that Alvogen (or its designee) agrees at the written request of the applicable Regulatory Agency in the Territory will be conducted following such approval.
Regulatory Documentation means the New Drug Application used to apply for NDA Approval with respect to Product filed by or under authority of Pfenex with the FDA, including all Know-How (including data and information) incorporated therein.
Regulatory Materials means, with respect to a Product, regulatory applications (including MAAs), submissions, notices, notifications, communications, correspondence, Registrations or other filings (including requests for Therapeutic Equivalence designation) made to, received from or otherwise conducted with any Regulatory Agency (including minutes of meetings with any Regulatory Agency) that are necessary for or otherwise relate to the development, manufacture or Commercialization of such Product prepared based on or incorporating Know-How from the Regulatory Documentation.
Safety Reasons means it is a Partys reasonable belief that there is an unacceptable risk for harm in humans based upon (a) preclinical safety data, including data from animal toxicology studies, or (b) the observation of serious adverse effects in humans after Product has been administered to humans, such as during a clinical study or after the First Commercial Sale, in each of clauses (a) and (b), which would materially impact the safety or efficacy and the commercial feasibility of Product.
Sublicensee means a Third Party approved in writing in advance by Pfenex, including the entity set forth in the Product Memo, to whom Alvogen grants a sublicense under the Product License under Section 2.1 to Commercialize Product.
Tax or Taxes means any and all taxes, including value added taxes, duties, imposts, charges, withholdings, rates, levies and other governmental impositions and other taxes of any kind whatsoever imposed, assessed or charged.
Taxing Authority means any Governmental Authority responsible for the imposition, assessment or collection of any Tax, including the United States Internal Revenue Service.
Territory means Afghanistan, Algeria, Armenia, Azerbaijan, Bahrain, Chad, Comoros, Cyprus, Djibouti, Egypt, Eritrea, Georgia, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Mali, Mauritania, Morocco, Niger, Oman, Pakistan, Palestine, Qatar, Sahrawi Arab Democratic Republic, Saudi Arabia, Somalia, Sudan, Syria, Tunisia, Turkey, United Arab Emirates and Yemen.
Third Party means any Person other than a Party and such Partys Affiliates.
Trademark means, any trademark, service mark, trade dress, trade name, assumed name and entity name, together with the goodwill associated with and symbolized by such trademark, service mark, trade dress, trade name and entity name, in each case whether or not registered.
[***]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.