EXHIBIT 10.7
LICENSE AGREEMENT
BETWEEN
DR. CRAIG HILL,
DR. RAYMOND
SCHINAZI
AND
PHARMASSET, LTD.
Certain portions of this Exhibit have been
omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets and asterisks [***], have
been separately filed with the Commission.
TABLE OF CONTENTS
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LICENSE AGREEMENT
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1
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ARTICLE 1.
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DEFINITIONS
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1
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1.1.
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“Affiliate”
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1
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1.2.
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“Agreement” or “License
Agreement”
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2
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1.3.
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“Effective Date”
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2
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1.4.
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“Field of
Use”
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2
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1.5.
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“First
Commercial Sale”
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2
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1.6.
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“IND”
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2
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1.7.
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“Indemnitees”
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2
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1.8.
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“Licensed
Patents”
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2
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1.9.
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“Licensed
Product”
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3
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1.10.
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“Licensed
Technology”
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3
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1.11.
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“NDA”
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3
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1.12.
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“Net
Selling Price”
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3
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1.13.
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“Party”
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4
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1.14.
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“Phase
II”
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4
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1.15.
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“Sale or
Sold”
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4
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1.16.
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“Sublicensee”
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5
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1.17.
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“Sublicense Payments”
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5
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1.18.
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“Sublicense Royalties”
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5
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1.19.
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“Valid
Claim”
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5
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ARTICLE 2.
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GRANT OF
LICENSE
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6
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2.1.
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License Grant
from Dr. Hill
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6
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2.2.
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License Grant
from Dr. Schinazi
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6
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2.3.
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Retained
License
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6
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2.4.
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Sublicense
Rights
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6
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2.5.
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Diligence and
Commercialization
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7
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2.6.
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Lack of
Diligence
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7
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ARTICLE 3.
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PAYMENT
OBLIGATIONS
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7
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3.1.
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License
Fee
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7
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3.2.
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Reimbursement
of Patent Expenses
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8
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3.3.
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Milestone
Payments
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8
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3.4.
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Royalties
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9
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ARTICLE 4.
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REPORTS AND
PAYMENTS
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10
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4.1.
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Payments
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10
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4.2.
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Progress
Reports
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10
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4.3.
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Royalty
Reports
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10
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4.4.
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Currency
Conversion
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11
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4.5.
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Interest
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12
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i
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ARTICLE 5.
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RECORDS
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12
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5.1.
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Records of
Sales
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12
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5.2.
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Audit of
Records
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12
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ARTICLE 6.
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PATENT
PROSECUTION
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13
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6.1.
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Prosecution and
Maintenance of Licensed Patents
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13
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6.2.
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Extension of
Licensed Patents
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13
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6.3.
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Further
Obligations
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13
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ARTICLE 7.
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ABATEMENT OF
INFRINGEMENT
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15
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7.1.
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Infringement
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15
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7.2.
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Abandonment of
Infringement
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16
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ARTICLE 8.
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CONFIDENTIALITY
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16
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8.1.
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Confidential
Information
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16
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8.2.
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Disclosure of
Confidential Information
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17
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8.3.
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Prior
Agreements
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17
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ARTICLE 9.
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LIMITED
WARRANTY, MERCHANTABILITY AND EXCLUSION OF WARRANTIES
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18
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9.1.
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Limited
Warranty
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18
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ARTICLE 10.
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DAMAGES,
INDEMNIFICATION, AND INSURANCE
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18
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10.1.
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No
Liability
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18
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10.2.
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Indemnification
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19
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10.3.
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No Patent
Infringement Suit
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19
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10.4.
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Insurance
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19
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10.5.
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Notice of
Claims
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20
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ARTICLE 11.
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TERM AND
TERMINATION
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20
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11.1.
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Term
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20
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11.2.
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Termination by
Dr. Hill and Dr. Schinazi
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20
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11.3.
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Notice of
Bankruptcy
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21
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11.4.
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Exercise
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21
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11.5.
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Failure to
Enforce
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21
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11.6.
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Termination by
Pharmasset
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21
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11.7.
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Effect
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22
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11.8.
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Survival
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22
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ARTICLE 12.
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ASSIGNMENT
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22
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ARTICLE 13.
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ARBITRATION
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23
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ARTICLE 14.
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MISCELLANEOUS
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23
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14.1.
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Export
Controls
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23
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ii
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14.2.
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Legal
Compliance
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23
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14.3.
