Common use of Additional Development Work for Product Clause in Contracts

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 Abbott) 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 Abbott or PRONOVA to obtain an FDA approval for the NDA for the Product results in a “not approvable letter” or an equivalent communication from the FDA (a “Not Approvable Letter”) for the indication HTG, (i) RELIANT’s option under this Section 3.3 shall become immediately exercisable (and in the event RELIANT fails to provide a written notice to PRONOVA under Section 3.3(a) or Section 3.3(b) within thirty (30) days after the date of RELIANT’s receipt of the Not Approvable Letter, RELIANT shall be deemed to have exercised the option set forth in Section 3.3(b)), (ii) RELIANT shall not be obligated to make any payments under Section 4.1 otherwise payable following the issuance of an Approvable Letter or final FDA approval until such time as an Approvable Letter or final FDA approval is issued, if ever, and (iii) subject to any applicable expiration or termination provision of this Agreement, this Agreement shall remain in force as so modified.

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 AbbottXxxxxx) 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 Abbott Xxxxxx or PRONOVA to obtain an FDA approval for the NDA for the Product results in a “not approvable letter” or an equivalent communication from the FDA (a “Not Approvable Letter”) for the indication HTG, (i) RELIANT’s option under this Section 3.3 shall become immediately exercisable (and in the event RELIANT fails to provide a written notice to PRONOVA under Section 3.3(a) or Section 3.3(b) within thirty (30) days after the date of RELIANT’s receipt of the Not Approvable Letter, RELIANT shall be deemed to have exercised the option set forth in Section 3.3(b)), (ii) RELIANT shall not be obligated to make any payments under Section 4.1 otherwise payable following the issuance of an Approvable Letter or final FDA approval until such time as an Approvable Letter or final FDA approval is issued, if ever, and (iii) subject to any applicable expiration or termination provision of this Agreement, this Agreement shall remain in force as so modified.