definiens: means, as to a given Development Candidate, eithe r ( A ) any Initial Indication or any of its Related In dications, or ( B ) an Indication that is expected by the Parties, in good faith, on the basis of market data from a reco gnized provider such as IMS Health, to have anticip ated aggregate annual Net Sales for the Product containi ng such Development Candidate in the Territory in a ny [ * * * ] ( [ * * * ] ) of the [ * * * ] full Calendar Years immediate following the launch date of such Product of at lea st [ * * * ] Dollars ( $ [ * * * ] ) for such Calendar Year ; ( 2 ) if such Development Candidate is a NextGen Targeted AIM that has been Developed under a Joint Exploratory Development Pla n directly preceding such determination ( or Develop ed by Reata in an Alternative Indication pursuant to this Section 4.2(e)(ii)(2 ) ), then [ * * * ] . Notwithstandin g the foregoing, if [ * * * ] proposed that such Development Candidate should be designated as a Product Candida te for a First Indication, and [ * * * ] in the exercise of its final decision - making authority determines not to c onfer Product Candidate status on such Development Candidate for such First Indication or any other then - eligible In dication, then at the time [ * * * ] exercises such final decisio n - making authority [ * * * ] must inform [ * * * ] in writi ng [ * * * ] ; ( 3 ) if such Development Candidate is a NextGen Targeted AIM that has been Developed under a Joint Exploratory Development Pla n directly preceding such determination ( or Develop ed by the decision - making Party in an Alternative Indicat ion pursuant to this Section 4.2(e)(ii)(3 ) ), then, after the Initial Studies Period, [ * * * ] shall have the final determination as to whether such Development Candid ate shall be designated as a Product Candidate, and if so, th e Indication for which it will be Developed [ * * * ] ), exercising reasonable good faith judgment consistent with the Principles . Notwithstanding the foregoing, if at th e time of such decision - making the other Party proposed that such Development Candidate should be designated as a Product Candidate for a First Indication, and the P arty [ * * * ] in the exercise of its final decision - ma king authority determines not to confer Product Candidate status o n such Development Candidate for such First Indicat ion or any other then - eligible Indication, then at the tim e the decision - making Party exercises such final de cision - making authority the decision - making Party must inf orm the other Party in writing [ * * * ] ; ( 4 ) if such Development Candidate is a FirstGen Targete d AIM or NextGen Targeted AIM developed under a Party ’s Unilateral Explorator y Development Plan, then the Participating Explorat ory Party shall have the final decision- making authori ty on whether such Development Candidate shall be designated as a Product Candidate, and if so, the I ndication(s ) for which it will be Developed and [ * * * ] ; provided that, in each case of ( 1 ), ( 2 ), ( 3 ) and ( 4 ) above, neither Party may exercise its final decis ion - making authority to determine to Develop a particular Prod uct Candidate in more than [ * * * ] Indication without the other Party ’s written consent, except as otherwise provid ed in Section 5.7 . Once a Development Candidate is designated a Product Candidate, its further Develop ment shall be governed by the applicable Joint Deve lopment Committee and in accordance with Article 5