Initial Indication Sample Clauses
Initial Indication. The Parties acknowledge and agree that, as of the Effective Date, Evommune intends for the Initial Indication to be chronic spontaneous urticaria. Evommune shall use Commercially Reasonable Efforts to Develop the Product for chronic spontaneous urticaria as the Initial Indication, and shall keep Maruho reasonably informed regarding such efforts through the JSC; provided, however, that Evommune’s obligation to use Commercially Reasonable Efforts shall be deemed satisfied upon [***]. Notwithstanding the foregoing, Evommune shall have the right to change the Initial Indication; provided, however, that if Evommune changes the Initial Indication, Evommune shall provide Maruho with written notice of such change, and the Parties shall discuss in good faith [***]; and, if the Parties agree accordingly, the Parties shall [***]. For the avoidance of doubt, in the event that the Parties fail to reach an agreement regarding [***], then [***], provided, however, that, in such case, [***].
Initial Indication. 3SBio shall be responsible, at its sole expense, for conducting: (i) those clinical studies described in the Initial Indication Development Plan, including [***], and (ii) any and all other studies required by the Regulatory Authorities in the [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Licensed Territory for Regulatory Approval of the Product for the Initial Indication in the Licensed Territory ((i) and (ii), collectively, the “Initial Indication Studies”). The Initial Indication Studies will be conducted in accordance with clinical protocols approved by the JSC pursuant to Section 2.2(a)(iv) and shall be conducted in the Licensed Territory.
Initial Indication. (i) Following the Effective Date, ANTHERA shall assume all Shared Costs for the Initial Indication under the Joint Development Plan except as provided in Section 7.4(a)(ii)(1). In addition, Anthera shall assume [***]expenses for the Product for the Initial Indication incurred by or under right from ANTHERA within the ANTHERA Territory pursuant to the ANTHERA Development Plan.
(ii) Following the Effective Date, ZENYAKU shall
(1) reimburse to ANTHERA on a quarterly basis one hundred percent (100%) of the Shared Costs in the ZENYAKU Territory under the Joint Development Plan. In addition, ZENYAKU shall reimburse ANTHERA [***] percent of the Shared Cost in the ANTHERA Territory under the Joint Development Plan. Such reimbursement will be due thirty (30) days after the date of invoice from ANTHERA. For clarity and solely as an example, if, as outlined in Exhibit C, the Shared Costs for the Initial Indication incurred by or on behalf of ANTHERA related to the clinical trial for the Initial Indication (i.e. the BRIGHT-SC clinical trial) for a given quarter equal $[***] in the ANTHERA Territory, and $[***] in the ZENYAKU Territory, the ZENYAKU reimbursement to ANTHERA would be calculated as follows: (a) [***] for Shared Costs within the ANTHERA Territory, plus (b) [***] for Shared Costs within the ZENYAKU Territory. The total Shared Costs reimbursement from ZENYAKU to ANTHERA for these activities in the quarter would be $[***]. For the avoidance of doubt, ZENYAKU shall not be required to reimburse ANTHERA for any expenses that would result in double-counting of reimbursement for any individual patient expense.
(2) assume one hundred percent (100%) of any clinical development expenses for the Product for the Initial Indication incurred by or under right from ZENYAKU within the ZENYAKU Territory pursuant to the ZENYAKU Development Plan.
(3) not be responsible for any Initial Indication development costs for Products other than as specified in this Section 7.4(a)(ii). Accounting for Shared Costs shall be as provided for below in subsection (c).
Initial Indication. The term “