Common use of Failure to Launch Clause in Contracts

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 To the extent such Third Party license is no longer applicable or useful to Fujisawa, Fujisawa shall assign to DTI all of its rights and obligations thereunder, rather than grant a sublicense under, such license agreement.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. (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 -------------------------------------------------------------------------------- * Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. -------------------------------------------------------------------------------- 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. (ai) Subject to 4.2(b) and Section 11.5, if Fujisawa or its sublicensee does not launch In the event that a Licensed Product for treatment has not obtained Regulatory Approval in a particular XXXXXX because GSK decides to reject a Pricing Decision, GSK shall notify Impax of each its decision within thirty (30) Business Days of the Primary Indications receipt of such Pricing Decision and shall provide Impax with an explanation of such decision, including a financial analysis thereof. Where GSK’s decision to reject such Pricing Decision in such country is founded on GSK’s good faith belief that the Licensed Product is not commercially viable in such country, for example because of pricing and reimbursement concerns or that the launch of the Licensed Product in such country would adversely affect the amount of Net Sales that would be achieved in the United States within nine Licensed Territory, Impax shall not have the right to terminate this Agreement in such country, except as described in Sections 6.4(b)(ii) and 6.4(b)(iii). However, for the avoidance of doubt: (9A) months after obtaining XXXXXX; (B) XXXXXX; and (C) XXXXXX. The Parties hereby accept that the failure to launch a particular Licensed Product in any country in which it has received Regulatory Approval shall not, per se, be deemed a breach of GSK’s obligations pursuant to Section 6.4(a). For purposes of this Section 6.4(b)(i), if GSK decides to appeal a Pricing Decision (in any country where appeal of a Pricing Decision is possible), GSK shall not be deemed to have rejected the Pricing Decision until the appeal process is concluded and GSK has elected not to accept the Pricing Decision resulting from such Licensed Product for such Primary Indication in the United Statesappeal process. (ii) Notwithstanding anything else herein, or sooner notifies DTI where (A) GSK has decided under Section 6.4(b)(i) that it will not launch such Licensed Product reject a Pricing Decision 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 XXXXXX, or (B) GSK has failed to achieve First Commercial Sale of any Licensed Product in XXXXXX following a Pricing Approval within 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 timeframe contemplated by Section 4.2(a6.4(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 Impax has the right to do soterminate this Agreement in all XXXXXX by giving GSK sixty (60) days written notice to that effect at any time thereafter; provided, however, that GSK has not in the interim, prior to receipt of notice of termination from Impax, notified Impax that it XXXXXX. For purposes of this Section 6.4(b)(ii), if GSK decides to appeal a sublicense Pricing Decision (in any country where appeal of a Pricing Decision is possible), GSK shall not be deemed to have rejected the Pricing Decision until the appeal process is concluded and GSK elects not to accept the Pricing Decision resulting from such appeal process. (iii) Notwithstanding anything else herein, where (A) GSK has decided under Section 6.4(b)(i) that it will reject a Pricing Decision for any Third Party licenses Licensed Product in XXXXXX, or (B) GSK has failed to which Fujisawa achieve First Commercial Sale any Licensed Product in XXXXXX following a Pricing Approval within XXXXXX (XXXXXX) months after the Regulatory Approval (including Pricing Approval, if required by applicable Laws) has rightsbeen obtained in the relevant XXXXXX, Impax has the right to terminate this Agreement in all XXXXXX by giving GSK sixty (60) days written notice to that effect at any time thereafter; provided, however, that GSK has not in the interim, prior to receipt of notice of termination from Impax, notified Impax that it XXXXXX; provided, further, such XXXXXX (XXXXXX) month period shall be extended to the extent that such rights are necessary or useful to make, have made, use, import, export, offer for sale and sell such the achievement of First Commercial Sale of a Licensed Product for such Primary Indication. DTI shall thereafter assume is delayed on account of Impax’s failure to supply Licensed Product ordered by GSK pursuant to the cost of maintaining its proportionate share Supply Agreement and GSK provides prompt notification of such Third Party license failure. For purposes of this Section 6.4(b)(iii), if GSK decides to appeal a Pricing Decision (in any country where appeal of a Pricing Decision is possible), GSK shall not be deemed to have rejected the Pricing Decision until the appeal process is concluded and shall perform GSK elects not to accept the Pricing Decision resulting from 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 agreementappeal process.