Income Tax Matters (a) In order to comply with all applicable federal or state income tax laws or regulations, the Company may take such action as it deems appropriate to ensure that all applicable federal or state payroll, withholding, income or other taxes, which are the sole and absolute responsibility of Grantee, are withheld or collected from Grantee.
(b) The Company shall reasonably determine the amount of any federal, state, local or other income, employment, or other taxes which the Company or any of its affiliates may reasonably be obligated to withhold with respect to the grant, vesting, or other event with respect to the Restricted Stock Units. The Company may, in its sole discretion, withhold a sufficient number of shares of Common Stock in connection with the vesting of the Restricted Stock Units at the Fair Market Value of the Common Stock (determined as of the date of measurement of the amount of income subject to such withholding) to satisfy the minimum amount of any such withholding obligations that arise with respect to the vesting of such Restricted Stock Units. The Company may take such action(s) without notice to the Grantee, and the Grantee shall have no discretion as to the satisfaction of tax withholding obligations in such manner. If, however, any withholding event occurs with respect to the Restricted Stock Units other than upon the vesting of such Restricted Stock Units, or if the Company for any reason does not satisfy the withholding obligations with respect to the vesting of the Restricted Stock Units as provided above in this Section 8(b), the Company shall be entitled to require a cash payment by or on behalf of the Grantee and/or to deduct from other compensation payable to the Grantee the minimum amount of any such withholding obligations.
(c) The Restricted Stock Unit Award evidenced by this Agreement, and the issuance of shares of Common Stock to the Grantee in settlement of vested Restricted Stock Units, is intended to be taxed under the provisions of Section 83 of the Code, and is not intended to provide and does not provide for the deferral of compensation within the meaning of Section 409A(d) of the Code. Therefore, the Company intends to report as includible in the Grantee’s gross income for any taxable year an amount equal to the Fair Market Value of the shares of Common Stock covered by the Restricted Stock Units that vest (if any) during such taxable year, determined as of the date such Restricted Stock Units vest. In furtherance of this intended tax treatment, all vested Restricted Stock Units shall be automatically settled and payment to the Grantee shall be made as provided in Section 1(c) hereof, but in no event later than March 15th of the year following the calendar year in which such Restricted Stock Units vest. The Grantee shall have no power to affect the timing of such settlement or payment. The Company reserves the right to amend this Agreement, without the Grantee’s consent, to the extent it reasonably determines from time to time that such amendment is necessary in order to achieve the purposes of this Section.
Transitional Matters (a) Each of the parties acknowledges and agrees that the transition of the Business from the Selling Companies to Buyer will require that certain transactions and relationships will need to be entered into, restructured and reorganized in connection with the transition of the Business from the Selling Companies to Buyer. The parties agree that prior to the Closing Date, the parties shall cooperate with each other to identify all such transactions and relationships and negotiate in good faith to enter into a mutually acceptable Transitional Agreement effective as of the Closing Date, which agreement shall provide for all such transactions and relationships as are reasonably necessary to provide,
(i) for (A) the operation of the Business and use of the Purchased Assets by Buyer, (B) the operation and use of the Excluded Assets by Sellers and the Selling Subsidiaries and (C) the separation of the Business, the Purchased Assets and the Assumed Liabilities from Parent and its Affiliates (including the Selling Companies), in each case during the period commencing on and after the Closing Date and ending no later than the one year anniversary of the Closing Date or such longer period as the parties may agree, including the following:
(1) the transitioning of the financial systems, assets and hedging valuation systems, asset management systems, payroll and employee benefits systems and any other applicable business operating systems;
(2) the provision of rights of access (provided that access to the ALSS Platform shall be governed and limited by the Intellectual Property Rights Agreement and the Services Agreement) to the Parent and its Affiliates to Intellectual Property currently owned (or licensed) by the Selling Companies (and included in the Purchased Assets) and used by Parent or the Selling Companies in the ordinary course of their business, or required by the Selling Companies for the operation and use of the Excluded Assets or Excluded Liabilities; provided, that access to the ALSS Platform and other Software shall be governed solely by the Intellectual Property Rights Agreement and the Services Agreement and, provided further, anything foregoing to the contrary notwithstanding, Buyer shall not be required to disclose or deliver trade secret or confidential information regarding the ALSS Platform, Software or Acquired Intellectual Property unless required by the Intellectual Property Rights Agreement, the Services Agreement or required by law or legal proceedings and under the type of protective provisions in the Intellectual Property Rights Agreement.
