CONFIDENTIAL TREATMENT REQUESTED BY NOVABAY PHARMACEUTICALS, INC.

 

This First Amendment to Collaboration and License Agreement (“First Amendment”) is entered into as of November 4, 2010 (the “First Amendment Effective Date”) by and between NovaBay Pharmaceuticals, Inc., a Delaware corporation having its principal place of business at 5980 Horton Street, Suite 550, Emeryville, CA 94608 (collectively, “NovaBay”) and Alcon Research, Ltd., a Delaware corporation, having its principal place of business at 620 I S. Freeway, Fort Worth, Texas 76134-2099 (“Alcon”). NovaBay and Alcon are each referred to herein by name, or individually as a “Party” or collectively as “Parties.”

 

A.  NovaCal Pharmaceuticals, Inc. (“NovaCal”) and Alcon Manufacturing, Ltd. Entered into a Collaboration and License Agreement (the “Agreement”) on August 29, 2006.

 

B.  On February 9, 2007, NovaCal merged into NovaBay Pharmaceuticals, Inc., California (“NovaBay California”) and assumed all of its obligations.

 

C.  On June 29, 2010, NovaBay California merged into and assigned all rights and responsibilities to NovaBay.

 

D.  On January 1, 2008, Alcon Manufacturing, Ltd. merged into and assigned all rights and responsibilities to Alcon Research, Ltd.

 

E.  In connection with NovaCal’s (and after the name change, NovaBay’s) performance of the Discovery Research Program under the Agreement, the Parties agree that the structures of certain chemical entities subject to the Agreement have exceeded the scope of “Aganocide Compounds” as originally defined therein and the Parties wish to expand the definition of such term to include such chemical entities, together with certain other provisions of this Agreement, as set forth in this First Amendment.

 

NOW, THEREFORE, in consideration of the mutual covenants and agreements provided herein below and other consideration to the receipt and sufficiency of which is hereby acknowledged, NovaBay and Alcon hereby agree to amend the Agreement as follows:

 

 

10.           The Parties acknowledge and agree that pursuant to the Certificate of Ownership executed on February 9, 2007, a copy of which is attached as Exhibit A, NovaBay California assumed, and hereby assumes, all rights and obligations of NovaCal

under the Agreement. Accordingly, the name “NovaCal” is hereby replaced by the name “NovaBay” in all places where “NovaCal” appears in the Agreement.

 

 

11.           The Parties acknowledge and agree that pursuant to the Certificate of Merger effective June 29, 2010, a copy is attached as Exhibit B, NovaBay assumed, and hereby assumes all rights and obligations of NovaBay California under the agreement.

 

12.            The Parties acknowledge and agree that pursuant to the Certificate of Merger effective January 1, 2008, a copy of which is attached as Exhibit C, Alcon Research, Ltd. assumed, and hereby assumes, all rights and obligations of Alcon Manufacturing, Ltd. under the Agreement. Accordingly, the name “Alcon Manufacturing, Ltd.” is hereby replaced by the name “Alcon Research, Ltd.” in all places where “Alcon Manufacturing, Ltd.” appears in the Agreement.

 

13.            Section 1.3 of the Agreement is hereby amended to read in its entirety as follows:

1.3          “Aganocide Compound” shall mean (A) any chemical entity (i) having bactericidal, antibacterial, anti-infective, antimicrobial, antifungal, anti-parasidic, sporicidal, antiviral, immunomodulatory or anti-inflammatory activity, and (ii) consisting of either hypochlorous acid or consisting of the following chemical formula: [***].  For clarity, Aganocide Compounds include the compounds listed in Exhibit 1.3B.

 

14.            Exhibit 1.3 is hereby amended in its entirety and replaced by Exhibit 1.3B, as attached to this First Amendment.

 

15.            Section 1.37 of the Agreement is hereby amended to read in its entirety as follows:

1.37 “Funding Term” shall mean, subject to (i) earlier termination by Alcon in accordance with Section 8.2.3 and (ii) extension by mutual written agreement of the Parties referencing this Section 1.37, the period commencing on the Effective Date and expiring upon the earlier of (a) December 31, 2015 and (b) termination of this Agreement in accordance with Article 12.

 

16.            Section 1.38 of the Agreement is hereby amended to read in its entirety as follows:

1.38 [Intentionally left blank].

 

17.            The first sentence of Section 3.4 is hereby amended to read in its entirety as follows:

3.4  Designation of Development Compounds.  From time to time during the Exclusivity Period, either Party may recommend to the Coordination Committee a particular Licensed Compound for consideration as a Development Compound for Development as a Licensed Product hereunder, based on the profile of such Licensed Compound.

