Ownership of Approvals. All Approval Applications, Approvals, supporting documentation and data relating to the Product shall be the solely owned property of Novartis and shall be treated by the Parties as Confidential Information.
Ownership of Approvals. All Permits obtained pursuant to Section 4.1.1 shall be owned and controlled by System Owner. To the extent that any such Permits must be obtained or owned by Host Customer, Host Customer agrees that it shall cooperate with System Owner with respect to such Permits.
Ownership of Approvals. Ownership of the approvals shall reside with ---------------------- the party responsible for obtaining and maintaining the regulatory approvals.
Ownership of Approvals. Tutogen shall be the record owner of all ---------------------- regulatory approvals to sell Products in the Territory and for the Field of Use.
Ownership of Approvals. Tutogen shall be the record owner of all FDA ---------------------- approvals to make regulated Processed Tissues available in the Territory for the Field of Use.
Ownership of Approvals. REPLIDYNE shall own and control all Regulatory Approvals and applications, amendments or supplements underlying any such Regulatory Approval. It is expressly understood that the Drug Master File for the Drug Substance shall be registered and controlled by DSP and/or NISSO and DSP and/or NISSO shall give a reference letter to the Regulatory Authorities in connection with REPLIDYNE’s efforts in seeking Regulatory Approvals and submitting any such applications, amendments, or supplements for Drug Products.
Ownership of Approvals. The parties agree that Xxxxxx may be ---------------------- ------ applied for and obtained in Nippon Eurotec's name, and if so, that Nippon Eurotec shall hold such Xxxxxx solely for the benefit of Natus ------ subject to the terms of this Agreement. Nippon Eurotec agrees that at Natus's unilateral request, Nippon Eurotec shall take all actions required to transfer Product Xxxxxx to Natus or its nominee, and at ------ such time Nippon Eurotec shall be reimbursed for its direct out-of- pocket expenses in connection with each Product Xxxxxx obtained by ------ Nippon Eurotec in an amount [***] to [***] by a number the [***] of which shall be the [***] of this Agreement and the [***] of which shall be the number of [***] in the [***] of this Agreement. Notwithstanding the foregoing, Nippon Eurotec shall not be reimbursed for its expenses if this Agreement is terminated (i) by Natus for Nippon Eurotec's breach; (ii) by expiration of this Agreement; or (iii) by Natus for Nippon Eurotec's inability to obtain Xxxxxx under ------ this section.
Ownership of Approvals. Section 10.2.1 All permits and approvals obtained shall be owned and controlled by Service Provider. To the extent that any such permits or approvals must be obtained and/or held by Host Customer, then Host Customer agrees that it will grant all material decision-making rights with respect to such permits and approvals to Service Provider and will fully cooperate in the process of obtaining such permits. Host Customer shall grant, convey, or transfer any and all easements or rights of way as may be deemed issued to the Service Provider as necessary for obtaining such permits.
Ownership of Approvals. BIOMARIN shall own and control all Regulatory Approvals and applications, amendments or supplements underlying any such Regulatory Approval. DSP shall cause SHIRATORI to provide BIOMARIN with such reasonable assistance as BIOMARIN may require in completing portions of applications for Regulatory Approval, or amendments or supplements related thereto, related to the manufacture of Drug Substance.
Ownership of Approvals. All Approval Applications and Approvals relating to a Product in the Territory shall be held by FOREST; and together with the supporting documentation and data shall be treated by the Parties as Confidential Information. Unless already in the possession of ALMIRALL, FOREST shall provide ALMIRALL with a copy of all documentation submitted to the FDA, including a copy of the Approval documentation. ALMIRALL shall have the right to freely use all information and documentation relating to all Approval Applications and Approvals relating to LAS Monotherapy Products and Combination Products in the countries not included in the Territory. The IND held by ALMIRALL as of the date of this Agreement shall be transferred to FOREST, as soon as reasonably practicable, when so decided by the Joint Development Committee with the intent to avoid any delays in the regulatory strategy in the Territory.
