1
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 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
EXHIBIT 10.25
COLLABORATION AGREEMENT
BETWEEN
XXXXXXX PHARMACEUTICAL, INC.
AND
SMITHKLINE XXXXXXX CORPORATION
MARCH 26, 1999
2
TABLE OF CONTENTS
PAGE
ARTICLE 1 DEFINITIONS...................................................................1
1.1 "004 Trial"...................................................................1
1.2 "Additional Indications"......................................................1
1.3 "Affiliate(s)"................................................................1
1.4 "Anti-CD20 Antibody"..........................................................2
1.5 "B1 Murine Antibody"..........................................................2
1.6 "Bexxar"......................................................................2
1.7 "BLA".........................................................................2
1.8 "Commercially Reasonable Efforts".............................................2
1.9 "Control".....................................................................2
1.10 "Co-Promotion"................................................................3
1.11 "Cost of Goods"...............................................................3
1.12 "Xxxxxxx Patent Rights".......................................................4
1.13 "Cross-Territory Trials"......................................................4
1.14 "Development".................................................................4
1.15 "Development Costs"...........................................................4
1.16 "Distribution Costs"..........................................................5
1.17 "Europe"......................................................................5
1.18 "European Facility"...........................................................5
1.19 "Existing Third Party License"................................................5
1.20 "Existing Third Party License Costs"..........................................6
1.21 "FD&C Act"....................................................................6
1.22 "FDA".........................................................................6
1.23 "Field".......................................................................6
1.24 "Finance Subteam".............................................................6
1.25 "First Commercial Sale".......................................................6
1.26 "First Indication"............................................................6
1.27 "Force Majeure Occurrence"....................................................6
1.28 "FTE".........................................................................6
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
i.
3
TABLE OF CONTENTS
(CONTINUED)
PAGE
1.29 "Good Clinical Practice" or "GCP".............................................6
1.30 "Good Laboratory Practice" or "GLP"...........................................7
1.31 "Good Manufacturing Practice" or "GMP"........................................7
1.32 "Guaranteed COGS Plus Royalties Percent"......................................7
1.33 "Guaranteed COGS Territory"...................................................7
1.34 "Intellectual Property Rights"................................................7
1.35 "Invention"...................................................................7
1.36 "Joint Commercialization Committee" or "JCC"..................................7
1.37 "Joint Development Committee" or "JDC"........................................7
1.38 "Joint Development Plan"......................................................7
1.39 "Joint Manufacture Development Plan"..........................................8
1.40 "Joint Marketing Plan"........................................................8
1.41 "Joint P&L"...................................................................8
1.42 "Know-How"....................................................................8
1.43 "Licensed Compound"...........................................................8
1.44 "Loan and Security Agreements"................................................8
1.45 "MAA".........................................................................8
1.46 "Major Indications"...........................................................9
1.47 "Major Market Country"........................................................9
1.48 "Major Markets in Territory C"................................................9
1.49 "Manufacture and Supply Chain Subteam"........................................9
1.50 "Manufacture Development".....................................................9
1.51 "Manufacture Development Costs"...............................................9
1.52 "Marketing Costs"............................................................10
1.53 "[*]"........................................................................11
1.54 "Net Sales"..................................................................11
1.55 "New Third Party Manufacture and Supply Chain Agreements"....................11
1.56 "New Third Party License"....................................................11
1.57 "New Third Party License Costs"..............................................12
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
ii.
4
TABLE OF CONTENTS
(CONTINUED)
PAGE
1.58 "Non-USA COGS"...............................................................12
1.59 "Non-USA Marketing Plan".....................................................12
1.60 "Non-USA Territory"..........................................................12
1.61 "North America"..............................................................12
1.62 "Operating Profit or Loss"...................................................12
1.63 "Other Operating Income/Expense".............................................12
1.64 "Out-of-Pocket Costs"........................................................12
1.65 "Patent Costs"...............................................................12
1.66 "Patent Rights"..............................................................12
1.67 "PHS Act"....................................................................13
1.68 "Planned Clinical Trials"....................................................13
1.69 "Pre-Existing Third Party Manufacture and Supply Chain Agreements"...........13
1.70 "Product"....................................................................13
1.71 "QA/QC Costs"................................................................13
1.72 "Radiolabeled Antibody"......................................................14
1.73 "Regulatory Approval"........................................................14
1.74 "Regulatory Personnel".......................................................14
1.75 "Sales Costs"................................................................14
1.76 "Sales Effort"...............................................................14
1.77 "SB Option Exercise Notice"..................................................14
1.78 "SB Patent Rights"...........................................................14
1.79 "Second Generation Antibody".................................................14
1.80 "Second Generation Antibody Candidate".......................................14
1.81 "Second Generation Licensed Compound"........................................15
1.82 "Second Generation Licensed Compound Candidate"..............................15
1.83 "Second Generation Licensed Compound Candidate Development Costs"............15
1.84 "Second Generation Licensed Compound Candidate Manufacture Development
Costs".......................................................................16
1.85 "Second Indication"..........................................................16
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
iii.
5
TABLE OF CONTENTS
(CONTINUED)
PAGE
1.86 "Stock Purchase Agreement"...................................................16
1.87 "Term of Co-Promotion".......................................................16
1.88 "Territory"..................................................................16
1.89 "Territory A"................................................................16
1.90 "Territory B"................................................................16
1.91 "Territory C"................................................................16
1.92 "Third Indication"...........................................................16
1.93 "Third Party(ies)"...........................................................17
1.94 "Trademark"..................................................................17
1.95 "Trademark Costs"............................................................17
1.96 "Unaffiliated Expert"........................................................17
1.97 "Unconjugated Antibody"......................................................17
ARTICLE 2 MANAGEMENT OF COLLABORATION..................................................17
2.1 Joint Development Committee (JDC)............................................17
2.1.1 Formation; Membership.................................................17
2.1.2 Decision-Making.......................................................18
2.1.3 Meetings..............................................................18
2.1.4 Specific Responsibilities of the JDC..................................18
2.2 Joint Commercialization Committee (JCC)......................................19
2.2.1 Formation; Membership.................................................19
2.2.2 Decision-Making.......................................................20
2.2.3 Meetings..............................................................20
2.2.4 Specific Responsibilities of the JCC..................................20
2.3 Manufacture and Supply Chain Subteam.........................................21
2.3.1 Formation; Membership.................................................21
2.3.2 Decision-Making.......................................................22
2.3.3 Meetings..............................................................22
2.3.4 Specific Responsibilities of the Manufacture and Supply Chain
Subteam...............................................................22
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
iv.
6
TABLE OF CONTENTS
(CONTINUED)
PAGE
2.4 Finance Subteam..............................................................23
2.4.1 Formation; Membership.................................................23
2.4.2 Meetings..............................................................23
2.4.3 Responsibilities of the Finance Subteam...............................23
ARTICLE 3 DEVELOPMENT OF LICENSED COMPOUND.............................................24
3.1 Initial and Subsequent Focus of the Collaboration............................24
3.2 Development..................................................................24
3.2.1 Joint Development Plan................................................24
3.2.2 Implementation of Development.........................................25
3.2.3 Designation of Clinical Trials........................................26
3.2.4 Lead Party for Development............................................26
3.2.5 Development Diligence Milestones in Non-USA Territory.................27
3.2.6 Funding of Development................................................28
3.3 Manufacture Development......................................................30
3.3.1 Joint Manufacture Development Plan....................................30
3.3.2 Lead Party for Manufacture Development................................31
3.3.3 Funding of Manufacture Development....................................32
3.4 Records, Reports and Information Exchange....................................32
3.4.1 Technology and Information Transfer...................................32
3.4.2 Record Keeping........................................................33
3.5 Regulatory Compliance........................................................33
3.6 Regulatory Approvals.........................................................33
3.6.1 Territory A...........................................................33
3.6.2 Non-USA Territory.....................................................33
ARTICLE 4 ADDITIONAL INDICATIONS; SECOND GENERATION LICENSED COMPOUNDS.................34
4.1 Additional Indications.......................................................34
4.2 Second Generation Licensed Compounds.........................................35
4.2.1 Second Generation Licensed Compound Candidates; Reporting;
Notice................................................................35
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
v.
7
TABLE OF CONTENTS
(CONTINUED)
PAGE
4.2.2 SB Development and Commercialization Option...........................36
4.2.3 If Xxxxxxx is the Initiating Party and SB Does Not Provide an
SB Option Exercise Notice.............................................37
4.2.4 Xxxxxxx Development and Commercialization Rights; Xxxxxxx
Funding Option........................................................38
4.2.5 Modification of Joint Development Plan, Joint Manufacture
Development Plan and Joint Marketing Plan.............................39
ARTICLE 5 LICENSES.....................................................................40
5.1 Licenses to SB...............................................................40
5.2 Licenses to Xxxxxxx..........................................................41
5.3 New Third Party Licenses.....................................................42
5.3.1 Determination Regarding Need for New Third Party License..............42
5.3.2 Procedure for Obtaining...............................................42
5.3.3 New Third Party License Costs.........................................43
5.3.4 Upstream Licenses.....................................................43
5.4 Exclusivity..................................................................44
ARTICLE 6 CONSIDERATION TO XXXXXXX.....................................................46
6.1 Upfront Fees.................................................................46
6.2 Milestone Payments on Bexxar.................................................47
6.2.1 Definitions Relating to Milestone Payments............................50
6.2.2 Delay of Commercial Launch in Non-USA Territory.......................52
6.2.3 Non-Refundable and Non-Creditable Milestone Payments..................52
6.2.4 Offset Against Milestone Payment for Regulatory Approval in
Territory B...........................................................52
6.3 Milestone Payments on Products Containing Second Generation Licensed
Compounds....................................................................52
6.4 Section 9.10.5 Milestone.....................................................53
6.5 Method of Making Milestone Payments..........................................53
6.6 Royalties and Profit Sharing.................................................53
6.7 [*] Rights...................................................................54
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
vi.
8
TABLE OF CONTENTS
(CONTINUED)
PAGE
ARTICLE 7 MARKETING....................................................................55
7.1 Co-Promotion in Territory A..................................................55
7.1.1 Rights to Co-Promote..................................................55
7.1.2 Lead Party for Commercialization in Territory A.......................55
7.1.3 Joint Marketing Plan..................................................56
7.1.4 Product Team..........................................................56
7.1.5 Product Pricing.......................................................56
7.1.6 Efforts of the Parties................................................57
7.1.7 Compliance with Law...................................................58
7.1.8 Promotional and Advertising Materials.................................59
7.1.9 Samples...............................................................59
7.1.10 Orders, Distribution, Completion of Sales, Returns....................59
7.1.11 Exchange of Marketing Information.....................................60
7.1.12 Co-Promotion Expenses.................................................60
7.1.13 Allocation of Operating Profit or Loss................................60
7.1.14 Joint P&L.............................................................60
7.1.15 Election to Forego Co-Promotion Right.................................61
7.1.16 Sales Training........................................................62
7.2 Non-USA Territory............................................................63
7.2.1 General...............................................................63
7.2.2 Commercialization Milestones..........................................63
7.2.3 Third Party Distribution Agreements...................................65
7.2.4 Royalties in Non-USA Territory........................................65
7.2.5 Increase or Decrease in Royalties based on Non-USA COGS...............66
7.2.6 Decrease in Royalties Based on Substantial Competition................68
7.3 No Delegation................................................................68
7.4 Product Complaints...........................................................68
7.5 Product-Related Inquiries....................................................69
7.6 Adverse Drug Event Reporting.................................................69
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
vii.
9
TABLE OF CONTENTS
(CONTINUED)
PAGE
ARTICLE 8 ACCOUNTS AND RECORDS; WITHHOLDING TAX........................................69
8.1 No Double Counting of Costs..................................................69
8.2 Records......................................................................69
8.3 Audits.......................................................................69
8.4 Sales by Sublicensees........................................................70
8.5 Withholding..................................................................70
8.6 Currency of Payment..........................................................70
8.7 Accounting...................................................................71
ARTICLE 9 MANUFACTURING AND SUPPLY.....................................................71
9.1 Cooperation..................................................................71
9.2 Pre-Existing Third Party Manufacture and Supply Chain Agreements.............71
9.3 Conformity with Pre-Existing Third Party Manufacture and Supply Chain
Agreements and Any New Third Party Manufacture and Supply Chain
Agreements...................................................................72
9.4 Responsibility for Manufacture, Supply and Distribution......................72
9.4.1 Unconjugated Antibody.................................................72
9.4.2 Radiolabeled Antibody for Development.................................72
9.4.3 Radiolabeled Antibody for Commercial Sale.............................73
9.4.4 Specifications........................................................73
9.4.5 Non-compliance with Specifications....................................73
9.4.6 Distribution..........................................................75
9.5 Allocation in the Event of Product Shortages.................................75
9.5.1 Allocation Between Development and Commercialization..................75
9.5.2 Allocation of Shortages Between Territories (Commercial Supply).......75
9.5.3 No Liability for Product Shortages....................................75
9.6 Change in Responsibility for Manufacture and Supply..........................75
9.6.1 Unconjugated Antibody by SB...........................................75
9.6.2 Unconjugated Antibody or Radiolabeled Antibody by Xxxxxxx.............76
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
viii.
10
TABLE OF CONTENTS
(CONTINUED)
PAGE
9.7 Cost of Goods for Unconjugated Antibody and Radiolabeled Antibody for
Development and Manufacture Development; Manufacture Development Costs
(Including Capital Expenditures).............................................77
9.7.1 Cost of Goods for Unconjugated Antibody and Radiolabeled
Antibody for Development and Manufacture Development..................77
9.7.2 Manufacture Development Costs (Including [*]).........................77
9.8 Cost of Goods for Unconjugated Antibody and Radiolabeled Antibody for
Commercial Sale..............................................................77
9.8.1 Unconjugated Antibody.................................................77
9.8.2 Radiolabeled Antibody.................................................78
9.9 Cost of Unconjugated Antibody in Event of Transfer of Responsibility.........79
9.10 European Facility............................................................79
9.10.1 Overview..............................................................79
9.10.2 Selection of SB Option................................................80
9.10.3 Definitions...........................................................81
9.10.4 SB Performance; Xxxxxxx Remedies......................................81
9.10.5 Milestone Payment.....................................................82
9.10.6 Remainder of the Non-USA Territory....................................83
9.11 Term of Manufacture and Supply...............................................83
9.12 Forecasts....................................................................83
9.12.1 Unconjugated Antibody and Radiolabeled Antibody.......................83
9.12.2 Production Ordering Mechanism for Radiolabeled Antibody for
Development and Commercial Sale.......................................84
9.12.3 Delivery; Shipment....................................................84
9.13 Quality Control; Testing.....................................................85
9.14 Manufacturing Regulatory Compliance..........................................85
9.14.1 Territory A...........................................................85
9.14.2 Territory B and Territory C...........................................85
9.15 Recalls......................................................................85
9.16 Corrective Action for Supply of Unconjugated Antibody........................86
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
ix.
11
TABLE OF CONTENTS
(CONTINUED)
PAGE
9.17 Corrective Action for Supply of Radiolabeled Antibody........................87
9.18 Exchange of Information......................................................87
ARTICLE 10 TRADEMARKS...................................................................88
10.1 Selection and Ownership of Trademarks........................................88
10.1.1 Territory A...........................................................88
10.1.2 Non-USA Territory.....................................................88
10.2 Development of Trademarks....................................................88
10.3 License Grants...............................................................89
10.3.1 Territory A...........................................................89
10.3.2 Non-USA Territory.....................................................89
10.3.3 Licensed Trademarks...................................................89
10.4 Use of Trademarks............................................................89
10.4.1 Territory A Trademarks and Xxxxxxx Trademarks.........................89
10.4.2 SB Trademarks.........................................................90
10.4.3 Quality Maintenance...................................................90
10.5 Infringement of Trademarks...................................................90
10.6 Costs Related to Infringement................................................91
10.7 Trade Dress..................................................................91
ARTICLE 11 PROSECUTION, MAINTENANCE AND INFRINGEMENT OF INTELLECTUAL PROPERTY
RIGHTS.......................................................................92
11.1 Inventions...................................................................92
11.2 Prosecution And Maintenance Of Patent Rights; Allocation of Patent Costs.....93
11.3 Cooperation..................................................................93
11.4 Infringement of Intellectual Property Rights.................................93
11.4.1 Right to Bring Action; Treatment of Recovery..........................93
11.5 Defense and Settlement of Third Party Claims for Products in the
Territory; Opposition and Revocation Proceedings.............................95
11.7 Royalty Reduction in Territory B or Territory C..............................97
11.8 Foreclosure Under Security Agreement.........................................97
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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TABLE OF CONTENTS
(CONTINUED)
PAGE
11.9 Covenant Regarding Existing Third Party License Agreements with [*].........100
ARTICLE 12 FORCE MAJEURE...............................................................101
ARTICLE 13 TERM AND TERMINATION........................................................101
13.1 Term........................................................................101
13.2 General Conditions of Expiration and Termination............................102
13.3 Termination for Breach......................................................104
13.3.1 General..............................................................104
13.3.2 Breach by SB.........................................................104
13.4 Early Termination License of SB's License...................................104
13.5 Non-Exclusive License.......................................................105
13.6 Early Termination of Xxxxxxx'x License......................................106
13.7 No Limit on Remedies........................................................107
ARTICLE 14 ASSIGNMENT..................................................................107
14.1 Assignment..................................................................107
14.2 Performance by Affiliates and Local Operating Entities......................107
ARTICLE 15 INDEMNIFICATION AND INSURANCE...............................................107
15.1 Cross Indemnification.......................................................107
15.1.1 Indemnification in the Non-USA Territory.............................107
15.1.2 Indemnification in Territory A.......................................108
15.2 Indemnification Procedure...................................................109
15.3 Insurance...................................................................109
ARTICLE 16 WARRANTIES AND REPRESENTATIONS...........................................110
ARTICLE 17 CONFIDENTIAL INFORMATION.................................................112
17.1 Information.................................................................112
17.2 Exceptions..................................................................112
17.3 Permitted Disclosures.......................................................113
17.4 Disclosure of Agreement.....................................................113
17.5 Publicity...................................................................114
17.6 Publication.................................................................114
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
xi.
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TABLE OF CONTENTS
(CONTINUED)
PAGE
17.7 Prior Confidentiality Agreements............................................114
ARTICLE 18 DISPUTE RESOLUTION..........................................................115
18.1 General.....................................................................115
18.2 [*].........................................................................115
18.3 Recommendation of [*].......................................................115
18.4 Governing Law; Jurisdiction; Venue..........................................116
18.5 Arbitration for Reasonable Royalty Determination............................116
ARTICLE 19 MISCELLANEOUS...............................................................117
19.1 Conditions to Effectiveness.................................................117
19.2 No Waiver of Contractual Rights.............................................118
19.3 Execution and Amendments....................................................118
19.4 Severability................................................................118
19.5 Relationship between the Parties............................................119
19.6 Correspondence and Notices..................................................119
19.7 Counterparts................................................................120
19.8 Waiver Of Breach............................................................120
19.9 No Intellectual Property Rights Granted.....................................120
19.10 Recording...................................................................120
19.11 Headings; Interpretation....................................................121
19.12 Expenses....................................................................121
19.13 Further Actions.............................................................121
19.14 Official Language...........................................................121
19.15 Entire Agreement; Tax Agreement.............................................121
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
xii.
14
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 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
EXHIBIT 10.25
COLLABORATION AGREEMENT
This COLLABORATION AGREEMENT (the "Agreement") is executed by the
Parties as of October 23, 1998 to become effective on the Effective Date (as
defined in Section 19.1) hereof, by and between XXXXXXX PHARMACEUTICAL, INC., a
company incorporated under the laws of the State of Delaware, with its principal
place of business at 000 Xxxxxxxxxx Xxxxxx, Xxxxx 000, Xxxx Xxxx, Xxxxxxxxxx
00000, XXX ("Xxxxxxx"), and SMITHKLINE XXXXXXX CORPORATION, a company
incorporated under the laws of the Commonwealth of Pennsylvania, with its
principal place of business at Xxx Xxxxxxxx Xxxxx, Xxxxxxxxxxxx, Xxxxxxxxxxxx
00000, XXX ("SB"). Both Xxxxxxx and SB are referred to individually as a "Party"
and collectively as the "Parties."
WHEREAS, Xxxxxxx has rights to and is developing that certain compound
known as BEXXAR(TM) (as such term is defined below); and
WHEREAS, SB would like to obtain the worldwide rights (except for Japan)
to develop and commercialize BEXXAR and other PRODUCTS in the FIELD (as such
terms are defined below); and
WHEREAS, Xxxxxxx and SB wish to jointly commercialize BEXXAR and other
PRODUCTS in the United States of America (excluding its territories, possessions
and the Commonwealth of Puerto Rico); and
WHEREAS, simultaneous with the execution of this Agreement, the Parties
are entering into the LOAN AGREEMENT (as such term is defined below) and the
STOCK PURCHASE AGREEMENT (as such term is defined below);
NOW THEREFORE, in consideration of the foregoing premises and the mutual
promises, covenants and conditions contained in this Agreement, the Parties
agree as follows:
ARTICLE 1
DEFINITIONS
For the purposes of this Agreement, the terms hereunder shall have the
meanings as defined below:
1.1 "004 TRIAL" shall mean Xxxxxxx'x clinical trial with Protocol No.
RIT-II-004 ("Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody
(Murine) Radioimmunotherapy for Chemotherapy-Refractory Low-Grade B-Cell
Lymphomas and Low-
1.
15
Grade Lymphomas That Have Transformed to Higher Grade Histologies") for which
enrollment and interim analysis was completed prior to the Effective Date.
1.2 "ADDITIONAL INDICATIONS" shall mean any indications in the FIELD,
other than the MAJOR INDICATIONS.
1.3 "AFFILIATE(S)" shall mean, in the case of either Xxxxxxx or SB, any
corporation, joint venture, or other business entity which directly or
indirectly controls, is controlled by, or is under common control with that
Party. "Control," as used in this Section 1.3 only, shall mean having the power
to direct, or cause the direction of, the management and policies of an entity,
whether through ownership of voting securities, by contract or otherwise.
1.4 "ANTI-CD20 ANTIBODY" shall mean:
(i) the B1 MURINE ANTIBODY or any derivative of the B1
MURINE ANTIBODY, including without limitation, any genetically engineered
construct of the B1 MURINE ANTIBODY;
(ii) any other anti-CD20 monoclonal antibody other than
the B1 MURINE ANTIBODY including, without limitation, human, humanized,
primatized, or chimerized antibody;
(iii) any [*] of (i) or (ii);
(iv) any [*] of (i) or (ii);
(v) any [*] of (i) or (ii);
(vi) any [*] of (i) or (ii);
(vii) any [*] (i) or (ii); and
(viii) any [*].
1.5 "B1 MURINE ANTIBODY" shall mean the unconjugated IgG2a anti-CD20
murine monoclonal antibody which is one of the active agents tested in the 004
TRIAL.
1.6 "BEXXAR" shall mean B1 MURINE ANTIBODY conjugated with 131Iodine or
unconjugated, depending upon context.
1.7 "BLA" shall mean a Biologics License Application, as defined by the
regulations promulgated under the United States FD&C ACT and PHS ACT and any
supplements thereunder, as amended from time to time.
1.8 "COMMERCIALLY REASONABLE EFFORTS" shall mean efforts and resources
normally used by a Party for a compound owned by it or to which it has rights,
which is of similar market
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
2.
16
potential at a similar stage in its product life, taking into account the [*],
the [*] of [*], the [*], the [*], and other relevant factors including, [*] or
[*].
1.9 "CONTROL" shall mean, except as otherwise provided in Section 1.3,
licensed or otherwise having rights to use, with the right to grant sublicenses,
as provided in this Agreement without violating the terms of any THIRD PARTY
agreement.
1.10 "CO-PROMOTION" shall mean the promotion, marketing and selling of
the PRODUCT, including, without limitation, the detailing of the PRODUCT to
physicians, jointly through the sales forces of Xxxxxxx and SB in TERRITORY A
under the TRADEMARK and REGULATORY APPROVAL held by Xxxxxxx.
1.11 "COST OF GOODS" shall mean the cost of UNCONJUGATED ANTIBODY or
RADIOLABELED ANTIBODY (in any form) sold and included in NET SALES or used in
DEVELOPMENT or MANUFACTURE DEVELOPMENT and shall be computed in accordance with
United States generally accepted accounting principles. COST OF GOODS shall
include, without limitation, but subject to Section 8.1:
(a) (i) in the case of UNCONJUGATED ANTIBODY or RADIOLABELED
ANTIBODY acquired from THIRD PARTIES, payments made by either Party to such
THIRD PARTIES in respect of such materials, including, but not limited to, [*]
the UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY, [*] payments, [*] payments
and [*] owed to such THIRD PARTIES, or
(ii) in the case of UNCONJUGATED ANTIBODY manufactured by
SB pursuant to an SB Supply Agreement (as defined in Section 9.6.1) which is
entered into by the Parties pursuant to Section 9.6.1, the amounts set forth on
the [*] attached to such SB Supply Agreement, or
(iii) in the case of UNCONJUGATED ANTIBODY or RADIOLABELED
ANTIBODY manufactured by Xxxxxxx pursuant to a Xxxxxxx Supply Agreement (as
defined in Section 9.6.2) which is entered into by the Parties pursuant to
Section 9.6.2, the amounts set forth on the [*] attached to such Xxxxxxx Supply
Agreement, plus
(b) QA/QC COSTS, plus
(c) EXISTING THIRD PARTY LICENSE COSTS and NEW THIRD PARTY
LICENSE COSTS, plus
(d) the cost of forward foreign currency contracts to protect
against risk of changes in foreign exchange rates, provided that such costs are
approved in advance by the Parties, plus
(e) the OUT-OF-POCKET COST of freight and tariffs associated with
transporting UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY from the source of
manufacture to the end
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
3.
17
user, inclusive of interim points of delivery, but excluding (i) any such costs
which are separately invoiced to a customer, [*] involved in the [*].
COST OF GOODS shall exclude [*], which shall be separately borne by the Parties.
COST OF GOODS shall also exclude [*] and [*], although [*] incurred in TERRITORY
A shall be included as an element of the JOINT P&L. Subject to Section 1.58, [*]
incurred outside of TERRITORY A shall be borne solely by [*].
In the event SB acquires UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY for
TERRITORY A from a THIRD PARTY [*] has [*] of at [*], and if [*] has a
reasonable good faith belief that [*] in the [*] THIRD PARTY, then [*] shall
[*], and the Parties shall promptly meet to discuss the situation in good faith
to determine whether or not [*] for [*] from the [*] to be agreed between the
Parties [*], if any, in the [*] THIRD PARTY. In the event Xxxxxxx acquires
UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY for TERRITORY A from a THIRD
PARTY [*] has [*] of at [*], and if [*] has a reasonable good faith belief that
[*] in the [*] THIRD PARTY, then [*], and the Parties shall promptly meet to
discuss the situation in good faith to determine whether or not [*] for [*] from
the [*] to be agreed between the Parties [*], if any, in the [*] THIRD PARTY.
1.12 "XXXXXXX PATENT RIGHTS" shall mean all PATENT RIGHTS owned or
CONTROLLED by Xxxxxxx as of the Effective Date or during the term of this
Agreement. A list of the XXXXXXX PATENT RIGHTS existing as of the date of mutual
execution of this Agreement is set out in Exhibit A hereto and will be updated
by Xxxxxxx on a semi-annual basis.
1.13 "CROSS-TERRITORY TRIALS" shall have the meaning set forth in
Section 3.2.3.
1.14 "DEVELOPMENT" shall mean the following activities related to
LICENSED COMPOUNDS or PRODUCTS within the FIELD performed in accordance with [*]
JOINT DEVELOPMENT PLAN or [*] and [*] the [*] JOINT DEVELOPMENT PLAN and related
to PLANNED CLINICAL TRIALS: (i) the pre-clinical development of a LICENSED
COMPOUND for use in the FIELD; (ii) the clinical development of a PRODUCT for
use in the FIELD through and including REGULATORY APPROVAL; (iii) regulatory
activities associated with seeking REGULATORY APPROVALS of PRODUCT; and (iv) any
post-REGULATORY APPROVAL clinical studies for label expansion or publication
purposes or required by regulatory authorities for the PRODUCT for use in the
FIELD, including Phase IV clinical studies. "DEVELOPMENT" shall not include any
activities included in the definition of "MANUFACTURE DEVELOPMENT".
1.15 "DEVELOPMENT COSTS" shall mean, subject to Section 8.1, the
following costs, to the extent incurred by a Party (i) in accordance with [*]
JOINT DEVELOPMENT PLAN, or (ii) reasonably incurred by a Party [*] and [*] the
[*] of such a plan, provided that any such DEVELOPMENT COSTS [*] a PLANNED
CLINICAL TRIAL or [*] a PLANNED CLINICAL TRIAL shall be approved in advance by
the co-chairpersons of the JDC:
(a) all OUT-OF-POCKET COSTS charged to the DEVELOPMENT of any
LICENSED COMPOUND or PRODUCT for use in the FIELD [*], including, but not
limited to, [*]; plus
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
4.
18
(b) an appropriate allowance of FTES as required to support the
activities outlined in Section 1.15(a), excluding, however, REGULATORY
PERSONNEL; plus
(c) COST OF GOODS for DEVELOPMENT incurred under Section 9.7.
1.16 "DISTRIBUTION COSTS" shall have the meaning set forth at Section
B.3.2 on Exhibit B-1.
1.17 "EUROPE" shall mean all countries and territories set forth on
Exhibit C.
1.18 "EUROPEAN FACILITY" shall have the meaning set forth in Section
9.10.1.
1.19 "EXISTING THIRD PARTY LICENSE" shall mean any of the following
agreements:
(i) Agreement between Xxxxxx Xxxxxx Cancer Institute and
Xxxxxxx Electronics, Inc., dated July 23, 1981.
(ii) Modification Agreement between Xxxx-Xxxxxx Cancer
Institute and Xxxxxxx Electronics, Inc., dated Xxxxx 0, 0000.
(xxx) License Agreement between Xxxx-Xxxxxx Cancer
Institute and Xxxxxxx Immunology, Division of Xxxxxxx Corporation, dated April
28, 1983.
(iv) Modification Agreement No. 2 between Xxxx-Xxxxxx
Cancer Institute and Xxxxxxx Immunology, Division of Xxxxxxx Corporation, dated
April 1, 1987.
(v) Agreement between Xxxxxxx Corporation and Xxxx-Xxxxxx
Cancer Institute, Inc., dated April 1, 1994.
(vi) Assignment Agreement among Xxxxxxx Pharmaceutical,
Inc., Xxxxxxx Corporation, InterWest Partners V, L.P. and InterWest Investors V,
dated February 24, 1995.
(vii) Commercialization Agreement between Xxxxxxx
Corporation and the Regents of the University of Michigan, dated November 1,
1994.
(viii) Amendment to Commercialization Agreement between
Xxxxxxx and the Regents of the University of Michigan, dated June 1, 1997.
(ix) Any amendment to (i) through (viii) executed by
Xxxxxxx prior to the Effective Date (as defined in Section 19.1) and disclosed
to SB prior to SB's acceptance or waiver of the conditions to effectiveness set
forth in Section 19.1.
Xxxxxxx agrees to provide SB with an update of this Section 1.19 as of the
Effective Date (as defined in Section 19.1).
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
5.
19
1.20 "EXISTING THIRD PARTY LICENSE COSTS" shall mean any amounts to be
paid by Xxxxxxx to a THIRD PARTY licensor under any EXISTING THIRD PARTY
LICENSE, to the extent such amounts (i) relate to LICENSED COMPOUND or PRODUCT,
and (ii) become payable after the Effective Date; provided, however, EXISTING
THIRD PARTY LICENSE COSTS shall exclude [*] and [*] which are [*] (which [*] and
[*] shall be [*] (a) in the event [*] the [*] of the [*] (or the [*] does [*] a
[*] of such [*,] or (b) in the event that [*] does [*] a [*] of [*].
1.21 "FD&C ACT" shall mean the United States Federal Food, Drug and
Cosmetic Act, as amended.
1.22 "FDA" shall mean the United States Food and Drug Administration or
its successor.
1.23 "FIELD" shall mean the treatment, prevention or palliation of any
indication in humans. [*] shall [*] of [*].
