Backup Compounds. The JRC and JDC shall ensure that the Research Plan and Phase I Plan for each Collaboration Target contains a plan for the research and development of Backup Compounds. […***…]. Progress of up to […***…] Collaboration Compounds satisfying CCS Criteria through GLP Tox Studies for a Collaboration Target shall be at BPM’s sole expense. Additional Backup Compounds may be progressed through a GLP Tox Study at Roche’s sole discretion and expense (including any supply thereof) as part of the Research Plan and under the supervision of the JRC, provided that BPM will have the right to conduct (or have conducted) any such GLP Tox Study, and if BPM elects such right then Roche shall reimburse BPM for any personnel costs, Allocable Overhead or Out of Pocket Expenses incurred by BPM with respect thereto. All Phase I Development Costs for the first Backup Compound for a Collaboration Target in a Phase I Study shall be shared as set forth in Section 12.5 (including subject to the cap stated therein); provided that BPM shall only be obligated to fund one (1) Collaboration Compound for a Collaboration Target at a time in a Phase I Study. Thereafter, all Phase I Development Costs for any Backup Compound for a Collaboration Target in a Phase I Study shall be at Roche’s sole expense and discretion (including any supply thereof) as part of the Phase I Plan and under the supervision of the JDC, provided that BPM will have the right to conduct (or have conducted) any such Phase I Study, and if BPM elects such right then Roche shall reimburse BPM for any Phase I Development Costs incurred by BPM with respect thereto.
Backup Compounds. If, at any time prior to obtaining Regulatory Approval for a Licensed Product that contains the Lead Compound, Anteris determines to discontinue all further Development of the Lead Compound based on any technical or scientific reason (such as, by way of example only and not limitation, unsatisfactory results related to formulation, pharmacokinetics, safety, or tolerability or issues relating to length of market exclusivity), Anteris shall have the right to substitute a Backup Compound for the Lead Compound in accordance with this Section 4.5.
(a) If Anteris makes such a determination, it shall give written notice of such determination to vTv (which notice may be given to vTv’s JAC members) and the Parties shall meet within thirty (30) days after vTv’s receipt of such notice, or such later date as may be agreed by the Parties. If requested by Anteris, the Parties will meet through the JAC at a specially convened meeting of the JAC. Prior to such meeting, vTv shall provide to Anteris information relating to all Backup Compounds that are identified by vTv as Controlled by vTv and not licensed to a Third Party or the subject of an active vTv Development program (and thus available for licensing to Anteris hereunder), including data and reports from non-clinical studies and Clinical Trials (if any), CMC data and other technical data and information relating to such Backup Compounds, that Anteris or vTv considers to be reasonably necessary for Anteris to assess such Backup Compounds and make an informed decision about substituting a Backup Compound for the Lead Compound. All such information provided to Anteris shall be the Confidential Information of vTv and subject to the terms of Article 11. At their meeting, the Parties shall review and discuss such information and the potential Backup Compounds and shall agree upon a Backup Compound to replace the Lead Compound, such agreement not to be unreasonably withheld, conditioned, or delayed.
(b) The Backup Compound that is agreed by the Parties to replace the Lead Compound shall automatically be deemed to be a Licensed Compound under this Agreement and the Lead Compound shall automatically cease to be included as a Licensed Compound under this Agreement. Upon replacement of the Lead Compound with such Backup Compound, Anteris’ license under Section 2.1 with respect to the Lead Compound shall terminate without any further action by the Parties and, subject to the terms and conditions of this Agreement, including Sec...
Backup Compounds. If development of RSD1235 is replaced with a Backup Compound in accordance with Section 2.6 prior to the occurrence of one or more milestone(s) described in Section 4.2, Fujisawa will be obligated to pay such milestone payments only upon the occurrence of such milestones in respect of the Backup Compound replacing RSD1235. Subject to Section 2.6(b), Fujisawa will make the milestone payment for that and each subsequent milestone achieved by the Backup Compound and shall pay the royalties respecting such Backup Compound in accordance with the terms and conditions of this Agreement as if such Backup Compound were RSD1235.
Backup Compounds. From time to time pursuant to this Section 4.1.6, Forest may request that Microbia synthesize peptides which are guanylate cyclase C agonists designed for the diagnostic, prophylactic or therapeutic treatment of IBS, CC or OIC in the Field. Upon such request, Microbia will use Commercially Reasonable Efforts to [***]. All costs incurred in such [***] will be included as [***] hereunder. Any such [***]. Forest's right to request the [***] pursuant to this Section 4.1.6 will expire upon [***], provided that if such [***], then Forest's right to request [***]. Notwithstanding the foregoing, Forest may not request that [***] in a request made pursuant to this Section 4.1.6 during any [***] period. Upon the addition of any such [***], the JDC will determine the appropriate Development activities, if any, to be undertaken with respect to such Collaboration Compound, [***]. Subject to Section 4.1.1(c), neither Party shall have any operational or financial obligations with respect to the [***] except to the extent set forth in a Development Plan approved by the JDC.
Backup Compounds. (a) Provisions Relating to BMS’ Exercise of its Co-Development Option. If BMS does not exercise its Co-Development Option with respect to a Provisional Collaboration Program by the applicable deadline, then EXEL shall retain all right, title and interest in all compounds generated for such Provisional Collaboration Program, subject to [*]. If BMS does exercise its Co-Development Option with respect to a Provisional Collaboration Program, then any compounds generated for such Provisional Collaboration Program (or Lead Op Program that became such Provisional Collaboration Program) that satisfy the definition of a Program Backup shall become part of the Collaboration Program, and, subject to Section 8.1(d), neither BMS nor EXEL shall use any such compounds for any purpose outside of the Collaboration without the prior written consent of the other Party. The compounds generated for such Provisional Collaboration Program (or Lead Op Program that became such Provisional Collaboration Program) that do not satisfy the definition of Program Backups shall become Unrelated Compounds, and EXEL shall be free to use such Unrelated Compounds outside of the Collaboration, subject to Section 8.6. For clarity, BMS shall pay EPC the milestone payments described in Section 9.5 for Program Backups that are Royalty-Bearing Products and that meet the applicable milestone events.
