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Page
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1.
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Definitions
and interpretation
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1
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1.1
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Definitions
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1
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1.2
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Interpretation
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5
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1.3
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Headings
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6
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2.
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Exploitation
of Phosphagenics Intellectual Property
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6
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2.1
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License
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6
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2.2
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[Intentionally
Omitted.]
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6
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2.3
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Sub-License
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6
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3.
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Payments
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6
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3.1
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Acknowledgments.
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6
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3.2
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No
refund of Payments
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7
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4.
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Manufacture
and Sale of Products
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7
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5.
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Inspection
Right
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7
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6.
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Confidentiality
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8
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6.1
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Phosphagenics
Confidential Information
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8
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6.2
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Company
Confidential Information
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8
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6.3
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Permitted
Disclosure
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9
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6.4
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Use
of Other Parties’ Names
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9
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6.5
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Quigley
Confidential Information
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9
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7.
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Intellectual
Property
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10
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7.1
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IP
Ownership
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10
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7.2
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Infringement
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10
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7.3
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Property
in and Sharing of Documents, Data and Other Information
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11
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7.4
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Improvements
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11
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8.
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Warranties
and Representations
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12
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8.1
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The
Company’s warranties and representations
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12
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8.2
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Phosphagenics’
warranties and representations
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12
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9.
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Liability
and Indemnities
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13
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9.1
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Phosphagenics
not liable; Phosphagenics indemnifies the Company
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13
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9.2
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The
Company indemnifies Phosphagenics
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15
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10.
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Term
and Termination
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15
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10.1
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Term
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15
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10.2
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Termination
with Cause
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15
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11.
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Consequences
of Termination/Expiration
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16
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11.1
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Return
of documents
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16
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11.2
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No
further rights
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17
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12.
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Assignment
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17
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12.1
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Restriction
upon Assignment
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17
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12.2
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Permitted
Assigns
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17
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12.3
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Restriction
upon Sub-Contracting
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17
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13.
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Force
Majeure
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17
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13.1
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Force
Majeure Events
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17
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13.2
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Reliance
Upon Force Majeure
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18
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14.
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Dispute
Resolution
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18
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15.
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Notices
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18
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16.
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Governing
Law; Jurisdiction and Venue
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18
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17.
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General
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18
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17.1
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Relationship
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18
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17.2
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Further
acts
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19
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17.3
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Expenses
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19
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17.4
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Amendments
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19
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17.5
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Waiver
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19
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17.6
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Counterparts
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19
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17.7
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Indemnities
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19
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17.8
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Entire
License Agreement
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20
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17.9
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Survival
of certain provisions; no merger
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20
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1.
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Definitions
and interpretation
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1.1
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Definitions
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(a)
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“Anti-Wrinkle Creams”
means proprietary formulations developed by Phosphagenics containing TPM
in combination with retinol, ubiquinone, acetyl octapeptide, l-carnosine
and such other additives as the parties may agree; provided, however, that
the Company will not have rights to anti-wrinkle cream products sold in
high-end, up-scale retail stores, such as (by way of example) Nieman
Marcus and Bloomingdales.
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(b)
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“Company Confidential
Information” means confidential information disclosed by the
Company to Phosphagenics that is identified by the Company as being
confidential under the terms of this License Agreement, but that does not
include any part of the Phosphagenics Confidential
Information.
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(c)
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“Company Intellectual
Property” means all Intellectual Property Rights, know-how,
technical information, data, improvements, and developments owned or
controlled by the Company relating to the Field and the Non-Exclusive
Field.
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(d)
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“Cosmetic Compounds”
means articles intended to be rubbed, poured, sprinkled, or sprayed on,
introduced into, or otherwise applied to the human body for cleansing,
beautifying, promoting attractiveness, or altering the appearance; provided, however, that a
product which contains an OTC Drug will not be deemed to be a Cosmetic
Compound even though it has the ancillary effect of cleansing,
beautifying, promoting attractiveness, or altering the
appearance.
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(e)
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“Dietary Supplements”
means orally consumed products intended to provide nutrients to humans to
supplement any nutrient that may be missing from or not adequately
consumed in a person’s diet.
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(f)
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“Drugs” means substances
or articles (other than a food or device) that are intended for use in the
diagnosis, cure, relief, treatment, or prevention of disease and any
articles intended to affect the structure or function of the body of man
or other animals. For the sake of clarity, Drugs do not include Cosmetic
Compounds or Dietary Supplements.
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(g)
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“Field” means OTC Drugs
and Anti-Wrinkle Creams.
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(h)
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“Governmental Entity”
means any entity exercising executive, legislative, judicial, regulatory
or administrative functions of or pertaining to any federal, state or
local government, or any international, multinational or other government,
and any department, commission, board, agency, instrumentality, political
subdivision, bureau, official or other regulatory, administrative or
judicial authority of any of the
foregoing.
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(i)
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“Improvements” means any
improvement, substantial alteration or modification to the Field and/or
the Non-Exclusive Field or to the method of delivering the Field and/or
the Non-Exclusive Field.
