Terminated Product Reversion. 13.4.1 In the event of any termination of this Agreement, upon Precision’s request, TGTX shall perform the following obligations, and Precision shall reimburse TGTX for the actual, reasonable costs associated with the performance of such obligations: (a) to the extent permitted by Applicable Laws or the terms of any applicable Third Party agreements (including Third Party agreements under which TGTX or any of its Affiliates are granted a license related to the Exploitation of any Terminated Product), (i) assign to Precision (A) TGTX’s and its Affiliates’ entire right, title and interest in and to all materials, preclinical and clinical data, safety data and all other supporting data, in each case, relating to such Terminated Product that is in TGTX’s or its Affiliates’ Control, and (B) TGTX’s and its Affiliates’ entire right, title and interest in and to all such Third Party agreements that are freely assignable and relate to the Exploitation of any applicable Terminated Product and for which such Third Party agrees to release TGTX for obligations and liabilities arising from and after such assignment, provided, that TGTX will retain the right to use any of the assigned materials or data as necessary for legal or compliance purposes, (ii) with respect to any Third Party agreements that are not assigned under (i) and under which TGTX or any of its Affiliates are granted a license related to Exploitation of any Terminated Product and pursuant to which TGTX or its Affiliates have a right or ability to grant sublicenses to Precision, grant a sublicense to Precision of all license rights granted to TGTX thereunder, on and subject to the same terms and conditions (including financial terms) set forth in the applicable Third Party agreement solely to Exploit such Terminated Product in all fields in the Territory, and (iii) deliver to Precision a copy of all relevant Know-How, in each case that relates to, and to the extent necessary or reasonably useful for, Precision to continue the Exploitation of such Terminated Product; (b) to the extent permitted by Applicable Laws and the terms of any applicable Third Party agreements, transfer to Precision ongoing Clinical Trials or other studies being conducted by or under authority of TGTX related to such Terminated Product as of the date of the applicable termination notice and furnish Precision with reasonable cooperation to transition to Precision the management and continued performance of such Clinical Trials or other studies or, if requested by Precision, terminate such Clinical Trials or other studies, in each case in a manner in compliance with Applicable Laws and ethical guidelines; (c) to the extent permitted by Applicable Laws and the terms of any applicable Third Party agreements, transfer to Precision any and all Regulatory Filings and related regulatory data (including pharmacovigilance databases, adverse drug experience reports and associated documents) and nonclinical, clinical and other data contained or referenced in or supporting any Regulatory Filings and related Know-How, manufacturing records, Regulatory Approvals, Marketing Authorizations and all other correspondence (including minutes and official contact reports relating to any communications with any Regulatory Authority), filings and submissions with and to Regulatory Authorities with respect to such Terminated Product; and, to this end, TGTX shall file for transfer with the relevant Regulatory Authorities and to give all other notifications and approvals necessary under Applicable Laws for the transfer of such Regulatory Filings and related regulatory data and Know-How, Regulatory Approvals, Marketing Authorizations and such other filings and submissions; (d) after fulfillment of TGTX’s existing commitments to its customers (including its Distributors) (which fulfillment period shall not in any event exceed [***] following termination of this Agreement as set forth in Section 13.3.1), sell to Precision TGTX’s then-existing inventory of such Terminated Product, at TGTX’s cost of goods sold for such Terminated Product as calculated in accordance with U.S. GAAP without mark-up; provided that Precision shall not be obligated to purchase such inventory; (e) if an application seeking Marketing Authorization for a given Terminated Product has been filed as of the effective date of termination of this Agreement, assign to Precision all right, title and interest in and to the Licensed Product Trademarks that have been used in commerce solely with such Terminated Product, together with all goodwill relevant thereto, throughout the Territory; provided, however, that such obligation to assign will not extend to (i) any corporate name or logo of TGTX or any of its Affiliates, or (ii) any trademarks used by TGTX or any of its Affiliates on products that are not a Terminated Product; (f) TGTX shall not withdraw or cancel any such Terminated Product’s Regulatory Approval or Marketing Authorization or application for either, unless expressly instructed so by Precision in writing or required by Applicable Laws or any Regulatory Authority; provided that Precision shall be responsible for all costs and expenses for the maintenance of all Regulatory Approvals and Marketing Authorizations following receipt of notice of termination; (g) TGTX shall thereafter refrain from making any statement, public or otherwise, regarding any Terminated Product unless TGTX is required to make such statement pursuant to Applicable Law or requirements of any Regulatory Authority and such statement is limited to the fact that TGTX is no longer Developing or Commercializing such Terminated Product or Precision shall have approved any such statement in writing; and (h) following written request by Precision, TGTX shall take such other actions and execute such other instruments, assignments and documents that are reasonably necessary to effect the transfers and grants of rights under this Section 13.4.1
Appears in 2 contracts
Samples: License Agreement (Precision Biosciences Inc), License Agreement (Tg Therapeutics, Inc.)