Backup Compounds. Except as provided in this Section 6.10.2, Xxxxxx-Xxxxxxx shall not have to make milestone payments under Section 6.10.1 with respect to Trigger Events for any Collaboration Lead Compound it designates to be a backup compound (the "Backup Compound") to a more developmentally advanced Collaboration Lead Compound for which it is obligated to make milestone payments under Section 6.10.
1. If development of the more advanced Collaboration Lead Compound is abandoned prior to occurrence of the Trigger Event described in Section 6.10.1, Xxxxxx-Xxxxxxx will only have to make milestone payments for Trigger Events achieved by the Backup Compound that were not achieved by the abandoned Collaboration Lead Compound. If the Backup Compound reaches a Trigger Event before the Collaboration Lead Compound for which it is a backup compound, Xxxxxx-Xxxxxxx will make the milestone payment for that and each subsequent Trigger Event reached by the Backup Compound but shall not be required to make milestone payment for that and each subsequent Trigger Event realized by the Collaboration Lead Compound. If the Backup Compound reaches the Trigger Event described in Section 6.10.1 before abandonment of the more advanced Collaboration Lead Compound, then Xxxxxx-Xxxxxxx will make the milestone payments for the Trigger Event described in Section 6.10.1 and for each subsequent Trigger Event reached by the Backup Compound.
Backup Compounds. Except as provided in this Section 6.10.2, *** *** ***. If development of the more advanced Collaboration Lead Compound is abandoned prior to occurrence of a Trigger Event described in Section 6.10.1, BMS will *** *** . If the Backup Compound reaches a Trigger Event before the Collaboration Lead Compound for which it is a Backup Compound, BMS will make the milestone payment for that and each subsequent Trigger Event reached by the Backup Compound but shall not be required to make milestone payment for that and each subsequent Trigger Event realized by the Collaboration Lead Compound as long as its Backup Compound remains in a more developmentally advanced stage. Milestones which have not been paid for any Backup Compound or Collaboration Lead Compound in accordance with this provision shall become due and payable in full upon achievement of Trigger Event 6.10.1 (e) for such Backup Compound or Collaboration lead Compound.
Backup Compounds. While no rights to any Backup Compounds are licensed hereunder, upon completion of a Phase IIb clinical trial of a Backup Compound (if any), BioCryst shall give prompt written notice thereof to Roche. Roche shall have *** (***) days after receipt of such notice from BioCryst to request in writing that BioCryst provide Roche with a data package for that Backup Compound. Commencing on the date that Roche receives the data package, Roche shall have the right to conduct due diligence related to the Backup Compound for a period of up to *** (***) days (the “Backup Compound Diligence Period”). BioCryst shall cooperate with Roche during the Backup Compound Diligence Period. Roche’s due diligence may include, but is not limited to, the following: (i) a full clinical and manufacturing audit of BioCryst with respect to the Backup Compound, at Roche’s expense, (ii) the right to request all data, including raw data, obtained to date relating to the Backup Compound, (iii) the right to inspect BioCryst’s facilities and, to the extent within the reasonable control of BioCryst, the facilities of its clinicians and manufacturers, each with respect to the Backup Compound (and BioCryst agrees to use good faith and commercially reasonable efforts so that Roche may inspect the facilities of such third parties), and (iv) a complete detailed report of the Development Costs actually incurred with respect to the Backup Compound. The data package, all information learned by Roche during any audit pursuant to this Section 2.2 and any and all other information provided by BioCryst to Roche relating to the Backup Compound shall be treated by Roche as the Confidential Information of BioCryst in accordance with the provisions of ARTICLE 10 of this Agreement. Roche agrees that BioCryst shall have no obligations hereunder to develop any Backup Compounds.
Backup Compounds. (1) If the Collaboration is terminated by Nuvelo pursuant to Section 13.1(b) or by Archemix pursuant to Section 13.1(a), then Archemix shall:
a. acquire all right, title and interest in any Collaboration Compounds, and Nuvelo’s right, title and interest in any such Collaboration Compounds shall terminate; and
b. have no obligation to continue any research or development program then ongoing to identify further Collaboration Compounds.
(2) If the Collaboration is terminated by Archemix pursuant to Section 13.1(b) or by Nuvelo pursuant to Section 13.1(a), then any Collaboration Compounds shall be deemed Nuvelo Product for the purposes of this Article 13. Any compound arising from Research under the Collaboration meeting the JSC criteria for a Backup Compound also shall be deemed to be a Nuvelo Product.
Backup Compounds. With respect to any Lead Compound that is a backup compound (the "Backup Compound") for a Lead Compound with respect to which Warner has previously become obligated under Sections 9.0, 9.1 or 9.2 to make any of the milestone payments referred to in such sections (the "Replaced Compound"), Warner shall become obligated, upon the occurrence of each Trigger Event with respect to such Backup Compound, to make the corresponding milestone payment under such sections to Synaptic; provided, however, that no such payment obligation shall arise upon the occurrence of any Trigger Event if such Trigger Event (a) would not have triggered a payment obligation with respect to the Replaced Compound or (b) had previously occurred with respect to the Replaced Compound.
