Conduct of the Study 3.1 Athenex shall act as the sponsor of the Study and shall hold the IND/CTA relating to the Study; provided, however, that in no event shall Athenex file a separate IND/CTA for the Study unless required by Regulatory Authorities to do so. If a Regulatory Authority requests a separate IND/CTA for the Study the Parties will meet and mutually agree on an approach to address such requirement.
3.2 Athenex shall ensure that the Study is performed in accordance with this Agreement, the Protocol and all Applicable Law, including GCP.
3.3 Athenex shall ensure that all directions from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are followed. Further, Athenex shall ensure that all Regulatory Approvals from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are obtained prior to initiating performance of the Study. Athenex shall participate in and lead all discussions with any Regulatory Authority regarding the Study, provided, however, that Lilly shall have the right (but no obligation) to participate in any discussions with a Regulatory Authority, and prior review and approval of any written communications with a Regulatory Authorty, regarding matters related to the Lilly Compound.
3.4 Athenex shall maintain reports and all related documentation (paper or electronic versions as applicable) in good scientific manner and in compliance with Applicable Law. Athenex shall provide any Study information and documentation reasonably requested to enable Lilly to (i) comply with any of its legal and regulatory obligations, or any request by any Regulatory Authority, in each case, to the extent related to the Study or such the Lilly Compound, (ii) satisfy any contractual obligation to a subcontractor engaged pursuant to Section 2.4 hereof, and (iii) to determine whether the Study has been performed by Athenex in accordance with this Agreement.
3.5 Athenex shall ensure that all patient authorizations and consents, and all consents from other data subjects, for the processing, use and disclosure of their data and the Clinical Data, required under HIPAA, the EU Data Protection Directive, EU General Data Protection Regulation, and any other similar Applicable Law in connection with the Study, permit the use and sharing of the Clinical Data as set forth in this Agreement, including the sharing of Clinical Data with Lilly.
3.6 All Clinical Data, including raw data and results, generated under this Agreement, as well as the protocol(s), analyses, plans and any other documentation prepared by one or more of the Parties under this Agreement specifically for use in connection with the Study and related to the Lilly Compound, shall be jointly owned by Lilly and Athenex.
Conduct of the Parties The parties will not engage in behaviour that is, or may reasonably be considered to be intimidating, bullying, or harassing or commit any act or behaviour which is offensive or abusive in connection with this Agreement.
Conduct of Research Each Party will perform its Research Activities diligently and in good scientific manner, in compliance with all Applicable Laws, including cGMP, GLP, and GCP, as applicable. Each Party will devote the efforts of suitably qualified and trained employees and research assistants capable of carrying out the Research Activities set forth under the Research Plan to a professional workmanlike standard.
Conduct of Business and Maintenance of Existence (a) Continue to engage in its principal line of business as now conducted by it, (b) preserve, renew and keep in full force and effect its corporate existence and (c) take all reasonable action to maintain all rights, privileges and franchises necessary or desirable in the normal conduct of its principal line of business, except, in any such case, as otherwise permitted pursuant to subsection 6.5 or to the extent that failure to do so would not have a Material Adverse Effect.
Conduct of Logging Unless otherwise specifi- cally provided herein, Purchaser shall fell trees desig- nated for cutting and shall remove the portions that meet Utilization Standards, as provided in B2.2, prior to accep- tance of subdivision for completion of logging under B6.36. Forest Service may make exceptions for occa- sional trees inadvertently not cut or trees or pieces not removed for good reason, including possible damage to forest resources or gross economic impracticability at the time of removal of other timber. Logging shall be con- ducted in accordance with the following, unless C6.4 pro- visions set forth requirements to meet special or unusual logging conditions:
Conduct of Third Party Claims If the matter or circumstance that may give rise to a Claim other than a Tax Claim is a result of or in connection with a claim by a third party (a “Third Party Claim”) then:
11.4.1 the Purchaser shall, to the extent reasonably practicable and subject to Applicable Law, consult with the Seller in relation to the conduct of the Third Party Claim and shall take reasonable account of the views of the Seller before taking any action in relation to the Third Party Claim;
11.4.2 no admissions in relation to the Third Party Claim shall be made by or on behalf of the Purchaser or any member of the Purchaser’s Group and the Third Party Claim shall not be compromised, disposed of or settled without the written consent of the Seller, such consent not to be unreasonably withheld or delayed;
11.4.3 subject to the Seller indemnifying the Purchaser or member of the Purchaser’s Group concerned against all reasonable costs and expenses (including legal and professional costs and expenses) that may be incurred thereby, the Purchaser shall, or the Purchaser shall procure that the members of the Purchaser’s Group shall, take such action as the Seller may reasonably request to avoid, dispute, deny, defend, resist, appeal, compromise or contest the Third Party Claim;
11.4.4 the Seller shall, subject in each case to being paid all reasonable out-of-pocket costs and expenses:
