Common use of Ownership of and Assistance with Regulatory Filings Clause in Contracts

Ownership of and Assistance with Regulatory Filings. If requested by Biogen, Ionis’ and Biogen’s regulatory teams will meet and begin to prepare a plan, which plan will be complete no later than [***] prior to such anticipated filing date, for drafting and reviewing the sections of the NDA and MAA for the applicable Product (including establishing responsibilities for drafting and reviewing common technical document (“CTD”) modules, authorship, plan activity timelines and associated costs and expenses) to ensure a smooth transition to Biogen, accelerate CTD completion and facilitate rapid NDA and MAA filing. The Parties will act in good faith and mutually agree upon each such plan; provided, however, that after exercising an Option for the applicable Collaboration Program, Biogen will have final decision-making authority with respect to the [***]. Once such plan is complete, each Party will use Commercially Reasonable Efforts to execute their respective tasks and responsibilities under such plan in the time frames set forth in such plan. After the License Effective Date for a particular Collaboration Program, if Biogen requests, Ionis will assist Biogen in preparing regulatory filings for the Product, under terms negotiated in good faith between Ionis and Biogen, including payment for Ionis’ time at Ionis’ then applicable FTE Rate plus any reasonable out of pocket expenses incurred by Ionis in providing such assistance.

Ownership of and Assistance with Regulatory Filings. If requested by Biogen, Ionis’ and Biogen’s regulatory teams will meet and begin to prepare a plan, which plan will be complete completed no later than [***] prior to such anticipated filing date, for drafting and reviewing the sections of the NDA and MAA for the applicable Collaboration Product (including establishing responsibilities for drafting and reviewing common technical document (“CTD”) modules, authorship, plan activity timelines and associated costs and expenses) and assigning all necessary filings with any Regulatory Authority related to the applicable Collaboration Product to Biogen to ensure a smooth transition to Biogen, accelerate CTD completion and facilitate rapid NDA and MAA filing. Each CTD will be consistent with the Specific Performance Milestone Events for the applicable Collaboration Program. The Parties regulatory teams will submit such plan to the CSC, if still active. The Parties will act in good faith and mutually agree upon each such plan; , provided, however, that that, after exercising an Option for the applicable Collaboration Program, Biogen will have final decision-making authority with respect to the [***]. Once such plan is complete, each Party will use Commercially Reasonable Efforts to execute their respective tasks and responsibilities under such plan in the time frames set forth in such plan. After the License Effective Date exercising an Option for a particular Collaboration Program, if Biogen requests, Ionis will assist Biogen in preparing regulatory filings for the Collaboration Product, under terms negotiated in good faith between Ionis and Biogen, including payment for Ionis’ time at Ionis’ then applicable FTE Rate plus any reasonable out of pocket expenses incurred by Ionis in providing such assistance, utilizing the payment mechanism set forth in Section 1.14.1.

Ownership of and Assistance with Regulatory Filings. If requested by Biogen[***] prior to the date on which Biogen Idec reasonably anticipates filing an NDA or MAA covering the Product, IonisIsis’ and BiogenBiogen Idec’s regulatory teams will meet and begin to prepare a plan, which plan will be complete no later than [***] prior to such anticipated filing date, for drafting and reviewing the sections of the NDA and MAA for the applicable Product (including establishing responsibilities for drafting and reviewing common technical document (“CTD”) modules, authorship, plan activity timelines and associated costs and expenses) to ensure a smooth transition to BiogenBiogen Idec, accelerate CTD completion and facilitate rapid NDA and MAA filing. The Parties will act in good faith and mutually agree upon each such a plan; , provided, however, that that, after exercising an Option for the applicable Collaboration Programexercise, Biogen Idec will have final decision-decision making authority with respect to the [***]. Once such plan is complete, each Party will use Commercially Reasonable Efforts to execute their respective tasks and responsibilities under such plan in the time frames set forth in such plan. After the License Effective Date for a particular Collaboration ProgramOption exercise, if Biogen Idec requests, Ionis Isis will assist Biogen Idec in preparing regulatory filings for the Product, under terms negotiated in good faith between Ionis Isis and BiogenBiogen Idec, including payment for IonisIsis’ time at IonisIsis’ then applicable FTE Rate plus any reasonable out of pocket expenses incurred by Ionis Isis in providing such assistance.

