Common use of Ongoing Studies Clause in Contracts

Ongoing Studies. 5.3.1 ARIAD US shall be responsible for the conduct of the Ongoing Studies. For clarity, if the Ongoing Studies are Global Studies they are not subject to Section 5.7. ARIAD SWISSCO shall reimburse ARIAD US for ongoing Third Party Development Costs incurred by ARIAD US in the Ongoing [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Studies, subject to a maximum aggregate amount of US$7,000,000 for the period from the Effective Date until December 31, 2016 and US$7,000,000 for the calendar year 2017 (together, the “Ongoing Studies Budget”). ARIAD SWISSCO shall reimburse the actual, undisputed Third Party Development Costs quarterly within [**] of receipt of ARIAD US’s quarterly invoice and supporting evidence of the Third Party Development Costs having been incurred. Payment shall be made into such bank account as ARIAD US shall specify from time to time. For the period ending [**], no invoice shall be in excess of [**] (provided that for [**] in which the Effective Date occurs the invoice shall be for a pro-rated amount) and no invoice shall be delivered before [**]. For clarity if a [**] invoice during the calendar year ending [**] does not include the maximum of [**] any excess may be included in a subsequent invoice for calendar year [**], provided however that no excess at the end of the calendar year [**] may be rolled over to the calendar year [**]. If either the OPTIC Clinical Trial or the OPTIC 2L Clinical Trial is terminated prior to [**], then the maximum aggregate amount owed by ARIAD SWISSCO with effect from the date of termination of the relevant Ongoing Study, shall be [**] of the remaining Ongoing Studies Budget. If both the OPTIC Clinical Trial and the OPTIC 2L Clinical Trial are terminated prior to [**], then no further amounts will be payable by ARIAD SWISSCO after the date of termination of the last of the OPTIC Clinical Trial and the OPTIC 2L Clinical Trial. In addition to the Ongoing Studies Budget, ARIAD SWISSCO shall pay ARIAD US (i) [**] and (ii) [**] upon either (a) [**]; or (b) [**]. For clarity, [**] will not be [**] in the event of [**]. For clarity, [**] will not be [**]. For clarity, ARIAD US shall continue to control the conduct of the Ongoing Studies and shall continue to be listed as the sponsor until completion. ARIAD US will be responsible for collection and reporting of all serious adverse events from these trials to the regulatory agencies in which the trials are being conducted. No amounts will be due under this Section 5.3.1 and payable by ARIAD SWISSCO if the Buy-Back Option has been exercised. 5.3.2 In relation to the OPTIC Clinical Trial, ARIAD US shall pay to ARIAD SWISSCO on calendar [**] basis an amount equal to (i) the number of patients greater than [**] enrolled (the “Target Enrollment”) in the OPTIC Clinical Trial in countries in the Territory in which the Product has a Marketing Authorization multiplied by (ii) [**], multiplied by (iii) [**]. ARIAD US may deduct [**] from the amount of such payment and pay the net amount to ARIAD SWISSCO. Such payments shall be made within [**] after the end of each [**] for amounts accrued in such [**]. If the OPTIC Clinical Study projected enrollment of [**] subjects is changed, the Target Enrollment shall be adjusted proportionally. 5.3.3 ARIAD US shall provide to ARIAD SWISSCO within [**] of the end of each calendar month, [**] for the Ongoing Studies (other than the Optic 2L Clinical Trial, for which reports shall be provided quarterly) including the following for such calendar month: [**]. In addition, ARIAD US shall within [**] of receipt, provide ARIAD SWISSCO with copies of all (i) material communications and safety reports to or from Regulatory [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Authorities and minutes from meetings with Regulatory Authorities related to the Ongoing Studies and (ii) any related material post-marketing requirements communications to or from Regulatory Authorities. Subject to ARIAD SWISSCO making the applicable payments due to ARIAD US under Section 5.3.1 ARIAD SWISSCO shall have the right to use all Development Data (including any needed right of reference) from the Ongoing Studies as necessary or useful for Registration in the Territory. 5.3.4 ARIAD US shall report the results of each of the Ongoing Studies to ARIAD SWISSCO by sending a substantially complete draft of the CSR as soon as practicable and a copy of the draft of the final CSR to ARIAD SWISSCO within [**] of database lock for the applicable study. ARIAD SWISSCO will provide ARIAD US with any comments within [**] of its receipt of the draft of the final CSR. ARIAD US shall consider in good faith such comments, but it shall be in the sole discretion of ARIAD US whether to make changes to CSR Report to accommodate ARIAD SWISSCO comments. If the final CSR for the OPTIC 2L Clinical Trial demonstrates Superiority on the Primary Efficacy Endpoint, ARIAD SWISSCO shall submit a variation application to the Regulatory Authority to support the approval of the Second Line CML indication within [**] of ARIAD SWISSCO’S receipt of the final CSR. 5.3.5 Should ARIAD US elect to discontinue one or more of the Ongoing Studies, ARIAD US shall promptly, but in all cases prior to such discontinuance, notify ARIAD SWISSCO of such decision.

