s expense, one (1) mutually acceptable representative of the other Party to attend, solely as an observer, material, substantive meetings with the Regulatory Authorities in the major market countries within such Party’s Territory pertaining to any Licensed Product. Each Party shall furnish the other Party with drafts of all copies of such Party’s filings and submissions made by it to for Regulatory Authorities regarding the Licensed Products; providedApproval (including draft INDs, howeverNDAs, that after Phase I Completion, Alnylam shall not communicate with any Regulatory Authority orphan drug applications and designations) regarding any Licensed Product without MedCoin such Party’s Territory in a timely manner in sufficient time prior written consentto making such filings and submissions to allow the other Party a reasonable opportunity to review and comment thereon and shall consider the other Party’s timely comments in good faith. In addition, except as required by Law or as requested or required by a Regulatory Authority. MedCo each Party shall provide Alnylam the other Party with written notice of (x) all filings and submissions for Regulatory Approval regarding any Licensed Product in the such Party’s Territory in a timely manner; and (y) all Regulatory Approvals obtained or denied denied; and the filing of any IND for any Licensed Product within fifteen (15z) days after such event[**]; provided, however, that in all circumstances except as required by Lawcircumstances, MedCo each Party shall inform Alnylam the other Party of such event prior to public disclosure of such event by MedCosuch Party.

Regulatory Filings and Interactions. Alnylam shall be the “Regulatory Lead” with respect to Licensed Products through Phase I Completion and MedCo shall be the Regulatory Lead with respect to Licensed Products thereafter. Except as otherwise provided in the Initial Development Plan or Section 2.6.2, (a) each Party will own the INDs, the NDAs and related regulatory documents submitted to the applicable Regulatory Authorities by it with respect to Licensed Products and (b) the Regulatory Lead will, as to Licensed Products, (i) oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, each Regulatory Authority, (ii) be CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. responsible for interfacing, corresponding and meeting with each Regulatory Authority, and (iii) be responsible for maintaining all regulatory filings. Alnylam will promptly notify the JSC in writing of all material communications received by it from Regulatory Authorities regarding the Licensed Products and of all filings and submissions made by it to Regulatory Authorities regarding the Licensed Products; provided, however, that after Phase I Completion, Alnylam shall not communicate with any Regulatory Authority regarding any Licensed Product without MedCo’s 's prior written consent, except as required by Law or as requested or required by a Regulatory Authority. MedCo shall provide Alnylam with written notice of (x) all filings and submissions for Regulatory Approval regarding any Licensed Product in the Territory in a timely manner; and (y) all Regulatory Approvals obtained or denied and the filing of any IND for any Licensed Product within fifteen (15) days after such event; provided, however, that in all circumstances except as required by Law, MedCo shall inform Alnylam of such event prior to public disclosure of such event by MedCo.

Regulatory Filings and Interactions. Alnylam shall be 3.1.1 Ownership of Regulatory Filings. Genzyme will own all INDs, NDAs and related regulatory documentation submitted to any Regulatory Authority in the “Regulatory Lead” Licensed Territory with respect to any Global AT3 Licensed Products through Phase I Completion Product, excluding any drug master files maintained by or on behalf of Alnylam. At Genzyme’s request following the Implementation Date for a Global AT3 Licensed Product, Alnylam will promptly assign and MedCo shall be transfer to Genzyme all INDs, NDAs and other regulatory documentation submitted to any Regulatory Authority in the Regulatory Lead Licensed Territory with respect to such Global AT3 Licensed Products thereafter. Except as otherwise provided Product that is in the Initial Development Plan possession or Section 2.6.2control of Alnylam, (a) excluding any drug master files maintained by or on behalf of Alnylam, and each Party will own submit all filings, letters and other documentation necessary to effect such assignment and transfer to the applicable Regulatory Authority no later than [***] days after such request for such Global AT3 Licensed Product. Alnylam hereby appoints Genzyme as Alnylam’s agent for all matters related to each Global AT3 Licensed Product involving Regulatory Authorities in the Licensed Territory during the period beginning on the Implementation Date for such Global AT3 Licensed Product and ending on the date that the transfer of all INDs, the NDAs and related regulatory documents filed with or submitted to the applicable any Regulatory Authorities by it with respect to Licensed Products and (b) the Regulatory Lead will, as to Licensed Products, (i) oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, each Regulatory Authority, (ii) be CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. Authority in the Licensed Territory that relate to such Global AT3 Licensed Product, excluding any drug master files maintained by or on behalf of Alnylam, becomes effective, and Genzyme hereby accepts such appointment. 