COLLABORATION AGREEMENTCollaboration Agreement |
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[ * ] = CERTAIN
CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS
BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 406 OF THE SECURITIES EXCHANGE ACT OF 1933, AS AMENDED.
EXHIBIT 10.1
COLLABORATION AGREEMENT
BETWEEN
MILES INC.
AND
ONYX PHARMACEUTICALS, INC.
[ * ] = CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES EXCHANGE ACT OF 1933, AS AMENDED.
TABLE OF CONTENTS
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Page |
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CHAPTER 1 |
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1 |
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Article 1 — Defined Terms |
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1 |
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1.1
“Advertising and Education” |
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1 |
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1.2
“Advertising and Education Expense” |
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1 |
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1.3
“Affiliate” |
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1 |
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1.4
“Allocable Overhead Costs” |
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2 |
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1.5
“Allowable Expenses” |
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2 |
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1.6
“Analoging Program” |
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2 |
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1.7
“Back-Up Compound” |
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2 |
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1.8
“Clinical Development Period” |
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2 |
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1.9
“Collaboration Compound” |
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2 |
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1.10
“Collaboration Product” |
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3 |
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1.11
“Collaboration Revenue” |
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3 |
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1.12
“Control” |
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3 |
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1.13
“Cost of Goods Sold” |
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3 |
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1.14
“Co-Development” |
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3 |
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1.15
“Co-Development Costs” |
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4 |
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1.16
“Co-Development Plan” |
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4 |
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1.17
“Co-Promote” |
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4 |
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1.18
“Co-Promotion Program” |
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4 |
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1.19
“Co-Promotion Product” |
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4 |
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1.20
“Development Compound” |
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4 |
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1.21
“Distribution Costs” |
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4 |
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1.22
“Effective Date” |
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4 |
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1.23
“Field” |
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4 |
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1.24
“Field of Collaborative Research” |
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5 |
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1.25
“Information” |
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5 |
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1.26
“Joint Research and Development Committee” or “JRDC” |
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5 |
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1.27
“Lead Structure” |
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5 |
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1.28
“Marketing Plan” |
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5 |
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1.29
“Marketing Profit or Loss” |
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5 |
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1.30
“Miles Know-How” |
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5 |
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1.31
“Miles Patents” |
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5 |
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1.32
“Net Sales” |
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5 |
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1.33
“Onyx Know-How” |
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6 |
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1.34
“Onyx Patents” |
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6 |
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1.35
“Patent” |
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6 |
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1.36
“Preclinical Development Period” |
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6 |
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1.37
“Pre-Marketing Activities” |
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6 |
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1.39
“Post-Collaboration Compound” |
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6 |
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1.40
“Ras Pathway” |
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7 |
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1.41
“Ras Function” |
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7 |
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1.42
“Regulatory Approval” |
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7 |
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1.43
“Research” |
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7 |
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[ * ] = CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES EXCHANGE ACT OF 1933, AS AMENDED.
1
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Page |
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1.44
“Research Plan” |
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7 |
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1.45
“Research Term” |
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7 |
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1.46
“Royalty-Bearing Product” |
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7 |
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1.47
“Selling and Promotion Expenses” |
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8 |
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1.48
“Sublicense Revenues” |
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8 |
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1.49
“Third Party” |
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8 |
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1.50
“Third Party Royalties” |
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8 |
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CHAPTER 2 |
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9 |
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Article 2 — Initial Payment
And Board Representation |
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9 |
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2.1
Purchase of Series D Preferred Stock |
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9 |
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2.2
Board Representation |
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9 |
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3.1
Joint Research and Development Committee |
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10 |
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3.2
Meetings of the JRDC |
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10 |
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3.3
Functions and Powers of the JRDC |
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10 |
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3.4
Obligations of Parties |
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11 |
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3.5
Project Leader |
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11 |
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3.6
General |
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11 |
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Article 4 — Licenses |
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12 |
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4.1
Research Licenses |
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12 |
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4.2
Collaboration Product Commercialization Licenses |
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12 |
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4.3
Limitations on Exclusivity |
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12 |
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4.4
Royalty-Bearing Product Commercialization Licenses |
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13 |
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4.6
Onyx License After Research Termination |
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13 |
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CHAPTER 3 |
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14 |
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Article 5 — Collaborative
Research Program |
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14 |
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5.1
Program Management |
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14 |
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5.2
Decision Points During Research |
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14 |
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5.3
Research Efforts and Expenses |
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14 |
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5.4
Annual Plan and Budget |
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14 |
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5.5
Extension of Research Term |
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14 |
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5.6
Termination of Research with Substitution of New Research Target |
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15 |
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5.7
Consequences of Research Substitution |
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15 |
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5.8
Termination of Research by Miles |
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16 |
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5.9
Key Employee Departure |
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16 |
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Article 6 — Specification of
Research Field and Assays |
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18 |
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6.1
Refinement of Field of Collaborative Research |
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18 |
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6.2
Restriction of the Field of Collaborative Research |
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18 |
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6.3
Specification of Ras Function Assay Standards |
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19 |
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Article 7 — Allocation of
Research Tasks |
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19 |
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7.1
Onyx Research Obligations |
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19 |
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7.2
Miles Research Obligations |
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19 |
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7.3
Independent Funded Research Of Onyx Subject to Buy-Back |
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20 |
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7.4
Miles Buy-Back |
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20 |
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7.6
Conduct of Studies |
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20 |
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Article 8 — Research
Material and Information |
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21 |
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[ * ] = CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES EXCHANGE ACT OF 1933, AS AMENDED.
2
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Page |
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8.1
Rights In Materials |
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21 |
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8.2
Acquisition of Third Party Technology |
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21 |
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Article 9 — Research Funding |
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21 |
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9.1
Miles Financial Support |
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22 |
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9.2
Minimum Level of Financial Support |
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22 |
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9.3
Restriction on Government Support |
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22 |
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9.4
Manner of Payments |
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22 |
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9.5
Application of Funds; Reporting |
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22 |
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9.6
Research Activities After Research Term |
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22 |
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Article 10 — Research
Reports |
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24 |
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10.1
Information and Reports During Research |
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24 |
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10.2
Reports After Research Term |
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24 |
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CHAPTER 4 |
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25 |
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Article 11 — Co-Development |
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25 |
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11.1
Scope of Development |
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25 |
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11.2
Preclinical Investigation and Development |
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25 |
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11.3
Synthesis of Preclinical Materials |
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25 |
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11.4
Selection of Collaboration Compounds for Co-Development |
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25 |
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11.5
Budget for Development |
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26 |
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11.6
Performance of Co-Development |
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26 |
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11.7
Funding of Co-Development |
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27 |
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11.8
Development Payments |
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