FDA Matters As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have or reasonably be expected to result in a Material Adverse Effect. There is no pending, completed or, to the Company’s knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have or reasonably be expected to result in a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.
Fiscal Matters a. The School District will provide all required Course Materials (textbooks and electronic materials) and will be billed for applicable Instructional Materials charges embedded in courses requiring electronic materials in accordance with the College respective course agreement. b. The School District will act as the fiscal agent for purposes of this MOU, including student fees. Based on School District policies, the School District may recover fees incurred by students. c. Any transportation and applicable food services required for Students participating in Dual Credit programs at the College site will be provided by the School District. d. All personal fines, late fees, parking tickets, etc. incurred by Student at the College are the student’s individual responsibility. e. Adjunct Instructors at the School site delivering dual credit courses may teach students enrolled in ECHS and Traditional Dual Credit in the same course section. However, Alamo Colleges District will only pay dual credit stipends for dual credit courses with 15 dual credit students or more in each course section. Dual Credit students constitute those in traditional Dual Credit or ECHS. f. The Cost-Sharing Model was implemented beginning with the 2017-18 Academic Year. Following the model of who primarily funds the cost of the Dual Credit Instructor, the Alamo Colleges District will either pay a stipend to the School District or the School District will pay the Alamo Colleges District the appropriate amount listed below. The College will verify all student enrollments per College census dates. i. Where the School District contracts the instructor to teach college courses, the Alamo Colleges District will pay $600 for each course section that contains at least 15 students. The official student enrollment count will be taken on the course sections’ census date. The Alamo Colleges District Business Office will communicate with the School District Business Office to provide the appropriate payment to be paid the first full week of December for the Fall semester and the third full week of April for the Spring semester. ii. Where the College contracts the college instructor to teach a course section and the student enrollment in each specific course section totals less than 80% of the total student enrollment count of the said course section, the School District will pay $100 per student to the Alamo Colleges District. The official student enrollment count will be taken on the course sections’ census date. The Alamo Colleges District Business Office will communicate with the School District Business Office to provide an invoice by mid-January for the Fall semester and the third full week of April for the Spring semester. Each of these invoices are to be paid net 45 days from the date of the invoice. iii. Where the College contracts the college instructor to teach a course section and the student enrollment in each specific course section totals to 80% or greater of the total student enrollment of the said course, the School District will pay $2,800 per course to the Alamo Colleges District. The official student enrollment count will be taken on the course sections’ census date. The Alamo Colleges District Business Office will communicate with the School District Business Office to provide an invoice by mid-January for the Fall semester and the third full week of April for the Spring semester. Each of these invoices are to be paid net 45 days from the date of the invoice. iv. Where Students are required to use Course Materials as part of the prescribed courses in their degree plan, as referenced in Section 13 – Course Materials, the Alamo Colleges District Business Office will communicate with the School District Business Office to provide an invoice by mid-January for the Fall semester and the third full week of April for the Spring semester. Each of these invoices are to be paid net 45 days from the date of the invoice. g. School District’s failure to meet its financial responsibilities as the fiscal agent will result in a College’s refusal of enrollment of its Students for the next Academic Year after determination of payment default and may be subject to outside collection agency action. h. Tuition promotions, incentives or discounts vary during each academic year. All current promotions are published on the Alamo Colleges District web site at: ▇▇▇.▇▇▇▇▇.▇▇▇, and are available in printed or electronic formats. Applicability of said for students enrolled in Dual Credit programs, Early College High School or Alamo Academies must be verified at the time of enrollment. Examples of promotional incentives include the “Summer Momentum Plan” published in the Alamo Colleges District web site at: ▇▇▇▇://▇▇▇.▇▇▇▇▇.▇▇▇/free.
Litigation and Environmental Matters (a) There are no actions, suits or proceedings by or before any arbitrator or Governmental Authority pending against or, to the knowledge of the Borrower, threatened against or affecting the Borrower or any of its Subsidiaries (i) as to which there is a reasonable possibility of an adverse determination and that, if adversely determined, could reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect (other than the Disclosed Matters) or (ii) that involve this Agreement or the Transactions. (b) Except for the Disclosed Matters and except with respect to any other matters that, individually or in the aggregate, could not reasonably be expected to result in a Material Adverse Effect, neither the Borrower nor any of its Subsidiaries (i) has failed to comply with any Environmental Law or to obtain, maintain or comply with any permit, license or other approval required under any Environmental Law, (ii) has become subject to any Environmental Liability, (iii) has received notice of any claim with respect to any Environmental Liability or (iv) knows of any basis for any Environmental Liability. (c) Since the date of this Agreement, there has been no change in the status of the Disclosed Matters that, individually or in the aggregate, has resulted in, or materially increased the likelihood of, a Material Adverse Effect.
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.
Environmental and Safety Matters (a) The Company and its Subsidiaries have at all times complied in all material respects with all applicable Environmental and Safety Requirements, which compliance has included obtaining and complying in all material respects at all times with all material permits, licenses and other authorizations required pursuant to Environmental and Safety Requirements for the occupation of their facilities and the operation of their respective businesses. (b) Except as set forth in Section 4.27(b) of the Disclosure Schedule, since February 19, 2008, neither the Company nor any of its Subsidiaries has received any notice, report, order, or directive regarding any, and is not subject to any litigation, proceedings or order regarding any, actual or alleged violation of Environmental and Safety Requirements, or any liability or potential liability arising under Environmental and Safety Requirements, in effect prior to and as of the date of the applicable Closing, relating to the business, the Owned Real Property or Leased Real Property. (c) Except as set forth in Section 4.27(c) of the Disclosure Schedule, neither the Company nor any of its Subsidiaries has treated, stored, disposed of, arranged for or permitted the disposal of, transported, handled, released, or exposed any Person to, any substance (including without limitation any hazardous substance), owned or operated any property or facility which is or has been contaminated by any substance, so as to give rise to any current or future liabilities under any Environmental and Safety Requirements in effect at the time of such treatment, storage, disposal, transportation, handling, release or exposure. (d) Except as set forth in Section 4.27(d) of the Disclosure Schedule, neither the Company nor any of its Subsidiaries has assumed, undertaken, or provided any indemnity with respect to, any liability of any other Person relating to Environmental and Safety Requirements. (e) The Company has furnished to Investor true and correct copies of all environmental audits, reports, assessments and all other documents materially bearing on environmental, health or safety liabilities relating to the past or current operations or facilities of the Company and all of its Subsidiaries, in each case which are in its possession or under its reasonable control.