CONFIDENTIAL TREATMENT REQUESTED
BY NOVABAY PHARMACEUTICALS, INC.
COLLABORATION AND LICENSE
AGREEMENT
by and between
NOVABAY PHARMACEUTICALS,
INC.
and
GALDERMA S.A.
dated as of March 20,
2009
***Confidential treatment requested
pursuant to a request for confidential treatment filed with the
Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.
TABLE OF CONTENTS
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Article II
GOVERNANCE; COORDINATION
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2.1
Coordination Committee
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2.2 Day-to-Day
Responsibilities
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2.4.2 Minimization of
Substitutability
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Article III DEVELOPMENT PROGRAM
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3.2 During
the Initial Period
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***Confidential treatment requested
pursuant to a request for confidential treatment filed with the
Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.
TABLE OF CONTENTS
(Continued)
3.3 During
the Continuation Period
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3.5 Development
Proposals
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3.5.5 Inability to Agree on
Terms
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3.5.7 Excluded Indications
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3.7 Disclosure
of Formulation Technology
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Article IV
COMMERCIALIZATION OF COLLABORATION PRODUCTS
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4.2 Commercialization
Plan
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4.3 Galderma
Marketing Partners
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***Confidential treatment requested
pursuant to a request for confidential treatment filed with the
Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.
TABLE OF CONTENTS
(Continued)
4.4 NovaBay’s
Right to Co-promote to Healthcare Institutions in North
America
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4.5 Cooperation
and Consultation
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4.6 Galderma
First Right of Negotiation
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Article V
DEVELOPMENT AND COMMERCIALIZATION IN JAPAN
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5.1.1 Japan Election Notice
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5.1.2 Pre-Pivotal Development
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5.1.3 Pre-Pivotal Japan Report
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5.2 Commercialization
in Japan
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5.2.3 Royalties to Galderma on Japan
Sales
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Article VI
MANUFACTURING AND SUPPLY, REGULATORY &OTHER
MATTERS
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6.1 Manufacturing
and Supply
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6.1.1 Collaboration Compounds
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6.1.2 Collaboration Products
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6.2.2 Clinical Safety Reporting;
Pharmacovigilance
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6.2.4 Regulatory Inspection/Audit
Rights
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6.3 Transfer
of Data and Regulatory Filings
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7.1.3 No
Other Active Ingredients
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***Confidential treatment requested
pursuant to a request for confidential treatment filed with the
Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.
TABLE OF CONTENTS
(Continued)
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7.3 Use
of NovaBay Technology
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7.4 Use
of Galderma Technology
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7.5 Conflicts
of Interest
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8.1.3 Completion of Formulation Feasibility
Studies
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8.2.2 Certain Reimbursements
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8.3 Galderma
Funding During the Continuation Period
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8.4 Development
Milestone Payments
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8.4.2 Milestone Payment Timing
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8.5 Royalty
Payments to NovaBay
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8.5.2 Anti-Bacterial Products
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8.5.3 Anti-Fungal Products
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8.5.4 Anti-Viral Products
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8.5.7 Sales Supported by NovaBay
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8.5.8 Certain Royalty Conditions
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8.5.9 Term
of NovaBay Royalties
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***Confidential treatment requested
pursuant to a request for confidential treatment filed with the
Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.
TABLE OF CONTENTS
(Continued)
8.6 Royalty
Payments to Galderma
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8.6.1 For
Collaboration Products in Japan
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8.6.2 Royalty-Bearing NovaBay
Products
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8.7 Material
Adverse Events
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8.12 Inspection
of Records
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Article IX
INTELLECTUAL PROPERTY
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9.1 Ownership
of Inventions
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9.1.2 Compound Improvements
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9.1.3 Agreements with Affiliates and Third
Parties
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9.2.2 Projected Patent Filings
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9.3 Defense
of Third Party Infringement Claims
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9.4.1 Initiating Enforcement
Actions
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9.5 Third
Party Technologies
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9.5.1 By
NovaBay after the Effective Date
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9.5.2 By
Galderma after the Effective Date
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***Confidential treatment requested
pursuant to a request for confidential treatment filed with the
Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.
TABLE OF CONTENTS
(Continued)
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9.7.1 Galderma Product Marks
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9.7.2 NovaBay Product Marks
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9.7.5 World-wide Branding
Strategies
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Article X
CONFIDENTIALITY
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10.1 Confidentiality;
Exceptions
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10.2 Authorized
Use and Disclosure
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10.4.1 Confidential Terms
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Article XI
REPRESENTATIONS, WARRANTIES AND COVENANTS;
INDEMNIFICATION
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11.1 General
Representations and Warranties
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11.2 NovaBay’s
Warranties
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11.4 Disclaimer
of Warranties
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11.5.1 Indemnification by
NovaBay
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11.5.2 Indemnification by
Galderma
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Article XII TERM AND TERMINATION
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12.2 Termination
by Galderma
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12.2.1 Failure of Formulation
Feasibility
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12.2.2 Prior to Continuation
Period
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12.2.3 During the Continuation
Period
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12.2.4 For
Safety Reasons
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12.2.5 Competitive Change of
Control
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12.3 Termination
for Breach
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12.3.2 Termination of the Licenses in
7.1.2(c)
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***Confidential treatment requested
pursuant to a request for confidential treatment filed with the
Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.
TABLE OF CONTENTS
(Continued)
12.4 Termination
for Failure to Pay the Continuation Fee
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12.5 General
Effects of Expiration or Termination
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12.5.1 Accrued Obligations
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12.5.2 Non-Exclusive Remedy
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12.5.3 No
Milestone Payment
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12.5.4 Return of Materials
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12.6 Effects
of Certain Terminations
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12.6.1 Transition Assistance
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12.6.4 Regulatory Filings/Data
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12.6.5 Technology Licenses
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12.6.7 Marketing Partners
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12.6.9 Suspension of Activities
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12.7 Termination
With Respect to Collaboration Products
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12.8 Termination
for Competitive Change of Control
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12.8.1 Termination of Certain
Provisions
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12.8.4 In-Process Collaboration
Products
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12.9 Termination Pursuant to
Section 12.3.2
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12.10 Termination Press Releases
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***Confidential treatment requested
pursuant to a request for confidential treatment filed with the
Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.
TABLE OF CONTENTS
(Continued)
Article XIII DISPUTE RESOLUTION
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13.2 Pre-Arbitration
Dispute Resolution
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13.3.3 Enforcement/Service
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13.3.4 Confidentiality of
Proceedings
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13.4 Provisional
Remedies
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Article XIV MISCELLANEOUS
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14.6 Entire
Agreement/Modification
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14.7 Relationship
of the Parties
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14.9 Compliance
with Laws
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***Confidential
treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission.
Omitted portions have been filed separately with the
Commission
-viii-
COLLABORATION AND LICENSE
AGREEMENT
This COLLABORATION AND LICENSE AGREEMENT (this
“ Agreement ”) is entered into as of the 20th
day of March, 2009 (the “ Effective Date ”) by
and between NovaBay Pharmaceuticals, Inc., a California
corporation, having its principal place of business at 5980 Horton
Street, Suite 550, Emeryville, California 94608 (“
NovaBay ”), and Galderma S.A., a Swiss corporation,
having its principal place of business at Zugerstrasse 8, Cham
CH-6330, Switzerland (“ Galderma
”). NovaBay and Galderma are each referred to
herein by name or, individually, as a “ Party ”
or, collectively, as “ Parties .”
BACKGROUND
A. NovaBay
has developed certain proprietary technologies and compounds
related to or comprising Aganocide Compounds (as defined
below).
B. Galderma
is a leader in the discovery, development, and commercialization of
pharmaceutical products and medical devices for the prevention and
treatment of skin diseases.
C. NovaBay
and Galderma wish to collaborate to develop and obtain regulatory
approval for, and commercialize, pharmaceutical products
incorporating Collaboration Compounds (as defined below) in the
Field (as defined below).