1.24 "FINANCE SUBTEAM" shall have the meaning set forth in Section 2.4.
1.25 "FIRST COMMERCIAL SALE" shall mean the first commercial sale of a
PRODUCT in a given jurisdiction after the PRODUCT has been granted REGULATORY
APPROVAL by the competent authorities in such jurisdiction.
1.26 "FIRST INDICATION" shall mean the label claim(s) which are approved
in the first REGULATORY APPROVAL for BEXXAR in a given jurisdiction, provided
that such claims are for a MAJOR INDICATION.
1.27 "FORCE MAJEURE OCCURRENCE" shall have the meaning set forth in
Article 12.
1.28 "FTE" shall mean a full-time equivalent professional employee of a
Party, other than a clerical, administrative assistant, or secretarial employee,
for whom reimbursement is to be paid under this Agreement at the applicable
rates set forth on Exhibit B-2. By way of example, (i) if an employee is a
full-time employee and spends one hundred percent (100%) of his or her time on
activities for which reimbursement is to be paid under this Agreement, such
employee shall count as one (1) FTE, and (ii) if an employee is a full-time
employee and spends forty percent (40%) of his or her time on activities for
which reimbursement is to be paid under this Agreement, such employee shall
count as four-tenths (0.4) of an FTE.
1.29 "GOOD CLINICAL PRACTICE" or "GCP" shall mean the then current
standards for clinical trials for pharmaceuticals, as set forth in (i) the FD&C
ACT and applicable regulations and guidances promulgated thereunder, including
without limitation the Code of Federal Regulations, as amended from time to time
and, as applicable, (ii) the rules and regulations of the International
Conference on Harmonization, and (iii) any other applicable requirements for
clinical trial activities under the laws, rules or regulations of TERRITORY A
and the other countries of the TERRITORY.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
6.
20
1.30 "GOOD LABORATORY PRACTICE" or "GLP" shall mean the then current
standards for laboratory activities for pharmaceuticals, as set forth in the
FD&C ACT and applicable regulations and guidances promulgated thereunder,
including without limitation the Code of Federal Regulations, as amended from
time to time, and subject to Section 9.14.2, any other applicable requirements
for laboratory activities under the laws, rules or regulations of TERRITORY A
and the other countries of the TERRITORY.
1.31 "GOOD MANUFACTURING PRACTICE" or "GMP" shall mean the current
standards for the manufacture of pharmaceuticals, as set forth in the FD&C ACT
and applicable regulations and guidances promulgated thereunder, including
without limitation the Code of Federal Regulations, as amended from time to
time, and subject to Section 9.14.2, any other applicable manufacturing
requirements under the laws, rules or regulations of TERRITORY A, such as the
Nuclear Regulatory Commission Guidelines, and the other countries of the
TERRITORY.
1.32 "GUARANTEED COGS PLUS ROYALTIES PERCENT" shall have the meaning set
forth in Section 7.2.5(c).
1.33 "GUARANTEED COGS TERRITORY" shall mean [*], as may be expanded in
accordance with Section 7.2.5(g).
1.34 "INTELLECTUAL PROPERTY RIGHTS" shall mean all PATENT RIGHTS,
copyrights, regulatory filings, KNOW-HOW and/or trade secrets, or any other
intellectual property other than trademarks, which are owned or CONTROLLED as of
the Effective Date or during the term of this Agreement by one Party hereto or
jointly by the Parties, with regard to the DEVELOPMENT, manufacture, importing,
use, marketing and/or sale of the PRODUCT. INTELLECTUAL PROPERTY RIGHTS shall
include any rights obtained by either Party from a THIRD PARTY license pursuant
to Section 5.3, subject to the terms and conditions of such license. The term
"INTELLECTUAL PROPERTY RIGHTS," however, shall not include PATENT RIGHTS,
copyrights, regulatory filings, KNOW-HOW and/or trade secrets, or any other
intellectual property of [*] for the [*] whether developed prior to or after the
Effective Date.
1.35 "INVENTION" shall mean an invention conceived or reduced to
practice in the course of or as a result of the performance of this Agreement by
an employee or agent of a Party. The term "INVENTION" however, shall not include
an invention conceived or reduced to practice in the course of or as a result of
the performance of this Agreement by an employee or agent of SB, other than
jointly with an employee or agent of Xxxxxxx, for the [*].
1.36 "JOINT COMMERCIALIZATION COMMITTEE" or "JCC" shall mean the
committee appointed by the Parties as set forth in Section 2.2.
1.37 "JOINT DEVELOPMENT COMMITTEE" or "JDC" shall mean the committee
appointed by the Parties as set forth in Section 2.1.
1.38 "JOINT DEVELOPMENT PLAN" shall be the then current plan and budget
which is described in Section 3.2.1 and approved in accordance with Section
3.2.1(c). The PLANNED
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
7.
21
CLINICAL TRIALS as of the Effective Date, which will be a part of the JOINT
DEVELOPMENT PLAN for BEXXAR, are attached hereto as Exhibit D.
1.39 "JOINT MANUFACTURE DEVELOPMENT PLAN" shall mean the then current
plan and budget which is described in Section 3.3.1 and approved in accordance
with Section 3.3.1(c).
1.40 "JOINT MARKETING PLAN" shall mean the then current plan and budget
which is described in Section 7.1.3 and approved in accordance therewith.
1.41 "JOINT P&L" shall have the meaning set forth in Section 7.1.14.
1.42 "KNOW-HOW" shall mean all know-how, including DEVELOPMENT,
MANUFACTURE DEVELOPMENT and commercialization data, processes and information,
including any copyright relating thereto, owned or CONTROLLED by either Party as
of the Effective Date or acquired during the term of this Agreement relating to:
(a) ANTI-CD20 ANTIBODY, including any LICENSED COMPOUND or
PRODUCT;
(b) any component of (a);
(c) any intermediate in the making of any of (a) or (b);
(d) methods of making any of (a), (b) or (c);
(e) any method of using any of (a), (b), or (c);
(f) any use of (a);
(g) any formulation or delivery system for (a); and/or
(h) any other data related to the development, manufacture,
marketing or sale of (a).
The term "KNOW-HOW," however, shall not include (i) any know-how,
processes, information and data which is, as of the Effective Date or becomes
later on, available to the public except by fault of the receiving Party, or
(ii) proprietary know-how of [*] for the [*] whether developed prior to or after
the Effective Date.
1.43 "LICENSED COMPOUND" shall mean BEXXAR and any SECOND GENERATION
LICENSED COMPOUNDS.
1.44 "LOAN AND SECURITY AGREEMENTS" shall mean the loan and security
agreements between the Parties described in Section 6.1.2(b).
1.45 "MAA" shall mean that regulatory application in the European
Community which is the equivalent of a BLA.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
8.
22
1.46 "MAJOR INDICATIONS" shall mean the following indications within the
FIELD:
(a) [*];
(b) [*];
(c) [*];
(d) [*];
(e) [*];
(f) [*]; and
(g) [*].
The MAJOR INDICATIONS set forth in (a)-(f) hereof may be treated [*].
1.47 "MAJOR MARKET COUNTRY" shall mean [*].
1.48 "MAJOR MARKETS IN TERRITORY C" shall have the meaning set forth in
Section 6.2.1(d).
1.49 "MANUFACTURE AND SUPPLY CHAIN SUBTEAM" shall mean the subteam
appointed by the Parties as set forth in Section 2.3.
1.50 "MANUFACTURE DEVELOPMENT" shall mean the following activities
related to LICENSED COMPOUNDS or PRODUCTS within the FIELD performed in
accordance with the then current JOINT MANUFACTURE DEVELOPMENT PLAN: (i) PRODUCT
improvement activities, such as reformulation, whether occurring before or after
REGULATORY APPROVAL; (ii) the development of manufacturing processes for the
UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY; including without limitation,
process development and optimization, manufacturing scale-up, validation,
qualification, and certification; (iii) the [*] or [*] of [*] or equipment for
the manufacture of UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY; and (iv) any
[*] associated with (i), (ii), and (iii) above. "MANUFACTURE DEVELOPMENT" shall
not include any activities included in the definition of "DEVELOPMENT".
1.51 "MANUFACTURE DEVELOPMENT COSTS" shall mean, subject to Section 8.1:
(i) the following costs to the extent incurred by a Party [*] and
[*] of [*] JOINT MANUFACTURE DEVELOPMENT PLAN: OUT-OF-POCKET COSTS (plus FTE
costs to the extent described in the last sentence of this subsection (i))
reasonably incurred by a Party [*] the [*] and directly related to:
(a) BLA preparation at the [*] manufacturing site,
(b) scale-up and BLA preparation at the [*] manufacturing
site,
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
9.
23
(c) qualification of the [*] at the [*] site, and
(d) [*] at [*],
provided that any particular MANUFACTURE DEVELOPMENT COSTS incurred under this
subsection (i)
(a) shall be in accordance with the forecast provided to SB in
the [*]
(b) any individual amount for a specific program or activity is
not in excess of [*] and
(c) the total OUT-OF-POCKET COSTS prior to the adoption of such
JOINT MANUFACTURE DEVELOPMENT PLAN shall not [*]
unless such amount has received the prior written approval of the
co-chairpersons of the JDC within ten (10) business days of presentation to such
co-chairpersons of a statement describing and requesting such expenditures. To
the extent there are FTE costs, excluding REGULATORY PERSONNEL, reasonably
incurred by a Party [*] to the [*] JOINT MANUFACTURE DEVELOPMENT PLAN in direct
support of the activities mentioned under this subsection (i), such FTE costs
shall be [*] to [*] based upon [*] upon the necessary FTEs required to perform
such work under the initial JOINT MANUFACTURE DEVELOPMENT PLAN; and
(ii) the following costs to the extent incurred in accordance
with [*] JOINT MANUFACTURE DEVELOPMENT PLAN:
(a) all OUT-OF-POCKET COSTS charged to the MANUFACTURE
DEVELOPMENT of any LICENSED COMPOUND or PRODUCT for use in the FIELD [*]; plus
(b) an appropriate allowance of FTES as required to
support the activities outlined in Section 1.51(ii)(a), excluding, however,
REGULATORY PERSONNEL.
To the extent [*] are included within MANUFACTURE DEVELOPMENT COSTS, such [*]
shall be allocated in the manner provided in Section 3.3.3.
1.52 "MARKETING COSTS" shall have the meaning set forth on Exhibit B-1,
subject to Section 8.1, to the extent incurred [*] and (i) in accordance with
the then current JOINT MARKETING PLAN, or (ii) reasonably incurred by a Party
prior to the adoption of such a plan, provided, however, that, under this clause
(ii), any individual amount for a specific program or activity shall not exceed
[*] and the total amounts spent prior to the adoption of such JOINT MARKETING
PLAN shall not exceed [*], each without the prior written approval of the
co-chairpersons of the JCC within ten (10) business days of presentation of a
statement to such co-chairpersons describing and requesting such expenditures.
1.53 "[*]" shall mean a [*] filed with the [*].
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
10.
24
1.54 "NET SALES" shall mean gross amounts invoiced for sales of the
PRODUCT in the FIELD in the relevant TERRITORY by either Party, its AFFILIATES
or sublicensees, as appropriate, to THIRD PARTIES, less the following items: (i)
trade, quantity and cash discounts or rebates actually allowed and taken and any
other adjustments, including, without limitation, those granted on account of
price adjustments, billing errors, rejected goods, damaged goods and recall
returns; (ii) credits, rebates, charge-back and prime vendor rebates, fees,
reimbursements or similar payments granted or given to wholesalers and other
distributors, buying groups, health care insurance carriers, pharmacy benefit
management companies, health maintenance organizations or other institutions or
health care organizations; (iii) any tax, tariff, customs duties, excise or
other duties or other governmental charge (other than an income tax) levied on
the sale, transportation or delivery of a PRODUCT and borne by the seller
thereof; (iv) payments or rebates paid in connection with sales of PRODUCTS to
any governmental or regulatory authority in respect of any state or federal
Medicare, Medicaid or similar programs; (v) any charge for freight, insurance or
other transportation costs charged to the customer; and (vi) any write-offs for
bad debt.
Sales of PRODUCT by and between a Party and its AFFILIATES are not sales to
THIRD PARTIES (except where such AFFILIATES are end users) and shall be excluded
from NET SALES calculations for all purposes. Notwithstanding the immediately
preceding sentence, it is understood that any transactions between SB or any of
its AFFILIATES or any of its or their sublicensees on the one hand and [*] on
the other hand will be deemed to be transactions with THIRD PARTIES for the
purposes of computing NET SALES, provided that the conditions of such sales to
[*], including any and all rebates and discounts allocated to transactions with
any such [*], shall be on an arms length basis and shall be fully deductible for
such computation purposes. In the event that any [*] type activity is within SB
or within any of its AFFILIATES or its or their sublicensees as only part of its
or their total activities rather than in a separate AFFILIATE, a notional NET
SALES figure will be calculated on an arms length basis to cover such
activities. [*] or [*] or [*] a [*] for or [*] including [*]. As of the
Effective Date, an [*] the [*] of [*], a [*] of [*] and [*] of [*].
1.55 "NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS" shall
have the meaning set forth in Section 9.3.
1.56 "NEW THIRD PARTY LICENSE" shall have the meaning set forth in
Section 5.3.2.
1.57 "NEW THIRD PARTY LICENSE COSTS" shall have the meaning set forth in
Section 5.3.3(d).
1.58 "NON-USA COGS" shall mean, for each country in the GUARANTEED COGS
TERRITORY:
(a) the COST OF GOODS for such country, plus
(b) SB's OUT-OF-POCKET COSTS of distributing PRODUCT in such
country not already included in Section 1.58(a); plus
(c) SB's OUT-OF-POCKET COST of [*] or [*] in [*].
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
11.
25
NON-USA COGS shall exclude any UNCONJUGATED ANTIBODY [*] provided that at the
time of shipping of such UNCONJUGATED ANTIBODY by Xxxxxxx or the THIRD PARTY
manufacturer to SB there is expiration dating approved by the relevant
regulatory authority remaining of not less than [*] for such UNCONJUGATED
ANTIBODY in [*], such expiration dating to be extended, as approved by the
relevant regulatory authorities, up to a maximum of [*] as real time data
becomes available.
1.59 "NON-USA MARKETING PLAN" shall mean that marketing plan which
relates to the commercialization of PRODUCT in the NON-USA TERRITORY as produced
by SB in accordance with SB's standard internal procedures.
1.60 "NON-USA TERRITORY" shall mean TERRITORY B and TERRITORY C.
1.61 "NORTH AMERICA" shall mean [*] TERRITORY A; [*].
1.62 "OPERATING PROFIT OR LOSS" shall have the meaning set forth on
Exhibit B-1.
1.63 "OTHER OPERATING INCOME/EXPENSE" shall have the meaning set forth
on Exhibit B-1.
1.64 "OUT-OF-POCKET COSTS" shall mean any out-of-pocket payment made by
a Party to a THIRD PARTY who is not an AFFILIATE of such Party but only to the
extent such payment relates to costs which are incurred by a Party [*] with
respect to DEVELOPMENT COSTS, MANUFACTURE DEVELOPMENT COSTS, or MARKETING COSTS,
or after the Effective Date with respect to all other out-of-pocket payments.
1.65 "PATENT COSTS" shall mean the OUT-OF-POCKET COSTS incurred after
the Effective Date in connection with the filing, prosecution and maintenance of
PATENT RIGHTS, as well as the costs of any patent interference, reexamination,
reissue, opposition and revocation proceedings in connection with PATENT RIGHTS.
PATENT COSTS shall also include those costs incurred by a Party under Sections
11.4 or 11.5 with respect to TERRITORY A.
1.66 "PATENT RIGHTS" shall mean all patents or patent applications,
throughout the relevant TERRITORY and all divisionals, continuations,
continuations-in-part, reissues, extensions, supplementary protection
certificates thereof, owned or CONTROLLED by a Party or the Parties and existing
as of the Effective Date or filed or issuing during the term of this Agreement,
at least one claim of which covers:
(a) an ANTI-CD20 ANTIBODY, including any LICENSED COMPOUND or
PRODUCT;
(b) any component of (a);
(c) any intermediate in the making of any of (a) or (b);
(d) methods of making any of (a), (b) or (c);
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
12.
26
(e) any method of using any of (a), (b), or (c);
(f) any use of (a);
(g) any formulation or delivery system for (a); and/or
(h) any other subject matter related to the development,
manufacture, formulation, use or sale of (a).
The term "PATENT RIGHTS" however shall not include [*] to the extent that they
cover [*] including, without limitation, [*] as a result of [*], other than [*],
related to [*].
1.67 "PHS ACT" shall mean the United States Public Health Service Act,
as amended.
1.68 "PLANNED CLINICAL TRIALS" shall mean those clinical trials of
BEXXAR which as of the Effective Date the Parties intend to complete or
undertake as part of the Development. A list and description of the PLANNED
CLINICAL TRIALS, as of the Effective Date, is attached hereto as Exhibit D. The
actual clinical trial program for PRODUCTS and budget therefor shall be defined
by the JOINT DEVELOPMENT COMMITTEE pursuant to the JOINT DEVELOPMENT PLAN
adopted from time to time in accordance with Section 3.2.1.
1.69 "PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS"
shall have the meaning set forth in Section 9.2.
1.70 "PRODUCT" shall mean any pharmaceutical PRODUCT containing a
LICENSED COMPOUND in any formulation or mode of administration.
1.71 "QA/QC COSTS" shall mean, subject to Section 8.1, OUT-OF-POCKET
COSTS and FTE costs of quality assurance and quality control work performed by
the Parties related to PRODUCT release and PRODUCT testing of the UNCONJUGATED
ANTIBODY and RADIOLABELED ANTIBODY determined in accordance with this Section
1.71, but only to the extent that such quality assurance and quality control
work is required by the FDA or other relevant regulatory authorities. QA/QC
COSTS shall include a reasonable allocation of Xxxxxxx'x facility overhead, but
shall exclude [*] or any [*]. QA/QC COSTS shall be calculated on the basis of a
cost per batch to be mutually agreed by the Parties to approximate the actual
cost of such work. In any event, QA/QC COSTS shall not exceed [*] of
UNCONJUGATED ANTIBODY [*] of RADIOLABELED ANTIBODY.
1.72 "RADIOLABELED ANTIBODY" shall mean (i) the B1 MURINE ANTIBODY
conjugated to (131)Iodine [*] or (ii) any SECOND GENERATION ANTIBODY conjugated
to (131)Iodine [*], in each case in finished pharmaceutical form, packaged for
use by the end user (or for delivery to a radiopharmacy, as the case may be).
1.73 "REGULATORY APPROVAL" shall mean all authorizations by governmental
authorities which are required for the marketing, promotion, pricing and sale of
the PRODUCT in a given country or regulatory jurisdiction, including all
manufacturing, pricing and reimbursement
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
13.
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approvals. If the PRODUCT is being sold commercially in a country (other than
under a treatment Investigational New Drug application, compassionate use
program or foreign equivalent) by a Party, REGULATORY APPROVAL shall be deemed
to have occurred in any event.
1.74 "REGULATORY PERSONNEL" shall mean any individual that is primarily
involved in the preparation, filing or maintenance of a regulatory filing or
maintenance of a REGULATORY APPROVAL or any aspect of adverse event reporting,
with respect to a LICENSED COMPOUND or PRODUCT.
1.75 "SALES COSTS" shall have the meaning set forth on Exhibit B-1.
1.76 "SALES EFFORT" shall have the meaning set forth in Section
7.1.6(a).
1.77 "SB OPTION EXERCISE NOTICE" shall have the meaning set forth in
Section 4.2.2(a).
1.78 "SB PATENT RIGHTS" shall mean all PATENT RIGHTS owned or CONTROLLED
by SB during the term of this Agreement. [*] of the [*]. As such SB PATENT
RIGHTS [*], they will be added to Exhibit E as such exhibit is updated, which
update shall be on a semi-annual basis.
1.79 "SECOND GENERATION ANTIBODY" shall mean the antibody component of a
SECOND GENERATION LICENSED COMPOUND.
1.80 "SECOND GENERATION ANTIBODY CANDIDATE" shall mean:
(i) any derivative of the B1 MURINE ANTIBODY, including
without limitation, any genetically engineered construct of the B1 MURINE
ANTIBODY;
(ii) any other anti-CD20 monoclonal antibody other than
the B1 MURINE ANTIBODY including, without limitation, human, humanized,
primatized, or chimerized antibody;
(iii) any [*] of (i) or (ii);
(iv) any [*] of (i) or (ii);
(v) any [*] of (i) or (ii);
(vi) any [*] of (i) or (ii);
(vii) any [*] of (i) or (ii); or
(viii) any [*].
1.81 "SECOND GENERATION LICENSED COMPOUND" shall mean a SECOND
GENERATION LICENSED COMPOUND CANDIDATE (i) for which SB has provided an SB
OPTION EXERCISE NOTICE
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
14.
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pursuant to Section 4.2.2(a) or (ii) which has become a SECOND GENERATION
LICENSED COMPOUND in accordance with Section 4.2.4(a)-(b).
1.82 "SECOND GENERATION LICENSED COMPOUND CANDIDATE" shall mean (i) an
unconjugated SECOND GENERATION ANTIBODY CANDIDATE; (ii) B1 MURINE ANTIBODY
conjugated to [*] (iii) a SECOND GENERATION ANTIBODY CANDIDATE conjugated to
[*]; or (iv) a SECOND GENERATION ANTIBODY CANDIDATE conjugated to [*].
1.83 "SECOND GENERATION LICENSED COMPOUND CANDIDATE DEVELOPMENT COSTS"
shall mean, subject to Section 8.1, the following costs incurred by a Party
after the Effective Date and prior to the date on which a given SECOND
GENERATION LICENSED COMPOUND CANDIDATE becomes a SECOND GENERATION LICENSED
COMPOUND (pursuant to Section 4.2.2(a), 4.2.4(a) or 4.2.4(b), as applicable):
(a) all OUT-OF-POCKET COSTS reasonably charged to the
pre-clinical and clinical development of a SECOND GENERATION LICENSED COMPOUND
CANDIDATE for use in the FIELD, including, but not limited to, [*]
(b) an appropriate allowance of FTES as required to support the
activities outlined in Section 1.83(a), excluding, however, REGULATORY
PERSONNEL; plus
(c) COST OF GOODS of such SECOND GENERATION LICENSED COMPOUND
CANDIDATE for such pre-clinical and clinical development.
To the extent practical, SECOND GENERATION LICENSED COMPOUND CANDIDATE
DEVELOPMENT COSTS shall be calculated in the same manner as DEVELOPMENT COSTS;
provided, however, that there shall be no requirement that SECOND GENERATION
LICENSED COMPOUND CANDIDATE DEVELOPMENT COSTS be incurred under a
mutually-agreed plan.
1.84 "SECOND GENERATION LICENSED COMPOUND CANDIDATE MANUFACTURE
DEVELOPMENT COSTS" shall mean, subject to Section 8.1, the following costs
incurred by a Party after the Effective Date and prior to the date on which a
given SECOND GENERATION LICENSED COMPOUND CANDIDATE becomes a SECOND GENERATION
LICENSED COMPOUND (pursuant to Section 4.2.2, 4.2.4(a) or 4.2.4(b), as
applicable):
(a) all OUT-OF-POCKET COSTS reasonably charged to the development
of manufacturing processes for a SECOND GENERATION LICENSED COMPOUND CANDIDATE
for use in the FIELD, including without limitation, [*] and [*]; plus
(b) an appropriate allowance of FTES as required to support the
activities outlined in Section 1.84(a), excluding, however, REGULATORY
PERSONNEL.
To the extent practical, SECOND GENERATION LICENSED COMPOUND CANDIDATE
MANUFACTURE DEVELOPMENT COSTS shall be calculated in the same manner as
MANUFACTURE DEVELOPMENT COSTS; provided, however, that there shall be no
requirement that SECOND
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
15.
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GENERATION LICENSED COMPOUND CANDIDATE MANUFACTURE DEVELOPMENT COSTS be incurred
under a mutually-agreed plan.
1.85 "SECOND INDICATION" shall mean label claim(s), other than FIRST
INDICATION label claim(s), which are approved in a REGULATORY APPROVAL received
for BEXXAR in a given jurisdiction subsequent to the REGULATORY APPROVAL for the
FIRST INDICATION, provided that such claims are for a MAJOR INDICATION.
1.86 "STOCK PURCHASE AGREEMENT" shall mean that agreement between the
Parties described in Section 6.1.2(a).
1.87 "TERM OF CO-PROMOTION" shall mean, with respect to each PRODUCT,
the period extending from FIRST COMMERCIAL SALE of such PRODUCT in TERRITORY A
until termination or expiration of this Agreement in accordance with the
provisions hereof or termination of CO-PROMOTION of such PRODUCT pursuant to
Section 7.1.15.
1.88 "TERRITORY" shall mean all countries and territories of the world
except for Japan (i.e., the sum of TERRITORY A, TERRITORY B and TERRITORY C).
1.89 "TERRITORY A" shall mean [*].
1.90 "TERRITORY B" shall mean [*].
1.91 "TERRITORY C" shall mean [*].
1.92 "THIRD INDICATION" shall mean label claim(s), other than FIRST
INDICATION label claim(s) and SECOND INDICATION label claim(s), which are
approved in a REGULATORY APPROVAL received for BEXXAR in a given jurisdiction
subsequent to the REGULATORY APPROVAL for the FIRST INDICATION and the
REGULATORY APPROVAL for the SECOND INDICATION, provided that such claims are for
a MAJOR INDICATION.
1.93 "THIRD PARTY(IES)" shall mean any person(s) or entity(ies) other
than Xxxxxxx, XX or their respective AFFILIATES for so long as they remain
AFFILIATES.
1.94 "TRADEMARK" shall mean the trademark(s) under which the PRODUCT
shall be marketed throughout the TERRITORY, as more fully described in Article
10, as well as logos and slogans.
1.95 "TRADEMARK COSTS" shall mean the fees and expenses paid to outside
legal counsel and experts, and creation, search, prosecution, registration and
maintenance expenses, incurred after the Effective Date, in connection with the
registration and maintenance of TRADEMARKS. TRADEMARK COSTS shall also include
costs incurred by a Party under Section 10.5.
1.96 "UNAFFILIATED EXPERT" shall mean an individual who (i) is not a
current employee or director of, or consultant to, one of the Parties or of an
entity which currently has a commercial alliance with one of the Parties, (ii)
has disclosed any previous affiliation with one of
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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the Parties of the type described in clause (i) of this Section 1.96, (iii) is
mutually acceptable to the Parties, and (iv) has suitable expertise on the topic
in question.
1.97 "UNCONJUGATED ANTIBODY" shall mean the unconjugated B1 MURINE
ANTIBODY and any unconjugated SECOND GENERATION ANTIBODY. Except as otherwise
specified in this Agreement, UNCONJUGATED ANTIBODY shall mean both bulk and
filled material.
ARTICLE 2
MANAGEMENT OF COLLABORATION
2.1 JOINT DEVELOPMENT COMMITTEE (JDC).
2.1.1 FORMATION; MEMBERSHIP. Within thirty (30) days after the
Effective Date, the Parties will establish a JOINT DEVELOPMENT COMMITTEE to
oversee and coordinate DEVELOPMENT and MANUFACTURE DEVELOPMENT of the PRODUCT in
the FIELD. The JDC shall be composed of [*] of representatives appointed by each
of Xxxxxxx and SB. The JDC shall initially have [*] representatives of each
Party, but the JDC may change its size from time to time by mutual consent of
its members. In addition, the co-chairpersons of the JCC shall be members of the
JDC. Each Party may replace its JDC representatives at any time upon written
notice to the other Party. Each Party's representatives on the JDC shall be [*]
of such Party with the authority to make decisions on behalf of such Party
within the constraints of necessary internal approvals which will have been
previously obtained and at least [*] of each Party's representatives will [*] or
above for such Party. Each Party will name, from among its [*] representatives,
a co-chairperson of the JDC. The co-chairpersons of the JDC shall be responsible
for the administration of meetings (e.g., calling meetings, preparing and
circulating an agenda in advance of each meeting, running the meetings and
preparing and issuing written minutes of each meeting within thirty (30) days
thereafter) but shall have no additional powers or rights other than those held
by virtue of being a representative on the JDC. Minutes of the JDC meetings
shall be promptly reviewed by both Parties, and shall be deemed approved when
mutually accepted by the Parties as evidenced in writing.
2.1.2 DECISION-MAKING. Decisions of the JDC shall be by [*], with
each Party having [*]. Should the members of the JDC [*] on an issue, then [*]
to [*] the issue shall be [*] and the [*]. In the event that the [*] and the [*]
are [*] on the issue, the Parties shall pursue a dispute resolution process
pursuant to Section 18.3.
2.1.3 MEETINGS. The JDC shall meet at least one (1) time per
calendar quarter during the term of this Agreement, unless otherwise mutually
agreed by the Parties. Meetings of the JDC will be held at facilities
alternately selected by Xxxxxxx and by SB. Meetings of the JDC may be held by
video or audio conference with the consent of each Party. Meetings of the JDC
shall be effective only if a representative of each Party is present or
participating. Each Party shall promptly report to the JDC on all material
issues relating to DEVELOPMENT and MANUFACTURE DEVELOPMENT. Each Party shall
bear all expenses it incurs in regard to participating in such meetings of the
JDC, including all travel and living expenses, and such
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
17.
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expenses shall not be included in the calculation of the JOINT P&L, COST OF
GOODS, DEVELOPMENT COSTS or MANUFACTURE DEVELOPMENT COSTS.
2.1.4 SPECIFIC RESPONSIBILITIES OF THE JDC. In addition to its
general responsibility to oversee, monitor, review, coordinate and provide
strategic direction to the DEVELOPMENT and MANUFACTURE DEVELOPMENT according to
the JOINT DEVELOPMENT PLAN and the JOINT MANUFACTURE DEVELOPMENT PLAN and to
ensure a regular flow of DEVELOPMENT and MANUFACTURE DEVELOPMENT information
among the Parties, the JDC shall in particular:
(i) develop, approve and monitor the JOINT
DEVELOPMENT PLAN in accordance with Sections 3.2.1(b), (c) and (d);
(ii) review, approve and monitor the JOINT
MANUFACTURE DEVELOPMENT PLAN in accordance with Sections 3.3.1(b), (c) and (d);
(iii) review, coordinate and approve [*],
including, but not limited to, [*] and [*] conducted with respect to the PRODUCT
in the FIELD throughout the TERRITORY (it being understood that, by entering
into this Agreement, the Parties hereby approve the [*] as outlined on [*] as of
such date, subject to subsequent changes in the [*] by the JOINT DEVELOPMENT
COMMITTEE in accordance with Section 3.2.1);
(iv) facilitate the flow of information between the
Parties with respect to all DEVELOPMENT or MANUFACTURE DEVELOPMENT work being
conducted in the FIELD anywhere in the TERRITORY;
(v) oversee, with the MANUFACTURE AND SUPPLY CHAIN
SUBTEAM, preparation of [*] of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY
for DEVELOPMENT and MANUFACTURE DEVELOPMENT activities in accordance with
Sections 9.12.1(a) and 9.12.2;
(vi) consider whether the PRODUCT [*], as more
fully discussed in [*], and when appropriate, approve [*] DEVELOPMENT and
MANUFACTURE DEVELOPMENT and reflect in the JOINT DEVELOPMENT PLAN and JOINT
MANUFACTURE DEVELOPMENT PLAN which [*] and which tasks associated with such [*]
shall be performed by each Party;
(vii) coordinate and approve strategy for all [*]
to be made with respect to PRODUCT throughout the TERRITORY and approve [*] in
TERRITORY A in accordance with Section 3.2;
(viii) subject to clause (iii) above regarding [*]
and Section 3.2.1(c), review and approve any decision to be made [*] with
respect to DEVELOPMENT of the PRODUCT in the FIELD in the NON-USA TERRITORY
which is reasonably likely to have [*] DEVELOPMENT or commercialization of the
PRODUCT in the FIELD in TERRITORY A;
(ix) oversee the MANUFACTURING AND SUPPLY CHAIN
SUBTEAM, to the extent described in Section 2.3;
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
18.
