Common use of Joint Development Program Clause in Contracts

Joint Development Program. In the event that the Joint Development Team determines, on or before *********, that the Parties should jointly undertake a MOD Development Program, the Parties, acting through the Joint Development Team and the Joint Steering Committee, shall agree upon a MOD Program Plan to reflect the agreed-upon activities to be conducted pursuant to the MOD Development Program, and shall append such MOD Program Plan to this Agreement. In such event, and subject to oversight by the Joint Development Team: (a) Transcend shall have principal responsibility for, and shall utilize reasonable diligence in connection with, (i) the conduct of the MOD Development Program in the Territory (excluding Japan), in accordance with the MOD Program Plan, (ii) compliance with required product-related regulatory approval procedures, and (iii) seeking all applicable required regulatory approvals necessary for the marketing of Licensed Products in the Territory (excluding Japan) for the treatment or prevention of MOD. (b) Unless in accordance with Section 4.1.2 BI has elected not to develop Procysteine I.V. for ARDS in Japan and the applicable rights have reverted to Transcend, BI shall have principal responsibility for, and shall utilize reasonable diligence in connection with, (i) the clinical development of Procysteine I.V. for the treatment or prevention of MOD in Japan in accordance with the MOD Program Plan, (ii) compliance with all required product-related approval procedures, and (iii) seeking applicable required regulatory approvals necessary for the marketing of Licensed Products in Japan for the treatment or prevention of MOD. (c) All Development Expenses relating to the MOD Development Program and regulatory activities undertaken pursuant to Section 4.2.2(a), including, but not limited to, out-of-pocket expenses incurred by a Party in connection with such activities at the request of the other Party, shall be borne fifty percent (50%) by each Party. BI shall bear all Development Expenses relating to the MOD Development Program and regulatory activities undertaken pursuant to Section 4.2.2 (b), Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omissions. including, but not limited to, out-of-pocket expenses incurred by Transcend in connection with such activities at the request of BI. (d) In the event that the Parties jointly undertake the MOD Development Program but the Joint Development Team is unable to reach agreement on whether to commence Phase III clinical trials, either Party shall have the right to commence Phase III clinical trials relating to the use of Procysteine I.V. for the treatment or prevention of MOD and to seek regulatory approval therefor in the Territory, and shall provide written notice of its intent to commence such trials to the Joint Steering Committee. The Party or Parties commencing such Phase III clinical trials pursuant to this subsection (d) is/are referred to as the "Commencing Party". The Commencing Party shall, except as provided below, pay ***************************** of the Development Expenses incurred in connection with the Phase III clinical trial or trials and all regulatory activities in connection therewith. If the Commencing Party files an NDA in the United States or a Major Market Country of the E.U. based on such Phase III clinical trials and receives regulatory approval for the use of Procysteine I.V. in the treatment or prevention of MOD, the other Party shall reimburse the Commencing Party for ******************************* of the Development Expenses incurred by the Commencing Party pursuant to this subsection (d). In addition, if the Commencing Party is Transcend and (i) BI wishes to retain commercialization rights to Procysteine I.V. for the treatment or prevention of MOD, BI shall, ***************** ************************************ in the United States or a Major Market Country of the E.U., pay to Transcend *********************************** with respect to ************************************* (when applicable), the filing for ************* and the receipt of ***********, as specified in Section 7.3 below; or (ii) if BI does not wish to retain commercialization rights to Procysteine I.V. for the treatment or prevention of MOD, all rights relating to Procysteine I.V. for the treatment or prevention of MOD in the Territory shall revert to Transcend, and the licenses granted under Section 3.1 shall terminate with respect to Procysteine I.V. for the treatment or Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omissions. prevention of MOD in the Territory. BI shall indicate to Transcend in writing ***************************** *************************************** of its election concerning retention of commercialization rights, PROVIDED THAT failure of BI to reimburse Transcend for Development Expenses and to make ************************************* shall be deemed to be an election by BI under subsection (d)(ii) above. If BI makes or is deemed to make an election under subsection (d)(ii) above, Transcend shall have the right to commercialize, alone or with a Third Party, Procysteine I.V. in the Territory for the treatment or prevention of MOD, PROVIDED THAT Transcend or any such Third Party shall utilize a different product name for Procysteine I.V. than is being utilized by BI for any Procysteine I.V. product for ARDS.