3.1.2 Responsibilities for Regulatory Matters. Genzyme will be solely responsible for all regulatory matters relating to Global AT3 Licensed Products in the Licensed Territory, including (i) overseeing, monitoring and coordinating all regulatory actions, communications and filings with, and submissions to, each Regulatory Authority in the Licensed Territory with respect to Global AT3 Licensed Products; (ii) interfacing, corresponding and meeting with each Regulatory Authority, Authority in the Licensed Territory with respect to Global AT3 Licensed Products; and (iii) be responsible for seeking and maintaining all regulatory filings. Alnylam will promptly notify the JSC filings in writing of all material communications received by it from Regulatory Authorities regarding the Licensed Products and of all filings and submissions made by it Territory with respect to Regulatory Authorities regarding the Global AT3 Licensed Products; provided. 3.1.3 Communications with Regulatory Authorities. Genzyme will provide Alnylam, howeverthrough the AJSC, that after Phase I Completionas part of the quarterly updates regarding Development activities described in Section 2.5.1 (Development Activities), Alnylam shall not communicate with a brief description in English, of the principal issues raised in any material communication with any Regulatory Authority regarding in the Licensed Territory with respect to any Global AT3 Licensed Product without MedCo’s prior written consentduring the preceding Calendar Quarter. For purposes of this Section 3.1.3, except as required by Law “material communication” with Regulatory Authorities include meetings with Regulatory Authorities and Regulatory Authority questions or as requested concerns regarding significant issues, including any of the following: key product quality attributes (e.g., purity), safety findings affecting the platform (e.g., Serious Adverse Events, emerging safety signals), clinical or required by a Regulatory Authority. MedCo shall provide Alnylam with written notice nonclinical findings affecting patient safety, or lack of (x) all filings and submissions for Regulatory Approval regarding any Licensed Product in the Territory in a timely manner; and (y) all Regulatory Approvals obtained or denied and the filing of any IND for any Licensed Product within fifteen (15) days after such event; provided, however, that in all circumstances except as required by Law, MedCo shall inform Alnylam of such event prior to public disclosure of such event by MedCoefficacy.

Regulatory Filings and Interactions. Alnylam shall be Subject to Sections 5.2 and 14.2.3(a), as between the “Regulatory Lead” with respect to Licensed Products through Phase I Completion and MedCo shall be the Regulatory Lead with respect to Licensed Products thereafter. Except as otherwise provided in the Initial Development Plan or Section 2.6.2Parties, (a) each Party Argos will own the INDs, the NDAs and related any regulatory documents and applications submitted to the applicable Regulatory Authorities by it in the Territory with respect to the Licensed Products Product in the Field unless and (b) until Medinet exercises the Regulatory Lead willOption, as to in which case, Medinet will own such documents and applications. Without limiting the foregoing, Medinet shall during any period in which it is responsible for the Commercialization of the Licensed Products, Product in the Territory (i) oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, each Regulatory Authority, (ii) be CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. responsible for interfacing, corresponding and meeting with each Regulatory Authority, and (iii) be responsible for maintaining all regulatory filings. Alnylam will promptly notify , and (iv) apprise the JSC in writing other Party of all material communications received by it from Regulatory Authorities regarding as soon as reasonably possible but in any event within [**] business days. Argos will have the right to reference Medinet’s and its Related Parties’ INDs and other filings with and submissions to Regulatory Authorities with respect to the Licensed Products Product for the purpose of conducting its Development activities and to otherwise obtain Regulatory Approval of the Licensed Product outside the Territory. In addition, during any period in which the Commercialization License is not in effect, Medinet shall deliver to Argos copies of all filings and submissions made by it to Regulatory Authorities regarding Authorities, including without limitation Regulatory Approvals, no less than [**] days prior to submission to the Licensed Products; provided, however, that after Phase I Completion, Alnylam Regulatory Authorities. Medinet shall not communicate with any Regulatory Authority regarding any Licensed Product without MedCo’s prior written consent, except as required by Law or as requested or required by a Regulatory Authority. MedCo shall provide Alnylam with written notice of (x) all include in such filings and submissions for Regulatory Approval regarding any Licensed Product in the Territory in a timely manner; and (y) all Regulatory Approvals obtained or denied and the filing comments made by Argos within [**] days of any IND for any Licensed Product within fifteen (15) days after such event; provided, however, that in all circumstances except as required by Law, MedCo shall inform Alnylam Argos’ receipt of such event prior submissions and filings, except to public disclosure the extent such comments would cause such submissions or filings to be in violation of such event by MedCoapplicable laws.

