Common use of Opt-Out Rights Clause in Contracts

Opt-Out Rights. Either Party may elect to discontinue (a “Discontinuing Party”) joint research on, development and commercialization of a Clinical Development Candidate or a Cell Therapy Product upon six (6) months prior written notice (“Opt-Out Notice”) to the other Party; provided that the effective date of either Party’s election to opt out shall not be prior to the completion of the first Phase I Study conducted by the Parties hereunder, and provided further that neither Party shall be relieved of its obligations to pay for its share of Clinical Development Costs for a clinical study that is ongoing at the effective date of a Party’s election to opt-out with respect to the applicable Clinical Development Candidate. Notwithstanding the foregoing, if a Party is unable to pay any or all of its portion of Clinical Development Costs when due, such Party shall be deemed to have delivered an Opt-Out Notice on the date such payment was due. Upon delivery of the Opt-Out Notice, the subject Clinical Development Candidate or Cell Therapy Product shall be deemed a “Rejected Product.” The Discontinuing Party shall be required to continue co-funding all of its activities under this Strategic Alliance Agreement during such six (6) month notice period (subject to the first sentence of this Section 6.1). Upon receipt of an Opt-Out Notice for a Clinical Development Candidate or Cell Therapy Product, the non-discontinuing Party shall have the option (the “Sole Development Option”), exercisable by providing written notice to the Discontinuing Party by the end of such six (6) month period, to continue the development and commercialization of such Rejected Product in the Therapeutic Field (and in such event, Table of Contents such Rejected Product shall thereafter be referred to as a “Sole Development Product”), at its own expense. Upon the exercise of such option, the non-discontinuing Party shall be deemed the “Developing Party,” and the Developing Party shall be released from its exclusivity obligations set forth in Section 2.5 above with respect only to such Sole Development Product. The Parties shall have the following rights and obligations upon exercise of the Sole Development Option: (a) if Angiotech is the Developing Party, such Sole Development Product shall continue to be considered a Clinical Development Candidate or Cell Therapy Product (as applicable) for purposes of the Transaction Agreements; provided, however that (i) the provisions of Section 2.4 and ARTICLES III, V, VII (other than Sections 7.5-7.10) and IX (other than Sections 9.7 and 9.8) shall no longer apply to such Sole Development Product; (ii) a Supply Disruption shall be deemed to have occurred pursuant to Section 9.7 (and Section 9.7 shall apply in its entirety with respect to such Supply Disruption), and Angiotech shall have the right to engage a back-up supplier pursuant to Section 9.8 (and Section 9.8 shall apply in its entirety with respect to engagement of such back-up supplier); and further provided that if neither a Third-Party manufacturer nor a Third-Party back-up manufacturer of the Cells, Clinical Development Candidates and/or Cell Therapy Products is reasonably available at the effective date of Athersys’ opt-out, Athersys shall manufacture and supply Cells, Clinical Development Candidates and/or Cell Therapy Products to Angiotech (as the supply chain for each exists at such time) for the Territory for a period of up to twenty-four (24) months after the effective date of such opt-out (during which Section 9.6 shall apply in its entirety), wherein such Cells, Clinical Development Candidates and/or Cell Therapy Products supply shall be provided by Athersys on commercially reasonable terms and conditions to be discussed and agreed upon by Angiotech and Athersys at such time (which terms shall include a reasonable price, and shall set forth any subsequent period (after such 24-month period) during which Athersys is willing (in its sole discretion) to supply Cells, Clinical Development Candidates and/or Cell Therapy Products to Angiotech); and (iii) Angiotech shall be responsible for all activities described in ARTICLE X with respect to such Sole Development Product; (b) if Athersys is the Developing Party, such Sole Development Product shall no longer be considered a Clinical Development Candidate or Cell Therapy Product for purposes of the License Agreement and Sublicense Agreement, but shall continue to be considered a Clinical Development Candidate or Cell Therapy Product for purposes of this Strategic Alliance Agreement; provided, however, that (i) the provisions of ARTICLES II, III, V, VII (other than Sections 7.5-7.10), VIII and IX shall no longer apply to such Sole Development Product, and (ii) Athersys shall be responsible for all activities described in ARTICLE X with respect to such Sole Development Product; (c) any Regulatory Approvals filed, and clinical data owned or licensed, and any product trademarks owned or licensed by the Discontinuing Party or its Affiliates relating to the applicable Sole Development Product shall be (i) assigned or (ii) exclusively licensed to the Developing Party or any Third Party or Affiliate designated by such Party, until such time as the Developing Party or its designee is qualified to hold such Regulatory Approvals or product trademarks under applicable laws and regulations, Table of Contents and then shall be transferred or assigned to the Developing Party or its designee, as appropriate, as soon as practicable thereafter; provided, however, that in any country where such transfer or assignment is not possible, the Discontinuing Party shall use Commercially Reasonable Efforts to ensure that the Developing Party has the benefit of such Regulatory Approvals and product trademarks, and to this end consents to any regulatory authority cross-referencing to the data and information on file with any regulatory authority as may be necessary; and (d) the Developing Party shall pay a royalty on Sole Development Products to the Discontinuing Party and shall share Sole Development Income with the Discontinuing Party in accordance with Sections 7.5 through 7.10 below.