Ongoing Studies. 5.3.1 ARIAD US shall be responsible for the conduct of the Ongoing Studies. For clarity, if the Ongoing Studies are Global Studies they are not subject to Section 5.7. ARIAD SWISSCO shall reimburse ARIAD US for ongoing Third Party Development Costs incurred by ARIAD US in the Ongoing [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Studies, subject to a maximum aggregate amount of US$7,000,000 for the period from the Effective Date until December 31, 2016 and US$7,000,000 for the calendar year 2017 (together, the “Ongoing Studies Budget”). ARIAD SWISSCO shall reimburse the actual, undisputed Third Party Development Costs quarterly within [***] of receipt of ARIAD US’s quarterly invoice and supporting evidence of the Third Party Development Costs having been incurred. Payment shall be made into such bank account as ARIAD US shall specify from time to time. For the period ending [***], no invoice shall be in excess of [***] (provided that for [***] in which the Effective Date occurs the invoice shall be for a pro-rated amount) and no invoice shall be delivered before [***]. For clarity if a [***] invoice during the calendar year ending [***] does not include the maximum of [***] any excess may be included in a subsequent invoice for calendar year [***], provided however that no excess at the end of the calendar year [***] may be rolled over to the calendar year [***]. If either the OPTIC Clinical Trial or the OPTIC 2L Clinical Trial is terminated prior to [***], then the maximum aggregate amount owed by ARIAD SWISSCO with effect from the date of termination of the relevant Ongoing Study, shall be [***] of the remaining Ongoing Studies Budget. If both the OPTIC Clinical Trial and the OPTIC 2L Clinical Trial are terminated prior to [***], then no further amounts will be payable by ARIAD SWISSCO after the date of termination of the last of the OPTIC Clinical Trial and the OPTIC 2L Clinical Trial. In addition to the Ongoing Studies Budget, ARIAD SWISSCO shall pay ARIAD US (i) [***] and (ii) [***] upon either (a) [***]; or (b) [***]. For clarity, [***] will not be [***] in the event of [***]. For clarity, [***] will not be [***]. For clarity, ARIAD US shall continue to control the conduct of the Ongoing Studies and shall continue to be listed as the sponsor until completion. ARIAD US will be responsible for collection and reporting of all serious adverse events from these trials to the regulatory agencies in which the trials are being conducted. No amounts will be due under this Section 5.3.1 and payable by ARIAD SWISSCO if the Buy-Back Option has been exercised. 5.3.2 In relation to the OPTIC Clinical Trial, ARIAD US shall pay to ARIAD SWISSCO on calendar [***] basis an amount equal to (i) the number of patients greater than [***] enrolled (the “Target Enrollment”) in the OPTIC Clinical Trial in countries in the Territory in which the Product has a Marketing Authorization multiplied by (ii) [***], multiplied by (iii) [***]. ARIAD US may deduct [***] from the amount of such payment and pay the net amount to ARIAD SWISSCO. Such payments shall be made within [***] after the end of each [***] for amounts accrued in such [***]. If the OPTIC Clinical Study projected enrollment of [***] subjects is changed, the Target Enrollment shall be adjusted proportionally. 5.3.3 ARIAD US shall provide to ARIAD SWISSCO within [***] of the end of each calendar month, [***] for the Ongoing Studies (other than the Optic 2L Clinical Trial, for which reports shall be provided quarterly) including the following for such calendar month: [***]. In addition, ARIAD US shall within [***] of receipt, provide ARIAD SWISSCO with copies of all (i) material communications and safety reports to or from Regulatory [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Authorities and minutes from meetings with Regulatory Authorities related to the Ongoing Studies and (ii) any related material post-marketing requirements communications to or from Regulatory Authorities. Subject to ARIAD SWISSCO making the applicable payments due to ARIAD US under Section 5.3.1 ARIAD SWISSCO shall have the right to use all Development Data (including any needed right of reference) from the Ongoing Studies as necessary or useful for Registration in the Territory. 