Regulatory Filings and Interactions. Alnylam Promptly following the Effective Date (and in any event [***] after the Effective Date), Endoceutics shall be the “and hereby does assign and transfer all Regulatory Lead” with respect to Licensed Products through Phase I Completion Filings and MedCo shall be the Regulatory Lead with respect Approval (including the NDA 208470) for the Product in VVA in the Territory to Licensed Products thereafter. Except AMAG; provided that Endoceutics shall retain IND 108801 solely for the purposes of conducting the FSD Study as otherwise provided in Section 5.2. Promptly following completion of the Initial Development Plan or Section 2.6.2FSD Study, (a) each Party will own Endoceutics shall and hereby does assign and transfer IND 108801 to AMAG. Promptly following such assignment, AMAG shall file an application for Regulatory Approval for the INDs, Product in FSD with the NDAs and related regulatory documents submitted to the applicable Regulatory Authorities by it with respect to Licensed Products and (b) the Regulatory Lead will, as to Licensed Products, (i) oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, each Regulatory Authority, (ii) be CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “FDA [***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934For clarity, notwithstanding each Party’s respective obligation to pursue Regulatory Approval for the Product in FSD in the Territory, if [***]. responsible For clarity, Endoceutics will not be required to transfer any DMFs or any manufacturing information (except as contained in the CMC section of any such Regulatory Filings and/or Regulatory Approvals for interfacingthe Product in the Territory) maintained by or on behalf of Endoceutics or any Third Party, corresponding including any contract manufacturer; provided that AMAG has access to or rights to cross-reference those DMFs and/or relevant manufacturing information for the Product pursuant to this Agreement and meeting the Supply Agreement to permit AMAG to comply with its regulatory obligations with respect to the Product in the Field in the Territory or to exercise AMAG’s rights under this Agreement or the Supply Agreement. [***]. AMAG shall be the holder of all Regulatory Approvals for the Product in the Field in the Territory (other than any DMFs (except as contained in the CMC section of any such Regulatory Approvals for the Product in the Territory)) and shall have responsibility for maintaining such Regulatory Approval and for interactions with Regulatory Authorities with respect to the Product in the Field in the Territory, other than with respect to DMF or manufacturing matters as otherwise set forth in this Section 5.1 or the Supply Agreement. The Parties shall consult with each Regulatory Authorityother through the JSC regarding, and (iii) be responsible for maintaining all regulatory filingskeep the other Party regularly and fully informed of, the preparation, Regulatory Authority review, and approval of submissions and communications with Regulatory Authorities with respect to the Product in the Field in the Territory. Alnylam will In addition, each Party shall promptly notify provide the JSC in writing other Party with copies of all material documents, information, and correspondence received from a Regulatory Authority and, upon reasonable request, with copies of any other documents, reports and communications received by it from Regulatory Authorities regarding the Licensed Products and of all filings and submissions made by it or to Regulatory Authorities regarding the Licensed Products; provided, however, that after Phase I Completion, Alnylam shall not communicate with any Regulatory Authority regarding any Licensed relating to the Product without MedCo’s prior written consent, except as required by Law or as requested or required by a Regulatory Authorityactivities under this Agreement. MedCo shall provide Alnylam with written notice of (x) all filings and submissions for Regulatory Approval regarding any Licensed Product in the Territory in a timely manner; and (y) all Regulatory Approvals obtained or denied and the filing of any IND for any Licensed Product within fifteen (15) days after such event; provided, however, that in all circumstances except as required by Law, MedCo shall inform Alnylam of such event prior to public disclosure of such event by MedCo[***].