D. Galderma
will be responsible for developing, marketing and selling such
products in the Galderma Territory (as defined below) and NovaBay
will have the right with respect thereto in the NovaBay Territory
(as defined below), all on the terms and conditions set forth
herein below.
NOW, THEREFORE, in consideration of the mutual
covenants and agreements provided herein below and in consideration
of the receipt and sufficiency of which is hereby acknowledged,
NovaBay and Galderma hereby agree as follows:
ARTICLE I
DEFINITIONS
The following capitalized terms shall have the
meanings given in this Article I when used in this
Agreement:
1.1 “
Accounting Standards ” shall mean then-current
applicable (i) generally accepted accounting principles in the
United States (“ GAAP ”) as established by the
Financial Accounting Standards Board or any successor entity
thereto or other entity generally recognized as having the right to
establish such principles, or (ii) International Financial
Reporting Standards (“ IFRS ”) as established by
the International Accounting Standards Board or any successor
entity thereto or other entity generally recognized as having the
right to establish such standards, in each case consistently
applied by the applicable Person.
***Confidential treatment requested
pursuant to a request for confidential treatment filed with the
Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.
1.2 “ Adverse
Drug Reaction ” shall have the meaning as defined in the
then-current guidelines and regulations promulgated by the ICH
(International Conference on Harmonization of Technical
Requirements for Registration of Pharmaceuticals for Human Use) and
shall include any “Adverse Drug Experience” as defined
in the then-current 21 CFR Section 314.80.
1.3 “ Acne
Plan ” shall mean the then-current comprehensive plan
(including timelines) for the following: (i) during the
Initial Period, (A) appropriate study(ies) to determine the
feasibility of one or more formulations for an Acne Product (the
“ Formulation Feasibility Studies ”) and
(B) the Development of such an Acne Product for the Galderma
Territory through the completion of the first Phase II
Clinical Trial with respect thereto (the “ Acne POC
”), and (ii) during the Continuation Period, further
Development of Acne Products in the Field for the Galderma
Territory through to Marketing Approval therefor.
1.4 “ Acne
Product ” shall mean any Collaboration Product that is
labeled for (or Developed for) the treatment or prevention of acne
in humans.
1.5 “
Affiliate ” shall mean, with respect to the subject
Person, another Person that controls, is controlled by or is under
common control with such subject Person, for so long as such
control exists. For purposes of this definition only,
“control” shall mean beneficial ownership (direct or
indirect) of more than fifty percent (50%) of the shares of a
Person that is a corporation entitled to vote in the election of
directors (or, in the case of a Person that is not a corporation,
in the election of the corresponding managing
authority). For the avoidance of doubt, neither
L’Oréal S.A. nor Nestlé S.A., nor any of their
respective Affiliates (other than Galderma and its subsidiaries),
will be deemed an “Affiliate” of Galderma
hereunder.
1.6 “
Aganocide Compound ” shall mean any chemical entity
(i) having bactericidal, antibacterial, anti-infective,
antimicrobial, antifungal, anti-parasitic, sporicidal, antiviral,
immunomodulatory or anti-inflammatory activity, and
[***].
1.7 “
Aganocide Product ” shall mean any pharmaceutical
product incorporating an Aganocide Compound as an
ingredient.
1.8 “ Capture
Period ” shall mean the period of time starting upon the
Effective Date and expiring three (3) years after the date on which
Galderma ceases to fund at least five (5) NovaBay FTEs per year
pursuant to Section 8.3.1.
1.9 “
Collaboration ” shall mean all activities performed by
or on behalf of each Party with respect to the Field under this
Agreement, including all activities of each Party under any
Plan.
1.10 “
Collaboration Compound ” shall mean [***].
1.11 “
Collaboration Product ” shall mean each pharmaceutical
product (i) incorporating a Collaboration Compound as one of
its ingredients, and (ii) which requires approval by the FDA
of a new drug application, as more fully defined in 21 C.F.R.
§314.50 et. seq., in order to initiate marketing and sales of
such pharmaceutical product in the United States or approval by the
applicable Regulatory Authority of a similar application or
submission in order to initiate marketing and sales of such
pharmaceutical product in another Major Market, in each case
whether sold as prescription only medication (POM), pharmacy only
medication (P), over the counter or general sale license
(GSL). For clarity, Collaboration Product shall include
any formulation, delivery device, dispensing device or packaging
required for effective use of such pharmaceutical
product.
***Confidential treatment requested
pursuant to a request for confidential treatment filed with the
Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.
1.12 “
Combination Product ” shall mean any Collaboration
Product that incorporates at least one pharmaceutically active
ingredient (each, an “ Other API ”) in addition
to one or more Collaboration Compound(s), which Other API has
independent biologic or chemical activity in the Field when present
alone, and where the Collaboration Compound(s) and Other API(s) are
sold as a single dosage form or in a single package or kit or where
the labeling for the Collaboration Product requires use of such
Collaboration Compound(s) with such Other API(s) and the
Collaboration Compound(s) and Active Component(s) are sold at a
combined price. For clarity, all references to
“Collaboration Product” in this Agreement shall be
deemed to include Combination Product.
1.13 “
Commercialization ” shall mean, with respect to a
particular Collaboration Product in the Field, the conduct of any
and all processes and activities to establish and maintain sales
for such Collaboration Product (including with respect to
reimbursement and patient access), including offering for sale,
selling (including launch), marketing (including education and
advertising activities), promoting, storing, transporting,
distributing, and importing such Collaboration Product, in each
case with respect to the Field. “
Commercialize ” and “ Commercializing
” shall have their correlative meanings.
1.14 “
Commercially Reasonable Efforts ” shall mean, with
respect to a Person, use by or on behalf of such Person of
sustained, continued and active efforts and the level of resources
and urgency applied by such Person to a certain activity or
activities that is consistent in each case with such Person’s
practices for its other pharmaceutical products of a similar stage
of product life, safety, efficacy and commercial
potential. Without limiting the foregoing, Commercially
Reasonable Efforts shall require the applicable Person to:
(i) promptly assign responsibilities for activities for which
it is responsible to specific employee(s) who are held accountable
for the progress, monitoring and completion of such activities,
(ii) set and consistently seek to achieve meaningful
objectives for carrying out such activities, and (iii) make
and implement decisions and allocate resources necessary or
appropriate to advance progress with respect to and complete such
activities.
1.15 “
Continuation Period ” shall mean the period beginning
upon NovaBay’s receipt of the Continuation Fee and continuing
thereafter through the Agreement Term.
1.16 “
Control ” shall mean, with respect to particular
Know-How or a particular Patent, possession by the Party granting
the applicable right, license or sublicense to the other Party as
provided herein of the power and authority, whether arising by
ownership, license, or other authorization, to disclose and deliver
the particular Know-How to the other Party, and to grant and
authorize under such Know-How or Patent the right, license or
sublicense, as applicable, of the scope granted to such other Party
in this Agreement without giving rise to a violation of the terms
of any written agreement with any Third Party. “
Controlled ” and “ Controlling ”
shall have their correlative meanings.
***Confidential treatment requested
pursuant to a request for confidential treatment filed with the
Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.
1.17 “
Cover ” shall mean, with respect to any subject
matter, the manufacture, use, sale, offer for sale, importation,
exportation or other exploitation of such subject matter would
infringe a Valid Claim at the time thereof. For clarity
with respect to a Valid Claim of a patent application, “
Cover ” includes infringing such claim as if it were
issued as then prosecuted. “ Covered
” and “ Covering ” shall have their
correlative meanings.
1.18 “
Data ” shall mean any and all research and development
data, including preclinical data, pharmacology data, chemistry data
(including analytical, product characterization, manufacturing, and
stability data), toxicology data, clinical data (including
investigator reports (both preliminary and final), statistical
analyses, expert opinions and reports, safety and other electronic
databases) and all supporting data for each of the foregoing, in
each case specifically directed to, or used in the Development of,
a Collaboration Product and Controlled by a Party during the
Agreement Term.
