Regulatory and Compliance Matters. In respect of Personal Data provided to Upland by Customer in connection with the Agreement, Upland shall comply, and shall ensure that its personnel comply, with the requirements of state, federal and national privacy laws and regulations governing such Personal Data in Upland’s possession or under its control and applicable to Upland’s provision of Services. Customer is solely responsible for ensuring Customer’s, and its Users’, compliance with any legal, regulatory or similar restrictions applicable to the types of data Customer elects to Process with the Application.
Regulatory and Compliance Matters. (a) The Acquired Corporations have filed with the applicable regulatory authorities (including the FDA or any other Governmental Body performing functions similar to those performed by the FDA) all required material filings, declarations, listings, registrations, reports or submissions, including but not limited to adverse event reports. All such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable Legal Requirements when filed, and no deficiencies have been asserted in writing by any applicable Governmental Body with respect to any such filings, declarations, listings, registrations, reports or submissions.
(b) The Acquired Corporations hold all Regulatory Permits required for their business as currently conducted, and each such Regulatory Permit is valid and in in full force and effect. The Acquired Corporations are in compliance in all material respects with the terms and requirements of such Regulatory Permits. For the past six (6) years, no deficiencies have been asserted in writing by any applicable Governmental Body with respect to any Regulatory Permits of the Acquired Corporations.
(c) For the past six (6) years, the Acquired Corporations have not received any written notice from a Governmental Body that any of their products are misbranded as defined in 21 U.S.C. § 352 or adulterated as defined in 21 U.S.C. § 351, as amended, and the rules and regulations promulgated thereunder, or as defined in comparable Legal Requirements in any jurisdiction.
(d) Except as set forth in Company Disclosure Schedule, all preclinical and clinical investigations sponsored by the Acquired Corporations or, to the knowledge of the Company, any of the Acquired Corporations’ research, development, collaboration or similar commercialization partners with respect to any material products or product candidates of the Acquired Corporations while acting in such capacity (the “Collaboration Partners”) (each such preclinical or clinical investigation with respect to a material product or product candidate of the Acquired Corporations, a “Clinical Study”) have been and are being conducted in material compliance with applicable Legal Requirements, rules, regulations and guidances, including Good Clinical Practice Requirements and federal and state laws, rules, regulations and guidances restricting the use and disclosure of individually identifiable health information. No Acquired Corporation nor, to the knowledge of t...
Regulatory and Compliance Matters. (a) Neither the Company nor SHUSA shall, and each shall cause its Affiliates to not, take any action that would cause Xxxxxx Holdco or Sponsor Holdings to be required to register as a bank holding company under the Bank Holding Company Act, or a savings and loan holding company under the Home Owners’ Loan Act.
(b) The Company shall, to the maximum extent possible, take advantage of “controlled company” or other exceptions to retain the voting rights and corporate governance provisions applicable to the Company and the Shareholders pursuant to the terms of this Agreement.
Regulatory and Compliance Matters. (a) The Parties intend that (i) the Parties’ activities will be in all respects compliant with Applicable Laws and (ii) Genentech’s Educational Activities under the Tactical Plan will be structured and conducted so as to be educational disease awareness communications disseminated to healthcare professionals that discuss a particular disease or health condition, in order to encourage awareness of signs of the particular disease or heath condition or otherwise provide information to assist in the diagnosis of the particular disease or health condition, but do not mention any specific drug or device or make any representation or suggestion concerning a particular drug or device, and do not otherwise constitute product advertising or promotional labeling of a drug or medical device.
(b) Each Party shall be solely responsible for matters of compliance with Applicable Laws with respect to its conduct of activities under this Agreement and for interactions with Regulatory Authorities and Government Agencies with respect thereto, as follows: FMI shall be responsible for its conduct of the Training Activities; Genentech shall be responsible for its preparation of the Educational Materials and the conduct of the Educational Activities; and both Parties will be responsible for the establishment of priorities and tactics in the Tactical Plan and for discussions and sharing of information at the Education Support Working Group and otherwise between the Parties under this Agreement. If either Party receives a communication from a Regulatory Authority or Government Agency that its activities under this Agreement may violate or have violated any Applicable Law or regulation, including any notice of claim, demand, suit, investigation or proceeding that relates or may reasonably relate to any such activities, such Party shall promptly share that communication with the other Party, and the Parties shall confer on an appropriate response, provided that (i) the Party receiving the communication shall remain free to take any or no action in response to such communication including, without limitation, terminating this Agreement under Section 9.2.2 and (ii) if both Parties are responsible for any of the activities under this Agreement (as specified in this Section 2.1.6(b)) potentially relevant to such claim, demand, suit, investigation or proceeding, then the Parties shall discuss in good faith how to respond to it and how to handle it in an efficient manner.
Regulatory and Compliance Matters. (a) Neither the Company nor SHUSA shall, and each shall cause its Affiliates to not, take any action that would cause any Acquirer to be required to register as a bank holding company under the Bank Holding Company Act, or a savings and loan holding company under the Home Owners’ Loan Act.
(b) The Company and the Shareholders agree that (i) the Company will pursue best-in-class standards in the areas of risk-management, human resources, compliance, fair lending and other areas designated by the Board of Directors from time to time and (ii) management of the Company will work to develop and implement procedures and internal controls designed to achieve such standards. Management of the Company shall report to the Board of Directors on a regular basis (but not less frequently than quarterly) as to the specific standards adopted, compliance or deviation from those standards and any remediation programs being implemented to address any failures to meet or comply with those standards. In addition, the Company shall use reasonable best efforts to appoint a risk management officer with appropriate resources and responsibilities consistent with best industry practices.
(c) With respect to the State License Approvals (as defined in the New Acquirer Investment Agreement), by February 14, 2012, (i) the Company, together with the Company Subsidiaries, shall have obtained all authorizations, consents, orders, approvals and declarations and made all filings and (ii) all applicable waiting periods shall have expired.
Regulatory and Compliance Matters
