Additional Indications Sample Clauses
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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. 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. 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. (a) In the event that either Party desires to develop an Additional Indication for the Product for commercialization in the Field (by OPKO on a global basis and VF or any Sublicensee in the Territory), the development of such Additional Indication shall be proposed in writing in sufficient detail to the JSC. [***], which notice is within [***] after such proposal to the JSC, during which time the Parties are discussing the proposal, the [***] shall be determined in accordance with Section 4.1(c). Within [***] after a [***] or within such [***] period during which the Parties are discussing the proposal [***], the non-proposing Party shall elect whether to participate in the development of such Additional Indication ([***]). If the non-proposing Party elects to participate, the Parties are obligated to jointly develop the Additional Indication ([***]) and shall seek to reach a mutual written agreement on the additional terms and conditions for the development of such Additional Indication within next [***]. The terms of the written agreement, if any, would become part of the Development Plan, and all resulting data would be available for use by VF in connection with exercising its rights under this Agreement with respect to the Product in the Field and in the Territory and for use by OPKO outside the Territory in connection with the Product in the Field.
(b) If the Parties do not enter into the written mutual agreement contemplated under Section 4.1(a) with respect to a proposed Additional Indication and the JSC has not [***], the proposing Party may proceed with the development of such Additional Indication and will be [***] responsible for the conduct and costs of such development, in which case, if VF is not a proposing Party, such Additional Indication would be removed from the Field, except not to the extent that VF receives rights pursuant to Section 4.1(d) or 4.1(e). In such case, [***].
(c) If the non-proposing Party believes a proposed Additional Indication [***] for which the Product has been, is planned to be or is being developed in the Territory as to VF, or outside the Territory or the Field as to OPKO, or on the regulatory status of the Product in the Field in such respective territory, based on [***], such non-proposing Party will have the right to refer such matter to the JSC in writing for resolution by consensus [***]. If the JSC does not reach consensus with respect to the Additional Indication, the matter will be resolved (and JSC conse...
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. In the event CVT intends during the Term of this Agreement to submit an NDA for ranolazine [ * ], CVT shall provide Innovex with written notice at least [ * ] days prior to the then current estimated filing date of the NDA therefor, and the Parties shall negotiate in good faith the minimum sales and marketing effort which will be required therefor. If the Parties reach an agreement thereon within [ * ] days after commencement of such [ * ] day period prior to the then current estimated NDA filing date, ranolazine [ * ] shall be added to the definition of Product under this Agreement, and the corresponding provisions for minimum Innovex sales and marketing efforts under this Agreement shall be revised. If the Parties do not reach agreement within such time period, the definition of Product shall not be expanded.
Additional Indications. During the Term, OpenBiome may request that the definition of the LMIC Field be amended to include additional Indications and ▇▇▇▇▇ shall consider such request(s) in good faith; provided that, ▇▇▇▇▇ shall have no obligation to amend the LMIC Field to include such additional Indications.
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