1.19 “
Development ” shall mean, with respect to any
Collaboration Product in the Field, any and all processes and
activities conducted to prepare and file for, obtain and maintain
any Marketing Approval for such Collaboration Product, which may
include scale-up, non-clinical and preclinical testing, ADME
(absorption, distribution, metabolism and excretion) and toxicology
studies, clinical trials (including trials for additional
indications in the Field for a Collaboration Product for which a
Marketing Approval has been obtained), quality of life assessments,
pharmacoeconomics, mandatory post-marketing studies, label
expansion studies, regulatory affairs (including CMC (chemistry,
manufacturing and controls) and Regulatory Filings), and further
activities related to development of such Collaboration
Product. For clarity, Development shall exclude all
Manufacturing and Commercialization processes and
activities. “ Develop ” and “
Developing ” shall have their correlative
meanings.
1.20 “
Development Plan ” shall mean, on an
indication-by-indication basis, the Acne Plan, the Impetigo Plan
and each Accepted Indication Plan, if any.
1.21 “
Development Program ” shall mean all activities
conducted by or on behalf of the Parties in accordance with the
Development Plans.
1.22 “
Excluded Field ” shall mean (i) any and all
applications related to the genito-urinary, gastrointestinal,
ophthalmological (including the eye) or otolaryngological
(including the ear or nasal passages) systems or any other mucosal
surfaces, (ii) any and all applications related to wound care,
(iii) any and all applications related to the prevention or
disinfection of pre-, peri- or post-surgical infections (it being
understood that the reference to “post-surgical
infections” shall not limit the license grant under
Section 7.1.1(c)), and (iv) any and all cosmetic
applications (it being understood that the reference to
“cosmetic applications” shall not limit the license
grant under Section 7.1.1(c)).
***Confidential treatment requested
pursuant to a request for confidential treatment filed with the
Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.
1.23 “ FDA
” shall mean the United States Food and Drug Administration
or any successor entity.
1.24 “
Field ” shall mean the prevention or treatment of any
and all dermatological diseases and disorders in humans (
i.e ., diseases or disorders of the skin or nails, but
excluding onychomycosis, diseases and disorders of the hair and any
and all Rare Diseases, collectively, the “ Dermatology
Field ”), but shall exclude all Excluded
Indications. For clarity, the Field excludes the
Excluded Field. For purposes of the foregoing, “
Rare Diseases ” shall mean any disease or condition
that meets the criteria for an orphan or rare disease or condition
in a Major Market, including, for example in the United States, in
§526(a)(2)(1) of the Federal Drug and Cosmetic Act (U.S.
Orphan Drug Act (1983)); in Europe, in the Orphan Drug
Regulation 141/2000; and in Japan, in the Orphan Drug
Amendment (1993).
1.25 “
Formulation Technology ” shall mean technologies,
materials or New Inventions used in the formulation of any
Collaboration Compound hereunder to provide or to enhance
properties thereof, including efficacy, durability, safety, ease of
handling, compatibility, stability, bioavailability, solubility,
delivery route or the like, together with any and all formulations
comprising a Collaboration Compound with such technologies,
materials or inventions. For clarity, Formulation
Technology shall exclude for all purposes any and all active
pharmaceutical ingredients themselves.
1.26 “ FTE
” shall mean a full time equivalent year (consisting of a
total of 1,880 person hours per year) of research or development
work on or related to the Development Program. Research
and development work on or related to the Development Program shall
include those tasks and activities described in the Development
Plans, as applicable, together with related managerial and
preparation activities.
1.27 “ FTE
Rate ” shall mean [***] U.S. Dollars ($[***]) per year
per FTE, subject to adjustment as set forth in
Section 8.3.1
1.28 “
Galderma Formulation Technology ” shall mean any and
all Formulation Technology Controlled by Galderma during the
Agreement Term.
1.29 “
Galderma Know-How ” shall mean any and all Know-How
Controlled by Galderma during the Agreement Term that is
(i) used in the Development, Manufacture or Commercialization
of a Collaboration Product in the Field, or (ii) otherwise
made available to NovaBay hereunder.
1.30 “
Galderma Patents ” shall mean any and all Patents
Controlled by Galderma during the Agreement Term (i) claiming
(A) any Galderma Formulation Technology, (B) the
composition or method of manufacture or use of any Collaboration
Product, or (C) any New Invention, or (ii) that are
otherwise necessary or useful for the development, manufacture or
commercialization of any Aganocide Product.
***Confidential treatment requested
pursuant to a request for confidential treatment filed with the
Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.
1.31 “
Galderma Technology ” shall mean the Galderma
Formulation Technology, Galderma Know-How and Galderma
Patents.
1.32 “
Galderma Territory ” shall mean all jurisdictions in
the world other than those within the NovaBay Territory.
1.33 “ Generic
Product ” shall mean, with respect to a Collaboration
Product or Royalty-Bearing NovaBay Product in a particular country,
a pharmaceutical product that is registered as a generic product
pursuant to applicable Law in such country ( e.g ., the
Abbreviated New Drug Application (ANDA) process as described in the
U.S. Drug Price Competition and Patent Term Restoration Act of 1984
in the United States) and marketed for the same indication as such
Collaboration Product or Royalty–Bearing NovaBay Product, as
applicable, in such country, which pharmaceutical product has been
granted appropriate approvals by the applicable Regulatory
Authority to allow marketing thereof in such country.
1.34 “ GLP
” shall mean the then-current good laboratory practice (or
similar standards) for the performance of laboratory activities for
pharmaceutical products as are required by any Regulatory Authority
in the applicable jurisdiction.
1.35 “ GMP
” shall mean the then-current good manufacturing practice (or
similar standards) for the manufacture, handling and storage of
pharmaceutical products applicable to a Collaboration Product as
required by the Regulatory Filings and approvals for such
Collaboration Product in the applicable jurisdiction, including any
IND, MAA or Marketing Approval.
1.36 “
Impetigo Plan ” shall mean the then-current
comprehensive plan (including timelines) for the following:
(i) during the Initial Period, the Development of an Impetigo
Product for the Galderma Territory through the completion of the
first Phase II Clinical Trial with respect thereto including
appropriate toxicology studies (the “ Impetigo POC
”), and (ii) during the Continuation Period, further
Development of Impetigo Products in the Field for the Galderma
Territory through to Marketing Approval therefor.
1.37 “
Impetigo Product ” shall mean any Collaboration
Product that is labeled for (or Developed for) the treatment or
prevention of impetigo in humans.
1.38 “ IND
” shall mean an investigational new drug application filed
with the FDA, as more fully defined in 21 C.F.R. §312.3
or similar application ( i.e ., a filing that must be made
prior to commencing clinical testing in humans) filed with a
Regulatory Authority in another jurisdiction ( e.g .,
clinical trial authorization (CTA)).
***Confidential treatment requested
pursuant to a request for confidential treatment filed with the
Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.
1.39 “ Initial
Period ” shall mean the period commencing on the
Effective Date and expiring upon NovaBay’s receipt of the
Continuation Fee.
1.40 “
Japanese Partner ” shall mean a Third Party to which
NovaBay has granted rights to: (i) market and sell a
Collaboration Product in the Field on such Third Party’s own
behalf in Japan, or (ii) promote, co-promote or otherwise
offer to sell a Collaboration Product on such Third Party’s
own behalf in Japan. For clarity, Japanese Partner shall
exclude distributors, wholesalers and resellers of Collaboration
Products appointed by NovaBay that do not engage in any marketing
of the Collaboration Products in Japan.
1.41 “
Know-How ” shall mean any and all information,
tangible materials and New Inventions comprising (i) ideas,
discoveries, inventions, improvements or trade secrets,
(ii) techniques, methods, formulas, processes and Data, and
(iii) compositions of matter, including Collaboration
Compounds. Know-How shall exclude any Patent rights with
respect thereto.