Regulatory Filings and Interactions. Alnylam shall be Subject to Sections 5.2 and 14.2.3(a), as between the “Regulatory Lead” with respect to Licensed Products through Phase I Completion and MedCo shall be the Regulatory Lead with respect to Licensed Products thereafter. Except as otherwise provided in the Initial Development Plan or Section 2.6.2Parties, (a) each Party Argos will own the INDs, the NDAs and related any regulatory documents and applications submitted to the applicable Regulatory Authorities by it in the Territory with respect to the Licensed Products Product in the Field unless and (b) until MEDcell exercises the Regulatory Lead willOption, as to in which case, MEDcell will own such documents and applications. Without limiting the foregoing, MEDcell shall during any period in which it is responsible for the Commercialization of the Licensed Products, Product in the Territory (i) oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, each Regulatory Authority, (ii) be CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. responsible for interfacing, corresponding and meeting with each Regulatory Authority, and (iii) be responsible for maintaining all regulatory filings. Alnylam will promptly notify , and (iv) apprise the JSC in writing other Party of all material communications received by it from Regulatory Authorities regarding as soon as reasonably possible but in any event within [**] business days. Argos will have the right to reference MEDcell’s and its Related Parties’ INDs and other filings with and submissions to Regulatory Authorities with respect to the Licensed Products Product for the purpose of conducting its Development activities and to otherwise obtain Regulatory Approval of the Licensed Product outside the Territory. In addition, during any period in which the Commercialization License is not in effect, MEDcell shall deliver to Argos copies of all filings and submissions made by it to Regulatory Authorities regarding Authorities, including without limitation Regulatory Approvals, no less than [**] days prior to submission to the Licensed Products; provided, however, that after Phase I Completion, Alnylam Regulatory Authorities. MEDcell shall not communicate with any Regulatory Authority regarding any Licensed Product without MedCo’s prior written consent, except as required by Law or as requested or required by a Regulatory Authority. MedCo shall provide Alnylam with written notice of (x) all include in such filings and submissions for Regulatory Approval regarding any Licensed Product in the Territory in a timely manner; and (y) all Regulatory Approvals obtained or denied and the filing comments made by Argos within [**] days of any IND for any Licensed Product within fifteen (15) days after such event; provided, however, that in all circumstances except as required by Law, MedCo shall inform Alnylam Argos’ receipt of such event prior submissions and filings, except to public disclosure the extent such comments would cause such submissions or filings to be in violation of such event by MedCoapplicable laws.

Regulatory Filings and Interactions. Alnylam shall be 3.1.1 Ownership of Regulatory Filings. Genzyme will own all INDs, NDAs and related regulatory documentation submitted to any Regulatory Authority in the “Regulatory Lead” Licensed Territory with respect to any Global AT3 Licensed Products through Phase I Completion Product, excluding any drug master files maintained by or on behalf of Alnylam. At Genzyme’s request following the Implementation Date for a Global AT3 Licensed Product, Alnylam will promptly assign and MedCo shall be transfer to Genzyme all INDs, NDAs and other regulatory documentation submitted to any Regulatory Authority in the Regulatory Lead Licensed Territory with respect to such Global AT3 Licensed Products thereafter. Except as otherwise provided Product that is in the Initial Development Plan possession or Section 2.6.2control of Alnylam, (a) excluding any drug master files maintained by or on behalf of Alnylam, and each Party will own submit all filings, letters and other documentation necessary to effect such assignment and transfer to the applicable Regulatory Authority no later than [***] days after such request for such Global AT3 Licensed Product. Alnylam hereby appoints Genzyme as Alnylam’s agent for all matters related to each Global AT3 Licensed Product involving Regulatory Authorities in the Licensed Territory during the period beginning on the Implementation Date for such Global AT3 Licensed Product and ending on the date that the transfer of all INDs, the NDAs and related regulatory documents filed with or submitted to any Regulatory Authority in the applicable Licensed Territory that relate to such Global AT3 Licensed Product, excluding any drug master files maintained by or on behalf of Alnylam, becomes effective, and Genzyme hereby accepts such appointment. 