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Independent
Contractor
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24
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14.4.
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Patent
Marking
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24
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14.5.
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Use of
Names
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24
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14.6.
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Place of
Execution
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24
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14.7.
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Governing
Law
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24
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14.8.
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Entire
Agreement
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24
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14.9.
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Severability
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25
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14.10
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Force
Majeure
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25
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ARTICLE 15.
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NOTICES
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25
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EXHIBIT A
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iii
LICENSE
AGREEMENT
THIS LICENSE AGREEMENT is made by
and between Pharmasset Ltd., a corporation organized under the laws
of Barbados (“Pharmasset”), Dr. Craig L. Hill
an individual residing in the State of Georgia, USA (“Dr.
Hill”) and Dr. Raymond Schinazi, an individual residing
in the State of Georgia, U.S.A.
(“Dr. Schinazi”).
WITNESSETH
:
WHEREAS, Dr. Hill and
Dr. Schinazi are the co-inventor and owner of certain
intellectual property rights, including U.S. and European patents
and application listed in Exhibit A, on different proprietary and
uses of polyoxometalates and have the right to grant licenses to
this intellectual property.
WHEREAS, Pharmasset is a company
dedicated to the development and production of antiviral compounds
and desires to obtain a license to the patent application
referenced above, and all U.S. and corresponding foreign patents
issuing therefrom.
NOW, THEREFORE, in consideration of
the mutual covenants and promises contained in this Agreement and
for other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, Pharmasset,
Dr. Hill, and Dr. Schinazi agree as follows:
ARTICLE 1.
DEFINITIONS
The following terms, whether used in
the singular or plural, shall have the following
meanings:
1.1 “ Affiliate ”
shall mean any corporation, partnership, or other business entity
which is directly or indirectly controlled by Pharmasset or any
entity which directly or indirectly
controls Pharmasset. “Controls” as
used herein means owns directly or indirectly at least thirty
percent (30%) of the outstanding voting securities.
1.2 “ Agreement ”
or “ License Agreement ” shall mean this
Agreement, including all Exhibits attached to this
Agreement.
1.3. “ Effective Date
” means the later of (i) the date on which Pharmasset
executes this Agreement, (ii) the date on which Dr. Hill
executes this Agreement, or (iii) the date on which
Dr. Schinazi executes this Agreement.
1.4. “ Field of Use
” shall mean all human antiviral (including HIV) applications
and uses.
1.5. “ First Commercial
Sale ” means, with respect to each Licensed Product, the
first commercial sale by Pharmasset, its Affiliates, sublicensees
and/or distributors of such Licensed Product, other than for
clinical trial purposes or compassionate use.
1.6. “ IND ”
means an Investigational New Drug Application filed with the United
States Food and Drug Administration (“FDA”) in respect
of the Licensed Technology.
1.7. “ Indemnitees
” shall mean Dr. Hill and Dr. Schinazi, and their
heirs, executors, administrators, legal representatives.
1.8. “ Licensed Patents
” means all patents and patent applications listed in
attached Exhibit A (which shall be updated as additional patents or
patent applications are added to this Agreement by mutual agreement
of the Parties) throughout the world, including any substitutions,
extensions, reissues, reexaminations, renewals, divisions,
continuations or continuations-in-part, which Dr. Hill and
Dr. Schinazi own, or otherwise has the right to grant licenses
under.
2
1.9. “ Licensed Product
” means a product which, or the manufacture, use or sale of
which is covered by a Valid Claim of any of the Dr. Hill and
Dr. Schinazi Patent Rights in the country where the product is
manufactured, used or sold.
1.10. “ Licensed
Technology ” shall mean all designs, technical
information, know-how, knowledge, data, specifications, test
results and other information, whether or not patented, which is
known to Dr. Hill and Dr. Schinazi on the date of this
Agreement and is useful for the manufacture, use or sale of any
Licensed Product.
1.11. “ NDA ”
means a New Drug Application filed with the FDA relating to the
Licensed Technology.
