EXHIBIT 10.6
LICENSE AGREEMENT
BETWEEN
DR. MAHMOUD H. el
KOUNI,
DR. FARDOS M. N.
NAGUIB,
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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ARTICLE 1. 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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1
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1.3
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Effective Date
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1
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1.4
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Field of Use
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1
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1.5
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First Commercial Sale
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1
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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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2
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1.10
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Licensed Technology
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2
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1.11
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NDA
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2
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1.12
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Net Selling Price
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2
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1.13
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Party
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3
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1.14
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Phase II
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3
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1.15
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Sale or Sold
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3
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1.16
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Sublicensee
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3
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1.17
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Sublicense Payments
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3
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1.18
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Sublicense Royalties
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4
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1.19
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Valid Claim
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4
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ARTICLE 2. GRANT OF LICENSE
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4
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2.1
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License Grant from Dr. el Kouni
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4
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2.2
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License Grant from Dr. Naguib
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4
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2.3
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License Grant from Dr. Schinazi
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4
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2.4
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Retained License
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4
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2.5
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Sublicense Rights
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4
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2.6.
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Diligence and Commercialization
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5
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2.7.
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Lack of Diligence
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5
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ARTICLE 3. PAYMENT OBLIGATIONS
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5
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3.1.
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License Fee
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5
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3.2.
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Reimbursement of Patent Expenses
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5
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3.3.
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Milestone Payments
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6
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3.4.
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Royalties
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6
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ARTICLE 4. REPORTS AND PAYMENTS
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7
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4.1
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Payments
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7
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4.2
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Progress Reports
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7
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4.3
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Royalty Reports
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7
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4.4
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Currency Conversion
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8
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4.5
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Interest
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8
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ARTICLE 5. RECORDS
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8
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5.1
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Records of Sales
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8
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5.2
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Audit of Records
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8
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ARTICLE 6. PATENT PROSECUTION
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9
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6.1
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Prosecution and Maintenance of Licensed
Patents
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9
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6.2.
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Extension of Licensed Patents
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9
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6.3
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Further Obligations
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9
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i
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ARTICLE 7. ABATEMENT OF
INFRINGEMENT
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10
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7.1
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Infringement
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10
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7.2
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Abandonment of Infringement
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11
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ARTICLE 8. CONFIDENTIALITY
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11
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8.1
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Confidential Information
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11
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8.2
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Disclosure of Confidential
Information
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12
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8.3
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Prior Agreements
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12
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ARTICLE 9. LIMITED WARRANTY, MERCHANTABILITY
AND EXCLUSION OF WARRANTIES
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12
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9.1
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Limited Warranty
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12
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ARTICLE 10. DAMAGES, INDEMNIFICATION, AND
INSURANCE
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12
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10.1
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No Liability
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12
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10.2
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Indemnification
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13
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10.3
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No Patent Infringement Suit
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13
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10.4
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Insurance
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13
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10.5
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Notice of Claims
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13
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ARTICLE 11. TERM AND TERMINATION
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13
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11.1
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Term
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13
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11.2
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Termination by Dr. el Kouni, Dr. Naguib and Dr.
Schinazi
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14
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11.3
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Notice of Bankruptcy
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14
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11.4
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Exercise
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14
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11.5
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Failure to Enforce
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14
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11.6
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Termination by Pharmasset
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14
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11.7
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Effect
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15
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11.8
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Survival
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15
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ARTICLE 12. ASSIGNMENT
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15
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ARTICLE 13. ARBITRATION
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15
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ARTICLE 14. MISCELLANEOUS
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16
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14.1
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Export Controls
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16
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14.2
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Legal Compliance
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16
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14.3
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Independent Contractor
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16
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14.4
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Patent Marking
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16
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14.5
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Use of Names
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16
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14.6
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Place of Execution
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16
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14.7
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Governing Law
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16
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14.8
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Entire Agreement
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16
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14.9
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Severability
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17
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14.10
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Force Majeure
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17
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ARTICLE 15. NOTICES
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ii
LICENSE AGREEMENT
THIS LICENSE AGREEMENT is made by
and between Pharmasset Ltd., a corporation organized under the laws
of Barbados (“Pharmasset”), Dr. el Kouni an
individual residing in the State of Alabama, USA (“Dr. el
Kouni”), Dr. Naguib an individual residing in the State
of Alabama, USA and (“Dr. Naguib”) and Dr. Raymond
Schinazi, an individual residing in the State of Georgia, U.S.A.
(“Dr. Schinazi”).
WITNESSETH:
WHEREAS, Dr. Mahmoud H. el
Kouni, Dr. Fardos N. M. Naguib and
Dr. Raymond F. Schinazi are the co-inventor and owner of
certain intellectual property rights, including U.S. and European
patents and application listed in Exhibit A, entitled “Novel
inhibitors, their synthesis, and methods for use” 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. el Kouni, Dr. Naguib, 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. el Kouni
executes this Agreement, (iii) the date on which
Dr. Schinazi executes this Agreement, or (iv) the date on
which Dr. Naguib executes this Agreement.
