Common use of Failure to Achieve Development Objectives Clause in Contracts

Failure to Achieve Development Objectives. With respect to only those programs ([***]) of TDTx or its Affiliates that TDTx intends to apply towards meeting its Minimum Potential Revenue Stream obligations as stated under Section 6.3, and for each program of a Sublicensee, the following provisions of this Section 6.1.4 shall apply to TDTx (or its Affiliate or Sublicensee as applicable). In the event that, despite the use of Commercially Reasonable Efforts, TDTx becomes aware that, due to any relevant scientific, regulatory, safety, development, or commercial circumstances beyond the reasonable control of TDTx or any of its Affiliates or Sublicensees, as applicable, (a) any of the development or regulatory or commercial launch milestone dates set forth in Section 6.1.2 will not be achieved or (b) any [***] will not be achieved, or (c) it will be unable to [***], then TDTx will notify Licensors in writing via the JSC in advance of such failure to achieve the expected development or regulatory or commercial launch milestone dates, and the Parties will confer in good faith via the JSC to discuss a revised General Development Plan that is reasonably acceptable to TDTx and Licensors and mitigates or otherwise takes into account such circumstances to the extent reasonably feasible in view of [***]. For the avoidance of doubt, [***]. Licensors shall notify TDTx via the JSC of any objections to any revised General Development Plan within [***] after submission by TDTx to the JSC, failing which such General Development Plan shall be deemed approved by Licensors. In the event that Licensors provide TDTx with timely notice via the JSC of its objection to any revised General Development Plan and, following at least [***] of good faith discussions and efforts to reach agreement on a revised General Development Plan, the Parties cannot agree on a reasonably acceptable revision or other remedy, then Licensors may request that TDTx provide further evidence of its Commercially Reasonable Efforts to achieve the relevant milestone set forth above. If, and only if, after reviewing such further information requested and provided, Licensors make a determination that TDTx has failed to demonstrate that it has used Commercially Reasonable Efforts to meet its diligence obligations as stated under this Article 6 for any Licensed Product, Licensors shall notify TDTx of such determination in writing and may treat such failure to meet its diligence obligations as a material breach of this Agreement. Any such allegation of breach shall be subject to TDTx’s rights under this Agreement to dispute and/or cure it.

Failure to Achieve Development Objectives. With respect to only those programs ([***]) of TDTx or its Affiliates that TDTx intends to apply towards meeting its Minimum Potential Revenue Stream obligations as stated under Section 6.3, and for each program of a Sublicensee, the following provisions of this Section 6.1.4 shall apply to TDTx (or its Affiliate or Sublicensee as applicable). In the event that, despite the use of Commercially Reasonable Efforts, TDTx Akouos becomes aware that, due to any relevant scientific, regulatory, safety, development, or commercial circumstances beyond the reasonable control of TDTx Akouos or any of its Affiliates or Sublicensees, as applicable, (a) any of the development or regulatory or commercial launch milestone dates set forth in Section 6.1.2 5.1.3 will not be achieved or (b) any [***] similarly material milestone dates or development commitments set forth in the General Development Plan or any Target Development Plan will not be achieved, or (c) it will be unable to [***]commence or continue the pre-clinical or clinical development activities as contemplated under the applicable Target Development Plan or General Development Plan, then TDTx Akouos will notify Licensors Lonza in writing via the JSC in advance of such failure to achieve the expected development or regulatory or commercial launch milestone dates, and the Parties will confer in good faith via the JSC to discuss a revised General Development Plan or Target Development Plan, as applicable, that is reasonably acceptable to TDTx Akouos and Licensors Lonza and mitigates or otherwise takes into account such circumstances to the extent reasonably feasible in view of [***]circumstances. For the avoidance of doubt, [***]failure to achieve any of the minimum diligence obligations or perform any particular activities specified in a General Development Plan or Target Development Plan (including as either may be updated) will not, in and of itself, be considered a breach of this Agreement so long as Akouos has complied with its obligations to continuously use Commercially Reasonable Efforts to achieve such minimum diligence obligations and the objectives and timelines of the General Development Plan or Target Development Plan, as applicable. Licensors Lonza shall notify TDTx via the JSC Akouos of any objections to any revised General Development Plan or Target Development Plan within [***] after submission by TDTx to the JSCAkouos, failing which such General Development Plan or Target Development Plan shall be deemed approved by LicensorsLonza. In the event that Licensors provide TDTx Lonza provides Akouos with timely notice via the JSC of its objection to any revised General Development Plan or Target Development Plan and, following at least [***] of good faith discussions and efforts to reach agreement on a revised General Development Plan or Target Development Plan, the Parties cannot agree on a reasonably acceptable revision or other remedy, then Licensors Lonza may request that TDTx Akouos provide further evidence of its Commercially Reasonable Efforts to achieve the relevant milestone set forth above. If, and only if, after reviewing such further information requested and provided, Licensors make Lonza makes a determination that TDTx Akouos has failed to demonstrate that it Akouos has used Commercially Reasonable Efforts to meet its diligence obligations as stated under this Article 6 5 for any Committed Licensed ProductGene Target or any Licensed Product directed to any Committed Licensed Gene Target, Licensors Lonza shall notify TDTx Akouos of such determination in writing and may treat such failure to meet its diligence obligations as a material breach of this Agreement. Any such allegation of breach shall be subject to TDTx’s Akouos’ rights under this Agreement to dispute and/or cure it.