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(j)
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“Intellectual Property
Rights” means all rights of ownership and the exclusive entitlement
to claim ownership and/or registration of exclusive rights created under
or by copyright, design registration, patent registration, trade mark
registration and all other exclusive rights in or to intangible property,
including rights in present and future intangible property and rights in
information, including know-how, granted by law or equity from time to
time under a Law or otherwise in the Territory or any other jurisdiction
throughout the world.
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(k)
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“Know-How” means any and
all data, instructions, processes, formulae, trade secrets, expert
opinions and other information (in written or other tangible form)
including, without limitation, any chemical, pharmacological,
toxicological, clinical, assay, control and manufacturing data, biological
materials, manufacturing or related technology, analytical methodology,
chemical and quality control procedures, protocols, techniques,
improvements and results of experimentation and
testing.
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(l)
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“Law” means any
constitution, law, statute, treaty, rule, directive, ordinance,
requirement, compact or agreement with or by any Governmental Entity, any
Order and any rules or regulations of any self-regulatory
organization.
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(m)
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“Non-Exclusive Field”
means those products identified in Exhibit B
hereto.
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(n)
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“Nonprescription Drugs”
means Drugs which in the United States may be dispensed without a
prescription issued from a licensed professional with governmental
approval to prescribe Drugs. For the purposes of this License
Agreement, Nonprescription Drugs shall include, but not be limited to,
caffeine solely for use in energy-related
products. Additionally, for the purposes of clarity,
Nonprescription Drugs shall include nicotine. Additionally,
Nonprescription Drugs shall not include the drug
diclofenac. Nonprescription Drugs also shall include those
products listed as such in the United States Homeopathic
Pharmacopeia. For the avoidance of doubt, if a Drug is a
prescription Drug in the United States as of the Effective Date, but such
prescription Drug subsequently becomes a non-prescription Drug in the
United States, then such Drug will be deemed to be a “Nonprescription
Drug” for purposes of this License
Agreement.
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(o)
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“Operating Agreement”
means the agreement entered by the parties, the Company and
Phosphagenics, Inc., a Delaware corporation, contemporaneously with the
entry into this License Agreement, which sets out the operations of the
Company.
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(p)
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“Order” means any award,
injunction, judgment, decree, order, writ, determination, ruling, subpoena
or verdict or other decision issued, promulgated or entered by any
Governmental Entity of competent
jurisdiction.
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(q)
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“OTC Drugs” means
Nonprescription Drugs that are permitted by law to be sold directly to
consumers in the United States.
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(r)
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“Patents” means all
letters patent and pending applications for, and disclosures related to,
patents of any jurisdictions throughout the world and all reissues,
reexaminations, divisions, continuations and extensions
thereof.
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(s)
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“Phosphagenics Confidential
Information” means confidential information disclosed by
Phosphagenics that is identified by Phosphagenics as being confidential
under the terms of this License Agreement, but does not include any
Company Confidential Information.
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(t)
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“Phosphagenics Intellectual
Property” means the Phosphagenics Patents identified in Exhibit A,
all Intellectual Property Rights, know-how, technical information, data,
improvements, and developments owned or controlled by Phosphagenics
relating to the use of TPM.
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(u)
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“Phosphagenics
Technology” means the Patents identified in Exhibit A
and the Know How associated
therewith.
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(v)
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“Program Patents” means
all patent applications lodged jointly in the names of Phosphagenics and
the Company during the course of and as a direct result of carrying out
their respective obligations under the Operating Agreement or the research
program contemplated therein.
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(w)
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“Program IP” means all
Program Patents, results, research data, know-how, materials, compounds,
inventions, and intellectual property relating to the Field or the
Non-Exclusive Field that are created by Phosphagenics or the Company
during the course of the term of the Operating Agreement or the research
program contemplated therein.
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(x)
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“Quigley Intellectual
Property” means all Intellectual Property Rights, know-how,
technical information, data, improvements, and developments owned or
controlled by Quigley relating to the Field and the Non-Exclusive
Field.
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(y)
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“Related Body Corporate”
means where a body corporate is a person that is related to such body
corporate, including, without limitation, the
following:
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(i)
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a
holding company of another body
corporate;
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(ii)
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a
subsidiary of another body corporate;
or
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(iii)
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a
subsidiary of a holding company of another body
corporate.
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(z)
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“Regulatory Approval”
means an approval of the Relevant Regulatory Authority permitting the
marketing of the Field and/or the Non-Exclusive Field in the Territory or
any part of the Territory.
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(aa)
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“Relevant Regulatory
Authorities” means a governmental authority, whether Federal, State
or municipal, regulating the importation, distribution, marketing and/or
sale of therapeutic substances in a country in the
Territory.
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(bb)
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“Term” has the meaning
given to that term in clause 10.1.
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(cc)
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“Territory” means the
World, excluding the manufacture anywhere in the world for use in
Australia or high-end stores, and excluding the sale or distribution of
Anti-Wrinkle products in Australia.
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(dd)
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“TPM” means tocopheryl
phosphate mixtures.