5.3.4 ARIAD US shall report the results of each of the Ongoing Studies to ARIAD SWISSCO by sending a substantially complete draft of the CSR as soon as practicable and a copy of the draft of the final CSR to ARIAD SWISSCO within [***] of database lock for the applicable study. ARIAD SWISSCO will provide ARIAD US with any comments within [***] of its receipt of the draft of the final CSR. ARIAD US shall consider in good faith such comments, but it shall be in the sole discretion of ARIAD US whether to make changes to CSR Report to accommodate ARIAD SWISSCO comments. If the final CSR for the OPTIC 2L Clinical Trial demonstrates Superiority on the Primary Efficacy Endpoint, ARIAD SWISSCO shall submit a variation application to the Regulatory Authority to support the approval of the Second Line CML indication within [***] of ARIAD SWISSCO’S receipt of the final CSR. 5.3.5 Should ARIAD US elect to discontinue one or more of the Ongoing Studies, ARIAD US shall promptly, but in all cases prior to such discontinuance, notify ARIAD SWISSCO of such decision.

Ongoing Studies. 5.3.1 ARIAD US shall be responsible for the conduct of the Ongoing Studies. For clarity, if the Ongoing Studies are Global Studies they are not subject to Section 5.7. ARIAD SWISSCO shall reimburse ARIAD US for ongoing Third Party Development Costs incurred by ARIAD US in the Ongoing [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Studies, subject to a maximum aggregate amount of US$7,000,000 for the period from the Effective Date until December 31, 2016 and US$7,000,000 for the calendar year 2017 (together, the “Ongoing Studies Budget”). ARIAD SWISSCO shall reimburse the actual, undisputed Third Party Development Costs quarterly within [***] of receipt of ARIAD US’s quarterly invoice and supporting evidence of the Third Party Development Costs having been incurred. Payment shall be made into such bank account as ARIAD US shall specify from time to time. For the period ending [***], no invoice shall be in excess of [***] (provided that for [***] in which the Effective Date occurs the invoice shall be for a pro-rated amount) and no invoice shall be delivered before [***]. For clarity if a [***] invoice during the calendar year ending [***] does not include the maximum of [***] any excess may be included in a subsequent invoice for calendar year [***], provided however that no excess at the end of the calendar year [***] may be rolled over to the calendar year [***]. If either the OPTIC Clinical Trial or the OPTIC 2L Clinical Trial is terminated prior to [***], then the maximum aggregate amount owed by ARIAD SWISSCO with effect from the date of termination of the relevant Ongoing Study, shall be [***] of the remaining Ongoing Studies Budget. If both the OPTIC Clinical Trial and the OPTIC 2L Clinical Trial are terminated prior to [***], then no further amounts will be payable by ARIAD SWISSCO after the date of termination of the last of the OPTIC Clinical Trial and the OPTIC 2L Clinical Trial. In addition to the Ongoing Studies Budget, ARIAD SWISSCO shall pay ARIAD US (i) [***] and (ii) [***] upon either (a) [***]; or (b) [***]. For clarity, [***] will not be [***] in the event of [***]. For clarity, [***] will not be [***]. For clarity, ARIAD US shall continue to control the conduct of the Ongoing Studies and shall continue to be listed as the sponsor until completion. ARIAD US will be responsible for collection and reporting of all serious adverse events from these trials to the regulatory agencies in which the trials are being conducted. No amounts will be due under this Section 5.3.1 and payable by ARIAD SWISSCO if the Buy-Back Option has been exercised. 