(3) the provision of rights of access (to the extent not covered by the Intellectual Property Rights Agreement) to Buyer to Intellectual Property currently owned (or licensed) by Parent (or the Selling Companies) and used by the Selling Companies in connection with the Purchased Assets or Assumed Liabilities;
(4) moving corporate records related to the Selling Companies; and
(5) the provision of office space, computer equipment and supplies sufficient to enable the Selling Companies to complete any transition services; and
(ii) for such services and facilities as Sellers and Selling Subsidiaries may require to monitor compliance with, and implementation of the Subservicing Agreement, during its term, including the provision of office space, computer equipment and supplies sufficient to enable Sellers to monitor compliance with the Retained Portfolio Subservicing Agreement throughout its term.
(b) In addition to the matters to be identified pursuant to paragraph (a) of this Section 5.12, the Transition Agreement shall specifically provide for the transactions and matters outlined in Section 5.12 of Sellers' Disclosure Schedule.
(c) For the purpose of facilitating the transition of the financial system, on or prior to the 15th day prior to the Closing Date, the Selling Companies shall create on their general ledger, a separate general ledger company ("GL Company"), as well as accounts for such GL Company ("Buyer GL Accounts"), which accounts shall be duplicative of the Selling Companies' own accounts ("Seller GL Accounts") and are intended to be used by the Buyer in the operation of the Business, the Purchased Assets and the Assumed Liabilities from and after the Closing Date. From and after the creation of the Buyer GL Accounts, until Closing, the Selling Companies shall maintain such accounts (as duplicate entries on the books of the Selling Companies in the name of the GL Company). From and after Closing until the completion of the transition of the financial system of the Selling Companies, the Buyer shall operate the Business by recording entries using the Buyer GL Accounts, and shall maintain on behalf of the Selling Companies, the Seller GL Accounts on its general ledger.
(d) The party receiving service under the Transitional Agreement shall pay to the party providing service the costs incurred by such providing party. Services provided under the Transitional Agreement shall be performed at the same standard as the providing party performs such service for its own account.
Operational Matters 7.1 The LGB shall comply with the obligations set out in Appendix 2 which deals with the day-to-day operation of, and delegation of responsibilities to, the LGB.
7.2 The LGB will adopt and will comply with all policies of the Trustees communicated to the LGB from time to time.
7.3 Both the Trustees and all members of the LGB have a duty to act with integrity, objectivity and honesty in the best interests of the Company and the Academy and shall be open about decisions and be prepared to justify those decisions except in so far as any matter may be considered confidential.
7.4 The LGB will review its policies and practices on a regular basis, having regard to recommendations made by the Trustees from time to time, in order to ensure that the governance of the Academy is best able to adapt to the changing political and legal environment.
7.5 The LGB shall provide such data and information regarding the business of the Academy and the pupils attending the Academy as the Trustees may require from time to time.
7.6 The LGB shall submit to any inspections by the Trustees, and any inspections pursuant to section 48 of the Education Act 2005 (Statutory Inspections of Anglican and Methodist Schools).
7.7 The LGB shall work closely with and shall promptly implement any advice or recommendations made by the Trustees in the event that intervention is either threatened or is carried out by the Secretary of State and the Trustees expressly reserve the unfettered right to review or remove any power or responsibility conferred on the LGB under this Scheme in such circumstances.