Opt-Out Rights. Either Party may elect to discontinue (a “Discontinuing Party”) joint research on, development and commercialization of a Clinical Development Candidate or a Cell Therapy Product upon six (6) months prior written notice (“Opt-Out Notice”) to the other Party; provided that the effective date of either Party’s election to opt out shall not be prior to the completion of the first Phase I Study conducted by the Parties hereunder, and provided further that neither Party shall be relieved of its obligations to pay for its share of Clinical Development Costs for a clinical study that is ongoing at the effective date of a Party’s election to opt-out with respect to the applicable Clinical Development Candidate. Notwithstanding the foregoing, if a Party is unable to pay any or all of its portion of Clinical Development Costs when due, such Party shall be deemed to have delivered an Opt-Out Notice on the date such payment was due. Upon delivery of the Opt-Out Notice, the subject Clinical Development Candidate or Cell Therapy Product shall be deemed a “Rejected Product.” The Discontinuing Party shall be required to continue co-funding all of its activities under this Strategic Alliance Agreement during such six (6) month notice period (subject to the first sentence of this Section 6.1). Upon receipt of an Opt-Out Notice for a Clinical Development Candidate or Cell Therapy Product, the non-discontinuing Party shall have the option (the “Sole Development Option”), exercisable by providing written notice to the Discontinuing Party by the end of such six (6) month period, to continue the development and commercialization of such Rejected Product in the Therapeutic Field (and in such event, Table of Contents such Rejected Product shall thereafter be referred to as a “Sole Development Product”), at its own expense. Upon the exercise of such option, the non-discontinuing Party shall be deemed the “Developing Party,” and the Developing Party shall be released from its exclusivity obligations set forth in Section 2.5 above with respect only to such Sole Development Product. The Parties shall have the following rights and obligations upon exercise of the Sole Development Option: (a) if Angiotech is the Developing Party, such Sole Development Product shall continue to be considered a Clinical Development Candidate or Cell Therapy Product (as applicable) for purposes of the Transaction Agreements; provided, however that (i) the provisions of Section 2.4 and ARTICLES III, V, VII (other than Sections 7.5-7.10) and IX (other than Sections 9.7 and 9.8) shall no longer apply to such Sole Development Product; (ii) a Supply Disruption shall be deemed to have occurred pursuant to Section 9.7 (and Section 9.7 shall apply in its entirety with respect to such Supply Disruption), and Angiotech shall have the right to engage a back-up supplier pursuant to Section 9.8 (and Section 9.8 shall apply in its entirety with respect to engagement of such back-up supplier); and further provided that if neither a Third-Party manufacturer nor a Third-Party back-up manufacturer of the Cells, Clinical Development Candidates and/or Cell Therapy Products is reasonably available at the effective date of Athersys’ opt-out, Athersys shall manufacture and supply Cells, Clinical Development Candidates and/or Cell Therapy Products to Angiotech (as the supply chain for each exists at such time) for the Territory for a period of up to twenty-four (24) months after the effective date of such opt-out (during which Section 9.6 shall apply in its entirety), wherein such Cells, Clinical Development Candidates and/or Cell Therapy Products supply shall be provided by Athersys on commercially reasonable terms and conditions to be discussed and agreed upon by Angiotech and Athersys at such time (which terms shall include a reasonable price, and shall set forth any subsequent period (after such 24-month period) during which Athersys is willing (in its sole discretion) to supply Cells, Clinical Development Candidates and/or Cell Therapy Products to Angiotech); and (iii) Angiotech shall be responsible for all activities described in ARTICLE X with respect to such Sole Development Product; (b) if Athersys is the Developing Party, such Sole Development Product shall no longer be considered a Clinical Development Candidate or Cell Therapy Product for purposes of the License Agreement and Sublicense Agreement, but shall continue to be considered a Clinical Development Candidate or Cell Therapy Product for