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(x) oversee the FINANCE SUBTEAM, to the extent
described in Section 2.4; and
(xi) perform any other responsibilities set forth
for the JDC in this Agreement.
2.2 JOINT COMMERCIALIZATION COMMITTEE (JCC).
2.2.1 FORMATION; MEMBERSHIP. Within thirty (30) days after the
Effective Date, the Parties will establish a JOINT COMMERCIALIZATION COMMITTEE
to oversee and coordinate the commercialization of the PRODUCT in the FIELD in
TERRITORY A and to perform those activities described in Section 2.2.4. The JCC
shall be composed of [*] of representatives appointed by each of Xxxxxxx and SB.
The JCC shall initially have [*] representatives of each Party, but the JCC may
change its size from time to time by mutual consent of its members. In addition,
the co-chairpersons of the JDC shall be members of the JCC. Each Party may
replace its JCC representatives at any time upon written notice to the other
Party. Each Party's representatives on the JCC shall be [*] of such Party with
the authority to make decisions on behalf of such Party within the constraints
of necessary internal approvals which will have been previously obtained and at
[*] of each Party's representatives will [*] or above for such Party. Each Party
will name, from among its [*] representatives, a co-chairperson of the JCC. The
co-chairpersons shall be responsible for the administration of meetings (e.g.,
calling meetings, preparing and circulating an agenda in advance of each
meeting, running the meetings and preparing and issuing written minutes of each
meeting within thirty (30) days thereafter) but shall have no additional powers
or rights other than those held by virtue of being a representative on the JCC;
provided, however, the co-chairpersons shall be authorized, between meetings of
the JCC, to make joint operational decisions as needed with respect to TERRITORY
A, consistent with the approved JOINT MARKETING PLAN. Minutes of the JCC
meetings shall be promptly reviewed and shall be deemed approved when mutually
accepted by the Parties as evidenced in writing.
2.2.2 DECISION-MAKING. Decisions of the JCC shall be [*], with
each Party having [*]. Should the members of the JCC [*] on an issue, then after
[*] to [*] the issue shall be [*] and the [*]. In the event the [*] and the [*]
are [*] on the issue, the Parties shall pursue a dispute resolution process
pursuant to Section 18.3.
2.2.3 MEETINGS. The JCC shall meet at least one (1) time per
calendar quarter during the term of this Agreement, unless otherwise mutually
agreed by the Parties. It is anticipated that, during certain time periods
(e.g., immediately before and immediately after commercial launch in TERRITORY
A), the JCC will meet more frequently than once per calendar quarter. Meetings
of the JCC will be held at facilities alternately selected by Xxxxxxx and by SB.
Meetings of the JCC may be held by video or audio conference with the consent of
each Party. Meetings of the JCC shall be effective only if a representative of
each Party is present or participating. Each Party shall promptly report to the
JCC on all material issues relating to the commercialization of PRODUCT. Each
Party shall bear all expenses it incurs in regard to participating in such
meetings of the JCC, including all travel and living expenses, and such
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
19.
33
expenses shall not be included in determining the JOINT P&L outlined in
Paragraph 7.1.14 or COST OF GOODS, DEVELOPMENT COSTS, or MANUFACTURE DEVELOPMENT
COSTS.
2.2.4 SPECIFIC RESPONSIBILITIES OF THE JCC. In addition to its
general responsibility to oversee, monitor, review, coordinate and provide
strategic direction to the commercialization of PRODUCT according to the JOINT
MARKETING PLAN and to ensure a regular flow of commercialization information
among the Parties, the JCC shall in particular:
(i) oversee and coordinate the activities of the
Parties in marketing, selling and distributing PRODUCT in TERRITORY A prior to
and following REGULATORY APPROVAL in TERRITORY A, including [*] and determining
the [*] of each Party in CO-PROMOTION of the PRODUCT, consistent with Article 7;
(ii) develop and approve the first JOINT MARKETING
PLAN (which shall [*] the [*] the [*] REGULATORY APPROVAL in TERRITORY A) in
accordance with Section 7.1.3(b), it being understood that such JOINT MARKETING
PLAN shall include at least the [*] described in Section 9.12;
(iii) develop and approve each subsequent JOINT
MARKETING Plan, in accordance with Section 7.1.3(b), the timing and structure of
such plan [*] for such development and approval, provided that such must occur
no less than [*];
(iv) monitor compliance with the JOINT MARKETING
PLAN and approve any changes to the JOINT MARKETING PLAN, in accordance with
Section 7.1.3(b);
(v) establish [*] of UNCONJUGATED ANTIBODY and
RADIOLABELED ANTIBODY for commercial sale in TERRITORY A, to be submitted to the
MANUFACTURE AND SUPPLY SUBTEAM pursuant to Section 9.12.1(b) and 9.12.2;
(vi) approve any contract by the Parties relating
to the commercialization of PRODUCT in TERRITORY A which is either (a) not
included in the JOINT MARKETING PLAN; or (b) is [*]; or (c) contains [*];
(vii) determine [*] sales force deployment by the
Parties and sales force strategy consistent with Article 7;
(viii) decide on PRODUCT pricing in TERRITORY A,
including [*], and matters related to [*], in accordance with Section 7.1.5;
(ix) oversee the MANUFACTURING AND SUPPLY CHAIN
SUBTEAM, to the extent described in Section 2.3;
(x) oversee the FINANCE SUBTEAM, to the extent
described in Section 2.4;
(xi) oversee matters related to the [*] TERRITORY
A;
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
20.
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(xii) oversee the development of procedures for the
handling of product complaints in accordance with Section 7.4; and
(xiii) perform any other responsibilities set forth
for the JCC in this Agreement.
2.3 MANUFACTURE AND SUPPLY CHAIN SUBTEAM.
2.3.1 FORMATION; MEMBERSHIP. Within thirty (30) days after the
Effective Date, the Parties will establish a "MANUFACTURE AND SUPPLY CHAIN
SUBTEAM" to oversee the logistics of the manufacture of PRODUCT, the supply and
distribution chain for PRODUCT and the MANUFACTURE DEVELOPMENT of the PRODUCT in
the FIELD. The MANUFACTURE AND SUPPLY CHAIN SUBTEAM shall be composed of [*] of
representatives appointed and replaced by each of Xxxxxxx and SB. Each Party
will name, from among its representatives, a co-chairperson of the MANUFACTURE
AND SUPPLY CHAIN SUBTEAM. The co-chairpersons of the MANUFACTURE AND SUPPLY
CHAIN SUBTEAM shall be responsible for the administration of meetings (e.g.,
calling meetings, preparing and circulating an agenda in advance of each
meeting, running the meetings and preparing and issuing written minutes of each
meeting within thirty (30) days thereafter) but shall have no additional powers
or rights other than those held by virtue of being a representative on the
MANUFACTURE AND SUPPLY CHAIN SUBTEAM. Minutes of the MANUFACTURE AND SUPPLY
CHAIN SUBTEAM meetings shall be promptly reviewed and shall be deemed approved
when mutually accepted by both Parties as evidenced in writing.
2.3.2 DECISION-MAKING. Decisions of the MANUFACTURE AND SUPPLY
CHAIN SUBTEAM shall be [*] with each Party having [*]. Should the members of the
MANUFACTURE AND SUPPLY CHAIN SUBTEAM [*] on an issue, then after [*] to [*] the
issue shall be presented to the JDC for matters relating to DEVELOPMENT or
MANUFACTURE DEVELOPMENT and to the JCC for matters relating to commercial supply
and all other matters.
2.3.3 MEETINGS. The MANUFACTURE AND SUPPLY CHAIN SUBTEAM shall
meet at such times as may be agreed to by the Parties, it being understood that
the MANUFACTURE AND SUPPLY CHAIN SUBTEAM will meet at least quarterly unless
otherwise agreed by the Parties. Meetings of the MANUFACTURE AND SUPPLY CHAIN
SUBTEAM will be held at facilities jointly selected by the Parties. Meetings of
the MANUFACTURE AND SUPPLY CHAIN SUBTEAM may be held by video or audio
conference with the consent of each Party. Meetings of the MANUFACTURE AND
SUPPLY CHAIN SUBTEAM shall be effective only if a representative of each Party
is present or participating. Each Party shall bear all expenses it incurs in
regard to participating in such meetings of the MANUFACTURE AND SUPPLY CHAIN
SUBTEAM, including all travel and living expenses, and such expenses shall not
be included in the calculation of COST OF GOODS, DEVELOPMENT COSTS, MANUFACTURE
DEVELOPMENT COSTS or included in the JOINT P&L.
2.3.4 SPECIFIC RESPONSIBILITIES OF THE MANUFACTURE AND SUPPLY
CHAIN SUBTEAM. In addition to its general responsibility to oversee the
logistics of the manufacturing of PRODUCT, the supply and distribution chain for
PRODUCT and the MANUFACTURE DEVELOPMENT of the PRODUCT in the FIELD, the
MANUFACTURE AND SUPPLY CHAIN SUBTEAM shall in particular:
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
21.
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(i) prepare, update and implement the JOINT
MANUFACTURE DEVELOPMENT PLAN, subject to the approval of the JDC (and the JCC,
to the extent the JOINT MANUFACTURE DEVELOPMENT PLAN includes elements related
to commercial supply), in accordance with Section 3.3.1;
(ii) report to the JDC on manufacture and supply
chain matters relating to DEVELOPMENT or MANUFACTURE DEVELOPMENT (excluding
commercial supply);
(iii) report to the JCC on manufacture and supply
chain matters relating to commercial supply in the TERRITORY and all other
manufacture and supply chain issues which do not relate to DEVELOPMENT or
MANUFACTURE DEVELOPMENT;
(iv) prepare an estimate of MANUFACTURE DEVELOPMENT
COSTS and QA/QC COSTS for submission to the FINANCE SUBTEAM;
(v) together with the JDC regarding supply for
DEVELOPMENT and MANUFACTURE DEVELOPMENT and the JCC regarding supply for
commercial sale, [*] UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY in the
event of [*] throughout the TERRITORY, pursuant to Section 9.5;
(vi) together with the JDC regarding supply for
DEVELOPMENT and MANUFACTURE DEVELOPMENT and the JCC regarding supply for
commercial sale, oversee the preparation of forecasts pursuant to Sections
9.12.1 and 9.12.2; and
(vii) perform any other responsibilities set forth
for the MANUFACTURE AND SUPPLY CHAIN SUBTEAM in this Agreement.
2.4 FINANCE SUBTEAM.
2.4.1 FORMATION; MEMBERSHIP. Within thirty (30) days after the
Effective Date, the Parties will establish a "FINANCE SUBTEAM" which shall be
composed of as many representatives as each of Xxxxxxx and SB shall deem to be
necessary. Each Party will name, from among its representatives, a
co-chairperson of the FINANCE SUBTEAM. The co-chairpersons of the FINANCE
SUBTEAM shall be responsible for the administration of meetings (e.g., calling
meetings, preparing and circulating an agenda in advance of each meeting,
running the meetings and preparing and issuing written minutes of each meeting
within thirty (30) days thereafter) but shall have no additional powers or
rights other than those held by virtue of being a representative on the FINANCE
SUBTEAM.
2.4.2 MEETINGS. The FINANCE SUBTEAM shall meet at such times as
may be agreed to by the members of the FINANCE SUBTEAM. Meetings of the FINANCE
SUBTEAM may be held by video or audio conference or at facilities selected by
the members of the FINANCE SUBTEAM. Meetings of the FINANCE SUBTEAM shall be
effective only if a representative of each Party is present or participating.
Each Party shall bear all expenses it incurs in regard to participating in such
meetings of the FINANCE SUBTEAM, including all travel and living expenses,
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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and such expenses shall not be included in the calculation of COST OF GOODS,
DEVELOPMENT COSTS, MANUFACTURE DEVELOPMENT COSTS or included in the JOINT P&L.
2.4.3 RESPONSIBILITIES OF THE FINANCE SUBTEAM. The
responsibilities of the FINANCE SUBTEAM shall include, without limitation, (i)
overseeing the estimation of DEVELOPMENT COSTS, MANUFACTURE DEVELOPMENT COSTS
and [*] under the JOINT P&L, consistent with the terms of this Agreement and
subject to necessary approvals by the JDC and JCC; (ii) developing, if possible,
and approving a strategy regarding [*], (iii) any other responsibilities set
forth for the FINANCE SUBTEAM in this Agreement, and (iv) to the extent
determined to be necessary by the members of the FINANCE SUBTEAM, reporting to:
(a) the JDC on financial matters relating to DEVELOPMENT
or MANUFACTURE DEVELOPMENT in the TERRITORY;
(b) the JCC on financial matters relating to commercial
sale in TERRITORY A and all other financial issues in TERRITORY A which do not
relate to DEVELOPMENT or MANUFACTURE DEVELOPMENT; and
(c) the Parties on financial matters relating to
commercial sale outside of TERRITORY A and all other financial issues outside of
TERRITORY A which do not relate to DEVELOPMENT or MANUFACTURE DEVELOPMENT.
ARTICLE 3
DEVELOPMENT OF LICENSED COMPOUND
3.1 INITIAL AND SUBSEQUENT FOCUS OF THE COLLABORATION. The initial focus
of the collaboration will be on manufacturing, developing, supplying, and
commercializing BEXXAR for the treatment of non-Hodgkin's lymphoma in those
MAJOR INDICATIONS outlined in Sections 1.46 [*]. During the term of this
Agreement, the JDC will consider, and approve as it deems appropriate, whether
the Parties should also pursue the manufacture, development, supply, and
commercialization of BEXXAR for the additional MAJOR INDICATIONS not discussed
in the preceding sentence (i.e., those outlined in Sections 1.46 [*]) or for
[*]. In addition, in the event either Party exercises its option as provided in
Sections 4.2.2 and 4.2.4 to manufacture, develop, supply, and commercialize one
or more particular SECOND GENERATION LICENSED COMPOUNDS, the Parties will pursue
manufacture, development, supply, and commercialization of such SECOND
GENERATION LICENSED COMPOUNDS in the FIELD in accordance with Sections 4.2.2 and
4.2.5.
3.2 DEVELOPMENT.
3.2.1 JOINT DEVELOPMENT PLAN.
(a) PURPOSE OF JOINT DEVELOPMENT PLAN. The DEVELOPMENT of
the PRODUCT will be governed by a "JOINT DEVELOPMENT PLAN". The JOINT
DEVELOPMENT PLAN will attempt, to the extent practicable, to describe the plan
and budget for DEVELOPMENT of the
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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PRODUCT throughout the TERRITORY, including overall DEVELOPMENT strategy,
operating guidelines and estimated filing dates, guidelines for filing for
REGULATORY APPROVAL, any clinical studies to be conducted and forecasts of
UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY for clinical supply or other
DEVELOPMENT requirements.
(b) PREPARATION OF JOINT DEVELOPMENT PLAN. A draft of the
initial JOINT DEVELOPMENT PLAN will be prepared by the Parties, in accordance
with the allocation of responsibilities set forth in this Section 3.2.1(b), no
later than one hundred twenty (120) days after the Effective Date. Thereafter,
an updated JOINT DEVELOPMENT PLAN will be drafted and presented to the JDC at
such times as the JDC deems appropriate, but no less frequently than annually.
[*] will draft that portion of the initial JOINT DEVELOPMENT PLAN and that
portion of each annual update of the JOINT DEVELOPMENT PLAN which covers
activities, [*] that relate to DEVELOPMENT for purposes of receiving REGULATORY
APPROVAL in TERRITORY A only. [*] will draft that portion of the initial JOINT
DEVELOPMENT PLAN and that portion of each annual update of the JOINT DEVELOPMENT
PLAN which covers activities, including [*], that relate to DEVELOPMENT for
purposes of receiving REGULATORY APPROVAL in the [*].
(c) REVIEW AND APPROVAL OF JOINT DEVELOPMENT PLAN. The JDC
will review the initial JOINT DEVELOPMENT PLAN and each update thereto and will
amend such plan as required to achieve approval by the JDC no later than sixty
(60) days after submission of the drafts prepared by the Parties pursuant to
Section 3.2.1(b). With respect to the approval of the Non-USA Territory Portion,
Xxxxxxx, through the JDC, will not withhold its approval of those parts of the
Non-USA Territory Portion which are not reasonably likely to have a material
effect on DEVELOPMENT or commercialization of PRODUCT in TERRITORY A. When
considering the components of the then current JOINT DEVELOPMENT PLAN, the JDC
will give strong consideration to the specific regulatory and market needs in
each country of the TERRITORY consistent with each Party's employment of
COMMERCIALLY REASONABLE EFFORTS with respect to such country.
(d) MONITORING OF JOINT DEVELOPMENT PLAN. The JDC will
monitor implementation of the initial JOINT DEVELOPMENT PLAN and each update
thereto. With respect to monitoring implementation of those parts of the Non-USA
Territory Portion which are not reasonably likely to have a material effect on
DEVELOPMENT or commercialization of PRODUCT in TERRITORY A, the SB
representatives on the JDC will be responsible for such monitoring, but will
report to Xxxxxxx'x representative on the JDC regarding the results of such
monitoring, if reasonably requested by Xxxxxxx.
3.2.2 IMPLEMENTATION OF DEVELOPMENT.
(a) In TERRITORY A, the JDC shall determine those
operational areas relating to the DEVELOPMENT for which each Party is
responsible (e.g., those clinical trials for which Xxxxxxx will have
responsibility and those for which SB will have responsibility [*]), consistent
with the then current JOINT DEVELOPMENT PLAN and the PLANNED CLINICAL TRIALS.
The Parties agree that Xxxxxxx will have responsibility for conducting the
PLANNED CLINICAL TRIALS in TERRITORY A, unless otherwise agreed by the JDC. A
Party which has responsibility for a particular operational area relating to the
DEVELOPMENT in TERRITORY A shall make and
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
24.
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implement any decisions involving such operational area ("Development
Operational Decisions"), provided that such Development Operational Decisions
and implementation thereof are consistent with the terms of this Agreement, the
then current JOINT DEVELOPMENT PLAN, any direction provided by the JDC and
Sections 3.2.2(b) and (c).
(b) Any Development Operational Decisions made by Xxxxxxx
in TERRITORY A relating to the following shall be [*] the JDC, subject to
ratification by the JDC at the next meeting of the JDC:
(i) the review of [*] to make sure that
appropriate [*] are included;
(ii) [*] to specific investigators;
(iii) determination of [*] the PRODUCT which will
be [*], and
(iv) approval of any [*] and [*] thereto.
(c) Any Development Operational Decisions made by SB in
TERRITORY A relating to the following shall be approved in advance by [*] JDC,
subject to ratification by the JDC at the next meeting of the JDC:
(i) the review of selected [*] to make sure that
[*] are included;
(ii) [*] to specific investigators;
(iii) determination of [*] the PRODUCT which will
be [*]; and
(iv) approval of any [*] and [*] thereto.
(d) The list of Development Operational Decisions set
forth in Sections 3.2.2(b) and 3.2.2(c) may be expanded or reduced as determined
by the JDC.
(e) DEVELOPMENT in the NON-USA TERRITORY shall be
conducted by the Parties as described in Sections 3.2.4(b).
(f) Each Party agrees to use its respective COMMERCIALLY
REASONABLE EFFORTS to conduct the DEVELOPMENT with the intent of obtaining
REGULATORY APPROVAL in TERRITORY A and in the NON-USA TERRITORY and bringing a
PRODUCT to market in the FIELD in the TERRITORY. Neither Party shall subcontract
any of its DEVELOPMENT obligations hereunder anywhere in the TERRITORY without
the prior approval of the JDC or co-chairpersons of the JDC.
3.2.3 DESIGNATION OF CLINICAL TRIALS. After the Effective Date,
at the time the JDC approves a clinical trial, other than a PLANNED CLINICAL
TRIAL, pursuant to Section 2.1.4(iii), (each newly approved clinical trial to be
known as a "Future Clinical Trial"), it shall decide whether the results of such
Future Clinical Trial are most likely to be used primarily in (i)
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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TERRITORY A only ("Territory A Trials"), (ii) the NON-USA TERRITORY only
("Non-USA Territory Trials") or (iii) both TERRITORY A and the NON-USA TERRITORY
("Cross-Territory Trials"), and shall designate such Future Clinical Trial
accordingly. [*] will have the [*] of [*] the [*] as [*]. The Parties have
agreed that [*].
3.2.4 LEAD PARTY FOR DEVELOPMENT.
(a) TERRITORY X. Xxxxxxx shall be the lead Party for
implementation of the DEVELOPMENT conducted in TERRITORY A, consistent with the
terms of this Agreement, the then current JOINT DEVELOPMENT PLAN and any
direction provided by the JDC. Such DEVELOPMENT work in TERRITORY A shall
include without limitation, PLANNED CLINICAL TRIALS, Territory A Trials (as
defined in Section 3.2.3), and Cross-Territory Trials (as defined in Section
3.2.3).
(b) NON-USA TERRITORY.
(i) Initially, Xxxxxxx will be the lead Party for
implementation of the DEVELOPMENT conducted in the NON-USA TERRITORY, subject to
the terms of this Section 3.2.4 and consistent with the terms of this Agreement,
the then current JOINT DEVELOPMENT PLAN and any prior direction provided by the
JDC. Such DEVELOPMENT work shall include without limitation, PLANNED CLINICAL
TRIALS and Cross-Territory Trials (as defined in Section 3.2.3) that are
approved in the then current JOINT DEVELOPMENT PLAN. SB will provide [*] FTE
assistance to Xxxxxxx in performing clinical trials or other Development work in
the NON-USA TERRITORY as identified in the JOINT DEVELOPMENT PLAN and agreed by
the JDC. Except [*], all FTE support provided by SB in connection with
DEVELOPMENT in the NON-USA TERRITORY shall be provided at [*] expense, [*].
Xxxxxxx shall not be responsible for delays in DEVELOPMENT in the NON-USA
TERRITORY arising from [*] in the NON-USA TERRITORY in accordance with the then
current JOINT DEVELOPMENT PLAN.
(ii) [*], SB will become the lead Party for
implementation of the DEVELOPMENT conducted in the NON-USA TERRITORY consistent
with the terms of this Agreement, the then current JOINT DEVELOPMENT PLAN and
any direction provided by the JDC, [*] for the [*]. If SB assumes the role of
lead Party for DEVELOPMENT in the NON-USA Territory [*], SB shall [*] the [*],
on the [*] with respect to [*].
(iii) At all times, regardless of which Party is
the lead Party for implementation of the DEVELOPMENT in the NON-USA TERRITORY,
SB shall be responsible for all regulatory work in the NON-USA TERRITORY,
including without limitation obtaining necessary approvals for all clinical
trial protocols, reporting on adverse events (subject to Section 7.6) and
managing other communications with regulatory authorities. In addition, SB shall
be at all times responsible for all Non-USA Territory Trials (as defined in
Section 3.2.3). Xxxxxxx will provide assistance to SB as reasonably requested by
SB in conducting such Non-USA Territory Trials and [*] and [*]. SB shall inform
the JDC of any significant decisions made by SB or its permitted sublicensees
regarding implementation of the then current JOINT DEVELOPMENT PLAN relating to
the NON-USA TERRITORY sufficiently in advance of such implementation to enable
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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Xxxxxxx to comment upon such decisions, and SB shall take such comments into
serious consideration but shall not be bound by them.
3.2.5 DEVELOPMENT DILIGENCE MILESTONES IN NON-USA TERRITORY.
(a) DEVELOPMENT DILIGENCE MILESTONES IN THE MAJOR MARKET
Countries. SB shall seek to file an MAA and an NDS for BEXXAR for the FIRST
INDICATION by a date no later than [*] after the BLA for BEXXAR for the FIRST
INDICATION has been accepted for review by the FDA in TERRITORY A, provided that
each such date shall be extended as required to account for delays which are
beyond SB's reasonable control, including, without limitation, [*].
(b) FAILURE TO ACHIEVE MILESTONES. In the event SB
determines that it will be unable to achieve a given milestone by [*] (the
"Milestone Achievement Date"), either because such date has occurred or because
it is reasonably apparent to SB that it will not be able to achieve such
milestone by the Milestone Achievement Date, SB shall notify Xxxxxxx within
thirty (30) days of such determination and the JDC shall meet promptly to work
out a plan (the "Milestone Achievement Plan") designed to allow SB to meet such
milestone in the given territory [*] of the Milestone Achievement Date, subject
to any extension to such date that may be permitted as outlined in [*]. In the
event SB is unable to meet such milestone in such territory within such [*] but
has made good faith efforts to do so consistent with the Milestone Achievement
Plan, provided that such date shall be extended as required to account for
delays which are beyond SB's reasonable control, the JDC shall meet promptly
after the end of such [*] period to work out an extended plan (the "Extended
Milestone Achievement Plan") designed to allow SB to meet such milestone in the
given territory within [*] of the Milestone Achievement Date, provided that such
date shall be extended as required to account for delays which are beyond SB's
reasonable control. In the event SB (i) has not made good faith efforts to meet
a milestone within [*] under the Milestone Achievement Plan in a given MAJOR
MARKET COUNTRY, subject to any extension permitted under Section 3.2.5(a) or
(ii) is unable to meet a milestone for any reason within [*] of the Milestone
Achievement Date under the Extended Milestone Achievement Plan in such MAJOR
MARKET COUNTRY, subject to any extension permitted under [*], the licenses
granted by Xxxxxxx under this Agreement shall be automatically adjusted to
exclude the MAJOR MARKET COUNTRY in which such milestone was not achieved and
the terms of Section 13.4 shall apply for such MAJOR MARKET COUNTRY.
3.2.6 FUNDING OF DEVELOPMENT. [*] shall bear the cost of [*] and
[*] aggregate [*] (including, without limitation, [*] related to [*]) [*],
provided that it is understood that no expenses of [*] shall be [*] used to [*]
unless [*] are [*] or are within [*]. [*].
(a) [*] shall be [*] and handled as set forth in [*]; and
(b) DEVELOPMENT COSTS shall be shared by the Parties as
follows:
(i) SB will bear the SB Share of Development Costs
(as defined below) and Xxxxxxx will bear the Xxxxxxx Share of Development Costs
(as defined below). [*]. No expenses of a Party shall be included within
DEVELOPMENT COSTS except as provided in Section 1.15.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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(ii) The Parties agree that:
(1) "SB Share of Development Costs" shall
equal A + B + C, where
A = [*] multiplied by all DEVELOPMENT COSTS
associated with Cross-Territory Trials (as defined
in Section 3.2.3) incurred [*]; and
B = [*] multiplied by all DEVELOPMENT COSTS
associated with Territory A Trials (as defined in
Section 3.2.3) and incurred [*]; and
C = [*] multiplied by all DEVELOPMENT COSTS
associated with Non-USA Territory Trials (as
defined in Section 3.2.3) and incurred after
October 1, 1998.
(2) "Xxxxxxx Share of Development Costs"
shall equal D + E, where
D = [*] multiplied by all DEVELOPMENT COSTS
associated with all Cross-Territory Trials (as
defined in Section 3.2.3) incurred [*]; and
E = [*] multiplied by all DEVELOPMENT COSTS
associated with Territory A Trials (as defined in
Section 3.2.3) incurred [*].
(3) Notwithstanding the foregoing, in the
event that the JDC uses data from a Non-USA Territory Trial to support a
regulatory filing to demonstrate the efficacy of the PRODUCT regarding a
previously unapproved indication for purposes of label expansion in TERRITORY A,
then upon the date of filing for such label expansion in TERRITORY A, Xxxxxxx
shall reimburse to SB [*] of the costs of such Non-USA Territory Trial even if
such filing [*]; provided, however, that the amount of such payment by Xxxxxxx
shall be included in [*] used to [*]. Further, in the event that SB uses data
from a Territory A Trial to demonstrate the efficacy of the PRODUCT regarding a
previously unapproved indication for purposes of label expansion in the NON-USA
TERRITORY, then upon the date of filing for such label expansion in the NON-USA
TERRITORY, SB shall reimburse to Xxxxxxx [*] of the costs of such Territory A
Trial (i.e., [*] from [*]).
(iii) No later than thirty (30) days after the end
of each calendar quarter, each Party shall submit to the FINANCE SUBTEAM an
accounting of all DEVELOPMENT COSTS incurred by such Party during such quarter.
The FINANCE SUBTEAM shall promptly calculate whether any payments are due from
one Party to the other Party under this Section. In the event such payment is
due, the Party which owes the payment shall make such payment to the other Party
within thirty (30) days after it has received such a determination, in writing,
from the FINANCE SUBTEAM. The Party receiving the payment shall issue an invoice
to the Party making the payment which invoice shall be in the amount to be paid.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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(c) Notwithstanding Section 3.2.4(b)(i) and Section
3.2.6(a), in the event that the actual FTE assistance provided to Xxxxxxx by SB
to support Cross-Territory Trials exceeds the FTE amounts set forth in the
initial JOINT DEVELOPMENT PLAN approved by the JDC by greater than [*], then the
total amount of such additional FTE assistance in excess of such approved
amount, to the extent approved by the JDC, [*].
3.3 MANUFACTURE DEVELOPMENT.
3.3.1 JOINT MANUFACTURE DEVELOPMENT PLAN.
(a) PURPOSE OF JOINT MANUFACTURE DEVELOPMENT PLAN. The
MANUFACTURE DEVELOPMENT of the PRODUCT will be governed by a "JOINT MANUFACTURE
DEVELOPMENT PLAN." The JOINT MANUFACTURE DEVELOPMENT PLAN will attempt, to the
extent practicable, to describe the plan and budget for the MANUFACTURE
DEVELOPMENT of the PRODUCT throughout the TERRITORY, including without
limitation, process development and optimization, manufacturing scale-up,
validation, qualification, and certification, [*] equipment for the manufacture
of UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY.
(b) PREPARATION OF JOINT MANUFACTURE DEVELOPMENT PLAN. A
draft of the initial JOINT MANUFACTURE DEVELOPMENT PLAN will be prepared and
approved by the MANUFACTURE AND SUPPLY CHAIN SUBTEAM pursuant to Section
2.3.4(i), no later than ninety (90) days after the Effective Date. Thereafter,
an updated JOINT MANUFACTURE DEVELOPMENT PLAN will be drafted and presented to
the JDC (and the JCC, to the extent such JOINT MANUFACTURE DEVELOPMENT PLAN
includes elements related to commercial supply) at such times as the JDC and/or
JCC, as applicable, deems appropriate, but no less frequently than annually.
(c) REVIEW AND APPROVAL OF JOINT MANUFACTURE DEVELOPMENT
PLAN. The JDC (and the JCC, to the extent such JOINT MANUFACTURE DEVELOPMENT
PLAN includes elements related to commercial supply) will review the initial
JOINT MANUFACTURE DEVELOPMENT PLAN and each update thereto and will amend such
plan as required to achieve approval by the JDC (and the JCC, to the extent such
JOINT MANUFACTURE DEVELOPMENT PLAN includes elements related to commercial
supply) no later than seventy-five (75) days after submission of the drafts
prepared by the MANUFACTURE AND SUPPLY CHAIN SUBTEAM pursuant to Section
3.3.1(b). When considering the components of the then current JOINT MANUFACTURE
DEVELOPMENT PLAN, the JDC will give strong consideration to the specific
regulatory and market needs in each country of the TERRITORY consistent with
each Party's employment of COMMERCIALLY REASONABLE EFFORTS with respect to such
country.
(d) MONITORING OF JOINT MANUFACTURE DEVELOPMENT PLAN. The
JDC will monitor implementation of the initial JOINT MANUFACTURE DEVELOPMENT
PLAN and each update thereto. With respect to monitoring implementation of those
parts of the JOINT MANUFACTURE DEVELOPMENT PLAN relating to the NON-USA
TERRITORY which are not reasonably likely to have a material effect on
DEVELOPMENT or commercialization of PRODUCT in TERRITORY A, the SB
representatives on the JDC will be responsible for such monitoring, but will
report to Xxxxxxx'x representative on the JDC regarding the results of such
monitoring, if reasonably requested by Xxxxxxx.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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(e) INTERNAL APPROVALS. Each Party shall endeavor to
obtain all necessary internal approvals for capital expenditures in a manner
that supports the timely implementation of the JOINT DEVELOPMENT PLAN and the
JOINT MANUFACTURE DEVELOPMENT PLAN and so as not to delay PRODUCT regulatory
filings and the PRODUCT timelines in accordance with its internal procedures
normally employed for such matters and in accordance with its COMMERCIALLY
REASONABLE EFFORTS. Notwithstanding the above, each Party shall only be liable
to make [*] in accordance with the then approved JOINT MANUFACTURE DEVELOPMENT
PLAN, or in accordance with the approved expenses outlined in Section 1.51(i).