Terminated Product Reversion. 13.4.1 In (a) Precision shall have the event option, exercisable within [***] following the effective date of any termination of this AgreementAgreement with respect to a Terminated Product, to have Lilly and its Affiliates grant Precision the license and rights set forth in this Section 15.5.3(a) with respect to such Terminated Product (the “Reversion Option”). Effective upon Precision’s delivery of written notice to Lilly of exercise of the Reversion Option with respect to a given Terminated Product, (i) subject to Section 15.5.3(c), Lilly agrees to grant and hereby grants (on behalf of itself and its Affiliates) to Precision an exclusive (even as to Lilly and its Affiliates), [***] license under Lilly Collaboration IP, and (ii) [***], in each case (i) and (ii), to the extent relating to such Terminated Product or developed pursuant to the Research Program, to Research, Develop, Manufacture, have Manufactured, use, keep, import, export, offer for sale, sell, Commercialize and otherwise exploit such Terminated Product in any and all fields; provided, that (x) if Precision does not exercise the Reversion Option with respect to a given Terminated Product within [***] of termination of this Agreement with respect to such Terminated Product, Lilly shall have no obligation to grant Precision such license or rights with respect to such Terminated Product and (y) in no event shall Precision receive, and Lilly shall have no obligation to grant to Precision, any rights or licenses to any Excluded Technologies.
(b) Except as otherwise set forth in Section 15.5.3(c) (if applicable), if Precision exercises the Reversion Option with respect to a given Terminated Product, then[***].
(c) If Precision exercises the Reversion Option with respect to a given Terminated Product in a case where this Agreement was terminated [***].
(d) If Precision exercises the Reversion Option with respect to a given Terminated Product, upon Precision’s request, TGTX request Lilly shall perform the following obligations, and Precision shall reimburse TGTX for the actual, reasonable costs associated with the performance of such obligations[***]:
(ai) to the extent permitted by Applicable Laws or the terms of any applicable Third Party agreements (including Third Party agreements under which TGTX or any of its Affiliates are granted a license related to the Exploitation of any Terminated Product)agreements, (iA) assign to Precision (Ax) TGTX’s its and its Affiliates’ entire right, title and interest in and to all materials, preclinical and clinical data, safety data and all other supporting data, in each case, solely relating to such Terminated Product that is in TGTXLilly’s or its Affiliates’ Control, and (By) TGTX’s and its Affiliates’ entire right, title and interest in and to all such Third Party agreements that are freely assignable and relate to the Exploitation of any applicable Terminated Product and for which such Third Party agrees to release TGTX for obligations and liabilities arising from and after such assignment, provided, that TGTX will retain the right to use any of the assigned materials or data as necessary for legal or compliance purposes, (ii) with respect to any Third Party agreements that are not assigned under (i) and under which TGTX or any of its Affiliates are granted a license related to Exploitation of any Terminated Product and pursuant to which TGTX or its Affiliates have a right or ability to grant sublicenses to Precision, grant a sublicense to Precision of all license rights granted to TGTX thereunder, on and subject to the same terms and conditions (including financial terms) set forth in the applicable Third Party agreement solely to Exploit such Terminated Product in all fields in the Territory[***], and (iiiB) deliver to Precision a copy of all relevant Know-How, in each case that relates to, and to the extent reasonably necessary or reasonably useful for, Precision to WEIL:\97737446\1\59474.0121 EXECUTION VERSION continue the Exploitation Research, Development, Manufacture, use and Commercialization of such Terminated Product; provided, that Lilly shall not be obligated to translate or reformat any data or to convert or adapt any database or software (it being understood that such data and databases shall be transferred on an as-is basis) or to provide any Excluded Technologies, and Lilly will retain the right to use any of the assigned materials or data as necessary for legal or compliance purposes;
