Additional Development Work for Product Sample Clauses

Additional Development Work for Product. In the event the NDA filed for the Product results in an “approvable” letter or a succeeding equivalent communication from the FDA in the form of a regulatory decision letter (an “Approvable Letter”), RELIANT shall have the option to either: (a) notify PRONOVA in writing within thirty (30) days after the date of RELIANT’s receipt of the Approvable Letter, that RELIANT will contribute to the continued development of the Product and pay to PRONOVA the Approvable Letter milestone payment pursuant to Section 4.1 (as set out in Schedule 4.1). In such event, RELIANT will contribute to and fund all further development of the Product (other than development costs otherwise funded by ▇▇▇▇▇▇) in order to obtain a final FDA approval of the Product for the indication HTG; provided, however, that PRONOVA shall be solely responsible for any expenses with respect to supply chain or manufacturing issues raised by the FDA; provided, further, that in the event that RELIANT determines that it no longer desires to continue to fund such development costs, it may cease such funding and transfer the Registration for the Product to PRONOVA free of charge, save for an equitable distribution of any proceeds of any subsequent transaction involving the Registration for the Product within two years after RELIANT ceased funding, which shall be agreed between the Parties in good faith to discussions. Upon final FDA approval RELIANT will pay to PRONOVA the final approval payment pursuant to Section 4.1 (as set out in Schedule 4.1), which will be reduced by 50% of all pre-marketing development costs actually incurred prior to final FDA approval by or on behalf of RELIANT in accordance with this Section 3.3, provided that in no event shall such reduction reduce the final approval payment below USD 0; or (b) notify PRONOVA in writing within thirty (30) days after the date of RELIANT’s receipt of the Approvable Letter, that RELIANT will not contribute to the work and expenses necessary to meet the conditions required to obtain an FDA approval. In such event (or in the event RELIANT fails to provide a written notice to PRONOVA under Section 3.3(a) or 3.3(b) within thirty (30) days after the date of RELIANT’s receipt of the Approvable Letter), the initial up front payment paid by RELIANT pursuant to Section 4.1 (as set out in Schedule 4.1) will remain with PRONOVA and this Agreement shall automatically terminate. In the event that the initial effort by ▇▇▇▇▇▇ or PRONOVA to obtain an FDA approv...