Disclosed Matters 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.
Material Litigation Promptly after the commencement thereof, notice of all actions, suits, investigations, litigation and proceedings before any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, affecting any Loan Party or any of its Subsidiaries of the type described in Section 4.01(f), and promptly after the occurrence thereof, notice of any material adverse change in the status or the financial effect on any Loan Party or any of its Subsidiaries of the Material Litigation from that described on Schedule 4.01(f) hereto.
Resolving Disputes The Company and the customer will use all reasonable endeavours to resolve any dispute between them. If they cannot resolve their dispute between them, they will:-
a. Refer the dispute to mediation which will be conducted in accordance with the Resolution Institute New Zealand Standard Mediation Agreement; and
b. If mediation is unsuccessful, the matter of dispute shall be referred to a single arbitrator in accordance with the provisions contained in the Arbitration Xxx 0000 and any amendments. Nothing in this clause will preclude either party from taking immediate steps to seek urgent equitable relief before an appropriate Court.
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.
Litigation Matters If the FDIC Party and the Assuming Institution do not agree to submit the Dispute Item to arbitration, the Dispute Item may be resolved by litigation in accordance with Federal or state law, as provided in Section 13.10 of the Purchase and Assumption Agreement. Any litigation shall be filed in a United States District Court in the proper district.
Third Party Litigation In the event that a Third Party institutes a patent or other infringement suit against any of NovaDel, PAR or HANA or any of its respective Affiliates during the Term, alleging manufacture, use or sale of a Licensed Product in the Territory, infringes one or more patent or other intellectual property rights held by such Third Party (an “Infringement Suit”), the Parties shall cooperate with one another in defending such suit. PAR, as the NDA holder, shall have the first right to direct and control, at its expense, any Infringement Suit (including settlement negotiations, settlement or compromise thereof) to the extent that it relates to the manufacture, use or sale of a Licensed Product but does not implicate the Licensed Technology or Licensed Process. In the event that the Infringement Suit relates to the use of the Licensed Technology or Licensed Process, NovaDel shall have the first right to direct and control, at its expense, any such Infringement Suit (including settlement negotiations, settlement or compromise thereof). To the extent that any amounts become payable to any Third Party as a result of such action, whether through judgment or settlement, then PAR shall, unless HANA is jointly promoting and commercializing the Licensed Product pursuant to Section 2.4 and subject to Section 12.2, bear [***] percent ([***]%) of such amounts with respect to the Exploitation of the Licensed Product; provided, however, that PAR shall have the right to credit [***] percent ([***]%) of any amounts paid by PAR through judgment or settlement with respect to such country against the royalty payments to be paid by PAR to HANA with respect to the sale of the Licensed Product under Section 6.3; provided further, however, that no royalty payment when due, regardless of the amount or number of credits available to PAR shall be reduced by more than [***] percent ([***]%) of the amounts otherwise owed pursuant to Section 6.3 in any calendar quarter. Credits not exhausted in any calendar quarter may be carried into future calendar quarters. Notwithstanding the foregoing, in the event that no payments are due or owing, or contemplated to be due or owing, by PAR to HANA under Article 6 with respect to the sale of the Licensed Product, then NovaDel shall pay to PAR such amount owed to a Third Party up to a cap of [***]% of such amount owed to such Third Party, less any amount already credited to PAR under this Section 10.3. Notwithstanding the foregoing, NovaDel shall have no obligation under this Section 10.3 for any costs, expenses or damages that are paid or payable to a Third Party as a result of an actual or alleged infringement by PAR or HANA to the extent such costs, expenses or damages result from the use of a Product Trademark.
Labour Disputes 15.01 If employees are prevented from performing their duties because of a strike or lock-out on the premises of another employer, the employees shall report the matter to the Employer, and the Employer will make reasonable efforts to ensure that such employees are employed elsewhere, so that they shall receive their regular pay and benefits to which they would normally be entitled.
Dispute In the event of any disagreement between the undersigned or the person or persons named in the instructions contained in this Agreement, or any other person, resulting in adverse claims and demands being made in connection with or for any papers, money or property involved herein, or affected hereby, the Escrow Agent shall be entitled to refuse to comply with any demand or claim, as long as such disagreement shall continue, and in so refusing to make any delivery or other disposition of any money, papers or property involved or affected hereby, the Escrow Agent shall not be or become liable to the undersigned or to any person named in such instructions for its refusal to comply with such conflicting or adverse demands, and the Escrow Agent shall be entitled to refuse and refrain to act until: (a) the rights of the adverse claimants shall have been fully and finally adjudicated in a Court assuming and having jurisdiction of the parties and money, papers and property involved herein or affected hereby, or (b) all differences shall have been adjusted by agreement and the Escrow Agent shall have been notified thereof in writing, signed by all the interested parties.
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.
Settlement of Investment Disputes 1. Any dispute between an investor of one Contracting Party and the other Contracting Party shall be subject to a written notification by the most expeditious party. the notification shall be accompanied by an aide-memoire sufficiently detailed. To the extent possible, the parties will endeavour to resolve the dispute through negotiations, a professional opinion possible use of a third party, or by conciliation between the Contracting Parties through diplomatic channels.
2. In the absence of amicable settlement by direct arrangement between the parties to the dispute by conciliation or through diplomatic channels within six months of its notification, the dispute shall be submitted, at the choice of the investor, either to the competent court of the State in which the investment has been made or to international arbitration. To this end, each Contracting Party consents advance irrevocable and that any dispute to arbitration. this consent implies that they shall waive the requirement of exhaustion of administrative or judicial remedies.
3. In the event of recourse to international arbitration, the dispute shall be submitted to an arbitral institutions described below, at the choice of the investor: — An ad hoc arbitration tribunal established under the Arbitration Rules of the United Nations Commission on United Nations Commission on International Trade Law (UNCITRAL); — The International Centre for the Settlement of Investment Disputes (ICSID, established by the Convention on the Settlement of Investment Disputes between States and Nationals of Other States, opened for signature at Washington, on 18 March 1965, when each State Party to this agreement would be a member thereof. as long as this requirement is not fulfilled, each Contracting Party consents that the dispute be submitted to arbitration under the ICSID Additional Facility Rules: — The Court of Arbitration of the International Chamber of Commerce in Paris; — The Arbitration Institute of the Stockholm Chamber of Commerce. If the arbitration procedure has been introduced on the initiative of a Contracting Party, it shall invite in writing of the investor concerned to express his choice in the arbitration body which shall be seized of the dispute.
4. Neither of the Contracting Party, Party to the dispute raise objection shall not, at any stage of the arbitration proceedings or enforcement of an arbitration award, on account of the fact that the investor, opposing party in the dispute has received an indemnity covering the whole or part of its losses by virtue of an insurance policy or to the guarantee provided for in article 9 of this Agreement.
5. The arbitration awards shall be final and binding on the parties to the dispute. each Contracting Party undertakes to execute the decisions in accordance with its national law.