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1.2
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Interpretation
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(a)
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a
clause, exhibit, annexure or schedule is a reference to a clause, annexure
or schedule in or to this License
Agreement;
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(b)
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a
document (including this License Agreement) includes any variation,
amendment or replacement of it;
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(c)
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the
singular includes the plural and vice
versa;
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(d)
|
the
word “person” includes an individual, a firm, a body corporate, a
partnership, joint venture, an unincorporated body or association or any
government agency (including the Relevant Regulatory
Authorities);
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(e)
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an
agreement, representation or warranty in favour of two or more persons is
for the benefit of them jointly and each of them
individually;
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(f)
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an
agreement, representation or warranty by two or more persons binds them
jointly and each of them
individually;
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(g)
|
a
day is to be interpreted as the period of time commencing at midnight and
ending 24 hours later;
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(h)
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a
group of persons or things is a reference to any two or more of them
jointly and to each of them
individually;
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(i)
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A
reference to “$” is a reference to the lawful currency of the United
States;
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(j)
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a
statute, regulation, proclamation, code (which has the force of law),
ordinance or by-law includes all statutes, regulations, proclamations,
codes (which have the force of law), ordinances or by-laws amending,
consolidating or replacing it and a reference to a statute includes all
regulations, proclamations, ordinances and bylaws issued under that
statute;
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(k)
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the
words “include”, “including”, “for example” or “such as” are not used as,
and are not to be interpreted as, words of limitation and, when
introducing an example, do not limit the meaning of the words to which the
example relates to that example or examples of a similar kind;
and
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(l)
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if
a period of time dates from a given day or the day of an act or event, it
is to be calculated exclusive of that
day.
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1.3
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Headings
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2.
|
Exploitation
of Phosphagenics Intellectual
Property
|
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2.1
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License
|
|
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(a)
|
Phosphagenics
hereby grants to the Company:
|
|
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(i)
|
an
exclusive, royalty-free, paid-up license to exploit the Field embodying
the Phosphagenics Technology within the Territory;
and
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(ii)
|
a
non-exclusive, royalty-free, paid-up license to exploit the Non-Exclusive
Field embodying the Phosphagenics Technology within the Territory for use
in a product combining the Non-Exclusive Field with an OTC Drug or in a
product that is part of a regimen or routine that includes the application
of an OTC Drug. By way of example only, the Company may be
permitted to use the licensed technology in a non-OTC Drug product as part
of a regimen or routine that includes the application of an OTC Drug. For
illustrative purposes only, if an acne treatment program includes the use
of non-OTC Drug products containing TPM, then the Company may market and
sell cleaning and moisturizing products containing
TPM.
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|
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(b)
|
Phosphagenics
shall not, directly or through third parties, exploit the Phosphagenics
Intellectual Property with respect to the Field in the
Territory.
|
|
2.2
|
[Intentionally
Omitted.]
|
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2.3
|
Sub-License
|
|
3.
|
Payments
|
|
3.1
|
Acknowledgments.
|
|
3.2
|
No
refund of Payments
|
|
4.
|
Manufacture
and Sale of Products
|
|
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(a)
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The
Company hereby has the exclusive right, for the Term, to manufacture
and/or otherwise exploit the Field in the Territory and Phosphagenics
shall, subject to the terms contained in the Operating Agreement, be the
supplier of TPM to the Company to enable it to manufacture and/or
otherwise exploit the Field.
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(b)
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The
Company hereby has the non-exclusive right, for the Term, to manufacture
and/or otherwise exploit the Non-Exclusive Field worldwide and
Phosphagenics shall, subject to the terms contained in the Operating
Agreement, be the supplier of TPM to the Company to enable it to
manufacture and otherwise exploit the Non-Exclusive Field in accordance
with this License Agreement.
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|
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(c)
|
The
Company shall use commercially reasonable efforts to develop the Field in
the Territory. Without limiting any of the foregoing or being
limited thereby, the Company shall be responsible for ensuring that the
activities it undertakes or causes to be undertaken to develop the Field
are consistent with and supportive of the efficient and expeditious
development and regulatory approval of
Field.
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(d)
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The
Company shall use commercially reasonable efforts to commercialise the
Field throughout the Territory.
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(e)
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Without
limiting any of the foregoing or being limited thereby, the Company shall
be responsible for ensuring that the activities it undertakes or causes to
be undertaken to commercialise the Field are consistent with and
supportive of the ensuring that all commercially reasonable efforts are
used to market, promote, offer for sale and sell the Field so as to
optimise sales throughout the
Territory.
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(f)
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The
Company is responsible for determining strategies for marketing, selling,
distributing and determining pricing and other terms of sale for the
Field.
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(g)
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The
Company, if required, shall prosecute before Relevant Regulatory
Authorities any matter with respect to Field and the Non-Exclusive Field,
shall have the exclusive right to do so, and shall own all filings it or
its Related Body Corporate submit to any Relevant Regulatory Authority
relating to the Field and the Non-Exclusive
Field.
|
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5.
