Regulatory Activities. Ono, at its sole cost and expense and in accordance with this Agreement and the requirements of all Applicable Laws, will use Commercially Reasonable Efforts to take all actions necessary to prepare and file all Regulatory Filings with respect to the Products required to obtain and maintain Regulatory Approval for the Products in the Ono Territory. Without limiting the applicability of the foregoing and the remainder of this ARTICLE V, Ono and [[Forty Seven:Organization]], through the JSC, will keep the other Party reasonably informed of all material events and developments occurring in the course of obtaining Regulatory Approval in its own Territory. Neither Party shall file any Regulatory Filings for Products in the other Party’s Territory, except as reasonably necessary for [[Forty Seven:Organization]] to fulfill its Manufacturing and supply obligations hereunder or as expressly permitted under [Section 2.6.2 or 2.7.2]2].

Regulatory Activities. Janssen will be responsible for the submission of Regulatory Filings and hold the INDs relating to the Licensed Constructs and Licensed Products in the Territory. Janssen will be responsible for maintaining all Regulatory Filings including all INDs, for each Licensed Construct and/or Licensed Product in the Territory.

The Development Plan shall set forth the regulatory strategy for seeking Regulatory Approval for the Compound and Products by the appropriate Regulatory Authorities in the Licensee Territory and Ovid Territory. Subject to the oversight of the CGB and except as otherwise set forth in the Development Plan and the remainder of this [Section 5.1(a)(i)], each Party shall be responsible for implementing such regulatory strategy in its territory. The Development Plan shall also specify which Party shall apply for and hold Regulatory Filings in each country with respect to the conduct of Development activities, provided that # Ovid shall apply for and hold all Regulatory Filings and Regulatory Approvals for the Ovid Ongoing Trials

Regulatory Activities. Atara shall be solely responsible, at Atara’s expense, for preparing all submissions to any regulatory authority and making all regulatory filings in the Territory in relation to CTL Products arising from # activities conducted with respect to the Allogeneic CTL Programs, # activities conducted with respect to the Autologous CTL Programs, and # New CTL Products and Program [ * ] arising out of New Research Programs conducted hereunder, in each case in accordance with [Section 5.5] of the License Agreement. Institute was solely responsible at Institute’s expense, for preparing all submissions to any regulatory authority and making all regulatory filings in the Territory in relation to CTL Products arising from activities conducted with respect to the Autologous CTL Programs prior to the exercise of the Option pursuant to Section 2.2 of the License Agreement.

Regulatory Activities. Catalyst shall be responsible for submitting the INDs and NDAs for all indications for the Product in the Territory, and ISU shall be responsible for submitting any INDs and NDAs for all indications for the Product in [[Address B:Address]], provided that ISU shall # promptly deliver to Catalyst all material correspondence regarding any Product received from the Ministry of Food and Drug Safety (“MFDS”), # consult with Catalyst regarding the responses to any such correspondence or with respect to any anticipated material filings or submissions to MFDS and # allow Catalyst to participate in any in-person meetings with MFDS regarding any Product. As between the Parties, Catalyst shall own all right, title and interest in all INDs and other regulatory filings designed to obtain or support Regulatory Approval in the Territory, and ISU shall own all right, title and interest in all INDs and other regulatory filings designed to obtain or support Regulatory Approval in [[Address B:Address]].

Regulatory Activities. As of the Effective Date, Coya, directly or through any Affiliates or Sublicensees, shall have the sole right to prepare, obtain and maintain all INDs, Regulatory Approval Applications (including the setting of the overall regulatory strategy therefor), other Regulatory Approvals, Pricing Approvals and other submissions and to conduct communications with the Regulatory Authorities and Governmental Authorities in the Territory for the Products. ARScience Bio shall cooperate with Coya as may be reasonably necessary in preparing and filing INDs and obtaining Regulatory Approvals and Pricing Approvals for the Products and in the activities in support thereof.

Regulatory Activities. Atara shall be solely responsible, at Atara’s expense, for preparing all submissions to any regulatory authority and making all regulatory filings in the Territory in relation to CTL Products arising from # activities conducted with respect to the Allogeneic CTL Programs, # activities conducted with respect to the Autologous CTL Programs, and # New CTL Products and Program ​ arising out of New Research Programs conducted hereunder, in each case in accordance with [Section 5.5] of the License Agreement. Institute was solely responsible at Institute’s expense, for preparing all submissions to any regulatory authority and making all regulatory filings in the Territory in relation to CTL Products arising from activities conducted with respect to the Autologous CTL Programs prior to the exercise of the Option pursuant to Section 2.2 of the License Agreement.