1.12. “ Net Selling
Price ” of Licensed Products shall mean the gross
invoiced price paid to Pharmasset, its Affiliates, or sublicensees
by a purchaser of a Licensed Product less the following discounts:
(a) customary trade, quantity and cash discounts actually
allowed and taken; (b) credit actually given for rejected or
returned Licensed Products; (c) freight and insurance costs,
if separately itemized on the invoice paid by the customer; and
(d) custom and excise taxes included in the invoiced amount,
and (e) to the extent separately stated on purchase orders,
invoices or other documents of Sale, all taxes including VAT and
sales or similar taxes. Where a Sale is deemed consummated by a
gift, use, or other disposition of Licensed Products for other than
a selling price stated in cash, the term “Net Selling
Price” shall mean the average gross selling price paid to
Pharmasset in consideration of Sales of the same quantity of
Licensed Products during the six (6) month period immediately
preceding such Sale, without reduction of any kind (other than as
provided for in (a) - (d) above). If no Sales of Licensed Products
have occurred in the preceding six (6) months, then sales of
comparable products shall be used in such determination.
“Net Selling Price” with
respect to any Combination Product (a Licensed Product
incorporating additional active ingredients) shall be negotiated in
good faith by the parties with the intention of agreeing upon a
fair and equitable formula; provided, however, that if the
parties
3
Certain portions of this Exhibit have been
omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets and asterisks [***], have
been separately filed with the Commission.
are unable to agree upon such
definition within a reasonable period of time, Net Selling Price
with respect to such Combination Product shall mean the gross sales
of such Product paid by independent customers, less all the
allowances, adjustments, reductions, discounts, taxes, duties,
rebates or other charges referred to in the above definition of Net
Selling Price multiplied by a fraction, the numerator of which
shall be the average invoice price per gram of compound contained
in the most comparable stock keeping unit of Licensed Product
having the compound as the sole active ingredient during the
applicable royalty period in a country of the Licensed Territory,
when such comparable Licensed Product is Sold for the same
indication as such Combination Product and the denominator of which
shall be the average invoice price per gram of the compound sold
alone as described immediately above plus the average invoice
price(s) per gram of the other active ingredient(s) contained in
such Combination Product in such country during the applicable
royalty period when such active ingredients are Sold alone for the
same indication as such Combination Product. If there is no average
invoice price per gram in a given country for a compound or for one
or more of the active ingredients comprising a Combination Product,
Net Selling Price with respect to such Combination Product shall be
deemed to be [***] Percent ([***]%) of the gross Sales of such
Combination Product paid by independent customers, less all the
allowances, adjustments, reductions, discounts, taxes, duties,
rebates or other charges referred to in the above definition of Net
Selling Price.
1.13. “ Party ”
means Pharmasset or Dr. Hill or Dr. Schinazi; “
Parties ” means Pharmasset and Dr. Hill and
Dr. Schinazi.
1.14. “ Phase II
” means the first controlled FDA approved first controlled
clinical trials conducted with a limited number of human patients
and are designed to measure the effectiveness of a new
pharmaceutical product, that is, the effective dose and regiment
for further study in larger clinical trials. Completion of Phase II
represents a milestone to then begin the Phase III clinical trials
that are pivotal to product approval.
1.15. “ Sale or Sold
” shall mean the sale, transfer, exchange, or other
disposition of Licensed Products whether by gift or otherwise,
including but not limited to the use of Licensed Products by any
person authorized by Pharmasset other than Pharmasset. Neither
(a) the
4
Certain portions of this Exhibit have been
omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets and asterisks [***], have
been separately filed with the Commission.
provision of Licensed Products, prior to the
approval of Licensed Products in a country and pursuant to a
requirement issued by the appropriate governmental agency in that
country, for consumption by or administration to persons for
humanitarian purposes or compassionate use, (b) the provision
of Licensed Products for use in clinical trials, nor (c) the
provision of samples in reasonable quantities without charge for
promotional purposes shall be deemed a Sale for the purposes of
this Agreement. Sales of Licensed Products shall be deemed
consummated upon the first to occur of: (a) receipt of payment
from the purchaser; (b) delivery of Licensed Products to the
purchaser or a common carrier; (c) release of Licensed
Products from consignment; (d) if deemed Sold by use, when
first put to such use; or (e) if otherwise transferred,
exchanged, or disposed of whether by gift or otherwise when such
transfer, exchange, gift, or other disposition occurs.
1.16. “ Sublicensee
” means any third party other than an Affiliate granted the
right, subject to the terms and conditions of Article 2, to make,
use and sell a Licensed Product, but not including a third party
that is not granted the right to make such Product but merely
purchases such Product in finished form for resale.
