Common use of Transfer of Regulatory Filings and Regulatory Approvals Clause in Contracts

Transfer of Regulatory Filings and Regulatory Approvals. Following the effectiveness of any termination of this Agreement pursuant to Section 12.3 (Early Termination), after Lyra’s written request, Lian will, to the extent permitted under applicable Laws and not commercially infeasible, and at Lyra’s sole cost and expense (unless the applicable termination giving rise to Lyra’s rights under this Section 12.5(h) (Transfer of Regulatory Filings and Regulatory Approvals) was for Lian’s material breach pursuant to Section 12.3(a) (Termination for Material Breach), in which case such transfer will be at Lian’s sole cost and expense), assign and transfer to Lyra all Regulatory Filings, filings for Pricing and Reimbursement Approval and Marketing Authorizations for Licensed Products that are held by or owned by Lian or its Affiliates or Sublicensees as of the effective date of termination and will take such actions and execute such other instruments, assignments, and documents as may be necessary to effect the transfer of rights under such Regulatory Filings, filings for Pricing and Reimbursement Approval and Marketing Authorizations to Lyra. If applicable Laws or relevant Regulatory Authorities prevent or delay the transfer of ownership of any such Regulatory Filing, filing for Pricing and Reimbursement Approval and Marketing Authorizations to Lyra, or if it is commercially infeasible for Lian to do so, then Lian will grant, and hereby does grant, to Lyra and its Affiliates, Sublicensees, and licensees an exclusive and irrevocable right of access and right of reference to such Regulatory Filing, filing for Pricing and Reimbursement Approval and Marketing Authorizations for Licensed Products in the Field in the Territory, as the case may be, and will reasonably cooperate with Lyra, at Lyra’s expense (unless the applicable termination giving rise to Lyra’s rights under this Section 12.5(h) (Transfer of Regulatory Filings and Regulatory Approvals) was for Lian’s material breach pursuant to Section 12.3(a) (Termination for Material Breach) in which case such transfer will be at Lian’s sole cost and expense), to make the benefits of such Regulatory Filings, filings for Pricing and Reimbursement Approval and Marketing Authorizations available to Lyra or its designee(s).

Appears in 2 contracts

Samples: License and Collaboration Agreement (Lyra Therapeutics, Inc.), License and Collaboration Agreement (LianBio)

AutoNDA by SimpleDocs

Transfer of Regulatory Filings and Regulatory Approvals. Following Promptly following the effectiveness of any termination of this Agreement by AVEO pursuant to Section 12.3 (Early Termination), after Lyra’s written request, Lian will, to the extent permitted under applicable Laws and not commercially infeasible, and at Lyra’s sole cost and expense (unless the applicable termination giving rise to Lyra’s rights under this Section 12.5(h) (Transfer of Regulatory Filings and Regulatory Approvals) was for Lian’s material breach pursuant to Section 12.3(a) 12.2.1 (Termination for Material Breach) or by CANbridge pursuant to Section 12.2.2 (Termination by CANbridge for Convenience), in which case such transfer will be or by AVEO pursuant to Section 12.2.3 (Termination by AVEO) or Section 12.2.4 (Termination for Challenge) and upon AVEO’s written request, CANbridge will, at LianCANbridge’s sole cost and expense), assign and transfer to Lyra AVEO all Regulatory Filings, filings for Pricing and Reimbursement Approval and Marketing Authorizations for Licensed Products that are held by or owned by Lian under authority of CANbridge or its Affiliates or Sublicensees as of the effective date of termination termination, with respect to the terminated country or the Licensed Territory, as the case may be, and will take such actions and execute such other instruments, assignments, assignments and documents as may be necessary to effect the transfer of rights under such Regulatory Filings, filings for Pricing and Reimbursement Approval and Marketing Authorizations to LyraAVEO. If applicable Laws Law prevents or relevant Regulatory Authorities prevent or delay delays the transfer of ownership of any such Regulatory Filing, filing for Pricing and Reimbursement Approval and or Marketing Authorizations to LyraAVEO, or if it is commercially infeasible for Lian to do so, then Lian CANbridge will grant, and does hereby does grant, to Lyra and its Affiliates, Sublicensees, and licensees AVEO an exclusive and irrevocable right of access and right of reference to such Regulatory Filing, filing for Pricing and Reimbursement Approval and Marketing Authorizations for Licensed the Products in the Field in Licensed Territory or the Territoryterminated country, as the case may be, and will reasonably cooperate with Lyra, at Lyra’s expense (unless the applicable termination giving rise to Lyra’s rights under this Section 12.5(h) (Transfer of Regulatory Filings and Regulatory Approvals) was for Lian’s material breach pursuant to Section 12.3(a) (Termination for Material Breach) in which case such transfer will be at Lian’s sole cost and expense), to make the benefits of such Regulatory Filings, filings for Pricing and Reimbursement Approval and Marketing Authorizations available to Lyra AVEO or its designee(s). AVEO will have the right to grant licenses or sublicenses (as applicable) under the rights granted to it under this Section 12.3.4 (Transfer of Regulatory Filings and Regulatory Approvals) to its Affiliates and Third Parties, through multiple tiers.

