Unilateral Right to Terminate. (a) MERCK may terminate this Agreement, effective on any anniversary of the Effective Date on or after the third anniversary of the Effective Date, by providing written notice to ARIAD not less than twelve (12) months prior to such anniversary of the Effective Date. (b) MERCK may terminate this Agreement (i) at its sole discretion, after meeting with ARIAD as set forth below in Section 9.2.1(c), on written notice to ARIAD in the event that the President of Merck Research Laboratories, following such meeting, determines in good faith that it is not advisable for MERCK to continue Development or Commercialization of the Product for use in a Cancer Indication as a result of a serious safety issue regarding the use of the Product in a Cancer Indication, or (ii) effective upon not less than six (6) months prior written notice to ARIAD, given within ninety (90) days after ARIAD notifies MERCK of the determination in the following clause (x) or the termination in clause (y), in the event that (x) ARIAD has made a final determination that the initial Phase 3 Clinical Trial for a Sarcoma Indication has failed to meet its primary endpoint, or (y) ARIAD terminates such Clinical Trial based on the recommendation of the data monitoring committee of such trial, as specified in the statistical analysis plan for the trial, to terminate the trial early for a reason other than on the basis of significant evidence of efficacy, unless the Product has received Commercialization Regulatory Approval (other than pricing and government reimbursement approval) in the U.S. Territory or the European Union or the Parties have agreed to file a Drug Approval Application for Commercialization Regulatory Approval in a Sarcoma Indication on the basis of results other than meeting the primary endpoint. MERCK agrees that, in determining whether to terminate this Agreement pursuant to Section 9.2.1(b)(ii), it will consider ARIAD’s achievement of any secondary endpoint and/or other efficacy data toward meeting any endpoint. For clarity, MERCK’s right to terminate this Agreement under clause (ii)(x) or (ii)(y) shall not be conditioned on ARIAD giving notice of the determination or termination described in such clauses. (c) In the event that MERCK believes in good faith that it is not advisable for MERCK to continue Development or Commercialization of the Product as a result of a serious safety issue regarding the use of the Product in a Cancer Indication, MERCK and ARIAD agree to meet promptly following notice of such belief from MERCK to ARIAD in person or by videoconference. The President of Merck Research Laboratories will attend the meeting, and at such meeting, MERCK will (i) provide ARIAD with any preclinical and clinical data related to the Product not previously provided in writing by MERCK to ARIAD that demonstrates such serious safety issue; and (ii) explain in detail to ARIAD the basis for MERCK’s good faith belief that it is not advisable for MERCK to continue Development or Commercialization of the Product as a result of such serious safety issue, including the factors supporting MERCK’s belief, and ARIAD may provide to MERCK any preclinical and clinical data related to the Product that ARIAD believes will demonstrate that it is not inadvisable to continue Development or Commercialization of the Product for use in Cancer Indications. (d) Except to the extent the following is unenforceable under the law of a particular jurisdiction where a patent application with the ARIAD Patent Rights is pending or a patent within the ARIAD Patent Rights is issued, ARIAD may terminate this Agreement immediately upon written notice to MERCK in the event that MERCK or any of its Affiliates or Sublicensees Challenges any ARIAD Patent Right or voluntarily assists a Third Party in initiating a Challenge of any ARIAD Patent Right.
Appears in 1 contract
Sources: Collaboration Agreement (Ariad Pharmaceuticals Inc)
Unilateral Right to Terminate. (a) MERCK may terminate this Agreement, effective on any anniversary of the Effective Date on or after the third anniversary of the Effective Date, Agreement by providing written notice to ARIAD not less than twelve nine (129) months prior to the effective date of such anniversary of the Effective Datetermination.
(b) MERCK may terminate this Agreement (i) at its sole discretion, after meeting with ARIAD as set forth below in Section 9.2.1(c), on written notice to ARIAD in the event that the President of Merck Research Laboratories, following such meeting, determines in good faith that it is not advisable for MERCK to continue Development or Commercialization of the Product for use in a Cancer Indication as a result of a serious safety issue regarding the use of the Product in a Cancer Indication, or (ii) effective upon not less than six (6) months prior written notice to ARIAD, given within ninety (90) days after ARIAD notifies MERCK of the determination in the following clause (x) or the termination in clause (y), in the event that (x) ARIAD has made a final determination that the initial Phase 3 Clinical Trial for a Sarcoma Indication has failed to meet its primary endpoint, or (y) ARIAD terminates such Clinical Trial based on the recommendation of the data monitoring committee of such trial, as specified in the statistical analysis plan for the trial, to terminate the trial early for a reason other than on the basis of significant evidence of efficacy, unless the Product has received Commercialization Regulatory Approval (other than pricing and government reimbursement approval) in the U.S. Territory or the European Union or the Parties have agreed to file a Drug Approval Application for Commercialization Regulatory Approval in a Sarcoma Indication on the basis of results other than meeting the primary endpoint. MERCK agrees that, in determining whether to terminate this Agreement pursuant to Section 9.2.1(b)(ii), it will consider ARIAD’s achievement of any secondary endpoint and/or other efficacy data toward meeting any endpoint. For clarity, MERCK’s right to terminate this Agreement under clause (ii)(x) or (ii)(y) shall not be conditioned on ARIAD giving notice of the determination or termination described in such clauses.
