AMENDMENT NO. 1 TO THE OPTION AND LICENSE AGREEMENT
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.30
AMENDMENT NO. 1
TO THE
This Amendment No. 1 (the “Amendment”) dated January 14, 2023 (“Amendment Effective Date”) is made by and between Clearside Biomedical, Inc., a Delaware corporation (“Clearside”) and REGENXBIO Inc., a Delaware corporation (“REGENXBIO”). Clearside and REGENXBIO may each be referred to herein individually as a “Party” and collectively as the “Parties.”
WHEREAS, the Parties have entered into that certain Option and License Agreement, dated August 29, 2019, as amended, supplemented or otherwise modified to the date hereof (the “Agreement”);
WHEREAS, REGENXBIO has entered into an agreement related to a Covered Product known as RGX-314 (“RGX-314”) with AbbVie Global Enterprises Ltd., a Bermuda company and its Affiliates (collectively, “AbbVie”) in particular the License and Collaboration Agreement, dated September 10, 2021 by and between REGENXBIO and AbbVie (the “AbbVie Collaboration”);
WHEREAS, Clearside has been informed by REGENXBIO that AbbVie is a Collaboration Partner of REGENXBIO with respect to RGX-314, as defined in and pursuant to the AbbVie Collaboration; and
WHEREAS, the Parties hereto desire to amend the Agreement, as described below, on the terms and subject to the conditions set forth herein.
NOW, THEREFORE, in consideration of the foregoing and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, hereby agree as follows:
“1.78.7 For the avoidance of doubt, no sales between or among REGENXBIO and/or its Covered Product Sellers shall be considered a sale for determining Net Sales under the Agreement.”
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
“4.5. Sharing of Information and Cooperation. Pursuant to Section 3.2, REGENXBIO shall identify to Clearside collaboration partners that have been granted rights by REGENXBIO related to the Development or Commercialization of Covered Products and their Affiliates and Sublicensees (collectively, “Collaboration Partners”). Clearside hereby acknowledges that it has been informed by REGENXBIO that AbbVie is a Collaboration Partner of REGENXBIO, as it relates to the Development and/or Commercialization of that certain Covered Product known as RGX-314 or other Covered Products resulting from that certain License and Collaboration Agreement, dated September 10, 2021 by and between REGENXBIO and AbbVie (“AbbVie Collaboration”). Clearside agrees to engage in 3-way discussions between Clearside,
2
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
REGENXBIO, and AbbVie as reasonably requested by REGENXBIO, and to disclose the same information in such 3-way discussions that Clearside would otherwise share or disclose directly to REGENXBIO under this Agreement, including any Quality Agreement or Pharmacovigilance Agreement entered into pursuant to this Agreement, provided that AbbVie is bound by a confidentiality agreement containing terms of confidentiality and non-use at least as stringent as the applicable terms set forth in this Agreement. Further, REGENXBIO may share any information with AbbVie that Clearside has shared or disclosed directly to REGENXBIO under this Agreement, including any Quality Agreement or Pharmacovigilance Agreement entered into pursuant to this Agreement, and including but not limited to information related to obtaining Regulatory Approvals pursuant to Section 4.2.1(a), provided that AbbVie is bound by a confidentiality agreement containing terms of confidentiality and non-use at least as stringent as the applicable terms set forth in this Agreement.”
“6.4.1. Royalty Rates. As further consideration for the rights granted to REGENXBIO hereunder and subject to the terms and conditions of this Agreement, during the Royalty Term, REGENXBIO will pay to Clearside a royalty in the amount of [***] of Net Sales of Covered Products by REGENXBIO or its Affiliates or any Covered Product Seller (including but not limited to AbbVie pursuant to the AbbVie Collaboration), subject to the royalty reductions set forth below. For the avoidance of doubt, in no case shall REGENXBIO owe to Clearside more than one such royalty on a sale of a Covered Product. REGENXBIO will have no obligation to pay any royalty with respect to Net Sales of Covered Product in any country after the Royalty Term for such Covered Product in such country has expired. Following the expiration of the Royalty Term for Covered Product in a country, the grants in Section 3.1 will become full-paid, royalty-free, perpetual and irrevocable for such Covered Product in such country, and no further royalties will be payable. REGENXBIO will include any Covered Product Sellers’ sales in the reports described in Section 6.5 of the Agreement and use reasonable efforts to ensure that each Covered Product Seller retains accurate financial books and records as set forth in Section 6.8 of the Agreement.”
3
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
[Signatures follow on next page]
4
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
IN WITNESS WHEREOF, the Parties by their authorized representatives have executed this Amendment as of the Amendment Effective Date.
|
REGENXBIO Inc.
|
/s/ Xxxxxx Xxxxxxxx |
/s/ Xxxxxxx Xxxxxxxxx |
Signature
|
Signature |
Xxxxxx Xxxxxxxx |
Xxxxxxx Christmas |
By: Name |
By: Name
|
President and Chief Executive Officer |
Chief Legal Officer |
Title |
Title
|
January 14, 2023 |
January 17, 2023 |
Date |
Date |