SPONSOR AND CONDUCT OF THE STUDY Sample Clauses

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SPONSOR AND CONDUCT OF THE STUDY. 4.1 In General.

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Related to SPONSOR AND CONDUCT OF THE STUDY

• Conduct of Research Program Each Party:

• Conduct of the Company’s Business The Company covenants and agrees that, prior to the Effective Time, unless Parent shall otherwise consent in writing or as otherwise expressly contemplated by this Agreement:

• Conduct of the Business (a) Except as (i) set forth in Section 5.2(a) of the Sellers’ Disclosure Schedule or (ii) as is necessary and commercially reasonable in response to a Contagion Event or Contagion Event Measures, subject to Sellers providing Purchaser with advance notice and obtaining Purchaser’s prior written consent in respect of any such action (unless it is not reasonably practicable under the circumstances to provide such prior notice and obtain prior consent, in which case Sellers shall provide notice to Purchaser as soon as reasonably practicable), from the date hereof until the earlier of the Closing Date or the termination of this Agreement, the Sellers shall cause the Bank and the Transferred Subsidiaries to (1) carry on their businesses in the ordinary course of business in all material respects; (2) use commercially reasonable efforts to preserve their present business organizations and relationships; and (3) use commercially reasonable efforts to preserve the rights, franchises, goodwill and relations of their customers, clients and others with whom business relationships exist; provided, that this Section 5.2(a) shall not apply to the Excluded Assets and Liabilities. (b) Except as set forth in Section 5.2(b) of the Sellers’ Disclosure Schedule or to the extent required to effect the Excluded Assets and Liabilities Transfer, from the date hereof until the earlier of the Closing Date or the termination of this Agreement, except as (A) otherwise expressly required by this Agreement, (B) consented to in writing in advance by Purchaser (which consent shall not be unreasonably conditioned, withheld or delayed), or (C) required by applicable Law, Sellers shall cause the Bank and the Transferred Subsidiaries not to: (i) amend the Bank’s or any Transferred Subsidiaries’ Constituent Documents or permit any waiver or grant any consent under their respective Constituent Documents; (ii) (A) merge or consolidate with any other Person, (B) acquire (including by merger, consolidation, or acquisition of stock or assets) any interest in any other Person or any division thereof or any assets, securities or property, other than (x) acquisitions of securities under the Bank’s or an applicable Transferred Subsidiary’s investment portfolio consistent with the Bank’s or an applicable Transferred Subsidiary’s investment policy in effect as of the date hereof, (y) as may be deemed necessary or advisable by it in the exercise of its rights in connection with an Extension of Credit, or (z) acquisitions in the ordinary course of business, or (C) adopt a plan of complete or partial liquidation, dissolution, recapitalization, restructuring or other reorganization; -55- purchases of federal funds, borrowings from any Federal Home Loan Bank, sales of certificates of deposit, issuances of commercial papers, entry into repurchase agreements and satisfaction of legal requirements in the exercise of trust powers, in each case, on terms and in amounts consistent with past practice) or (y) for any Excluded Assets and Liabilities, (A) subject any material asset of the Bank or of any Transferred Subsidiary to a Lien or permit, allow or suffer to exist any Lien in respect thereof, other than Permitted Liens; or (B) incur any liability for borrowed money (or guarantee any indebtedness for borrowed money), issue any debt securities, assume, guarantee, endorse or otherwise as an accommodation become responsible for the obligations of any other Person (other than a Transferred Subsidiary); (viii) dispose of any material assets (without limiting Section 5.2(b)(xii), other than Intellectual Property) to any person other than a Transferred Subsidiary, including existing branches of the Bank, except in the ordinary course of business or pursuant to Contracts in force as of the date of this Agreement; (ix) other than as required by the terms of any Benefit Plan existing as of the date hereof, (A) increase the compensation or benefits of any Business Employee, other than the payment of incentive compensation for completed performance periods based upon corporate performance, the performance of such employee and, if applicable, such employee’s business, in each case determined in accordance with the terms of the applicable Benefit Plan and in the ordinary course of business consistent with past practice, (B) enter into any change-in-control, retention, employment, severance, termination or other similar agreement or arrangement with any Business Employee, or increase or commit to increase the change-in-control, severance or termination pay or benefits payable to any Business Employee, (C) pay or award, or commit to pay or award, any bonuses or incentive compensation to any Business Employee other than incentive compensation payments contemplated by clause (A) above, (D) enter into, establish, adopt, terminate or amend any Benefit Plan or any plan, program, arrangement, practice or agreement that would be a Benefit Plan if it were in existence on the date hereof, except for de minimis administrative amendments that would not increase the benefits provided thereunder or the cost thereof to the Bank and the Transferred Subsidiaries, (E) take any action to amend or waive any performance or vesting criteria or accelerate vesting, exercisability or funding under any Benefit Plan, with respect to any Business Employee, (F) hire any Business Employee, other than as permitted under Section 5.10(e), (G) terminate the employment of any Business Employee with the title of Managing Director or above, other than for cause or pay any severance, termination pay or benefits to any employee without obtaining an effective comprehensive general release of claims against the Bank and the Transferred Subsidiaries, (H) transfer the employment of any Business Employee to Sellers or any of their Affiliates (other than the Bank or any Transferred Subsidiary), or transfer the employment of any employee, officer, director, or natural person independent contractor of Sellers or any of their Affiliates (other than the Bank or any Transferred Subsidiary) to the Bank or its Affiliates (other than as permitted under Section 5.10(e)), (I) grant to any Business Employee any right to reimbursement, indemnification, or payment for any Taxes incurred under Section 409A or 4999 of the Code, or (J) recognize any union, labor organization or