(bii) to the extent permitted by Applicable Laws and the terms of any applicable Third Party agreements, [***];
(iii) to the extent permitted by Applicable Laws and the terms of any applicable Third Party agreements, transfer to Precision ongoing Clinical Trials or other studies being conducted by or under authority of TGTX related to such Terminated Product as of the date of the applicable termination notice and furnish Precision with reasonable cooperation to transition to Precision the management and continued performance of such Clinical Trials or other studies or, if requested by Precision, terminate such Clinical Trials or other studies, in each case in a manner in compliance with Applicable Laws and ethical guidelines[***];
(c) to the extent permitted by Applicable Laws and the terms of any applicable Third Party agreements, transfer to Precision any and all Regulatory Filings and related regulatory data (including pharmacovigilance databases, adverse drug experience reports and associated documents) and nonclinical, clinical and other data contained or referenced in or supporting any Regulatory Filings and related Know-How, manufacturing records, Regulatory Approvals, Marketing Authorizations and all other correspondence (including minutes and official contact reports relating to any communications with any Regulatory Authority), filings and submissions with and to Regulatory Authorities with respect to such Terminated Product; and, to this end, TGTX shall file for transfer with the relevant Regulatory Authorities and to give all other notifications and approvals necessary under Applicable Laws for the transfer of such Regulatory Filings and related regulatory data and Know-How, Regulatory Approvals, Marketing Authorizations and such other filings and submissions;
(div) after fulfillment of TGTXLilly’s existing commitments to its customers (including its Distributors) (which fulfillment period shall not in any event exceed [***] following termination of this Agreement as set forth in Section 13.3.115.5.1), sell to Precision TGTXLilly’s then-existing inventory of such Terminated Product, at TGTX’s cost of goods sold for such Terminated Product as calculated in accordance with U.S. GAAP without mark-up[***]; provided that Precision shall not be obligated to purchase such inventory;
(e) inventory and such sale shall only occur if an application seeking Marketing Authorization for a given Terminated Product has been filed as of Precision shall notify Lilly within [***] after the effective date of termination of this Agreement, assign that Precision elects to exercise such right;
(v) grant to Precision all righta non-exclusive, title and interest in and to worldwide, royalty-free, fully paid up license for use of the Licensed Product Trademarks that have been used in commerce solely with such Terminated ProductProduct (excluding any corporate name or logo of Lilly or any of its Affiliates and any trademarks that are used by Lilly or any of its Affiliates on products that are not Terminated Products), together with all goodwill relevant thereto, throughout the Territory; provided, however, that such obligation to assign will not extend to (i) any corporate name or logo of TGTX or any of its Affiliates, or (ii) any trademarks used by TGTX or any of its Affiliates on products that are not a Terminated Product;
(fvi) TGTX Lilly shall not withdraw or cancel any such Terminated Product’s Regulatory Approval or Marketing Authorization or application for either, unless expressly instructed so by Precision in writing or required by Applicable Laws or any Regulatory Authoritywriting; provided that Precision shall be responsible for all costs and expenses for the maintenance of all Regulatory Approvals and Marketing Authorizations following receipt of notice of termination;
(g) TGTX shall thereafter refrain from making any statement, public or otherwise, regarding any Terminated Product unless TGTX is required to make such statement pursuant to Applicable Law or requirements of any Regulatory Authority and such statement is limited to the fact that TGTX is no longer Developing or Commercializing such Terminated Product or Precision shall have approved any such statement in writing; and
(hvii) following written request by Precision, TGTX Lilly shall take such other actions and execute such other instruments, assignments and documents that are reasonably necessary to effect the transfers and grants of rights under this Section 13.4.115.5.3(c)
Appears in 1 contract
Samples: Development and License Agreement (Precision Biosciences Inc)