Franchise Matters (a) As of the Effective Date, Schedule 3.27(a) attached hereto sets forth a true and complete list of all Franchise Agreements to which the Loan Parties or any of their Subsidiaries is a party or by which the Loan Parties or any of their Affiliates or Subsidiaries or its or their properties is bound (other than any such agreements between a person and its Subsidiaries or among its Subsidiaries) and that grant to a person (a “Franchisee”) the right to operate or license others to operate or to develop within a specific geographic area or at a specific location an F45 training franchised business (each a “Franchised Business”). True, correct, and complete copies of all Franchise Agreements (or documents purporting to contain substantially the content of each such Franchise Agreement) set forth on Schedule 3.27(a) are, upon request by the Administrative Agent or any Lender, available to the Lenders. As of the Effective Date, the countries listed on Schedule 3.27(a) are the only countries in which the Loan Parties have sold or granted a Franchise or master franchise for the right to operate any Franchised Business and the right to sub-franchise such rights, if any.
(b) All the Franchise Agreements of the Loan Parties and their Subsidiaries are in full force and effect and are valid and binding obligations of the Loan Parties and their Subsidiaries that are party thereto and enforceable against such Loan Parties and their Subsidiaries and, to the knowledge of the Borrower, the other parties thereto in accordance with their respective terms, subject, as to enforceability, to bankruptcy, insolvency, and other laws of general applicability relating to or affecting creditors’ rights and to general equity principles. All Franchise Agreements comply in all material respects with the Requirement of Law applicable thereto. The execution and delivery by the Loan Parties of this Agreement do not, and the consummation of the Transactions and the other transactions contemplated by this Agreement and compliance with the provisions of this Agreement will not, conflict with, or result in any violation of, or default (with or without notice or lapse of time, or both) under, or give rise to a right of termination, cancellation or acceleration of any obligation or to the loss of a benefit under, or result in the creation of any Lien upon any of the properties or assets of the Loan Parties or any of their Subsidiaries under (other than any Lien permitted by the terms of this Agreement) or any right of rescission or set-off under, any provision of any Franchise Agreement. Except by operation of law, no Franchise Agreement expressly grants any Franchisee any right of rescission or set-off; and no Franchisee has asserted in writing any such right of rescission or set-off. There is no default under any Franchise Agreement by the Loan Parties or any of their Subsidiaries or, to the knowledge of the Borrower, by any other party thereto, and no event has occurred that with the lapse of time or the giving of notice or both would constitute a default thereunder by the Loan Parties or any of their Subsidiaries or, to the knowledge of the Borrower, by any other party thereto, except, in each case, any default that, individually or in the aggregate, could not reasonably be expected to result in a Material Adverse Effect or to result in an adverse determination with a monetary liability in an aggregate amount in excess of $2,500,000 against one or more Loan Parties or their Subsidiaries.
(c) As of the Effective Date, Schedule 3.27(c) sets forth a true and correct list of: (i) the United States jurisdictions in which the Loan Parties and their Subsidiaries are currently, registered or authorized to offer and sell franchises (under a Franchise Law) and the jurisdictions in which the Loan Parties or any of their Subsidiaries sold a Franchised Business under a Franchise Law and under the FTC Franchise Rule and (ii) the non-United States jurisdictions in which the Loan Parties or any of their Subsidiaries has sold or entered into, offered, Franchises.
(d) The Loan Parties and their Subsidiaries have prepared and maintained each uniform franchise offering circular, franchise disclosure document and similar document used in the offer and sale of franchises anywhere in the world by the Loan Parties (“FDD”) in compliance with: (A) franchise guidelines published by the FTC and the North American Securities Administrators Association (collectively, “Franchise Guidelines”); (B) the FTC Franchise Rule; and (C) the Franchise Laws, except, in each case, where any failure to comply, individually or in the aggregate, could not reasonably be expected to result in (i) a Material Adverse Effect or (ii) an adverse determination with a monetary liability in an aggregate amount in excess of $2,500,000 against one or more Loan Parties or their Subsidiaries. The Loan Parties and their Subsidiaries have offered and sold each Franchise Agreement for a Franchised Business to be located in any non-United States jurisdiction (the “Foreign Franchises”) in compliance with the Requirement of Law, including pre-sale registration and disclosure laws, except, in each case, where any failure to comply, individually or in the aggregate, could not reasonably be expected to result in (i) a Material Adverse Effect or (ii) an adverse determination with a monetary liability in an aggregate amount in excess of $2,500,000 against one or more Loan Parties or their Subsidiaries.