Appears in 1 contract

Samples: Collaboration and License Agreement (Aveo Pharmaceuticals Inc)

Transfer of Regulatory Filings and Regulatory Approvals. Following the effectiveness of any termination of this Agreement pursuant to Section 12.3 (Early Termination)12.3, as promptly as practicable after LyraCompany’s written request, Lian Licensee will, to the extent permitted under applicable Laws and not commercially infeasible, and at LyraCompany’s sole cost and expense (unless the applicable termination giving rise to LyraCompany’s rights under this Section 12.5(h) (Transfer of Regulatory Filings and Regulatory Approvals12.4(g) was for LianLicensee’s material breach pursuant to Section 12.3(a) (Termination for Material Breach), in which case such transfer will be at LianLicensee’s sole cost and expense), assign and transfer to Lyra Company all Regulatory Filings, filings for Pricing and Reimbursement Approval and Marketing Authorizations for Licensed Products that are held by or owned by Lian Licensee or its Affiliates or Sublicensees as of the effective date of termination termination, with respect to the terminated Region, as the case may be, and will take such actions and execute such other instruments, assignments, assignments and documents as may be necessary to effect the transfer of rights under such Regulatory Filings, filings for Pricing and Reimbursement Approval and Marketing Authorizations to LyraCompany. If applicable Laws or relevant Regulatory Authorities prevent or delay the transfer of ownership of any such Regulatory Filing, filing for Pricing and Reimbursement Approval and Marketing Authorizations to Lyra, Company or if it is commercially infeasible for Lian Licensee to do so, then Lian Licensee will grant, and hereby does grant, to Lyra and its Affiliates, Sublicensees, and licensees Company an exclusive and irrevocable right of access and right of reference to such Regulatory Filing, filing for Pricing and Reimbursement Approval and Marketing Authorizations for Licensed Products in the Field in the TerritoryTerritory or the terminated Region, as the case may be, and will reasonably cooperate with LyraCompany, at LyraCompany’s expense (unless the applicable termination giving rise to LyraCompany’s rights under this Section 12.5(h) (Transfer of Regulatory Filings and Regulatory Approvals12.4(g) was for LianLicensee’s material breach pursuant to Section 12.3(a) (Termination for Material Breach) ), in which case such transfer will be at LianLicensee’s sole cost and expense), to make the benefits of such Regulatory Filings, filings for Pricing and Reimbursement Approval and Marketing Authorizations available to Lyra Company or its designee(s).

Appears in 1 contract

Samples: Exclusive License Agreement (LianBio)