(i) make available to the Purchaser and the relevant Group Company such persons and all such information as the Purchaser may reasonably request for assessing, contesting, disputing, defending, compromising or appealing the Third Party Claim; and
(ii) shall give the Purchaser and the relevant Group Company reasonable access to its premises and to its books and records for such purpose during normal business hours on any Business Day following reasonable notice being given to the Seller;
11.4.5 subject to 11.4.3, the Seller shall be entitled at its own expense and in its absolute discretion, by notice in writing to the Purchaser, to assume conduct of any Third Party Claim and to have the conduct of any related proceedings, negotiations or appeals;
11.4.6 if the Seller sends a notice to the Purchaser pursuant to Clause 11.4.5 and until such time as any final compromise, agreement, expert determination or non-appealable decision of a court or tribunal of competent jurisdiction is made in respect of that Third Party Claim or that Third Party Claim is otherwise finally disposed of:
(i) the Purchaser shall, and the Purchaser shall procure that any member of the Purchaser’s Group shall:
(a) give, subject to being paid all reasonable costs and expenses, all such information and assistance including access to premises and personnel, and the right to examine and copy or photograph any assets, accounts, documents and records (excluding, in each case, information or documents which are protected by legal professional privilege but including, in each case, information or documents that are subject to common interest privilege), as the Seller may reasonably request, including instructing such professional or legal advisers as the Seller may nominate to act on behalf of the Purchaser or other member of the Purchaser’s Group concerned but in accordance with the Seller’s instructions, provided that the appointment of such adviser or advisers shall have been approved in writing by the Purchaser (such approval not to be unreasonably withheld, conditioned or delayed); and
(b) not make any admission of liability, agreement or compromise in relation to that Third Party Claim without the prior written approval of the Seller (such approval not to be unreasonably withheld, conditioned or delayed);
(ii) the Seller shall:
(a) consult with the Purchaser and take reasonable account of the views of the Purchaser before taking any action in relation to the Third Party Claim;
(b) without prejudice to its ability to defend the Third Party Claim, conduct the Third Party Claim with a view to minimising any material harm to the goodwill and reputation of the Wider Group or the Purchaser’s Group;
(c) keep the Purchaser informed of all relevant matters relating to the Third Party Claim and shall promptly forward or procure to be forwarded to the Purchaser copies of all correspondence and other written communications with such other information, including non-written records (except information or documents which are protected by legal professional privilege), relating to the Third Party Claim;
(d) not make any admission of liability, settlement or compromise of the Third Party Claim without the written consent of the Purchaser, such consent not to be unreasonably withheld, conditioned or delayed. If the Purchaser or member of the Purchaser’s Group fails to consent to a settlement or compromise, the maximum liability of the Seller shall (without prejudice to Clause 10) not exceed the full amount of the proposed settlement or compromise and the Purchaser or member of the Purchaser’s Group shall be liable for any damages awarded in excess of the proposed settlement or compromise and costs incurred from (and including) the date the Seller notified the Purchaser of the settlement or compromise; and
(e) indemnify, save as set out in Clause 11.4.6(ii)(d), the Purchaser or other member of the Purchaser’s Group concerned against all reasonable costs and expenses (including legal and professional costs and expenses) that may be incurred as a result of the Seller assuming conduct of the Third Party Claim.
11.4.7 The covenants in this Clause 11.4 may be enforced:
(i) by any Group Company against the Seller; and
(ii) by any member of the Seller’s Group against the Purchaser or a Group Company, under the Contracts (Rights of Third Parties) Xxx 0000.
11.4.8 The provisions of this Clause 11.4 may be varied or terminated by agreement between the Seller and the Purchaser (and the Purchaser may also release or compromise in whole or in part any liability in respect of rights or claims contemplated by this Clause 11.4) without the consent of any Group Company.
Conduct of the Business (a) Except as required by applicable Law, Judgment or a Governmental Authority, as expressly contemplated, required or permitted by this Agreement or the Merger Agreement or otherwise undertaken to implement this Agreement, any Ancillary Agreement or the Merger Agreement, or as set forth in Schedule 6.01, during the period from the date of this Agreement until the Closing (or such earlier date on which this Agreement is terminated pursuant to Section 9.01), unless Purchaser otherwise consents in writing (such consent not to be unreasonably withheld, delayed or conditioned), (i) Seller shall, and shall cause the other Asset Seller Entities to, use its and their commercially reasonable efforts to carry on the Business in all material respects in the ordinary course consistent with past practice, and (ii) to the extent consistent with the foregoing, Seller shall, and shall cause the other Asset Seller Entities to, use its and their commercially reasonable efforts to (A) preserve the business organizations of the Business substantially intact and (B) preserve existing relations with key customers and distributors of the Business and with other Persons with whom Seller and the other Asset Seller Entities have significant business relationships with respect to the Business, in each case, consistent with past practice.