1.42 “ Law
” shall mean, individually and collectively, any and all
laws, ordinances, orders, rules, rulings, directives and
regulations of any kind whatsoever of any governmental or
regulatory authority within the applicable jurisdiction.
1.43 “ Major
Market ” shall mean any of the following: France,
Germany, Italy, Spain, United Kingdom or the United
States.
1.44 “
Manufacturing ” shall mean, with respect to
Collaboration Products, any and all processes and activities
conducted for the GLP or GMP manufacture of such Collaboration
Products in final dosage form (but not the Collaboration Compound (
i.e ., the active pharmaceutical ingredient) therein in bulk
or other form) for Development or Commercialization thereof,
including formulating a Collaboration Compound into the final
dosage form of the Collaboration Product incorporating such
Collaboration Compound, packaging, labeling and other finishing
activities, quality control and assurance testing, formulation
development and other activities performed in support of the CMC
(chemistry, manufacturing and controls, or equivalent) section of a
Regulatory Filing, in each case with respect to such Collaboration
Product. For clarity, Manufacturing shall exclude all
Development and Commercialization processes and activities, as well
as process and activities directed to the manufacture of
Collaboration Compounds alone ( i.e ., not as part of a
Collaboration Product). “ Manufacture
” shall have the correlative meaning.
1.45 “
Marketing Approval ” shall mean, with respect to a
Collaboration Product for an indication within the Field in a
particular jurisdiction, approval by the applicable Regulatory
Authority of (i) an MAA for such Collaboration Product for
such indication, together with pricing approval in jurisdictions
where pricing is established by the Regulatory Authority or other
governmental agency, and (ii) any marketing authorization for
any device required for use of the Collaboration Product (as
indicated on the label of the Collaboration Product), in each case
required for Commercialization in such
jurisdiction. Notwithstanding the foregoing, if approval
of such MAA is not required in accordance with applicable Law to
market the Collaboration Product in such jurisdiction, Marketing
Approval shall be deemed to have occurred for a particular
indication for a Collaboration Product in such jurisdiction upon
the first commercial sale of such Collaboration Product in such
jurisdiction with labeling for such indication.
***Confidential treatment requested
pursuant to a request for confidential treatment filed with the
Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.
1.46 “
Marketing Approval Application ” or “ MAA
” shall mean a New Drug Application (as defined in
21 C.F.R. §314.50 et. seq.) or similar filing, or a
comparable filing for authorization to initiate marketing
activities in a jurisdiction other than the United States, in each
case with respect to a Collaboration Product.
1.47 “
Marketing Partner ” shall mean a Third Party to which
Galderma has granted rights to: (i) market and sell a
Collaboration Product in the Field on such Third Party’s own
behalf, or (ii) promote, co-promote or otherwise offer to sell
a Collaboration Product in the Field on such Third Party’s
own behalf, in each case in the Galderma Territory. For
clarity, Marketing Partner shall exclude distributors, wholesalers
and resellers of Collaboration Products appointed by Galderma that
do not engage in any marketing of the Collaboration
Products.
1.48 “
Multiple-Field Compound ” shall mean a Collaboration
Compound for which NovaBay (itself or through one or more Third
Parties) has initiated clinical development or commercialization
for applications outside of the Field.
1.49 “ Net
Sales ” shall mean the gross amounts invoiced for
(i) Collaboration Products sold by Galderma, its Affiliates or
Marketing Partners in the Galderma Territory or NovaBay, its
Affiliates or Japanese Partners in Japan, or
(ii) Royalty-Bearing NovaBay Products sold by NovaBay, its
Affiliates or sublicensees (such Person selling such product, the
“ Selling Party ”), in each case to independent,
unaffiliated Third Parties and recognized in the accounting records
of the Selling Party as gross sales, (A) less the following
deductions to the extent related to such gross amounts:
(I) normal and customary trade, cash, formulary discounts and
other quantity discounts and allowances actually allowed and taken,
(II) credits or allowances actually granted to the customer
for damaged goods, returns, recalls, rebates or rejections of
Collaboration Products or Royalty-Bearing NovaBay Products,
(III) import, export, sales, use, excise and other consumption
taxes and custom duties or tariffs, or ad valorem taxes (to the
extent borne by Selling Party and separately stated on the invoice
and included in the gross amounts), (IV) Third Party cash
rebates and chargebacks related to sales of Collaboration Products
or Royalty-Bearing NovaBay Products, to the extent allowed and
taken by such Third Party, (V) freight, insurance and other
transportation and handling fees, (VI) retroactive price
reductions that are actually allowed or granted to and taken by
Third Parties, (VII) compulsory payments and rebates directly
related to the sale of Collaboration Products or Royalty-Bearing
NovaBay Products, accrued, paid, or deducted pursuant to written
agreements with Third Parties (including managed care agreements)
or government regulations, (VIII) royalties or other similar
fees paid for Third-Party intellectual property based on the sales
of the applicable Collaboration Products or Royalty-Bearing NovaBay
Products, (IX) bad debts computed and allocated in accordance
with the applicable Accounting Standards, and (X) any other
specifically identifiable costs or charges included in the gross
amounts invoiced for such Collaboration Products or Royalty-Bearing
NovaBay Products, as applicable, substantially equivalent to those
listed in clauses (I) – (IX) above, and (B) with respect
to (y) sales of Collaboration Products by Galderma to any
Marketing Partner or by NovaBay to a Japanese Partner or
(z) sales of Royalty-Bearing NovaBay Products by NovaBay to a
sublicensee, plus in either case an additional amount reasonably
determined by Galderma or NovaBay, as applicable, in good faith to
gross up the actual amount invoiced for sale of the Collaboration
Product or Royalty-Bearing NovaBay Product by Galderma or NovaBay,
as applicable, in order to adjust such sales up to an amount
corresponding to the gross amounts Galderma or NovaBay, as
applicable, would have invoiced had Galderma or NovaBay, as
applicable, made such sales directly to the end
customer. In the event that a Selling Party makes any
adjustment to deductions described in clause (A) above after
the associated Net Sales have been reported pursuant to this
Agreement, the adjustments and payment of any amounts due shall be
reported with the next quarterly report due hereunder.
***Confidential treatment requested
pursuant to a request for confidential treatment filed with the
Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.
1.49.1 A Collaboration
Product or Royalty-Bearing NovaBay Product shall not be deemed sold
if the Collaboration Product or Royalty-Bearing NovaBay Products,
as applicable, is provided free of charge to a Third Party as a
sample consistent with Selling Party’s normal promotional and
sample practices and applicable Law in direct support of the
promotion, marketing or other Commercialization of the
Collaboration Product.
1.49.2 If a sale,
transfer or other disposition of a Collaboration Product or
Royalty-Bearing NovaBay Product, as applicable involves
consideration other than cash or is not at arm’s length, then
the Net Sales from such sale, transfer or other disposition shall
be calculated from the average selling price for such Collaboration
Product or Royalty-Bearing NovaBay Product during the calendar
quarter in the country where such sale, transfer or disposition
took place.
1.49.3 In the event a
Selling Party sells any Collaboration Product as a Combination
Product, Net Sales of such Combination Product shall be calculated
by multiplying the Net Sales (as described above) of the
Combination Product by the fraction A divided by (A+B), in which A
is the Gross Selling Prices of Collaboration Compound(s) contained
in the Combination Product sold separately in commercial quantities
in arm’s-length transactions during the previous calendar
quarter in the country where such Collaboration Product is sold,
and B is the sum of the Gross Selling Prices of Other API(s)
contained in the Combination Product sold separately in commercial
quantities in arm’s-length transactions made during the
previous calendar quarter in the country where such Collaboration
Product is sold. In the event that no separate sales of
either Collaboration Compound(s) or any Other API(s) contained in
the Combination Product were made during the applicable calendar
quarter in such country or if the Gross Selling Price cannot
otherwise be determined, Net Sales allocable to the Collaboration
Compound(s) and Other API(s) contained in the Combination Product
shall be determined in good faith by the Parties. If
such determination cannot be made, either Party may refer the issue
to arbitration pursuant to Section 13.1. For
purposes of the foregoing, “ Gross Selling Price
” means the weighted average gross price at which a product
is sold to a Third Party, before discounts, deductions, credits,
taxes or allowances; Gross Selling Price shall not take into
consideration the price for any product sold or used for
development purposes (including for clinical trials) or as samples
or free goods (including product transferred in connection with
patient assistance programs or other charitable
purposes).