(e) The Loan Parties and their Subsidiaries have not, in any FDD, other franchise disclosure document, in applications or filings with states under the Franchise Laws, made any untrue statement of a material fact, omitted to state a material fact required to be stated therein, or omitted to state any fact necessary to make the statements made therein, taken as a whole, not misleading.
(f) Except as set forth in Schedule 3.27(f), the Loan Parties and their Subsidiaries have not, and have not authorized any Person to furnish: (i) to prospective franchisees in any United States jurisdiction any materials or information that could be construed as an “earnings claim” or “financial performance representation” as specified in the FTC Franchise Rule, and Franchise Guidelines (collectively, “FPRs”), and no FPR has been made to any prospective Franchisee in any United States jurisdiction; or (ii) to prospective franchisees in any non-United States jurisdiction any materials or information from which a specific level or range of actual or potential sales, costs, income, or profit from franchised or non-franchised units may be easily ascertained, except, in the case of clauses (i) and (ii) above, where the furnishing of such information, individually or in the aggregate, could not reasonably be expected to result in (i) a Material Adverse Effect or (ii) an adverse determination with a monetary liability in an aggregate amount in excess of $2,500,000 against one or more Loan Parties or their Subsidiaries.
(g) As of the Effective Date, Schedule 3.27(g) lists each contract pursuant to which the Loan Parties or any of their Subsidiaries or Affiliates receives rebates in excess of $250,000 in any Fiscal Year as a result of transactions between the Franchisees and suppliers selling products or services to the Franchisees. No contract pursuant to which the Loan Parties or their Subsidiaries or Affiliates receives a rebate is (i) prohibited by any Franchise Agreement, (ii) not disclosed in accordance with the Franchise Guidelines in the relevant FDD, if applicable, or (iii) not disclosed in accordance with the Requirement of Law with respect to Foreign Franchises.
(h) The Loan Parties and their Subsidiaries have made on a timely and accurate basis all required additional filings under the Franchise Laws, including filings with respect to material changes, advertising, broker and salesperson registrations, amendments, and renewals, and the Loan Parties and their Subsidiaries have not offered or executed a Franchise Agreement or offered or sold the rights granted therein in any jurisdiction in which such offer and sale was not duly registered (if registration was required by a Franchise Law) or exempt from registration at the time the offer was made and the sale occurred, and the Loan Parties and their Subsidiaries have otherwise complied with all applicable FDD and Franchise Agreement delivery requirements under applicable Franchise Laws, and, in each case, obtained receipts evidencing delivery and receipt thereof, except where any failure to make such additional filings or to register such offer and sale could not reasonably be expected to result in a Material Adverse Effect. The Loan Parties and their Subsidiaries have not otherwise engaged in the offer, sale, or execution of Franchise Agreements in violation of applicable Franchise Laws, or unfair or deceptive trade practices law or regulation or similar law or regulation.
(i) Neither the Loan Parties nor any of their Subsidiaries is subject to any currently effective order, injunction, or similar mandate with respect to the offer or sale of Franchise Agreements in any jurisdiction. Except as set forth in Schedule 3.27(i), there are no proceedings pending (or to the knowledge of the Loan Parties, threatened in writing) against the Loan Parties or any of their Subsidiaries alleging failure to comply with any Franchise Laws or Relationship Laws, or any similar Requirement of Law of any other jurisdiction, foreign or domestic.
(j) Except to the extent granted to a Franchisee in its Franchise Agreement, and except as provided by operation of law: (A) no Franchisee has a protected territory, exclusive territory, right of first refusal, option, or other similar arrangement with respect to a Franchised Business and (B) no person currently holds any right or option to operate, develop, or locate a Franchised Business, or to exclude the Loan Parties, any of their Subsidiaries or Affiliates, or others from operating or licensing a third party to operate a Franchised Business, in any geographic area or at any location.
(k) Except as disclosed in writing in the Loan Parties’ most-recently issued FDD, none of Loan Parties’ Subsidiaries or Affiliates presently offer or sell franchises or business opportunities in any line of business, and no Subsidiary or Affiliate of Loan Parties that has offered or sold franchises or business opportunities in any line of business (other than the Franchised Business) is obligated or liable in any respect under or in connection with such franchises or business opportunities.
