FDA Matters (a) The Corporation has (i) complied in all material respects with all applicable laws, regulations and specifications with respect to the manufacture, design, sale, storing, labeling, testing, distribution, inspection, promotion and marketing of all of the Corporation’s products and product candidates and the operation of manufacturing facilities promulgated by the U.S. Food and Drug Administration (the “FDA”) or any corollary entity in any other jurisdiction and (ii) conducted, and in the case of any clinical trials conducted on its behalf, caused to be conducted, all of its clinical trials with reasonable care and in compliance in all material respects with all applicable laws and the stated protocols for such clinical trials.
(b) All of the Corporation’s submissions to the FDA and any corollary entity in any other jurisdiction, whether oral, written or electronically delivered, were true, accurate and complete in all material respects as of the date made, and remain true, accurate and complete in all material respects and do not misstate any of the statements or information included therein, or omit to state a fact necessary to make the statements therein not materially misleading.
(c) The Corporation has not committed any act, made any statement or failed to make any statement that would breach the FDA’s policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar laws, rules or regulations, whether under the jurisdiction of the FDA or a corollary entity in any other jurisdiction, and any amendments or other modifications thereto. Neither the Corporation nor, to the Corporation’s Knowledge, any officer, employee or agent of the Corporation has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in (i) debarment under 21 U.S.C. Section 335a or any similar state or foreign law or regulation or (ii) exclusion under 42 U.S.C. Section 1320a 7 or any similar state or foreign law or regulation, and neither the Corporation nor, to the Corporation’s Knowledge, any such person has been so debarred or excluded.
(d) The Corporation has not sold or marketed any products prior to receiving any required or necessary approvals or consents from any federal or state governmental authority, including but not limited to the FDA under the Food, Drug & Cosmetics Act of 1976, as amended, and the regulations promulgated thereunder, or any corollary entity in any jurisdiction. The Corporation has not received any notice of, nor is the Corporation aware of any, actions, citations, warning letters or Section 305 notices from the FDA or any corollary entity.
UCC Matters Such Seller shall not change its state of organization or incorporation or its name, identity or corporate structure such that any financing statement filed to perfect the Purchaser’s interests under this Agreement would become seriously misleading, unless such Seller shall have given the Purchaser not less than thirty (30) days’ prior written notice of such change.
Employment Matters (a) Section 3.21(a) of the Disclosure Schedules contains a list of all persons who are employees, independent contractors or consultants of Seller as of the date hereof, including any employee who is on a leave of absence of any nature, paid or unpaid, authorized or unauthorized, and sets forth for each such individual the following: (i) name; (ii) title or position (including whether full-time or part-time); (iii) hire or retention date; (iv) current annual base compensation rate or contract fee; (v) commission, bonus or other incentive-based compensation; and (vi) a description of the fringe benefits provided to each such individual as of the date hereof. As of the date hereof, all compensation, including wages, commissions, bonuses, fees and other compensation, payable to all employees, independent contractors or consultants of Seller for services performed on or prior to the date hereof have been paid in full (or accrued in full on the balance sheet) and there are no outstanding agreements, understandings or commitments of Seller with respect to any compensation, commissions, bonuses or fees.
(b) Seller is not a party to, bound by, or negotiating any collective bargaining agreement or other Contract with a union, works council or labor organization (collectively, “Union”), and there is not, and has not been, any Union representing or purporting to represent any employee of Seller, and, to Seller’s Knowledge, no Union or group of employees is seeking or has sought to organize employees for the purpose of collective bargaining. There has never been, nor has there been any threat of, any strike, slowdown, work stoppage, lockout, concerted refusal to work overtime or other similar labor disruption or dispute affecting Seller or any of its employees. Seller has no duty to bargain with any Union.
(c) Seller is and has been in compliance in all material respects with all applicable Laws pertaining to employment and employment practices. All individuals characterized and treated by Seller as independent contractors or consultants are properly treated as independent contractors under all applicable Laws. All employees of Seller classified as exempt under the Fair Labor Standards Act and state and local wage and hour laws are properly classified. There are no Actions against Seller pending, or to the Seller’s Knowledge, threatened to be brought or filed, by or with any Governmental Authority or arbitrator in connection with the employment of any current or former applicant, employee, consultant, or independent contractor of Seller.