3.3.2 LEAD PARTY FOR MANUFACTURE DEVELOPMENT.
(a) UNCONJUGATED ANTIBODY MANUFACTURE DEVELOPMENT. [*]
will take the lead with respect to the MANUFACTURE DEVELOPMENT of UNCONJUGATED
ANTIBODY unless [*], at which [*]. The JDC can adjust the responsibilities of
the Parties with respect to the MANUFACTURE DEVELOPMENT of UNCONJUGATED ANTIBODY
as it deems appropriate.
(b) RADIOLABELED ANTIBODY MANUFACTURE DEVELOPMENT. [*]
will take the lead with respect to the MANUFACTURE DEVELOPMENT of any
RADIOLABELED ANTIBODY to the extent that such occurs in connection with [*]
otherwise for supply in TERRITORY A. [*] will take the lead with respect to the
MANUFACTURE DEVELOPMENT of any RADIOLABELED ANTIBODY to the extent that such
occurs in connection with a EUROPEAN FACILITY (as defined in Section 9.10.1)
other than [*]. The JDC (based on the recommendation of the MANUFACTURING AND
SUPPLY CHAIN SUBTEAM) will determine which Party shall take the lead on any
other activities related to the MANUFACTURE DEVELOPMENT of any RADIOLABELED
ANTIBODY. Further, the JDC can adjust the responsibilities of the Parties with
respect to the MANUFACTURE DEVELOPMENT of RADIOLABELED ANTIBODY as it deems
appropriate.
3.3.3 FUNDING OF MANUFACTURE DEVELOPMENT
(a) CAPITAL AND NON-CAPITAL EXPENDITURES
(i) Any MANUFACTURE DEVELOPMENT COSTS which are
incurred by either Party with respect to activities related solely to TERRITORY
A shall be borne [*].
(ii) Any MANUFACTURE DEVELOPMENT COSTS which are
incurred by either Party with respect to activities related solely to outside of
TERRITORY A shall be borne [*].
(iii) Any MANUFACTURE DEVELOPMENT COSTS which are
incurred by either Party with respect to activities both inside and outside of
TERRITORY A shall be borne [*].
(iv) No later than thirty (30) days after the end
of each calendar quarter, each Party shall submit to the FINANCE SUBTEAM
established by Section 2.4 an accounting of all MANUFACTURING DEVELOPMENT COSTS
incurred by such Party during such quarter. The FINANCE SUBTEAM shall promptly
calculate whether any payments are due from one
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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Party to the other Party under this Section. In the event such payment is due,
the Party which owes the payment shall make such payment to the other Party
within thirty (30) days after it has received such a determination, in writing,
from the FINANCE SUBTEAM. The Party receiving the payment shall issue an invoice
to the Party making the payment which invoice shall be in the amount to be paid.
(b) ECONOMIC INTEREST IN CAPITAL EXPENDITURES.
(i) Xxxxxxx [*] SB shall have [*] in any fixed
assets derived from such MANUFACTURE DEVELOPMENT COSTS incurred under Section
3.3.3(a)(i), in accordance with mechanisms to be agreed by the Parties.
(ii) SB [*] any fixed assets derived from
MANUFACTURE DEVELOPMENT COSTS incurred under Section 3.3.3(a)(ii).
(iii) Xxxxxxx [*] SB shall have [*] in any fixed
assets derived from such MANUFACTURE DEVELOPMENT COSTS incurred jointly under
Section 3.3.3(a)(iii) in the [*], such economic interest to be structured in
accordance with mechanisms to be agreed by the Parties.
3.4 RECORDS, REPORTS AND INFORMATION EXCHANGE.
3.4.1 TECHNOLOGY AND INFORMATION TRANSFER. Following the
Effective Date, Xxxxxxx will promptly provide to SB all KNOW-HOW and other
information, including, but not limited to, preclinical and clinical data, as SB
reasonably deems necessary to enable it to carry out the DEVELOPMENT and
MANUFACTURE DEVELOPMENT of LICENSED COMPOUND and PRODUCT and commercialization
of PRODUCT and to obtain REGULATORY APPROVAL throughout the TERRITORY.
Thereafter, during the term of this Agreement, each Party shall promptly make
available to the other all KNOW-HOW and other information, including, but not
limited to, preclinical and clinical data, as such Party reasonably deems
necessary to carry out the DEVELOPMENT and MANUFACTURE DEVELOPMENT of LICENSED
COMPOUND and PRODUCT and commercialization of PRODUCT and to obtain REGULATORY
APPROVAL throughout the TERRITORY. All information transferred, provided or
exchanged under this Section 3.4.1 will be subject to the confidentiality
requirements set forth in Article 17.
3.4.2 RECORD KEEPING. With respect to the DEVELOPMENT and
MANUFACTURE DEVELOPMENT work conducted by or on behalf of a given Party, such
Party will maintain records in sufficient detail and in good scientific manner
appropriate for REGULATORY APPROVAL and patent purposes.
3.5 REGULATORY COMPLIANCE. Each Party shall comply with GLP, GCP, GMP
and all other applicable governmental, regulatory and administrative laws, rules
and regulations of the FDA and other applicable authorities in the conduct of
the DEVELOPMENT, MANUFACTURE DEVELOPMENT and in preparing and filing all
regulatory dossiers for PRODUCT in the TERRITORY.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
31.
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3.6 REGULATORY APPROVALS.
3.6.1 TERRITORY X. Xxxxxxx shall file all regulatory dossiers
(e.g., the BLA) for PRODUCT in the FIELD in TERRITORY A under its name in
accordance with the use of its COMMERCIALLY REASONABLE EFFORTS. Xxxxxxx shall
own all such TERRITORY A REGULATORY APPROVALS. To the extent legally
permissible, SB shall have the right of reference to the extent necessary to
exercise its rights or to meet its obligations hereunder. Xxxxxxx shall be
responsible for undertaking all activities required of the holder of regulatory
dossiers in TERRITORY A, including, but not limited to, any adverse event
reporting (subject to Section 7.6). Xxxxxxx shall be responsible for all
communications with regulatory agencies relating to the PRODUCT in the FIELD in
TERRITORY A, subject to its obligation to keep the JDC and/or the JCC informed.
3.6.2 NON-USA TERRITORY.
(a) SB RESPONSIBILITIES. SB shall file all regulatory
dossiers, as well as any necessary or desired pricing approvals, for PRODUCT in
the FIELD in the NON-USA TERRITORY under its name in accordance with the use of
its COMMERCIALLY REASONABLE EFFORTS. SB shall own all such NON-USA TERRITORY
REGULATORY APPROVALS. To the extent legally permissible, Xxxxxxx shall have the
right of reference to the extent necessary to exercise its rights or to meet its
obligations hereunder. SB shall be responsible for undertaking all activities
required of the holder of regulatory dossiers in the NON-USA TERRITORY,
including, but not limited to, any adverse event reporting (subject to Section
7.6). SB shall be responsible for all communications with regulatory agencies
relating to the PRODUCT in the FIELD in the NON-USA TERRITORY, subject to its
obligation to keep the JDC and/or the JCC informed.
(b) XXXXXXX RESPONSIBILITY TO PROVIDE TECHNICAL ASSISTANCE
IN THE NON-USA TERRITORY. Xxxxxxx shall provide to SB, at SB's request,
reasonable technical assistance within Xxxxxxx'x area of expertise concerning
registration of PRODUCT in the NON-USA TERRITORY. Provision of such technical
assistance shall include, but not be limited to, supply of any KNOW-HOW owned or
CONTROLLED by Xxxxxxx which SB may require. Pursuant to such obligation, Xxxxxxx
shall make available to SB, Xxxxxxx'x representatives as are reasonably
requested by SB in connection with regulatory and scientific matters relating to
the filing of regulatory applications in the NON-USA TERRITORY, including timely
response to questions raised by regulatory authorities regarding the MAA or
equivalent regulatory filings in the NON-USA TERRITORY, and travel as reasonably
required for meetings with regulatory authorities. In the event that SB requests
that Xxxxxxx perform work under this Section 3.6.2(b), SB shall reimburse
Xxxxxxx for [*] OUT-OF-POCKET COSTS incurred by Xxxxxxx with respect to such
performance within thirty (30) days of receipt of an invoice from Xxxxxxx,
provided that [*] incurred by Xxxxxxx under this Section 3.6.2(b) shall be based
on [*]. Such OUT-OF-POCKET COSTS shall not be deemed to be DEVELOPMENT COSTS.
All work or other assistance provided to SB under this Section 3.6.2(b), such
as, without limitation, [*], and the provision of existing Xxxxxxx reports, data
and information to assist SB with responses to questions or requests from
regulatory authorities, shall be provided to SB [*] in the case where (i) a
Xxxxxxx FTE is requested by SB [*] or (ii) Xxxxxxx is requested to undertake an
individual project that requires more than [*], provided that Xxxxxxx provides
SB [*] that the project is of such a magnitude. In the event that
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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[*], SB shall [*] Xxxxxxx, on an FTE rate basis for the [*] rendering such
assistance, at an FTE rate of [*].
ARTICLE 4
ADDITIONAL INDICATIONS;
SECOND GENERATION LICENSED COMPOUNDS
4.1 ADDITIONAL INDICATIONS. Upon the prior approval of the JDC, each of
SB and Xxxxxxx shall have the right to conduct research and pre-clinical
development of any LICENSED COMPOUND for any ADDITIONAL INDICATIONS. Unless
agreed otherwise by the Parties, the cost of such research and pre-clinical
development for an ADDITIONAL INDICATION shall be [*]. If, based on such
pre-clinical research and development, SB or Xxxxxxx discovers or determines
that any LICENSED COMPOUND may have efficacy in the treatment, prevention or
palliation of any ADDITIONAL INDICATION and if such Party desires to pursue
clinical trials of such LICENSED COMPOUND for such ADDITIONAL INDICATION, it
will promptly notify the other Party in writing and disclose to the other Party
its rationale therefor, including all relevant data. Through the JDC, the
Parties will then decide whether to go forward with the DEVELOPMENT and
commercialization of the LICENSED COMPOUND for such ADDITIONAL INDICATION
pursuant to this Agreement. In the event the JDC decides not to go forward with
the DEVELOPMENT and commercialization of the LICENSED COMPOUND for such
ADDITIONAL INDICATION, [*]. In the event the JDC does decide to go forward, [*]
will be the lead Party in pursuing DEVELOPMENT for the ADDITIONAL INDICATION in
TERRITORY A and [*] will be the lead Party in pursuing DEVELOPMENT for the
ADDITIONAL INDICATION in TERRITORY B and TERRITORY C unless otherwise determined
by the JDC.
4.2 SECOND GENERATION LICENSED COMPOUNDS.
4.2.1 SECOND GENERATION LICENSED COMPOUND CANDIDATES; REPORTING;
NOTICE.
(a) The Parties intend during the term of this Agreement
to work cooperatively to evaluate the feasibility of developing SECOND
GENERATION LICENSED COMPOUND CANDIDATES, while maintaining their independent
ability to develop such compounds, subject to the terms of this Section 4.2.
Accordingly, the Parties agree that, at any time during the term of this
Agreement, either Party may elect, [*], to pursue research and development of a
specific SECOND GENERATION LICENSED COMPOUND CANDIDATE in the FIELD. The Party
making the foregoing election shall be deemed to be the "Initiating Party".
(b) The Initiating Party shall [*] (the "Non-Initiating
Party") promptly following its commencement of any work related to a SECOND
GENERATION LICENSED COMPOUND CANDIDATE in the FIELD, and shall [*] keep the
Non-Initiating Party informed of the results of any such research and
development and shall make appropriate personnel available, at reasonable times,
to discuss with the Non-Initiating Party the attributes of the SECOND GENERATION
LICENSED COMPOUND CANDIDATE and any studies the Initiating Party has undertaken
relating to the research and development of such SECOND GENERATION LICENSED
COMPOUND CANDIDATE in the
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
33.
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FIELD. The Initiating Party shall provide written [*] reports to the JDC on the
status of research and development of such SECOND GENERATION LICENSED COMPOUND
CANDIDATE in the FIELD. On a [*], subject to Section 4.2.3, the Initiating Party
shall provide the Non-Initiating Party with a summary of the SECOND GENERATION
LICENSED COMPOUND CANDIDATE DEVELOPMENT COSTS and the SECOND GENERATION LICENSED
COMPOUND CANDIDATE MANUFACTURE DEVELOPMENT COSTS to date in developing such
SECOND GENERATION LICENSED COMPOUND CANDIDATE, with such costs [*].
(c) The Initiating Party shall provide written notice to
the Non-Initiating Party no later than [*] prior to the date on which the
Initiating Party plans to [*] for such SECOND GENERATION LICENSED COMPOUND
CANDIDATE in the FIELD. Such written notice shall include the planned filing
date, as well as all material information developed or obtained by the
Initiating Party relevant to its interest in the SECOND GENERATION LICENSED
COMPOUND CANDIDATE in the FIELD not previously provided to the Non-Initiating
Party.
(d) The Initiating Party shall provide written notice to
the Non-Initiating Party no later than [*] prior to the date on which the
Initiating Party plans to [*] for such SECOND GENERATION LICENSED COMPOUND
CANDIDATE in the FIELD. Such written notice shall include the [*] as well as all
material information developed or obtained by the Initiating Party, and not
previously provided to the Non-Initiating Party, which is relevant to the
Initiating Party's interest in the SECOND GENERATION LICENSED COMPOUND CANDIDATE
in the FIELD.
4.2.2 SB DEVELOPMENT AND COMMERCIALIZATION OPTION.
(a) In the event Xxxxxxx is the Initiating Party, at any
time after receipt of Xxxxxxx'x first [*] report pursuant to Section 4.2.1(b)
and until [*] after Xxxxxxx provides notice to SB of Completion of [*], required
for such SECOND GENERATION LICENSED COMPOUND CANDIDATE (the "SB Option
Termination Date"), SB may provide written notice to Xxxxxxx indicating that it
is interested in pursuing the development and commercialization of such SECOND
GENERATION LICENSED COMPOUND CANDIDATE in the FIELD (an "SB Option Exercise
Notice"). In the event SB provides an SB Option Exercise Notice on or before the
SB Option Termination Date, such SECOND GENERATION LICENSED COMPOUND CANDIDATE
shall thereafter be deemed to be a SECOND GENERATION LICENSED COMPOUND for
purposes of this Agreement and the terms of Section 4.2.2(b) and 4.2.5 shall
apply. The SB Option Termination Date [*].
(b) Within [*] days of Xxxxxxx'x receipt of an SB Option
Exercise Notice, SB shall reimburse Xxxxxxx for [*] of the SECOND GENERATION
LICENSED COMPOUND CANDIDATE DEVELOPMENT COSTS and [*] of the SECOND GENERATION
LICENSED COMPOUND CANDIDATE MANUFACTURE DEVELOPMENT COSTS associated with such
SECOND GENERATION LICENSED COMPOUND CANDIDATE; provided, however, if the SB
Option Exercise Notice is delivered by SB [*] Xxxxxxx provides SB with notice of
the Completion of Phase II Trials (as defined in Section 4.2.2(c)) for such
SECOND GENERATION LICENSED COMPOUND CANDIDATE and on or before the SB Option
Termination Date, SB shall reimburse Xxxxxxx for [*] of such SECOND GENERATION
LICENSED COMPOUND CANDIDATE DEVELOPMENT COSTS and [*] of such SECOND GENERATION
LICENSED COMPOUND CANDIDATE MANUFACTURE DEVELOPMENT COSTS.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
34.
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(c) "Completion of Phase II Trials" shall be deemed to
have occurred with respect to a given SECOND GENERATION LICENSED COMPOUND
CANDIDATE in the FIELD when the Initiating Party has given written notice to the
Non-Initiating Party that (i) the Initiating Party has [*] which the Initiating
Party [*]; (ii) the Initiating Party has [*]; and (iii) the Initiating Party has
[*] and has [*] and [*] was [*]. Included with such notice shall be (w) a
written report containing all material information and studies developed or
obtained by the Initiating Party relevant to the SECOND GENERATION LICENSED
COMPOUND CANDIDATE in the FIELD as of such date; (x) a copy of the [*]; (y) a
summary prepared by the Initiating Party of the [*] a [*] the [*]; and (z) [*]
the SECOND GENERATION LICENSED COMPOUND CANDIDATE DEVELOPMENT COSTS and the
SECOND GENERATION LICENSED COMPOUND CANDIDATE MANUFACTURE DEVELOPMENT COSTS to
date with respect to such SECOND GENERATION LICENSED COMPOUND CANDIDATE, with
such costs [*]. In the event the Initiating Party has determined in good faith
that [*] on the [*] such [*] to [*] on [*] to the [*]. Included with such notice
shall be a written report containing all information and studies developed or
obtained by the Initiating Party relevant to the SECOND GENERATION LICENSED
COMPOUND CANDIDATE in the FIELD as of such date, [*] of the SECOND GENERATION
LICENSED COMPOUND CANDIDATE DEVELOPMENT COSTS and the SECOND GENERATION LICENSED
COMPOUND CANDIDATE MANUFACTURE DEVELOPMENT COSTS to date with respect to such
SECOND GENERATION LICENSED COMPOUND CANDIDATE, with such costs [*].
(d) A "Second Generation Licensed Compound Candidate
Pivotal Trial" shall mean a study in humans which is prospectively designed to
demonstrate statistically whether a given SECOND GENERATION LICENSED COMPOUND
CANDIDATE is safe and effective for use in the FIELD in a manner necessary to
obtain REGULATORY APPROVAL to market such compound for use in the FIELD.
(e) A "Phase II Trial" shall mean that portion of clinical
development of pharmaceutical PRODUCTS that provides for additional assessment
of safety and preliminary assessment of efficacy at particular dosage levels of
a SECOND GENERATION LICENSED COMPOUND CANDIDATE, in human patients, which is
intended to gather information to support the pivotal human clinical trials
using the SECOND GENERATION LICENSED COMPOUND CANDIDATE, performed in accordance
with the FD&C ACT and applicable regulations promulgated thereunder (including,
without limitation, 21 CFR Part 312), as amended from time to time, or any
comparable foreign laws and regulations.
4.2.3 IF XXXXXXX IS THE INITIATING PARTY AND SB DOES NOT PROVIDE
AN SB OPTION EXERCISE NOTICE. In the event Xxxxxxx is the Initiating Party and
SB does not provide an SB OPTION EXERCISE NOTICE with respect to a given SECOND
GENERATION LICENSED COMPOUND CANDIDATE by the SB Option Termination Date (as
such may be extended by Xxxxxxx under Section 4.2.2(a)), Xxxxxxx shall [*] with
respect to such SECOND GENERATION LICENSED COMPOUND CANDIDATE and shall [*]. In
the event Xxxxxxx, a Xxxxxxx AFFILIATE or a Xxxxxxx THIRD PARTY licensee
commences a Second Generation Licensed Compound Candidate Pivotal Trial on such
compound, Xxxxxxx shall notify SB. In the event Xxxxxxx has completed a Second
Generation Licensed Compound Candidate Pivotal Trial (as defined in Section
4.2.2(d)) and has decided to file a BLA on the basis of such trial, Xxxxxxx
shall immediately provide written notice to SB of such decision. In the event
Xxxxxxx receives REGULATORY APPROVAL to sell such SECOND
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
35.
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GENERATION LICENSED COMPOUND CANDIDATE in TERRITORY A and has not, as of the
date on which such REGULATORY APPROVAL is received, [*] an [*] to [*] in
TERRITORY A or otherwise [*] the [*] to [*] in TERRITORY A, Xxxxxxx shall
immediately provide written notice to SB of such situation. At any time within
[*] days of the date of Xxxxxxx'x notice as set forth in the previous sentence,
SB may, upon written notice to Xxxxxxx, require Xxxxxxx to make the election set
forth in Section 7.1.15, provided that, in such event, Xxxxxxx'x right to
participate in the CO-PROMOTION of PRODUCT in TERRITORY A will cease immediately
upon such election. In the event SB does not provide an SB OPTION EXERCISE
NOTICE on or before the SB Option Termination Date, the obligations of Xxxxxxx
contained in Section 4.2.1(b) shall terminate as of the SB Option Termination
Date, but the provisions of this Section 4.2.3 shall still apply.
4.2.4 XXXXXXX DEVELOPMENT AND COMMERCIALIZATION RIGHTS; XXXXXXX
FUNDING OPTION.
(a) AUTOMATIC CONVERSION OF SECOND GENERATION LICENSED
COMPOUND CANDIDATE TO SECOND GENERATION LICENSED COMPOUND. The Parties
understand that, in the event SB is the Initiating Party for a SECOND GENERATION
LICENSED COMPOUND CANDIDATE, such compound will automatically be converted to a
SECOND GENERATION LICENSED COMPOUND at the time set forth in Section 4.2.4(b).
Xxxxxxx'x payment obligations and economic participation with respect to such
compound are set forth in this Section 4.2.4.
(b) EXERCISE OF FUNDING OPTION. In the event SB is the
Initiating Party, at any time after receipt of SB's first [*] report pursuant to
Section 4.2.1(b) and [*] SB discloses to Xxxxxxx the Pivotal Trial Data (as
defined in this Section 4.2.4(b)) for such SECOND GENERATION LICENSED COMPOUND
CANDIDATE (the "Xxxxxxx Funding Option Termination Date"), Xxxxxxx may provide
written notice to SB indicating that it is interested in reimbursing SB for a
portion of the SECOND GENERATION LICENSED COMPOUND CANDIDATE DEVELOPMENT COSTS
and the SECOND GENERATION LICENSED COMPOUND CANDIDATE MANUFACTURE DEVELOPMENT
COSTS (a "Xxxxxxx Funding Option Exercise Notice") as set forth in Section
4.2.4(c)(i) or 4.2.4(c)(ii). As of the date on which Xxxxxxx provides a Xxxxxxx
Funding Option Exercise Notice, such SECOND GENERATION LICENSED COMPOUND
CANDIDATE shall be deemed to be a SECOND GENERATION LICENSED COMPOUND and the
terms of Sections 4.2.4(c)(i), 4.2.4(c)(ii) and 4.2.5 shall apply. In the event
Xxxxxxx does not provide a Xxxxxxx Funding Option Exercise Notice on or before
the Xxxxxxx Funding Option Termination Date, such SECOND GENERATION LICENSED
COMPOUND CANDIDATE automatically shall be deemed to be a SECOND GENERATION
LICENSED COMPOUND as of the Xxxxxxx Funding Option Termination Date and the
terms of Sections 4.2.4(c)(iii) and 4.2.5 shall apply. "Pivotal Trial Data"
shall mean clinical data from a study in humans which [*], demonstrate
statistically that PRODUCT containing a SECOND GENERATION LICENSED COMPOUND
CANDIDATE is safe and effective for use in the FIELD in a manner necessary to
obtain REGULATORY APPROVAL to market PRODUCT in TERRITORY A for use in the
FIELD.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
36.
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(c) PAYMENT OBLIGATIONS OF XXXXXXX.
(i) In the event SB is the Initiating Party for a
given SECOND GENERATION LICENSED COMPOUND CANDIDATE and Xxxxxxx provides the
Xxxxxxx Funding Option Exercise Notice to SB before the Completion of Phase II
Trials (as defined in Section 4.2.2(c)) for such compound, within [*] of
delivery of such notice, Xxxxxxx shall reimburse SB for [*] of the SECOND
GENERATION LICENSED COMPOUND CANDIDATE DEVELOPMENT COSTS and [*] of the SECOND
GENERATION LICENSED COMPOUND CANDIDATE MANUFACTURE DEVELOPMENT COSTS associated
with seeking REGULATORY APPROVAL for such compound in TERRITORY A.
(ii) In the event SB is the Initiating Party for a
given SECOND GENERATION LICENSED COMPOUND CANDIDATE and Xxxxxxx provides the
Xxxxxxx Funding Option Exercise Notice to SB on or after the Completion of Phase
II Trials (as defined in Section 4.2.2(c)) for such compound and on or before
the Xxxxxxx Funding Option Termination Date for such compound, within [*] days
of delivery of such notice, Xxxxxxx shall reimburse SB for [*] of the SECOND
GENERATION LICENSED COMPOUND CANDIDATE DEVELOPMENT COSTS and [*] of the SECOND
GENERATION LICENSED COMPOUND CANDIDATE MANUFACTURE DEVELOPMENT COSTS associated
with seeking REGULATORY APPROVAL for such compound in TERRITORY A.
(iii) In the event SB is the Initiating Party for a
given SECOND GENERATION LICENSED COMPOUND CANDIDATE and Xxxxxxx does not provide
the Xxxxxxx Funding Option Exercise Notice to SB on or before the Xxxxxxx
Funding Option Termination Date for such compound, (i) SB shall owe no
milestones to Xxxxxxx with respect to such compound pursuant to Section 6.3 and
(ii) SB shall pay [*] of the SECOND GENERATION LICENSED COMPOUND CANDIDATE
DEVELOPMENT COSTS and the SECOND GENERATION LICENSED COMPOUND CANDIDATE
MANUFACTURE DEVELOPMENT COSTS and any other DEVELOPMENT COSTS or MANUFACTURE
DEVELOPMENT COSTS for such compound once such SECOND GENERATION LICENSED
COMPOUND CANDIDATE becomes a SECOND GENERATION LICENSED COMPOUND pursuant to
Section 4.2.4(b), but may offset [*] of the SECOND GENERATION LICENSED COMPOUND
CANDIDATE DEVELOPMENT COSTS and [*] of the SECOND GENERATION LICENSED COMPOUND
CANDIDATE MANUFACTURE DEVELOPMENT COSTS associated with seeking REGULATORY
APPROVAL for such compound in TERRITORY A and [*] of any other DEVELOPMENT COSTS
and MANUFACTURE DEVELOPMENT COSTS associated with seeking REGULATORY APPROVAL
for such compound in TERRITORY A, against Xxxxxxx'x [*] share of OPERATING
PROFIT in TERRITORY A, pursuant to Section 7.1.13, for PRODUCT containing such
compound.
4.2.5 MODIFICATION OF JOINT DEVELOPMENT PLAN, JOINT MANUFACTURE
DEVELOPMENT PLAN AND JOINT MARKETING PLAN. Promptly upon a SECOND GENERATION
LICENSED COMPOUND Candidate becoming a SECOND GENERATION LICENSED COMPOUND
pursuant to Section 4.2.2(a) or 4.2.4(b), the JDC and JCC shall modify the JOINT
DEVELOPMENT PLAN, the JOINT MANUFACTURE DEVELOPMENT PLAN and the JOINT MARKETING
PLAN then in effect as required to achieve the requisite approvals of the
modified documents by the JDC and JCC, following the procedures set forth in
Article 2, in order to incorporate the SECOND GENERATION LICENSED COMPOUND into
such documents. Consistent with this Agreement and the modified JOINT
DEVELOPMENT PLAN, the modified JOINT MANUFACTURE DEVELOPMENT PLAN and modified
JOINT
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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MARKETING PLAN, the JDC and JCC shall allocate responsibility for the
DEVELOPMENT, MANUFACTURE DEVELOPMENT and commercialization of such SECOND
GENERATION LICENSED COMPOUND, provided, however, such allocation shall be [*].
ARTICLE 5
LICENSES
5.1 LICENSES TO SB. Subject to the other provisions of this Agreement,
Xxxxxxx hereby grants to SB:
5.1.1 A license, under Xxxxxxx'x INTELLECTUAL PROPERTY RIGHTS, to
develop, make, have made, use, sell, offer for sale, and import LICENSED
COMPOUND, PRODUCT and ANTI-CD20 ANTIBODY in the FIELD in TERRITORY A, subject to
Section 5.1.3 and Section 5.1.4 and the other terms and conditions set forth in
this Agreement. Such license shall be exclusive except as to Xxxxxxx and shall
be subject to the terms set forth in this Agreement.
5.1.2 A license, under Xxxxxxx'x INTELLECTUAL PROPERTY RIGHTS, to
develop, make, have made, use, sell, offer for sale, and import LICENSED
COMPOUND, PRODUCT and ANTI-CD20 ANTIBODY in the FIELD in the NON-USA TERRITORY,
subject to Section 5.1.3 and Section 5.1.4 and the other terms and conditions
set forth in this Agreement (including without limitation circumstances under
which SB's rights in certain countries may terminate or become non-exclusive).
Such license shall be exclusive except as to Xxxxxxx'x rights (i) to develop,
make, have made, use and import LICENSED COMPOUND and PRODUCT for SB in the
Field in the NON-USA TERRITORY as set forth in this Agreement and (ii) as
described in Section 5.1.4.
5.1.3 The license to SB outlined in Sections 5.1.1 and 5.1.2
shall be exercisable by SB only with respect to
(a) PRODUCT or LICENSED COMPOUND; and
(b) SECOND GENERATION LICENSED COMPOUND CANDIDATEs for use
in the FIELD throughout the TERRITORY, but only to the extent set forth in
Section 4.2.
5.1.4 As used in Sections 5.1.1 and 5.1.2, a license that is
"exclusive except as to Xxxxxxx" means that Xxxxxxx shall not grant any other
entity (other than Xxxxxxx AFFILIATES but only for so long as they remain
AFFILIATES) any license under Xxxxxxx'x INTELLECTUAL PROPERTY RIGHTS in the
FIELD except as otherwise provided in Section 11.4.3, but that otherwise Xxxxxxx
retains all its rights of ownership in such licensed rights, including without
limitation the right to practice such property rights, subject only to the
license granted. In particular, Xxxxxxx shall retain the right to develop, make,
have made, use, sell, offer for sale and import LICENSED COMPOUND and PRODUCT in
the FIELD in TERRITORY A, and to develop, make, have made, and use SECOND
GENERATION LICENSED COMPOUND CANDIDATES and LICENSED COMPOUNDS in the FIELD
throughout the TERRITORY, in all cases subject to the terms set forth in this
Agreement. For the avoidance of doubt, nothing contained in this Section 5.1 (a)
grants SB any rights under Xxxxxxx'x INTELLECTUAL PROPERTY RIGHTS outside the
FIELD, (b) grants SB the right to exercise its
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
38.
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license for products other than the PRODUCT, LICENSED COMPOUND and SECOND
GENERATION LICENSED COMPOUND CANDIDATEs (subject to Section 4.2), (c) precludes
Xxxxxxx or any licensee of Xxxxxxx from practicing such rights outside the FIELD
or for a purpose not related to ANTI-CD20 ANTIBODIES in the FIELD, or (d) grants
Xxxxxxx the right to exercise its retained rights related to ANTI-CD20
ANTIBODIES for products other than the PRODUCT, LICENSED COMPOUND and SECOND
GENERATION LICENSED COMPOUND CANDIDATEs (subject to Section 4.2).
5.1.5 Under no circumstances may XX xxxxx sublicenses in
TERRITORY A under the licenses granted in this Section 5.1 except to AFFILIATES
of SB and only for so long as such AFFILIATES remain AFFILIATES (except in the
event that Xxxxxxx loses its rights to CO-PROMOTE PRODUCT under Section 7.1.15)
and only to develop, make, have made, use, sell, offer for sale and import
PRODUCT, LICENSED COMPOUND, and SECOND GENERATION LICENSED COMPOUND CANDIDATES.
Subject to Section 7.2.3, the licenses granted in this Section 5.1 shall only be
sublicensable by SB in the MAJOR MARKET COUNTRIES with the prior written consent
of Xxxxxxx which shall not be unreasonably withheld, except SB may grant
sublicenses in the MAJOR MARKET COUNTRIES to AFFILIATES of SB, and only for so
long as such AFFILIATES remain AFFILIATES, without the prior consent of Xxxxxxx.
In all countries other than the TERRITORY A and the MAJOR MARKET COUNTRIES, SB
may grant sublicenses under the licenses granted in this Section 5.1 without the
prior consent of Xxxxxxx, provided, however, SB shall provide written notice to
Xxxxxxx at least five (5) business days prior to entering into such sublicense
agreements. Such notice shall include the name of the THIRD PARTY sublicensee
and a brief description of the proposed agreement.