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Inspection
Right
|
|
|
(a)
|
The
Company shall permit Phosphagenics or its agent or representative at all
reasonable times to enter any place where the manufacture of the Field by
the Company shall be carried on for the purpose of inspection of methods
of manufacture of the Field and the Non-Exclusive
Field.
|
|
|
(b)
|
The
Company shall provide Phosphagenics with copies of all communications to
and from Relevant Regulatory Authorities relating to the Field and/or the
Non-Exclusive Field within ten (10) working days of receipt or
transmission of the communication.
|
|
6.
|
Confidentiality
|
|
6.1
|
Phosphagenics
Confidential Information
|
|
|
(a)
|
The
Company agrees that Phosphagenics Confidential Information is and will be
considered for the purposes of this License Agreement to be confidential
information and will be the property solely of
Phosphagenics.
|
|
|
(b)
|
The
Company agrees that its officers, employees and/or agents will not
disclose or make direct or derivative use of the Phosphagenics
Confidential Information other than for the purposes of this License
Agreement and for obtaining the registration and approval, if any, of the
Field and Non-Exclusive Field from the Relevant Regulatory
Authorities.
|
|
|
(c)
|
The
Company agrees to hold such Phosphagenics Confidential Information in
strict confidence and will disclose such Phosphagenics Confidential
Information only in strict confidence to its officers, employees or agents
or to those officers, employees, or agents of its subsidiaries or related
bodies corporate, only on a “need to know” basis and only to those
officers, employees, professional advisers and agents who agree to be
bound and obligated by the same provisions of confidentiality as the
Company.
|
|
6.2
|
Company
Confidential Information
|
|
|
(a)
|
Phosphagenics
agrees that the Company Confidential Information is and will be considered
for the purposes of this License Agreement to be confidential information
and will be the property solely of the
Company.
|
|
|
(b)
|
Phosphagenics
agrees that its officers, employees and/or agents will not disclose or
make direct or derivative use of the Company Confidential Information
other than for the purposes of this License Agreement and for obtaining
the registration and approval, if any, of the Field and Non-Exclusive
Field from the Relevant Regulatory
Authorities.
|
|
|
(c)
|
Phosphagenics
agrees to hold the Company Confidential Information in strict confidence
and will disclose the Company Confidential Information in only strict
confidence to its officers, employees or agents or to those officers,
employees, or agents of its subsidiaries or related bodies corporate, only
on a “need to know” basis and only to those officers, employees,
professional advisers and agents who agree to be bound and obligated by
the same provisions of confidentiality as
Phosphagenics.
|
|
6.3
|
Permitted
Disclosure
|
|
|
(a)
|
any
information that is now or later becomes publicly available through no
fault of the party receiving such information (the “Recipient”) , its
officers, employees or agents;
|
|
|
(b)
|
any
information that the Recipient obtains from a third party that is not
under a confidentiality obligation to the discloser of such information
with respect to such information;
|
|
|
(c)
|
any
information that the Recipient already has in its possession prior to its
disclosure by the discloser of such information, as indicated by the
Recipient’s written records;
|
|
|
(d)
|
any
information that the Recipient is required to disclose by Law or the
listing rules of a stock exchange on which the shares of the Recipient (or
a Related Body Corporate of the Recipient) are listed; provided, that
(i) the Recipient shall use diligent efforts to limit such disclosure
and to obtain confidential treatment or a protective order for such
Confidential Information, (ii) the Recipient shall allow the
disclosing party to participate in such process undertaken to protect
Confidential Information, (iii) the Recipient shall cooperate with
the disclosing party, upon the disclosing party’s reasonable request, in
connection therewith, and (iv) in the absence of a protective order
or other appropriate remedy, the Recipient may disclose only that portion
of such Confidential Information that is legally required to be disclosed;
or
|
|
|
(e)
|
any
information that is necessary or desirable to include in any application
for regulatory approval or Intellectual Property registration in the
Territory.
|
|
6.4
|
Use
of Other Parties’ Names
|
|
6.5
|
Quigley
Confidential Information
|
|
7.
|
Intellectual
Property
|
|
7.1
|
IP
Ownership
|
|
|
(a)
|
In
the event that the Program IP gives rise to patentable subject matter, the
parties shall join together to file and prosecute patent applications in
such parts of the Territory as they may agree upon. All Patents costs
shall be paid for by the Company.
|
|
|
(b)
|
Program
IP will be owned by the Company, except as
follows:
|
|
|
(i)
|
All
inventions pertaining solely to Company Intellectual Property made by or
on behalf of any party or jointly will be owned solely by the
Company. The parties hereby assign any and all existing and/or
future right, title and interest in and to Company Intellectual Property
to the Company. The parties shall execute all documents and do
such things as are necessary or reasonably requested by the Company in
order to perfect the assignment referred to in this
clause 7.1(b)(i).
|
|
|
(ii)
|
All
inventions pertaining solely to Phosphagenics Intellectual Property made
by or on behalf of any party or jointly will be owned solely by
Phosphagenics. The parties hereby assign any and all existing
and/or future right, title and interest in and to Phosphagenics
Intellectual Property to Phosphagenics. The parties shall
execute all documents and do such things as are necessary or reasonably
requested by Phosphagenics in order to perfect the assignment referred to
in this clause 7.1(b)(ii).