Investment Matters Each Member, severally and not jointly, hereby warrants and represents to the Company and to each other Member that (i) such Member is acquiring his, her or its Units solely for investment and not with a view to the distribution or resale thereof or to divide his or its participation with others, (ii) such Member is acquiring his, her or its Units with his, her or its own funds and for his, her or its own account and not on behalf of any other Person, (iii) neither such Member nor any other Person acting on his, her or its behalf has paid any commission or other compensation to any Person in connection with such Member’s acquisition of his, her or its Units, and (iv) such Member acknowledges that none of the Units has been registered or qualified under the Securities Act of 1933, as amended from time to time (the “Securities Act”), or any applicable state securities laws, and, in addition to the other restrictions on disposition contained in this Agreement, the Units may not be sold, transferred or otherwise disposed of in whole or in part unless a registration statement under the Securities Act with respect to such Units and qualification in accordance with all applicable state securities laws has become effective, or unless such Member establishes to the satisfaction of the Company that an exemption from such registration and qualification is available.
Litigation and Related Matters The commencement of, or any material development in, any action, suit, proceeding or investigation affecting the Borrower or any of its Subsidiaries or any of their respective properties before any arbitrator or Governmental Authority, (i) in which the amount involved that the Borrower reasonably determines is not covered by insurance or other indemnity arrangement is $50,000,000 or more, (ii) with respect to any Document or any material Indebtedness or preferred stock of the Borrower or any of its Subsidiaries or (iii) which, if determined adversely to the Borrower or any of its Subsidiaries, could reasonably be expected to have a Material Adverse Effect.
FINRA Matters All of the information provided to the Underwriters or to counsel for the Underwriters by the Company, its counsel, its officers and directors and the holders of any securities (debt or equity) or options to acquire any securities of the Company in connection with the offering of the Offered Shares is true, complete, correct and compliant with FINRA’s rules and any letters, filings or other supplemental information provided to FINRA pursuant to FINRA Rules or NASD Conduct Rules is true, complete and correct.
FCC Matters (a) The license attached hereto as Exhibit A is a true and correct copy of the License. There is no other condition, to the knowledge of Seller, imposed by the FCC as part of the License that is neither set forth on the face of the License as issued by the FCC, or contained in the FCC rules applicable generally to the licenses of the type, nature and class or location of the License. No other licenses or authorizations are required from the FCC for the operations of facilities in compliance with the License on the Seller Channels in the market area as of the Effective Date. Except as set forth in Section 3.5 below, no Person other than Seller has any right, title, interest or claim in or to the License. The License has been granted to Seller by Final Order and is in full force and effect.
(b) Excluding the proceedings in WT Docket No. 03-66, there is not pending or, to the knowledge of Seller, threatened against Seller or the License before the FCC or any other Governmental Authority any application, action, petition, objection or other pleading, or any proceeding with the FCC or any other Governmental Authority, which (i) questions or contests the validity of, or seeks the revocation, forfeiture, non-renewal or suspension of, the License, (ii) seeks the imposition of any modification or amendment with respect thereof, (iii) which would adversely affect the ability of Seller to consummate the Transactions, or (iv) seeks the payment of a fine, sanction, penalty, damages or contribution in connection with the use of the License. To Seller's knowledge there are no facts or circumstances existing that would give rise to any such application, action, petition, objection or other pleading, or proceeding with the FCC or any other Governmental Authority.
(c) Other than under the Interference Agreements listed in Exhibit E hereto, Seller has not located, in a search of its readily available records as of the Effective Date, any other written agreements to accept or allow any electromagnetic interference from any other FCC licensees, permittees or applicants with respect to the License and/or Seller Channels, and, to Seller's knowledge, no other such licensees, permittees or applicants have agreed to accept electromagnetic interference from Seller with respect to their respective facilities.
(d) To Seller's knowledge, Seller is in compliance with all applicable Laws except for any non-compliance that, individually or in the aggregate, will not have a material adverse effect on the License or on Seller's ability to consummate the Transactions. To Seller's knowledge, since the grant of the Seller's most recent renewal application for the License, Seller has complied in all material respects with FCC Laws applicable to the License, including without limitation the Communication Act of 1934, as amended. Since the issuance of the License, Seller has not received a notice of non-compliance from the FCC. To Seller's knowledge all material documents required to be filed at any time by Seller with the FCC with respect to the License have been timely filed or the time period for such filing has not lapsed. To Seller's knowledge, all such documents filed since the date that the License was issued to Seller are correct in all material respects. All amounts owed to the FCC in connection with the License have been timely paid.
(e) As of the Effective Date, the facilities subject to the License for which certification or notification of completion of construction has been filed with the FCC are not operating.
Patent Matters (a) As of the Effective Date:
(i) SANGAMO warrants and represents that, except as SANGAMO otherwise has advised BAXTER in writing prior to the Effective Date, it has not received written notice from any Third Party that any composition, process or use claimed by the Patent Rights infringes an issued patent of such Third Party;
(ii) SANGAMO warrants and represents that (A) it has conducted searches of public databases for issued patents and published Third Party patent applications that contain the words "zinc finger" or "nucleic acid binding proteins" in the title or abstract, and (B) that it has disclosed to BAXTER all issued patents and published Third Party patent applications that have been disclosed to SANGAMO in the results of such searches.