5.1.6 Unless otherwise provided in this Agreement, SB covenants
that it shall not, nor shall it cause any AFFILIATE to knowingly, use or
practice directly or indirectly any INTELLECTUAL PROPERTY RIGHTS of Xxxxxxx for
any purposes other than those set forth in Sections 5.1.1, 5.1.2 and 5.1.3.
5.2 LICENSES TO XXXXXXX.
5.2.1 Subject to the other provisions of this Agreement, SB
hereby grants to Xxxxxxx a license under SB's INTELLECTUAL PROPERTY RIGHTS, to
develop, make, have made, use, sell, offer for sale and import LICENSED
COMPOUND, PRODUCT, and ANTI-CD20 ANTIBODY in the FIELD in the TERRITORY, subject
to Section 5.2.2 and the other terms and conditions of this Agreement. The
license granted under this Section 5.2.1 shall be (i) royalty-free, (ii)
exclusive except as to SB and any authorized sublicensee of SB under Section
5.1.5 within the scope of such sublicense, and (iii) shall not be sublicenseable
by Xxxxxxx without the consent of SB, except to AFFILIATES of Xxxxxxx, and only
for so long as such AFFILIATES remain AFFILIATES.
5.2.2 The license to Xxxxxxx set forth in Section 5.2.1 shall be
exercisable by Xxxxxxx only with respect to:
(a) the development and manufacture (including THIRD PARTY
manufacture for Xxxxxxx) of LICENSED COMPOUND, PRODUCT and SECOND GENERATION
COMPOUND CANDIDATES to the extent set forth in Section 4.2, for use in the FIELD
throughout the TERRITORY, and
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
39.
53
(b) the CO-PROMOTION of the PRODUCT in the FIELD in
TERRITORY A, and
(c) otherwise to comply with its obligations under this
Agreement, and
(d) in the case of SB KNOW-HOW, only to the extent such SB
KNOW-HOW has been described to Xxxxxxx under this Agreement.
5.2.3 As used in Section 5.2.1, a license that is "exclusive
except as to SB and any authorized sublicensee of SB under Section 5.1.5" means
that SB shall not grant any other entity (except such a sublicensee acting
within the scope of such sublicense) any license under SB's INTELLECTUAL
PROPERTY RIGHTS in the FIELD (except as otherwise provided in Section 11.4.3),
but that otherwise SB retains all of its rights of ownership in such licensed
rights, including without limitation, the right to practice such property
rights, subject only to the license granted.
5.2.4 The license granted to Xxxxxxx herein expressly excludes
any license under SB technology for the [*]. SB agrees, however, that during the
term of this Agreement it will not grant licenses to THIRD PARTIES for [*]
ANTI-CD20 ANTIBODIES without the prior written consent of Xxxxxxx.
5.2.5 SB hereby grants to Xxxxxxx an exclusive, royalty-free
license, with a right to sublicense, under SB's INTELLECTUAL PROPERTY RIGHTS, to
develop, make, have made, use, import, market, offer for sale and sell PRODUCT
or LICENSED COMPOUND in the FIELD in Japan.
5.2.6 Unless otherwise provided in this Agreement, Xxxxxxx
covenants that it shall not, nor shall it cause any AFFILIATE to knowingly, use
or practice directly or indirectly any INTELLECTUAL PROPERTY RIGHTS of SB for
any purposes other than those set forth in Sections 5.2.1, 5.2.2 and 5.2.5.
5.3 NEW THIRD PARTY LICENSES.
5.3.1 DETERMINATION REGARDING NEED FOR NEW THIRD PARTY LICENSE.
In the event either Xxxxxxx or SB believes that one or more licenses under
intellectual property held by a THIRD PARTY are necessary or desirable in order
to manufacture or develop or commercialize the PRODUCT anywhere in the
TERRITORY, or otherwise assure that their activities under this Agreement do not
infringe the intellectual property rights of such THIRD PARTY, then the Parties
will discuss the situation in good faith. In the event that the Parties cannot
make a unanimous decision regarding whether or not a license is necessary or
desirable, the Parties shall submit such issue promptly thereafter to an
UNAFFILIATED EXPERT who is a patent attorney. The expenses of engaging such
UNAFFILIATED EXPERT patent attorney for such determination shall be shared
equally by the Parties. If such UNAFFILIATED EXPERT patent attorney determines
that a license is needed, the determination shall be binding on the Parties and
Section 5.3.3(b) or 5.3.3(c) shall be applicable.
5.3.2 PROCEDURE FOR OBTAINING. Once a determination has been
made, in accordance with Section 5.3.1, that one or more licenses under
intellectual property held by a THIRD PARTY are necessary or desirable in order
to manufacture or develop or commercialize the
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
40.
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PRODUCT anywhere in the TERRITORY, or otherwise assure that their activities
under this Agreement do not infringe the intellectual property rights of such
THIRD PARTY, the appropriate Party (i.e., Xxxxxxx for TERRITORY A and SB for the
NON-USA TERRITORY) will seek to obtain a license to such intellectual property
(a "NEW THIRD PARTY LICENSE"). In the event such NEW THIRD PARTY LICENSE imposes
costs on the Party who is not obtaining the license pursuant to Section 5.3.3
(i.e., SB for TERRITORY A and Xxxxxxx for the NON-USA TERRITORY), the economic
terms of such license [*] and such approved terms shall be included within the
NEW THIRD PARTY LICENSE COSTS. Should the Parties [*], then [*] to [*] the issue
shall be presented to the [*] and the [*]. In the event that the [*] and the [*]
are [*] on the issue, then [*] the decision regarding such economic terms
provided, however, that, [*] shall not enter into any NEW THIRD PARTY LICENSE
which [*] during the term of the guarantee set forth in Section 7.2.5.
5.3.3 NEW THIRD PARTY LICENSE COSTS.
(a) The NEW THIRD PARTY LICENSE COSTS in TERRITORY A will
be included as an element of COST OF GOODS as outlined in Section 1.11(c).
(b) In the event that the JDC (or an UNAFFILIATED EXPERT
under Section 5.3.1) determines that, in the absence of a NEW THIRD PARTY
LICENSE, SB would be blocked from making, using or selling the PRODUCT in the
NON-USA TERRITORY, then the NEW THIRD PARTY LICENSE COSTS for such NON-USA
TERRITORY license will be [*].
(c) In the event that the JDC (or an UNAFFILIATED EXPERT
under Section 5.3.1) determines that, in the absence of a NEW THIRD PARTY
LICENSE, SB would not be blocked from making, using or selling the PRODUCT in
the NON-USA TERRITORY, then SB shall have the right, at its discretion, to enter
in any such NEW THIRD PARTY LICENSE, provided that any NEW THIRD PARTY LICENSE
COSTS for such license will be borne entirely by SB.
(d) "NEW THIRD PARTY LICENSE COSTS" shall mean any amounts
paid to a THIRD PARTY licensor under a given NEW THIRD PARTY LICENSE. All NEW
THIRD PARTY LICENSE COSTS [*] under Section 5.3.3(a) or 5.3.3(b) shall be
approved in accordance with Section 5.3.2.
5.3.4 UPSTREAM LICENSES. It is understood that the licenses
granted under this Article 5 anticipate sublicenses of technology licensed from
THIRD PARTIES by Xxxxxxx to SB or by SB to Xxxxxxx, pursuant to license
agreements in effect as of the Effective Date and/or NEW THIRD PARTY LICENSES
(collectively, the "Upstream Licenses"). All such sublicenses granted hereunder
are subject to the terms and conditions, including provisions regarding
exclusivity, of any such Upstream Licenses. Each Party will [*] this Agreement
for any relevant Upstream Licenses obtained after the Effective Date (within the
scope of such new Upstream Licenses).
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
41.
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5.4 EXCLUSIVITY.
5.4.1
(a) In the event SB or an SB AFFILIATE files a BLA in
TERRITORY A or a MAA or [*] in a MAJOR MARKET COUNTRY for a MAJOR INDICATION for
a Competitive Product (as defined in Section 5.4.3) or commences marketing a
Competitive Product for a MAJOR INDICATION in TERRITORY A or a MAJOR MARKET
COUNTRY, SB shall immediately notify Xxxxxxx. At any time thereafter, Xxxxxxx
may, upon [*] prior written notice to SB, either (i) terminate the licenses
contained in this Article 5 for those countries of TERRITORY A or MAJOR MARKET
COUNTRIES in which SB or an SB AFFILIATE has filed a BLA or a MAA or an [*] for
a MAJOR INDICATION for a Competitive Product or has commenced marketing a
Competitive Product for a MAJOR INDICATION, provided, however, that if one of
the MAJOR MARKET COUNTRIES in which such regulatory or marketing events occurred
is in the European Union, then such termination shall be effective for the
entire European Union; and/or (ii) convert the licenses contained in this
Article 5 in any such country or countries to non-exclusive licenses. Upon
termination pursuant to clause (i), the terms of Section 13.4 shall apply. Upon
conversion to non-exclusive rights pursuant to clause (ii), the terms of Section
13.5 shall apply. In the event of a termination of the license in TERRITORY A or
MAJOR MARKET COUNTRIES pursuant to clause (i), Xxxxxxx will thereafter have no
obligation to make any payments to SB with respect to PRODUCT in TERRITORY A or
MAJOR MARKET COUNTRIES under this Agreement. Notwithstanding the foregoing,
Xxxxxxx will not exercise the option set forth in the second sentence of this
Section 5.4.1(a) if:
(i) the BLA in TERRITORY A or a MAA or [*] in a
MAJOR MARKET COUNTRY for the Competitive Product is not for a MAJOR INDICATION;
(ii) the Competitive Product is not being
commercialized for treatment of any MAJOR INDICATIONS;
(iii) with respect to TERRITORY A, neither Party is
then utilizing any sales representatives to support PRODUCT in TERRITORY A in
accordance with a JCC determination under Section 7.1.6(a) that such sales
effort is not desirable; or
(iv) with respect to either TERRITORY A or a MAJOR
MARKET COUNTRY, ten (10) years have passed since the date of commercial launch
of PRODUCT in the relevant country.
(b) In the event Xxxxxxx or a Xxxxxxx AFFILIATE files a
BLA in TERRITORY A for a MAJOR INDICATION for a Competitive Product or commences
marketing a Competitive Product for a MAJOR INDICATION in TERRITORY A, Xxxxxxx
shall immediately notify SB. At any time thereafter, SB may, upon six (6) months
prior written notice to Xxxxxxx, terminate Xxxxxxx'x right to CO-PROMOTE PRODUCT
in TERRITORY A, and SB will thereafter have no obligation to make any payments
to Xxxxxxx with respect to PRODUCT in TERRITORY A under this Agreement.
Notwithstanding the foregoing, SB will not exercise the option set forth in the
second sentence of this Section 5.4.1(b) if:
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
42.
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(i) the BLA for the Competitive Product is not for
a MAJOR INDICATION;
(ii) the Competitive Product is not being
commercialized for treatment of any MAJOR INDICATION;
(iii) neither Party is then utilizing any sales
representatives to support PRODUCT in TERRITORY A in accordance with a JCC
determination under Section 7.1.6(a) that such sales effort is not desirable; or
(iv) ten (10) years have passed since the date of
commercial launch of PRODUCT in TERRITORY A.
5.4.2
(a) In the event that SB shall be acquired by or merge
with a THIRD PARTY who is commercializing a Competitive Product at the time of
such acquisition or merger in TERRITORY A or in a MAJOR MARKET COUNTRY for a
MAJOR INDICATION, or in the event that SB acquires a THIRD PARTY who is
commercializing a Competitive Product at the time of such acquisition in
TERRITORY A or in a MAJOR MARKET COUNTRY for a MAJOR INDICATION, the Parties
shall promptly meet to discuss, in good faith, an equitable resolution to such
situation. In the event the Parties are unable, despite good faith efforts, to
reach an equitable resolution to such situation within [*] to discuss the
situation and SB has not, within [*] of the [*] either granted an exclusive
license to a THIRD PARTY to make, use and sell such Competitive Product in
TERRITORY A and the MAJOR MARKET COUNTRIES for all MAJOR INDICATIONS or
otherwise transferred to a THIRD PARTY the exclusive right to make, use and sell
such Competitive Product in TERRITORY A and the MAJOR MARKET COUNTRIES for all
MAJOR INDICATIONS, Xxxxxxx may at any time thereafter, either (i) terminate the
licenses contained in this Article 5 for those countries of TERRITORY A or MAJOR
MARKET COUNTRIES for which SB has not taken the actions described in the
preceding sentence (or for the entire European Union, if the Competitive Product
is on the market in any MAJOR MARKET COUNTRY of the European Union); and/or (ii)
convert the licenses contained in this Article 5 in any such country or
countries to non-exclusive licenses. Upon termination pursuant to clause (i),
the terms of Section 13.4 shall apply. Upon conversion to non-exclusive rights
pursuant to clause (ii), the terms of Section 13.5 shall apply. In the event of
a termination of the license in TERRITORY A or MAJOR MARKET COUNTRIES pursuant
to clause (i), Xxxxxxx will thereafter have no obligation to make any payments
to SB with respect to PRODUCT in TERRITORY A or MAJOR MARKET COUNTRIES under
this Agreement. Notwithstanding the foregoing, Xxxxxxx will not exercise the
option set forth in the second sentence of this Section 5.4.2(a) if:
(i) the Competitive Product obtained by SB as a
result of such acquisition or merger is not being commercialized for treatment
of any MAJOR INDICATIONS;
(ii) with respect to TERRITORY A, neither Party is
then utilizing any sales representatives to support PRODUCT in TERRITORY A in
accordance with a JCC determination under Section 7.1.6(a) that such sales
effort is not desirable; or
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
43.
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(iii) with respect to either TERRITORY A or a MAJOR
MARKET COUNTRY, ten (10) years have passed since the date of commercial launch
of PRODUCT in the relevant country.
(b) In the event that Xxxxxxx shall be acquired by or
merge with a THIRD PARTY who is commercializing a Competitive Product at the
time of such acquisition or merger in TERRITORY A for a MAJOR INDICATION, or in
the event that Xxxxxxx acquires a THIRD PARTY who is commercializing a
Competitive Product at the time of such acquisition in TERRITORY A for a MAJOR
INDICATION, the Parties shall promptly meet to discuss, in good faith, an
equitable resolution to such situation. In the event the Parties are unable,
despite good faith efforts, to reach an equitable resolution to such situation
within [*] of their first meeting to discuss the situation and Xxxxxxx has not,
within [*] of the end of such [*] either granted an exclusive license to a THIRD
PARTY to make, use and sell such Competitive Product in TERRITORY A for all
MAJOR INDICATIONS or otherwise transferred to a THIRD PARTY the exclusive right
to make, use and sell such Competitive Product in TERRITORY A and the MAJOR
MARKET COUNTRIES for all MAJOR INDICATIONS, SB may at any time thereafter, upon
written notice to Xxxxxxx, terminate Xxxxxxx'x right to CO-PROMOTE PRODUCT in
TERRITORY A, and SB will thereafter have no obligation to make any payments to
Xxxxxxx with respect to PRODUCT in TERRITORY A under this Agreement.
Notwithstanding the foregoing, SB will not exercise the option set forth in the
preceding sentence with respect to such Competitive Product if:
(i) the Competitive Product obtained by Xxxxxxx as
a result of such acquisition or merger is not being commercialized for treatment
of any MAJOR INDICATIONS;
(ii) neither Party is then utilizing any sales
representatives to support PRODUCT in TERRITORY A in accordance with a JCC
determination under Section 7.1.6(a) that such sales effort is not desirable; or
(iii) ten (10) years have passed since the date of
commercial launch of PRODUCT in TERRITORY A.
5.4.3 For purposes of this Section 5.4, "Competitive Product"
shall mean any product, other than a PRODUCT, LICENSED COMPOUND or a SECOND
GENERATION LICENSED COMPOUND CANDIDATE which is an ANTI-CD20 ANTIBODY.
5.4.4 For the avoidance of doubt, Section 5.4 shall not be
applicable to a Party, an AFFILIATE of a Party or any licensee of a Party with
respect to making, having made, using, selling, importing, or offering for sale
any product which is not an ANTI-CD20 ANTIBODY.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
44.
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ARTICLE 6
CONSIDERATION TO XXXXXXX
6.1 UPFRONT FEES.
6.1.1 In consideration for the license under Xxxxxxx'x
INTELLECTUAL PROPERTY RIGHTS granted to SB under this Agreement, SB shall pay to
Xxxxxxx Thirty Four Million Two Hundred Fifty Thousand U.S. Dollars (U.S.
$34,250,000) in cash within five (5) business days after the Effective Date.
6.1.2
(a) In connection with this Agreement, SB shall pay to
Xxxxxxx Seven Million Two Hundred Fifty Thousand U.S. Dollars (U.S. $7,250,000),
within five (5) business days after the Effective Date, for the purchase of
Common Stock of Xxxxxxx pursuant to a STOCK PURCHASE AGREEMENT, to be entered
into simultaneous with the execution of this Agreement. Such stock purchase is
more fully described in the STOCK PURCHASE AGREEMENT.
(b) In further consideration for the license under
Xxxxxxx'x INTELLECTUAL PROPERTY RIGHTS granted to SB under this Agreement, SB
shall make available a loan to Xxxxxxx of Fifteen Million U.S. Dollars (U.S.
$15,000,000), within five (5) business days after the Effective Date pursuant to
a LOAN AND SECURITY AGREEMENT, to be entered into simultaneously with the
execution of this Agreement. Such loan is more fully described in the LOAN AND
SECURITY AGREEMENT.
6.1.3 All amounts paid under Sections 6.1.1 and 6.1.2(a) shall be
non-refundable and non-creditable, provided, however, in the event of
termination of this Agreement by SB due to material breach by Xxxxxxx, the
foregoing shall not preclude SB from seeking whatever damages are available at
law.
6.2 MILESTONE PAYMENTS ON BEXXAR. In consideration for the rights
granted hereunder with respect to BEXXAR, SB shall pay to Xxxxxxx the following
amounts in cash within twenty (20) days after the following events occur with
respect to BEXXAR (in its unconjugated and radiolabeled form) in the applicable
territories:
TERRITORY A MILESTONE EVENTS
--------------------------------------------------------------------------------
MILESTONE EVENT AMOUNT
--------------------------------------------------------------------------------
Acceptance of all BLAs necessary for commercialization of BEXXAR $[*]
for the first MAJOR INDICATION in TERRITORY A.
REGULATORY APPROVAL of BEXXAR in TERRITORY A for FIRST $[*]
INDICATION.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
45.
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REGULATORY APPROVAL of BEXXAR in TERRITORY A for SECOND $[*]
INDICATION.
REGULATORY APPROVAL of BEXXAR in TERRITORY A for THIRD $[*]
INDICATION.
Sub-Total for TERRITORY A $[*]
TERRITORY B MILESTONE EVENTS
--------------------------------------------------------------------------------
MILESTONE EVENT AMOUNT
--------------------------------------------------------------------------------
Filing of all XXXx necessary for commercialization of $[*]
BEXXAR for the first MAJOR INDICATION in the European Community.
REGULATORY APPROVAL in the [*] for FIRST INDICATION $[*]
(Subject to [*], [*] REGULATORY APPROVAL is received in such country;
[*]).
Selection of EUROPEAN FACILITY (as defined in Section $[*]
9.10.1) for BEXXAR. Payment to be made according to the
payment schedule set forth in Section 9.10.5(a) and (b)
REGULATORY APPROVAL in the [*] for SECOND INDICATION ([*] $[*]
for [*] such REGULATORY APPROVAL, [*] such approval is received in
such country; [*].
REGULATORY APPROVAL in the [*] for THIRD INDICATION ([*] $[*]
for [*] such REGULATORY APPROVAL, [*] such approval is received in
such country; [*]).
Acceptance of all [*] Applications necessary for $[*]
commercialization of BEXXAR for a MAJOR INDICATION in [*].
REGULATORY APPROVAL of [*] Application in [*] for FIRST $[*]
INDICATION.
REGULATORY APPROVAL of [*] Application in [*] for SECOND $[*]
INDICATION.
REGULATORY APPROVAL of [*] Application in [*] for THIRD $[*]
INDICATION.
Outpatient [*] Guidelines (as defined in Section 6.2.1(b)) $[*]
are in effect and [*] (as defined in Section [*]) [*] (the
"Outpatient Milestone")
The one (1) year anniversary of the Outpatient Milestone $[*]
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
46.
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First calendar year in which NET SALES in [*] are in excess $[*]
of [*].
Sub-Total for TERRITORY B $[*]
TERRITORY C MILESTONE EVENTS
MILESTONE EVENT AMOUNT
--------------------------------------------------------------------------------
Filing of all applications necessary for commercialization of $[*]
BEXXAR for the first MAJOR INDICATION in the MAJOR MARKETS IN
TERRITORY C ([*] for which such filing occurs, [*]).
REGULATORY APPROVAL in TERRITORY C for the FIRST INDICATION ([*] for $[*]
which such REGULATORY APPROVAL is received, [*] this milestone.).
REGULATORY APPROVAL in TERRITORY C for the SECOND INDICATION [*] for $[*]
which such REGULATORY APPROVAL is received, [*] this milestone.).
REGULATORY APPROVAL in TERRITORY C for the THIRD INDICATION ([*] for $[*]
which such REGULATORY APPROVAL is received, [*] this milestone.).
Sub-Total for TERRITORY C $[*]
OTHER MILESTONE EVENTS
MILESTONE EVENT AMOUNT
--------------------------------------------------------------------------------
Initiation of the first Pivotal Study of BEXXAR in [*] (Study [*]) $[*]
Initiation of the first study of BEXXAR in [*] (Study [*]) $[*]
Initiation of the first Pivotal Study of BEXXAR in [*] (Study [*]) $[*]
Subtotal for DEVELOPMENT Events $[*]
TOTAL BEXXAR MILESTONE PAYMENTS $[*]
No payment shall be owed for a milestone which is not achieved and in no event
shall the milestone payments made by SB to Xxxxxxx upon the occurrence of the
milestone events set forth in the tables above in this Section 6.2 exceed the
amounts set forth opposite the milestone events in such tables. In the event
that REGULATORY APPROVAL of BEXXAR is granted concurrently for the FIRST
INDICATION and the SECOND INDICATION in the FIELD in, respectively, (i)
TERRITORY A, (ii) the
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
47.
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[*], (iii) [*] or (iv) any of the first four MAJOR MARKETS IN TERRITORY C, then
the applicable milestone payments set forth in this Section 6.2 for REGULATORY
APPROVAL with regard to such FIRST INDICATION and SECOND INDICATION in the
relevant geographic area shall both be due from SB to Xxxxxxx, and shall both be
paid within the time frame provided in this Section 6.2 (and the next MAJOR
INDICATION for which REGULATORY APPROVAL is granted in the relevant geographic
area shall be, and shall trigger the milestone payment for, the THIRD
INDICATION).
6.2.1 DEFINITIONS RELATING TO MILESTONE PAYMENTS.
(a) "Acceptance of all BLAs necessary for
commercialization of BEXXAR for the first MAJOR INDICATION in TERRITORY A" of a
given BLA shall be deemed to have occurred upon the earlier of (i) written
notice of acceptance from the FDA of all BLAs filed by or on behalf of Xxxxxxx
or SB under this Agreement [*] or (ii) [*] of such BLA with the FDA, [*].
"Acceptance of all [*] Applications necessary for commercialization of BEXXAR
for a MAJOR INDICATION in [*]" for a given [*] shall be deemed to have occurred
upon the date of receipt of a letter from the [*] confirming that the [*] for
BEXXAR for a MAJOR INDICATION filed by or on behalf of SB under this Agreement
has [*].
(b) The term "Outpatient [*] Guidelines" shall mean that
the [*].
(c) The term "Key [*] Cancer Centers" means the following
entities:
[*] CANCER CENTER
[*] [*]
[*]
[*]
[*]
[*]
[*]
[*] [*]
[*]
[*]
[*]
[*]
[*] [*]
[*]
[*]
(d) The term MAJOR MARKETS IN TERRITORY C consists of the
following countries: [*].
(e) The term "Initiation of a study of [*]" shall mean the
date that the [*] in the first clinical study of [*] which study is being
performed in accordance with the FD&C
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
48.
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ACT and applicable regulations promulgated thereunder (including without
limitation 21 CFR Part 312).
(f) The term "Initiation of a Pivotal Study of [*]" shall
mean the date that the [*] in the first pivotal clinical study of [*], which
pivotal study is being performed in accordance with the FD&C ACT and applicable
regulations promulgated thereunder (including without limitation 21 CFR Part
312).
(g) The term "Initiation of a Pivotal Study of [*]" shall
mean the date that the [*] in the first pivotal clinical study of [*], which
pivotal study is being performed in accordance with the FD&C ACT and applicable
regulations promulgated thereunder (including without limitation 21 CFR Part
312).
In the event that one or more of the clinical trials defined in Sections
6.2.1(e), 6.2.1(f) or 6.2.1(g) are canceled, the Parties will substitute
appropriate alternative clinical trial(s) therefor. Such alternative clinical
trial(s) must be Cross-Territory Trial(s) or Territory A Trial(s) (each as
defined in Section 3.2.3).
6.2.2 DELAY OF COMMERCIAL LAUNCH IN NON-USA TERRITORY. With
respect to any milestone outlined in this Section 6.2 which is payable upon
REGULATORY APPROVAL in any jurisdiction in the NON-USA TERRITORY, if at the time
of such REGULATORY APPROVAL, SB gives notice to Xxxxxxx that commercial launch
will be delayed in such jurisdiction due to manufacture and supply problems
beyond SB's reasonable control, then the milestone relating to the receipt of
REGULATORY APPROVAL for such jurisdiction will not be due and payable until
first commercial sale of BEXXAR in such territory.
6.2.3 NON-REFUNDABLE AND NON-CREDITABLE MILESTONE PAYMENTS. All
amounts paid under this Section 6.2 shall be non-refundable and non-creditable,
provided, however, in the event of termination of this Agreement by SB due to
material breach by Xxxxxxx, the foregoing shall not preclude SB from seeking
whatever damages are available at law.
6.2.4 OFFSET AGAINST MILESTONE PAYMENT FOR REGULATORY APPROVAL IN
TERRITORY B. The Parties acknowledge and agree that in [*] there may be costs
incurred with regard to PRODUCT due to the need for special warehousing of
radiolabeled materials and/or the use of qualified nuclear medicine personnel,
both as required by regulatory authorities. In the event that such special
warehousing and use of nuclear medicine personnel are required by the applicable
regulatory authorities in [*] and SB determines that it will incur the
additional costs for such special warehousing and/or the use of nuclear medicine
personnel, then the Parties agree that [*] of such actual costs in [*] shall be
offset against the milestone payment owed by SB to Xxxxxxx under Section 6.2 for
REGULATORY APPROVAL in the [*] for a FIRST INDICATION in the FIELD. Any amounts
so offset shall be excluded from the determination of NON-USA COGS.
6.3 MILESTONE PAYMENTS ON PRODUCTS CONTAINING SECOND GENERATION LICENSED
Compounds. In the event SB sends Xxxxxxx an SB OPTION EXERCISE NOTICE as set
forth in Section 4.2.2 with respect to a SECOND GENERATION LICENSED COMPOUND, SB
shall pay to
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Xxxxxxx the following amounts in cash within twenty (20) days after
the first achievement of each of the following events:
MILESTONE EVENT AMOUNT
-----------------------------------------------------------------------------
Acceptance of BLA in TERRITORY A for the first [*] Second $[*]
Generation Product.
Filing of MAA in European Community for the first [*] $[*]
Second Generation Product
REGULATORY APPROVAL of BLA in TERRITORY A for the first $[*]
[*] Second Generation Product.
REGULATORY APPROVAL of MAA in the first MAJOR MARKET $[*]
COUNTRY in the European Community for the first [*] Second
Generation Product.
Acceptance of BLA in TERRITORY A for the first [*] Second $[*]
Generation Product.
Filing of MAA in European Community for the first [*] $[*]
Second Generation Product.
REGULATORY APPROVAL of BLA in TERRITORY A for the first $[*]
[*] Second Generation Product.
REGULATORY APPROVAL of MAA in the first MAJOR MARKET $[*]
COUNTRY in the European Community for the first [*] Second
Generation Product.
"Second Generation Product" shall mean a PRODUCT containing a SECOND GENERATION
LICENSED COMPOUND. Each of the foregoing milestones shall be payable only once
under this Agreement, regardless of the number of [*] Second Generation Products
for which SB exercises its option and no payment shall be owed for a milestone
which is not achieved. All amounts paid under this Section 6.3 shall be
non-refundable and non-creditable, provided, however, in the event of
termination of this Agreement by SB due to material breach by Xxxxxxx, the
foregoing shall not preclude SB from seeking whatever damages are available at
law. Notwithstanding the above, or any other provision of this Agreement, in no
event shall SB owe Xxxxxxx any milestone payment under this Section 6.3 for the
achievement of any of the foregoing milestones by a SECOND GENERATION LICENSED
COMPOUND for which Xxxxxxx fails to provide the Xxxxxxx Funding Option Exercise
Notice (defined in Section 4.2.4(b)) on or before the Xxxxxxx Funding Option
Termination Date (defined in Section 4.2.4(b)).
6.4 SECTION 9.10.5 MILESTONE. The milestone payments outlined in Section
9.10.5 related to the selection of a EUROPEAN FACILITY (as defined in Section
9.10.1) for BEXXAR by SB shall be paid in accordance with the provisions of such
Section.
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RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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6.5 METHOD OF MAKING MILESTONE PAYMENTS. All payments to be made to
Xxxxxxx under Sections 6.1, 6.2, 6.3 and 6.4 shall be made by SB to Xxxxxxx by
way of wire transfer to such account as Xxxxxxx shall designate before such
payment is due.
6.6 ROYALTIES AND PROFIT SHARING. SB shall, in addition to the payments
set forth above, also pay to Xxxxxxx royalties and such other amounts as set
forth in Article 7.
6.7 [*] RIGHTS. If for any reason, SB determines, in good faith, that
BEXXAR will not be able to be [*] on or before [*], SB shall have the right to
[*] with respect to [*] and to substitute in its [*] under this Agreement [*]
(the [*]), all subject to the terms and conditions of this Section 6.7. The term
[*] as used in this Section means any [*], including without limitation, any [*]
as well as any [*], including without limitation, any [*] of any [*] any [*] of
any [*] any [*], any [*] of any [*], any [*] of any [*]; or any [*]. The [*] may
be [*] by SB from [*] which: (i) are owned or [*] as of the [*] (as defined
below); (ii) may be [*] the [*] as shown by, at least, [*]; and (iii) Xxxxxxx
has not [*] in [*] as of the [*] or is not otherwise engaged as of such [*] in
advanced [*] related to [*] in [*] by Xxxxxxx to such [*] as proven by written
documentation (e.g., a non-binding letter of intent with respect to the [*] by
[*] or other similar written evidence).
The date that SB provides written notice to Xxxxxxx of SB's determination under
this Section 6.7 shall be the [*]. Within [*] after receipt of such notice,
Xxxxxxx shall provide to SB [*] the [*] together with the essential information
available to Xxxxxxx regarding [*]. If requested by SB, Xxxxxxx shall meet with
SB as soon as possible to [*] and provide such further information as SB may
request and Xxxxxxx possesses. In any event, if SB desires to proceed with the
exercise of its rights under this Section 6.7, SB shall [*] and provide notice
of such [*] within [*] from Xxxxxxx of [*] and essential information available
to Xxxxxxx regarding [*] such [*] (the [*] being referred to herein as the [*]).
