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. 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. (a) The Parties may pursue Additional Indications as set forth in this Section 4.7. If either Party (the “Proposing Party”) desires to Develop the Product for an Additional Indication, then the Proposing Party will present a proposal to the other Party (the “Non-Proposing Party”) through the JSC, including a synopsis of the additional Development activities, the role of each Party with respect to Development, the timeline for the additional Development activities and the estimated costs associated with such additional Development.
(b) If the Non-Proposing Party provides notice within sixty (60) days after the date of the Proposing Party’s proposal that it believes that Development of the Product for the proposed Additional Indication would satisfy the Additional Indication Rejection Condition, the determination specified in Section 4.7(f) shall be made. Within thirty (30) days after a determination (if a determination is requested) is made pursuant to Section 4.7(f) if such determination is that the Additional Indication Rejection Condition is not satisfied or within such sixty (60) day period (during which the Parties are discussing the proposal) if no such determination is requested, the Non-Proposing Party shall elect whether to participate in the Development of such Additional Indication by written notice to the Proposing Party.
(c) If the Non-Proposing Party elects to participate, the Parties shall jointly Develop the Product in such Additional Indication in accordance with this Article 4, provided that [***] of the internal costs (at the FTE Rate) and external costs incurred by the Parties for Developing the Product for such Additional Indication under *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. an agreed budget. For clarity, if ChemoCentryx is the Proposing Party, VIT will not be required to pay any costs incurred for Development activities for the Product for an Additional Indication that are conducted solely to satisfy requirements for Regulatory Approval of the Product outside the Territory, if such requirements are in addition to requirements of the FDA and EMA.
(d) In such event, the Parties shall prepare a Development Plan for the Additional Indication to include the applicable Development activities and submit such Development Plan, and an associated budget, to the JSC for review and approval, and all resulting L...
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 ▇▇▇▇▇ 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
Additional Indications. Maruho may, at any time, suggest to JDC new indications to develop for Japan for discussion purpose. The JDC shall reasonably consider such additional indications in accordance with the principles set out in Section 6.1 below. [***]. Once the new indication is approved by the JDC, this indication will become an integral part of Upstream’s development plan for execution using reasonable development efforts and JDC shall discuss and decide reasonable timeline in advance of commencement of such development. If Upstream fails to initiate clinical trials in the new indication within [***] after the target date for initiation of such clinical trial agreed by the JDC, Upstream shall present to the JDC a detailed explanation for the delay and specify the actions it is taking to expedite development and further discuss with ▇▇▇▇▇▇ whether to delegate the right to continue to develop the Product on its own in that indication in Japan. If Upstream fails to submit a CTN of clinical trials in the new indication within [***] after the target date for submission of a CTN of such clinical trial agreed by the JDC, ▇▇▇▇▇▇ will have the right to continue to develop the drug on its own in that indication in Japan, in consultation with and with reasonable support of Upstream.
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.