Glossary

Governmental authority :- The government of any nation, or of any political subdivision thereof, whether state or local, and any agency, authority , instrumentality, regulatory body, court, central bank or other entity exercising executive, legislative, judicial, taxing, regulatory or administrative powers or functions of or pertaining to government.

 

Regulatory authority :- Any applicable government regulatory authority involved in granting approvals for the manufacturing, marketing, reimbursement and/or pricing of a Product in the Territory.

 

Taxing authority :-, With respect to any Tax, the Governmental Entity that imposes such Tax, and the agency (if any) charged with the collection of such Tax for such Governmental Entity.

 

Governmental Approvals :- All authorizations, consents, approvals , licenses and exemptions of, registrations and filings with, and reports to, all Governmental Authorities.

 

Regulatory Approvals :- With respect to a Compound, any and all permissions (other than the Manufacturing approvals ) required to be obtained from Regulatory Authorities and any other competent authority for the development, registration, importation and distribution of such Compound in the United States, Europe or other applicable jurisdictions for use in the Study.

 

Tax authority :- Any Governmental authority having jurisdiction over the assessment, determination, collection or imposition of any Tax.

 

Taxes :- All present or future taxes, levies, imposts, duties, deductions, withholdings (including backup withholding), assessments, fees or other charges imposed by any Governmental authority , including any interest, additions to tax or penalties applicable thereto.

 

Authority :- Any governmental, regulatory or administrative body, agency or authority , any court or judicial authority , any arbitrator, or any public, private or industry regulatory authority , whether international, national, Federal, state, or local.

 

Permits :- All permits, licenses, franchises, approvals , authorizations, registrations, certificates, variances and similar rights obtained, or required to be obtained, from Governmental Authorities.

 

Laws :- Collectively, all international, foreign, Federal, state and local statutes, treaties, rules, guidelines, regulations, ordinances, codes and administrative or judicial precedents or authorities, including the interpretation or administration thereof by any Governmental authority charged with the enforcement, interpretation or administration thereof, and all applicable administrative orders, directed duties, requests, licenses, authorizations and permits of, and agreements with, any Governmental authority , in each case whether or not having the force of law.

 

Governmental Entity :- Any national, federal, state, municipal, local, territorial, foreign or other government or any department, commission, board, bureau, agency, regulatory authority or instrumentality thereof, or any court, judicial, administrative or arbitral body or public or private tribunal.

 

Action :- Any claim, action, suit, arbitration, inquiry, proceeding or investigation by or before any Governmental authority .

 

Regulatory Approval :- Any and all approvals, licenses, registrations, or authorizations of the relevant Regulatory authority , necessary for the Development, manufacture, use, storage, import, transport and Commercialization of a given Licensed Product in a particular country or jurisdiction. For the avoidance of doubt, Regulatory Approval outside of the United States shall include any pricing or marketing approval needed prior to the sale of a Licensed Product in the Field.

 

Environmental Law :- Any applicable Law, and any Governmental Order or binding agreement with any Governmental authority : (a) relating to pollution (or the cleanup thereof) or the protection of natural resources, endangered or threatened species, human health or safety, or the environment (including ambient air, soil, surface water or groundwater, or subsurface strata); or (b) concerning the presence of, exposure to, or the management, manufacture, use, containment, storage, recycling, reclamation, reuse, treatment, generation, discharge, transportation, processing, production, disposal or remediation of any Hazardous Materials.

 

Tax Returns :- Any and all reports, returns, declarations, claims for refund, elections, disclosures, estimates, information reports or returns or statements required to be supplied to a taxing authority in connection with Taxes, including any schedule or attachment thereto or amendment thereof.

 

Government authority :- Any: (a) nation, principality, state, commonwealth, province, territory, county, municipality, district or other jurisdiction of any nature; (b) federal, state, local, municipal, foreign or other government; (c) governmental or quasi governmental authority of any nature (including any governmental division, subdivision, department, agency, bureau, branch, office, commission, council, board, instrumentality, officer, official, representative, organization, unit, body or Person and any court or other tribunal); or (d) individual, Person or body exercising, or entitled to exercise, any executive, legislative, judicial, administrative, regulatory, police, military or taxing authority or power of any nature.

 

Tax :- Any present or future tax, levy, impost, duty, charge, assessment or fee of any nature (including interest, penalties and additions thereto) that is imposed by any government or other taxing authority in respect of any payment under this Agreement other than a stamp, registration, documentation or similar tax.

 

approvals :- All authorizations, licenses, permits, concessions, clearances, consents, orders and other approvals required to be obtained from any person, including any Governmental authority or stock exchange, in connection with the completion of the transactions contemplated by this Agreement.

