Common use of Regulatory Filings Transfer Clause in Contracts

Regulatory Filings Transfer. (a) Within [*] days after the Effective Date (or such other date as mutually agreed by the Parties), Novacea shall transfer to Schering all existing INDs and other Regulatory Applications that it owns or controls covering the Licensed Product and reasonably assist Schering in obtaining the transfer of such INDs and other Regulatory Applications that it does not own or control. The Parties agree that Novacea will continue to execute ASCENT-2 in accordance with the Core Development Plan, and Schering hereby delegates such responsibility to Novacea. Novacea shall, upon request, timely provide to Schering information and reports related to ASCENT-2 necessary to satisfy Schering’s routine Regulatory Authority reporting obligations. For a period of at least [*] days after the Effective Date, Novacea will provide, at its own cost and expense and at Schering’s request, necessary information and support to Schering with respect to regulatory correspondence, discussions and meetings between Novacea and Regulatory Authorities that took place prior to the Effective Date. After the Effective Date, other than with respect to the DMF owned by Plantex under the Existing Supply Agreement, all further submissions to any Governmental Authorities relating to such Regulatory Applications and/or INDs or any other Regulatory Applications covering the Licensed Product, shall be [*] = 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. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. owned by, filed by and in the name of Schering or its Affiliates. Schering or its Affiliates shall hold all Regulatory Approvals for Licensed Product throughout the Territory. (b) In accordance with Section 2.4, within forty-five (45) days after the Effective Date (or such other date as mutually agreed by the Parties), Novacea shall transfer to Schering one copy of all documents and records that have been generated by or on behalf of Novacea with respect to any existing INDs and other Regulatory Applications that it owns or controls covering the Licensed Product in the Territory, as well as any correspondence between Novacea and Governmental Authorities related to Licensed Products. (c) Other than with respect to the DMF owned by Plantex under the Existing Supply Agreement, Schering shall be solely responsible for overseeing, monitoring and coordinating all regulatory actions, communications and filings with the FDA and other Governmental Authorities in the Territory and preparing, submitting and maintaining all Regulatory Applications and health registrations with respect to all Licensed Product. (d) Other than with respect to the DMF owned by Plantex under the Existing Supply Agreement, Schering shall be solely responsible for interfacing, corresponding and meeting with the FDA and other Governmental Authorities throughout the Territory with respect to Licensed Product. Schering shall provide Novacea with copies of any non-routine material correspondence with FDA or other Governmental Authorities in the Major Markets relating to approval of Licensed Product, within thirty (30) days of any such correspondence. Schering shall also provide Novacea with meeting minutes from any material meetings with Regulatory Authorities in the Major Markets concerning the approval of Licensed Product. Schering will provide Novacea with reasonable advance notice of any scheduled meeting with the FDA relating to Development of the Licensed Product and/or any Regulatory Application for the Licensed Product in the United States.

