Development and Regulatory Approval Clause Samples
Development and Regulatory Approval. NewCo shall use Commercially Reasonable Efforts to develop, and to file for and seek to obtain Regulatory Approval for Royalty-Bearing Products in and for the United States and for Royalty-Bearing Products other than the Servier Products, the European Union (including for such purpose, the United Kingdom), which such obligation shall remain in effect until the tenth anniversary of the Closing Date.
Development and Regulatory Approval. 6.01 Without limiting the rights granted in Article 2 above, Sunesis shall have the right and obligation to take at its sole expense, risk and responsibility, or have its Affiliates and/or the Sublicensees take at their expense, risk and responsibility, either by itself or themselves or through its or their designee, all necessary steps for securing and maintaining the Regulatory Approval and carrying out the Tests. Sunesis shall undertake, or have its Affiliates and/or the Sublicensees undertake, such activities in accordance with Articles 6 and 14 and any applicable laws or regulations in the Territory. Dainippon shall have no obligation to carry out any Test, and Sunesis agrees that no Test will be carried out by Dainippon.
6.02 Promptly after the Effective Date, Dainippon shall supply Sunesis at no additional cost to Sunesis with all quantities of the Compounds and intermediates as are available to Dainippon as of the Effective Date as set forth in Schedule 6.02 attached hereto. Dainippon shall have no obligation to synthesize nor manufacture any further Compounds including any intermediates thereof, and Sunesis agrees that no further Compounds including any intermediates thereof will be synthesized nor manufactured by Dainippon.
6.03 Sunesis has provided Dainippon with its preliminary development plan for the Compounds and the Products as set forth in Schedule 6.03 attached hereto. Sunesis shall provide Dainippon with a draft of the development plan for the Compounds and the Products within six (6) months after the Effective Date, and with a draft of the update annually to the extent the plans have been updated; provided that if the development plan has not been updated in such annual reporting period, Sunesis shall so state. Dainippon shall review, and may comment on, the draft of the development plan and the update thereof, and the parties may discuss such comments and plans.
6.04 Sunesis shall, promptly after they become available to Sunesis, provide Dainippon with a copy of the letter of approval and the summary of product characteristic/package insert. In addition, Sunesis shall, upon reasonable notice, provide Dainippon with (i) the initial IND package for the United States of America in written and/or computerized form, and (ii) electronic copies of the NDAs filed in the Major Market Countries, to the extent such copies exist in electronic format, in each case subject to Section 19.03 below and to the extent Sunesis has the right to provide the...
Development and Regulatory Approval. The Company shall consult with Buyer with respect to any activities undertaken after the date hereof and prior to the Closing relating to any pre-clinical testing or clinical trials of the Milestone Product. Without limiting the foregoing, the Company shall not, without ▇▇▇▇▇’s prior written consent (not to be unreasonably withheld) make any material modification to, or materially deviate from, the Development and Regulatory Plan for development of the Milestone Product. Section 7.9.
Development and Regulatory Approval. Purchaser shall, either itself or through its Affiliates, licensees (including the Existing Licensees) or sublicensees, use Diligent Efforts to develop and manufacture the Product and to pursue the Regulatory Milestone Events set forth in Table A of Section 3.1(a).
Development and Regulatory Approval. OF THE PRODUCTS 17 SECTION 4 – COMMERCIALIZATION 18
Development and Regulatory Approval. (a) Licensor will develop the Licensed Product and the Licensed Process for commercialization at Licensor's sole and complete expense including the research, planning, development and manufacture of prototypes and finished product working models of all Licensed Product using the Licensed Process and the Technology to be sold to Licensee or any Sublicensee. Licensor shall also be responsible for all costs of obtaining all regulatory and governmental permits and authorizations as may be required.
(b) Licensee shall control the process for obtaining marketing licenses and approvals for the Licensed Product and the Licensed Process. Licensee shall bear the complete costs for obtaining the regulatory and marketing approvals for the Licensed Product and the Licensed Process including all costs arising out of or related to modifying or altering any machine after it has been manufactured to conform to said requirements.
(c) Licensor will in good faith participate in and provide necessary information, and data which may be necessary for obtaining regulatory and/or marketing approvals for the Licensed Product and the Licensed Process, and Licensee agrees to reimburse Licensor for all commercially reasonable expense incurred by such participation; provided, however, that all regulatory licenses and approvals that require modifications to the prototypes or any existing Licensed Products shall future be at the sole cost and expense of the Licensor.
Development and Regulatory Approval. (a) Licensor will develop the Licensed Process for commercialization at Licensor's sole and complete expense including the research, planning, development and manufacture of prototypes and finished product working models of apparatuses using the Licensed Process and the Technology to be sold by Licensee or any Sublicensee. Licensor shall also be responsible for all costs of filing, prosecuting and maintaining all Patent Rights in the United States and Licensee shall be responsible for all costs of obtaining local regulatory and governmental permits and authorizations as may be required.
(b) Licensee shall control the process for obtaining marketing licenses and approvals for the Licensed Process. Licensee shall bear the complete costs for obtaining the marketing approvals for the Licensed Process.
(c) Licensor will in good faith participate in and provide necessary information, and data which may be necessary for obtaining marketing approvals for the Licensed Process, and Licensee agrees to reimburse Licensor for all commercially reasonable expense incurred by such participation; provided, however, that all regulatory licenses and approvals that require modifications to the prototypes or any existing Licensed Process shall be at the sole cost and expense of the Licensor.
Development and Regulatory Approval