5.3.2 In relation to the OPTIC Clinical Trial, ARIAD US shall pay to ARIAD SWISSCO on calendar [**] basis an amount equal to (i) the number of patients greater than [**] enrolled (the “Target Enrollment”) in the OPTIC Clinical Trial in countries in the Territory in which the Product has a Marketing Authorization multiplied by (ii) [**], multiplied by (iii) [**]. ARIAD US may deduct [**] from the amount of such payment and pay the net amount to ARIAD SWISSCO. Such payments shall be made within [**] after the end of each [**] for amounts accrued in such [**]. If the OPTIC Clinical Study projected enrollment of [**] subjects is changed, the Target Enrollment shall be adjusted proportionally. 5.3.3 ARIAD US shall provide to ARIAD SWISSCO within [**] of the end of each calendar month, [**] for the Ongoing Studies (other than the Optic 2L Clinical Trial, for which reports shall be provided quarterly) including the following for such calendar month: [**]. In addition, ARIAD US shall within [**] of receipt, provide ARIAD SWISSCO with copies of all (i) material communications and safety reports to or from Regulatory [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Authorities and minutes from meetings with Regulatory Authorities related to the Ongoing Studies and (ii) any related material post-marketing requirements communications to or from Regulatory Authorities. Subject to ARIAD SWISSCO making the applicable payments due to ARIAD US under Section 5.3.1 ARIAD SWISSCO shall have the right to use all Development Data (including any needed right of reference) from the Ongoing Studies as necessary or useful for Registration in the Territory. 5.3.4 ARIAD US shall report the results of each of the Ongoing Studies to ARIAD SWISSCO by sending a substantially complete draft of the CSR as soon as practicable and a copy of the draft of the final CSR to ARIAD SWISSCO within [**] of database lock for the applicable study. ARIAD SWISSCO will provide ARIAD US with any comments within [**] of its receipt of the draft of the final CSR. ARIAD US shall consider in good faith such comments, but it shall be in the sole discretion of ARIAD US whether to make changes to CSR Report to accommodate ARIAD SWISSCO comments. If the final CSR for the OPTIC 2L Clinical Trial demonstrates Superiority on the Primary Efficacy Endpoint, ARIAD SWISSCO shall submit a variation application to the Regulatory Authority to support the approval of the Second Line CML indication within [**] of ARIAD SWISSCO’S receipt of the final CSR. 5.3.5 Should ARIAD US elect to discontinue one or more of the Ongoing Studies, ARIAD US shall promptly, but in all cases prior to such discontinuance, notify ARIAD SWISSCO of such decision.

Ongoing Studies. 5.3.1 ARIAD US shall be responsible for the conduct of the Ongoing Studies. For clarity, if the Ongoing Studies are Global Studies they are not subject to Section 5.7. ARIAD SWISSCO shall reimburse ARIAD US for ongoing Third Party Development Costs incurred by ARIAD US in the Ongoing [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Studies, subject to a maximum aggregate amount of US$7,000,000 for the period from the Effective Date until December 31, 2016 and US$7,000,000 for the calendar year 2017 (together, the “Ongoing Studies Budget”). ARIAD SWISSCO shall reimburse the actual, undisputed Third Party Development Costs quarterly within [**] of receipt of ARIAD US’s quarterly invoice and supporting evidence of the Third Party Development Costs having been incurred. Payment shall be made into such bank account as ARIAD US shall specify from time to time. For the period ending [**], no invoice shall be in excess of [**] (provided that for [**] in which the Effective Date occurs the invoice shall be for a pro-rated amount) and no invoice shall be delivered before [**]. For clarity if a [**] invoice during the calendar year ending [**] does not include the maximum of [**] any excess may be included in a subsequent invoice for calendar year [**], provided however that no excess at