The Development Plan shall set forth the regulatory strategy for seeking Regulatory Approval for the Compound and Products by the appropriate Regulatory Authorities in the Licensee Territory and Ovid Territory. Subject to the oversight of the CGB and except as otherwise set forth in the Development Plan and the remainder of this [Section 5.1(a)(i)], each Party shall be responsible for implementing such regulatory strategy in its territory. The Development Plan shall also specify which Party shall apply for and hold Regulatory Filings in each country with respect to the conduct of Development activities, provided that # Ovid shall apply for and hold all Regulatory Filings and Regulatory Approvals for the Ovid Ongoing Trials and Ovid’s Independent Development Activities and # Licensee shall apply for and hold all Regulatory Filings for the Licensee Territory arising from the Licensee Territory Development Activities, Licensee’s Independent Development Activities, and Joint Development Activities. Except as otherwise provided herein or in the Development Plan or required by Applicable Law, each Party shall # be responsible for the preparation and submission of any and all Product Certain identified information marked with ​ has been excluded from the exhibit because it is both not material and is the type that the registrant treats as private or confidential.

Regulatory Activities. Catalyst shall be responsible for submitting the INDs and NDAs for all indications for the Product in the Territory, and ISU shall be responsible for submitting any INDs and NDAs for all indications for the Product in [[Address B:Address]], provided that ISU shall # promptly deliver to Catalyst all material correspondence regarding any Product received from the Ministry of Food and Drug Safety (“MFDS”), # consult with Catalyst regarding the responses to any such correspondence or with respect to any anticipated material filings or submissions to MFDS and # allow Catalyst to participate in any in-person meetings with MFDS regarding any Product. As between the Parties, Catalyst shall own all right, title and interest in all INDs and other regulatory filings designed to obtain or support Regulatory Approval in the Territory, and ISU shall own all right, title and interest in all INDs and other regulatory filings designed to obtain or support Regulatory Approval in [[Address B:Address]].

Regulatory Activities. [[Savara:Organization]] shall be responsible for conducting all Development activities related to regulatory filings for the Initial Indication and any Additional Indications in the USA and the EU and shall use Diligent Efforts to obtain and support Regulatory Approval for such Initial Indication and any Additional Indications of the Licensed Product in the USA and the EU. Subject to Section 13.2 of this Agreement, [[Savara:Organization]] shall conduct a new Phase 3 clinical trial (as that term is defined in 21 C.F.R. §312.21(c)) on the Initial Indication and complete such Phase 3 clinical trial – and the results of that Phase 3 clinical trial made available to [[Grifols:Organization]] – within five (5) years from the Effective Date of this Agreement. Notwithstanding the foregoing, if such Phase 3 clinical trial is “on-going” on the fifth (5th) anniversary of the Effective Date and [[Savara:Organization]], in accordance with this Section 4.1, has used Diligent Efforts to conduct such Phase 3 clinical trial, such period shall be extended for as long as is reasonably necessary to complete such Phase 3 clinical trial, with such additional period to not to exceed two (2) years. For the purposes of the preceding sentence, a Phase 3 clinical trial shall be “on-going” if such Phase 3 clinical trial has already concluded the enrollment of subjects in such trial or enrolled at least two hundred (200) subjects in such trial. In addition, [[Savara:Organization]] shall be responsible, for submitting the NDAs for all Licensed Products in such other countries selected by [[Savara:Organization]], provided that [[Savara:Organization]] shall use Diligent Efforts to submit NDAs to the FDA in the USA and to the EMA in the EU for the Initial Indication in accordance with this Agreement. In all countries in the Territory, [[Savara:Organization]] shall be solely responsible for all regulatory matters and for maintaining all NDAs and other regulatory approvals. [[Savara:Organization]] shall use Diligent Efforts to file and, subject to Section 11.6, [[Savara:Organization]] shall own all right, title and interest in all Regulatory Materials designed to obtain or support such Regulatory Approval. If any Regulatory Authority requires [[Grifols:Organization]] consent or participation or otherwise seeks to inquire with [[Grifols:Organization]] with respect to any Regulatory Approval of a Licensed Product, then [[Savara:Organization]] hereby grants to [[Grifols:Organization]] effective on the date of [[Savara:Organization]]’s written notification from such Regulatory Authority of such requirement or inquiry, an exclusive, fully-paid license to use the Regulatory Materials in the Territory solely as necessary to respond to such Regulatory Authority.