1.49.4 In the event that
any Royalty-Bearing NovaBay Product is sold as a combination
product, then the Net Sales of such Royalty-Bearing NovaBay Product
shall be apportioned between the Collaboration Compound(s) therein
and other active pharmaceutical ingredient(s) on a similar basis as
described in Section 1.49.3.
1.50 “ North
America ” shall mean Canada, Mexico and the United States
and their territories and protectorates.
1.51 “ NovaBay
Formulation Technology ” shall mean any and all
Formulation Technology Controlled by NovaBay during the Agreement
Term.
1.52 “ NovaBay
Know-How ” shall mean any and all Know-How Controlled by
NovaBay during the Agreement Term that is (i) used in for the
Development, Manufacture or Commercialization of a Collaboration
Product in the Field or (ii) otherwise made available to
Galderma hereunder.
1.53 “ NovaBay
Patents ” shall mean any and all Patents Controlled by
NovaBay during the Agreement Term (i) claiming (A) the
composition or method of manufacture or use of a Collaboration
Compound, or (B) any New Invention, or (ii) that are
otherwise necessary or useful for the Development, Manufacture or
Commercialization of Collaboration Products, in each case within
the Field.
1.54 “ NovaBay
Technology ” shall mean the NovaBay Formulation
Technology, NovaBay Know-How and NovaBay Patents.
1.55 “ NovaBay
Territory ” shall mean those countries listed on
Exhibit 1.55 .
1.56 “
NVC-[***] shall mean [***].
1.57 “
Patent ” shall mean any of the following, whether
existing as of the Effective Date or during the Agreement Term
anywhere in the world: (i) any issued patent, including
inventor’s certificates, extensions, reissues,
re-examination, renewal or any like governmental grant for
protection of inventions, and (ii) any pending application for
any of the foregoing, including any continuation, divisional,
substitution, continuations-in-part, provisional and converted
provisional applications.
1.58 “
Person ” shall mean any individual, corporation,
partnership, association, joint-stock company, trust,
unincorporated organization or government or political subdivision
thereof.
***Confidential treatment requested
pursuant to a request for confidential treatment filed with the
Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.
1.59 “
Phase II Clinical Trial ” shall mean any human
clinical trial where a principal purpose is to determine
preliminary evidence of efficacy and safety or to establish a dose
or dose range for Phase III Clinical Trials of a Collaboration
Product in a patient population that has the indication being
studied (including any human clinical trial described in
21 C.F.R. §312.21(b) or, with respect to a jurisdiction
other than the United States, a similar clinical
trial). For clarity, Phase II Clinical Trial shall
include any Phase IIa clinical trial.
1.60 “
Phase III Clinical Trial ” shall mean any human
clinical trial that is intended to be a pivotal trial for seeking
or obtaining a Marketing Approval or to otherwise establish safety
and efficacy in patients with the indication being studied for
purposes of filing an MAA (including any human clinical trial
described in 21 C.F.R. §312.21(c), or, with respect to a
jurisdiction other than the United States, a similar clinical
trial).
1.61 “ Pivotal
Trial ” shall mean with respect to a Collaboration
Product in the Field, any clinical trial that, if the end point(s)
therefor as set forth in the applicable protocol are met, is
intended to support the filing of an MAA for such Collaboration
Product in Japan. For clarity, a non-Phase III
bridging study or a Phase III Clinical Trial can be a Pivotal
Trial.
1.62 “ Primary
Indications ” shall mean, collectively and individually,
(i) acne and (ii) impetigo.
1.63 “
Regulatory Authority ” shall mean any federal,
national, multinational, state, provincial or local regulatory
agency, department, bureau or other governmental entity with
authority over the Development, Manufacture, Commercialization or
other use (including the granting of Marketing Approvals) of any
Collaboration Product in any jurisdiction, including the FDA,
European Medicines Agency, any pertinent national European agency,
and the Ministry of Health, Labor and Welfare or Pharmaceuticals
and Medical Devices Agency in Japan.
1.64 “
Regulatory Filing ” shall mean any filing or
application with any Regulatory Authority, including INDs and MAAs
and authorizations, approvals or clearances arising from the
foregoing, including Marketing Approvals, and all correspondence
with such Regulatory Authority, as well as minutes of any material
meetings, telephone conferences or discussions with such Regulatory
Authority, in each case with respect to a Collaboration Product in
the Field.
1.65 “
Royalty-Bearing NovaBay Products ” shall mean
(i) any Collaboration Product sold in a country in the
Galderma Territory in the Dermatology Field (but outside the Field)
(A) for which the Marketing Approval Application for such
Collaboration Product in such country includes material Data (other
than Data related to safety) generated by or on behalf of Galderma,
or (B) which is Covered by a Galderma Patent in such country
(each, an “ In-Territory Product ”),
(ii) any Collaboration Product sold in a country in the
NovaBay Territory in the Field (A) for which the Marketing
Approval Application for such Collaboration Product in such country
includes material Data (other than Data related to safety)
generated by or on behalf of Galderma, or (B) which is Covered
by a Galderma Patent in such country (each, an “
Ex-Territory Product ”), or (iii) an Aganocide
Product sold in any country outside the Field and Covered by a
Galderma Patent in such country (each, an “ Ex-Field
Product ”).
***Confidential treatment requested
pursuant to a request for confidential treatment filed with the
Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.
1.66 “ Third
Party ” shall mean any Person other than a Party or an
Affiliate of a Party.
1.67 “ Valid
Claim ” shall mean a claim of an issued and unexpired
patent or a claim of a pending patent application that has not been
held invalid or unenforceable by a court or other government agency
of competent jurisdiction; provided , however , that
if the holding of such court or agency is later reversed by a court
or agency with overriding authority, the claim shall be reinstated
as a Valid Claim with respect to Net Sales made after the date of
such reversal.
1.68 Definitions
. Each of the following terms shall have the meanings
defined in the corresponding Section of this Agreement indicated
below:
|
|
|
|
Acceptance
|
8.4.1(a)(i)
|
|
Accepted
Indication
|
3.5.2 and
3.5.3
|
|
Accounting
Standards
|
1.1
|
|
[***]
|
[***]
|
|
Acne
Plan
|
1.3
|
|
Acne
POC
|
1.3
|
|
Acne
Product
|
1.4
|
|
Actual Labor
Cost
|
Exhibit
6.1.4
|
|
Actual
Materials
Cost
|
Exhibit
6.1.4
|
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Adverse Drug
Reaction
|
1.2
|
|
Affiliate
|
1.5
|
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Aganocide
Compound
|
1.6
|
|
Aganocide
Product
|
1.7
|
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Agreement
|
Preamble
|
|
Agreement
Term
|
12.1
|
|
Agreement
Wind-Down
Period
|
12.6.1
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Alcon
Agreement
|
11.2.14
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Allocable
Overhead
|
Exhibit
6.1.4
|
|
Annual Net
Sales
|
8.5.6(a)
|
|
Anti-Bacterial
Products
|
8.5.6(b)
|
|
Anti-Fungal
Products
|
8.5.6(c)
|
|
Anti-Viral
Products
|
8.5.6(d)
|
|
Base
Patent
|
1.10
|
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Board
|
6.4.2
|
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Capture
Period
|
1.8
|
|
[***]
|
[***]
|
|
Co-Chair
|
2.1.3
|
***Confidential treatment requested
pursuant to a request for confidential treatment filed with the
Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.