Transfer of Regulatory Filings and Regulatory Approvals. Following the effectiveness of any termination of this Agreement pursuant to Section 12.3 (Early Termination)Agreement, as promptly as practicable after LyraCompany’s written request, Lian Licensee will, to the extent permitted under applicable Laws and not commercially infeasibleLaws, and at LyraLicensee’s sole cost and expense (unless the applicable termination giving rise to Lyra’s rights under this Section 12.5(h) (Transfer of Regulatory Filings and Regulatory Approvals) it was for Lian’s material breach terminated by Licensee pursuant to Section 12.3(a) (Termination for Material Breachor Section 12.3(d), in which case such transfer will be at LianCompany’s sole cost and expense), assign and transfer to Lyra Company all Regulatory Filings, filings for Pricing and Reimbursement Approval and Marketing Authorizations for Licensed Products that are held by or owned by Lian Licensee or its Affiliates or Sublicensees as of the effective date of termination termination, with respect to the terminated Region, as the case may be, and will take such actions and execute such other instruments, assignments, assignments and documents as may be necessary to effect the transfer of rights under such Regulatory Filings, filings for Pricing and Reimbursement Approval and Marketing Authorizations to LyraCompany. If applicable Laws or relevant Regulatory Authorities prevent or delay the transfer of ownership of any such Regulatory Filing, filing for Pricing and Reimbursement Approval and Marketing Authorizations to Lyra, Company or if it is commercially infeasible for Lian Licensee to do so, then Lian Licensee will grant, and hereby does grant, to Lyra and its Affiliates, Sublicensees, and licensees Company an exclusive and irrevocable right of access and right of reference to such Regulatory Filing, filing for Pricing and Reimbursement Approval and Marketing Authorizations for Licensed Products in the Field in Territory or the Territoryterminated Region, as the case may be, and will reasonably cooperate with LyraCompany, at LyraLicensee’s expense (unless the applicable termination giving rise to Lyra’s rights under this Section 12.5(h) (Transfer of Regulatory Filings and Regulatory Approvals) it was for Lian’s material breach terminated by Licensee pursuant to Section 12.3(a) (Termination for Material Breach) or Section 12.3(d), in which case such transfer grant of access and right of reference and cooperation will be at LianCompany’s sole cost and expense), to make the benefits of such Regulatory Filings, filings for Pricing and Reimbursement Approval and Marketing Authorizations available to Lyra Company or its designee(s).

Appears in 1 contract

Samples: Exclusive License Agreement (LianBio)

AutoNDA by SimpleDocs

Transfer of Regulatory Filings and Regulatory Approvals. Following the effectiveness of any termination of this Agreement pursuant to Section 12.3 (Early Termination)14.3, as promptly as practicable after LyraSutro’s written request, Lian BioNova will, to the extent permitted under applicable Laws and not commercially infeasible, and at LyraSutro’s sole cost and expense (unless the applicable termination giving rise to LyraSutro’s rights under this Section 12.5(h) (Transfer of Regulatory Filings and Regulatory Approvals14.4(g) was for LianBioNova’s material breach pursuant to Section 12.3(a) (Termination for Material Breach14.3(a), in which case such transfer will be at LianBioNova’s sole cost and expense), assign and transfer to Lyra Sutro all Regulatory Filings, filings for Regulatory Approvals, Pricing and Reimbursement Approval Approvals and Marketing Authorizations for Licensed Products that are held by or owned by Lian BioNova or its Affiliates or its or their Sublicensees as of the effective date of termination termination, with respect to the terminated Region, as the case may be, and will take such actions and execute such other instruments, assignments, assignments and documents as may be necessary to effect the transfer of rights under such Regulatory Filings, filings for Regulatory Approvals, Pricing and Reimbursement Approval Approvals and Marketing Authorizations to LyraSutro. If applicable Laws or relevant Regulatory Authorities prevent or delay the transfer of ownership of any such Regulatory Filing, filing for Regulatory Approvals, Pricing and Reimbursement Approval Approvals and Marketing Authorizations to Lyra, Sutro or if it is commercially infeasible for Lian BioNova to do so, then Lian BioNova will grant, and hereby does grant, to Lyra and Sutro, its Affiliates, Sublicensees, Sublicensees and licensees (other than BioNova) an exclusive and irrevocable right of access and right of reference to such Regulatory Filing, filing for Regulatory Approvals, Pricing and Reimbursement Approval Approvals and Marketing Authorizations for Licensed Products in the Field in the TerritoryTerritory or the terminated Region, as the case may be, and will reasonably cooperate with LyraSutro, at LyraSutro’s expense (unless the applicable termination giving rise to LyraSutro’s rights under this Section 12.5(h) (Transfer of Regulatory Filings and Regulatory Approvals14.4(g) was for LianBioNova’s material breach pursuant to Section 12.3(a) (Termination for Material Breach) 14.3(a), in which case such transfer will be at LianBioNova’s sole cost and expense), to make the benefits of such Regulatory Filings, filings for Regulatory Approvals, Pricing and Reimbursement Approval Approvals and Marketing Authorizations available to Lyra Sutro or its designee(s).

Appears in 1 contract

Samples: Option and License Agreement (Sutro Biopharma, Inc.)

Time is Money Join Law Insider Premium to draft better contracts faster.