BEC » Topics » 3.18 Regulatory Matters.

This excerpt taken from the BEC 8-K filed Mar 26, 2007.

3.18 Regulatory Matters.

(a) The Company and the Company Subsidiaries have established and administer compliance programs (including written compliance policies) applicable to the Company and the Company Subsidiaries (i) to assist the Company, the Company Subsidiaries and their respective directors, officers and employees in complying with all Legal Requirements and guidelines (including those administered by the FDA) applicable to the Company, the Company Subsidiaries or their businesses and (ii) to provide compliance policies governing activities and requirements applicable to medical device companies (including pre-clinical and clinical testing, product design and development, product testing, product manufacturing, product labeling, product storage, pre-market clearance and approval, marketing, advertising and promotion, product sales and distribution, medical device recall and reporting regulations, and record keeping).

(b) Except as set forth in Part 3.18(b) of the Company Disclosure Schedule, the Company and each Company Subsidiary is in compliance in all material respects with all Legal Requirements applicable to the Company’s products and activities, including product design, development, testing, manufacture, marketing, distribution, labeling, storage and transport, in all jurisdictions in which such acts or any of them occur or are reasonably likely to occur or such products or any of them are likely to be sold or used (including any FDA Laws). All applications, submissions, information, claims, reports and statistics and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests for authorizations, approvals, certificates, waivers, certifications, clearances, exemptions, notifications, consents, orders, registrations, licenses or permits of the FDA or comparable Governmental Entities relating to the Company, the Company Subsidiaries, their businesses and their products were, when submitted to the FDA or other Governmental Entities, true, complete and correct in all material respects and in conformance with Legal Requirements as of the date of submission and any updates, changes, corrections or modification to such applications, submissions, information and data which were or are necessary or required to be filed, maintained, or furnished to the FDA or other Governmental Entities have been timely filed, maintained, or furnished and were true, complete and correct in all material respects and in conformance with Legal Requirements as of the date of submission. The labeling claims made

 

26


by the Company and the Company Subsidiaries for each of their products are consistent with the scope of regulatory clearance, exemption or approval for each product in each jurisdiction where it is marketed in all material respects, and supported by proper research design, testing, analysis and disclosure that conforms with Legal Requirements.

(c) The activities, products and facilities of the Company and the Company Subsidiaries, as well as, to the Company’s knowledge, its suppliers, distributors, contractors and other intermediaries, are in compliance with all applicable requirements of CLIA, the FDCA and implementing FDA regulations, including the registration, listing, labeling and manufacturing requirements of 21 C.F.R. Parts 807, 809 and 820, all to the extent applicable to the Company’s products and services. The Company and each Company Subsidiary is not subject to any obligation arising under any consent decree, consent agreement, or warning letter issued by or entered into with the FDA or any other Governmental Entity or other notice, response or commitment made to the FDA or any other Governmental Entity. The Company has delivered to Parent true, correct and complete copies of all customer complaints relating to the Company’s and the Company Subsidiaries’ products and all Medical Device Reports, in each case, filed with the FDA within the last five years. The Company has delivered to Parent true, complete and correct copies of all warning letters, untitled letters, notices of inspectional observations (Form FDA 483s), or similar notices, or other correspondence relating to the Company’s and the Company Subsidiaries’ products and its compliance with Legal Requirements from the FDA and any other Governmental Entity and all of the Company’s responses thereto within the last five years.

(d) Except as set forth in Part 3.18(d) of the Company Disclosure Schedule, since January 1, 2003, no exemptions, clearances or approvals for the Company and the Company Subsidiaries’ products have been subjected to reevaluation or suspension of sale by the FDA and no products manufactured, marketed or sold by the Company or any Company Subsidiary have been recalled or subject to a field notification, field correction or safety alert (whether voluntarily or otherwise) and no proceedings have occurred (whether completed or pending) seeking to recall, reclassify, re-label, suspend, or seize any product sold or proposed to be sold by the Company or a Company Subsidiary. To the Company’s knowledge, there are no facts which are reasonably likely to cause: (A) the recall, suspension, field notification, field correction, reclassification, re-labeling or safety alert of any product sold or intended to be sold by the Company or any Company Subsidiary; (B) a change in the marketing classification or a material change in labeling of any such products; or (C) a termination or suspension of marketing of any such products.