Regulatory Filings Transfer. (a) Within i. Alnylam shall as promptly as reasonably practicable, but in no event later than [* * *] days after following the Effective Date (or such other date as mutually agreed by the Parties“Regulatory Filings Transfer Period”), Novacea transfer to Dicerna all Regulatory Filings and Regulatory Approvals that are Controlled by Alnylam and its Affiliates and that are related to ALN-AAT02 and any Backups thereof (including all ownership and rights thereto), and copies of any other regulatory materials Controlled by Alnylam and its Affiliates [* * *] for the Research, Development or Commercialization of such Product in the Field in the Territory. Notwithstanding the foregoing, Alnylam shall transfer to Schering all existing INDs and other Regulatory Applications that it owns or controls covering the Licensed Product and reasonably assist Schering in obtaining the transfer of such INDs and other Regulatory Applications that it does not own or control. The Parties agree that Novacea will [* * *], Alnylam shall continue to execute ASCENT-2 in accordance file all necessary pharmacovigilance reports required with respect thereto with the Core Development Planapplicable Regulatory Authorities. In connection with the foregoing, Alnylam shall execute all documents and Schering hereby delegates such responsibility take all actions, including any additional filings with the relevant Regulatory Authorities, as are necessary [* * *] to Novaceavest all ownership and rights to the Regulatory Filings and Regulatory Approvals with Dicerna and to reflect Dicerna as the holder of all Regulatory Filings and Regulatory Approvals. Novacea shallFor the avoidance of doubt, upon Dicerna shall be responsible, at its own cost, with respect to all other matters related to Regulatory Filings and Regulatory Approvals for [* * *] and any Backups thereof. Following the Regulatory Filings Transfer Period, at Dicerna’s request, timely Alnylam shall provide from time to Schering information time reasonably requested regulatory-related assistance from its own employees, subject to the availability of any such employees, in which case Dicerna shall compensate Alnylam at the FTE Rate. Dicerna shall reimburse Alnylam for all actual out-of-pocket costs [* * *] that Alnylam may incur after the Regulatory Filings Transfer Period associated with assistance, if any, provided by any consultants or Third Parties that are not employees of Alnylam. Alnylam shall invoice Dicerna on a [* * *] basis for any of the foregoing amounts and reports related to ASCENT-2 necessary to satisfy Schering’s routine Regulatory Authority reporting obligations. For a period of at least Dicerna shall pay all such undisputed amounts within [* * *] days after following the date on which it receives each such invoice. If, as of the Effective Date, Novacea will provideAlnylam or its Affiliates are conducting any Clinical Trials for ALN-AAT02 or any Backup thereof, then at Dicerna’s request and at Alnylam’s cost and expense, Alnylam shall, and shall cause its Affiliates to, reasonably cooperate with Dicerna to transfer the conduct of such Clinical Trial to Dicerna or its designees and complete such transfer reasonably promptly. ii. Following Alnylam’s exercise of the Alnylam Commercialization Option for a particular Product pursuant to Section 4.3, Dicerna shall as promptly as reasonably practicable, but in no event later than [* * *] days following Alnylam’s exercise of the Alnylam Commercialization Option for such Product (the “Optioned Regulatory Filings Transfer Period”), transfer to Alnylam all Regulatory Filings and Regulatory Approvals that are Controlled by Dicerna and its Affiliates and that are related to such Product (including all ownership and rights thereto) outside the [* * *], and copies of any other regulatory materials Controlled by Dicerna and its Affiliates that are reasonably necessary for the Research, || Development or Commercialization of such Product in the Field outside the United States. In connection with the foregoing, Dicerna shall execute all documents and take all actions, including any additional filings with the relevant Regulatory Authorities related to such Product outside the United States, as are necessary or otherwise reasonably requested by Alnylam to vest all ownership and rights to the Regulatory Filings and Regulatory Approvals for such Product outside the United States with Alnylam and to reflect Alnylam as the holder of all Regulatory Filings and Regulatory Approvals for such Product outside the United States. Following the Optioned Regulatory Filings Transfer Period, at its own cost and expense and at ScheringAlnylam’s request, necessary information and support Dicerna shall provide from time to Schering