definiens: means, collectively, the gross invoiced sales price of all Licensed Pr oducts sold by FHI ( or for the purposes of Section 3.7(e ) and Section 8.2(b ) only, CVT or its Affiliates or sublicensees ), or its Affiliates or its Sublicensees to Third Party purchasers after deduction of the following items whether currently in effect or which become effective during the Term as they pertain to the Licensed Products : ” In addition, the final paragraph of Section 1.37 of the Agreement is hereby amended and restated as follows : “ No deductions shall be made from Net Sales for commission s paid to individuals whether they are with independent sales agencies or are regularly employed by FHI ( or for the purposes of Section 3.7(e ) and Section 8.2(b ) only, CVT or its Affiliates or sublicensees ), and/or its Affiliates or its Sublicensees and ar e on its or their payroll, or for the cost of collections . Licensed Products shall be considered when billed out or invoiced . Sales by FHI ( or for the purposes of Section 3.7(e ) and Section 8.2(b ) only, CVT or its Affiliates or sublicensees ), or its Affiliates or Sublicensees of a Licensed Product to a Third Party distributor of such Licensed Product in any given country shall be considered a sale to a Third Party purchaser . Sale or transfer to an Affiliate or Sublicensee for re -sale by such Affiliat e or Sublicensee shall not be considered a sale for the purpose of this provision, but the resale by such Affiliate or Sublicensee to a Third Party shall be a sale for such purposes . ” 8 . Cost of Goods . A new Section 1.53 of the Agreement is hereby added as follows : shall have the meaning ascribed in Section 3.4(c)(ii ) . ” 9 . CVT Manufacturing Contracts . A new Section 1.54 of the Agreement is hereby added as follows : shall have the meaning ascribed in Section 3.4(e ) . ” 10 . FHI Manufacturing Contracts . A new Section 1.55 of the Agreement is hereby added as follows : shall have the meaning ascribed in Section 3.4(d ) . ” 11 . FHI Manufacturing Technology . A new Section 1.56 of the Agreement is hereby added as follows : means Information and Improvements Controlled by FHI as of the Effective Date or during the Term that ( i ) are necessary or use ful for the commercial manufacture of Licensed Compounds and/or Licensed Products ; and ( ii ) specifically result from the CVT Manufacturing Activities or FHI Manufacturing Activities under the Agreement, including any such Information or Improvements Contro lled by FHI and arising under any CVT Manufacturing Contracts or FHI Manufacturing Contracts, or contained in the Validation Package, provided that in any case with respect to such CVT Manufacturing Activities or FHI Manufacturing Activities ( to include wo rk on the Validation Package ), such activities are Paid by CVT . For avoidance of doubt, FHI Manufacturing Technology or Improvements thereto shall only include the Information or Improvements arising under any CVT Manufacturing Contracts or FHI Manufacturi ng Contracts that are developed prior to FDA approval of the first NDA for the first Licensed Product hereunder or, as to Information or Improvements developed while preparing, conducting or completing the Validation Package, that have been developed as of completion of said Validation Package activities, irrespective of whether the timing of completion is before or after the receipt of FDA approval of the first NDA for the first Licensed Product . ” 12 . Paid by CVT . A new Section 1.57 of the Agreement is hereby added as follows : shall mean with respect to any CVT Manufacturing Activities or any FHI Manufacturing Activities, that ( A ) CVT has contributed its twenty five percent ( 25 % ) share of Development Cost payments under Sections 3 . 4(c)(i ) or ( ii ) ; or ( B ) FHI may deduct twenty five percent ( 25 % ) of the Cost of Goods under Section 3.4(c)(ii ) ; or ( C ) CVT under said Section 3.4(c)(ii ) does not owe its share because the Validation Batches or other batches could be and were sold commercia lly . ” 13 . Validation Batches . A new Section 1.58 of the Agreement is hereby added as follows : shall have the meaning ascribed in Section 3.4(c)(ii ) . ” 14 . Validation Package . A new Section 1.59 of the Agreement is hereby added as follows : shall mean the validation of the manufacturing process for the first Licensed Product for the first NDA, including, without limitation, preparation of validatio n protocols and process documentation, the manufacture of validation batches and associated batch records, and any and all validation reports and other validation -associated documentation, including any of the foregoing that is included in the first NDA fo r the first Licensed Product . ” 15 . CVT Manufacturing Activities . Section 3.4(a ) of the Agreement is hereby amended to revise the definition of CVT Manufacturing Activities to read as follows : shall mean : ( i ) CVT ’s activities in identifying, selecting, qualifying and entering into definitive agreement(s ) with Third Party(ies ) to manufacture clinical supplies of Licensed Compounds and Licensed Products and to supply raw materials and components for clinical supplies of Licensed Compounds and Licensed Products ; and ( ii ) CVT ’s activities in support of FHI Manufacturing Activities, including in connection with process development and scale up work, preparation of primary stability lots and registra tion batches, the Validation Package, and other CVT activities in support of FHI Manufacturing Activities by FHI ( on its own and with Third Parties under FHI Manufacturing Contracts ) under the Agreement . ” 16 . FHI Manufacturing Activities . Section 3.4(a ) of the Agreement is hereby further amended to revise the definition of FHI Manufacturing Activities to read as follows : shall mean FHI ’s activities up to and in connection with FDA approval of the first N DA for the first Licensed Product hereunder, in accordance with the timeline(s ) and transition plan to be determined by the Management Committee as provided above, to : ( i ) identify, select, qualify and enter into definitive agreement(s ) with Third Party(ie s ) to contract manufacture commercial supplies of Licensed Compounds and Licensed Products and to supply raw materials and components for commercial supplies of Licensed Compounds and Licensed Products ; and ( ii ) to conduct process development and scale up work to develop a commercial process for the manufacture and supply of Licensed Compounds and Licensed Products, including, without limitation, related analytical and stability work and the Validation Package . For avoidance of doubt, FHI Manufacturing Acti vities shall specifically include FHI ’s activities in securing additional sources for commercial supplies of Licensed Compound and Licensed Products . ” 17 . CVT Reimbursement of FHI . Section 3.4 ( c ) of the Agreement respecting CVT ’s responsibility to reim burse FHI for a portion of FHI Development Costs is hereby amended to become Section 3.4(c)(i ), and to add the following new Section 3.4(c)(ii ) which reads as follows : “ ( ii ) Notwithstanding the foregoing in Section 3.4(c)(i ), financial responsibility for FHI ’s Development Costs related to manufacturing Validation Batches ( defined below ) shall be allocated as follows : FHI shall be responsible for one hundred percent ( 1 00 % ) of the Cost of Goods ( defined below ) of all such batches that could by sold by FHI commercially . CVT shall be responsible for twenty -five percent ( 25 % ) of the Cost of Goods of all such batches that could not be sold by FHI commercially . FHI shall pay at the time of manufacture ( i ) one hundred percent ( 100 % ) of the Cost of Goods for batches that the Management Committee assesses could be sold commercially, and ( ii ) seventy five percent ( 75 % ) of the Cost of Goods for batches that the Management Committee assesses could not be sold commercially ; and in the event that batches for which FHI previously paid one hundred percent ( 100 % ) were not sold commercially ten ( 10 ) months prior to the expiration of the approved shelf life, FHI may deduct CVT ’s twenty -five percent ( 25 % ) allocation of such Cost of Goods from royalty and milestone payments owed under Article 5 or other monies that FHI may owe CVT hereunder . As for FHI ’s Development Costs other than Cost of Goods relating to Validation Batches, CVT shall be re sponsible for paying its twenty -five percent ( 25 % ) share of FHI ’s Development Costs as and when specified in Section 3.4(c)(i ) . As used herein, means commercial -scale batches that are manufactured for the purpose of obtaining a Regul atory Approval for a Licensed Product in the Development Field in the United States . As used herein means that portion of FHI ’s Development Costs representing ( i ) if manufactured by FHI, the directly allocable out -of - pocket costs for raw ma terials and components used in the manufacture of Validation Batches, as well as FTE Charges and any other labor charges directly resulting from the manufacture of Validation Batches ; and ( ii ) if manufactured by a Third Party, the actual invoiced price for manufacture of such Validation Batches . ” 18 . FHI Manufacturing Contracts . A new Section 3.4(d ) of the Agreement relating to FHI Manufacturing Contracts is hereby added as follows : “ ( d ) FHI hereby covenants and agrees as follows with respect to all c ontracts that it enters into with Third Parties relating to the manufacture of Licensed Compounds or Licensed Products, including for commercial scale manufacture of drug substance, drug product or finished Licensed Products during the Term ( collectively, ): ( i ) FHI will not enter into FHI Manufacturing Contracts that would contradict the terms of the Agreement or prevent CVT from having access to and the right to use FHI Manufacturing Technology and Improvements thereto Cont rolled by FHI, as provided in the Agreement . In addition, FHI will not enter into any FHI Manufacturing Contract with a Third Party that contains any exclusivity provisions that would prevent CVT from also contracting with such Third Party consistent with CVT ’s license rights under Section 8.2(b)(i ) below for the manufacture and supply of Licensed Compounds and/or Licensed Products using FHI Manufacturing Technology and Improvements thereto Controlled by FHI, as the same have been licensed by FHI to CVT und er Section 8.2(b)(i ) of the Agreement