Terminated Product Reversion. 13.4.1 In (a) Precision shall have the event option, exercisable within [***] following the effective date of any termination of this AgreementAgreement with respect to a Terminated Product, to have Prevail and its Affiliates grant Precision the license and rights set forth in this Section 15.5.3(a) with respect to such Terminated Product (the “Reversion Option”). Effective upon Precision’s delivery of written notice to Prevail of exercise of the Reversion Option with respect to a given Terminated Product, (i) subject to Section 15.5.3(c), Prevail agrees to grant and hereby grants (on behalf of itself and its Affiliates) to Precision an exclusive (even as to Prevail and its Affiliates), [***] license under Prevail Collaboration IP, and (ii) [***], in each case (i) and (ii), to the extent relating to such Terminated Product or developed pursuant to the Research Program, to Research, Develop, Manufacture, have Manufactured, use, keep, import, export, offer for sale, sell, Commercialize and otherwise exploit such Terminated Product in any and all fields; provided, that (x) if Precision does not exercise the Reversion Option with respect to a given Terminated Product within [***] of termination of this Agreement with respect to such Terminated Product, Prevail shall have no obligation to grant Precision such license or rights with respect to such Terminated Product and (y) in no event shall Precision receive, and Prevail shall have no obligation to grant to Precision, any rights or licenses to any Excluded Technologies.
(b) Except as otherwise set forth in Section 15.5.3(c) (if applicable), if Precision exercises the Reversion Option with respect to a given Terminated Product, then[***],
(c) If Precision exercises the Reversion Option with respect to a given Terminated Product in a case where this Agreement was terminated [***].
(d) If Precision exercises the Reversion Option with respect to a given Terminated Product, upon Precision’s request, TGTX request Prevail shall perform the following obligations, and Precision shall reimburse TGTX for the actual, reasonable costs associated with the performance of such obligations[***]:
(ai) to the extent permitted by Applicable Laws or the terms of any applicable Third Party agreements (including Third Party agreements under which TGTX or any of its Affiliates are granted a license related to the Exploitation of any Terminated Product)agreements, (iA) assign to Precision (Ax) TGTX’s its and its Affiliates’ entire right, title and interest in and to all materials, preclinical and clinical data, safety data and all other supporting data, in each case, solely relating to such Terminated Product that is in TGTXPrevail’s or its Affiliates’ Control, and (By) TGTX’s and its Affiliates’ entire right, title and interest in and to all such Third Party agreements that are freely assignable and relate to the Exploitation of any applicable Terminated Product and for which such Third Party agrees to release TGTX for obligations and liabilities arising from and after such assignment, provided, that TGTX will retain the right to use any of the assigned materials or data as necessary for legal or compliance purposes, (ii) with respect to any Third Party agreements that are not assigned under (i) and under which TGTX or any of its Affiliates are granted a license related to Exploitation of any Terminated Product and pursuant to which TGTX or its Affiliates have a right or ability to grant sublicenses to Precision, grant a sublicense to Precision of all license rights granted to TGTX thereunder, on and subject to the same terms and conditions (including financial terms) set forth in the applicable Third Party agreement solely to Exploit such Terminated Product in all fields in the Territory[***], and (iiiB) deliver to Precision a copy of all relevant Know-How, in each case that relates to, and to the extent reasonably necessary or reasonably useful for, Precision to continue the Exploitation Research, Development, Manufacture, use and Commercialization of such Terminated Product; provided, that Prevail shall not be obligated to translate or reformat any data or to convert or adapt any database or software (it being understood that such data and databases shall be transferred on an as-is basis) or to provide any Excluded Technologies, and Prevail will retain the right to use any of the assigned materials or data as necessary for legal or compliance purposes;
(bii) to the extent permitted by Applicable Laws and the terms of any applicable Third Party agreements, [***];
