Development and Regulatory Approval Sample Clauses

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.
Sample 1Sample 2Sample 3
AutoNDA by SimpleDocs
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...
Sample 1Sample 2
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 Xxxxx’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.
Sample 1
Development and Regulatory Approval. OF THE PRODUCTS 17 SECTION 4 – COMMERCIALIZATION 18
Sample 1
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.
Sample 1
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.
Sample 1
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).
Sample 1
AutoNDA by SimpleDocs
Development and Regulatory Approval 
Sample 1Sample 2Sample 3See All (7)

Related to Development and Regulatory Approval

  • Regulatory Approval 25.1 The Parties understand and agree that this Agreement and any amendment or modification hereto will be filed with the Commission for approval in accordance with Section 252 of the Act and may thereafter be filed with the FCC. The Parties believe in good faith and agree that the services to be provided under this Agreement are in the public interest. Each Party covenants and agrees to fully support approval of this Agreement by the Commission or the FCC under Section 252 of the Act without modification.

  • Required Regulatory Approvals (a) The obligations of each Party under this Agreement are expressly contingent upon (i) each Party receiving all licenses, permits, permissions, certificates, approvals, authorizations, consents, franchises and releases from any local, state, or federal regulatory agency or other governmental agency or authority (which may include, without limitation and as applicable, the NYISO and the PSC) or any other third party that may be required for such Party in connection with the performance of such Party’s obligations under or in connection with this Agreement (the “Required Approvals”), (ii) each Required Approval being granted without the imposition of any modification or condition of the terms of this Agreement or the subject transactions, unless such modification(s) or condition(s) are agreed to by both Parties in their respective sole discretion, and (iii) all applicable appeal periods with respect to the Required Approvals having expired without any appeal having been made or, if such an appeal has been made, a full, final and non-appealable determination having been made regarding same by a court or other administrative body of competent jurisdiction, which determination disposes of or otherwise resolves such appeal (or appeals) to the satisfaction of both Parties in their respective sole discretion. (b) If any application or request is made in connection with seeking any Required Approval and is denied, or is granted in a form, or subject to conditions, that either Party rejects, in its sole discretion, as unacceptable, this Agreement shall terminate as of the date that a Party notifies the other Party of such denial or rejection, in which event the obligations of the Parties under this Agreement shall cease as of such date and this Agreement shall terminate, subject to NYSEG’s obligation to pay National Grid in accordance with the terms of this Agreement (including, without limitation, Section 10.3 above) for all Reimbursable Costs. All of National Grid’s actual costs in connection with seeking Required Approvals shall be included within the meaning of the term Reimbursable Costs and shall be paid for by NYSEG.

  • Regulatory Approvals (a) Each Party shall, and shall cause its ultimate parent entity (as such term is defined in the HSR Act) to, use reasonable best efforts to file or otherwise submit, as soon as practicable after the date of this Agreement, all applications, notices, reports, filings and other documents reasonably required to be filed by such Party or its ultimate parent entity with or otherwise submitted by such Party or its ultimate parent entity to any Governmental Body with respect to the Contemplated Transactions, and shall file no later than ten (10) Business Days thereafter the Notification and Report Forms required by the HSR Act. Each Party shall (i) promptly supply the other with any information which may be required in order to effectuate such filings, (ii) submit promptly any additional information which may be reasonably requested by any such Governmental Body, and (iii) coordinate with the other Party in making any such filings or information submissions pursuant to and in connection with the foregoing that may be necessary, proper, or advisable in order to consummate and make effective the Contemplated Transactions. (b) Without limiting the generality of anything contained in this Section 5.4, in connection with its efforts to obtain all requisite approvals and authorizations, and the expiration or termination of all applicable waiting periods for the Contemplated Transactions under any Antitrust Law, each Party hereto shall use its reasonable best efforts to (i) cooperate with the other with respect to any investigation or other inquiry; (ii) promptly provide to the other a copy of all communications received by such Party from, or given by such Party to, any Governmental Body, in each case regarding the Contemplated Transactions; and (iii) to the extent not prohibited under applicable Antitrust Law, permit the other to review in advance any communication given by it to any Governmental Body concerning the Contemplated Transactions, consider in good faith the views of the other in connection with any proposed written communications by such Party to any Governmental Body concerning the Contemplated Transactions, and consult with each other in advance of any meeting or telephone or video conference with, any Governmental Body, and give the other or its outside counsel the opportunity to attend and participate in such meetings and conferences unless prohibited by the applicable Governmental Body; provided, that materials required to be provided pursuant to this Section 5.4(b) may be restricted to outside counsel and redacted to (A) remove references concerning the valuation of either Party, (B) comply with contractual arrangements, and (C) preserve attorney-client privilege. Neither Party shall commit to or agree with any Governmental Body to stay, toll or extend any applicable waiting period under applicable Antitrust Law, or pull and refile under the HSR Act, without the prior written consent of the other. Parent and the Company shall each pay one-half of the filing fee under the HSR Act relating to the HSR filing required for the Merger; provided, however, that each Party shall bear its own legal fees. (c) Except as required by this Agreement, prior to Closing, neither the Company nor Parent shall, and shall cause its Affiliates not to, acquire or agree to acquire by merging or consolidating with, or by purchasing a substantial portion of the assets of or equity in, or by any other manner, any Person or portion thereof, or otherwise acquire or agree to acquire any assets, if the entering into of an agreement relating to or the consummation of such acquisition, merger or consolidation would reasonably be expected to (i) impose any delay in the obtaining of, or significantly increase the risk of not obtaining, any authorizations, consents, orders, declarations or approvals of any Governmental Body necessary to consummate the Contemplated Transactions or the expiration or termination of any applicable waiting period, or (ii) increase the risk of any Governmental Body entering an order prohibiting the consummation of the Contemplated Transactions.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

  • No Regulatory Approval By the Company or Parent, if its Board of Directors so determines by a vote of a majority of the members of its entire Board, in the event any Requisite Regulatory Approval shall have been denied by final, nonappealable action by such Governmental Authority or a Governmental Authority shall have requested the permanent withdrawal of an application therefor.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • Governmental and Regulatory Approvals Approvals from any Governmental or Regulatory Authority (if any) necessary for consummation of the transactions contemplated hereby shall have been obtained.

  • Requisite Regulatory Approvals All Consents required to be obtained from or made with any Governmental Authority in order to consummate the transactions contemplated by this Agreement shall have been obtained or made.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!