Relief Termination. (a) Notwithstanding any other provision of this Agreement to the contrary, Relief may for any reason in its sole discretion decide on three (3) months’ written notice (or any shorter period to which Acer agrees in its sole discretion) to not proceed with Development and Commercialization in all countries within the Relief Territory or Relief may decide on thirty (30) days written notice (or any shorter period to which Acer agrees in its sole discretion) delivered not before January 3, 2022 to not proceed with Development and Commercialization in all countries within the Relief Territory if an NDA for the Acer Product for a UCD has not been accepted for review by the FDA (a “Relief Termination”), in which case (A) Relief will not be responsible for any further monetary or other obligations to Acer that accrue following a Relief Termination, but without limiting its obligations for activities and obligations prior to such cessation, (B) all payments made by Relief as of the Relief Termination (i.e., Milestone Payments, the Reimbursement Payment, the Development Payments (notwithstanding the provisions of Section 5.2(d) for this purpose) and any other payments and reimbursements) are non-refundable and (C) all rights and data with respect to Product will thereupon revert or transfer to Acer; provided, however, that after commercial launch of Product occurs in at least one Significant European Market, Relief may decide to not proceed with Development and Commercialization in one or more countries within the Relief Territory which are identified to Acer in writing (the “Excluded Countries”) without triggering a Relief Termination so long as Relief continues to exercise Commercially Reasonable Efforts for Development and Commercialization for the remaining countries within the Relief Territory and otherwise performs this Agreement in accordance with its terms, with Relief agreeing that any Excluded Countries shall, following such identification by Relief to Acer in writing, be excluded from the Relief Territory for purposes of this Agreement. (b) In the event of a Relief Termination, (i) the Acer Territory will be the entire world for purposes of Product, (ii) all rights and responsibilities of Relief with respect to Development will revert to Acer, (iii) Relief will transfer sponsorship of the management of any Development in the Relief Territory to Acer to the extent requested by Acer and (iv) Acer will thereafter be free to Develop and Commercialize anywhere in the world in its sole discretion and at its sole expense, provided that Relief will be responsible for the monetary obligations under Article 5 accrued as of the Relief Termination. (c) If a clinical trial for Product is terminated or any Development is ended while a clinical trial is ongoing (the “Terminated Trial”), then the Party responsible for the Territory in which the Terminated Trial occurred will be responsible for the orderly wrapping up of such trial consistent with good clinical practices and the costs of such activities.
Appears in 2 contracts
Sources: Collaboration and License Agreement (Relief Therapeutics Holding SA), Collaboration and License Agreement (Acer Therapeutics Inc.)
Relief Termination. (a) Notwithstanding any other provision of this Agreement to the contrary, Relief may for any reason in its sole discretion decide on three (3) months’ written notice (or any shorter period to which Acer agrees in its sole discretion) to not proceed with Development and Commercialization in all countries within the Relief Territory or Relief may decide on thirty (30) days written notice (or any shorter period to which Acer agrees in its sole discretion) delivered not before January 3, 2022 to not proceed with Development and Commercialization in all countries within the Relief Territory if an NDA for the Acer Product for a UCD has not been accepted for review by the FDA (a “Relief Termination”), in which case (Ai) Relief will not be responsible for any further monetary or other obligations to Acer that accrue following a Relief Termination, but without limiting its obligations for activities and obligations prior to such cessation, (Bii) all payments made by Relief under this Agreement as of the Relief Termination (i.e., Milestone Payments, the Reimbursement Payment, the Development Payments (notwithstanding the provisions of Section 5.2(d) for this purpose) and any other payments and reimbursements) are non-refundable and (Ciii) all rights and data with respect to Product will thereupon revert or transfer to Acer; provided, however, that after commercial launch the occurrence of Product occurs the First Commercial Sale in at least one Significant European Market, Relief may decide to not proceed with Development and Commercialization in one or more countries within the Relief Territory which are identified to Acer in writing (the “Excluded Countries”) without triggering a Relief Termination so long as Relief continues to exercise Commercially Reasonable Efforts for Development and Commercialization for the remaining countries within the Relief Territory and otherwise performs this Agreement in accordance with its terms, with Relief agreeing that any Excluded Countries shall, following such identification by Relief to Acer in writing, be excluded from the Relief Territory for purposes of this Agreement.
(b) In the event of a Relief Termination, (i) Acer will immediately regain worldwide rights to Product, and the Acer Territory will License shall be immediately terminated except to the entire world extent necessary for purposes of ProductRelief to fulfill its ongoing obligations until completed, (ii) all rights and responsibilities of Relief with respect to Development in the Relief Territory will revert to Acer, (iii) Relief will transfer sponsorship of the management of any Development in the Relief Territory to Acer to the extent requested by Acer and (iv) Acer will thereafter be free to Develop and Commercialize the Product anywhere in the world in its sole discretion and at its sole expense, provided that Relief will be responsible for the monetary obligations under Article 5 accrued as of the Relief Termination. Acer shall refund to Relief all the reasonable out-of-pocket expenses borne by Relief in relation to the activities required under this Section 3.3 (b).
(c) If a clinical trial for Product is terminated or any Development is ended while a clinical trial is ongoing (the “Terminated Trial”), then the Party responsible for the Territory in which the Terminated Trial occurred will be responsible for the orderly wrapping up of such trial consistent with good clinical practices and the costs of such activities.
Appears in 2 contracts
Sources: Exclusive License Agreement (Relief Therapeutics Holding SA), Exclusive License Agreement (Acer Therapeutics Inc.)