purposes of this Strategic Alliance Agreement; provided, however, that (i) the provisions of ARTICLES II, III, V, VII (other than Sections 7.5-7.10), VIII and IX shall no longer apply to such Sole Development Product, and (ii) Athersys shall be responsible for all activities described in ARTICLE X with respect to such Sole Development Product; (c) any Regulatory Approvals filed, and clinical data owned or licensed, and any product trademarks owned or licensed by the Discontinuing Party or its Affiliates relating to the applicable Sole Development Product shall be (i) assigned or (ii) exclusively licensed to the Developing Party or any Third Party or Affiliate designated by such Party, until such time as the Developing Party or its designee is qualified to hold such Regulatory Approvals or product trademarks under applicable laws and regulations, Table of Contents and then shall be transferred or assigned to the Developing Party or its designee, as appropriate, as soon as practicable thereafter; provided, however, that in any country where such transfer or assignment is not possible, the Discontinuing Party shall use Commercially Reasonable Efforts to ensure that the Developing Party has the benefit of such Regulatory Approvals and product trademarks, and to this end consents to any regulatory authority cross-referencing to the data and information on file with any regulatory authority as may be necessary; and (d) the Developing Party shall pay a royalty on Sole Development Products to the Discontinuing Party and shall share Sole Development Income with the Discontinuing Party in accordance with Sections 7.5 through 7.10 below.

Opt-Out Rights. Either Following the start date of any Co-Development Plan of the other Party may elect or the start date of any Co-Commercialisation Agreement, and without prejudice to discontinue the termination rights set out in Clauses 17.3 - 17.5 below, a Party (a “Discontinuing Notifying Party”) joint research onmay notify the other Party (“Non-notifying Party”) in writing that it wishes to opt-out of its funding obligation under any such Co-Development Plan or Co-Commercialisation Agreement, development and commercialization of a Clinical Development Candidate or a Cell Therapy Product upon six (6) months prior written notice as appropriate (“Opt-Out out Notice”) ). Any Opt-out Notice shall be subject to the other Party; following: 17.2.1 Any Opt-out Notice may only be provided that the effective date of either Party’s election to opt out shall not be prior to the completion of the first Phase I Study conducted by the Parties hereunderNotifying Party in relation to, in the case of Adaptimmune, any Bellicum Candidate or Bellicum Therapy, and provided further that neither Party shall be relieved in the case of its obligations Bellicum, any Adaptimmune Candidate or Adaptimmune Therapy (such Candidate or Therapy in relation to pay for its share of Clinical Development Costs for a clinical study that is ongoing at which the effective date of a Party’s election to optOpt-out with respect to Notice has been provided, the applicable Clinical Development Candidate. Notwithstanding the foregoing, if a Party is unable to pay any or all of its portion of Clinical Development Costs when due, such Party shall be deemed to have delivered an “Opt-Out Candidate/ Therapy”). *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 17.2.2 The Opt-out Notice shall take effect on the date notified by the Notifying Party in the Opt-out Notice, such payment was duedate to be no earlier than *** from date of receipt of Opt-out Notice by Non-notifying Party (“Opt-out Date”). Upon During such period between delivery of the Opt-Out Noticeout Notice and the Opt-out Date, the subject Clinical Non-notifying Party may only incur expenses in accordance with the then-current budget for such Opt-Out Candidate/ Therapy, and the Notifying Party shall continue to bear its share of expenses for such Opt-Out Candidate/ Therapy in accordance with Article 10. 