1.17. “ Sublicense
Payments ” means sublicense fees, milestone payments and
other cash consideration (excluding royalties) received by
Pharmasset from a Sublicensee, provided that in no event
shall Sublicense Payments include any funds provided by a
Sublicensee to fund research, development, and clinical trials, to
reimburse Pharmasset for research, development, and clinical trial
expenses or to purchase equity securities of Pharmasset.
1.18. “ Sublicense
Royalties ” means royalties on sales of Licensed Product
received by Pharmasset from a Sublicensee.
1.19. “ Valid Claim
” means a claim which (i) in the case of any unexpired
United States or foreign patent, shall not have been donated to the
public, disclaimed, nor held invalid or unenforceable against the
other Party by a court of competent jurisdiction in an unappealed
or unappealable decision, or (ii) in the case of any United
States or foreign patent application, shall not have been
cancelled, withdrawn, abandoned nor been pending for more than
[***] ([***]) years.
5
ARTICLE 2. GRANT OF
LICENSE
2.1. License Grant from
Dr. Hill . Dr. Hill hereby grants to Pharmasset, and
Pharmasset hereby accepts, an exclusive sublicense, including the
right to grant further sublicenses pursuant to Section 2.4,
under the Licensed Patents in Exhibit A to make, have made, use,
import, offer for sale, and sell Licensed Products covered by such
Licensed Patents only and to practice Licensed Technology with
respect to such Licensed Patents only for the Field of Use during
the term of the Agreement.
2.2. License Grant from
Dr. Schinazi . Dr. Schinazi hereby grants to
Pharmasset, and Pharmasset hereby accepts, an exclusive license,
including the right to grant sublicenses pursuant to
Section 2.4, under the Licensed Patents in Exhibit A to make,
have made, use, import, offer for sale, and sell Licensed Products
covered by such Licensed Patents only and to practice Licensed
Technology with respect to such Licensed Patents only for the Field
of Use during the term of the Agreement.
2.3. Retained License . Left
blank intentionally.
2.4. Sublicense Rights .
Pharmasset shall have the right to grant sublicenses under the
sublicense granted pursuant to Section 2.1 above and under the
license granted pursuant to Section 2.2 above to parties with
whom Pharmasset has agreed to jointly develop and/or commercialize
Licensed Products; provided that any sublicense granted by
Pharmasset under this Agreement shall be subject and subordinate
to, and consistent with, the terms and conditions of this
Agreement, and shall provide that any such sublicensee shall not
further sublicense except on terms consistent with this
Section 2.4. Pharmasset shall provide Dr. Hill and
Dr. Schinazi with a copy of any sublicense granted pursuant to
this Section 2.4 within one (1) month after the execution
thereof. Such copy may be redacted to exclude confidential
scientific information and other information required by a
sublicensee to be kept confidential, provided that
all relevant financial terms and information shall be retained
therein. In the event of a material default by any sublicensee
under a sublicense agreement, Pharmasset will inform Dr. Hill
and Dr. Schinazi
6
and take such action, after consultation with
Dr. Hill and Dr. Schinazi, which in Pharmasset’s
reasonable business judgment will address such default.
2.5. Diligence and
Commercialization . Pharmasset shall use its reasonable best
efforts, either directly or through Affiliates or sublicensees,
throughout the term of this Agreement to bring Licensed Products to
market through a thorough, vigorous, and diligent program for
exploitation of the right and license granted in this Agreement to
Pharmasset and to create, supply, and service as extensive a market
as possible. In no instance shall Pharmasset’s reasonable
best efforts be less than efforts customary in Pharmasset’s
industry.
2.6. Lack of Diligence . If
Dr. Hill and Dr. Schinazi conclude that Pharmasset is not
diligent in development or Sales of Licensed Products pursuant to
Article 2.5 for any reason other than (a) the withholding by a
regulatory agency or marketing approval despite Pharmasset’s
diligent effort to obtain such approval; (b) unanticipated
technical or scientific problems which have been promptly reported
to Dr. Hill and Dr. Schinazi in writing; or
(c) other causes beyond the reasonable control of Pharmasset
which have been promptly reported to Dr. Hill and
Dr. Schinazi in writing; then Dr. Hill and
Dr. Schinazi may give notice to Pharmasset stating the basis
for its conclusion and, upon the request of Dr. Hill and
Dr. Schinazi, Pharmasset shall show cause why the license
granted hereunder should not be terminated. If within ninety
(90) days after Pharmasset’s receipt of said notice, the
parties have not resolved the matter through good faith
negotiations in a mutually acceptable manner, the parties shall
submit the dispute to arbitration under the provisions of Article
13 of this Agreement.