(iii) to the extent permitted by Applicable Laws and the terms of any applicable Third Party agreements, transfer to Precision ongoing Clinical Trials or other studies being conducted by or under authority of TGTX related to such Terminated Product as of the date of the applicable termination notice and furnish Precision with reasonable cooperation to transition to Precision the management and continued performance of such Clinical Trials or other studies or, if requested by Precision, terminate such Clinical Trials or other studies, in each case in a manner in compliance with Applicable Laws and ethical guidelines[***];
(c) to the extent permitted by Applicable Laws and the terms of any applicable Third Party agreements, transfer to Precision any and all Regulatory Filings and related regulatory data (including pharmacovigilance databases, adverse drug experience reports and associated documents) and nonclinical, clinical and other data contained or referenced in or supporting any Regulatory Filings and related Know-How, manufacturing records, Regulatory Approvals, Marketing Authorizations and all other correspondence (including minutes and official contact reports relating to any communications with any Regulatory Authority), filings and submissions with and to Regulatory Authorities with respect to such Terminated Product; and, to this end, TGTX shall file for transfer with the relevant Regulatory Authorities and to give all other notifications and approvals necessary under Applicable Laws for the transfer of such Regulatory Filings and related regulatory data and Know-How, Regulatory Approvals, Marketing Authorizations and such other filings and submissions;
(div) after fulfillment of TGTXPrevail’s existing commitments to its customers (including its Distributors) (which fulfillment period shall not in any event exceed [***] following termination of this Agreement as set forth in Section 13.3.115.5.1), sell to Precision TGTXPrevail’s then-existing inventory of such Terminated Product, at TGTX’s cost of goods sold for such Terminated Product as calculated in accordance with U.S. GAAP without mark-up[***]; provided that Precision shall not be obligated to purchase such inventory;
(e) inventory and such sale shall only occur if an application seeking Marketing Authorization for a given Terminated Product has been filed as of Precision shall notify Prevail within [***] after the effective date of termination of this Agreement, assign that Precision elects to exercise such right;
(v) grant to Precision all righta non-exclusive, title and interest in and to worldwide, royalty-free, fully paid up license for use of the Licensed Product Trademarks that have been used in commerce solely with such Terminated ProductProduct (excluding any corporate name or logo of Prevail or any of its Affiliates and any trademarks that are used by Prevail or any of its Affiliates on products that are not Terminated Products), together with all goodwill relevant thereto, throughout the Territory; provided, however, that such obligation to assign will not extend to (i) any corporate name or logo of TGTX or any of its Affiliates, or (ii) any trademarks used by TGTX or any of its Affiliates on products that are not a Terminated Product;
(fvi) TGTX Prevail shall not withdraw or cancel any such Terminated Product’s Regulatory Approval or Marketing Authorization or application for either, unless expressly instructed so by Precision in writing or required by Applicable Laws or any Regulatory Authoritywriting; provided that Precision shall be responsible for all costs and expenses for the maintenance of all Regulatory Approvals and Marketing Authorizations following receipt of notice of termination;
(g) TGTX shall thereafter refrain from making any statement, public or otherwise, regarding any Terminated Product unless TGTX is required to make such statement pursuant to Applicable Law or requirements of any Regulatory Authority and such statement is limited to the fact that TGTX is no longer Developing or Commercializing such Terminated Product or Precision shall have approved any such statement in writing; and
(hvii) following written request by PrecisionXxxxxxxxx, TGTX Prevail shall take such other actions and execute such other instruments, assignments and documents that are reasonably necessary to effect the transfers and grants of rights under this Section 13.4.115.5.3(c)
Appears in 1 contract
Samples: Development and License Agreement (Precision Biosciences Inc)