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):
(i) ICN may so notify Schering by providing Schering with a description of ICN's development activities, all associated preclinical and clinical data, ICN's aggregate costs and expenses incurred in pursuing such development activities to date, and the estimated costs and expenses for remaining activities, and such other information as Schering may reasonably request. In such event, Schering shall have the right, exercisable by notice to ICN given not later than 75 days after receipt of the notice from ICN, to elect to have such indication become included in and subject to the terms and conditions of this Agreement (including without limitation, those relating to territory and royalties), and all definitions shall be appropriately adjusted to include such additional indication, effective upon receipt by ICN of Regulatory Approval with respect to such indication in any country in the Territory. If Schering exercises such right, then (A) Schering shall assume and be responsible for any and all further development activities with respect to such indication in accordance with the terms and conditions of this Agreement, and (B) promptly after receiving such Regulatory Approval, ICN shall notify Schering of ICN's aggregate costs and expenses incurred in pursuing Regulatory Approval for such indication, and Schering shall reimburse ICN for such costs and expenses within 45 days after receipt of an invoice from ICN. Schering shall have the right to audit such costs and expenses in accordance with the provisions of Section 6.10(b).
(ii) If ICN does not provide such notice to Schering or if Schering declines to exercise such rights, then ICN shall be free to pursue such indication without further obligation to Schering, except as expressly provided under this Agreement; provided, however, that (i) ICN shall not sell the Product for any such indication in any country in the Territory until five years after the date of the first commercial sale in such country by Schering of the Product for the chronic hepatitis C indication, and (ii) ICN shall not subl...
Additional Indications. 20 3.9 Improvements .............................................. 21
Additional Indications. The choice of Other Indications will be stated in the Development Plan and will be the focus of clinical development activities after or in parallel to, but with a lower priority than, the First Indication.
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. Indicates that material has been omitted and confidential treatment has been requested therefor. All such omitted material has been filed separately with the Commission pursuant to Rule 24b-2.
(a) Both Parties acknowledge that the development of the Licensed Product will expand beyond the initial indications, and each Party shall have the right to conduct development of Licensed Products for such additional indications, subject to this Section 8.7. This may include additional indication(s) for External Cancers and/or Internal Cancers, other than the Initial Internal Cancers and the Initial External Cancers. In the event that either Party determines to pursue additional indication(s) for the Licensed Product, it shall notify the other party and shall provide to the JDC all such data requested by such other Party so as to enable such other Party to determine whether to pursue such indication collaboratively, under this Article 8 and the JDC. Should the other Party agree to pursue the indication(s), all Development Expenses will be shared in the same percentages as outlined in Section 8.11. Further, JDC will determine the Development Plan and Budget for such and indication(s).
(i) In the event that NYCOMED determines that, for commercial reasons, it does not choose to pursue collaboratively the development of an additional indication proposed by PHARMACYCLICS, it shall provide the information upon which its decision was based to PHARMACYCLICS. Should PHARMACYCLICS agree that NYCOMED'S decision is supportable, then NYCOMED shall have the right, but no obligation, to participate in the development of such additional indication as set forth below in this Section 8.7(c).
(ii) Should PHARMACYCLICS not agree that NYCOMED'S decision is supportable, the dispute shall be resolved pursuant to Article 8.4 hereof.
(iii) Should such dispute be resolved in favor of PHARMACYCLICS then NYCOMED shall be obliged to participate in the development of such additional indication at such time in the development process as NYCOMED shall determine but nonetheless as set forth in this Article 8.7(c).
(iv) Should such dispute be resolved in favor of NYCOMED then NYCOMED shall not be obligated to participate in the development of such additional indication but shall have the opportunity to participate, at its election, in accordance with Section 8.7(c).
(c) In the event that one Party elects not to participate in the development of an additional indication, the remaining Party may proce...
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. 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.
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. 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 Budget, and (b) such Proposed Development Plan and Budget shall thereafter be a “CPP Additional Indication Development Plan and Budget”.