(iii) SANGAMO warrants and represents that it has no actual knowledge (without any duty of inquiry) of any current action conducted by a Third Party which is or would constitute an infringement of the Patent Rights in the Field;
(iv) BAXTER has had the opportunity to review such materials and to ask such questions of SANGAMO and its advisors, as BAXTXX xxxxx xxxessary or appropriate, regarding the Patent Rights. SANGAMO warrants and represents that such materials provided to BAXTER and responses to such inquiries did not contain any untrue statement of a
(v) SANGAMO warrants and represents that it has reviewed its intellectual property portfolio and believes that there are no other patents or patent applications owned by SANGAMO or licensed to SANGAMO with the right to grant sublicenses which would be infringed in the practice of the Patent Rights in the Field in the Territory. Should it later eventuate that any patent or patent application, that as of the Effective Date is owned by SANGAMO or licensed to SANGAMO with the right to grant sublicenses, would be infringed in the practice of the Patent Rights in the Field in the Territory, then that patent or patent application shall be deemed to be licensed to BAXTXX xx part of the Patent Rights under this Agreement but only to the extent necessary for BAXTER to exercise the license rights granted to it under this Agreement.
Antitrust Matters KBR and Halliburton each agree, on behalf of itself and the members of its Group, to at all times during the term of this Agreement use reasonable best efforts to assist with the other party’s full cooperation with any Governmental Authority in its investigation of Antitrust Matters and such other party’s investigation, defense and/or settlement of any claim by any Governmental Authority relating to or arising out of the Antitrust Matters. Without limiting the foregoing, a party’s reasonable best efforts to assist with the other party’s full cooperation contemplated by the preceding sentence shall include:
(a) Without limiting or qualifying the parties’ rights and obligations in Section 8.4 or Section 3.4, each of Halliburton and KBR agrees, on behalf of itself and the members of its Group, to provide, or cause to be provided, to each other as soon as reasonably practicable after written request therefor, any Information relating to the Antitrust Matters, in the possession or under the control of such party that the requesting party reasonably needs: (i) to comply with reporting, disclosure, filing or other requirements imposed on the requesting party (including under applicable securities laws) by a Governmental Authority having jurisdiction over the requesting party, (ii) for use in any Regulatory Proceeding, judicial proceeding or other proceeding or in order to satisfy audit, accounting, claims, regulatory, litigation, subpoena or other similar requirements, (iii) to allow the other party to defend or settle any claim relating to Antitrust Matters for which such party may be responsible, or (iv) to comply with its obligations under this Agreement or any Ancillary Agreement; provided, however, that neither party shall be required by this Section 8.15 to violate any Law or waive any attorney-client or other work-product privilege. In the event that any party determines that such provision of Information pursuant to this Section 8.15 could violate any Law or agreement, or waive any attorney-client or work-product privilege, the parties shall take all reasonable measures to permit the compliance with such obligations in a manner that avoids any such harm or consequence.
(b) Notwithstanding Section 8.4, each party hereby undertakes, on behalf of itself and the members of its Group, to preserve, maintain and retain all documents, records and other tangible evidence related to Antitrust Matters.
(c) Each party agrees, on behalf of itself and the members of its Group, to use reasonable best efforts to (i) make available any of its current and former directors, officers, employees, agents, distributors, attorneys and Affiliates who may have been involved in the Antitrust Matters and whose cooperation is requested by the other party, the DOJ or other Governmental Authority; and (ii) recommend orally and in writing that any and all such persons cooperate fully (including by appearing for interviews with Governmental Authorities or testimony, including sworn testimony before a grand jury) with any investigation conducted by a party, the DOJ or other Governmental Authority with respect to the Antitrust Matters.
(d) Each party agrees to promptly inform and disclose to the other party any developments, communications or negotiations between such party or any member of its Group, on the one hand, and any Governmental Authority or third party, on the other hand, with respect to Antitrust Matters, except as prohibited by law or lawful order of a Governmental Authority. In addition, upon either party’s reasonable request, the attorneys, accountants, consultants or other advisors of the Board of Directors or any committee thereof of a requested party shall brief the Board of Directors or any committee thereof of the requesting party concerning the status of or issues arising under or relating to the Antitrust Matters.
Matters To indemnify Indemnitee on account of any suit in which judgment is rendered against Indemnitee for disgorgement of profits made from the purchase or sale by Indemnitee of securities of the Company pursuant to the provisions of Section 16(b) of the Securities Exchange Act of 1934, as amended.