|
Collaboration
|
1.9
|
|
Collaboration
Compound
|
1.10
|
|
Collaboration
Product
|
1.11
|
|
Combination
Product
|
1.12
|
|
Commercialization
|
1.13
|
|
Commercialization
Plan
|
4.2
|
|
Commercialize
|
1.13
|
|
Commercializing
|
1.13
|
|
Commercially
Reasonable
Efforts
|
1.14
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
Compound
Improvement
|
9.1.2
|
|
Confidential
Information
|
10.1
|
|
Constraints
|
3.5.6
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Continuation
Fee
|
8.2.1
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Continuation
Period
|
1.15
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Control
|
1.16
|
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Controlled
|
1.16
|
|
Controlling
|
1.16
|
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Cooperating
Party
|
10.4.2
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Coordination
Committee
|
2.1.1
|
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Co-Chair
|
2.1.3
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Co-Promote
|
4.4.1
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Co-Promotion
Plan
|
4.4.2(a)(i)
|
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Cover
|
1.17
|
|
Covered
|
1.17
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Covering
|
1.17
|
|
Data
|
1.18
|
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Dermatology
Field
|
1.24
|
|
Develop
|
1.19
|
|
Developing
|
1.19
|
|
Development
|
1.19
|
|
Development
Plan
|
1.20
|
|
Development
Program
|
1.21
|
|
Development
Proposal
|
3.5.1
|
|
[***]
|
[***]
|
|
Dispute
|
13.1
|
|
Effective
Date
|
Preamble
|
|
Enabling
Party
|
6.2.3
|
|
Enforcement
Action
|
9.4
|
|
Excluded
Field
|
1.22
|
***Confidential treatment requested
pursuant to a request for confidential treatment filed with the
Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.
|
Excluded
Indication
|
3.5.7
|
|
Ex-Field
Product
|
1.65
|
|
Existing Patent
Rights
|
11.2.1
|
|
Ex-Territory
Product
|
1.65
|
|
FDA
|
1.23
|
|
Field
|
1.24
|
|
Filing
Party
|
6.2.3
|
|
First
Negotiation
Period
|
3.5.2
|
|
Formulation
Feasibility
Studies
|
1.3
|
|
Formulation
Technology
|
1.25
|
|
FTE
|
1.26
|
|
FTE
Rate
|
1.27
|
|
GAAP
|
1.1
|
|
Galderma
|
Preamble
|
|
Galderma
Formulation
Technology
|
1.28
|
|
Galderma
Indemnitees
|
11.5.1
|
|
Galderma
Know-How
|
1.29
|
|
Galderma
Patents
|
1.30
|
|
Galderma
Product
Marks
|
9.7.1
|
|
Galderma
Technology
|
1.31
|
|
Galderma
Territory
|
1.32
|
|
Galderma Third
Party
Technology
|
9.5.2
|
|
Generic
Competition
|
8.5.9(b)
|
|
Generic
Product
|
1.33
|
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GLP
|
1.34
|
|
GMP
|
1.35
|
|
Gross Selling
Price
|
1.49.3
|
|
Healthcare
Institutions
|
4.4
|
|
IFRS
|
1.1
|
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Impetigo
Plan
|
1.36
|
|
Impetigo
POC
|
1.36
|
|
Impetigo
Product
|
1.37
|
|
Impetigo
Reimbursement
Amount
|
8.2.2
|
|
IND
|
1.38
|
|
Indemnify
|
11.5.1
|
|
Infringing
Product
|
9.4
|
|
Initial
Period
|
1.39
|
|
initiation
|
8.4.1(a)(ii)
|
|
In-Process
Collaboration
Products
|
12.6.5(b)
|
|
In-Territory
Product
|
1.65
|
***Confidential treatment requested
pursuant to a request for confidential treatment filed with the
Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.
|
IP
Subcommittee
|
2.1.2
|
|
JAMS
|
13.3
|
|
Japan Election
Notice
|
5.1.1
|
|
Japanese
Development
Plan
|
5.1.1
|
|
Japanese
Election
Notice
|
5.1.3
|
|
Japanese Lead
Party
|
5.1.1
|
|
Japanese
Partner
|
1.40
|
|
Joint
Patent
|
9.2.5
|
|
Know-How
|
1.41
|
|
Law
|
1.42
|
|
[***]
|
[***]
|
|
Losses
|
11.5.1
|
|
MAA
|
1.46
|
|
Major
Market
|
1.43
|
|
Manufacture
|
1.44
|
|
Manufacturing
|
1.44
|
|
Manufacturing
Cost
|
Exhibit
6.1.4
|
|
Marketing
Approval
|
1.45
|
|
Marketing
Approval
Application
|
1.46
|
|
Marketing
Partner
|
1.47
|
|
Material
Adverse
Event
|
8.7
|
|
Milestone
Event
|
8.4
|
|
Milestone
Payment
|
8.4
|
|
Multiple-Field
Compound
|
1.48
|
|
Multiple-Field/Territory Product
Substitution
|
2.4.2
|
|
Net
Sales
|
1.49
|
|
New
Invention
|
9.1.1
|
|
North
America
|
1.50
|
|
Notice of
Interest
|
3.5.6
|
|
NovaBay
|
Preamble
|
|
NovaBay
Formulation
Technology
|
1.51
|
|
NovaBay
Indemnitees
|
11.5.2
|
|
NovaBay
Know-How
|
1.52
|
|
NovaBay
Logos
|
9.7.3
|
|
NovaBay
Patents
|
1.53
|
|
NovaBay Product
Marks
|
9.7.2
|
|
NovaBay
Technology
|
1.54
|
|
NovaBay
Territory
|
1.55
|
|
NovaBay Third
Party
Technology
|
9.5.1
|
|
NVC-[***]
|
[***]
|
|
Offer
Notice
|
4.6
|
***Confidential treatment requested
pursuant to a request for confidential treatment filed with the
Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.
|
Ordering
Party
|
Exhibit
6.1.5
|
|
Other
API
|
1.12
|
|
Other
Products
|
8.5.6(e)
|
|
Parties
|
Preamble
|
|
Party
|
Preamble
|
|
Patent
|
1.57
|
|
Payee
|
8.9
|
|
Payor
|
8.9
|
|
Person
|
1.58
|
|
Phase II
Clinical
Trial
|
1.59
|
|
Phase III
Clinical
Trial
|
1.60
|
|
Pivotal
Trial
|
1.61
|
|
Plan
|
2.2.1
|
|
PPOC
|
3.5.3
|
|
PPOC
Notice
|
3.5.3
|
|
Pre-Pivotal
Development
|
5.1.2
|
|
Pre-Pivotal
Development
Costs
|
5.1.3
|
|
Pre-Pivotal
Japan
Report
|
5.1.3
|
|
Primary
Indications
|
1.62
|
|
prior
|
8.4.1(c)
|
|
Product
|
Exhibit
6.1.5
|
|
Project
Team
|
2.2.2
|
|
Proposed
Collaboration
Products
|
12.6.5(b)
|
|
Proposed
Indication
|
3.5.1
|
|
Prosecute and
Maintain
|
0
|
|
Prosecution and
Maintenance
|
0
|
|
Quality
Agreement
|
Exhibit
6.1.5
|
|
Rare
Diseases
|
1.24
|
|
Regulatory
Authority
|
1.63
|
|
Regulatory
Filing
|
1.64
|
|
Requesting
Party
|
10.4.2
|
|
Royalty-Bearing
NovaBay
Products
|
1.65
|
|
Scale-up
Costs
|
6.1.1
|
|
Second
Negotiation
Period
|
3.5.3
|
|
Selecting
Party
|
3.7
|
|
Selling
Party
|
1.49
|
|
Specification
|
Exhibit
6.1.5
|
|
[***]
|
[***]
|
|
Submitting
Party
|
3.5.1
|
|
subsequent
|
8.4.1(c)
|
|
successful
completion
|
8.4.1(a)(iii)
|
***Confidential treatment requested
pursuant to a request for confidential treatment filed with the
Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.