|
|
|
(iii)
|
All
inventions pertaining solely to Quigley Intellectual Property made by or
on behalf of any party or jointly will be owned solely by
Quigley. The parties hereby assign any and all existing and/or
future right, title and interest in and to Quigley Intellectual Property
to Quigley. The parties shall execute all documents and do such
things as are necessary or reasonably requested by the Quigley in order to
perfect the assignment referred to in this clause
7.1(b)(iii).
|
|
|
(c)
|
The
Company acknowledges and agrees that Phosphagenics may license or
otherwise exploit the Phosphagenics Intellectual Property in any manner
other than with respect to the Field in the
Territory.
|
|
7.2
|
Infringement
|
|
|
(a)
|
In
the event of the Company or Quigley, as the case may be, becoming aware of
a patent or other third-party Intellectual Property Right which may be
potentially infringed by the use of the Phosphagenics Intellectual
Property or upon receiving a notice alleging such infringement, the
Company or Quigley, respectively, will immediately notify
Phosphagenics. The Company or Quigley, as the case may be, will
at Phosphagenics’ expense provide Phosphagenics with such assistance as
Phosphagenics may reasonably require in order to deal with the potential
alleged infringement.
|
|
|
(b)
|
Each
of the Company and Quigley agrees that it will not take or omit to take
any step in relation to the potential or alleged infringement, without
first receiving the informed prior written consent of
Phosphagenics.
|
|
7.3
|
Property
in and Sharing of Documents, Data and Other
Information
|
|
7.4
|
Improvements
|
|
|
(a)
|
If
Phosphagenics shall at any time during the Term devise, discover or
acquire rights in any Improvement it shall, to the extent that it is not
prohibited by law or by any obligation to any other person, promptly
notify the Company in writing giving details of it and shall, following
the request for the same, provide to the Company such information and
explanations as the Company shall reasonably require to be able to
effectively utilise the same. In any case where such Improvement
constrains or otherwise limits Company’s exploitation of the Field in the
Territory or the Non-Exclusive Field worldwide, and not dependant on the
rights licensed under this License Agreement, Phosphagenics shall grant
and hereby grants a royalty-free, paid-up, non-exclusive and irrevocable
licence under all rights protecting such Improvement throughout the world
to Company for use on the Field throughout the Territory and on the
Non-Exclusive Field worldwide under the terms of this License
Agreement.
|
|
|
(b)
|
If
the Company or Quigley, as the case may be, shall at any time during the
Term devise, discover or acquire rights in any Improvement it shall, to
the extent that it is not prohibited by law or by any undertaking given to
any other person, promptly notify Phosphagenics in writing giving details
of it and provide to Phosphagenics such information or explanations as
Phosphagenics may reasonably require to be able effectively to utilise the
same. In any case where such Improvement is severable from and not
dependant on the rights licensed under this License Agreement, Company or
Quigley, as the case may be, shall grant and hereby grants a royalty-free,
paid-up, irrevocable and non-exclusive licence under all rights protecting
such Improvement throughout the
world.
|
|
8.
|
Warranties
and Representations
|
|
8.1
|
The
Company’s warranties and
representations
|
|
|
(a)
|
it
has and will during the Term have the personnel, expertise, resources, and
capability to carry out its obligations under this License
Agreement;
|
|
|
(b)
|
it
has and will during the Term have all other licenses, authorisations,
consents, approvals and permits required by applicable Laws in order to
perform its obligations under this License
Agreement;
|
|
|
(c)
|
it
will at all times comply with any applicable Laws, cGMP and cGLP (if
applicable) in performing its obligations under this License
Agreement;
|
|
|
(d)
|
it
has and will during the Term have the unfettered right, power and
entitlement to enter into and perform this License Agreement;
and
|
|
|
(e)
|
it
has taken all necessary actions to authorise the execution and performance
of this License Agreement.
|
|
8.2
|
Phosphagenics’
warranties and representations
|
|
|
(a)
|
it
has and will during the Term have the unfettered right, power and
entitlement to enter into and perform this License Agreement;
and
|
|
|
(b)
|
it
has taken all necessary actions to authorise the execution and performance
of this License Agreement.
|
|
|
(c)
|
it
is the exclusive owner of the Phosphagenics Intellectual Property and it
has the unfettered right, power and entitlement to grant the license
provided in clause 2.1;
|
|
|
(d)
|
it
is not aware of any Intellectual Property Rights owned by a third party
that will be infringed or misused by the manufacture, use, or sale of the
Field and/or the Non-Exclusive Field in the Territory or the exercise or
exploitation of Phosphagenics Technology for the Field and/or the
Non-Exclusive Field in the
Territory;
|
|
|
(e)
|
except
as disclosed to the Company, as at the Effective Date and to
Phosphagenics’ best knowledge and belief no person has asserted any
written claim alleging:
|
|
|
(i)
|
that
the Phosphagenics Intellectual Property or any part thereof is
invalid;
|
|
|
(ii)
|
a
contrary claim to ownership of the Phosphagenics Intellectual
Property;
|
|
|
(iii)
|
opposition
to the Phosphagenics Intellectual Property or any part
thereof.
