Action means any proceeding, action, claim (formal or informal, including by way of a letter), arbitration, administrative or regulatory action or other type of legal action, whether taken as a plaintiff or an initiating party (including through a request for declaratory judgment) or by way of counter-claim or defense.
Adverse Drug Responses shall be defined in more detail in any PV Agreement to include any Adverse Drug Experience as defined in the then-current 21 C.F.R. Section 314.80 and Adverse Drug Responses as defined in the then-current guidelines and regulations promulgated by the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), and any applicable equivalents.
Affiliate means any Person controlled by, controlling or under common control with another Person; provided, however, that (i) any direct or indirect stockholder of a Party that is a financial sponsor, professional investor, or investment fund (of whatever nature) and (ii) any portfolio companies or investments that is held, controlled or managed by any Person described in clause (i) shall, in each of cases (i) and (ii), be deemed to not be an Affiliate of such Party for purposes of this Agreement. For purposes of this definition, control means (a) direct or indirect beneficial ownership of fifty percent (50%) or more of the voting stock in Person, or (b) the possession, directly or indirectly, of any other power to direct or cause the direction of the management and policies of such Person, whether through ownership of voting securities, by contract or otherwise.
Alvogens Knowledge means the actual knowledge, after reasonable inquiry, of the President, Chief Financial Officer, Vice President of Legal Affairs, and Vice President of Business Development, in each case of Alvogen Inc., a Delaware corporation.
Annual Period means (a) for calendar year 2019, the period commencing on the Effective Date and ending on December 31, 2019 (or the date this Agreement is terminated if such termination occurs prior to December 31, 2019), (b) for each successive calendar year during the Term (other than the calendar year in which the Term expires or this Agreement is terminated) the period beginning on January 1st of such year and ending on December 31st of such year, and (c) for the calendar year (other than 2019) in which the Term expires or this Agreement is terminated, the period beginning on January 1st of such calendar year and ending on the effective date of the termination of this Agreement.
Applicable Law means each applicable federal, state, local or foreign constitution, treaty, law, statute, ordinance, rule, regulation, directive, policy, order, writ, award, decree, injunction, judgment, stay or restraining order of any Governmental Authority (including the EMA and FDA), the terms of any MAA Approval or Regulatory Approval, and any other ruling or decision of, agreement with or by, or requirement of any Governmental Authority.
Assignee means any Person (other than Pfenex and Alvogen) that is assigned or transferred, or succeeds to, any rights under this Agreement.
Average Sale Price means, with respect to a particular country and particular period, the weighted average sale price of Product, Bundled Product or other product or service included in a Bundled Product, as applicable, as determined by dividing (a) the Net Sales on commercial
[***]Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.