Failure to Launch Clause Samples
The "Failure to Launch" clause defines the consequences and procedures if a project or product does not commence or become operational by a specified date. Typically, this clause outlines the responsibilities of each party in the event of a delayed or unsuccessful launch, such as the right to terminate the agreement, impose penalties, or trigger alternative remedies. Its core practical function is to allocate risk and provide a clear framework for addressing delays or failures in project initiation, thereby protecting both parties from uncertainty and potential losses.
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Failure to Launch. (a) Subject to 4.2(b) and Section 11.5, if Fujisawa or its sublicensee does not launch a Licensed Product for treatment of each of the Primary Indications in the United States within nine (9) months after obtaining Regulatory Approval of such Licensed Product for such Primary Indication in the United States, or sooner notifies DTI that it will not launch such Licensed Product for such Primary Indication in the United States, Fujisawa's rights under this Agreement with respect to such Licensed Product for such Primary Indication and in the United States shall terminate upon the earlier of such notice or the 1 year anniversary of the grant of Regulatory Approval, and DTI shall be free to commercialize such Licensed Product for such Primary Indication in the Territory. In such event, Fujisawa shall promptly transfer to DTI all INDs, applications for Regulatory Approval and Regulatory Approvals, or their Canadian equivalents (as applicable) as it may hold with respect to such Licensed Product for such Primary Indication, and any written information as Fujisawa may possess which is useful to gain Regulatory Approval for and to commercialize such Licensed Product in the Territory for such Primary Indication. Such transfer shall be without cost to DTI, provided however that DTI shall pay any governmental filing or transfer fees that may be required.
(b) Upon the occurrence of the events in Section 4.2(a), Fujisawa shall also grant to DTI (i) an exclusive, fully-paid and royalty-free (subject to DTI's obligations under Section 5.5) license under the Fujisawa Technology to make, have made, use, import, export, offer for sale and sell such Licensed Product for such Primary Indication in the U.S., and (ii) to the extent it has the right to do so, a sublicense under any Third Party licenses to which Fujisawa has rights, to the extent that such rights are necessary or useful to make, have made, use, import, export, offer for sale and sell such Licensed Product for such Primary Indication. DTI shall thereafter assume the cost of maintaining its proportionate share of such Third Party license and shall perform such obligations of Fujisawa under such license agreement as are applicable to the relevant Licensed Products. To the extent such Third Party license is no longer applicable or useful to Fujisawa, Fujisawa shall assign to DTI all of its rights and obligations thereunder, rather than grant a sublicense under, such license agreement.
Failure to Launch. If Launch Date 2 or Launch Date 3 does not occur [***Redacted***] or less from the target date for such launch, as described in Section 4.3, the party not at fault may terminate this Agreement in accordance with such section.
Failure to Launch. Subject to the terms of this Section 11.2.3(a), upon [***] prior written notice to USWM, Company shall have, at its sole discretion, the right to terminate this Agreement if within [***] (or such longer period as agreed in writing by the Parties) after both (i) [***], and (ii) [***], USWM fails to Launch the Product in the Territory, provided such failure is for causes within USWM’s control. Company may terminate this Agreement pursuant to this Section 11.2.3(a) only with respect to the ZIMHI Product or the SYMJEPI Product individually to the extent USWM fails to Launch each of the Products individually on the terms and subject to the conditions otherwise set forth in this Section 11.2.3(a).
Failure to Launch. (a) If ▇▇▇▇▇▇▇ or its sublicensee does not launch a Licensed Product in a Major Country in the Territory within 12 months of obtaining Regulatory Approval for such Licensed Product in such Major Country, or sooner notifies DTI that it will not launch in such Major Country, ▇▇▇▇▇▇▇'▇ rights under this Agreement shall terminate upon the earlier of such notice or the 1 year anniversary of the grant of Regulatory Approval, and DTI shall be free to commercialize Licensed Products in such Major Country without any further obligation to ▇▇▇▇▇▇▇. In such event, ▇▇▇▇▇▇▇ shall promptly transfer to DTI all INDs, applications for Regulatory Approval and Regulatory Approvals, or their non-U.S. equivalents (as applicable) as it may hold with respect to Licensed Products in such Major Country, and any information as ▇▇▇▇▇▇▇ may possess which is useful to gain Regulatory Approval for and to commercialize the Licensed Products in such Major Country. Such transfer shall be without cost to DTI, provided however that DTI shall pay any governmental filing or transfer fees that may be required.
(b) If ▇▇▇▇▇▇▇ elects not to launch a Licensed Product in a country in the Territory other than a Major Country because ▇▇▇▇▇▇▇ has concluded in good faith that Licensed Products distributed in such country will be imported into other countries of the Territory where ▇▇▇▇▇▇▇ has retained exclusive rights, then ▇▇▇▇▇▇▇ will not be obligated to launch such Licensed Product in such country and DTI shall not launch Licensed Product in such country.
Failure to Launch. (a) For the avoidance of doubt and subject to the other terms in this Section 6.4, the Parties hereby accept that the failure to launch the Product in any country or countries shall not, per se, be deemed a breach of GSK’s obligations to use Commercially Reasonable Efforts to commercialize the Product. Where GSK’s decision not to launch in any specific country is founded on GSK’s good faith belief that the Product is not commercially viable in such country, for example because of pricing and reimbursement concerns or that the launch of the Product in such country would adversely affect the amount of Net Sales that would be achieved in the ▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇ shall not be required to and Sepracor shall not have the right to terminate this Agreement in such country, except as described in Section 6.4(b). However, for the avoidance of doubt: (i) GSK’s good faith belief must be supported by actual interactions with Regulatory Authorities or other good faith objective evidence which supports GSK’s conclusions; (ii) GSK must share its financial assessment, in reasonable detail, setting forth why the Product is not in good faith deemed commercially viable; and (iii) the JSC is to be notified and have the opportunity to review any such decision not to launch the Product in a country.
(b) Nothwithstanding anything else herein, where (i) the GSK decisions in Section 6.4(a) at any time combine so that GSK has decided that it will not launch in [**], or (ii) GSK has failed to launch in [**] following EMEA approval, Sepracor has the right to terminate this Agreement, on a country-by-country basis, in [**] by giving GSK sixty (60) days written notice to that effect at any time thereafter, provided that GSK has not in the interim, prior to receipt of notice of termination from Sepracor, notified Sepracor that it plans to launch in [**].
Failure to Launch. In the event that Elan fails to launch OT-fentanyl Products within a country of the Territory [ ] (a) a Regulatory Approval for OT-fentanyl Products within such country or (b) issuance of a Pricing Approval (where required or commercially desirable) for OT-fentanyl Products within such country, Anesta may terminate this Agreement as to such country, and Elan"s rights under Section 2.1 in such country, by giving Elan 90 days prior written notice.