17.2.3 From and after the Opt-out Date: (a) The Notifying Party (including its Affiliates) shall have no further obligation to reimburse the costs arising under the Co-Development Candidate Plan for such Opt-Out Candidate/ Therapy, save that the obligation to reimburse under Section 10.2 shall continue in relation to any costs and expenses incurred prior to the Opt-out Date. (b) The Notifying Party shall have no further license under the Non-notifying Party’s intellectual property rights in such Opt-Out Candidate/ Therapy, save as required for any remaining performance under Section 17.2.3(g) below. (c) The Notifying Party shall have no further right to commercialize or Cell develop (including conducting any clinical trials) such Opt-Out Candidate/ Therapy. (d) The Notifying Party shall have no right or obligation to share in any profit or loss, respectively, arising from sale of such Opt-Out Candidate/ Therapy, save that any right or obligation to share in any profit or loss arising from the sale of such Opt-Out Candidate/ Therapy Product prior to the Opt-out Date shall continue as provided under this Agreement or under the Co-Commercialisation Agreement (if separate). (e) The Non-notifying Party shall continue to be deemed a “Rejected Productlicensed and entitled to proceed with the development or commercialisation of such Opt-Out Candidate/ Therapy in accordance with Article 8 of this Agreement.” (f) The Discontinuing continuing Non-notifying Party shall be required to continue co-funding all of its activities under this Strategic Alliance Agreement during such six (6) month notice period (subject to fully responsible for the first sentence of this Section 6.1). Upon receipt of an Opt-Out Notice for a Clinical Development Candidate or Cell Therapy Product, the non-discontinuing Party shall have the option (the “Sole Development Option”), exercisable by providing written notice to the Discontinuing Party by the end of such six (6) month period, to continue the remaining development and commercialization of such Rejected Product Opt-Out Candidate/ Therapy, save as provided in Section 17.2.3(g) below; (g) The Non-notifying Party may request that the Therapeutic Field Notifying Party continue to perform certain of its obligations under the Co-Development Plan for such Opt-Out Candidate/ Therapy, particularly to the extent such obligations relate to any Reserved Activity of the Notifying Party, or to the Adaptimmune Technology or Bellicum Technology, as applicable to the Notifying Party, or to any safety reporting by the Notifying Party that has relevance to such Opt-Out Candidate/ Therapy. At the Non-notifying Party’s sole expense (and in such eventfor resources expended by the Notifying Party, Table of Contents such Rejected Product shall thereafter be referred to as a “Sole Development Product”)including payments for personnel on an FTE basis, at its own expense. Upon the exercise of such option, the non-discontinuing Party shall be deemed the “Developing Party,” and the Developing Party shall be released from its exclusivity obligations FTE rates set forth in Section 2.5 above Exhibit 2), the Notifying Party shall perform its obligations under the Co-Development Plan, including with respect only to such Sole Development ProductReserved Activities and/or to the Adaptimmune Technology or Bellicum Technology, as applicable to the Notifying Party, as reasonably and specifically requested by the Non-notifying Party in writing, and in each case as reasonably necessary for the further development and commercialization of such Opt-Out Candidate/ Therapy. The Parties Notifying Party shall ensure that it transfers to the Non-notifying Party, at the Non-notifying Party’s expense, any items and rights controlled by the Notifying Party that are necessary for the Non-notifying Party to advance such Opt-Out Candidate/ Therapy on its own *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the following rights Commission. through development and obligations upon exercise of the Sole Development Option: commercialization; provided that (a) if Angiotech is this obligation does not include *** ; and (b) this obligation does not include *** . Performance of activities (excluding co-funding activities) by the Developing Party, such Sole Development Product Notifying Party pursuant to this Clause 17.2.3(g) shall continue to be considered a Clinical Development Candidate or Cell Therapy Product (as applicable) for purposes of the Transaction Agreements; provided, however that (i) made in accordance with the provisions of Section 2.4 this Agreement and ARTICLES IIIthe applicable Co-Development Plan. (h) Provisions of this Agreement as are applicable to the continuing rights and activities of either Party following the Opt-out Date, Vfor any Candidate or Therapy of a Party in relation to which no Opt-out Notice has been provided, VII shall continue in full force and effect, including in relation to any Opt-Out Candidate/ Therapy, and shall include Article 5, Article 6, Article 8 (other than Sections 7.5as amended in this Clause 17.2.3), Article 9, Article 11 (in relation to any payments which remain due and owing or are payable under Clause 17.2.4 below), Article 12, Article 13, and Article 16. The provisions of Article 2, to the extent they relate to an Opt-7.10) Out Candidate/ Therapy, shall cease to apply, save that Clause 2.9 shall continue and IX (other than Sections 9.7 and 9.8) shall no longer apply survive. 