Such [*] shall [*] of [*] by [*] of the [*] and the terms of Section 13.4 of
this Agreement shall be applicable with respect to such [*]. Promptly following
such [*], the Parties shall meet to negotiate in good faith [*] to [*] and [*]
with respect to the [*], such [*] within [*] the [*]. The principles of the
agreement with respect to the [*] shall be (i) [*] shall be required of SB; (ii)
[*] and [*] in [*] related to the [*] shall be [*]; (iii) in [*], SB and Xxxxxxx
shall [*] and [*] as provided in this Agreement; and (iv) SB shall not be
responsible for [*] with respect to such [*] which have been previously paid
with respect to [*], but as to any such [*] which have not been paid, SB shall
[*] for the [*] of the same [*] provided for under this Agreement in the event
the [*] is [*] in [*] existed as of the [*], and subject to a [*] in the event
that the [*] is of [*], respectively, and based on the same events [*] (with the
Parties to agree [*] to the extent such [*]. All aspects of this Section 6.7
shall be subject to any [*] that [*] to the [*]. The Parties agree that (a)
between the [*] and the [*] which [*] of [*] under this Section 6.7, Xxxxxxx
shall not [*] regarding [*] of the [*] that are on the [*] and (b) [*] the [*]
which [*] of [*] under this Section 6.7, SB shall have no further claim to [*],
if [*] hereunder, the [*] by [*] the [*]. The Parties further agree that between
the [*] and [*] the Parties mutually agree that they will [*] the [*] and [*]
for the [*], or (y) [*] the [*] if for any reason the Parties have failed to [*]
the [*] and [*] for the [*]. Xxxxxxx shall not enter into [*] with [*] regarding
the rights to such [*] prior to [*] in the event that [*] has [*] to [*] (ii)
the failure by SB to [*] within the time periods specified above, or (iii) [*]
after the [*] if for any reason the Parties have failed to [*] the [*] and [*]
of the [*].
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RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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ARTICLE 7
MARKETING
7.1 CO-PROMOTION IN TERRITORY A.
7.1.1 RIGHTS TO CO-PROMOTE. With respect to the commercialization
of the PRODUCT in TERRITORY A, Xxxxxxx and SB shall have the right to CO-PROMOTE
the PRODUCT during the TERM OF CO-PROMOTION. Notwithstanding the foregoing, in
no event shall Xxxxxxx have responsibility to CO-PROMOTE the PRODUCT in the
Commonwealth of Puerto Rico or any territories or possessions of the United
States.
7.1.2 LEAD PARTY FOR COMMERCIALIZATION IN TERRITORY A. SB shall
be the lead Party for implementation of, and shall make tactical decisions with
regard to, CO-PROMOTION in TERRITORY A, consistent with the terms of this
Agreement, the then current JOINT MARKETING PLAN and any prior direction
provided by the JCC.
7.1.3 JOINT MARKETING PLAN.
(a) PURPOSE OF THE JOINT MARKETING PLAN. The CO-PROMOTION
of the PRODUCT will be governed by a "JOINT MARKETING PLAN" which will be in a
form consistent with SB's marketing planning process (in terms of both timetable
and required documentation, i.e., PRODUCT strategy plans and annual tactical
plans), the current format of which is attached hereto as Exhibit G, and with
the terms of this Article 7. The JOINT MARKETING Plan will take into
consideration factors such as market conditions, regulatory factors and
competition and the respective COMMERCIALLY REASONABLE EFFORTS of each Party.
Such JOINT MARKETING PLAN will attempt, to the extent practicable, to describe
the proposed plan for commercialization of the PRODUCT in the USA, including
overall marketing strategy, budget, operating guidelines (if any), market and
sales forecasts, pricing analysis and estimated launch date, guidelines for
discounting the PRODUCT, as well as advertising and other promotional materials
to be developed and used during the CO-PROMOTION.
(b) PREPARATION, APPROVAL AND MONITORING OF JOINT
MARKETING PLAN. A draft of the initial JOINT MARKETING PLAN will be developed
and approved by the JCC no later than ninety (90) days after the Effective Date.
Thereafter, an updated JOINT MARKETING PLAN will be developed and approved by
the JCC at such times as the JCC deems appropriate, but no less frequently than
annually. SB shall take the lead in preparing the JOINT MARKETING PLAN and each
update thereto in accordance with Section 7.1.6(b)(ii). The JCC will monitor
implementation of the initial JOINT MARKETING PLAN and each update thereto.
7.1.4 PRODUCT TEAM. In the interest of facilitating the
implementation of CO-PROMOTION in TERRITORY A, no later than thirty (30) days
after the Effective Date, the Parties shall form a "Product Team" composed of
both SB and Xxxxxxx personnel. Each member of the Product Team shall participate
as an equal member, provided that the Product Team shall be chaired by the
BEXXAR Product Manager from SB who shall provide direction and oversight with
respect to the implementation of the then current JOINT MARKETING PLAN and
associated tactics
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and programs. The Product Team shall develop objectives, strategies and
associated budgets for the implementation of the responsibilities indicated in
Exhibit F-1 in accordance with the then current JOINT MARKETING PLAN and SB's
marketing planning process. Coordination and updates should occur routinely
between the Product Team members. To facilitate the functioning of the Product
Team, each Party shall provide, promptly after the Effective Date and on an
ongoing basis throughout the term of the Agreement, all clinical, marketing, and
other related and necessary information that becomes available to such Party
which may be needed for the Product Team to function, provided that such
information shall be subject to the confidentiality requirements set forth in
Article 17. Each Party shall bear all travel and living expenses incurred by its
employees as a result of their participation in any of the meetings outlined in
this Section and such expenses shall not be included in the calculation of the
JOINT P&L outlined in Section 7.1.14.
7.1.5 PRODUCT PRICING. [*] PRODUCT pricing in TERRITORY A,
including discounting. Should [*] become [*] the issue of pricing, [*] shall be
handled according to the procedures set forth under Section 2.2.2.
7.1.6 EFFORTS OF THE PARTIES.
(a) SALES EFFORTS. Xxxxxxx and SB shall each use
COMMERCIALLY REASONABLE EFFORTS to CO-PROMOTE the PRODUCT in TERRITORY A
pursuant to the terms and conditions hereof. The JCC will agree upon and monitor
each Party's SALES EFFORT (as defined below) for each Co-promotion Year during
the TERM OF CO-PROMOTION. "Co-promotion Year" shall mean, for the calendar year
in which the Parties are first engaged in CO-PROMOTION, the portion of the
calendar year remaining beginning upon the date of the FIRST COMMERCIAL SALE of
the PRODUCT in TERRITORY A, and shall mean the relevant January 1 through
December 31 calendar year, or pro rata portion thereof, for all subsequent
calendar years during the TERM OF CO-PROMOTION. "SALES EFFORT" shall mean FTES
who [*] to [*] with [*] in TERRITORY A, in accordance with the then current
JOINT MARKETING PLAN, provided such [*] in an [*] and [*], including without
limitation, [*]. The Parties agree, as of the Effective Date, that in the first
Co-promotion Year Xxxxxxx will provide at least [*] FTES of SALES EFFORT in
connection with the CO-PROMOTION and SB shall provide at least [*] FTES of SALES
EFFORT in connection with the CO-PROMOTION. The number of FTES of SALES EFFORT
to be provided by each Party during each Co-Promotion Year shall be determined
by the JCC no later than [*] to the [*] of each subsequent Co-promotion Year,
provided that Xxxxxxx may provide at least [*] of such total SALES EFFORT during
each Co-Promotion Year. The JCC shall base its determination of the level of
SALES EFFORT provided by a Party on an FTE basis where, for example, one sales
representative spending [*] of his or her time on Product detailing is equal to
[*], and one sales representative spending [*] of his or her time on PRODUCT
detailing is equal to [*]. During any Co-Promotion Year, each Party shall use
its good faith efforts to deliver at least [*] of the number of FTES of SALES
EFFORT to be provided by such Party during each Co-Promotion Year as determined
by the JCC ("Minimum Sales Effort"). During any Co-Promotion Year in which a
Party [*], such Party [*] other Party [*] for each FTE (or the pro rata portion
thereof for each part FTE) for which [*] the [*]. By way of illustration, if the
number of FTES of SALES EFFORT to be provided by a Party
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during a Co-Promotion Year as determined by the JCC was [*] and the number of
FTES of SALES EFFORT [*], such Party [*] Party [*] according to the following:
(i) the [*] to be delivered by the Party during
such Co-Promotion Year would be [*] (i.e., [*]); and
(ii) [*] ([*]) [*] 1. FTE multiplied by [*].
(b) ALLOCATION OF SALES AND MARKETING RESPONSIBILITIES.
(i) SALES RESPONSIBILITIES. It is expected, as of
the Effective Date, that (i) the Xxxxxxx Sales Effort personnel will take the
lead on [*] and (ii) the SB Sales Effort personnel will take the lead on [*] not
detailed by Xxxxxxx under clause (i) above. It is further understood that the
fact that the JCC decides that one Party's Sales Effort personnel takes the lead
with respect to a particular target audience does not preclude the other Party's
Sales Effort personnel from detailing such target audience or from otherwise
providing input with respect to the lead Party's activities, provided that such
is in accordance with the then current JOINT MARKETING PLAN.
(ii) MARKETING RESPONSIBILITIES. Each Party will
contribute the expertise and undertake the activities set forth under its name
on Exhibit F-2, in accordance with the then current JOINT MARKETING PLAN. It is
understood that the JCC can reallocate the responsibilities among the Parties
set forth on Exhibit F-2 as it deems appropriate and Exhibit F-2 will be updated
accordingly. It is further understood that the fact that the JCC decides that
one Party should contribute its expertise and undertake the activities set forth
under its name on Exhibit F-2 does not preclude the other Party from
contributing its expertise or undertaking such activities or from otherwise
providing input with respect to the other Party's activities, provided that such
is in accordance with the then current JOINT MARKETING PLAN.
(c) COMPENSATION AND BONUS SYSTEM FOR SALES
REPRESENTATIVES. The Parties acknowledge that in order to attract and retain
professional pharmaceutical sales representatives, [*] SB's sales
representatives and [*] Xxxxxxx'x sales representatives. To ensure consistency
of effort between the sales representatives of the Parties, each Party agrees
that [*], each Party will [*], provided that each Party shall [*].
7.1.7 COMPLIANCE WITH LAW. Each Party shall cause its sales
force, and all other employees and approved agents and representatives, to
comply with all applicable laws, regulations and guidelines in connection with
the CO-PROMOTION of the PRODUCT, including, without limitation, the Prescription
Drug Marketing Act and the Federal Anti-Kickback Statute. Each Party shall cause
its sales force, in the course of its CO-PROMOTION of the PRODUCT, to (a) limit
its claims of efficacy and safety for PRODUCT to those which are consistent with
the JCC's then approved product circular for PRODUCT, (b) not delete or modify
claims of efficacy and safety in the CO-PROMOTION of PRODUCT so that they are
different in any way from those which are contained in the JCC's then approved
product circular for PRODUCT, or make any changes in promotional materials and
literature provided by the JCC, (c) conduct the CO-PROMOTION of PRODUCT in
strict adherence to the American Medical Association Gifts to Physicians From
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Industry Guidelines, and (d) not knowingly or negligently do anything which will
jeopardize the goodwill or reputation of PRODUCT.
7.1.8 PROMOTIONAL AND ADVERTISING MATERIALS. The Parties shall
disseminate in TERRITORY A only those promotional and advertising materials
which have been approved for use by the JCC, or the Product Team (defined in
Section 7.1.4) for those items delegated to it. SB will propose the promotional
and advertising materials to the Product Team and will be responsible for
creating and procuring any promotional and advertising materials determined to
be necessary or desirable by the Product Team. The cost of such materials shall
be included in MARKETING COSTS. [*] of such promotional and advertising
materials after review of such materials by both Parties, [*]. In the event [*]
on an [*] such promotional and advertising materials, [*] to [*], the [*] if an
[*]. In the event the [*] to [*] to [*]. All such materials shall be consistent
with the JOINT MARKETING PLAN approved by the JCC and neither Party shall make
any claims or representations in respect of the PRODUCT that have not been
approved by the JCC. All such written and visual materials and all documentary
information, promotional material, and oral presentations (where practical)
regarding the promotion of the PRODUCT will display the SB and Xxxxxxx names and
logos with equal prominence, to the extent permitted by applicable law. SB shall
have the right to make the final decision regarding the selection of the
advertising agency of record for the PRODUCT, provided that reasonably in
advance of SB implementing such decision Xxxxxxx shall have the opportunity to
participate in the selection process and to provide an opinion, and SB shall
take any Xxxxxxx comments into serious consideration, but shall not be bound by
them.
7.1.9 SAMPLES. Each of the Parties will keep accurate records as
to the distribution of free clinical trial materials and samples of PRODUCTS in
TERRITORY A, if any, provided that such distribution shall be strictly in
accordance with the determinations of the JCC and JDC, as applicable, and the
then current JOINT MARKETING PLAN and JOINT DEVELOPMENT PLAN, as applicable, and
comply with all applicable laws, rules and regulations dealing with the
distribution of such goods and samples.
7.1.10 ORDERS, DISTRIBUTION, COMPLETION OF SALES, RETURNS.
Xxxxxxx will have responsibility in TERRITORY A for (i) [*]; and (iii) [*]. SB
will have responsibility in TERRITORY A for [*]. The JCC shall determine whether
[*], and in the event such functions cannot be performed effectively by [*]. SB
shall make available to Xxxxxxx, in a format [*] to [*].
7.1.11 EXCHANGE OF MARKETING INFORMATION. From time-to-time the
JCC will develop call lists, schedules, and other appropriate information for
the purpose of determining the physicians and other persons involved in the drug
purchase decision-making process to whom Xxxxxxx and SB, respectively, may
detail and otherwise promote each Product. To the extent legally permitted, the
Parties agree to cooperate in finding an efficient, economical and expeditious
way to provide a call list and other information indicating the identity of
those physicians and other persons involved in the decision-making process
regarding the purchase of pharmaceuticals.
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BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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7.1.12 CO-PROMOTION EXPENSES.
(a) PRE-LAUNCH. Prior to commercial launch of PRODUCT in
TERRITORY A, each Party will be allowed to allocate to the JOINT P&L calculated
under Section 7.1.14 only OUT-OF-POCKET COSTS which are SALES COSTS, MARKETING
COSTS, PATENT COSTS, TRADEMARK COSTS or OTHER OPERATING INCOME/EXPENSE, all
subject to the prior approval of the JCC or in accordance with the then current
JOINT MARKETING PLAN, except that Xxxxxxx shall also be allowed to allocate to
the JOINT P&L an amount equal to [*] (i.e., [*]) for [*] the commercial launch
of PRODUCT in TERRITORY A (such amount [*]), provided that such allocation shall
not occur if the PRODUCT is not commercially launched in TERRITORY A, and such
allocation shall be made only after the PRODUCT is commercially launched in
TERRITORY A.
(b) POST-LAUNCH. After the commercial launch of PRODUCT in
TERRITORY A, those expenses outlined in Exhibit B-1 shall be allocated to the
JOINT P&L calculated under Section 7.1.14.
7.1.13 ALLOCATION OF OPERATING PROFIT OR LOSS. In consideration
for each Party's CO-PROMOTION efforts in TERRITORY A, for each calendar quarter,
SB shall be entitled to fifty percent (50%) of the OPERATING PROFIT OR LOSS for
such quarter and Xxxxxxx shall be entitled to fifty percent (50%) of the
OPERATING PROFIT OR LOSS for such quarter, such amounts to be distributed to the
Parties pursuant to Section 7.1.14.
7.1.14 JOINT P&L. Within one (1) month after the close of each
calendar quarter, or earlier if possible, during the term of this Agreement
(i.e., on or before the last day of each of the months of April, July, October
and January), Xxxxxxx shall furnish to SB a statement setting forth its COST OF
GOODS (subject to Sections 9.8.1, 9.8.2 and 9.9), MARKETING COSTS, SALES COSTS,
OTHER OPERATING INCOME/EXPENSE, DISTRIBUTION COSTS (to the extent not covered in
COST OF GOODS), PATENT COSTS and TRADEMARK COSTS (collectively, "Xxxxxxx
Operating Expenses") for such quarter in TERRITORY A, as defined in Exhibit B-1,
and all data on which the determination of such costs was calculated. Within two
(2) months after the close of each calendar quarter, or earlier if possible,
during the term of this Agreement (i.e., on or before the last day of each of
the months of May, August, November and February), SB shall furnish to Xxxxxxx a
statement (the "JOINT P&L") setting forth NET SALES in TERRITORY A during such
quarter, SB's COST OF GOODS (subject to Sections 9.8.1, 9.8.2 and 9.9),
MARKETING COSTS, SALES COSTS, OTHER OPERATING INCOME/EXPENSE, DISTRIBUTION COSTS
(to the extent not covered in COST OF GOODS), PATENT COSTS and TRADEMARK COSTS
(collectively, "SB Operating Expenses") for such quarter in TERRITORY A, as
defined in Exhibit B-1, and all data, including Xxxxxxx Operating Expenses, on
which the determination of OPERATING PROFIT OR LOSS for such quarter was
calculated. Whenever SB provides Xxxxxxx with a statement of SB Operating
Expenses, or Xxxxxxx provides SB with a statement of Xxxxxxx Operating Expenses,
the providing Party shall include supporting documentation and promptly after
request by the receiving Party, the supporting journal entries made in the
disclosing Party's books of accounts. In the event OPERATING PROFIT OR LOSS for
such quarter is a positive number, SB will submit to Xxxxxxx, with the JOINT
P&L, an amount equal to (i) Xxxxxxx Operating Expenses for such quarter plus
(ii) fifty percent (50%) of the OPERATING PROFIT OR LOSS for such quarter. In
the event OPERATING PROFIT OR LOSS for such
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RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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quarter is a negative number, either (a) SB will submit to Xxxxxxx, with the
JOINT P&L an amount equal to Xxxxxxx Operating Expenses for such quarter less
Xxxxxxx'x fifty percent (50%) share of the OPERATING PROFIT OR LOSS for such
quarter if Xxxxxxx'x Operating Expenses for such quarter exceeded Xxxxxxx'x
fifty percent (50%) share of the OPERATING PROFIT OR Loss for such quarter, or
(b) Xxxxxxx will submit to SB, within thirty (30) days after receiving the JOINT
P&L an amount equal to Xxxxxxx'x fifty percent (50%) share of the OPERATING
PROFIT OR LOSS for such quarter less Xxxxxxx Operating Expenses for such quarter
if Xxxxxxx'x Operating Expenses for such quarter is less than Xxxxxxx'x fifty
percent (50%) share of the OPERATING PROFIT OR LOSS for such quarter. If the
TERM OF CO-PROMOTION ends during an accounting quarter, the amounts due
hereunder shall be calculated for such shortened calendar quarter. In the event
that the foregoing procedure does not permit one or both of the Parties to
comply with reporting requirements under applicable United States securities
laws, rules and regulations, the JCC will modify the foregoing procedure to
permit the Parties to comply with such reporting requirements, consistent with
the general approach set forth in this Section 7.1.14. The JCC will have the
authority to amend the method utilized for determining which expenses are
included within COST OF GOODS, MARKETING COSTS, SALES COSTS, OTHER OPERATING
INCOME/EXPENSE, DISTRIBUTION COSTS (to the extent not covered in COST OF GOODS),
PATENT COSTS and TRADEMARK COSTS, as defined in Exhibit B-1 as of the Effective
Date.
7.1.15 ELECTION TO FOREGO CO-PROMOTION RIGHT. It is Xxxxxxx'x
intent, at the time of execution of this Agreement, to participate in the
CO-PROMOTION during the term of this Agreement. SB understands, however, that
Xxxxxxx'x corporate strategy may change over time. Accordingly, upon twelve (12)
months prior written notice to SB, or such lesser period as approved by SB in
writing, Xxxxxxx may elect to forego its right to participate in the
CO-PROMOTION of the PRODUCT in TERRITORY X. Xxxxxxx may also lose its rights to
CO-PROMOTE PRODUCT in TERRITORY A in accordance with the notice in that regard
provided to Xxxxxxx by SB under Section 4.2.3, or in accordance with the notice
provided by SB to Xxxxxxx under Section 5.4.1(b) or Section 5.4.2(b). In the
event that Xxxxxxx loses its rights to CO-PROMOTE PRODUCT in TERRITORY A in
accordance with Section 5.4.1(b), the terms and condition of Section 5.4.1(b)
shall be applicable. In the event that Xxxxxxx loses its rights to CO-PROMOTE
PRODUCT in TERRITORY A in accordance with Section 5.4.2(b), the terms and
condition of Section 5.4.2(b) shall be applicable. In the event that Xxxxxxx
loses its rights to CO-PROMOTE the PRODUCT in TERRITORY A in accordance with
Section 4.2.3 or the third sentence of this Section 7.1.15, the Parties will
promptly meet to negotiate, in good faith, appropriate amendment of this
Agreement to reflect the fact that Xxxxxxx will no longer participate in the
CO-PROMOTION of PRODUCT and such amendment shall include the payment from SB to
Xxxxxxx of a commercially reasonable royalty rate on NET SALES of PRODUCT in
TERRITORY A which occur after the effective date of such Xxxxxxx loss of its
rights to CO-PROMOTE PRODUCT in TERRITORY A. It is agreed that such royalty rate
shall be higher than the royalty rate to be paid on NET SALES of PRODUCT in
TERRITORY B but less than the amount that Xxxxxxx would have received had it
continued to CO-PROMOTE PRODUCT in TERRITORY A. In the event that the Parties
cannot agree as to the appropriate royalty rate within four (4) months after the
date that Xxxxxxx has lost its rights to CO-PROMOTE PRODUCT in TERRITORY A in
accordance with Section 4.2.3 or the third sentence of this Section 7.1.15, the
Parties shall submit such decision to the dispute resolution mechanism outlined
in Section 18.5. As of the effective date on which Xxxxxxx has foregone its
rights to CO-PROMOTE under the third
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
57.
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sentence of this Section 7.1.15 or has lost its rights under Sections 4.2.3,
5.4.1(b) or 5.4.2(b), it shall have no further obligations relating to marketing
or selling PRODUCT and shall also lose its rights to be reimbursed for any
activities undertaken after such loss which are related to Xxxxxxx Operating
Expenses (defined in Section 7.1.14) or to any share of the OPERATING PROFIT OR
LOSS after such effective date, although Xxxxxxx will still be entitled to be
reimbursed for DEVELOPMENT COSTS and MANUFACTURE DEVELOPMENT COSTS as provided
in the Agreement. In the event that the Parties have not determined a
commercially reasonable royalty rate as of the effective date of Xxxxxxx'x loss
of its right to Co-Promote PRODUCT in TERRITORY A in accordance with Section
4.2.3 or the third sentence of this Section 7.1.15, then until such time as such
royalty rate has been determined by the Parties or by the procedure outlined in
Section 18.5, SB shall pay Xxxxxxx a royalty of [*] of NET SALES of PRODUCT in
TERRITORY A which occur after such effective date until the date of such royalty
rate determination. The [*] royalty rate set forth in the preceding sentence
shall not be used for evidentiary purposes under the procedure outlined in
Section 18.5. If the Parties determine a commercially reasonable royalty rate,
such rate shall be retroactive to the date of Xxxxxxx'x loss of its rights to
CO-PROMOTE PRODUCT in TERRITORY A, subject to any reconciliation for payments
already made to Xxxxxxx by SB during such time period under this Section 7.1.15,
including interest to Xxxxxxx for any underpayment by SB for such time period.
7.1.16 SALES TRAINING.
(a) SB shall use its existing sales training department,
infrastructure and process to lead in the development of training materials and
programs and shall use such existing resources to execute and coordinate the
overall sales training program for the PRODUCT. SB shall provide both SB's and
Xxxxxxx'x sales representatives (up to the target number for Xxxxxxx as
determined by the JCC pursuant to Section 7.1.6(a)) with promotional training
regarding the detailing and promotion of PRODUCT to target prescribers in
TERRITORY A in accordance with the then current JOINT MARKETING PLAN, provided
that such training shall be at the same level of product training as that which
would be provided to SB's own sales representatives who have previous
professional pharmaceutical sales experience. SB training of Xxxxxxx personnel
shall be timed so as to enable Xxxxxxx'x detailing efforts in support of PRODUCT
to commence no later than the date provided in the then current JOINT MARKETING
PLAN.
(b) Xxxxxxx and SB shall revise SB training program
materials as needed to develop PRODUCT-specific training program materials and,
where Xxxxxxx and SB are unable to revise SB training program materials for such
purpose, Xxxxxxx and SB shall develop new PRODUCT-specific training program
materials as required. Specifically, it is expected that Xxxxxxx will develop
training program materials regarding (i) non-Hodgkin's lymphoma (where such
materials are not commercially available), (ii) the nuclear medicine aspects of
the PRODUCT and (iii) the clinical aspects of the PRODUCT, including
administration, treatment course and outcomes data. Xxxxxxx shall provide
appropriate personnel where necessary to participate in the delivery of
PRODUCT-specific training program materials in the sales training programs.
(c) The Parties expect that during the CO-PROMOTION, their
respective sales forces will receive PRODUCT training at formal meetings of all
sales representatives of both
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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Parties to be held approximately once or twice each year (each, a "National
Meeting") and at more frequent informal meetings of groups of sales
representatives composed of less than the entire sales force of both Parties
(each, a "Regional Meeting"). Additionally, the Parties may choose to hold
training activities at National Meetings relating both to the PRODUCT and to
other products promoted by such sales representatives. The travel and
subsistence expenses incurred by the attendees at such sales meetings shall be
borne directly by the Parties and are excluded from the calculation of the JOINT
P&L outlined in Section 7.1.14.
(d) During the term of the Agreement, each Party shall
train their sales representatives in TERRITORY A on the collection of data for
the reporting of adverse drug experiences to regulatory authorities and
regarding product-related inquiries and product complaints in TERRITORY A, in
accordance, respectively, with the pharmacovigilance agreement attached to this
Agreement as EXHIBIT H, the product inquiry process described on EXHIBIT I and
the product complaint procedure that the Parties adopt pursuant to Section 7.4.
7.2 NON-USA TERRITORY.
7.2.1 GENERAL. SB will market and sell the PRODUCT in the NON-USA
TERRITORY using COMMERCIALLY REASONABLE EFFORTS, subject to the diligence
provisions set forth in Section 7.2.2. SB shall cause its sales force, and all
other employees and approved agents and representatives, to comply with all
applicable laws, regulations and guidelines in connection with the sale of the
PRODUCT in the NON-USA TERRITORY. SB shall give Xxxxxxx an opportunity to review
and comment upon the NON-USA MARKETING PLAN (when available, but in any event
prior to implementation of such marketing plan), provided that while SB shall
take such comments into serious consideration, SB shall not be bound by them. SB
shall inform Xxxxxxx of any significant decisions made by SB or its permitted
sublicensees regarding implementation of the NON-USA MARKETING PLAN sufficiently
in advance of such implementation to enable Xxxxxxx to comment upon such
decisions, and SB shall take such comments into serious consideration, but shall
not be bound by them.
7.2.2 COMMERCIALIZATION MILESTONES.
(a) In addition to the obligations set forth in Section
7.2.1, in each MAJOR MARKET COUNTRY in which SB receives REGULATORY APPROVAL for
the FIRST INDICATION, SB will achieve FIRST COMMERCIAL SALE for the FIRST
INDICATION [*] months of the date it receives such REGULATORY APPROVAL. Such
time period will be extended if factors beyond SB's reasonable control
(including without limitation, [*]) preclude FIRST COMMERCIAL SALE, but such
extension shall last only for so long as such factors continue. In the event SB
does not achieve such milestone in a given MAJOR MARKET COUNTRY by such date, as
such may be extended under this Section 7.2.2(a), and is unable to convince
Xxxxxxx to further extend such date, Xxxxxxx may elect to adjust the licenses
granted by Xxxxxxx under Article 5 of this Agreement to (i) exclude such MAJOR
MARKET COUNTRY from the TERRITORY or (ii) become non-exclusive in such MAJOR
MARKET COUNTRY. In the event Xxxxxxx makes such election, it shall provide
written notice to SB and, as of the date of such notice, the terms of Sections
13.4 or 13.5, as applicable, shall apply for such MAJOR MARKET COUNTRY.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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(b) In the event that, in any calendar year following the
third anniversary of the date of FIRST COMMERCIAL SALE in a MAJOR MARKET COUNTRY
for the FIRST INDICATION, the royalty amount payable under Section 7.2.4(a) for
a given calendar year is less than the Minimum Distribution Payment (as defined
in Section 7.2.2(c)) for such MAJOR MARKET COUNTRY for such calendar year, SB
may, within [*] of the end of such calendar year, pay Xxxxxxx the difference
between the Minimum Distribution Payment for such MAJOR MARKET COUNTRY for such
year (as determined in accordance with Section 7.2.2(c)) and the royalty amount
payable under Section 7.2.4(a) for such year (the "Differential"). In the event
SB elects not to pay the Differential for such MAJOR MARKET COUNTRY for such
calendar year, SB shall explain the circumstances for the Differential to
Xxxxxxx and Xxxxxxx shall consider such circumstances in good faith. Xxxxxxx may
elect either to (i) terminate the licenses granted by Xxxxxxx under this
Agreement for such MAJOR MARKET COUNTRY or (ii) adjust the licenses granted by
Xxxxxxx under Article 5 of this Agreement to become non-exclusive for such MAJOR
MARKET COUNTRY. Prior to Xxxxxxx making such election, the Parties may mutually
agree to meet to discuss the percentage of RADIOLABELED ANTIBODY manufactured at
the EUROPEAN FACILITY (as defined in Section 9.10.1) (if such EUROPEAN FACILITY
is completed by SB and regulatory approval for such EUROPEAN FACILITY is granted
to SB) that SB shall make available to Xxxxxxx in the event Xxxxxxx makes the
election under clause (ii) above and the commercially reasonable prices at which
such RADIOLABELED ANTIBODY would be made available to Xxxxxxx. If the Parties
are unable to agree upon the terms under which SB would supply RADIOLABELED
ANTIBODY to Xxxxxxx, Xxxxxxx shall make the election set forth above regarding
the termination or non-exclusivity in such countries of the licenses granted by
Xxxxxxx under Article 5 of this Agreement. In the event Xxxxxxx makes the
election in clause (i), it shall provide written notice to SB and, as of the
date of such notice, the terms of Section 13.4 shall apply with regard to such
MAJOR MARKET COUNTRY. In the event Xxxxxxx makes the election in clause (ii), it
shall provide written notice to SB and, as of the date of such notice, the terms
of Section 13.5 shall apply for such MAJOR MARKET COUNTRY. In the event Xxxxxxx
makes the election in clause (ii) and grants a non-exclusive license to a THIRD
PARTY to sell PRODUCT in such MAJOR MARKET COUNTRY [*] are [*].
(c) A separate "Minimum Distribution Payment" will be
calculated for each MAJOR MARKET COUNTRY for each applicable calendar year
(i.e., each calendar year following the third anniversary of the date of FIRST
COMMERCIAL SALE in such country) and will equal A times B times C, where:
A = [*]; and
B = [*]; and
C = [*]
provided that (i) [*]; and (ii) [*] at [*] [*] in [*].
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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7.2.3 THIRD PARTY DISTRIBUTION AGREEMENTS.
(a) SB may enter into marketing distribution agreements
regarding the PRODUCT with THIRD PARTIES in the MAJOR MARKET COUNTRIES only upon
the prior written consent of Xxxxxxx, such consent not to be unreasonably
withheld. SB may enter into marketing distribution agreements regarding the
PRODUCT with THIRD PARTIES in those parts of the NON-USA TERRITORY which are not
MAJOR MARKET COUNTRIES without the consent of Xxxxxxx, provided, however, SB
shall provide written notice to Xxxxxxx at least fifteen (15) business days
prior to entering into such distribution agreements. Such notice shall include
the name of the THIRD PARTY distributor and a brief description of the proposed
agreement. Notwithstanding anything in this Section 7.2.3(a), SB shall not be
obligated to obtain Xxxxxxx'x consent to enter into agreements solely related to
supply chain distribution, including without limitation with radiopharmacies, in
the NON-USA TERRITORY.
(b) SB's obligations under this Agreement, as reasonably
applicable, will apply to any THIRD PARTIES that enter into permitted marketing
distribution or supply chain distribution agreements and sublicenses with SB
with regard to the PRODUCT. Sales of PRODUCT by distributors or sublicensees of
SB shall be handled as set forth in Section 8.4.
7.2.4 ROYALTIES IN NON-USA TERRITORY.
(a) TERRITORY B. Subject to Sections 7.2.2(b), 7.2.5,
7.2.6 and 11.7, within forty five (45) days of the end of each calendar quarter
following FIRST COMMERCIAL SALE in TERRITORY B, SB shall pay to Xxxxxxx
royalties on NET SALES of Products by SB or its AFFILIATES and sublicensees in
TERRITORY B at a rate of [*] of such NET SALES. Included with each payment shall
be an accounting setting forth NET SALES in such territory during the applicable
quarter, on a country-by-country basis expressed in unit sales, local currency
and dollar equivalents.