the end of the calendar year [**] may be rolled over to the calendar year [**]. If either the OPTIC Clinical Trial or the OPTIC 2L Clinical Trial is terminated prior to [**], then the maximum aggregate amount owed by ARIAD SWISSCO with effect from the date of termination of the relevant Ongoing Study, shall be [**] of the remaining Ongoing Studies Budget. If both the OPTIC Clinical Trial and the OPTIC 2L Clinical Trial are terminated prior to [**], then no further amounts will be payable by ARIAD SWISSCO after the date of termination of the last of the OPTIC Clinical Trial and the OPTIC 2L Clinical Trial. In addition to the Ongoing Studies Budget, ARIAD SWISSCO shall pay ARIAD US (i) [**] and (ii) [**] ]upon either (a) [**]; or (b) [**]. ] For clarity, [**] will not be [**] in the event of [**]. ] For clarity, [**] will not be [**]. ] For clarity, ARIAD US shall continue to control the conduct of the Ongoing Studies and shall continue to be listed as the sponsor until completion. ARIAD US will be responsible for collection and reporting of all serious adverse events from these trials to the regulatory agencies in which the trials are being conducted. No amounts will be due under this Section 5.3.1 and payable by ARIAD SWISSCO if the Buy-Back Option has been exercised. 5.3.2 In relation to the OPTIC Clinical Trial, ARIAD US shall pay to ARIAD SWISSCO on calendar [**] basis an amount equal to (i) the number of patients greater than [**] enrolled (the “Target Enrollment”) in the OPTIC Clinical Trial in countries in the Territory in which the Product has a Marketing Authorization multiplied by (ii) [**], multiplied by (iii) [**]. ARIAD US may deduct [**] from the amount of such payment and pay the net amount to ARIAD SWISSCO. Such payments shall be made within [**] after the end of each [**] for amounts accrued in such [**]. If the OPTIC Clinical Study projected enrollment of [**] subjects is changed, the Target Enrollment shall be adjusted proportionally. 5.3.3 ARIAD US shall provide to ARIAD SWISSCO within [**] of the end of each calendar month, [**] for the Ongoing Studies (other than the Optic 2L Clinical Trial, for which reports shall be provided quarterly) including the following for such calendar month: [**]. In addition, ARIAD US shall within [**] of receipt, provide ARIAD SWISSCO with copies of all (i) material communications and safety reports to or from Regulatory [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Authorities and minutes from meetings with Regulatory Authorities related to the Ongoing Studies and (ii) any related material post-marketing requirements communications to or from Regulatory Authorities. Subject to ARIAD SWISSCO making the applicable payments due to ARIAD US under Section 5.3.1 ARIAD SWISSCO shall have the right to use all Development Data (including any needed right of reference) from the Ongoing Studies as necessary or useful for Registration in the Territory. 5.3.4 ARIAD US shall report the results of each of the Ongoing Studies to ARIAD SWISSCO by sending a substantially complete draft of the CSR as soon as practicable and a copy of the draft of the final CSR to ARIAD SWISSCO within [**] of database lock for the applicable study. ARIAD SWISSCO will provide ARIAD US with any comments within [**] of its receipt of the draft of the final CSR. ARIAD US shall consider in good faith such comments, but it shall be in the sole discretion of ARIAD US whether to make changes to CSR Report to accommodate ARIAD SWISSCO comments. If the final CSR for the OPTIC 2L Clinical Trial demonstrates Superiority on the Primary Efficacy Endpoint, ARIAD SWISSCO shall submit a variation application to the Regulatory Authority to support the approval of the Second Line CML indication within [**] of ARIAD SWISSCO’S receipt of the final CSR. 5.3.5 Should ARIAD US elect to discontinue one or more of the Ongoing Studies, ARIAD US shall promptly, but in all cases prior to such discontinuance, notify ARIAD SWISSCO of such decision.