|
|
|
(f)
|
to
Phosphagenics’ best knowledge and belief the exercise or exploitation of
Phosphagenics Intellectual Property will not infringe any third party’s
Intellectual Property Rights;
|
|
|
(g)
|
to
Phosphagenics best knowledge and belief that the Phosphagenics Technology
is valid, and that there are no references, public disclosures, or other
information material to the rights inherent in the Phosphagenics
Technology;
|
|
|
(h)
|
to
Phosphagenics’ best knowledge and belief as at the date of this License
Agreement there is no litigation or threatened litigation in relation to
Phosphagenics or the Phosphagenics Intellectual Property that relates to
the subject matter of this License Agreement, except as identified on
Exhibit C
hereto;
|
|
|
(i)
|
to
the knowledge of Phosphagenics, no person is engaging in any activities
that constitute, or that Phosphagenics believes may constitute,
infringement of Phosphagenics, rights in the Phosphagenics Intellectual
Property in the Territory;
|
|
|
(j)
|
Other
than the Phosphagenics Technology, the Phosphagenics Intellectual Property
does not otherwise restrict Company’s exploitation of the Field in the
Territory and the Non-Exclusive Field worldwide, and should any
Phosphagenics Intellectual Property be asserted or determined to restrict
Company’s exploitation of the Field in the Territory, or the Non-Exclusive
Field worldwide, Phosphagenics shall and hereby does grant Company an
exclusive, royalty-free, irrevocable, and paid-up license to exploit the
Field embodying such Phosphagenics Intellectual Property within the
Territory, and a non-exclusive, royalty-free, irrevocable and paid-up
license to exploit the Non-Exclusive Field embodying such Phosphagenics
Intellectual Property worldwide;
and
|
|
|
(k)
|
it
will not during the Term offer for sale or sell products in the Field in
the Territory.
|
|
9.
|
Liability
and Indemnities
|
|
9.1
|
Phosphagenics
not liable; Phosphagenics indemnifies the
Company
|
|
|
(a)
|
except
as provided in clause 8.2, Phosphagenics disclaims all representations and
warranties, whether express, implied, or statutory, including any implied
warranty of merchantability or of fitness for a particular purpose and any
implied warranty arising from course of dealing or usage of
trade. Except as provided in clause 8.2, there is no warranty
against interference with the Company’s enjoyment of the license granted
under this License Agreement or any rights to the Field or with respect to
infringement.
|
|
|
(b)
|
Phosphagenics
shall not be liable for:
|
|
|
(i)
|
any
injury to or the death of any person (including any of the Company’s
personnel) arising out of the Company 's performance of its obligations
under this License Agreement; or
|
|
|
(ii)
|
any
loss of or damage to any property of any person (including the Company and
its personnel) arising out of the Company’s performance of its obligations
under this License Agreement, except to the extent that the same is caused
by the negligence of Phosphagenics, provided that in no case shall
Phosphagenics be liable for the payment of damages in respect of
consequential losses;
|
|
|
(c)
|
Phosphagenics
indemnifies, and shall defend and hold harmless, the Company and Quigley
against all claims, actions, damages, losses (other than consequential
losses), liabilities, costs, charges, expenses and outgoings
(collectively, “Losses”) that the
Company pays, suffers or incurs as a result of, in connection with, or
arising from:
|
|
|
(i)
|
breach
by Phosphagenics of this License Agreement (including any breach of a
warranty or representation given under clause
8);
|
|
|
(ii)
|
any
infringement on the intellectual property rights of a third party because
of the use of the Intellectual Property contemplated by this License
Agreement;
|
|
|
(iii)
|
any
claims by a third party that use of the Intellectual Property contemplated
by this License Agreement infringes on such third party’s rights;
or
|
|
|
(iv)
|
any
obligation of the Company under applicable law to withhold portions of the
amounts that the Company is required to pay pursuant to this License
Agreement.
|
|
|
(d)
|
Quigley
as Third-Party Beneficiary
|
|
9.2
|
The
Company indemnifies Phosphagenics
|
|
|
(a)
|
Subject
to clause 9.2(b), the Company indemnifies, and shall defend and hold
harmless, Phosphagenics from and against all Losses that Phosphagenics
pays, suffers or incurs as a result of, in connection with, or arising
from:
|
|
|
(i)
|
injuries
suffered or death sustained by persons as a result of the conduct of any
clinical trials in connection with the Field and/or the Non-Exclusive
Field;
|
|
|
(ii)
|
injuries
suffered or death sustained by persons as a result of any Field and/or the
Non-Exclusive Field developed pursuant to this License Agreement and
supplied by Phosphagenics to
consumers;
|
|
|
(iii)
|
wilful,
tortious or negligent conduct on the part of the Company;
or
|
|
|
(iv)
|
breach
by the Company of this License Agreement (including any breach of a
warranty or representation given by the Company under clause
8).