time requested regulatory-related assistance from its own employees, in which case Alnylam shall compensate Dicerna at the FTE Rate. Alnylam shall reimburse Dicerna for all actual out-of-pocket costs without markup that Dicerna may incur after the Optioned Regulatory Filings Transfer Period associated with respect to regulatory correspondenceassistance, discussions and meetings between Novacea and Regulatory Authorities if any, provided by any consultants or Third Parties that took place prior to the Effective Dateare not employees of Dicerna. After the Effective Date, other than with respect to the DMF owned by Plantex under the Existing Supply Agreement, all further submissions to any Governmental Authorities relating to such Regulatory Applications and/or INDs or any other Regulatory Applications covering the Licensed Product, Dicerna shall be invoice Alnylam on a [* * *] = 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. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. owned by, filed by and in the name of Schering or its Affiliates. Schering or its Affiliates shall hold all Regulatory Approvals basis for Licensed Product throughout the Territory. (b) In accordance with Section 2.4, within forty-five (45) days after the Effective Date (or such other date as mutually agreed by the Parties), Novacea shall transfer to Schering one copy of all documents and records that have been generated by or on behalf of Novacea with respect to any existing INDs and other Regulatory Applications that it owns or controls covering the Licensed Product in the Territory, as well as any correspondence between Novacea and Governmental Authorities related to Licensed Products. (c) Other than with respect to the DMF owned by Plantex under the Existing Supply Agreement, Schering shall be solely responsible for overseeing, monitoring and coordinating all regulatory actions, communications and filings with the FDA and other Governmental Authorities in the Territory and preparing, submitting and maintaining all Regulatory Applications and health registrations with respect to all Licensed Product. (d) Other than with respect to the DMF owned by Plantex under the Existing Supply Agreement, Schering shall be solely responsible for interfacing, corresponding and meeting with the FDA and other Governmental Authorities throughout the Territory with respect to Licensed Product. Schering shall provide Novacea with copies of any non-routine material correspondence with FDA or other Governmental Authorities in the Major Markets relating to approval of Licensed Product, within thirty (30) days of any such correspondence. Schering shall also provide Novacea with meeting minutes from any material meetings with Regulatory Authorities in the Major Markets concerning the approval of Licensed Product. Schering will provide Novacea with reasonable advance notice of any scheduled meeting with the FDA relating to Development of the Licensed Product and/or any Regulatory Application for foregoing amounts and Alnylam shall pay all such undisputed amounts within [* * *] days following the Licensed Product in the United Statesdate on which it receives each such invoice.

Regulatory Filings Transfer. (a) Within [*] days Schering covenants that, as of the Effective Date, it does not have any INDs or other Regulatory Applications covering the Licensed Product in the Field in the Territory. After the Effective Date, Licensee or its Affiliates or sublicensee, as applicable, shall hold all INDs and other Regulatory Applications and Regulatory Approvals for Licensed Product in the Field throughout the Territory. Schering shall be the exclusive owner of all INDs and other Regulatory Applications related to the Licensed Compounds and/or Licensed Product outside the Field in the Territory. (b) As soon as practicable after the Effective Date (or such other date as mutually agreed by the Parties), Novacea Schering shall transfer to Schering all existing INDs and other Regulatory Applications that it owns or controls covering the Licensed Product and reasonably assist Schering in obtaining the transfer of such INDs and other Regulatory Applications that it does not own or control. The Parties agree that Novacea will continue to execute ASCENT-2 in accordance with the Core Development Plan, and Schering hereby delegates such responsibility to Novacea. Novacea shall, upon request, timely provide to Schering information and reports related to ASCENT-2 necessary to satisfy Schering’s routine Regulatory Authority reporting obligations. For a period Licensee one (1) electronic copy in Microsoft Word or Adobe Acrobat (whichever format the document is currently available) of at least [*] days after the Effective Date, Novacea will provide, at its own cost and expense and at Schering’s request, necessary information and support to Schering with respect to regulatory correspondence, discussions and meetings between Novacea and Regulatory Authorities that took place prior to the Effective Date. After the Effective Date, other than with respect to the DMF owned by Plantex under the Existing Supply Agreement, (i) all further submissions to any Governmental Authorities relating to such Regulatory Applications and/or INDs or any other Regulatory Applications covering the Licensed Product, shall be [*] = 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. