7. LIABILITY AND CROSS-INDEMNIFICATIONS
7.1 Each Party shall indemnify and hold the other Party, its affiliates, and their respective officers, directors, employees and representatives, harmless from and against any third-party claims and liability, including liability for death or personal injury and reasonable attorney's fees, which results solely from breach of its obligations under this Agreement, its negligence or willful misconduct, or its violation of applicable laws.
7.2 The Party seeking indemnification for third party claims under Sections 6.1 shall promptly notify the other Party in writing of all matters which may give rise to the right to indemnification hereunder; failure to promptly give such written notice, to the extent prejudicial to the indemnifying Party’s defense of such claims, shall relieve the indemnifying Party’s obligation to the other Party under this Section 6.
7.3 EXCEPT FOR ITS INDEMNIFICATION OBLIGATIONS, BREACH OF SECTION 8, OR ITS GROSS NEGLIGENCE OR INTENTIONAL MISCONDUCT: (i) NEITHER PARTY WILL NOT BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, INCIDENTAL, PUNITIVE OR SPECIAL DAMAGES, INCLUDING LOSS OF PROFITS, GOODWILL OR REVENUE, DATA OR USE, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, ARISING IN ANY WAY OUT OF THIS AGREEMENT; and (ii) EACH PARTY MAXIMUM LIABILITY UNDER THIS AGREEMENT SHALL NOT EXCEED THE AMOUNT PAID BY MACLEODS TO CYTODYN WITHIN THIRTY (30) DAYS BEFORE THE EVENT GIVING RISE TO SUCH LIABILITY OCCURRED.
8. ADVERSE REACTIONS, COMPLAINTS AND RECALLS
8.1 MACLEODS and CYTODYN shall notify each other within twenty-four (24) hours by confirmed facsimile or email of any information concerning any serious or unexpected side effect, injury, toxicity, or sensitivity reaction, any unexpected incidents, or any adverse drug experience reports and the severity thereof associated with the Products, the use and sale thereof (collectively “Adverse Events”). To enable CYTODYN to comply with its regulatory reporting responsibilities, MACLEODS shall use commercially reasonable efforts to deliver to CYTODYN all Adverse Event information received by MACLEODS and all other information as required by CYTODYN by notice in writing to MACLEODS.
8.2 CYTODYN and MACLEODS shall each comply with CDSCO pharmacovigilance policy (i.e., Adverse drug experience reports).
8.3 Complaints with regard to the Products received by MACLEODS will be promptly sent by facsimile or email to CYTODYN at: ***@*** and ***@***.
9.1 “Confidential Information” means all confidential or proprietary information relating to the business and affairs of CYTODYN or its affiliates that are disclosed by or on behalf of CYTODYN to MACLEODS and all information derived therefrom, including without limitation financial information, business opportunities, information relating to pharmaceutical products of any nature in any form. MACLEODS shall not make available Confidential Information to any third party; except that it shall be entitled to disclose to government authorities to the extent necessary for obtaining [equivalent CSP] and EUA, in accordance with accepted practices in the pharmaceutical industry.
9.2 MACLEODS shall take all necessary steps to ensure that its employees who gain access to Confidential Information are bound in writing by terms similar to the terms of this