|
|
|
(b)
|
The
Company shall not be required to indemnify Phosphagenics to the extent
that any Loss suffered or incurred by Phosphagenics arises as a result of
any wilful, tortious or negligent conduct on the part of Phosphagenics or
any breach by Phosphagenics of this License
Agreement.
|
|
10.
|
Term
and Termination
|
|
10.1
|
Term
|
|
10.2
|
Termination
with Cause
|
|
|
(a)
|
the
other party:
|
|
|
(i)
|
is,
or is deemed by Law to be, unable to pay its
debts;
|
|
|
(ii)
|
resolves,
or proposes to resolve, that it be wound up;
or
|
|
|
(iii)
|
is
placed under official management;
|
|
|
(b)
|
an
administrator, receiver or receiver and manager, or other insolvency
administrator is appointed in respect of any of the property or assets of
the other party;
|
|
|
(c)
|
a
liquidator or a provisional liquidator is appointed to the other party,
except for the purposes of solvent amalgamation or reconstruction or
corporate reorganisation; or
|
|
|
(d)
|
the
other party enters into an arrangement or compromise with its creditors or
any class of creditors other than for the purposes of solvent amalgamation
or reconstruction or corporate reorganisation, provided that such
termination will be without prejudice to the rights and remedies of the
parties otherwise having arisen under this License
Agreement.
|
|
11.
|
Consequences
of Termination/Expiration
|
|
11.1
|
Return
of documents
|
|
|
(a)
|
Phosphagenics
will promptly deliver up or return to the Company any property of the
Company, including documents and records of the Company, in Phosphagenics’
possession, custody or control (other than any Phosphagenics Confidential
Information);
|
|
|
(b)
|
The
Company will promptly deliver up or return to Phosphagenics any property,
including documents and records, of Phosphagenics in the Company’s
possession, custody or control (other than any Company Confidential
Information);
|
|
|
(c)
|
The
Company shall cooperate with Phosphagenics and a cancellation of all or
any licenses registered pursuant to this License Agreement and shall
execute any and all such documents and do acts and things as may be
necessary in such connection;
|
|
|
(d)
|
The
Company shall within, six (6) months of the date of termination or expiry,
transfer to Phosphagenics all Regulatory Approvals and will work with
Phosphagenics to ensure that such transfer
occurs;
|
|
|
(e)
|
The
Company will promptly deliver to Phosphagenics all data information which
has been created or collected as a consequence of the carrying out of the
Development Plan including but not limited to any clinical trials
conducted in respect of the Field and/or the Non-Exclusive
Field.
|
|
|
(f)
|
The
Company shall have the right to dispose of all stocks of the Field and/or
the Non-Exclusive Field in its possession and in the normal course of
manufacture at the date of termination or expiry provided that any royalty
payable under the provisions of this License Agreement shall be received
within a period of ninety (90) days following termination or expiry;
and
|
|
|
(g)
|
All
rights and licenses, including sublicenses granted under this License
Agreement, shall cease except to the extent expressly provided otherwise
under the terms of this License
Agreement.
|
|
11.2
|
No
further rights
|
|
|
(a)
|
If
Phosphagenics terminates this License Agreement under clause 10.2, then,
except as provided in clause 11.1, the Company will have no further right
to manufacture or sell the Field and/or the Non-Exclusive
Field.
|
|
|
(b)
|
Subject
to this clause 11, termination of this License Agreement will not
prejudice any accrued rights or liabilities of a party or excuse any party
from a breach of this License Agreement occurring prior to termination or
expiration or excuse any party from paying any amount which is or becomes
due and payable to the other party in respect of performance by the other
party prior to termination.
|
|
12.
|
Assignment
|
|
12.1
|
Restriction
upon Assignment
|
|
12.2
|
Permitted
Assigns
|
|
12.3
|
Restriction
upon Sub-Contracting
|
|
13.
|
Force
Majeure
|
|
13.1
|
Force
Majeure Events
|
|
13.2
|
Reliance
Upon Force Majeure
|
|
14.
|
Dispute
Resolution
|
|
15.
|
Notices
|
|
Attention:
|
Ted
Karkus
|
|
Address:
|
Phusion
Laboratories, LLC
|
|
Attention:
|
Managing
Director,
|
|
|
Address:
|
Phosphagenics
Ltd.
|
|
16.
|
Governing
Law; Jurisdiction and Venue
|
|
17.
|
General
|
|
17.1
|
Relationship
|
|
|
(a)
|
The
parties are independent contractors and are not by this License Agreement
made agents or employees of the
other.
|
|
|
(b)
|
A
party has no authority to bind the other party in any manner whatsoever
and is not entitled at any time to hold itself out to third parties as
having authority to enter commitments, expenses, liabilities or
obligations of any nature on behalf of the first mentioned
party.