(l) As of the Effective Date, Schedule 3.27(l) lists the material contracts that are in effect as of the date hereof with any formal or informal franchisee association or group of Franchisees regarding any Franchise Agreement or franchise operational matter.
(m) As of the Effective Date, Schedule 3.27(m) lists the Franchisees, if any, that to the knowledge of the Loan Parties are currently the subject of a bankruptcy or similar proceeding.
(n) With respect to all expirations, terminations, and nonrenewals of Franchisees or Franchise Agreements, the Loan Parties and their Subsidiaries have complied with all applicable franchise termination, nonrenewal, unfair practices, and Relationship Laws, including the Requirement of Law with respect to the proper notice of default, time to cure, and the actual termination of any Franchisee or business opportunity operator, except, in each case, where the failure to comply, individually or in the aggregate, could not reasonably be expected to result in a Material Adverse Effect or result in an adverse determination with a monetary liability in an aggregate amount in excess of $2,500,000 against one or more Loan Parties or their Subsidiaries.
(o) Except as disclosed in writing to the Administrative Agent, since December 31, 2020, no Loan Party has waived any material right or benefit of any such Person, or any material obligation of any Franchisee, under any Franchise Agreement, including, without limitation, any buy-out option, and no waiver of any such rights is currently in effect.
(p) Except as set forth on Schedule 3.27(p) and any waiver, alteration or modification that could not reasonably be expected to result in a Material Adverse Effect or could not be expected to reduce such payments by more than $2,500,000 in the aggregate, since December 31, 2020, no Loan Party has waived, altered or modified any material provision regarding the calculation and payment of royalty fees in any Franchise Agreement, and no waiver regarding the calculation and payment of royalty fees is currently in effect.
(q) Except as set forth on Schedule 3.27(q) or disclosed in writing to the Administrative Agent, no Loan Party is (i) a guarantor or party to an agreement pursuant to which any of the Loan Parties is directly or contingently liable (as a co-xxxxxx or otherwise) for any material obligations of any Franchisee, subject to general vicarious liability and related principles, (ii) a lessor or sublessor of any real or personal property to any Franchisee, or (iii) a party to any financing arrangement with any Franchisee, including, but not limited to, any promissory note, guaranty or security agreement.
(r) Except as set forth on Schedule 3.27(r) or disclosed in writing to the Administrative Agent, there are no area representatives, development agents, regional directors or other Persons that provide support services to Franchisees on behalf of the Loan Parties pursuant to a written agreement with the Loan Parties, other than employees of the Loan Parties. Except for the Loan Parties or any employees of or consultants engaged by the Loan Parties, no Loan Party has ever used “franchise sellers” as such term is defined in the FTC Franchise Rules in connection with the offer or sale of Franchises.
(s) No Loan Party has exercised control over any Franchisee’s relationship with its employees, including hiring, firing, disciplining, compensation, benefits, supervision, and scheduling.
(t) None of the Franchise Agreements require any of the Loan Parties to notify any Franchisee of the financing transactions contemplated by this Agreement and no Franchise Agreement requires the Franchisee thereunder to consent to, or approve of, the financing transactions contemplated by this Agreement.
(u) None of the Franchise Agreements (i) require the consent of the franchisee thereunder in connection with the transfer or assignment by the franchisor of any of its rights or obligations thereunder to any Person or (ii) prohibit the franchisor thereunder from selling its assets to a third party, offering its securities privately or publicly, merging with or acquiring other Persons, or being acquired by another Person, or undertaking any refinancing, recapitalization, leverage buyout or other economic or financial restructuring.