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. owned by, filed by and in the name of Schering or its Affiliates. Schering or its Affiliates shall hold all Regulatory Approvals for Licensed Product throughout the Territory. (b) In accordance with Section 2.4, within forty-five (45) days after the Effective Date (or such other date as mutually agreed by the Parties), Novacea shall transfer to Schering one copy of all material documents and records that have been generated by or on behalf of Novacea Schering with respect to any existing INDs and other Regulatory Applications that it owns or controls covering the Licensed Product in the Territory, as well as Territory sufficient for Eiger to file an IND in its own name; and (ii) any correspondence documents and records (not provided pursuant to (b)(i)) between Novacea Schering and Governmental Regulatory Authorities related to Licensed ProductsProduct in the Field, if any. (c) Other than with respect to the DMF owned by Plantex under the Existing Supply AgreementLicensee shall oversee, Schering shall be solely responsible for overseeing, monitoring monitor and coordinating coordinate all regulatory actions, communications and filings with with, and submissions to, the FDA and other Governmental Regulatory Authorities in the Territory and preparing, submitting and maintaining all Regulatory Applications and health registrations with respect to all Licensed ProductProduct in the Field. (d) Other than with respect to the DMF owned by Plantex under the Existing Supply Agreement, Schering Licensee shall be solely responsible for interfacing, corresponding and meeting with the FDA and other Governmental Regulatory Authorities throughout the Territory with respect to Licensed ProductProduct in the Field. Schering Each Party shall provide Novacea the other Party with copies of any non-routine material correspondence with FDA or other Governmental Regulatory Authorities in the United States, the Major Markets European Countries and Japan relating to approval Regulatory Approval of Licensed Product, within thirty (30) days of any such correspondenceand respond to all reasonable inquiries by the other Party with respect thereto. Schering Each Party shall also provide Novacea the other Party in a timely manner with meeting minutes from any material meetings with Regulatory Authorities in the United States, the Major Markets European Countries and Japan concerning the approval Regulatory Approval of Licensed Product. Schering will Product in the Field. (e) Each Party shall provide Novacea with reasonable advance notice to the other Party a table report on an annual basis that contains the status of any scheduled meeting with the FDA relating to Development of the Licensed Product and/or any Regulatory Application Approvals for the Licensed Product in the United StatesTerritory. (f) In the event that any Regulatory Authority (a) threatens or initiates any action to remove a Licensed Product from the market in any country in the Territory or (b) requires a Party, its Affiliates, or its sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of Licensed Product in the Territory, such Party shall notify the other Party of such event within one (1) Business Day after such Party becomes aware of the action, threat, or requirement (as applicable). The Parties shall consult prior to initiating a recall or withdrawal of Licensed Product in the U.S., Japan, or a Major European Country; provided, however, that the final decision as to whether to recall or withdraw a Licensed Product in the Territory shall be made by (i) Licensee in the Field in its sole discretion, or (ii) Schering outside the Field in its sole discretion. A Party initiating a recall shall be responsible, at its sole expense, for conducting such recalls or taking such other necessary remedial action. (g) Schering’s obligations to provide assistance and support under this Section 4.1 shall not extend beyond Licensee’s initial IND filing date with respect to the Licensed Product in the Field. (h) Schering shall also provide copies of all safety reports with respect to Licensed Product outside of the Field in the Territory.

