Regulatory Expenses. Article 4.2. notwithstanding, each party shall be solely responsible for all costs and expenses related to obtaining any regulatory approvals which are required prior to beginning its own manufacturing and marketing activities, including without limitation the cost of any samples required to perform preclinical or clinical testing for purposes of obtaining such approval. Should one party request assistance from the other party in obtaining regulatory approvals, then the party requesting such assistance shall reimburse the other party for all costs and expenses reasonably incurred to provide such assistance.
Regulatory Expenses. Mercer shall, upon timely receipt of any information required from the Optionee, use its reasonable efforts to make any required regulatory filings relating to the grant of or exercise of the option granted under this Agreement on behalf of the Optionee. [Signature Page Follows]
Regulatory Expenses. The components of Allowable Expenses shall be calculated in accordance with the applicable definition thereof and the applicable terms of this Agreement, and consistent with the relevant plans and budgets approved from time to time.
Regulatory Expenses. BeiGene shall be responsible for all costs and expenses of preparing, maintaining, formatting, and filing Regulatory Filings for Licensed Products in the Licensed Territory and for maintaining Regulatory Approval for Licensed Products in the Licensed Territory.
Regulatory Expenses. Licensee shall be responsible for all costs and expenses of preparing, coordinating, maintaining, formatting, and filing Regulatory Filings for Licensed Products in the Licensed Territory and for maintaining Regulatory Approval for Licensed Products in the Licensed Territory. Licensee shall be responsible for all costs and expenses of providing English summaries of all information and documents (which are not in English) that Licensee is obligated to provide to Mirati under this Article 6.
Regulatory Expenses. Except with respect to (1) the Designated Clinical Trial, and any other Clinical Trials in the Territory consented to by Licensee pursuant to the last sentence of Section 4.1, and (2) Takeda’s, and any of its Affiliates and sublicensees, and any of their Third Party contractors’ Development or Manufacture activities in the Territory, Licensee shall bear all *** Certain Confidential Information Omitted expenses incurred related to the preparation, maintenance, formatting and filing of the Regulatory Materials in the Field in the Territory.
Regulatory Expenses. Except with respect to (a) any Clinical Trials conducted by Takeda in the Territory consented to by Licensee pursuant to the second sentence of Section 4.1, (b) Takeda’s, and any of its Affiliates and (Sub)licensees, and any of their Third Party contractors’ other Development or Manufacturing activities in the Territory, and (c) any Product IND filing costs required for the performance of the Licensee Japan Development Activities, Licensee shall bear all expenses incurred related to the preparation, maintenance, formatting and filing of the Regulatory Materials in the Field in the Territory and for the Licensee Japan Development Activities in Japan. Except with respect to (i) any Clinical Trials conducted by Licensee outside of the Territory consented to by Takeda pursuant to subsection (b) of the first sentence of Section 4.1, (ii) the Licensee Japan Development Activities (except as otherwise provided in the proceeding sentence), and (iii) Licensee’s, and any of its Affiliates and (Sub)licensees, and any of their Third Party contractors’ other Development or Manufacture activities outside of the Territory, Takeda shall bear all expenses incurred related to the preparation, maintenance, formatting and filing of the Regulatory Materials outside the Territory. Takeda shall reimburse Licensee for any Product IND filing costs required for the performance of the Licensee Japan Development Activities within [***] after receipt of an invoice therefor.
Regulatory Expenses. The Company shall bear any costs associated with the provision of information and other assistance it or the Manager is required to provide to any Government Agency, including without limitation any costs associated with the preparation and filing of financial statements, reports and other information with the SEC.
Regulatory Expenses. The Management Board shall determine the countries in which Regulatory Approval will be sought and the timing of seeking such Regulatory Approval. All expenses incurred to obtain Regulatory Approval are expenses subject to cost sharing under Section 3.5 and shall be part of the Final Project Total Budget, it being understood that Baxtxx'x xxxigation to share expenses for the S59 FFP Project shall be limited as provided in Section 3.3(b)(i); provided, however, that either party may, by notice given to the other party within thirty (30) days after such Management Board decision with respect to a particular country, elect to not share in the costs of Regulatory Approval in not more than five (5) countries outside of North America and Europe, which will result in an adjustment for each such country of Final Project Total Budget (as further provided in the definition of "Final Project Total Budget").
Regulatory Expenses. Except as otherwise expressly provided in this Agreement, (i) each Party will be responsible for the Territory-specific cost of *** Certain confidential information contained in this document, marked with 3 asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Act of 1934, as amended. development, clinical trials, Regulatory Approval Applications, changes to any Regulatory Approvals and ongoing clinical trials, development and post market surveillance required by the Regulatory Authorities relating exclusively to the Indications to which such Party has rights under this Agreement and (ii) the Parties will *** associated with changes to API or CMC for the Product ***. Each Party will be responsible for the costs associated with any Regulatory Approvals and clinical trials, development, and post market surveillance for the Product required by the Regulatory Authorities relating for the Indications they are responsible for that may result from such API or CMC changes to the Product.