ARTICLE 3. PAYMENT
OBLIGATIONS
3.1. License Fee . In
consideration of the rights granted to Pharmasset under this
Agreement, Pharmasset shall pay to Dr. Hill and
Dr. Schinazi the following non-refundable, non-creditable
license fee on the Effective Date:
(a) To Dr. Hill: 35,000 Common
Stock Options at US$1.00 and,
7
Certain portions of this Exhibit have been
omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets and asterisks [***], have
been separately filed with the Commission.
(b) To Dr. Schinazi: 35,000
Common Stock Options at US$1.00
Options will be exercisable for a
period of 10 years starting from March 1, 1999.
3.2. Reimbursement of Patent
Expenses . Pharmasset will forgive $20,000 of the obligation of
Dr. Schinazi under that certain Promissory Note, dated
January 29, 1999, made by Dr. Schinazi to Pharmasset in
the original principal amount of $320,500 in partial reimbursement
of patents costs associated with the technology listed in Exhibit
A. Within thirty (30) days after the end of each calendar
quarter, Dr. Hill and Dr. Schinazi shall provide
Pharmasset with an invoiced accounting of all patent related
expenses incurred by them, as described in Section 4.1, below,
during such calendar quarter. Pharmasset shall reimburse all such
invoiced patent related expenses within one (1) month after
receipt of such accounting.
3.3. Milestone Payments .
Within thirty (30) days after the occurrence of the milestones
specified below, Pharmasset shall make the following
non-refundable, non-creditable payments to Dr. Hill and Dr.
Schinazi:
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To Dr. Hill:
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Milestone
|
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Payment
|
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|
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Completion of
Phase II
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$
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[***]
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NDA
Approval
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$
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[***]
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To Dr.
Schinazi:
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Milestone
|
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Payment
|
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Completion of
Phase II
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$
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[***]
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NDA
Approval
|
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$
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[***]
|
8
Certain portions of this Exhibit have been
omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets and asterisks [***], have
been separately filed with the Commission.
The milestone payments in this Section 3.3
shall be payable only once, for each significant disease indication
for which the milestones are applicable.
3.4. Royalties .
(a) Pharmasset shall pay to
Dr. Hill and Dr. Schinazi, according to the payment
schedule described in subsection (b), during the applicable term
described in subsection (c), earned royalties at the rate of
(i) [***] percent ([***] %) of Net Sales of a Licensed Product
covered by a Valid Claim in the country of sale included in the
Licensed Patents and (ii) [***] percent ([***] %) of Net Sales
of a Licensed Product not covered by such a Valid Claim in the
country of sale, provided that in no event shall more than
one royalty be due Dr. Hill and Dr. Schinazi for the sale
of any Licensed Product.
(b) The earned royalties described
in subsection (a) above shall be paid to Dr. Hill and
Dr. Schinazi according to the following schedule:
(i) To Dr. Hill: [***] percent
([***]%) of the earned royalties, and,
(ii) To Dr. Schinazi: [***]
percent ([***]%) of the earned royalties.
(c) Pharmasset shall be obligated to
pay royalties at the rate set forth in subsection (a) (i), on
a country by country basis, so long as there continues to be a
Valid Claim included in the Licensed Patents that cover the
applicable Licensed Product in such country. Pharmasset shall be
obligated to pay royalties at the rate set forth in subsection
(a) (ii), on a country by country basis, on Net Sales of a
Licensed Product not covered by a Valid Claim (including a Licensed
Product which previously was covered by a Valid Claim) until the
[***] anniversary of the First Commercial Sale of such Licensed
Product in such country.
(d) Pharmasset shall pay to
Dr. Hill and Dr. Schinazi [***] percent ([***]%) of
Sublicense Payments.
9
Certain portions of this Exhibit have been
omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets and asterisks [***], have
been separately filed with the Commission.
(e) Pharmasset shall pay to
Dr. Hill and Dr. Schinazi [***] percent ([***]%) of
Sublicense Royalties.
(f) Notwithstanding the foregoing,
Pharmasset may deduct from royalties otherwise owed under
subsections (a) and (d) [***] percent ([***]%) of any
royalties or other payments required to be paid for licenses under
intellectual property rights of third parties.
ARTICLE 4. REPORTS AND
PAYMENTS
4.1. Payments . Unless
otherwise specified, all payments required