First Amendment to License Agreement, dated February 26, 2019, by and between the Registrant and F. Hoffmann-La Roche Ltd and Genentech, Inc

Exhibit 10.2

[*****] Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. Redacted information is indicated by brackets.

Execution Version

First Amendment to License Agreement

between

Dermira, Inc.
275 Middlefield Road, Suite 150
Menlo Park, California 94025
United States of America
(“Dermira”)

and

F. Hoffmann-La Roche Ltd
Grenzacherstrasse 124
4070 Basel
Switzerland
(“Roche Basel”)

and

Genentech, Inc.
1 DNA Way
South San Francisco
CA 94080
United States of America
(“Roche US”)

(hereinafter, Roche Basel and Roche US together referred to as “Roche”)

Whereas, Roche and Dermira entered into a certain license agreement effective September 14, 2017 (the “License Agreement”) under which Roche granted Dermira certain rights with respect to the Product, subject to certain other rights retained by Roche, including in the Roche Retained Field; and

Whereas, subject to Section 6.1.5 of the License Agreement and effective December 1, 2017, the Parties entered into that certain Supply and quality Agreement for lebrikizumab drug substance, drug product (unfinished and finished) and placebo (unfinished and finished) (the “Roche-Dermira Supply Agreement”); and

Whereas, on or about June 11, 2018, the Roche Reversion occurred as a result of Roche relinquishing certain of its retained rights in accordance with Section 2.6.3 of the License Agreement; and

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Whereas, Roche has validly given (i) the Drug Product Transfer Notice under Section 6.2.2 of the License Agreement on January 8, 2018, as well as (ii) the Drug Substance Transfer Notice under Section 6.2.1 of the License Agreement on November 23, 2018, which the Parties wish to supplement hereby; and

Whereas, the Parties desire to amend the License Agreement, in accordance with Section 21.11 (Amendments) thereof, in certain respects, including to create a governance structure for technology transfer, to provide for a present manufacturing license, to agree to modify certain provisions of the Roche-Dermira Supply Agreement and to modify certain of Dermira’s payment obligations to Roche in order to support Dermira in advancing the development of the Product to the market.

Now therefore, in consideration of the mutual covenants and promises contained in this First Amendment and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto, intending to be legally bound, do hereby agree as follows:

Except as expressly set forth in this First Amendment, Section 6.2.1 (Drug Substance) of the Agreement shall remain in full force and effect.  The Parties agree to the following amendments and supplemental provisions.

[*****] Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. Redacted information is indicated by brackets.

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To oversee all aspects of the Technology Transfer for the Manufacture of Drug Substance, the Parties shall establish a Technology Transfer Team (“TT Team”) and a plan for such technology transfer (“Technology Transfer Project Plan”).

The roles and responsibilities of the Parties for the Technology Transfer are described on Appendix 1 of this First Amendment; provided that, notwithstanding any provision therein to the contrary, the TT Team shall determine any major changes to the Technology Transfer Project Plan. A Dermira representative shall be the chairperson of the TT Team.  

Clause (a) of Section 2.1.2 (Manufacturing Rights) is hereby deleted in its entirety and replaced with the following:

“(a) hereby grants to Dermira a co-exclusive license under the Roche Patent Rights and all Roche Know-How that is disclosed by Roche to Dermira under this Agreement to make, have made, and Manufacture the Compound, Dermira Modified Compounds, Joint Modified Compounds and Products as conducted by Dermira in the Field in the Territory in accordance with this Agreement, and”.

Section 6.1.3 (Supply of Drug Substance) shall be modified to add the following paragraphs after the existing (unnumbered) paragraph (which, for clarity, shall remain):

“Notwithstanding the immediately foregoing paragraph and commencing with the First Amendment Effective Date, Roche shall supply to Dermira, as and when

[*****] Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. Redacted information is indicated by brackets.

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ordered by Dermira, all Drug Substance described in Appendix 2 of this First Amendment (such Drug Substance, the “Existing Drug Substance”) which Roche shall make [*****] efforts to retain and maintain solely for supply to Dermira pursuant to the Roche-Dermira Supply Agreement. [*****]. The Existing Drug Substance shall not be invoiced under Article 15 of the Roche-Dermira Supply Agreement nor under any other provision or agreement, but [*****] shall bear [*****] other related costs (e.g., [*****]) to the extent required thereunder.

Promptly after the First Amendment Effective Date, the Parties shall amend the Roche-Dermira Supply Agreement in the following regard:

In the table within Section 9.2 (Development Event Payments), the following changes will be made:

Section 9.4.2 (Royalty Rates for Product outside the Roche Retained Field) will be deleted entirely and replaced by the following:

The following royalty rates shall apply to the respective tiers of aggregate Calendar Year Net Sales of the Product in the Territory, on an incremental basis, as follows:

[*****] Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. Redacted information is indicated by brackets.

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For example, if Net Sales in all indications, for a given Calendar Year, are US$[*****], then the royalty applicable on such Net Sales of such Product for that year shall be calculated as follows:

([*****]%*[*****] US$) + ([*****]%*[*****] US$) = US$[*****].

“For other press releases related to the activities concerning this Agreement that disclose information other than set forth on Appendix 17.3 by Dermira during the Agreement Term, Dermira shall provide Roche with a copy of any draft press release at least [*****] prior to its intended publication for Roche's review. Roche may provide Dermira with suggested modification to the draft press release. Dermira shall consider Roche’s suggestions and, if such press release relates to the First Amendment, Dermira shall not issue its press release without Roche’s consent.”

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[*****] Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. Redacted information is indicated by brackets.

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IN WITNESS WHEREOF, the Parties have entered into this First Amendment as of the last date set forth below.

      /s/ Edward Harrington

List of Appendices:

Appendix 1:Roles & Responsibilities Matrix

Appendix 2:  Existing Drug Substance Inventory

[*****] Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. Redacted information is indicated by brackets.