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. As between the Parties, each Party will own any regulatory documents and applications submitted to the applicable Regulatory Authorities in its own Territory with respect to the Licensed Product, and each Party will, with respect to its own Territory and the Licensed Product, (i) oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, each Regulatory Authority, (ii) be responsible for interfacing, corresponding and meeting with each Regulatory Authority, (iii) be responsible for maintaining all regulatory filings, and (iv) apprise the other Party of all material communications from Regulatory Authorities as soon as reasonably possible but in any event within [**] business days. Each Party will have the right to reference the other Party’s (and the other Party’s Related Parties’ subject to any limitations set forth in a Party’s agreement with such Related Parties) INDs and other filings with and submissions to Regulatory Authorities with respect to the Licensed Product for the purpose of conducting its Development activities and to otherwise obtain Regulatory Approval of the Licensed Product in its own Territory.
Regulatory Filings and Interactions. As between the Parties, each Party will own any regulatory documents and applications submitted to the applicable Regulatory Authorities in its own Territory with respect to the Covered Product, and each Party will, with respect to its own Territory and the Covered Product, (i) oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, each Regulatory Authority, (ii) be responsible for interfacing, corresponding and meeting with each Regulatory Authority, (iii) be responsible for maintaining all regulatory filings, and (iv) apprise the other Party of all material communications from Regulatory Authorities that may affect the Covered Products in the other Party’s Territory as soon as reasonably possible but in any event within five (5) business days.
Regulatory Filings and Interactions. Subject to Sections 5.2 and 14.2.3(a), as between the Parties, Argos will own any regulatory documents and applications submitted to the applicable Regulatory Authorities in the Territory with respect to the Licensed Product in the Field unless and until Medinet exercises the Option, 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 Product in the Territory (i) oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, each Regulatory Authority, (ii) be responsible for interfacing, corresponding and meeting with each Regulatory Authority, (iii) be responsible for maintaining all regulatory filings, and (iv) apprise the other Party of all material communications from Regulatory Authorities 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 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 to Regulatory Authorities, including without limitation Regulatory Approvals, no less than [**] days prior to submission to the Regulatory Authorities. Medinet shall include in such filings and submissions any comments made by Argos within [**] days of Argos’ receipt of such submissions and filings, except to the extent such comments would cause such submissions or filings to be in violation of applicable laws.
Regulatory Filings and Interactions. 5.1.1. Responsibilities.
Regulatory Filings and Interactions. Except as otherwise provided in the applicable Development Plan, during the Collaboration Term for a Program (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 in such Program and (B) the Regulatory Lead will, as to such Licensed Products, (x) oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, each Regulatory Authority, (y) be responsible for interfacing, corresponding and meeting with each Regulatory Authority, and (z) be responsible for maintaining all regulatory filings. While Alnylam is the Regulatory Lead for a Program, Alnylam will promptly notify the JSC in writing of all material communications received by it from Regulatory Authorities, and of all filings and submissions made by it to Regulatory Authorities regarding the Licensed Products in such Program; provided, however, that once Alnylam is no longer the Regulatory Lead, [***]. With respect to each HBV Licensed Product and any ID Licensed Product, Vir shall provide Alnylam with written notice of all Regulatory Approvals [***] and the filing of any IND for such Licensed Product within [***] after such event; provided, however, that to the extent reasonably practicable and except as required by Law, Vir shall [***].
Regulatory Filings and Interactions. 3.1.1 Ownership of Regulatory Filings. Genzyme will own all INDs, NDAs and related regulatory documentation submitted to any Regulatory Authority in the Licensed Territory with respect to any Global AT3 Licensed 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 transfer to Genzyme all INDs, NDAs and other regulatory documentation submitted to any Regulatory Authority in the Licensed Territory with respect to such Global AT3 Licensed Product that is in the possession or control of Alnylam, excluding any drug master files maintained by or on behalf of Alnylam, and each Party will 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, NDAs and related regulatory documents filed with or submitted to any Regulatory 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.
Regulatory Filings and Interactions. 5.1.1. Responsibilities. Each Party will be [***] responsible for all regulatory matters relating to a Licensed Product in its Territory and will own all Regulatory Materials in its Territory with respect to such Licensed Product, provided that aTyr will, and will cause Third Parties who Manufacture ATYR1923 or the Licensed Products, [***], to (i) [***] as required by the Pharmaceuticals and Medical Device Agency (or successor agency), (ii) handle any regulatory matter relating thereto, and (iii) provide Kyorin [***]. Each Party will have the sole right to (a) oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, each Regulatory Authority in its Territory with respect to each Licensed Product; (b) interface, correspond and meet with each Regulatory Authority in its Territory with respect to each Licensed Product; and (c) seek and maintain all Regulatory Filings in its Territory with respect to each Licensed Product.
Regulatory Filings and Interactions. As between the Parties, each Party will own any regulatory documents and applications submitted to the applicable Regulatory Authorities in its own Territory with respect to a Licensed Product, and each Party will, with respect to its own Territory and a Licensed Product, (i) oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, each Regulatory Authority, (ii) be responsible for interfacing, corresponding and meeting with each Regulatory Authority, (iii) be responsible for maintaining all regulatory filings, and (iv) apprise the other Party of all material communications from Regulatory Authorities as soon as reasonably possible but in any event within [**] business days. Without limiting any other right of any Party hereunder, each Party will have the right to reference each other Party's and its Related Parties’ INDs and other filings with and submissions to Regulatory Authorities with respect to a Licensed Product for the purpose of conducting such Party's Development activities and to otherwise obtain Regulatory Approval of a Licensed Product in such Party'sTerritory; provided, however, that this right of reference Regional Partners’ INDs and other filings with and submissions to Regulatory Authorities shall apply to the extent, and only to the extent, Argos has the right to grant China Company those rights of reference.
Regulatory Filings and Interactions. Except as otherwise provided in the Development Plan, (a) each Party will own the INDs, the NDAs and related regulatory documents submitted to the applicable Regulatory Authorities in its own Territory with respect to the Licensed Product and (b) each Party will, with respect to its own Territory and the Licensed Product, (i) oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, each Regulatory Authority, (ii) be responsible for interfacing, corresponding and meeting with each Regulatory Authority, (iii) be responsible for maintaining all regulatory filings, and (iv) notify the JSC in writing, including a brief description in English of the principle issues raised, of all material communications from Regulatory Authorities within [**] business days, provide the JSC with a summary translation of such material communications in English as soon as reasonably possible but in any event within [**] business days, and provide a full translation of such material communications in English as soon as reasonably possible thereafter. Kyowa Hakko will provide the complete copies of the original correspondence in their native language to Alnylam upon request. Each Party will have the right to reference the other Party’s INDs, the NDAs and other filings with and submissions to Regulatory Authorities with respect to the Licensed Product for the purpose of conducting its Development activities (in the case of Kyowa Hakko, under the Development Plan) and to otherwise obtain Regulatory Approval of the Licensed Product in its own Territory.