(b) TERRITORY C. Subject to Sections 7.2.5, 7.2.6 and
11.7, within forty five (45) days of the end of each calendar quarter following
FIRST COMMERCIAL SALE in TERRITORY C, SB shall pay to Xxxxxxx royalties on NET
SALES of PRODUCTS by SB or its AFFILIATES and sublicensees in TERRITORY C at a
rate of [*] of such NET SALES. Included with each payment shall be an accounting
setting forth NET SALES in such territory during the applicable quarter, on a
country-by-country basis expressed in unit sales, local currency and dollar
equivalents.
(c) NON-USA DEDUCTION RATE. In the event that either (a)
the Non-USA Deduction Rate (as defined below) exceeds [*] in any given
continuous four (4) calendar quarter period (a "Rolling Year") or (b) the
Non-USA Deduction Rate for any given Rolling Year is greater than [*] and at
least [*] higher than the Non-USA Deduction Rate for the previous Rolling Year
(for example, if in one Rolling Year the Non-USA Deduction Rate is [*] and in
the next Rolling Year the Non-USA Deduction Rate is [*] or greater), SB shall,
upon the written request of Xxxxxxx, provide Xxxxxxx with a reasonably detailed
written explanation of why the Non-USA Deduction Rate was at such a level.
Xxxxxxx shall make such a request to SB no later than sixty (60) days after the
end of a given Rolling Year and SB shall provide Xxxxxxx with such an
explanation within forty-five (45) days of Xxxxxxx'x request. For purposes of
this Section 7.2.4(c), "Non-USA Deduction Rate" shall equal, for any given
calendar year, [*].
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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7.2.5 INCREASE OR DECREASE IN ROYALTIES BASED ON NON-USA COGS.
(a) In the event the NON-USA COGS plus Standard Royalties
(as defined in Section 7.2.5(f)), as expressed as a percent of NET SALES, for
any given country in the GUARANTEED COGS TERRITORY is greater than the
GUARANTEED COGS PLUS ROYALTIES PERCENT (as set forth in Section 7.2.5(c)) for
such country for the applicable calendar quarter, the royalties payable by SB to
Xxxxxxx for such quarter pursuant to Section 7.2.4 shall be adjusted downward so
that the NON-USA COGS plus royalty payable to Xxxxxxx for such country divided
by NET SALES for such country for such quarter equals the GUARANTEED COGS PLUS
ROYALTIES PERCENT, provided, however, in no event shall the Adjusted Royalties
(as defined in Section 7.2.5(f)) paid to Xxxxxxx for such country for such
quarter be less than the greater of (i) [*] of NET SALES for such country for
such quarter and (ii) [*] per Bexxar Therapy (as defined in Section 7.2.5(f)
below). This Section 7.2.5(a) shall have no further effect for a given country
in the GUARANTEED COGS TERRITORY following the twentieth (20th) Quarter After
First Commercial Sale in Such Country (as defined in Section 7.2.5(c)).
(b) In the event the NON-USA COGS plus Standard Royalties,
as expressed as a percent of NET SALES, for any given country in the GUARANTEED
COGS TERRITORY is less than the GUARANTEED COGS PLUS ROYALTIES PERCENT for such
country for the applicable calendar quarter, the royalties payable by SB to
Xxxxxxx for such quarter pursuant to Section 7.2.4 shall be adjusted upward so
that [*] of any difference between GUARANTEED COGS PLUS ROYALTIES PERCENT and
NON-USA COGS plus Standard Royalties, as expressed as a percent of NET SALES, is
added to the royalties which would otherwise be payable to Xxxxxxx under Section
7.2.4; provided, however, in no event shall the Adjusted Royalty paid to Xxxxxxx
for such country for such quarter be greater than [*] of NET SALES for such
country for such quarter. This Section 7.2.5(b) shall have no further effect for
a given country in the GUARANTEED COGS TERRITORY following the twentieth (20th)
Quarter After First Commercial Sale in Such Country (as defined in Section
7.2.5(c)).
(c) "GUARANTEED COGS PLUS ROYALTIES PERCENT" shall be
calculated on a country-by-country basis and a quarter-by-quarter basis and
shall be equal to the following:
Quarter After First Guaranteed COGS
Commercial Sale in Plus Royalties
Such Country Percent
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
For the avoidance of doubt, in the event the FIRST COMMERCIAL SALE in a
country in the GUARANTEED COGS TERRITORY occurs at any time after the first day
of a quarter, NET SALES of PRODUCT made on the remaining days in such country in
such quarter shall be subject to the [*] GUARANTEED COGS PLUS ROYALTIES PERCENT.
For purposes of this Section 7.2.5(c), the
[*] = 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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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subsequent quarter after such quarter during which the FIRST COMMERCIAL SALE is
made in such country shall be deemed the first "Quarter After First Commercial
Sale in Such Country."
(d) In the event that, at any time following the [*] after
FIRST COMMERCIAL SALE in a country in the GUARANTEED COGS TERRITORY, the NON-USA
COGS plus Standard Royalties, as expressed as a percent of NET SALES, for such
country is less than [*] of NET SALES for such country for such quarter, the
royalties payable by SB to Xxxxxxx for such quarter pursuant to Section 7.2.4
shall be adjusted upward so that [*] of any difference between [*] of NET SALES
for such country for such quarter and the NON-USA COGS plus Standard Royalties,
as expressed as a percent of NET SALES, for such country is added to the
royalties which would otherwise be payable to Xxxxxxx under Section 7.2.4,
provided, however, in no event shall the Adjusted Royalty paid to Xxxxxxx for
such country for such quarter be greater than [*] of NET SALES for such country
for such quarter.
(e) In the event SB assumes responsibility for
manufacturing or having manufactured UNCONJUGATED ANTIBODY for any country in
the GUARANTEED COGS TERRITORY under Section 9.6.1, for the purpose of
calculating the NON-USA COGS for such country, [*].
(f) Included with the quarterly accounting SB provides to
Xxxxxxx pursuant to Section 7.2.4 shall be, for each country in the GUARANTEED
COGS TERRITORY: (i) [*], (ii) [*] and (iii) [*]. All of the foregoing
calculations shall be performed [*] and on [*] for each country and expressed in
dollars and as a percent of NET SALES for such country for such quarter. For
purposes of this Section 7.2.5, "Bexxar Therapy" shall mean radioimmunotherapy
using BEXXAR as administered (i), [*] (ii) [*] or (iii) [*].
(g) The Parties may discuss from time to time the need to
expand the GUARANTEED COGS TERRITORY, and upon mutual agreement of the Parties,
such GUARANTEED COGS TERRITORY may be expanded to include additional countries.
7.2.6 DECREASE IN ROYALTIES BASED ON SUBSTANTIAL COMPETITION. If,
during the term of this Agreement, substantial competition occurs in a country
of TERRITORY B or TERRITORY C between PRODUCT and one or more THIRD PARTY
products which [*] as of the Effective Date, and for so long as such substantial
competition is continuing, the royalty rates payable by SB to Xxxxxxx on NET
SALES of PRODUCT under Sections 7.2.4(a) and 7.2.4(b) in the country or
countries where such competition exists shall decrease by [*]. For purposes of
this Paragraph, "substantial competition" shall mean a total sales volume of
such THIRD PARTIES combined, in the particular country of the TERRITORY, of at
least [*] of NET SALES volume of such PRODUCT in such country, and "continuing"
shall mean a period of at least [*]. SB shall give Xxxxxxx written notice of
such substantial competition with suitable and reasonable supporting
documentation, including, for example, but not limited to, copies of market
survey reports, THIRD PARTY bid activities, competitive promotional materials,
and internal financial statements. Any reduction in the payment due from SB as a
result of such THIRD PARTY competition shall be applied retroactively to the
date on which substantial competition appeared in the TERRITORY as supported by
reasonable documentation and shall be available to SB [*].
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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7.3 NO DELEGATION. Subject to Section 7.2.3, each of the Parties may use
only its own employees or the employees of one or more of its AFFILIATES in the
course of exercising sales efforts with respect to its CO-PROMOTION rights under
this Agreement in TERRITORY A, unless an alternative arrangement in TERRITORY A
is approved in advance by the JCC or, unless Xxxxxxx loses its rights to
CO-PROMOTE PRODUCT in TERRITORY A under Section 7.1.15, or unless an alternative
arrangement is approved in advance by Xxxxxxx in the event of distribution or
sublicense agreements in the MAJOR MARKET COUNTRIES under Sections 7.2.3 or
5.1.5.
7.4 PRODUCT COMPLAINTS. Each Party shall maintain a record of all
complaints it receives with respect to the PRODUCT (each, a "Product
Complaint"). For purposes of this Section 7.4, a "Product Complaint" is a report
of an actual or potential failure of the PRODUCT to meet the standards set forth
in regulatory filings or in agreements among the Parties. Such failure may
involve the finished PRODUCT or one of its intermediate stages. The
responsibilities of the Parties with respect to (a) notification of the Product
Complaint from the receiving Party to the other Party and (b) the handling of
Product Complaints shall all be performed in accordance with a procedure to be
mutually agreed by the Parties after the Effective Date.
7.5 PRODUCT-RELATED INQUIRIES. For handling any medical or technical
Product-related inquiries throughout the TERRITORY, the responsibilities of the
Parties shall be performed in accordance with the allocation set forth on
EXHIBIT I.
7.6 ADVERSE DRUG EVENT REPORTING. For the reporting of adverse drug
experiences to regulatory authorities throughout the TERRITORY, the
responsibilities of the Parties shall be performed in accordance with the
pharmacovigilance agreement attached to this Agreement as EXHIBIT H.
ARTICLE 8
ACCOUNTS AND RECORDS; WITHHOLDING TAX
8.1 NO DOUBLE COUNTING OF COSTS. For the purpose of determining any cost
or expense which is shared by the Parties under this Agreement or otherwise
invoiced by one Party to another under this Agreement, any cost or expense
allocated by either Party to a particular cost category shall be consistent with
the terms of this Agreement and shall not also be allocated to another category.
In the event a cost or expense might arguably fall into more than one category,
the FINANCE SUBTEAM shall determine which category such cost or expense most
appropriately falls into. In the event the FINANCE SUBTEAM is unable to agree on
such a determination, the JDC and/or JCC, as applicable, shall make such a
determination.
8.2 RECORDS. Each Party shall keep accurate books and accounts of record
in connection with any of the following costs which are incurred by it in
accordance with this Agreement: DEVELOPMENT COSTS, MANUFACTURE DEVELOPMENT
COSTS, SECOND GENERATION LICENSED COMPOUND CANDIDATE DEVELOPMENT COSTS, SECOND
GENERATION LICENSED COMPOUND CANDIDATE MANUFACTURE DEVELOPMENT COSTS, COST OF
GOODS, MARKETING COSTS, SALES COSTS, OTHER OPERATING INCOME/EXPENSE,
DISTRIBUTION COSTS, NET SALES, OPERATING
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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PROFIT OR LOSS, OUT-OF-POCKET COSTS, QA/QC COSTS, EXISTING THIRD PARTY LICENSE
COSTS, NEW THIRD PARTY LICENSE COSTS, PATENT COSTS, and TRADEMARK COSTS, as well
as any other costs which are relevant for determining any cost or expense which
is shared by the Parties under this Agreement, charged by one Party to the other
Party under this Agreement, or paid by one Party to the other Party under this
Agreement. Such books and accounts of record shall be kept in sufficient detail
to permit accurate determination of all figures necessary for verification of
royalties, profits and other compensation required to be paid hereunder. Each
Party shall maintain such records for a period of three (3) years after the end
of the year in which they were generated.
8.3 AUDITS. Each Party, through an independent certified public
accountant reasonably acceptable to the other Party, shall have the right, at
its own expense, to access the books and records of the other Party for the sole
purpose of verifying financial statements furnished by such Party under this
Agreement. Such access shall be permitted during the term of the Agreement and
for six (6) months after its termination; provided, however, that such
examination shall not take place more often than once a year and shall not cover
such records for more than the preceding two (2) years, unless a material
discrepancy is found, in which case such examination shall include the records
for the preceding three (3) years, provided further that such accountant shall
report to the other Party only as to the accuracy of the statements and payments
made by the Party under examination to the other Party, and further provided
that such access shall be conducted after reasonable prior written notice to the
other Party and during ordinary business hours and shall not be more frequent
than once during each calendar year. The Parties agree to keep in strict
confidence all information learned in the course of such audit, except when it
is necessary to reveal such information in order to enforce its rights under
this Agreement. In the event such audit reveals an underpayment of five percent
(5%) or more of the amount actually due, the Party subject to the audit shall
reimburse the auditing Party for the costs of such audit in addition to promptly
remitting to the auditing Party the amount of any underpayment. In the event
such audit reveals an overpayment of five percent (5%) or more of the amount
actually due, the auditing Party shall promptly reimburse such amount to the
Party subject to the audit.
8.4 SALES BY SUBLICENSEES. In the event SB grants licenses or
sublicenses to others to make or sell the PRODUCT or grants THIRD PARTIES the
right to distribute the PRODUCT, as permitted by Sections 5.1.5, 7.2.3 or 7.3,
such licenses or sublicenses or distribution agreements shall include an
obligation for the licensee, sublicensee or distributor to account for and
report its NET SALES of such PRODUCTS on the same basis as if such sales were
NET SALES by SB, and Xxxxxxx shall receive royalties in the same amounts as if
the NET SALES of the licensee, sublicensee or distributor were NET SALES of SB.
8.5 WITHHOLDING. Xxxxxxx shall pay any and all taxes levied on account
of royalties it receives under this Agreement. If laws or regulations require
that taxes be withheld, SB will (i) deduct those taxes from the remittable
royalty, (ii) pay the taxes to the proper taxing authority, and (iii) send
evidence of the obligation together with proof of payment to Xxxxxxx within
sixty (60) days following such payment. SB will cooperate to help Xxxxxxx
minimize, in any lawful manner, the foregoing taxes and will provide Xxxxxxx
with reasonable assistance to enable Xxxxxxx to recover such taxes as permitted
by law.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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8.6 CURRENCY OF PAYMENT. All dollar amounts contained in this Agreement
are in United States Dollars (US$) and all payments to be made under this
Agreement shall be made in United States Dollars to a bank account designated by
the Party to be paid. Royalties earned shall first be determined in the currency
of the country in which they are earned and then converted into United States
Dollars using the rate of exchange used by SB for AFFILIATE conversions,
provided however, that such rate of exchange shall approximate fair market value
and, in the event of rapidly changing exchange rates, SB shall consult with
Xxxxxxx and the Parties shall agree on a mechanism to assure that exchange rates
are calculated to reflect fair market values on an ongoing basis. In each
country where the local currency is blocked and cannot be removed from the
country, royalties accrued in that country shall be paid to Xxxxxxx in the
country in local currency by deposit in a local bank designated by Xxxxxxx,
unless the Parties otherwise agree.
8.7 ACCOUNTING. No later than thirty (30) days after the end of each
calendar quarter, each Party shall submit to the other Party an accounting of
all costs incurred by such Party during such quarter which are to be shared with
the other Party as provided under Sections 5.3.1, 5.3.3(b), 11.5.1, 11.5.3 or
19.15. In the event payment is due by the Party which is receiving the
accounting to the incurring Party, the Party which owes the payment shall make
such payment to the other Party within thirty (30) days after it has received
such accounting. The Party receiving the payment shall issue an invoice to the
Party making the payment which invoice shall be in the amount to be paid.
ARTICLE 9
MANUFACTURING AND SUPPLY
9.1 COOPERATION. Xxxxxxx and SB will cooperate to determine
manufacturing strategy and objectives for the supply of UNCONJUGATED ANTIBODY
and RADIOLABELED ANTIBODY, consistent with the terms of this Article 9, the
Lonza Agreements, the BI Pharma Agreements, the Cytogen Agreement and the
Nordion Agreements (as such terms are defined below) and any NEW THIRD PARTY
MANUFACTURE AND SUPPLY CHAIN AGREEMENTS. Such strategy and objectives will be
coordinated through the JDC, the JCC and the MANUFACTURE AND SUPPLY CHAIN
SUBTEAM, as more fully described in Article 2.
9.2 PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS. It
is acknowledged that, as of the Effective Date, Xxxxxxx has entered into the
following agreement with Lonza Biologics PLC relating to the B1 MURINE ANTIBODY:
Agreement between Lonza Biologics PLC and Xxxxxxx Pharmaceutical, Inc.,
dated May 28, 1998 (the "Lonza Agreement").
It is acknowledged that, as of the Effective Date Xxxxxxx will have
entered into an agreement with BI Pharma relating to the manufacture of
UNCONJUGATED ANTIBODY which is B1 MURINE ANTIBODY (the "BI Pharma Agreement").
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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It is acknowledged that, as of the Effective Date Xxxxxxx has entered
into the following agreement with Cytogen Corporation relating to vialing of the
B1 MURINE ANTIBODY:
Manufacturing Agreement between Cytogen Corporation and Xxxxxxx
Pharmaceutical, Inc., dated August 31, 1996, (the "Cytogen Agreement").
It is acknowledged that, as of the Effective Date Xxxxxxx has entered
into the following agreements with MDS Nordion Inc. relating to the
radiolabeling of the B1 MURINE ANTIBODY:
Facilities Agreement between MDS Nordion Inc. and Xxxxxxx
Pharmaceutical, Inc., dated August 31, 1998, and
Supply Agreement between MDS Nordion Inc. and Xxxxxxx Pharmaceutical,
Inc., dated August 31, 1998 (collectively, the "Nordion Agreements").
Copies of all of the foregoing agreements (collectively, the
"PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS") have been
provided to SB, except that the BI Pharma Agreement will be provided to SB prior
to the Effective Date pursuant to Section 19.1.
9.3 CONFORMITY WITH PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY
CHAIN AGREEMENTS AND ANY NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN
AGREEMENTS. As of the Effective Date, the terms of this Article 9, including,
but not limited to, those relating to forecasts, ordering procedures, regulatory
communication, regulatory inspections, QA/QC, inventory and testing procedures,
are consistent with the PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN
AGREEMENTS. Xxxxxxx shall not amend any of the PRE-EXISTING THIRD PARTY
MANUFACTURE AND SUPPLY CHAIN AGREEMENTS, and neither Xxxxxxx nor SB shall enter
into any other THIRD PARTY manufacturing or supply chain agreements with Lonza,
BI Pharma, Cytogen or Nordion or any other THIRD PARTY relating to the PRODUCT
(collectively, "NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS")
without the prior approval of the JDC, upon the review and recommendation of the
MANUFACTURE AND SUPPLY CHAIN SUBTEAM. In order to facilitate such review and
approval, Xxxxxxx shall provide such proposed amendments to the PRE-EXISTING
THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS and such proposed NEW THIRD
PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS to the MANUFACTURE AND SUPPLY
CHAIN SUBTEAM in a timely manner and the MANUFACTURE AND SUPPLY CHAIN SUBTEAM
and JDC shall consider such proposals in a timely manner. In the event that
Xxxxxxx, with the approval of the JDC, does enter into one or more NEW THIRD
PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS with Lonza, BI Pharma, Cytogen,
Nordion or any other THIRD PARTY and the terms of such NEW THIRD PARTY
MANUFACTURE AND SUPPLY CHAIN AGREEMENTS are inconsistent with the terms of this
Article 9, the Parties, upon the recommendation of the JDC, will amend the terms
of this Article 9 to make it consistent with the terms of such NEW THIRD PARTY
MANUFACTURE AND SUPPLY CHAIN AGREEMENTS.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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9.4 RESPONSIBILITY FOR MANUFACTURE, SUPPLY AND DISTRIBUTION.
9.4.1 UNCONJUGATED ANTIBODY. Except as set forth in Sections 9.6
and 9.16, Xxxxxxx shall manufacture or have manufactured and supply all
requirements in the TERRITORY for UNCONJUGATED ANTIBODY, whether for DEVELOPMENT
or commercial sale in accordance with the Specifications (as defined in Section
9.4.4). Except as set forth in Sections 9.6 and 9.16, SB shall obtain all
requirements in the TERRITORY for UNCONJUGATED ANTIBODY, whether for DEVELOPMENT
or commercial sale, from Xxxxxxx.
9.4.2 RADIOLABELED ANTIBODY FOR DEVELOPMENT. [*] or [*] and [*],
Xxxxxxx shall manufacture or have manufactured and supply all requirements of
RADIOLABELED ANTIBODY for DEVELOPMENT in the TERRITORY in accordance with
Specifications (as defined in Section 9.4.4). [*] and [*] and [*], SB shall
obtain all requirements for RADIOLABELED ANTIBODY for DEVELOPMENT in the
TERRITORY from Xxxxxxx, except in the event Xxxxxxx does not have sufficient
capacity, in which case the Parties shall proceed in the manner described in
Section 9.17.
9.4.3 RADIOLABELED ANTIBODY FOR COMMERCIAL SALE.
(a) Xxxxxxx shall manufacture or have manufactured and
supply all requirements of RADIOLABELED ANTIBODY for commercial sale in NORTH
AMERICA except as otherwise provided by Section 9.17. SB shall obtain all
requirements for RADIOLABELED ANTIBODY for commercial sale in NORTH AMERICA from
Xxxxxxx except as otherwise provided by Section 9.17.
(b) [*], Xxxxxxx shall manufacture or have manufactured
and supply all requirements of RADIOLABELED ANTIBODY for commercial sale in
TERRITORY B and TERRITORY C which the Parties agree Xxxxxxx is feasibly able to
supply, given transportation and distribution constraints. [*], SB shall obtain
all requirements for RADIOLABELED ANTIBODY for commercial sale in the TERRITORY
from Xxxxxxx, except in the event Xxxxxxx does not have sufficient capacity, in
which case the Parties shall proceed in the manner described in Section 9.17. In
no event will Xxxxxxx be obligated to supply RADIOLABELED ANTIBODY hereunder
[*]. In the event [*] under [*] for [*] to the [*].
9.4.4 SPECIFICATIONS. As used in this Section 9.4, and throughout
the Agreement, the term "Specifications" shall mean the requirements and
standards pertaining to UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY
(depending upon context) and consistent with filings made for REGULATORY
APPROVAL and the PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN
AGREEMENTS, which Specifications shall be reduced to writing by the JDC after
the Effective Date. After the Effective Date such Specifications shall be
subject to ongoing review by the Parties and may be modified from time to time,
which modifications shall be approved by the JDC. The Specifications shall be
release or stability specifications, as applicable, and each reference to
Specifications shall mean the type of such specifications appropriate to
context.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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9.4.5 NON-COMPLIANCE WITH SPECIFICATIONS.
(a) Xxxxxxx shall provide a Certificate of Analysis and a
Certificate of Conformance (together, a "COA") from the THIRD PARTY manufacturer
to SB as well as any report of separate quality control analysis of UNCONJUGATED
ANTIBODY or RADIOLABELED ANTIBODY performed by Xxxxxxx with each shipment of
UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY specifying that such UNCONJUGATED
ANTIBODY or RADIOLABELED ANTIBODY conforms with the Specifications (as defined
in Section 9.4.4). Xxxxxxx shall provide the results of such analysis along with
any supporting data. SB shall be under no obligation to accept any shipment of
UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY without an accompanying COA. If
the quality of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY supplied by
Xxxxxxx under this Agreement is found not to conform to the Specifications as
judged by comparison of the Specifications and the COA (as well as by comparison
to information regarding the quality of UNCONJUGATED ANTIBODY and RADIOLABELED
ANTIBODY developed by SB upon re-testing of such UNCONJUGATED ANTIBODY and
RADIOLABELED ANTIBODY, such re-testing to be performed by SB only in the event
that SB is legally required to do so by the relevant regulatory authorities), SB
shall notify Xxxxxxx of such nonconformity no later than thirty (30) days after
receipt thereof in the case of UNCONJUGATED ANTIBODY and no later than three (3)
days after receipt thereof in the case of RADIOLABELED ANTIBODY, and, subject to
Section 9.4.5(b), Xxxxxxx shall replace, at no additional expense to SB, such
UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY with new UNCONJUGATED ANTIBODY or
RADIOLABELED ANTIBODY which does conform to the Specifications within the
minimum number of days after receipt of SB's notification under this Section
9.4.5 that such replacement is permitted under the relevant PRE-EXISTING THIRD
PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS and NEW THIRD PARTY MANUFACTURE
AND SUPPLY CHAIN AGREEMENTS; provided that the foregoing shall not be
interpreted to change in any way Xxxxxxx'x ongoing supply obligations with
respect to other UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY ordered by SB in
conformance with the supply procedures outlined in this Agreement.
(b) If Xxxxxxx disagrees with SB's determination that the
rejected shipment did not meet the Specifications, a sample of the rejected
shipment shall be submitted to an independent, qualified THIRD PARTY laboratory
that is mutually acceptable and selected by the parties promptly in good faith.
Such laboratory shall determine whether the rejected UNCONJUGATED ANTIBODY or
RADIOLABELED ANTIBODY (as applicable) meets the Specifications, and such
laboratory's determination shall be final and determinative for purposes of this
Agreement, and Xxxxxxx'x obligation to replace the non-conforming UNCONJUGATED
ANTIBODY or RADIOLABELED ANTIBODY outlined in Section 9.4.5(a) shall be stayed
pending the result of such determination. The Party against whom the laboratory
rules shall bear all costs of the laboratory testing. If the laboratory rules
that the shipment failed to meet Specifications, the replacement shipment shall
be at no charge to SB (provided SB paid for the initial shipment). If the
laboratory rules the rejected shipment met the Specifications, then SB shall
accept such batch for use and shall reimburse Xxxxxxx for the replacement
shipment (including all costs of shipping and insurance). Xxxxxxx shall give SB
written instructions as to how SB should, at Xxxxxxx'x expense, dispose of the
non-conforming material, and such instructions shall comply with all appropriate
governmental requirements.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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(c) In the event that a Party assumes responsibility for
manufacturing UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY under Sections
9.6.1 or 9.6.2, the SB Supply Agreement or the Xxxxxxx Supply Agreement, as the
case may be, shall contain provisions substantially similar to those set forth
in this Section 9.4.5.
9.4.6 DISTRIBUTION. Distribution of the PRODUCT in TERRITORY A
shall be handled in the manner described in Section 7.1.10. Distribution of the
PRODUCT outside TERRITORY A shall be handled exclusively by SB.
9.5 ALLOCATION IN THE EVENT OF PRODUCT SHORTAGES.
9.5.1 ALLOCATION BETWEEN DEVELOPMENT AND COMMERCIALIZATION. In
the event of shortages of UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY,
available supplies shall be allocated first to permit any ongoing clinical
trials to continue on schedule unless the Parties otherwise agree at the time.
Supplies remaining available after that initial allocation shall be allocated as
between other DEVELOPMENT activities and commercialization activities by the
JCC. The use of additional material allocated for DEVELOPMENT activities shall
be determined by the JDC.
9.5.2 ALLOCATION OF SHORTAGES BETWEEN TERRITORIES (COMMERCIAL
SUPPLY). In the event of shortages of UNCONJUGATED ANTIBODY or RADIOLABELED
ANTIBODY, any material remaining available for commercial use after the
allocations to DEVELOPMENT activities made under Section 9.5.1 shall be
allocated by the JCC on a country-by-country basis, based upon [*] or some other
mechanism to be mutually agreed upon by the Parties, provided, however, at least
[*] of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY available for commercial
sale [*].
9.5.3 NO LIABILITY FOR PRODUCT SHORTAGES. The Parties recognize
that there is no assurance that PRODUCT supply will be sufficient to meet
demand. Neither Party shall be liable to the other for a failure to supply
UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY, provided, however, that a Party
may still be liable in the event of a failure to comply with the allocation
mechanisms of Sections 9.5.1 or 9.5.2.
9.6 CHANGE IN RESPONSIBILITY FOR MANUFACTURE AND SUPPLY.
9.6.1 UNCONJUGATED ANTIBODY BY SB. If at any time during the term
of the Agreement, SB desires to have responsibility for manufacture for supply
of UNCONJUGATED ANTIBODY, in whole or in part, for sale in the TERRITORY,
transferred from Xxxxxxx to SB, SB shall [*] to [*]. [*] in [*] for [*] (the "SB
Supply Agreement"). The SB Supply Agreement shall include [*]. [*] a [*] the [*]
to [*] of [*], the [*]. In any event, the decision whether to transfer the
responsibility for supply of UNCONJUGATED ANTIBODY from Xxxxxxx to SB pursuant
to an SB Supply Agreement [*]. If the Parties elect to enter into such SB Supply
Agreement, to the extent a transfer under such SB Supply Agreement requires a
modification of this Article 9, the Parties will promptly amend this Agreement
to facilitate such modification. If the Parties elect to transfer responsibility
for manufacture of bulk UNCONJUGATED ANTIBODY from Xxxxxxx to SB as set forth in
this Section 9.6.1, the Parties shall confer regarding assistance, [*], to be
provided to SB by Xxxxxxx to enable such transfer and the terms under which such
assistance will be
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
70.
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provided. In fulfilling any transferred manufacture obligations hereunder, SB
[*] of [*]. Any transfer under this Section 9.6.1 pursuant to [*] SB Supply
Agreement will be consistent with Xxxxxxx'x obligations under the PRE-EXISTING
THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS and any NEW THIRD PARTY
MANUFACTURE AND SUPPLY CHAIN AGREEMENTS.
9.6.2 UNCONJUGATED ANTIBODY OR RADIOLABELED ANTIBODY BY XXXXXXX.
As of the Effective Date, it is Xxxxxxx'x intention that all manufacture and
supply of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY for which it has
responsibility under this Agreement will be performed by THIRD PARTIES pursuant
to PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS and/or NEW
THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS. If at any time during the
term of the Agreement, Xxxxxxx believes it is in the best interest of the
collaboration for Xxxxxxx to manufacture and supply UNCONJUGATED ANTIBODY and/or
RADIOLABELED ANTIBODY itself, in whole or in part, for sale in the TERRITORY,
Xxxxxxx shall [*]. [*] is [*] in [*]. In any event, the decision whether to have
Xxxxxxx supply UNCONJUGATED ANTIBODY and/or RADIOLABELED ANTIBODY itself [*]. If
the Parties decide Xxxxxxx should supply UNCONJUGATED ANTIBODY and/or
RADIOLABELED ANTIBODY itself, the Parties [*] one or more agreements to
accomplish such purpose (a "Xxxxxxx Supply Agreement"). If the Parties elect to
enter into such Xxxxxxx Supply Agreement, to the extent a transfer under such
Xxxxxxx Supply Agreement requires a modification of this Article 9 or the rest
of this Agreement, the Parties will promptly amend this Agreement to facilitate
such modification. In fulfilling any transferred manufacture obligations
hereunder, Xxxxxxx will [*] for [*]. Any transfer under this Section 9.6.2
pursuant to the negotiation of a Xxxxxxx Supply Agreement will be consistent
with Xxxxxxx'x obligations under the PRE-EXISTING THIRD PARTY MANUFACTURE AND
SUPPLY CHAIN AGREEMENTS and any NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN
AGREEMENTS.
9.6.3 If a Party incurs costs in making a proposal with regard to
the transfer of manufacturing responsibility under Sections 9.6.1 or 9.6.2, it
shall do so for its own account and without charge to the other Party under this
Agreement.
9.7 COST OF GOODS FOR UNCONJUGATED ANTIBODY AND RADIOLABELED ANTIBODY
FOR DEVELOPMENT AND MANUFACTURE DEVELOPMENT; MANUFACTURE DEVELOPMENT COSTS
(INCLUDING CAPITAL EXPENDITURES).
9.7.1 COST OF GOODS FOR UNCONJUGATED ANTIBODY AND RADIOLABELED
ANTIBODY FOR DEVELOPMENT AND MANUFACTURE DEVELOPMENT. Xxxxxxx shall provide
UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY manufactured under Sections
9.4.1 and 9.4.2, respectively, for DEVELOPMENT and MANUFACTURE DEVELOPMENT in
the TERRITORY at its COST OF GOODS. Such amounts for DEVELOPMENT and MANUFACTURE
DEVELOPMENT in the TERRITORY shall be borne by the Parties in accordance with
the [*] and 3.3.3. Xxxxxxx shall not invoice SB for the percentage of COST OF
GOODS to be borne by SB for the use of UNCONJUGATED ANTIBODY and RADIOLABELED
ANTIBODY in Territory A Trials (as defined in Section 3.2.3) and Cross-Territory
Trials (as defined in Section 3.2.3) [*] the [*] (as defined in [*]) [*].