(b) Without limiting the generality of the foregoing, except as required by applicable Law, Judgment or a Governmental Authority, as expressly contemplated, required or permitted by this Agreement or the Merger Agreement or as set forth in Schedule 6.01, during the period from the date of this Agreement until the Closing (or such earlier date on which this Agreement is terminated pursuant to Section 9.01), unless Purchaser otherwise consents in writing (such consent not to be unreasonably withheld, delayed or conditioned), Seller shall not, and shall not permit any other Asset Seller Entity to, in each case solely to the extent relating to the Business:
(i) incur any Indebtedness that creates or results in a Lien (other than a Permitted Lien) upon any of the Purchased Assets, except for Indebtedness incurred in the ordinary course of business consistent with past practice that (A) constitutes an Excluded Liability, (B) does not result in a Lien (other than a Permitted Lien) on the Purchased Assets that will survive the Closing, or (C) constitutes a letter of credit, bank guarantee, security or performance bond or similar credit support instrument, overdraft facility or cash management program;
(ii) sell, lease, license or otherwise transfer, directly or indirectly, to any Person, in a single transaction or series of related transactions, any of the Purchased Assets, except (A) ordinary course dispositions of inventory to customers and distributors consistent with past practice, (B) dispositions consistent with past practice of (1) obsolete, surplus or worn out assets or (2) assets that are no longer used or useful in the Business, or (C) transfers among the Asset Seller Entities;
(iii) make any acquisition of, or investment in, any properties, assets, Securities or business for the Business, except for the acquisitions of supplies, inventory, equipment, merchandise or products in the ordinary course of business consistent with past practice;
(iv) grant any Lien (other than a Permitted Lien) on any of the Purchased Assets other than (A) to secure Indebtedness and other obligations permitted under Section 6.01(b)(i), or (B) any such Lien that will not survive the Closing and will not (1) require any Consent to be obtained in connection with the Transactions or (2) delay in any material respect the consummation thereof;
(A) modify, amend or terminate, or waive, in each case in any material respect, any rights or claims under, any Material Contract or any Restricted Contract other than in the ordinary course of business consistent with past practice or (B) enter into any new Contract that (1) would, in the twelve (12)-month period immediately following the entry into such Contract, reasonably be expected to meet the threshold monetary requirement set forth for such type of a Contract in Section 4.11(a)(iii) for the fiscal year ended December 31, 2016, (2) is a Restricted Contract, or (3) contains a change in control or similar provision in favor of the other party or parties thereto that would require a material payment to or would give rise to any material rights of such other party or parties in connection with the consummation of the Transactions (including in combination with any other event or circumstance), other than pursuant to a tender offer process for Contracts with a Governmental Authority in the ordinary course consistent with past practice; or
(vi) authorize any of, or commit or agree, in writing or otherwise, to take any of, the foregoing actions.
(c) Nothing contained in this Agreement is intended to give Purchaser, directly or indirectly, the right to control or direct the operations of the Business prior to the Closing, and nothing contained in this Agreement is intended to give Purchaser at any time, directly or indirectly, the right to control or direct any Excluded Businesses. Prior to the Closing, each of Purchaser and Seller shall exercise, consistent with the terms and conditions of this Agreement and with applicable Competition Laws, complete control and supervision over its and its Subsidiaries’ respective operations.
Conduct of Business and Maintenance of Existence, etc (a) (i) Preserve, renew and keep in full force and effect its corporate existence and (ii) take all reasonable action to maintain all rights, privileges and franchises necessary or desirable in the normal conduct of its business, except, in each case, as otherwise permitted by Section 7.4 and except, in the case of clause (ii) above, to the extent that failure to do so could not reasonably be expected to have a Material Adverse Effect; and (b) comply with all Contractual Obligations and Requirements of Law except to the extent that failure to comply therewith could not, in the aggregate, reasonably be expected to have a Material Adverse Effect.
Maintenance of Existence and Conduct of Business Each Credit Party shall: do or cause to be done all things necessary to preserve and keep in full force and effect its corporate existence and its rights and franchises; continue to conduct its business substantially as now conducted or as otherwise permitted hereunder; at all times maintain, preserve and protect all of its assets and properties used or useful in the conduct of its business, and keep the same in good repair, working order and condition in all material respects (taking into consideration ordinary wear and tear) and from time to time make, or cause to be made, all necessary or appropriate repairs, replacements and improvements thereto consistent with industry practices; and transact business only in such corporate and trade names as are set forth in Disclosure Schedule (5.1).
Conduct of mediation In consultation with the mediator, the parties must determine a location, timetable and procedure for the mediation or, if the parties cannot agree on these matters within 7 Working Days of the appointment of the mediator these matters will be determined by the mediator.