Ownership of and Assistance with Regulatory Filings. If requested by Biogen, Ionis’ and Biogen’s regulatory teams will meet and begin to prepare a plan, which plan will be complete completed no later than [***] prior to such anticipated filing date, for drafting and reviewing the sections of the NDA and MAA for the applicable Collaboration Product (including establishing responsibilities for drafting and reviewing common technical document (“CTD”) modules, authorship, plan activity timelines and associated costs and expenses) and assigning all necessary filings with any Regulatory Authority related to the applicable Collaboration Product to Biogen to ensure a smooth transition to Biogen, accelerate CTD completion and facilitate rapid NDA and MAA filing. Each CTD will be consistent with the Specific Performance Milestone Events for the applicable Collaboration Program. The Parties regulatory teams will submit such plan to the CSC, if still active. The Parties will act in good faith and mutually agree upon each such plan; , provided, however, that that, after exercising an Option for the applicable Collaboration Program, Biogen will have final decision-decision making authority with respect to the [***]. Once such plan is complete, each Party will use Commercially Reasonable Efforts to execute their respective tasks and responsibilities under such plan in the time frames set forth in such plan. After the License Effective Date exercising an Option for a particular Collaboration Program, if Biogen requests, Ionis will assist Biogen in preparing regulatory filings for the Collaboration Product, under terms negotiated in good faith between Ionis and Biogen, including payment for Ionis’ time at Ionis’ then applicable FTE Rate plus any reasonable out of pocket expenses incurred by Ionis in providing such assistance, utilizing the payment mechanism set forth in Section 1.14.1.

Ownership of and Assistance with Regulatory Filings. If requested by BiogenBiogen Idec, IonisIsis’ and BiogenBiogen Idec’s regulatory teams will meet and begin to prepare a plan, which plan will be complete no later than [***] prior to such anticipated filing date, for drafting and reviewing the sections of the NDA and MAA for the applicable Collaboration Product (including establishing responsibilities for drafting and reviewing common technical document (“CTD”) modules, authorship, plan activity timelines and associated costs and expenses) to ensure a smooth transition to BiogenBiogen Idec, accelerate CTD completion and facilitate rapid NDA and MAA filing. Each CTD will be consistent with the Specific Performance Milestone Events for the applicable Collaboration Program. The Parties regulatory teams will submit such plan to the CSC, if still active. The Parties will act in good faith and mutually agree upon each such plan; , provided, however, that that, after exercising an Option for the applicable Collaboration Program, Biogen Idec will have final decision-decision making authority with respect to the [***]. Once such plan is complete, each Party will use Commercially Reasonable Efforts to execute their respective tasks and responsibilities under such plan in the time frames set forth in such plan. After the License Effective Date exercising an Option for a particular Collaboration Program, if Biogen Idec requests, Ionis Isis will assist Biogen Idec in preparing regulatory filings for the Collaboration Product, under terms negotiated in good faith between Ionis Isis and BiogenBiogen Idec, including payment for IonisIsis’ time at IonisIsis’ then applicable FTE Rate plus any reasonable out of pocket expenses incurred by Ionis Isis in providing such assistance, utilizing the payment mechanism set forth in Section 1.14.

Ownership of and Assistance with Regulatory Filings. If requested by BiogenBiogen Idec, IonisIsis’ and BiogenBiogen Idec’s regulatory teams will meet and begin to prepare a plan, which plan will be complete no later than [***] prior to such anticipated filing date, for drafting and reviewing the sections of the NDA and MAA for the applicable Product (including establishing responsibilities for drafting and reviewing common technical document (“CTD”) modules, authorship, plan activity timelines and associated costs and expenses) to ensure a smooth transition to BiogenBiogen Idec, accelerate CTD completion and facilitate rapid NDA and MAA filing. The Parties will act in good faith and mutually agree upon each such plan; , provided, however, that that, after exercising an Option for the applicable Collaboration Program, Biogen Idec will have final decision-decision making authority with respect to the [***]. Once such plan is complete, each Party will use Commercially Reasonable Efforts to execute their respective tasks and responsibilities under such plan in the time frames set forth in such plan. After the License Effective Date exercising an Option for a particular Collaboration Program, if Biogen Idec requests, Ionis Isis will assist Biogen Idec in preparing regulatory filings for the Product, under terms negotiated in good faith between Ionis Isis and BiogenBiogen Idec, including payment for IonisIsis’ time at IonisIsis’ then applicable FTE Rate plus any reasonable out of pocket expenses incurred by Ionis Isis in providing such assistance.