1.4 “Field of Use” shall
mean all human antiviral (including HIV) and anticancer
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. el Kouni, Dr. Naguib, 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. el Kouni,
Dr. Naguib and Dr. Schinazi own, or otherwise has the
right to grant licenses under.
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 Licensed Patents 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. el
Kouni, Dr. Naguib 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
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
2
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.
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. el Kouni or Dr. Naguib or
Dr. Schinazi; “Parties” means Pharmasset and
Dr. el Kouni, Dr. Naguib 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 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.
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.
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.
ARTICLE 2. GRANT OF
LICENSE
2.1 License Grant from
Dr. el Kouni . Dr. el Kouni hereby grants to
Pharmasset, and Pharmasset hereby accepts, an exclusive sublicense,
including the right to grant further sublicenses pursuant to
Section 2.5, 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. Naguib . Dr. Naguib hereby grants to Pharmasset,
and Pharmasset hereby accepts, an exclusive sublicense, including
the right to grant further sublicenses pursuant to
Section 2.5, 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 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 2.5, 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.
2.4 Retained License . Left
blank intentionally.
2.5. 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 and under
the license granted pursuant to Section 2.3 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. el Kouni,
Dr. Naguib 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
4
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. el Kouni, Dr. Naguib and
Dr. Schinazi and take such action, after consultation with
Dr. el Kouni, Dr. Naguib and Dr. Schinazi, which in
Pharmasset’s reasonable business judgment will address such
default.
2.6. 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.
2.7. Lack of Diligence . If
Dr. el Kouni, Dr. Naguib 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. el Kouni,
Dr. Naguib and Dr. Schinazi in writing; or (c) other
causes beyond the reasonable control of Pharmasset which have been
promptly reported to Dr. el Kouni, Dr. Naguib and
Dr. Schinazi in writing; then Dr. el Kouni,
Dr. Naguib and Dr. Schinazi may give notice to Pharmasset
stating the basis for its conclusion and, upon the request of
Dr. el Kouni, Dr. Naguib 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. el Kouni,
Dr. Naguib and Dr. Schinazi the following non-refundable,
non-creditable license fee on the Effective Date:
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To Dr. Mahmoud H. el Kouni:
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17,500 Common Stock Options at US$1.00
and,
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To Dr. Fardos N. M.
Naguib:
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17,500 Common Stock Options at US$1.00
and,
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To Dr. Raymond F.
Schinazi:
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35,000 Common Stock Options at
US$1.00
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Options will be exercisable for a
period of 10 years starting from March 1, 1999.
3.2. Reimbursement of Patent
Expenses . Pharmasset will issue 18,000 preferred shares Series
A (price of $1.00 at time of signing) to Dr. el Kouni and
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. In addition, Dr. el Kouni will be permitted to purchase
7,000 shares of preferred shares series A at the price of $1.00 if
a check is received prior to April 30, 1999.
5
Certain portions of this Exhibit have been
omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets and asterisks [***], have
been separately filed with the Commission.
Within thirty (30) days after
the end of each calendar quarter, Dr. el Kouni and
Dr. Schinazi shall provide Pharmasset with an invoiced
accounting of all patent related expenses incurred by them, as
described in Section 4.1, below, during such calendar quarter.
Pharmasset shall reimburse all such invoiced patent related
expenses within one (1) month after receipt of such
accounting.
3.3. Milestone Payments .
Within thirty (30) days after the occurrence of the milestones
specified below, Pharmasset shall make the following
non-refundable, non-creditable payments to Dr. el Kouni,
Dr. Naguib and Dr. Schinazi:
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To Dr. el
Kouni:
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Milestone
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Payment
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Completion of
Phase II
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$[***]
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NDA
Approval
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$[***]
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To Dr.
Naguib:
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Milestone
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Payment
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Completion of
Phase II
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$[***]
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NDA
Approval
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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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NDA
Approval
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$[***]
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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 . Pharmasset
shall pay to Dr. el Kouni, Dr. Naguib 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. el Kouni, Dr. Naguib and Dr. Schinazi for the
sale of any Licensed Product.
The earned royalties described in
subsection (a) above shall be paid to Dr. el Kouni,
Dr. Naguib and Dr. Schinazi according to the following
schedule:
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To Dr. el
Kouni:
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[***] percent
([***]%) of the earned royalties, and,
|
|
|
|
|
To
Dr. Naguib:
|
|
[***] percent
([***]%) of the earned royalties, and,
|
|
|
|
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To
Dr. Schinazi:
|
|
[***] percent
([***]%) of the earned royalties.
|
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
6
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.
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.
Pharmasset shall pay to Dr. el
Kouni, Dr. Naguib and Dr. Schinazi [***] percent ([***]%)
of Sublicense Payments.
Pharmasset shall pay to Dr. el
Kouni, Dr. Naguib and Dr. Schinazi [***] percent ([***]%)
of Sublicense Royalties.
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 under this Agreement
shall be payable within thirty (30) days of the due date for
each payment. All payments due under this Agreement shall be made
either by wire transfer or immediately available funds or in person
or via the mail or private courier to the following
address:
Dr. Mahmoud H. el
Kouni
4632 Round Forest Drive
Mountain Brook, AL 35213,
USA
Dr. Raymond Schinazi
1524