Failure to Launch Sample Clauses

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.
Sample 1Sample 2Sample 3See All (4)
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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.
Sample 1Sample 2See All (4)
Failure to Launch. (a) If Xxxxxxx 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, Xxxxxxx'x 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 Xxxxxxx. In such event, Xxxxxxx 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 Xxxxxxx 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 Xxxxxxx elects not to launch a Licensed Product in a country in the Territory other than a Major Country because Xxxxxxx has concluded in good faith that Licensed Products distributed in such country will be imported into other countries of the Territory where Xxxxxxx has retained exclusive rights, then Xxxxxxx will not be obligated to launch such Licensed Product in such country and DTI shall not launch Licensed Product in such country.
Sample 1Sample 2Sample 3
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 XXX Xxxxxxxxx, XXX 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 [**].
Sample 1
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.
Sample 1
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).
Sample 1

Related to Failure to Launch

  • Failure to Supply 4.2.1 If Company becomes aware that a Supply Interruption is reasonably likely to occur, Company shall promptly notify AbbVie by telephone or by written notification and shall provide AbbVie with the opportunity to meet in person or by teleconference to discuss the details to the extent they are known by Company. 4.2.2 In the event that Company is unable, or notifies AbbVie that it is unable or otherwise receives notice from its CMO that it will be unable to supply, for any reason, except for a Force Majeure Event, to supply Product in accordance with the quantities and/or delivery dates specified by AbbVie for such Product via Purchase Orders, Company shall have a period of *** days or such longer time as necessary so long as Company is using commercially reasonable efforts to cure such interruption to supply, during which time Company will prioritize AbbVie Purchase Orders of Product over Company or other customer orders. If such interruption to supply continues after such sixty (60) day period, AbbVie may, in its sole discretion: (a) cancel outstanding Purchase Orders with Company; (b) require Company to supply the undelivered Product at a future date agreed upon by the Parties; or (c) at Company’s sole expense, manufacture or have manufactured by a Third Party designated and qualified by AbbVie such quantity of ribavirin as AbbVie may reasonably determine with notice to Company as will meet AbbVie’s worldwide requirements in light of such interruption to supply. AbbVie shall be entitled to receive from Company *** % of AbbVie’s cover damages, comprising cost differences between the Product’s cost and the replacement product’s cost, and reasonable costs associated with procuring replacements for the Product, until such time as Company is capable of resuming its supply obligations under this Agreement. Upon Company’s resolution of the interruption to supply to the reasonable satisfaction of AbbVie, AbbVie shall be required to resume purchasing the Applicable Percentage of AbbVie Product Requirements from Company but shall be excused from purchasing that portion attributable to the permitted purchases from the Third Party manufacturer under Section 4.2.2(c).

  • Failure to Meet Timelines Failure by the Union to comply with the timelines will result in the automatic withdrawal of the grievance. Failure by the Employer to comply with the timelines will entitle the Union to move the grievance to the next step of the procedure.

  • Failure to Notify If Contractor fails to specify in writing any problem or circumstance that materially affects the costs of its delivery of services or products, including a material breach by the Department, about which Contractor knew or reasonably should have known with respect to the period during the term covered by Contractor's status report, Contractor shall not be entitled to rely upon such problem or circumstance as a purported justification for an increase in the price for the agreed upon scope.

  • Failure to Provide Notice of Expiry If the HSP fails to provide the required 6 months’ Notice that it intends to allow this Agreement to expire, or fails to provide a Transition Plan along with any such Notice, this Agreement shall automatically be extended and the HSP will continue to provide the Services under this Agreement for so long as the Funder may reasonably require to enable all clients of the HSP to transition to new service providers.

  • Failure to Close (A) If Seller(s) fails to convey the property as provided in this contract: Buyer(s) may exercise legal remedies including suit for specific performances or damages. Agent may xxx Xxxxxx(s) to recover loss of commission. Agent may pay Xxxxxxx Money into a court of competent jurisdiction, or retain Xxxxxxx Money until directed to distribute the same by a court of competent jurisdiction. (B) If Buyer(s) fail to purchase the property as provided in this contract: Seller(s) may exercise legal remedies including suit for specific performance or damages. Seller(s) may elect to retain Xxxxxxx Money deposit as liquidated damages for breach of contract, in this case, it is agreed that Agent may retain from such Xxxxxxx Money deposit an amount not greater than his total commission of the sale had been consummated and the residue, if any, will be paid to Seller(s). (C) Xxxxx(s) and Seller(s) further agree that in the event of default by either that results in litigation, that the non-defaulting party may recover reasonable attorney fees and any other court costs, in addition to other damages provided for herein.

  • Failure to Produce In the event the Buyer fails to produce the aforementioned letter or other acceptable verification by the date above in Section IV(c), this Agreement may be terminated at the election of the Seller with written notice provided to the Buyer within calendar days from the date in Section IV(c);

  • Failure to Complete If Artist becomes ill, dies, or is otherwise unable or unwilling to complete the Project in accordance with the Agreement, any work already done on the Project will be the City’s property. The City will be entitled to withhold any sums not yet paid to Artist, and may use any such sums toward completion of the Project in any manner the City deems appropriate.

  • Failure to Fulfill Conditions In the event that either of the parties hereto determines that a condition to its respective obligations to consummate the transactions contemplated hereby cannot be fulfilled on or prior to the termination of this Agreement, it will promptly notify the other party.

  • Failure to Vacate If the Resident does not vacate the Residence on the expiry or early termination of this Agreement, (i) the Resident is liable for any financial loss sustained or incurred by the Institution or the Manager, and (ii) the Manager may remove the property of the Resident from the Room (whether or not the Resident is present at the time), and place the property in temporary storage in a location in the Residence of the Manager’s choice, at the Resident’s expense, without notice to the Resident and without liability to the Manager for any damage to or loss of the Resident’s property.

  • Failure to Agree If the Contractor claims entitlement to a change in the Contract, and the Department does not agree that any action or event has occurred to justify any change in time or compensation, or if the parties fail to agree upon the appropriate amount of the adjustment in time or compensation, the Department will unilaterally make such changes, if any, to the Contract, as it determines are appropriate pursuant to the Contract. The Contractor shall proceed with the Work and the Department's directives, without interruption or delay, and shall make a claim as provided in Article 12. Failure to proceed due to a dispute over a change request shall constitute a material breach of the Contract and entitle the Department to all available remedies for such breach, including, without limitation, termination for default.

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