• Conduct of the Company From the date of this Agreement until the Closing or the earlier termination of this Agreement in accordance with Article 8 (the “Pre-Closing Period”), except as (i) expressly required or expressly contemplated by this Agreement, (ii) set forth in Section 5.01 of the Company Letter, (iii) required by applicable Law or (iv) consented to in advance in writing by Parent or Buyer (such consent not to be unreasonably withheld, conditioned or delayed), the Company shall, and shall cause each of its Subsidiaries to, (A) conduct its business in all material respects in the ordinary course of business consistent with past practice, (B) use its reasonable best efforts to preserve intact in all material respects its business organization and material business relationships with suppliers, vendors, Governmental Authorities, Customers and other Persons with which the Company has material business relationships and keep available the services of its present officers and key employees and (C) use commercially reasonable efforts to undertake the actions enumerated in Section 5.01-1 of the Company Letter; provided, that none of the Company or any of its Subsidiaries shall be required to (or shall without Parent’s or Buyer’s prior consent, not to be unreasonably withheld, conditioned or delayed) make any payments to its business relationship counterparties, beyond that paid in the ordinary course of business in order to maintain such business relationships. In addition to and without limiting the generality of the foregoing, during the Pre-Closing Period, except as (w) expressly required or expressly contemplated by this Agreement, (x) set forth in Section 5.01 of the Company Letter, (y) required by applicable Law or (z) consented to in advance in writing by Parent or Buyer (such consent not to be unreasonably withheld, conditioned or delayed), the Company shall not, and shall cause its Subsidiaries not to:

• Conduct of Research The Parties shall use Diligent Efforts to conduct their respective tasks, as assigned under the Research Plan, throughout the Mode of Action Program and shall conduct the Mode of Action Program in good scientific manner, and in compliance in all material respects with the requirements of applicable laws, rules and regulations and all applicable good laboratory practices to attempt to achieve their objectives efficiently and expeditiously.

• Restrictions on Conduct of Executive (a) For purposes of this Section 11, the following definitions apply:

• Research Matters By entering into this Agreement, the Placement Agent does not provide any promise, either explicitly or implicitly, of favorable or continued research coverage of the Company and the Company hereby acknowledges and agrees that the Placement Agent’s selection as a placement agent for the Offering was in no way conditioned, explicitly or implicitly, on the Placement Agent providing favorable or any research coverage of the Company. In accordance with FINRA Rule 2711(e), the parties acknowledge and agree that the Placement Agent has not directly or indirectly offered favorable research, a specific rating or a specific price target, or threatened to change research, a rating or a price target, to the Company or inducement for the receipt of business or compensation.

• Conduct of Parent From the date hereof until the Effective Time, Parent and its Subsidiaries shall conduct their business in the ordinary course consistent with past practice and shall use their reasonable best efforts to preserve intact their business organizations and relationships with third parties. Without limiting the generality of the foregoing, except with the prior written consent of the Company or as contemplated by this Agreement, from the date hereof until the Effective Time Parent shall not, and shall not permit any of its Subsidiaries to:

• Commercialization Plans As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indication Product), including:

• Commercialization Plan On a Product by Product basis, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.