Failure to Achieve Development Objectives. With respect to only those programs ([***]) of TDTx or its Affiliates that TDTx intends to apply towards meeting its Minimum Potential Revenue Stream obligations as stated under Section 6.3, and for each program of a Sublicensee, the following provisions of this Section 6.1.4 shall apply to TDTx (or its Affiliate or Sublicensee as applicable). In the event that, despite the use of Commercially Reasonable Efforts, TDTx Akouos becomes aware that, due to any relevant scientific, regulatory, safety, development, or commercial circumstances beyond the reasonable control of TDTx Akouos or any of its Affiliates or Sublicensees, as applicable, (a) any of the development or regulatory or commercial launch milestone dates set forth in Section 6.1.2 5.1.3 will not be achieved or (b) any [***] similarly material milestone dates or development commitments set forth in the General Development Plan or any Target Development Plan will not be achieved, or (c) it will be unable to [***]commence or continue the pre-clinical or clinical development activities as contemplated under the applicable Target Development Plan or General Development Plan, then TDTx Akouos will notify Licensors MEE in writing via the JSC in advance of such failure to achieve the expected development or regulatory or commercial launch milestone dates, and the Parties will confer in good faith via the JSC to discuss a revised General Development Plan or Target Development Plan, as applicable, that is reasonably acceptable to TDTx Akouos and Licensors MEE and mitigates or otherwise takes into account such circumstances to the extent reasonably feasible in view of [***]circumstances. For the avoidance of doubt, [***]failure to achieve any of the minimum diligence obligations or perform any particular activities specified in a General Development Plan or Target Development Plan (including as either may be updated) will not, in and of itself, be considered a breach of this Agreement so long as Akouos has complied with its obligations to continuously use Commercially Reasonable Efforts to achieve such minimum diligence obligations and the objectives and timelines of the General Development Plan or Target Development Plan, as applicable. Licensors MEE shall notify TDTx via the JSC Akouos of any objections to any revised General Development Plan or Target Development Plan within [***] after submission by TDTx to the JSCAkouos, failing which such General Development Plan or Target Development Plan shall be deemed approved by LicensorsMEE. In the event that Licensors provide TDTx MEE provides Akouos with timely notice via the JSC of its objection to any revised General Development Plan or Target Development Plan and, following at least [***] of good faith discussions and efforts to reach agreement on a revised General Development Plan or Target Development Plan, the Parties cannot agree on a reasonably acceptable revision or other remedy, then Licensors MEE may request that TDTx Akouos provide further evidence of its Commercially Reasonable Efforts to achieve the relevant milestone set forth above. If, and only if, after reviewing such further information requested and provided, Licensors make MEE makes a determination that TDTx Akouos has failed to demonstrate that it Akouos has used Commercially Reasonable Efforts to meet its diligence obligations as stated under this Article 6 5 for any Committed Licensed ProductGene Target or any Licensed Product directed to any Committed Licensed Gene Target, Licensors MEE shall notify TDTx Akouos of such determination in writing and may treat such failure to meet its diligence obligations as a material breach of this Agreement. Any such allegation of breach shall be subject to TDTx’s Akouos’ rights under this Agreement to dispute and/or cure it.