|
Supply
Agreement
|
6.1.5
|
|
Supplying
Party
|
Exhibit
6.1.5
|
|
Terminated
Product
|
12.7
|
|
Third
Party
|
1.66
|
|
Third-Party
Claim
|
11.5.1
|
|
Third Party
Technology
|
9.5.3
|
|
Valid
Claim
|
1.67
|
1.69
Interpretation . The captions and headings in
this Agreement are for convenience only, and are to be of no force
or effect in construing or interpreting any of the provisions of
this Agreement. Unless specified to the contrary,
references to Articles, Sections or Exhibits mean the particular
Articles, Sections and Exhibits to this Agreement and references to
this Agreement include all Exhibits hereto. Unless
context otherwise clearly requires, whenever used in this
Agreement: (i) the words “include” or
“including” shall be construed as incorporating, also,
“but not limited to” or “without
limitation,” (ii) the word “day” or
“year” shall mean a calendar day or year unless
otherwise specified, (iii) the word “notice” shall
mean notice in writing (whether or not specifically stated) and
shall include notices, consents, approvals and other written
communications contemplated under this Agreement, (iv) the
words “hereof,” “herein,”
“hereby” and derivative or similar words refer to this
Agreement (including any Exhibits), (v) the word
“or” shall be construed as the inclusive meaning
identified with the phrase
“and/or,”(vi) provisions that require that a
Party, the Parties or a committee hereunder “agree,”
“consent” or “approve” or the like shall
require that such agreement, consent or approval be specific and in
writing, whether by written agreement, letter, approved minutes or
otherwise, (vii) words of either gender include the other
gender, (viii) words using the singular or plural number also
include the plural or singular number, respectively, and
(ix) references to any specific Law or article, section or
other division thereof, shall be deemed to include the then-current
amendments thereto or any replacement thereof. For
purposes of this Agreement, neither Party will be deemed to be
acting “under authority of” the other Party; however,
with respect to Galderma, its Affiliates, Marketing Partners and
Third Party contractors shall be deemed to be acting “under
authority of” Galderma, and with respect to NovaBay, its
Affiliates, Japanese Partners, sublicensees (other than Galderma)
and Third Party contractors shall be deemed to be acting
“under authority of” NovaBay.
***Confidential treatment requested
pursuant to a request for confidential treatment filed with the
Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.
ARTICLE II
GOVERNANCE;
COORDINATION
2.1 Coordination
Committee
Promptly after the Effective Date,
Galderma and NovaBay shall establish a coordination committee (the
“ Coordination Committee ”) to review and
coordinate the activities of the Parties hereunder, including the
performance of the Development Program and the Development,
Manufacture and Commercialization of Collaboration Products in the
Field.
The Coordination Committee shall be
responsible for: (i) reviewing and approving all Development
Plans (including applicable budgets therefor), subject to
Section 2.1.5, (ii) reviewing and accepting or rejecting
Development Proposals, (iii) providing strategic direction to
the Parties’ activities under the Collaboration,
(iv) reviewing and monitoring activities under the Development
Plans and the progress thereof, (v) managing the integration
and coordination of the Development Program (including the
manufacture of Collaboration Compounds and Collaboration Products)
and Commercialization of the Collaboration Products in the Field,
(vi) facilitating access to and the exchange of information
between the Parties related to the Collaboration Compounds and
Collaboration Products in the Field, (vii) ensuring that the
Development of the Collaboration Products in the Field for the
Galderma Territory proceed in a coordinated and expeditious manner,
(viii) establishing subcommittees as it deems appropriate to
manage specific activities under the Collaboration (including
subcommittee(s) for proposing, reviewing and coordinating
strategies for Patent and other intellectual property matters
consistent with Article IX (the “ IP Subcommittee
”)) and resolving disputes, disagreements and deadlocks of
such subcommittees, and (ix) undertaking or approving such
other matters as are specifically provided for the Coordination
Committee under this Agreement.
The Coordination Committee shall be
comprised of an equal number of representatives from each of
NovaBay and Galderma. The exact number of such
representatives shall be three (3) for each of Galderma and
NovaBay, or such other number as the Parties may
agree. Either Party may replace its respective
Coordination Committee representatives at any time with prior
notice to the other Party, provided that such replacement is
of comparable authority and scope of functional responsibility
within that Party’s organization as the individual he or she
is replacing. Without limiting the foregoing, each Party
shall appoint one of its members to the Coordination Committee to
co-chair the meetings of the Coordination Committee (each, a
“ Co-Chair ”). Each Co-Chair, working
together, shall (i) coordinate and prepare the agenda and
ensure the orderly conduct of the Coordination Committee’s
meetings, (ii) attend (subject to below) each meeting of the
Coordination Committee, and (iii) prepare and issue minutes of
each meeting within ten (10) business days thereafter accurately
reflecting the discussions and decisions of the Coordination
Committee at such meeting. Such minutes from each
Coordination Committee meeting shall not be finalized until the
Co-Chair from each Party has reviewed and confirmed the accuracy of
such minutes in writing. The Co-Chairs shall solicit
agenda items from the other Coordination Committee members and
provide an agenda along with appropriate information for such
agenda reasonably in advance (to the extent possible) of any
meeting. In the event the Co-Chair or another member of
the Coordination Committee from either Party is unable to attend or
participate in any meeting of the Coordination Committee, the Party
who designated such Co-Chair or member may designate a substitute
Co-Chair or other representative for the meeting.
***Confidential treatment requested
pursuant to a request for confidential treatment filed with the
Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.
Unless otherwise agreed by the Parties, the
Coordination Committee will meet telephonically or in person at
least once every four (4) months for so long as any Development of
Collaboration Products with respect to any Major Market is ongoing,
and semi-annually thereafter during the Agreement Term. The
location of such meetings shall alternate between NovaBay’s
headquarters and Galderma’s headquarters with the first
meeting to be held as agreed to by the Parties. Each
Party shall be responsible for its own expenses relating to such
meetings. As appropriate, other employee representatives
of the Parties may attend Coordination Committee meetings as
nonvoting observers, but no Third Party personnel may attend unless
otherwise agreed by the Parties. Each Party may also
call for special meetings to resolve particular matters requested
by such Party.
Decisions of the Coordination Committee
shall be made by consensus of the members participating in any
meeting, with at least one (1) representative from each Party
participating in such vote; provided that (i) during
the Initial Period, Galderma shall have the final say as to all
aspects of the Formulation Feasibility Studies and otherwise as to
the development and implementation of the Acne Plan and NovaBay
shall have the final say as to the development and implementation
of the Impetigo Plan, without limiting the second
sentence of Section 3.2.2, (ii) during the Continuation
Period, Galderma shall have the final say as to the implementation
of the Development and Commercialization of the Collaboration
Products in the Field for the Galderma Territory, except
that (A) the Japanese Lead Party, with respect to a particular
Collaboration Product, shall have final say as to the
implementation of the Development of such Collaboration Product in
the Field for Japan, and (B) the Commercialization of
Collaboration Product in Japan shall be determined as set forth in
Section 5.2, and (iii) NovaBay shall have the final say
as to all matters likely to affect the Development or
Commercialization of Multiple-Field Compounds outside of the
Field. For clarity, in the event that the Coordination
Committee is unable to reach consensus with respect to a matter not
subject to either Party’s final say, then either Party may,
by written notice to the other Party, refer such matter for dispute
resolution in accordance with
Article XIII. Notwithstanding anything herein to
the contrary, the Coordination Committee shall not have any
authority to amend, modify or waive compliance with any express
term or condition of this Agreement.
