Common use of Regulatory Data Clause in Contracts

Regulatory Data. Upon early termination of this Agreement for any reason (but not expiration), and for a period of [*] after the effective date of such termination (or for such other period of time mutually agreed to by the parties in writing), EMORY shall have the right to review, and/or have a third party review on its behalf, subject to EMORY entering into a confidentiality agreement with such third party containing provisions at least as restrictive as those contained in this Agreement (hereinafter referred to as the “3rd Party CDA”) and subject to EMORY being responsible and liable to ALIMERA for any breaches of the terms of confidentiality under the 3rd Party CDA by such third party, [*] (the “Summary Development Information”). For the avoidance of doubt, the parties acknowledge and agree that the Summary Development Information does not contain all [*]. The Summary Development Information shall be made available by ALIMERA for review at a location to be designated by ALIMERA and for a reasonable period of time. In the event that EMORY enters into a license agreement with a third party covering a Licensed Product(s) after EMORY or the third party has reviewed the Summary Development Information, and Emory or such third party requests that ALIMERA provide all [*] (the “Development Information”), ALIMERA shall use reasonable efforts to provide EMORY or such third party with full and complete copies of all Development Information in its possession or control, which EMORY or such third party may use and reference, only after (x) EMORY or such third party reimburses ALIMERA for all the documentable costs incurred by ALIMERA and ALIMERA’s Affiliates and sublicensees in connection with the clinical development, regulatory approval process and commercialization with respect to such Licensed Product(s) and (y) ALIMERA and EMORY and/or such third party, as applicable, agree to reasonable terms related to the use of the Development Information, including an agreement by EMORY and/or such third party, as applicable, to indemnify ALIMERA in connection with EMORY’s or such third party’s use of the Development Information. For the purpose of clarity, the 3rd Party CDA will expire upon the fulfillment of Subarticles 12.7(x) and 12.7(y) herein by EMORY and/or such third party.

Regulatory Data. Upon early termination of this Agreement for any reason (but not expiration), and for a period of [*] after the effective date of such termination (or for such other period of time mutually agreed to by the parties in writing), EMORY shall have the right to review, and/or have a third party review on its behalf, subject to EMORY entering into a confidentiality agreement with such third party containing provisions at least as restrictive as those contained in this Agreement (hereinafter referred to as the “3rd Party CDA”) and subject to EMORY being responsible and liable to ALIMERA for any breaches of the terms of confidentiality under the 3rd Party CDA by such third party, [*] (the “Summary Development Information”). For the avoidance of doubt, the parties acknowledge and agree that the Summary Development Information does not contain all [*]. The Summary Development Information shall be made available by ALIMERA for review at a location to be designated by ALIMERA and for a reasonable period of time. In the event that EMORY enters into a license agreement with a third party covering a Licensed Product(s) after EMORY or the third party has reviewed the Summary Development Information, and Emory or such third party requests that ALIMERA provide all [*] (the “Development Information”), ALIMERA shall use reasonable efforts to provide EMORY or such third party with full and complete copies of all Development Information in its possession or control, which EMORY or such third party may use and * Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. reference, only after (x) EMORY or such third party reimburses ALIMERA for all the documentable costs incurred by ALIMERA and ALIMERA’s Affiliates and sublicensees in connection with the clinical development, regulatory approval process and commercialization with respect to such Licensed Product(s) and (y) ALIMERA and EMORY and/or such third party, as applicable, agree to reasonable terms related to the use of the Development Information, including an agreement by EMORY and/or such third party, as applicable, to indemnify ALIMERA in connection with EMORY’s or such third party’s use of the Development Information. For the purpose of clarity, the 3rd Party CDA will expire upon the fulfillment of Subarticles 12.7(x) and 12.7(y) herein by EMORY and/or such third party.

