Common use of Plasma Clause in Contracts

Plasma. (a) Cerus and BHC acknowledge and agree that the Cooperative Development Work, as defined in the RBC/FFP Agreement, for the Plasma System; (i) continues with respect to activities directed toward obtaining CE ▇▇▇▇ in the European Territory; (ii) is terminated, effective January 1, 2005, with respect to activities directed to North America; (b) With respect to activities directed toward obtaining CE ▇▇▇▇ for the Plasma System and related manufacturing and validation, Baxter agrees, at Cerus’ request and expense, to carry out the further development activities set forth on Exhibit C to this Agreement within the time schedules set forth on such Exhibit for such activities. The charge for such activities will not exceed the amount set forth on such Exhibit, provided that the scope of such activities is not expanded. Cerus agrees to fund those Baxter activities, as well as Cerus activities, directed toward completing the application for CE ▇▇▇▇, including through funding from the Escrow Account pursuant to Section 2.8, above. (c) With respect to the countries of the BioOne Territory, it is acknowledged that Cerus has been discussing with BioOne and Baxter a potential transaction related to the Plasma System that is similar to the transaction previously EXECUTION 10 RESTRUCTURING AND SETTLEMENT AGREEMENT [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. entered into for the Platelet System. In the event such a transaction is entered into, it is anticipated that development and commercialization will be carried on by BioOne. Pending the completion of the transactions, the Parties do not expect that any Cooperative Development work will be funded specifically directed to the countries of the BioOne Territory. The parties agree to cooperate to supply information to BioOne and engage in discussions with BioOne to facilitate the completion of such transaction. Such activities will not be considered Cooperative Development work that is subject to funding under the RBC/FFP Agreement. In the event that such transaction is not entered into with BioOne or another entity within [ * ] months of the date of this Agreement, the Cooperative Development Work for the Plasma System will be considered terminated with respect to the countries of the BioOne Territory. (d) With respect to activities concerning the Plasma System directed to the ROW, the parties will pursue commercialization as provided in Section 2.13 hereof. Such activities will be at ▇▇▇▇▇▇’▇ expense and will not be considered Cooperative Development work that is subject to joint funding under the RBC/FFP Agreement, unless the parties otherwise agree at the Governance Committee level. It is understood that ▇▇▇▇▇▇ has no obligation to make any System modifications, or fund any clinical studies, that may be necessary to gain approval in any ROW country, but ▇▇▇▇▇▇ agrees that the expenses of any regulatory personnel and activities in such country will be solely ▇▇▇▇▇▇’▇ responsibility.

Appears in 1 contract

Sources: Restructuring Agreement (Cerus Corp)

Plasma. (a) Cerus and BHC acknowledge and agree that the Cooperative Development Work, as defined in the RBC/FFP Agreement, for the Plasma System; (i) continues with respect to activities directed toward obtaining CE ▇▇▇▇ in the European Territory; (ii) is terminated, effective January 1, 2005, with respect to activities directed to North America; (b) With respect to activities directed toward obtaining CE ▇▇▇▇ for the Plasma System and related manufacturing and validation, Baxter ▇▇▇▇▇▇ agrees, at Cerus’ request and expense, to carry out the further development activities set forth on Exhibit C to this Agreement within the time schedules set forth on such Exhibit for such activities. The charge for such activities will not exceed the amount set forth on such Exhibit, provided that the scope of such activities is not expanded. Cerus agrees to fund those Baxter ▇▇▇▇▇▇ activities, as well as Cerus activities, directed toward completing the application for CE ▇▇▇▇, including through funding from the Escrow Account pursuant to Section 2.8, above. (c) With respect to the countries of the BioOne Territory, it is acknowledged that Cerus has been discussing with BioOne and Baxter ▇▇▇▇▇▇ a potential transaction related to the Plasma System that is similar to the transaction previously EXECUTION 10 RESTRUCTURING AND SETTLEMENT AGREEMENT [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. entered into for the Platelet System. In the event such a transaction is entered into, it is anticipated that development and commercialization will be carried on by BioOne. Pending the completion of the transactions, the Parties do not expect that any Cooperative Development work will be funded specifically directed to the countries of the BioOne Territory. The parties agree to cooperate to supply information to BioOne and engage in discussions with BioOne to facilitate the completion of such transaction. Such activities will not be considered Cooperative Development work that is subject to funding under the RBC/FFP Agreement. In the event that such transaction is not entered into with BioOne or another entity within [ * [*] months of the date of this Agreement, the Cooperative Development Work for the Plasma System will be considered terminated with respect to the countries of the BioOne Territory. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. (d) With respect to activities concerning the Plasma System directed to the ROW, the parties will pursue commercialization as provided in Section 2.13 hereof. Such activities will be at ▇▇▇▇▇▇’▇ expense and will not be considered Cooperative Development work that is subject to joint funding under the RBC/FFP Agreement, unless the parties otherwise agree at the Governance Committee level. It is understood that ▇▇▇▇▇▇ has no obligation to make any System modifications, or fund any clinical studies, that may be necessary to gain approval in any ROW country, but ▇▇▇▇▇▇ agrees that the expenses of any regulatory personnel and activities in such country will be solely ▇▇▇▇▇▇’▇ responsibility.

Appears in 1 contract

Sources: Restructuring Agreement (Cerus Corp)