***Confidential treatment requested
pursuant to a request for confidential treatment filed with the
Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.
2.2 Day-to-Day
Responsibilities
Each Party shall: (i) be responsible
for day-to-day implementation and operations of the Development,
Manufacturing and Commercialization activities with respect to
Collaboration Compounds and Collaboration Products in the Field for
which it has or is otherwise assigned responsibility under the
applicable Plan or this Agreement, and (ii) keep the other
Party reasonably informed as to the progress of such activities, as
reasonably requested by the other Party. For purposes of
this Agreement, “ Plan ” shall mean any of the
Acne Plan, Impetigo Plan, Accepted Indication Plan or the
Commercialization Plan, in each case then-currently in
effect.
During the Initial Period and thereafter
as the Parties may agree, NovaBay and Galderma shall establish
project teams and subteams (with equal representation) composed as
the Parties may agree (including teams for the Acne Plan and
Impetigo Plan, respectively, each, a “ Project Team
”) to coordinate and oversee the day-to-day operations of the
Parties on a Collaboration Product-by-Collaboration Product and
indication-by-indication basis or as otherwise agreed by the
Parties. Each Project Team shall have telephonic or
physical meetings at least once per month (or as otherwise agreed
by the Parties) with the operational management team from each
Party responsible for the oversight and management of the
activities within the purview of such Project Team. One
goal of such meetings shall be to ensure that the expertise and
resources of both Parties is brought to bear upon the performance
of such activities. At each such meeting, each Party
will provide an update of the status of the activities under the
applicable Plan (including activities that are completed, under way
or scheduled). Each Party shall be responsible for its
own expenses relating to such meetings. Without limiting
the foregoing, each Party shall designate a member of its internal
project team and such members will coordinate periodically
regarding the activities under the Acne Plan and Impetigo
Plans.
Without limiting the other provisions of
this Agreement, each Party will keep the other reasonably informed
on a timely basis as to the plans for and results of the activities
of the Collaboration carried out by or under authority of such
Party through the Coordination Committee and Project
Teams. In addition, NovaBay will keep Galderma informed
on a timely basis with respect to plans for and results of
activities for Multiple-Field Compounds outside of the Field
carried out by or under authority of NovaBay through the
Coordination Committee and Project Teams.
The Parties acknowledge and agree that
NovaBay (itself or through its designees) shall have, subject to
the terms and conditions of this Agreement (including
Section 3.5) and the licenses granted herein, the right to
perform activities with respect to Aganocide Compounds, and
development, manufacture and commercialization activities with
respect to Aganocide Compounds and Aganocide Products (including
Collaboration Products) for applications outside of the Field at
NovaBay’s expense. Accordingly, the Parties,
through the Coordination Committee, shall use good faith efforts to
coordinate the development of Collaboration Compounds for use in
the Field hereunder with such activities of NovaBay (and its
designees) outside the Field, so as to minimize the duplication of
efforts and maximize quality and effectiveness of such activities,
and avoid conflicts with Development Programs and activities
outside the Field. Without limiting the foregoing and in
order to facilitate coordination of the development of
Collaboration Compounds outside the Field, NovaBay shall keep
Galderma informed on a timely basis with respect to development
plans for Collaboration Compounds to be conducted by or under
authority of NovaBay, including proposed clinical plans and
protocols, and give Galderma a reasonable opportunity to review and
comment upon such proposed plans and protocols. In
addition, NovaBay agrees to keep Galderma, through the Coordination
Committee, reasonably informed of its planned discovery activities
and development activities outside of the Field with respect to
products incorporating Collaboration Compounds to allow for such
coordination.
***Confidential treatment requested
pursuant to a request for confidential treatment filed with the
Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.
2.4.2 Minimization of
Substitutability
In order to reduce the chances that
quantities of Collaboration Products sold by Galderma or its
Affiliates, or their distributors in the Field will be used for any
application outside the Field in the Galderma Territory, and
similarly that products incorporating Multiple-Field Compounds sold
outside of the Field (and without limiting the Parties’
obligations, with respect to products incorporating Multiple-Field
Compounds for wound-healing applications) will be used in the Field
in the Galderma Territory, including via parallel importation (any,
a “ Multiple-Field/Territory Product Substitution
”), the Parties shall work together in good faith, through
the Coordination Committee to develop unique packaging, trademarks
and names, and, to the extent practicable, formulations, for
Collaboration Products in the Field in the Galderma Territory and
products incorporating Multiple-Field Compounds outside of the
Field, with the goal of reducing the risk of
Multiple-Field/Territory Product Substitutions. In the
event that a Party believes that a Multiple-Field/Territory Product
Substitution has adversely affected the Commercialization of a
Collaboration Product by such Party in accordance with this
Agreement, then it may notify the other Party and provide
reasonable evidence of such Multiple-Field/Territory Product
Substitution. Promptly after receipt of such notice, the
Parties shall negotiate in good faith an appropriate adjustment, if
any, to the economic terms of this Agreement to address such
Multiple-Field/Territory Product Substitution.
NovaBay acknowledges and agrees that
Galderma shall not be required to make changes to any of the
Development Plans for any Collaboration Product unless and until
Galderma is the Japanese Lead Party for such Collaboration Product
in order to meet the requirements of applicable Law of Japan in
connection with the Japanese Development Plan.
***Confidential treatment requested
pursuant to a request for confidential treatment filed with the
Securities and Exchange Commission. Omitted portions have been
filed separately with the Commission.
ARTICLE III
DEVELOPMENT
PROGRAM
NovaBay shall have primary responsibility
for (i) all chemistry discovery and optimization activities
with respect to Aganocide Compounds, and (ii) the conduct of
the Impetigo POC; and Galderma shall have primary responsibility
for all other activities with respect to the Development of the
Collaboration Products in the Field for the Galderma Territory,
including any formulation activities with respect
thereto. Without limiting the foregoing, each Party
shall (A) communicate with, seek advice from, and keep the
other Party reasonably informed on a regular basis with respect to
activities for which it has primary responsibility pursuant to the
prior sentence, and (B) use the expertise of the other Party
in connection therewith. Upon either Party’s
reasonable request, the other Party agrees to make available
appropriate employees and personnel to discuss any reasonable
questions or comments of such Party with respect to the other
Party’s Development of such Collaboration Products,
provided that doing so will not materially interfere with
the conduct of such other Party’s business or require such
other Party to incur any material expenses.
3.2 During the
Initial Period
Galderma shall, at its own expense, use
Commercially Reasonable Efforts to complete the activities assigned
to it under the Acne Plan within the time frames set forth
therein.
NovaBay shall, at its own expense (except
as provided in Section 8.2.2), use Commercially Reasonable
Efforts to complete the activities assigned to it under the
Impetigo Plan within the time frames set forth
therein. The Parties acknowledge that during the
Continuation Period Galderma may consider and use (if it so elects)
a different formulation of the Impetigo Product for the Galderma
Territory than the one used by NovaBay in the conduct of the
Impetigo POC.
3.3 During the
Continuation Period
During the Continuation Period, for each
Primary Indication and Accepted Indication, Galderma shall, at its
expense, take the lead and be responsible for conducting such
Development activities, including clinical trials, as may be
reasonably necessary to obtain Marketing Approvals for
Collaboration Products for each Primary Indication and Accepted
Indication throughout the Galderma Territory (except for Japan,
which shall be in accordance with Section 5.1), all in
accordance, in all material respects, with the applicable
Development Plan therefor (including the applicable timelines for
specific activities).
Each Party shall conduct its
responsibilities under the Development Program as assigned to it
under the Development Plans, in accordance with good scientific and
clinical practices, and in compliance in all material respects with
all applicable Law and regulatory standards, and shall use
Commercially Reasonable Efforts to achieve the objectives and
timelines within the Development Plans.
***Confidential treatment requested
pursuant to a request for confidential treatment filed with the
Securities and Exchange Commission. Omitted portions h