Regulatory Data. Upon early termination 10.1 Collaboration Gene Licensed to Bayer and Third Party(ies). 10.1.1 With respect to Collaboration Genes licensed by Evogene to both Bayer and one or more other Third Party licensee(s) of this Agreement Evogene (i.e. for any reason (but not expirationuse in crops other than Wheat), and for a period of [*] after Bayer agrees to cooperate with such licensee(s) with respect to regulatory approval matters relating to each such Collaboration Gene as set forth in this Section 10.1, provided that, with respect to each Collaboration Gene, the effective date of such termination (or for such other period of time mutually Third Party licensee has agreed to be bound by substantially the parties same terms (i.e. the same in writing), EMORY shall have the right to review, and/or have a third party review on its behalf, subject to EMORY entering into a confidentiality agreement with such third party containing provisions at least as restrictive as those contained in this Agreement (hereinafter referred to as the “3rd Party CDA”all material respects) and subject to EMORY being responsible and liable to ALIMERA for any breaches of the terms of confidentiality under the 3rd Party CDA by such third party, [*] (the “Summary Development Information”). For the avoidance of doubt, the parties acknowledge and agree that the Summary Development Information does not contain all [*]. The Summary Development Information shall be made available by ALIMERA for review at a location to be designated by ALIMERA and for a reasonable period of time. In the event that EMORY enters into a license agreement with a third party covering a Licensed Product(s) after EMORY or the third party has reviewed the Summary Development Information, and Emory or such third party requests that ALIMERA provide all [*] (the “Development Information”), ALIMERA shall use reasonable efforts to provide EMORY or such third party with full and complete copies of all Development Information in its possession or control, which EMORY or such third party may use and reference, only after (x) EMORY or such third party reimburses ALIMERA for all the documentable costs incurred by ALIMERA and ALIMERA’s Affiliates and sublicensees in connection with the clinical development, regulatory approval process and commercialization with respect to such Licensed Product(s) and (y) ALIMERA and EMORY and/or such third party, as applicable, agree to reasonable terms related Initials Bayer : page 62 of 89 Initials Evogene : *** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission. Collaboration Gene. Evogene will use good faith efforts to include in agreements with such Third Party licensee(s) entered into after the Effective Date, other than pursuant to Pre-existing Obligations, provisions pursuant to which such Third Party agrees to cooperate with Bayer with respect to regulatory approval matters as set forth in this Section 10.1 and that such Third Party Licensee(s) will be bound by the same regulatory obligations as those applying on Bayer set forth in this Section 10.1 with respect to Collaboration Genes and the products containing a Collaboration Gene in crops other than Wheat. Such agreements shall be referred to as “Compliant Future Agreements”. 10.1.2 Bayer shall notify Evogene when it has reached the stage of preparing data for inclusion in filings for Regulatory Approval with respect to a Licensed Product containing a Collaboration Gene. Promptly after receipt of such notice and subject to confidentiality obligations to Third Parties, Evogene will notify Bayer whether the Development InformationCollaboration Gene(s) contained in such Licensed Product is subject of another license(s) and, including an if so, will identify the other licensee(s), and will inform Bayer whether the license agreement made with such Third Party is a Compliant Future Agreement. Compliant Future Agreements will provide that Evogene shall receive notifications from the Third Party licensee(s) when these have reached the stage of preparing data for inclusion in filings for regulatory approval with respect to a product containing a Collaboration Gene in crops other than Wheat and Evogene, subject to confidentiality obligations to Bayer, shall inform such Third Party whether the Collaboration Gene(s) contained in such product is subject to a license to Bayer. 10.1.3 Except as set forth in Section 10.1.5 below, the following shall apply on Bayer and the Third Party licensee(s) in the case a Compliant Future Agreement has been made between Evogene and the Third Party: 10.1.3.1 Unless Bayer and such other licensee(s) agree otherwise, prior to the commencement by EMORY and/or such third party, as applicable, to indemnify ALIMERA in connection with EMORY’s Bayer or such third party’s use other licensee(s) of preparation of data intended for inclusion in filings for regulatory approval with respect to a Collaboration Gene, Bayer and the Development Information. For Third Party licensee will enter into a mutually acceptable confidentiality agreement covering the potential disclosures and discussions for the purpose of claritySection 10.1.3.2; 10.1.3.2 Thereafter, Bayer and such other licensee(s) shall consult with each other to review relevant regulatory and product stewardship issues and will use reasonable good faith efforts to agree upon the appropriate reasonable strategic plans and actions that will serve to preserve the registrability of and ability to respectively commercialize Licensed Products containing such Collaboration Gene and products containing such Collaboration Gene in crops other than Wheat. Such plans and actions may include performance of certain studies, sharing of protocols and payment of a reasonable access fees for regulatory data obtained up to a certain point in time. Initials Bayer : page 63 of 89 Initials Evogene : *** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission. 10.1.4 The above requirements relating to regulatory approval shall apply to Collaboration Genes licensed for as long as such Collaboration Genes remain licensed to both Bayer and such other licensee(s). 10.1.5 Notwithstanding the above, if the relevant Collaboration Gene is licensed to Monsanto, the 3rd Party CDA will expire upon the fulfillment provisions of Subarticles 12.7(x) and 12.7(y) herein by EMORY and/or such third partySection 10.2 shall apply.