(c) In the event that MERCK believes in good faith that it is not advisable for MERCK to continue Development or Commercialization of the Product as a result of a serious safety issue regarding the use of the Product in a Cancer Indication, MERCK and ARIAD agree to meet promptly following notice of such belief from MERCK to ARIAD in person or by videoconference. The President of Merck Research Laboratories will attend the meeting, and at such meeting, MERCK will (i) provide ARIAD with any preclinical and clinical data related to the Product not previously provided in writing by MERCK to ARIAD that demonstrates such serious safety issue; and (ii) explain in detail to ARIAD the basis for MERCK’s good faith belief that it is not advisable for MERCK to continue Development or Commercialization of the Product as a result of such serious safety issue, including the factors supporting MERCK’s belief, and ARIAD may provide to MERCK any preclinical and clinical data related to the Product that ARIAD believes will demonstrate that it is not inadvisable to continue Development or Commercialization of the Product for use in Cancer Indications.
(d) Except to the extent the following is unenforceable under the law of a particular jurisdiction where a patent application with the ARIAD Patent Rights is pending or a patent within the ARIAD Patent Rights is issued, ARIAD may terminate this Agreement immediately upon written notice to MERCK in the event that MERCK or any of its Affiliates or Sublicensees Challenges any ARIAD Patent Right or voluntarily assists a Third Party in initiating a Challenge of any ARIAD Patent Right.
Appears in 1 contract
Sources: Collaboration and Exclusive License Agreement (Ariad Pharmaceuticals Inc)
Unilateral Right to Terminate. (a) Subject to Section 22.2.5, this Agreement may be terminated by the Party specified below as follows:
16.2.1 Subject to Section 16.2.3, MERCK may terminate this Agreement, effective on in its entirety, at any anniversary of the Effective Date on or after the third anniversary of the Effective Datetime, by providing written notice to ARIAD not less than in its sole discretion, upon twelve (12) months prior to such anniversary of the Effective Date.
(b) MERCK may terminate this Agreement (i) at its sole discretion, after meeting with ARIAD as set forth below in Section 9.2.1(c), on written notice to ARIAD in the event that the President of Merck Research Laboratories, following such meeting, determines in good faith that it is not advisable for MERCK to continue Development or Commercialization of the Product for use in a Cancer Indication as a result of a serious safety issue regarding the use of the Product in a Cancer Indication, or (ii) effective upon not less than six (6) months months’ prior written notice to ARIAD, given within ninety (90) days after ARIAD notifies MERCK of the determination in the following clause (x) or the termination in clause (y)CARDIOME.
16.2.2 Subject to Section 16.2.3, in the event that (x) ARIAD has made a final determination that MERCK, after consulting the initial Phase 3 Clinical Trial for a Sarcoma Indication has failed to meet its primary endpointJSC, or (y) ARIAD terminates such Clinical Trial based on the recommendation of the data monitoring committee of such trial, as specified in the statistical analysis plan for the trial, to terminate the trial early for a reason other than on the basis of significant evidence of efficacy, unless the Product has received Commercialization Regulatory Approval (other than pricing and government reimbursement approval) in the U.S. Territory or the European Union or the Parties have agreed to file a Drug Approval Application for Commercialization Regulatory Approval in a Sarcoma Indication on the basis of results other than meeting the primary endpoint. MERCK agrees that, in determining whether to terminate this Agreement pursuant to Section 9.2.1(b)(ii), it will consider ARIAD’s achievement of any secondary endpoint and/or other efficacy data toward meeting any endpoint. For clarity, MERCK’s right to terminate this Agreement under clause (ii)(x) or (ii)(y) shall not be conditioned on ARIAD giving notice of the determination or termination described in such clauses.
(c) In the event that MERCK believes in good faith that it is not advisable for MERCK to continue Development or Commercialization of the a Product as a result of a serious safety issue regarding the use of the Product in a Cancer Indicationsuch Product, MERCK and ARIAD CARDIOME agree to meet promptly following written notice of such belief from MERCK to ARIAD CARDIOME, in person or by videoconference. The President of [Redacted - Merck Research Laboratories personnel] will attend the meeting, and at such meeting, MERCK will (i) provide ARIAD CARDIOME with any preclinical and clinical data related to the Product not previously provided in writing by MERCK to ARIAD CARDIOME that demonstrates such serious safety issue; and (ii) explain in detail to ARIAD CARDIOME the basis for MERCK’s good faith belief that it is not advisable for MERCK to continue Development or Commercialization of the Product as a result of such serious safety issue, including the factors supporting MERCK’s belief, and ARIAD CARDIOME may provide to MERCK any preclinical and clinical data related to the Product that ARIAD CARDIOME believes will demonstrate that it is not inadvisable to continue Development or Commercialization of the Product. After such meeting with CARDIOME as set forth above, MERCK may terminate this Agreement in its entirety, in its sole discretion, on written notice to CARDIOME in the event that MERCK determines in good faith that it is not advisable for MERCK to continue Development or Commercialization of any Product for use in Cancer Indicationsunder this Agreement, as a result of a serious safety issue regarding such Product. If any Clinical Trials are ongoing at the time of such termination, MERCK will close out such trials at MERCK’s expense.
(d) 16.2.3 MERCK may exercise its right to terminate this Agreement under Section 16.2.1 or 16.2.2 only after it has paid to CARDIOME the up-front fee referred to in Section 11.1.
16.2.4 Except to the extent the following is unenforceable under the law of a particular jurisdiction where a patent application with within the ARIAD Patent Rights CARDIOME Patents is pending or a patent within the ARIAD Patent Rights CARDIOME Patents is issued, ARIAD CARDIOME may terminate this Agreement in its entirety immediately upon written notice to MERCK in the event that MERCK or any of its Affiliates or Sublicensees Challenges any ARIAD CARDIOME Patent Right or voluntarily assists a Third Party in initiating a Challenge of any ARIAD Patent RightCARDIOME Patent.
Appears in 1 contract
Sources: Collaboration and License Agreement (Cardiome Pharma Corp)