Additional Indications. 20 3.9 Improvements .............................................. 21
Additional Indications. Prior to the execution of the License Agreement in accordance with Section 2, CPP shall have the right, in its sole discretion, to develop the Product in any indication; provided, however that if CPP wishes to develop the Product in the Field in the Territory in an indication other than familial adenomatous polyposis (“FAP”) (such indication, an “Additional Indication”), then CPP shall provide Sucampo with a proposed development plan and corresponding budget for the Product in such Additional Indication (“Proposed Development Plan and Budget”) at least seventy (70) days prior to CPP submitting any Regulatory Filing for the Product in such Additional Indication. Sucampo may, in its sole discretion, concur in the Development of the Product in such Additional Indication under such Proposed Development Plan and Budget in writing within sixty (60) days of receiving such Proposed Development Plan and Budget, or such later date as may be mutually agreed (such time period the “Indication Review Period”, such concurred indication, a “Sucampo-Approved Indication”, and such concurred Proposed Development Plan and Budget, a “Sucampo-Approved Indication Development Plan and Budget”). If, in response to a Proposed Development Plan and Budget, Sucampo does not concur in the development of such Additional Indication prior to the expiration of the Indication Review Period, then subject to Section 4.3, (a) CPP shall have the right to develop the Product in the corresponding Additional Indication at CPP’s sole cost and expense in accordance with the Proposed Development Plan and CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Budget, and (b) such Proposed Development Plan and Budget shall thereafter be a “CPP Additional Indication Development Plan and Budget”.
Additional Indications. In further recognition by the Parties that ICN's development studies with respect to other indications of the Product should not interfere with the development activities conducted by Schering with respect to the chronic hepatitis C indication, if ICN pursues an additional indication for the Product in any country in the Territory, then (subject to compliance with Section 3.1(f) in the case of a hepatitis C indication):
Additional Indications. 4.3.1. Xxxxxx and Onconova shall work together in good faith to maximize the value of the Licensed Product in future indications in hematology, oncology and other indications (beyond the Initial Indications). Not less than once every **, Onconova shall review with Xxxxxx potential new indications for the Licensed Product in the Licensed Field beyond the Initial Indications (each such indication, an “Additional Indication”) within the Licensed Territory. Onconova shall inform Xxxxxx in writing of such Additional Indication(s) and the Parties shall discuss the estimated timing, cost, revenue expectations, pre-clinical or clinical data and other relevant aspects of such Additional Indication(s). Xxxxxx shall, within ** of receipt of Onconova’s written proposal: (a) inform Onconova in writing of its intent to participate in the development of such Additional Indication(s) or (b) inform Onconova in writing that it is deferring the decision to participate in the clinical development for such Additional Indication(s). Xxxxxx’x failure to respond to Onconova’s proposal within such ** period shall be deemed Xxxxxx’x deferring the decision to participate in the development for such Additional Indication(s).
Additional Indications. At any time prior to [***] months before the [***], either Party may propose to Develop in the Profit Share Territory Licensed Products for one or more additional indications in the Field (i.e., in addition to the First Indication) by submitting to the JDC a written proposal for the Development thereof, including a proposed work plan, budget and timeline. Upon mutual written agreement by the Parties to Develop such indication(s), the JDC shall update the Core Development Plan to include such indication consistent with Section 4.2. Until the Profit Share Territory Transition Date, UGNX shall use Commercially Reasonable Efforts to Develop at least one additional indication mutually agreed-upon by the Parties pursuant to the foregoing sentence (each such indication, an “Additional Indication”) and shall complete any On-Going Clinical Trials. For the avoidance of doubt, subject to the terms of this Agreement, on and after the [***].
Additional Indications. Assignment of an Additional Indication as either a Roche Bioscience Indication or a Tularik Indication shall be negotiated in good faith between the Parties on an as needed basis. Following such negotiation, such Additional Indication shall become a Roche Bioscience Indication or a Tularik Indication, as the case may be; provided, however, that if after such negotiations, the parties cannot agree on the assignment of an Additional Indication, the Chair of the Research Management Committee shall throw a well-balanced United States coin into the air and a representative from Roche Bioscience shall call heads or tails while such coin is in the air. Heads shall mean the side of the coin containing the phrase "In God We Trust." Tails shall mean the side of the coin containing the phrase "E Pluribus Unum." If the coin lands with the side of the coin that the Roche Bioscience representative designated facing up, such Additional Indication shall be designated as a Roche
Additional Indications. At any time, either Party may propose to Develop in the Territory and/or the European Union Licensed Products for additional indications in the Field (i.e., in addition to the first indication) by submitting to the JDC a written proposal for the Development thereof, including a proposed work plan, budget and timeline. Upon unanimous agreement by the JDC members to Develop Licensed Products for such additional indication(s), the JDC will update the Development Plan to include such Development and submit the updated Development Plan for approval by the JSC. Neither Party will initiate such Development activities in the Territory and/or the European Union with respect to any additional indication in the Field without the unanimous approval by JSC.
Additional Indications. During the Term, OpenBiome may request that the definition of the LMIC Field be amended to include additional Indications and Xxxxx shall consider such request(s) in good faith; provided that, Xxxxx shall have no obligation to amend the LMIC Field to include such additional Indications.
Additional Indications. If at any time or times during the term of this AGREEMENT, GENAISSANCE commences or intends to commence any development activities for any PRODUCT(S), THERANOSTIC PRODUCTS or DIAGNOSTIC PRODUCTS for INDICATIONS other than the initial INDICATION, GENAISSANCE shall promptly design and submit to MERCK KGAA (through the JOINT COMMITTEE) a DEVELOPMENT PLAN and at an appropriate time a MARKETING PLAN for each of such PRODUCT(S), THERANOSTIC PRODUCTS and DIAGNOSTIC PRODUCTS.
Additional Indications. CTI (itself or through its Affiliates or Third Parties) shall use best efforts to pursue expanded label claims for the Product in the Territory for first-line acute promyelocytic leukemia (APL) and refractory multiple myeloma (each, an “Additional Indication”) in accordance with the registration trials plans, protocols, and timelines in CTI’s current development plan, a copy of which has been provided to PharmaBio. CTI shall not have failed to use best efforts as described in this Section 3.4A should it cease pursuing an Additional Indication because data from a clinical trial for such Additional Indication demonstrates that (i) continued pursuit of such Additional Indication is medically unsafe, or (ii) the Product is not efficacious for such Additional Indication, or (iii) the Additional Indication is not commercially viable because the Product is substantially less efficacious or less safe for such Additional Indication than its competitor.