Ongoing Studies. 5.3.1 ARIAD US shall be responsible for the conduct of the Ongoing Studies. For clarity, if the Ongoing Studies are Global Studies they are not subject to Section 5.7. ARIAD SWISSCO shall reimburse ARIAD US for ongoing Third Party Development Costs incurred by ARIAD US in the Ongoing [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Studies, subject to a maximum aggregate amount of US$7,000,000 for the period from the Effective Date until December 31, 2016 and US$7,000,000 for the calendar year 2017 (together, the “Ongoing Studies Budget”). ARIAD SWISSCO shall reimburse the actual, undisputed Third Party Development Costs quarterly within [**] of receipt of ARIAD US’s quarterly invoice and supporting evidence of the Third Party Development Costs having been incurred. Payment shall be made into such bank account as ARIAD US shall specify from time to time. For the period ending [**], no invoice shall be in excess of [**] (provided that for [**] in which the Effective Date occurs the invoice shall be for a pro-rated amount) and no invoice shall be delivered before [**]. For clarity if a [**] invoice during the calendar year ending [**] does not include the maximum of [**] any excess may be included in a subsequent invoice for calendar year [**], provided however that no excess at the end of the calendar year [**] may be rolled over to the calendar year [**]. If either the OPTIC Clinical Trial or the OPTIC 2L Clinical Trial is terminated prior to [**], then the maximum aggregate amount owed by ARIAD SWISSCO with effect from the date of termination of the relevant Ongoing Study, shall be [**] of the remaining Ongoing Studies Budget. If both the OPTIC Clinical Trial and the OPTIC 2L Clinical Trial are terminated prior to [**], then no further amounts will be payable by ARIAD SWISSCO after the date of termination of the last of the OPTIC Clinical Trial and the OPTIC 2L Clinical Trial. In addition to the Ongoing Studies Budget, ARIAD SWISSCO shall pay ARIAD US (i) [**] and (ii) [**] upon either (a) [**]; or (b) [**]. For clarity, [**] will not be [**] in the event of [**]. For clarity, [**] will not be [**]. For clarity, ARIAD US shall continue to control the conduct of the Ongoing Studies and shall continue to be listed as the sponsor until completion. ARIAD US will be responsible for collection and reporting of all serious adverse events from these trials to the regulatory agencies in which the trials are being conducted. No amounts will be due under this Section 5.3.1 and payable by ARIAD SWISSCO if the Buy-Back Option has been exercised. 5.3.2 In relation to the OPTIC Clinical Trial, ARIAD US shall pay to ARIAD SWISSCO on calendar [**] basis an amount equal to (i) the number of patients greater than [**] enrolled (the “Target Enrollment”) in the OPTIC Clinical Trial in countries in the Territory in which the Product has a Marketing Authorization multiplied by (ii) [**], multiplied by (iii) [**]. ARIAD US may deduct [**] from the amount of such payment and pay the net amount to ARIAD SWISSCO. Such payments shall be made within [**] after the end of each [**] for amounts accrued in such [**]. If the OPTIC Clinical Study projected enrollment of [**] subjects is changed, the Target Enrollment shall be adjusted proportionally. 5.3.3 ARIAD US shall provide to ARIAD SWISSCO within [**] of the end of each calendar month, [**] for the Ongoing Studies (other than the Optic 2L Clinical Trial, for which reports shall be provided quarterly) including the following for such calendar month: [**]. In addition, ARIAD US shall within [**] of receipt, provide ARIAD SWISSCO with copies of all (i) material communications and safety reports to or from Regulatory [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Authorities and minutes from meetings with Regulatory Authorities related to the Ongoing Studies and (ii) any related material post-marketing requirements communications to or from Regulatory Authorities. Subject to ARIAD SWISSCO making the applicable payments due to ARIAD US under Section 5.3.1 ARIAD SWISSCO shall have the right to use all Development Data (including any needed right of reference) from the Ongoing Studies as necessary or useful for Registration in the Territory. 5.3.4 ARIAD US shall report the results of each of the Ongoing Studies to ARIAD SWISSCO by sending a substantially complete draft of the CSR as soon as practicable and a copy of the draft of the final CSR to ARIAD SWISSCO within [**] of database lock for the applicable study. ARIAD SWISSCO will provide ARIAD US with any comments within [**] of its receipt of the draft of the final CSR. ARIAD US shall consider in good faith such comments, but it shall be in the sole discretion of ARIAD US whether to make changes to CSR Report to accommodate ARIAD SWISSCO comments. If the final CSR for the OPTIC 2L Clinical Trial demonstrates Superiority on the Primary Efficacy Endpoint, ARIAD SWISSCO shall submit a variation application to the Regulatory Authority to support the approval of the Second Line CML indication within [**] of ARIAD SWISSCO’S receipt of the final CSR. 5.3.5 Should ARIAD US elect to discontinue one or more of the Ongoing Studies, ARIAD US shall promptly, but in all cases prior to such discontinuance, notify ARIAD SWISSCO of such decision.