17.2.4 Non-notifying Party will pay to such Sole Development Product; (ii) a Supply Disruption Notifying Party *** for its use of the Notifying Party’s Licensed Intellectual Property in relation to an Opt-Out Candidate/ Therapy. The *** shall be deemed to have occurred pursuant to Section 9.7 (and Section 9.7 shall apply in its entirety with respect to *** until *** . For clarity, such Supply Disruption), and Angiotech shall have the right to engage a back-up supplier pursuant to Section 9.8 (and Section 9.8 shall apply in its entirety with respect to engagement of such back-up supplier); and further provided that if neither a Third-Party manufacturer nor a Third-Party back-up manufacturer of the Cells, Clinical Development Candidates and/or Cell Therapy Products is reasonably available at the effective date of Athersys’ opt-out, Athersys shall manufacture and supply Cells, Clinical Development Candidates and/or Cell Therapy Products to Angiotech (as the supply chain for each exists at such time) for the Territory for a period of up to twenty-four (24) months after the effective date of such opt-out (during which Section 9.6 shall apply in its entirety), wherein such Cells, Clinical Development Candidates and/or Cell Therapy Products supply *** shall be provided by Athersys on commercially reasonable payable *** . If the Parties enter into a related agreement that includes non-financial terms and conditions to be discussed and agreed upon by Angiotech and Athersys at such time regarding use of the Notifying Party’s Licensed Intellectual Property (which shall be consistent with the terms shall include a reasonable priceand conditions of this Agreement), and shall the*** set forth any subsequent period above (after such 24-month periodbut no other financial terms) during which Athersys is willing (in its sole discretion) to supply Cells, Clinical Development Candidates and/or Cell Therapy Products to Angiotech); and (iii) Angiotech shall be responsible for all activities described in ARTICLE X with respect to incorporated into such Sole Development Product; (b) if Athersys is the Developing Party, such Sole Development Product shall no longer be considered a Clinical Development Candidate or Cell Therapy Product for purposes of the License Agreement and Sublicense Agreement, but shall continue to be considered a Clinical Development Candidate or Cell Therapy Product for purposes of this Strategic Alliance Agreement; provided, however, that (i) the provisions of ARTICLES II, III, V, VII (other than Sections 7.5-7.10), VIII and IX shall no longer apply to such Sole Development Product, and (ii) Athersys shall be responsible for all activities described in ARTICLE X with respect to such Sole Development Product; (c) any Regulatory Approvals filed, and clinical data owned or licensed, and any product trademarks owned or licensed by the Discontinuing Party or its Affiliates relating to the applicable Sole Development Product shall be (i) assigned or (ii) exclusively licensed to the Developing Party or any Third Party or Affiliate designated by such Party, until such time as the Developing Party or its designee is qualified to hold such Regulatory Approvals or product trademarks under applicable laws and regulations, Table of Contents and then shall be transferred or assigned to the Developing Party or its designee, as appropriate, as soon as practicable thereafter; provided, however, that in any country where such transfer or assignment is not possible, the Discontinuing Party shall use Commercially Reasonable Efforts to ensure that the Developing Party has the benefit of such Regulatory Approvals and product trademarks, and to this end consents to any regulatory authority cross-referencing to the data and information on file with any regulatory authority as may be necessary; and (d) the Developing Party shall pay a royalty on Sole Development Products to the Discontinuing Party and shall share Sole Development Income with the Discontinuing Party in accordance with Sections 7.5 through 7.10 belowagreement.