3.1.2 Responsibilities for Regulatory Authorities by it with respect Matters. Genzyme will be solely responsible for all regulatory matters relating to Global AT3 Licensed Products and (b) in the Regulatory Lead willLicensed Territory, as to Licensed Products, including (i) overseeoverseeing, monitor monitoring and coordinate coordinating all regulatory actions, communications and filings with, and submissions to, each Regulatory Authority, Authority in the Licensed Territory with respect to Global AT3 Licensed Products; (ii) be CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. responsible for interfacing, corresponding and meeting with each Regulatory Authority, Authority in the Licensed Territory with respect to Global AT3 Licensed Products; and (iii) be responsible for seeking and maintaining all regulatory filings. Alnylam will promptly notify the JSC filings in writing of all material communications received by it from Regulatory Authorities regarding the Licensed Products and of all filings and submissions made by it Territory with respect to Regulatory Authorities regarding the Global AT3 Licensed Products; provided, however, that after Phase I Completion, Alnylam shall not communicate with any Regulatory Authority regarding any Licensed Product without MedCo’s prior written consent, except as required by Law or as requested or required by a Regulatory Authority. MedCo shall provide Alnylam with written notice of (x) all filings and submissions for Regulatory Approval regarding any Licensed Product in the Territory in a timely manner; and (y) all Regulatory Approvals obtained or denied and the filing of any IND for any Licensed Product within fifteen (15) days after such event; provided, however, that in all circumstances except as required by Law, MedCo shall inform Alnylam of such event prior to public disclosure of such event by MedCo.ACTIVE/100404760.2

Regulatory Filings and Interactions. Alnylam shall be the “Regulatory Lead” with respect to Licensed Products through Phase I Completion and MedCo shall be the Regulatory Lead with respect to Licensed Products thereafter. Except as otherwise provided agreed by the Parties in the Initial Development Plan or Section 2.6.2writing, (a) each Party Eurofarma will own the INDs, the NDAs and related regulatory documents submitted to file with the applicable Regulatory Governmental Authorities by it in the Eurofarma Territory all NDAs with respect to Licensed Products and will own such NDAs and all resulting Regulatory Approvals and (b) on a country-by-country and Licensed Product-by-Licensed Product basis in the Regulatory Lead Eurofarma Territory, beginning on the date that Eurofarma files the first NDA with respect to such Licensed Product in such country, Eurofarma will, as to such Licensed ProductsProduct in such country, (i) oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, each Regulatory Governmental Authority, (ii) be CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. responsible for interfacing, corresponding and meeting with each Regulatory Governmental Authority, and (iii) be responsible for maintaining all regulatory filings. Alnylam will promptly filings and (iv) notify Summit in writing, including a brief description in English of the JSC in writing principal issues raised, of all material communications received by it from Regulatory Governmental Authorities regarding the Licensed Products within [**] days, provide Summit with a summary translation of such material communications in English as soon as reasonably possible and provide, if appropriate, a full translation of such material communications in English as soon as reasonably possible thereafter. Eurofarma will provide complete copies of any such original correspondence in their native language to Summit upon request. Eurofarma shall provide Summit with reasonable advance notice of all material, substantive meetings with the Governmental Authorities in the Eurofarma Territory pertaining to any Licensed Products, or with as much advance notice as practicable under the circumstances. Eurofarma shall use Commercially Reasonable Efforts, to the extent reasonably practicable, to permit Summit to have, at Summit’s expense, one (1) mutually acceptable representative of Summit to attend material, substantive meetings with the Governmental Authorities in the Eurofarma Territory pertaining to any Licensed Product. Eurofarma shall furnish Summit with drafts of all copies of Eurofarma’s filings and submissions made by it to for Regulatory Authorities regarding the Licensed Products; provided, however, that after Phase I Completion, Alnylam shall not communicate with any Regulatory Authority Approval (including draft NDAs and orphan drug applications and designations) regarding any Licensed Product without MedCoin the Eurofarma Territory in a timely manner in sufficient time prior to making such filings and submissions to allow Summit a reasonable opportunity to review and comment thereon and shall implement all of Summit’s prior written consenttimely comments. In addition, except as required by Law or as requested or required by a Regulatory Authority. MedCo Eurofarma shall provide Alnylam Summit with (y) written notice of (xi) all filings and submissions for Regulatory Approval regarding any Licensed Product in the Eurofarma Territory in a timely manner; manner and (yii) all Regulatory Approvals obtained or denied and the filing of any IND for any Licensed Product within fifteen (15) [**] days after such event; provided, however, that in all circumstances except as required by Lawcircumstances, MedCo Eurofarma shall inform Alnylam Summit of such event prior to public disclosure of such event by MedCoEurofarma, and (z) copies of Eurofarma’s filings and submissions for Regulatory Approval (including NDAs and orphan drug applications and designations) regarding any Licensed Product in the Eurofarma Territory within a reasonable period of time after making such filings and submissions.