Regulatory Filings Transfer. (a) Within [*] days Schering covenants that, as of the Effective Date, it does not have any INDs or other Regulatory Applications covering the Licensed Product in the Field in the Territory. After the Effective Date, Licensee or its Affiliates or sublicensee, as applicable, shall hold all INDs and other Regulatory Applications and Regulatory Approvals for Licensed Product in the Field throughout the Territory. Schering shall be the exclusive owner of all INDs and other Regulatory Applications related to the Licensed Compounds and/or Licensed Product outside the Field in the Territory. (b) As soon as practicable after the Effective Date (or such other date as mutually agreed by the Parties), Novacea Schering shall transfer to Schering all existing INDs and other Regulatory Applications that it owns or controls covering the Licensed Product and reasonably assist Schering in obtaining the transfer of such INDs and other Regulatory Applications that it does not own or control. The Parties agree that Novacea will continue to execute ASCENT-2 in accordance with the Core Development Plan, and Schering hereby delegates such responsibility to Novacea. Novacea shall, upon request, timely provide to Schering information and reports related to ASCENT-2 necessary to satisfy Schering’s routine Regulatory Authority reporting obligations. For a period Licensee one (1) electronic copy in Microsoft Word or Adobe Acrobat (whichever format the document is currently available) of at least [*] days after the Effective Date, Novacea will provide, at its own cost and expense and at Schering’s request, necessary information and support to Schering with respect to regulatory correspondence, discussions and meetings between Novacea and Regulatory Authorities that took place prior to the Effective Date. After the Effective Date, other than with respect to the DMF owned by Plantex under the Existing Supply Agreement, (i) all further submissions to any Governmental Authorities relating to such Regulatory Applications and/or INDs or any other Regulatory Applications covering the Licensed Product, shall be [*] = 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. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. owned by, filed by and in the name of Schering or its Affiliates. Schering or its Affiliates shall hold all Regulatory Approvals for Licensed Product throughout the Territory. (b) In accordance with Section 2.4, within forty-five (45) days after the Effective Date (or such other date as mutually agreed by the Parties), Novacea shall transfer to Schering one copy of all material documents and records that have been generated by or on behalf of Novacea Schering with respect to any existing INDs and other Regulatory Applications that it owns or controls covering the Licensed Product in the Territory, as well as Territory sufficient for Eiger to file an IND in its own name; and (ii) any correspondence documents and records (not provided pursuant to (b)(i)) between Novacea Schering and Governmental Regulatory Authorities related to Licensed ProductsProduct in the Field, if any. (c) Other than with respect to the DMF owned by Plantex under the Existing Supply AgreementLicensee shall oversee, Schering shall be solely responsible for overseeing, monitoring monitor and coordinating coordinate all regulatory actions, communications and filings with with, and submissions to, the FDA and other Governmental Regulatory Authorities in the Territory and preparing, submitting and maintaining all Regulatory Applications and health registrations with respect to all Licensed ProductProduct in the Field. [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (d) Other than with respect to the DMF owned by Plantex under the Existing Supply Agreement, Schering Licensee shall be solely responsible for interfacing, corresponding and meeting with the FDA and other Governmental Regulatory Authorities throughout the Territory with respect to Licensed ProductProduct in the Field. Schering Each Party shall provide Novacea the other Party with copies of any non-routine material correspondence with FDA or other Governmental Regulatory Authorities in the United States, the Major Markets European Countries and Japan relating to approval Regulatory Approval of Licensed Product, within thirty (30) days of any such correspondenceand respond to all reasonable inquiries by the other Party with respect thereto. Schering Each Party shall also provide Novacea the other Party in a timely manner with meeting minutes from any material meetings with Regulatory Authorities in the United States, the Major Markets European Countries and Japan concerning the approval Regulatory Approval of Licensed Product. Schering will Product in the Field. (e) Each Party shall provide Novacea with reasonable advance notice to the other Party a table report on an annual basis that contains the status of any scheduled meeting with the FDA relating to Development of the Licensed Product and/or any Regulatory Application Approvals for the Licensed Product in the United StatesTerritory. (f) In the event that any Regulatory Authority (a) threatens or initiates any action to remove a Licensed Product from the market in any country in the Territory or (b) requires a Party, its Affiliates, or its sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of Licensed Product in the Territory, such Party shall notify the other Party of such event within one (1) Business Day after such Party becomes aware of the action, threat, or requirement (as applicable). The Parties shall consult prior to initiating a recall or withdrawal of Licensed Product in the U.S., Japan, or a Major European Country; provided, however, that the final decision as to whether to recall or withdraw a Licensed Product in the Territory shall be made by (i) Licensee in the Field in its sole discretion, or (ii) Schering outside the Field in its sole discretion. A Party initiating a recall shall be responsible, at its sole expense, for conducting such recalls or taking such other necessary remedial action. (g) Schering’s obligations to provide assistance and support under this Section 4.1 shall not extend beyond Licensee’s initial IND filing date with respect to the Licensed Product in the Field. (h) Schering shall also provide copies of all safety reports with respect to Licensed Product outside of the Field in the Territory.