 

18.            Section 7.1.2(b) of the Agreement is hereby amended to read in its entirety as follows:

 

 

19.            The Parties agree that Section 7.4.1 of the Agreement shall not apply to any activities of Alcon or its Affiliates prior to the First Amendment Effective Date with respect to any compounds that (i) were independently discovered and synthesized by Alcon or obtained from a Third Party (i.e., without use of or reliance upon any NovaBay Know-How or other Confidential Information of NovaBay and outside of the Discovery Research Program) and (ii) are now encompassed by the expanded definition of Aganocide Compound established by this First Amendment but were not Aganocide Compounds as originally defined in the Agreement.  Such compounds shall not be considered Aganocide Compounds for purposes of Section 7.4.1 and shall not be considered Licensed Compounds for purposes of the Agreement.

 

20.            Section 8.2.3 of the Agreement is hereby amended to read in its entirety as follows:

8.2.3  Termination of the Funding Term.  Alcon may terminate the Funding Term on written notice to NovaBay referencing this Section 8.2.3 provided not less than six (6) months in advance of the next funding date (i.e., January 1 or July 1 of each year during the Funding Term).

 

21.             Section 8.3.1 (f) of the Agreement is hereby amended to read in its entirety as follows:

22.             Section 9.1.1 of the Agreement is hereby amended to read in its entirety as follows:

9.1.1 General. As between the Parties, title to all inventions and other intellectual property made (i) solely by Alcon personnel in connection with the Agreement shall be owned by Alcon, (ii) solely by NovaBay personnel in connection with this Agreement shall be owned by NovaBay and (iii) made jointly by personnel of Alcon and NovaBay (such joint inventorship to be determined based upon U.S. patent law) in connection with the Agreement shall be jointly owned by Alcon and NovaBay. Except as expressly provided in this Agreement, it is understood that neither Party shall have any obligation to account to the other for profits, or to obtain any approval of the other Party to license, assign, or otherwise exploit such jointly owned inventions or intellectual property, by reasons of joint ownership thereof, and each Party hereby waives any right it may have under the laws of any jurisdiction to require any such approval or accounting.  In the event that Alcon elects not to Prosecute or Maintain any Patent covering inventions made by Alcon in connection with this Agreement at any time during the Term, then it shall promptly notify NovaBay of such election (and in any event at least sixty (60) days prior to the date any action is required to maintain rights in such Patent).  In such event, NovaBay shall have the right, at its option, to control the Prosecution and Maintenance of such Patent at its own expense in NovaBay’s name whereupon Alcon shall, upon request by NovaBay, transfer ownership of such invention and such Patent to NovaBay, together with all related documents and filings thereto and take such actions as NovaBay reasonably requests to effectuate such ownership, at NovaBay’s expense.

 

23.             The following sentences shall be added to the end of Section 9.2.2:

Without limiting the foregoing, in the event that the Party responsible for the Prosecution and Maintenance of Patents claiming subject matter jointly owned by the Parties, as mutually agreed from time to time (the “Prosecuting Party”), determines (i) to abandon any claims within such jointly owned Patent, or (ii) not to pay its allocated share of costs attributable to the Prosecution and Maintenance of such jointly owned Patent, then the Prosecuting Party shall provide the other Party (the “Second Party”) written notice thereof (a) at least sixty (60) days prior to the date such abandonment would become effective or (b) reasonably in advance of any other necessary action required to maintain rights in such jointly own Patent, as applicable.  In such case, the Second Party shall have the right, at its option, to control the Prosecution and Maintenance of such claims at its own expense and its own name, whereupon the Prosecuting Party shall, upon request by the Second Party, assign such claims to the Second Party, together with documents and filings with respect thereto, and take such actions as the Second Party reasonably requests to effectuate such ownership, at the Second Party’s expense.  Similarly, in the event the Second Party determines not to pay its allocated share of costs attributable to the Prosecution and Maintenance of any jointly owned Patent (as may be mutually agreed by the Parties on a case by case basis), and the Prosecuting Party elects to pay one hundred percent of the costs associated with the Prosecution and Maintenance of such jointly owned Patent, the Second Party shall assign its joint interest in such jointly owned Patent to the Prosecuting Party and take such further actions as reasonably requested by the Prosecuting Party to effectuate such ownership, at the Prosecuting Party’s expense.

 

24.             Section 12.2.1 of the Agreement is hereby amended to read in its entirety as follows:

12.2.1 Alcon shall have the right to terminate this Agreement in its entirety upon six (6) months’ prior notice to NovaBay referencing this Section 12.2.1; provided that during the XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX

 

Funding Term such notice is provided not less than six (6) months in advance of the next funding date (i.e., January 1 or July 1 of each year during the Funding Term).

 

 

EXCEPT AS MODIFIED BY THE TERMS OF THIS FIRST AMENDMENT, the provisions of the Agreement remain unchanged, in full force and effect, and binding upon the Parties hereto.

 

This Amendment may be executed in two counterparts, each of which shall be deemed an original, and all of which together shall constitute one and the same instrument.

 

IN WITNESS WHEREOF, the Parties have executed this First Amendment in duplicate original by their duly authorized representative as of the Effective Date.

 

 

 

Name		State of Incorporation
NovaBay Pharmaceuticals, Inc.		California
NovaBay Pharmaceuticals, Inc.		Delaware