(e) All products being manufactured, distributed, or developed by the Company and the Company Subsidiaries that are subject to the jurisdiction of the FDA or comparable Governmental Entity are being manufactured, labeled, stored, tested, distributed, and marketed in material compliance with all applicable requirements and implementing regulations thereunder.

(f) Except as set forth in Part 3.18(f) of the Company Disclosure Schedule, all pre-clinical trials and clinical trials conducted by or on behalf of the Company and the Company Subsidiaries have been, and are being conducted in material compliance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all

 

27


applicable Legal Requirements relating thereto, including the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56 and 812.

(g) Neither the Company, the Company Subsidiaries, nor, to the knowledge of the Company, any of their collective officers, employees or agents has committed any act, made any statement, or failed to make any statement, that would be reasonably expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto.

(h) Neither the Company, the Company Subsidiaries, nor, to the knowledge of the Company, any of their collective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion under 21 U.S.C. Section 335a or under any similar Legal Requirement. No claims, actions, proceedings or investigations that could reasonably be expected to result in such a material debarment or exclusion are pending or threatened against the Company, the Company Subsidiaries, or, to the knowledge of the Company, any of their collective officers, employees or agents.

(i) Except as disclosed on Part 3.18(i) of the Company Disclosure Schedule, there are no investigations, audits, actions or other proceedings pending with respect to a violation by the Company or any Company Subsidiary of any Legal Requirement that reasonably would be expected to result in administrative, civil, or criminal liability, and there are no facts or circumstances existing that would reasonably be expected to serve as a basis for such an investigation, audit, action or other proceeding.

(j) The Company and each of the Company Subsidiaries is in material compliance with all applicable FDA import and export requirements, including import-for-export requirements, export notifications or authorizations and record keeping requirements.

3.19 Product Recalls. Part 3.19 of the Company Disclosure Schedule sets forth a list of (i) all recalls, field notifications, field corrections and safety alerts with respect to products manufactured and/or distributed by the Company or any Company Subsidiary, or by any Person on behalf of the Company or any Company Subsidiary, in each case between January 1, 2004 and the date of this Agreement, and the dates, if any, such recalls, field notifications, field corrections and safety alerts were resolved or closed, and (ii) to the knowledge of the Company, any material complaints with respect to products produced by the Company or any or any Company Subsidiary, or by any Person on behalf of the Company or any or any Company Subsidiary, that are open as of the date of this Agreement. There are no outstanding recalls, field notifications, field corrections, safety alerts or product complaints with respect to the products manufactured and/or distributed by the Company or any or any Company Subsidiary, or by any Person on behalf of the Company or any or any Company Subsidiary, and to the Company’s knowledge, there are no facts that would be reasonably likely to result in a material product recall, field notification, field correction or safety alert with respect to any such products.

 

28


"3.18 Regulatory Matters." elsewhere:

Clarient (CLRT)
Wikinvest © 2006, 2007, 2008, 2009, 2010, 2011, 2012. Use of this site is subject to express Terms of Service, Privacy Policy, and Disclaimer. By continuing past this page, you agree to abide by these terms. Any information provided by Wikinvest, including but not limited to company data, competitors, business analysis, market share, sales revenues and other operating metrics, earnings call analysis, conference call transcripts, industry information, or price targets should not be construed as research, trading tips or recommendations, or investment advice and is provided with no warrants as to its accuracy. Stock market data, including US and International equity symbols, stock quotes, share prices, earnings ratios, and other fundamental data is provided by data partners. Stock market quotes delayed at least 15 minutes for NASDAQ, 20 mins for NYSE and AMEX. Market data by Xignite. See data providers for more details. Company names, products, services and branding cited herein may be trademarks or registered trademarks of their respective owners. The use of trademarks or service marks of another is not a representation that the other is affiliated with, sponsors, is sponsored by, endorses, or is endorsed by Wikinvest.
Powered by MediaWiki