 

Governmental Body :- Any government or governmental or regulatory body thereof, or political subdivision thereof, whether federal, state, local or foreign, or any agency, instrumentality or authority thereof, or any court or arbitrator (public or private).

 

Bail-In Action :- The exercise of any Write-Down and Conversion Powers by the applicable EEA Resolution authority in respect of any liability of an EEA Financial Institution.

 

Hazardous Substance :- Any substance or material meeting any one or more of the following criteria: (i) it is or contains a substance designated as a hazardous waste, hazardous substance, hazardous material, pollutant, contaminant or toxic substance under any Environmental Law, (ii) it is toxic, explosive, corrosive, ignitable, infectious, radioactive, mutagenic or otherwise hazardous to human health or the environment and is or becomes regulated by any Governmental authority , (iii) its presence may require investigation or response under any Environmental Law, (iv) it constitutes a nuisance, trespass or health or safety hazard to Persons or neighboring properties, or (v) it is or contains, without limiting the foregoing, asbestos, polychlorinated biphenyls, urea formaldehyde foam insulation, petroleum hydrocarbons, petroleum derived substances or wastes, crude oil, nuclear fuel, natural gas or synthetic gas.

 

Exercise Period :- The period during which a particular Option may be exercised and is the period from and including the Grant Date through to and including the Expiry Time on the Expiry Date provided, however, that no Option can be exercised unless and until all necessary Regulatory approvals have been obtained.

 

Governmental Order :- Any order, writ, judgment, injunction, decree, stipulation, determination or award entered by or with any Governmental authority .

 

Authorized Person :- Each employee of the Investment Adviser, whether or not an officer or an employee of a Fund, who is duly authorized by the Board to execute this Agreement and to give Instructions on behalf of such Fund as set forth in Exhibit B hereto, as may be updated from time to time, at the direction of the Fund or the Investment Adviser and each Authorized Person's scope of authority may be limited by setting forth such limitation in a written document signed by BNY Mellon and the applicable Fund. From time to time each Fund may deliver a new Exhibit B to add or delete any person and BNY Mellon shall be entitled to rely on the last Exhibit B actually received by BNY Mellon.

 

First Commercial Sale:- The first commercial sale of a Product, in exchange for cash or some equivalent to which value can be assigned, after regulatory approval has been granted by a Regulatory authority , other than the use of the Product for testing purposes and/or a sale for experimental, promotional, compassionate named patient or test market purposes. For the avoidance of any doubt, First Commercial Sale can only occur once worldwide, regardless of the jurisdiction in which it took place.

 

Eligible Assignee :- (a) A Lender, (b) An Affiliate of a Lender, (c) An Approved Fund, and (d) Any other Person (other than a natural person) approved by (i) the Administrative Agent, and (ii) unless an Event of Default has occurred and is continuing, the Borrower (each such approval not to be unreasonably withheld or delayed); provided that notwithstanding the foregoing, "Eligible Assignee" shall not include the Borrower or any of the Borrower's Affiliates or Subsidiaries.

 

Environmental permits :- Any permit, approval, identification number, license and other authorization required under any applicable Environmental Law.

Permit :- Any license, permit, approval, waiver, order, authorization, right or privilege of any nature whatsoever, granted, issued, approved or allowed by any Governmental authority .

 

Marketing Approval :- The approvalsof any federal, state or local regulatory agency, department, bureau or other government entity in a country, that are necessary to be obtained prior to the commercial sale of a Licensed Product in that country.

 

Business Combination :- A merger, consolidation, statutory share exchange or similar transaction that requires the approval of the Company's stockholders. Drug Approval

 

Application :- An application for Regulatory Approval which is required before commercial sale or use of the Product as a drug in the Territory.

 

Environmental Approval :- Any present or future permit, ruling, variance or other Authorization required under Environmental Laws.

 

Approval Date :- The date on which the stockholders of the Corporation approve a transaction the consummation of which would result in the occurrence of a Change in Control.

 

NDA :- A new Drug Application, or similar application for marketing approval of a Product for use in the Field submitted to the FDA, or its foreign equivalent.

 

Health Care Regulatory Authorizations :- Any approval, clearances, authorizations, registrations, certifications and licenses granted by any Governmental authority which administers Health Care Laws, including the FDA, the FTC, the DEA etc. In Dubai, DHA is the health care regulatory authorizator.

 

Authority Approval :- Any approval, authorization, clearance, consent or permit of a competent national or supranational authority , whether final and non-appealable or not, required by a Party under mandatory laws for the lawful and valid consummation of the sale and purchase of the Shares under this Agreement, excluding, for the sake of clarity, any approvals, authorizations or resolutions of any internal body of a Party or any of its Affiliates;