U.S. Tax Matters The Arrangement is intended to qualify as a “reorganization” within the meaning of Section 368(a)(1) of the Code, and this Agreement and the Plan of Arrangement are intended to constitute a “plan of reorganization” within the meaning of the U.S. Treasury Regulations promulgated under Section 368 of the Code for purposes of Sections 354 and 361 of the Code and the Parties will cooperate on a reasonable basis consistent with the Parties’ intention that the transactions contemplated by this Agreement and the Plan of Arrangement qualify as a reorganization within the meaning of Section 368(a) of the Code, including, if necessary, and upon the request of the Parties, restructuring such transactions to include one or more amalgamations of the Company (or any resulting person in any such amalgamation) with one or more wholly owned subsidiaries of the Purchaser. Each Party hereto shall treat the Arrangement as a “reorganization” within the meaning of Section 368(a) of the Code and shall treat this Agreement and the Plan of Arrangement as a “plan of reorganization” within the meaning of the U.S. Treasury Regulations promulgated under Section 368 of the Code, for all U.S. federal income tax purposes, and shall not take any position on any Return or otherwise take any Tax reporting position inconsistent with such treatment, unless otherwise required by applicable Law. Except as otherwise provided in this Agreement and in the Plan of Arrangement, each Party hereto shall act in a manner that is consistent with the Parties’ intention that the Arrangement be treated as a “reorganization” within the meaning of Section 368(a) of the Code for all U.S. federal income tax purposes, and shall not take any action, or knowingly fail to take any action, including any action that is reasonably requested by the other Party if such action or failure to act would reasonably be expected to prevent the Arrangement from qualifying as a reorganization within the meaning of Section 368(a) of the Code. Notwithstanding the foregoing, neither Party makes any representation, warranty or covenant to the other Party or to any Nomad Shareholder, Purchaser Shareholder or other holder of Nomad securities or Purchaser securities (including, without limitation, stock options, warrants, debt instruments or other similar rights or instruments) regarding the U.S. federal income tax treatment of the Arrangement, including, but not limited to, whether the Arrangement will qualify as a reorganization within the meaning of Section 368(a) of the Code or as a tax-deferred reorganization for purposes of any United States state or local income tax Law.
Accounting, Tax and Regulatory Matters Each Owner and the Company, -------------------------------------- jointly and severally, represents and warrants to Premiere that neither the Company, any Owner nor any Affiliate thereof has taken or agreed to take any action or has any knowledge of any fact or circumstance that is reasonably likely to (i) prevent the Merger from qualifying for pooling-of-interests accounting treatment or as a reorganization within the meaning of Section 368(a) of the Code, or (ii) materially impede or delay receipt of any consents referred to in Section 5.6 of the Uniform Terms or result in the imposition of a condition or restriction of the type referred to in the last sentence of such Section.
Personnel Matters 7.1 Verbal or written complaints regarding an employee made to any member of the Administration by any parent, student or other person which is to be placed in any personnel file or which may be used to evaluate or discipline an employee shall be promptly investigated. The employee shall be given prompt notice of such complaint and shall be given the opportunity to respond to the complaint. Unsubstantiated complaints shall not be placed in an employee’s file.
7.2 Each employee shall be entitled to access to his/her personnel file. This review shall take place during an agreed upon time; requests to examine the file need to be made to the Superintendent or his/her designee at least 24 hours prior and shall not be unreasonably withheld. The employee may, if he/she wishes, have a representative of the Association accompany him/her during such review.
7.3 The employee shall have the right to make a response to any material contained in his/her personnel file and such response shall be made a part of said employee’s file. Reproductions of such material may be made by hand or copying machine, if available.
7.4 No disciplinary material will be placed in an employee's personnel file without written or electronic notification to the employee.
7.5 The Board agrees to maintain, as part of its general policy manual, job descriptions for members of the bargaining unit; said policy manual to be made available to each member of the bargaining unit and any new employee. Whenever the District contemplates any changes in job description, the District will notify the Association on the planned action and convene the Job Description Team per the Memorandum of Understanding included in Exhibit 1.
Organizational Matters The Partners agree as follows:
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.
Company Counsel Matters i. On the Closing Date, the Placement Agent shall have received the favorable opinion of Hxxxxx and Bxxxx, LLP, outside counsel for the Company counsel to the Company, dated the Closing Date and addressed to the Placement Agent, substantially in form and substance reasonably satisfactory to the Placement Agent.