Joint Development Program. In the event that the Joint Development Team determines, on or before *********June 30, 1997, that the Parties should jointly undertake a MOD Development Program, the Parties, acting through the Joint Development Team and the Joint Steering Committee, shall agree upon a MOD Program Plan to reflect the agreed-upon activities to be conducted pursuant to the MOD Development Program, and shall append such MOD Program Plan to this Agreement. In such event, and subject to oversight by the Joint Development Team: (a) Transcend shall have principal responsibility for, and shall utilize reasonable diligence in connection with, (i) the conduct of the MOD Development Program in the Territory (excluding Japan), in accordance with the MOD Program Plan, (ii) compliance with required product-related regulatory approval procedures, and (iii) seeking all applicable required regulatory approvals necessary for the marketing of Licensed Products in the Territory (excluding Japan) for the treatment or prevention of MOD. (b) Unless in accordance with Section 4.1.2 BI has elected not to develop Procysteine I.V. for ARDS in Japan and the applicable rights have reverted to Transcend, BI shall have principal responsibility for, and shall utilize reasonable diligence in connection with, (i) the clinical development of Procysteine I.V. for the treatment or prevention of MOD in Japan in accordance with the MOD Program Plan, (ii) compliance with all required product-related approval procedures, and (iii) seeking applicable required regulatory approvals necessary for the marketing of Licensed Products in Japan for the treatment or prevention of MOD. (c) All Development Expenses relating to the MOD Development Program and regulatory activities undertaken pursuant to Section 4.2.2(a), including, but not limited to, out-of-pocket expenses incurred by a Party in connection with such activities at the request of the other Party, shall be borne fifty percent (50%) by each Party. BI shall bear all Development Expenses relating to the MOD Development Program and regulatory activities undertaken pursuant to Section 4.2.2 (b), Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omissions. including, but not limited to, out-of-pocket expenses incurred by Transcend in connection with such activities at the request of BI. (d) In the event that the Parties jointly undertake the MOD Development Program but the Joint Development Team is unable to reach agreement on whether to commence Phase III clinical trials, either Party shall have the right to commence Phase III clinical trials relating to the use of Procysteine I.V. for the treatment or prevention of MOD and to seek regulatory approval therefor in the Territory, and shall provide written notice of its intent to commence such trials to the Joint Steering Committee. The Party or Parties commencing such Phase III clinical trials pursuant to this subsection (d) is/are referred to as the "Commencing Party". The Commencing Party shall, except as provided below, pay ***************************** of the Development Expenses incurred in connection with the Phase III clinical trial or trials and all regulatory activities in connection therewith. If the Commencing Party files an NDA in the United States or a Major Market Country of the E.U. based on such Phase III clinical trials and receives regulatory approval for the use of Procysteine I.V. in the treatment or prevention of MOD, the other Party shall reimburse the Commencing Party for ******************************* of the Development Expenses incurred by the Commencing Party pursuant to this subsection (d). In addition, if the Commencing Party is Transcend and (i) BI wishes to retain commercialization rights to Procysteine I.V. for the treatment or prevention of MOD, BI shall, ***************** ************************************ in the United States or a Major Market Country of the E.U., pay to Transcend *********************************** with respect to ************************************* (when applicable), the filing for ************* and the receipt of ***********, as specified in Section 7.3 below; or (ii) if BI does not wish to retain commercialization rights to Procysteine I.V. for the treatment or prevention of MOD, all rights relating to Procysteine I.V. for the treatment or prevention of MOD in the Territory shall revert to Transcend, and the licenses granted under Section 3.1 shall terminate with respect to Procysteine I.V. for the treatment or Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omissions. prevention of MOD in the Territory. BI shall indicate to Transcend in writing ***************************** *************************************** of its election concerning retention of commercialization rights, PROVIDED THAT failure of BI to reimburse Transcend for Development Expenses and to make ************************************* shall be deemed to be an election by BI under subsection (d)(ii) above. If BI makes or is deemed to make an election under subsection (d)(ii) above, Transcend shall have the right to commercialize, alone or with a Third Party, Procysteine I.V. in the Territory for the treatment or prevention of MOD, PROVIDED THAT Transcend or any such Third Party shall utilize a different product name for Procysteine I.V. than is being utilized by BI for any Procysteine I.V. product for ARDS.