|
|
17.2
|
Further
acts
|
|
17.3
|
Expenses
|
|
17.4
|
Amendments
|
|
17.5
|
Waiver
|
|
|
(a)
|
Failure
to exercise or enforce or a delay in exercising or enforcing or the
partial exercise or enforcement of any right, power or remedy provided by
law or under this License Agreement by any party will not in any way
preclude, or operate as a waiver of, any exercise or enforcement, or
further exercise or enforcement of that or any other right, power or
remedy provided by law or under this License
Agreement.
|
|
|
(b)
|
Any
waiver or consent given by any party under this License Agreement will
only be effective and binding on that party if it is given or confirmed in
writing by that party.
|
|
|
(c)
|
No
waiver of a breach of any term of this License Agreement will operate as a
waiver of another breach of that term or of a breach of any other term of
this License Agreement.
|
|
17.6
|
Counterparts
|
|
17.7
|
Indemnities
|
|
|
(a)
|
Each
indemnity in this License Agreement is a continuing obligation, separate
and independent from the other obligations of the parties, and survives
termination, completion or expiration of this License
Agreement.
|
|
|
(b)
|
It
is not necessary for a party to incur expense or to make any payment
before enforcing a right of indemnity conferred by this License
Agreement.
|
|
17.8
|
Entire
License Agreement
|
|
|
(a)
|
embodies
the entire understanding of the parties, and constitutes the entire terms
agreed on between the parties; and
|
|
|
(b)
|
supersedes
any prior written or other agreement between the
parties.
|
|
17.9
|
Survival
of certain provisions; no merger
|
|
|
(a)
|
Clauses
1, 2, 6, 7, 8, 9, 11, 14, 15, 16 and this clause 17 will survive
rescission or termination of this License
Agreement.
|
|
|
(b)
|
If
this License Agreement is rescinded or terminated, no party will be liable
to any other party except:
|
|
|
(i)
|
under
the clauses set out in clause 17.9(a);
or
|
|
|
(ii)
|
in
respect of any breach of this License Agreement occurring before
rescission or termination.
|
|
|
(c)
|
No
right or obligation of any party will merge on completion of any
transaction under this License
Agreement.
|
|
PHOSPHAGENICS
LTD.
|
|
|
By:
|
/s/ Fred Banti
|
|
Name:
Fred Banti
|
|
|
Title:
Senior Vice President and Chief Business Officer
|
|
|
PHUSION
LABORATORIES, LLC
|
|
|
By:
|
/s/ Ted Karkus
|
|
Name:
Ted Karkus
|
|
|
Title:
Co-Chief Executive Officer
|
|
|
Acknowledged,
for purposes of clauses 6, 7 and 9.1
|
|
|
THE
QUIGLEY CORPORATION
|
|
|
By:
|
/s/ Ted Karkus
|
|
Name:
Ted Karkus
|
|
|
Title:
Chief Executive Officer
|
|
|
Name
|
Priority
date
|
Number
|
|
|
A
carrier comprising one or more di and/or mono-(electron transfer agent)
phosphate derivatives or complexes thereof
|
17
June 2005
|
WO
2006/133506
|
|
|
Formulation
Containing Phosphate Derivatives Of Electron Transfer
Agents
|
14
November 2000
|
WO
02/40033
|
|
|
Dermal
Therapy Using Phosphate Derivatives Of Electron Transfer
Agents
|
27
July 2001
|
WO
03/011303
|
|
|
Complexes
Of Phosphate Derivatives
|
14
November 2000
|
WO
02/40034
|
|
|
Transdermal
Transport Of Compounds
|
13
December 2001
|
WO
03/049774
|
|
|
Carrier
|
9
August 2002
|
WO
2004/014432
|
|
|
Improved
Process for Phosphorylation and Compounds Produced by this
Method
|
14
May 1999
|
WO
00/69865
|
|
|
Carrier
Composition
|
23
December 2009
|
US
provisional 61/289507
|
|
|
New
Carrier Composition
|
19
February 2010
|
US
provisional 61/306115
|
|
|
§
|
Peptides
|
|
|
§
|
Amino
acids
|
|
|
§
|
Lipoaminoacids
(Palmitoyl glycine
Cocoyl alanine) |
|
|
§
|
Alpha
hydroxy acids
|
|
|
§
|
Vitamins
B, C, D (all forms)
|
|
|
§
|
Alpha
lipoic acid
|
|
|
§
|
Sodium
hyaluronate
|
|
|
§
|
Allantoin
|
|
|
§
|
Panthenol
|
|
|
§
|
Ceramides
|
|
|
§
|
TPM
|
|
|
§
|
Niacinamide
|
|
|
§
|
Retinyl
propionate
|
|
|
§
|
Lycopene
|
|
|
§
|
Omega-3
fatty acids
|
|
|
§
|
GABA
|
|
|
§
|
Polyphenols
|
|
|
§
|
Phytosterols
|
|
|
§
|
Quercetin
|
|
|
§
|
Tea
Tree Oil
|
|
|
§
|
Evening
Primrose Oil
|
|
|
§
|
Phenylalanine
|
|
|
§
|
Glucuronolactone
|
|
|
§
|
Inositol
|
|
|
§
|
Tyrosine
|
|
|
§
|
Citicoline
|
|
|
§
|
Taurine
|