Xxxxxxx shall be reimbursed by SB for the percentage of COST OF GOODS to be
borne by SB for the use of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY in
(i) the Non-USA Territory Trials (defined in Section 3.2.3) [*] (ii) in all
clinical trials [*] the [*] and (iii) for MANUFACTURE
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
71.
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DEVELOPMENT pursuant to Section 3.3.3, each within thirty (30) days of SB's
receipt of an invoice therefor from Xxxxxxx provided such invoice is submitted
to SB after Xxxxxxx'x receipt of such UNCONJUGATED ANTIBODY and RADIOLABELED
ANTIBODY from the THIRD PARTY manufacturer thereof and provided further that
such reimbursement shall be paid to the extent that such UNCONJUGATED ANTIBODY
and RADIOLABELED ANTIBODY has met the appropriate quality assurance and quality
control tests. [*], provided that SB's obligation to pay such invoice shall be
subject to Section 9.4.5.
9.7.2 MANUFACTURE DEVELOPMENT COSTS (INCLUDING [*]). Any
MANUFACTURE DEVELOPMENT COSTS, including [*], which are incurred by either Party
with respect to the MANUFACTURE DEVELOPMENT for a process to be used to
manufacture UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY shall be handled in
accordance with the provisions of Section 3.3.3.
9.8 COST OF GOODS FOR UNCONJUGATED ANTIBODY AND RADIOLABELED ANTIBODY
FOR COMMERCIAL SALE.
9.8.1 UNCONJUGATED ANTIBODY. As consideration for the manufacture
and supply of UNCONJUGATED ANTIBODY under Section 9.4.1 for commercial sale in
TERRITORY A, Xxxxxxx shall be reimbursed by SB for [*] of Xxxxxxx'x COST OF
GOODS of such UNCONJUGATED ANTIBODY within thirty (30) days of SB's receipt of
an invoice therefor from Xxxxxxx. As consideration for the manufacture and
supply of UNCONJUGATED ANTIBODY under Section 9.4.1 for commercial sale in
TERRITORY B and TERRITORY C, subject to the last sentence of Section 7.2.2(b)
Xxxxxxx shall be reimbursed by SB for Xxxxxxx'x COST OF GOODS of such
UNCONJUGATED ANTIBODY within thirty (30) days of SB's receipt of an invoice
therefor from Xxxxxxx. Xxxxxxx may send an invoice to SB upon Xxxxxxx'x receipt
of an invoice from the THIRD PARTY supplier of the UNCONJUGATED ANTIBODY but
only to the extent that Xxxxxxx has determined that such supply of UNCONJUGATED
ANTIBODY has met all appropriate quality assurance and quality control tests.
Each such Xxxxxxx invoice provided under this Section 9.81 shall be accompanied
by [*], provided that SB's obligation to pay such invoice shall be subject to
Section 9.4.5. In TERRITORY A, such reimbursed amounts shall be included as part
of the COST OF GOODS element of SB's Operating Expenses for such quarter in
accordance with Section 7.1.14 for the quarter in which such UNCONJUGATED
ANTIBODY is sold, with Xxxxxxx'x [*] ownership in the UNCONJUGATED ANTIBODY sold
during said quarter in TERRITORY A to be included in the calculation of the COST
OF GOODS element of Xxxxxxx'x Operating Expenses for such quarter in accordance
with Section 7.1.14 for the quarter in which such UNCONJUGATED ANTIBODY is sold.
In TERRITORY B and TERRITORY C, such amounts shall be included in the NON-USA
COGS for the quarter in which such UNCONJUGATED ANTIBODY is sold.
9.8.2 RADIOLABELED ANTIBODY. As consideration for
(i) the manufacture and supply of RADIOLABELED
ANTIBODY under Section 9.4.3(a) for commercial sale in NORTH AMERICA, and
(ii) the manufacture and supply of RADIOLABELED
ANTIBODY under Section 9.4.3(b) for commercial sale in TERRITORY B and TERRITORY
C (under the conditions set forth in Section 9.4.3(b)),
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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Xxxxxxx shall be reimbursed by SB for (i) [*] of Xxxxxxx'x COST OF GOODS for
converting UNCONJUGATED ANTIBODY into RADIOLABELED ANTIBODY related to such
RADIOLABELED ANTIBODY for commercial sale in TERRITORY A and (ii) subject to the
last sentence of Section 7.2.2(b), [*] of Xxxxxxx'x COST OF GOODS for converting
UNCONJUGATED ANTIBODY into RADIOLABELED ANTIBODY related to such RADIOLABELED
ANTIBODY for commercial sale in TERRITORY B and TERRITORY C, within thirty (30)
days of SB's receipt of an invoice therefor from Xxxxxxx. Xxxxxxx may send an
invoice to SB upon Xxxxxxx'x receipt of an invoice from the THIRD PARTY supplier
of the RADIOLABELED ANTIBODY but only to the extent that Xxxxxxx has determined
that such supply of RADIOLABELED ANTIBODY has met all appropriate quality
assurance and quality control tests. Each such Xxxxxxx invoice provided under
this Section 9.8.2 shall be accompanied [*], provided that SB's obligation to
pay such invoice shall be subject to Section 9.4.5. In TERRITORY A, such
reimbursed amounts shall be included as part of the COST OF GOODS element of
SB's Operating Expenses for such quarter in accordance with Section 7.1.14 for
the quarter in which such RADIOLABELED ANTIBODY is sold, with Xxxxxxx'x [*]
ownership in the RADIOLABELED ANTIBODY sold during said quarter in TERRITORY A
to be included in the calculation of the COST OF GOODS element of Xxxxxxx'x
Operating Expenses for such quarter in accordance with Section 7.1.14 for the
quarter in which such RADIOLABELED ANTIBODY is sold, less any corresponding COST
OF GOODS already included under Section 9.8.1. In TERRITORY B and TERRITORY C,
such amounts shall be included in the NON-USA COGS for the quarter in which such
RADIOLABELED ANTIBODY is sold.
9.9 COST OF UNCONJUGATED ANTIBODY IN EVENT OF TRANSFER OF
RESPONSIBILITY.
(a) SB RESPONSIBILITY UNDER SECTION 9.6.1. In the event
responsibility for manufacture and supply of UNCONJUGATED ANTIBODY is
transferred from Xxxxxxx to SB pursuant to Section 9.6.1, SB will provide such
UNCONJUGATED ANTIBODY for sale in TERRITORY A at the prices [*] attached to such
SB Supply Agreement. Xxxxxxx will reimburse SB for the manufacture and supply of
UNCONJUGATED ANTIBODY under Section 9.6.1 for commercial sale in TERRITORY A. In
TERRITORY A, such reimbursed amounts shall be included as part of the COST OF
GOODS element of Xxxxxxx'x Operating Expenses for such quarter in accordance
with Section 7.1.14 for the quarter in which such UNCONJUGATED ANTIBODY is sold,
with [*] ownership in the UNCONJUGATED ANTIBODY sold during said quarter in
TERRITORY A to be included in the calculation of the COST OF GOODS element of
SB's Operating Expenses for such quarter in accordance with Section 7.1.14 for
the quarter in which such UNCONJUGATED ANTIBODY is sold. In TERRITORY B and
TERRITORY C, SB shall bear [*] of such cost and such amounts shall be included
in the NON-USA COGS for the quarter in which such UNCONJUGATED ANTIBODY is sold,
subject to Section 7.2.5(e).
(b) XXXXXXX RESPONSIBILITY UNDER SECTION 9.6.2. In the event
responsibility for manufacture and supply of UNCONJUGATED ANTIBODY is
transferred from a THIRD PARTY supplier to Xxxxxxx pursuant to Section 9.6.2,
Xxxxxxx will provide such UNCONJUGATED ANTIBODY for sale in TERRITORY A at the
prices set forth on the [*] attached to such Xxxxxxx Supply Agreement. SB will
reimburse Xxxxxxx for the manufacture and supply of UNCONJUGATED ANTIBODY under
Section 9.6.2 for commercial sale in TERRITORY A according to the same
procedures outlined in Section 9.8.1 for SB reimbursement to Xxxxxxx. In
TERRITORY A, such reimbursed amounts shall be included as part of the COST OF
GOODS element of SB's Operating
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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Expenses for such quarter in accordance with Section 7.1.14 for the quarter in
which such UNCONJUGATED ANTIBODY is sold, with Xxxxxxx'x [*] ownership in the
UNCONJUGATED ANTIBODY sold during said quarter in TERRITORY A to be included in
the calculation of the COST OF GOODS element of Xxxxxxx'x Operating Expenses for
such quarter in accordance with Section 7.1.14 for the quarter in which such
UNCONJUGATED ANTIBODY is sold. In TERRITORY B and TERRITORY C, SB shall bear [*]
of such cost and such amounts shall be included in the NON-USA COGS for the
quarter in which such UNCONJUGATED ANTIBODY is sold.
9.10 EUROPEAN FACILITY.
9.10.1 OVERVIEW. Subject to the time periods and mechanisms
described in this Section 9.10, either SB shall establish a [*] to supply the
requirements of EUROPE for [*] (the "EUROPEAN FACILITY") or Xxxxxxx shall have
the right described in Section 9.10.4 to adjust or terminate SB's license in
EUROPE. If SB does proceed to establish a EUROPEAN FACILITY, [*]. The EUROPEAN
FACILITY, if established by SB, shall be designed and constructed to supply [*]
for commercial sale in EUROPE, in accordance with all applicable laws and
regulations, [*]. [*].
9.10.2 SELECTION OF SB OPTION.
(a) Within [*] of the Effective Date, SB (with the
reasonable assistance of Xxxxxxx, such assistance including, without limitation,
the provision of necessary information by Xxxxxxx to SB as reasonably requested
by SB) shall have identified the options for a EUROPEAN FACILITY and shall have
communicated such options, along with an analysis of the advantages and
disadvantages of each option, to the MANUFACTURE AND SUPPLY CHAIN SUBTEAM which
shall have responsibility for monitoring SB's progress in identifying options
for the EUROPEAN FACILITY and fulfilling SB's obligations under this Section
9.10. Included with such analysis shall be a determination of the applicable
European Facility Commencement Date (as defined in Section 9.10.3(ii)), relative
to FIRST COMMERCIAL SALE in [*] for each EUROPEAN FACILITY option being
considered by SB.
(b) In the event that at some point following SB's
evaluation of the options for a EUROPEAN FACILITY identified under Section
9.10.2(a), SB determines that its first choice is to supply TERRITORY B
(excluding [*]) out of the [*] (as defined in [*]), then SB shall provide notice
of such election to Xxxxxxx, specifying in such notice SB's second choice as a
supply site. Within sixty (60) days of receiving such notice from SB, Xxxxxxx
shall advise SB whether it approves such use of the [*]; provided, however, in
no event shall Xxxxxxx be obligated to advise SB of its decision regarding such
approval earlier than [*] to the European Facility Commencement Date (as defined
in Section 9.10.3(ii)) for SB's second choice as a supply site as specified in
the SB notice to Xxxxxxx. Xxxxxxx'x consent, not to be unreasonably withheld,
shall be required in order to designate the [*] as the EUROPEAN FACILITY. If
Xxxxxxx does not consent to such designation, then SB shall proceed with its
second choice as a supply site, or if SB does not have a second choice, it shall
so notify Xxxxxxx. In the event Xxxxxxx does not approve the use of the [*] and
SB has notified Xxxxxxx that it has no second choice, then SB shall be deemed to
have given the notice under Section 9.10.2(c).
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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(c) At any time, SB may notify Xxxxxxx in writing that it
has determined not to construct a EUROPEAN FACILITY. In such event, Xxxxxxx'x
rights under Section 9.10.4 shall immediately become effective.
(d) At the request of SB, Xxxxxxx shall provide reasonable
assistance, within Xxxxxxx'x area of expertise, to help SB identify and validate
an appropriate site for the EUROPEAN FACILITY in order to allow SB to meet its
obligations under Section 9.10 to supply [*] for sale in TERRITORY B (excluding
[*]) and TERRITORY C (excluding [*]). Provision of such assistance shall
include, but not be limited to, (i) [*], and (ii) [*]. In the event that SB
requests that Xxxxxxx perform work under this Section 9.10.2(d), SB shall
reimburse Xxxxxxx for all OUT-OF-POCKET COSTS incurred by Xxxxxxx with respect
to such performance within thirty (30) days of receipt of an invoice from
Xxxxxxx, provided that travel costs incurred by Xxxxxxx under this Section
9.10.2(d) shall be based on business class airfares for travel outside the
United States, coach airfares for travel inside the United States and reasonable
business accommodations. All work or other assistance provided to SB under this
Section 9.10.2(d), such as, without limitation, [*], meetings reasonably
incidental to other business between the Parties, and the provision of existing
Xxxxxxx reports, data and information to assist SB with SB's activities under
this Section (such as the provision of information to assist SB with responses
to questions or requests from regulatory authorities) shall be provided to SB
without reimbursement for FTE resources, except in the case where (i) [*] or
(ii) Xxxxxxx is requested to undertake an individual project that requires more
than [*] of effort, provided that Xxxxxxx provides SB advance notice (which may
be verbal) that the project is of [*]. In the event that such trip is made under
clause (i) or a project is undertaken under clause (ii) by such Xxxxxxx FTE, SB
shall reimburse Xxxxxxx on an FTE rate basis for the hours spent rendering such
assistance, at an FTE rate of [*].
9.10.3 DEFINITIONS. For purposes of this Section 9.10, the
following definitions shall apply:
(i) "European Facility Completion Date" shall mean
that date which is the earlier of
(1) [*] after the later of the date of FIRST
COMMERCIAL SALE in [*] and the date of FIRST COMMERCIAL SALE in [*]; or
(2) [*] after the earlier of the date of
FIRST COMMERCIAL SALE in [*] or the date of FIRST COMMERCIAL SALE in [*].
(ii) "European Facility Commencement Date" shall
mean that date by which the MANUFACTURE AND SUPPLY CHAIN SUBTEAM determines it
would be reasonably necessary for SB to have entered into an agreement with a
THIRD PARTY pursuant to which such THIRD PARTY will commence construction of the
EUROPEAN FACILITY in such time as to finish construction and have such EUROPEAN
FACILITY available to manufacture and supply SB's estimated requirements of [*]
for commercial sale in [*], in accordance with all applicable European laws and
regulations, by the European Facility Completion Date, provided, however, in no
event will the European Facility Commencement Date be later than eighteen (18)
months prior to the European Facility Completion Date.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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9.10.4 SB PERFORMANCE; XXXXXXX REMEDIES. Following the
determination of its facility choice, as provided above, SB shall, not later
than the European Facility Commencement Date (as defined in Section 9.10.3(ii)),
execute a binding agreement with a THIRD PARTY for the construction of the
EUROPEAN FACILITY ("European Facility Agreement"). SB shall thereafter use
COMMERCIALLY REASONABLE EFFORTS to complete the construction of such facility
and have it ready for commercial supply not later than the European Facility
Completion Date (as defined in Section 9.10.3(i)). In the event that (i) SB
notifies Xxxxxxx that it does not intend to enter into a European Facility
Agreement, (ii) SB has not entered into a European Facility Agreement by the
European Facility Commencement Date or (iii) at any time after [*] after the
European Facility Commencement Date, the MANUFACTURE AND SUPPLY CHAIN SUBTEAM
makes a good faith determination that, for reasons other than a FORCE MAJEURE
OCCURRENCE, the EUROPEAN FACILITY is not reasonably likely to be completed and
available to manufacture and supply SB's estimated requirements of [*] for
commercial sale in EUROPE by [*] after the European Facility Completion Date (as
defined in Section 9.10.3(i)), Xxxxxxx may, at any time during the [*] month
period after such occurrence described in clause (i), (ii) or (iii), give notice
to SB that Xxxxxxx intends to (A) adjust the licenses granted by Xxxxxxx under
this Agreement to exclude EUROPE from the TERRITORY or (B) adjust the licenses
granted by Xxxxxxx under Article 5 of this Agreement to become non-exclusive for
EUROPE. In the event Xxxxxxx elects option (A), it shall provide written notice
to SB and, on the [*] anniversary of the date of such notice, the terms of
Section 13.4 shall apply for EUROPE. In the event Xxxxxxx elects option (B), it
shall provide written notice to SB and, as of the date of such notice, the terms
of Section 13.5 shall apply for EUROPE.
9.10.5 MILESTONE PAYMENT.
(a) In the event that the [*] (as defined in [*]) is
selected by SB as the EUROPEAN FACILITY and new construction of less than
[*] is required to establish the [*] as the EUROPEAN FACILITY, SB will notify
Xxxxxxx of such selection and within thirty (30) days of such selection date
(which shall, in any event, be no later than thirty (30) days following the
European Facility Commencement Date) (as defined in Section 9.10.3(ii)), SB
shall pay to Xxxxxxx [*].
(b) In the event that (A) a facility other than the [*] is
selected by SB as the EUROPEAN FACILITY or (B) the [*] is selected by SB as the
EUROPEAN FACILITY but new construction in excess of [*] is required to establish
the [*] as the EUROPEAN FACILITY, SB will notify Xxxxxxx of such selection and
will have the following payment obligations to Xxxxxxx:
(i) within thirty (30) days after initiation of
construction of the EUROPEAN FACILITY, SB shall pay to Xxxxxxx [*]; and
(ii) within thirty (30) days of filing of an MAA
supplement to manufacture PRODUCT at such EUROPEAN FACILITY for commercial
supply, SB shall pay to Xxxxxxx an additional [*]; and
(iii) within thirty (30) days of receipt of
approval of an MAA supplement to manufacture PRODUCT at such EUROPEAN FACILITY
for commercial supply and other necessary REGULATORY APPROVALs, if any, SB shall
pay to Xxxxxxx an additional [*].
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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(c) All amounts paid under this Section 9.10.5 shall be
non-refundable and non-creditable, provided, however, in the event of
termination of this Agreement by SB due to material breach by Xxxxxxx, the
foregoing shall not preclude SB from seeking whatever damages are available at
law.
9.10.6 REMAINDER OF THE NON-USA TERRITORY. In the event that,
pursuant to Section 9.10.4 Xxxxxxx adjusts the licenses granted under this
Agreement to exclude EUROPE from the TERRITORY or adjusts the licenses granted
under this Agreement to become non-exclusive for EUROPE, SB shall notify Xxxxxxx
whether it intends to develop and commercialize PRODUCT for sale in the
remainder of TERRITORY B (i.e., all countries other than those of EUROPE) and
TERRITORY C. If SB elects not to develop and commercialize Product for sale in
the remainder of TERRITORY B and TERRITORY C, the licenses granted by Xxxxxxx
under this Agreement shall be automatically adjusted to exclude the remainder of
TERRITORY B and TERRITORY C and the terms of Section 13.4 shall apply to such
countries. If SB elects to develop and commercialize PRODUCT for sale in the
remainder of TERRITORY B and TERRITORY C, Xxxxxxx shall be under no obligation
to supply PRODUCT to SB for such DEVELOPMENT and commercialization (except for
Canada and Mexico) and SB shall continue to have the obligations with respect to
such countries as are set forth in Sections 7.2.1 and 7.2.2. In the event SB
elects to develop and commercialize PRODUCT for sale in the remainder of
TERRITORY B and TERRITORY C and Xxxxxxx offers to supply PRODUCT for such
countries, but SB is not using good faith efforts to obtain REGULATORY APPROVAL
in such country and sell PRODUCT in such country, the licenses granted by
Xxxxxxx under this Agreement shall be automatically adjusted to exclude such
countries and the terms of Section 13.4 shall apply to such countries.
9.11 TERM OF MANUFACTURE AND SUPPLY. The term of the manufacture and
supply of PRODUCT under this Article 9 will be the term of this Agreement.
9.12 FORECASTS.
9.12.1 UNCONJUGATED ANTIBODY AND RADIOLABELED ANTIBODY.
(a) SUPPLY FOR DEVELOPMENT PURPOSES. During the first five
(5) business days of (i) each month in the case of RADIOLABELED ANTIBODY and
(ii) every third month in the case of UNCONJUGATED ANTIBODY, the MANUFACTURE AND
SUPPLY CHAIN SUBTEAM will confer regarding each Party's requirements for
UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY for use in DEVELOPMENT in the
TERRITORY for an appropriate amount of time following the date of such
conference, depending upon the lead time for ordering such UNCONJUGATED ANTIBODY
and RADIOLABELED ANTIBODY for DEVELOPMENT and MANUFACTURE DEVELOPMENT supplies
from THIRD PARTY suppliers. This approach to production planning for DEVELOPMENT
and MANUFACTURE DEVELOPMENT purposes may be modified as mutually agreed to by
the Parties based upon the Parties' experience in conducting clinical trials and
other DEVELOPMENT and MANUFACTURE DEVELOPMENT activities.
(b) COMMERCIAL SUPPLY. Upon receipt of REGULATORY APPROVAL
for a PRODUCT in any country in the TERRITORY, the Parties agree that
UNCONJUGATED ANTIBODY for commercial use will be ordered pursuant to a
forecasting mechanism developed by the
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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MANUFACTURE AND SUPPLY CHAIN SUBTEAM. Such forecasting mechanism shall (i) meet
the needs of the Parties for commercial supply of UNCONJUGATED ANTIBODY and (ii)
be consistent with the terms and conditions of the applicable PRE-EXISTING THIRD
PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENT and any NEW THIRD PARTY MANUFACTURE
AND SUPPLY CHAIN AGREEMENT. In the event that one of the Parties assumes
responsibility for the manufacture and supply of the UNCONJUGATED ANTIBODY
pursuant to Section 9.6, 9.16 or 9.17, the Parties shall meet to determine an
appropriate forecasting mechanism in the event of such transfer of
responsibility. If the Parties determine that greater flexibility in forecasting
supply of UNCONJUGATED ANTIBODY is required than is permitted under the
applicable PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENT and
any NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENT, Xxxxxxx shall use
COMMERCIALLY REASONABLE EFFORTS to negotiate appropriate modifications to such
agreements. Further, the MANUFACTURE AND SUPPLY CHAIN SUBTEAM will meet to
develop a detailed procedure pursuant to which Xxxxxxx will be provided with the
information necessary to submit consolidated purchase orders to the THIRD PARTY
manufacturer of UNCONJUGATED ANTIBODY and to establish a schedule setting forth
those dates after which UNCONJUGATED ANTIBODY purchase orders may not be placed
by the Parties. Such procedure and schedule shall be in accordance with the
terms and provisions of the PRE-EXISTING THIRD Party MANUFACTURE AND SUPPLY
CHAIN AGREEMENT and any NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENT
under which UNCONJUGATED ANTIBODY will be manufactured. Once such a procedure is
established, the Parties will work together to collect such information and
provide it to Xxxxxxx in sufficient time for Xxxxxxx to submit such consolidated
purchase orders to the THIRD PARTY manufacturer of UNCONJUGATED ANTIBODY.
9.12.2 PRODUCTION ORDERING MECHANISM FOR RADIOLABELED ANTIBODY
FOR DEVELOPMENT AND COMMERCIAL SALE. The Parties acknowledge the careful
planning and detailed information required in order to provide accurate and
timely orders for RADIOLABELED ANTIBODY to the THIRD PARTY manufacturer of such
RADIOLABELED ANTIBODY given the precise time frames required for radiolabeling
of UNCONJUGATED ANTIBODY. Within ninety (90) days of the Effective Date, the
MANUFACTURE AND SUPPLY CHAIN SUBTEAM will meet to develop a detailed procedure
pursuant to which Xxxxxxx will be provided with the information necessary to
submit consolidated purchase orders to the THIRD PARTY manufacturer of
RADIOLABELED ANTIBODY and to establish a schedule setting forth those dates
after which RADIOLABELED ANTIBODY purchase orders may not be placed by the
Parties. Such procedure and schedule shall be in accordance with the terms and
provisions of the PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN
AGREEMENT and any NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENT under
which RADIOLABELED ANTIBODY will be manufactured. Once such a procedure is
established, the Parties will work together to collect such information and
provide it to Xxxxxxx in sufficient time for Xxxxxxx to submit such consolidated
purchase orders to the THIRD PARTY manufacturer of RADIOLABELED ANTIBODY.
9.12.3 DELIVERY; SHIPMENT. The UNCONJUGATED ANTIBODY and
RADIOLABELED Antibody supplied under this Agreement will be delivered [*] the
THIRD PARTY manufacturer's facility ([*]). [*] shall be construed in accordance
with [*]. The MANUFACTURE AND SUPPLY CHAIN SUBTEAM will determine which Party
will make shipping arrangements with the carriers.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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9.13 QUALITY CONTROL; TESTING. Xxxxxxx shall maintain a quality control
and testing program consistent with GMP, as required by the FDA and/or any other
governmental entity whether in the United States or part of another applicable
foreign jurisdiction, with respect to the manufacture of UNCONJUGATED ANTIBODY
and RADIOLABELED ANTIBODY by or on behalf of Xxxxxxx hereunder. SB shall be
entitled to collaborate with Xxxxxxx to audit the quality control program for
the manufacture of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY.
9.14 MANUFACTURING REGULATORY COMPLIANCE.
9.14.1 TERRITORY A. Any manufacture of UNCONJUGATED ANTIBODY and
RADIOLABELED ANTIBODY for DEVELOPMENT and MANUFACTURE DEVELOPMENT purposes or
commercial sale in TERRITORY A, shall be performed in full compliance with GCP,
GLP and GMP and all applicable United States laws and regulations. Xxxxxxx or
its designee shall serve as the point of contact with the FDA and any other
applicable governmental entity in TERRITORY A concerning the manufacture and
supply of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY, but may, as
appropriate, request the assistance of SB or the JDC with FDA and/or other
applicable governmental entity communications.
9.14.2 TERRITORY B and TERRITORY C. Any manufacture of
UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY for DEVELOPMENT and MANUFACTURE
DEVELOPMENT purposes or commercial sale in TERRITORY B or TERRITORY C shall be
performed in full compliance with GCP, GLP and GMP and all applicable United
States laws and regulations. SB will notify Xxxxxxx of any regulatory
requirements for manufacture of UNCONJUGATED ANTIBODY and/or RADIOLABELED
ANTIBODY for sale in TERRITORY B or TERRITORY C with which it wishes THIRD PARTY
manufacturers of UNCONJUGATED ANTIBODY and/or RADIOLABELED ANTIBODY to comply.
To the extent Xxxxxxx can cause such manufacturers to comply with such
regulatory requirements under the PRE-EXISTING THIRD PARTY MANUFACTURE AND
SUPPLY CHAIN AGREEMENTS and any NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN
AGREEMENTS, Xxxxxxx will do so. If Xxxxxxx is unable to do so pursuant to such
agreements, the MANUFACTURE AND SUPPLY CHAIN SUBTEAM will meet to discuss how
best to address such regulatory requirements, including seeking to amend the
applicable PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS
and/or NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS to cause such
THIRD PARTY manufacturer to be in compliance with the applicable regulatory
requirements. The Parties will seek to enter into three-way technical agreements
with such manufacturers for the purpose of defining the respective
responsibilities of the Parties and such manufacturers for quality control and
regulatory compliance. SB shall be entitled to collaborate with Xxxxxxx to audit
GCP, GLP, and GMP and any other agreed-to compliance for the manufacture of
UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY. To the extent permitted by
applicable laws, SB or its designee shall serve as the point of contact with the
foreign equivalents of the FDA and any other applicable governmental entity in
TERRITORY B and TERRITORY C concerning the manufacture and supply of
UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY, but may, as appropriate,
request the assistance of Xxxxxxx or the JDC with communications with such
governmental entities.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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9.15 RECALLS. The Parties shall immediately inform each other in writing
of all information related to (a) any incident relating to a PRODUCT and/or any
lot of a PRODUCT that is the subject of recall, market withdrawal or correction,
or (b) any PRODUCT that may require, whether based on manufacturing defect,
tampering, or otherwise, a recall, field alert, product withdrawal or field
correction arising from any defect in any such PRODUCT provided under this
Agreement. If either Party believes that a recall of UNCONJUGATED ANTIBODY
and/or RADIOLABELED ANTIBODY is desirable or required by law, it will promptly
notify the other Party. The Parties will then discuss reasonably and in good
faith whether such recall is appropriate or required and the manner in which any
recall shall be handled; provided, however, in the event either Party determines
that a recall is necessary, such recall shall be implemented. Xxxxxxx shall be
solely responsible for the handling and disposition of such recalls of
UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY in TERRITORY A, pursuant to
procedures set forth on EXHIBIT J. SB shall cooperate with Xxxxxxx in allowing
such recall in TERRITORY A to occur pursuant to the procedures set forth on
EXHIBIT J. SB shall be solely responsible for the handling and disposition of
such recalls of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY in the NON-USA
TERRITORY, pursuant to procedures set forth on EXHIBIT X. Xxxxxxx shall
cooperate with SB in allowing such recall in the NON-USA TERRITORY to occur
pursuant to the procedures set forth on EXHIBIT J. EXHIBIT J may be modified at
any time by the MANUFACTURE AND SUPPLY CHAIN SUBTEAM subject to the approval of
the JDC and JCC.
9.16 CORRECTIVE ACTION FOR SUPPLY OF UNCONJUGATED ANTIBODY. In order to
ensure an uninterrupted supply of UNCONJUGATED ANTIBODY, the Parties agree that
in the event the JDC makes a good faith determination that (i) a THIRD PARTY
manufacturer which manufactures UNCONJUGATED ANTIBODY and any back-up
manufacturer to such THIRD PARTY manufacturer, or (ii) SB (in the event SB is
manufacturing UNCONJUGATED ANTIBODY under Section 9.6.1), or (iii) Xxxxxxx (in
the event Xxxxxxx is manufacturing UNCONJUGATED ANTIBODY under Section 9.6.2)
(collectively, the "Antibody Manufacturer") has been or will be an unreliable
supplier (as defined by the MANUFACTURE AND SUPPLY CHAIN SUBTEAM) of
UNCONJUGATED ANTIBODY for Development or commercial sale (a "Failure to Supply
Unconjugated Antibody") in TERRITORY A, TERRITORY B or TERRITORY C (the
"Affected Territory"), the Parties shall meet promptly to work with the
then-current Antibody Manufacturer to attempt to rectify the situation. If such
Antibody Manufacturer is unable to assure the Parties, to their reasonable
satisfaction, that it will thereafter be a reliable supplier of UNCONJUGATED
ANTIBODY, as determined by the JDC, within such Affected Territory, then,
subject to the terms of any applicable PRE-EXISTING THIRD PARTY MANUFACTURE AND
SUPPLY CHAIN AGREEMENTS and/or NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN
AGREEMENTS, the JDC shall either (i) identify another THIRD PARTY manufacturer
to become a new Antibody Manufacturer for UNCONJUGATED ANTIBODY in such Affected
Territory or (ii) agree that SB or Xxxxxxx may supply such UNCONJUGATED ANTIBODY
in such Affected Territory (assuming that SB or Xxxxxxx is not the Antibody
Manufacturer who is unable to supply). In the event the JDC elects to use
another THIRD PARTY manufacturer to become a new Antibody Manufacturer for
UNCONJUGATED ANTIBODY in such Affected Territory, Xxxxxxx shall promptly enter
into a manufacture agreement with such THIRD PARTY for the Affected Territory.
If SB becomes the Antibody Manufacturer pursuant to this Section 9.16, the
Parties shall agree on the economic terms of such supply and Xxxxxxx shall
transfer all Xxxxxxx KNOW-HOW, to the extent permitted under applicable THIRD
PARTY agreements, reasonably required to
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
80.
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permit SB to manufacture UNCONJUGATED ANTIBODY for DEVELOPMENT purposes or
commercial sale in such Affected Territory. In the event a Failure to Supply
Unconjugated Antibody by a THIRD PARTY Antibody Manufacturer occurs for reasons
beyond the reasonable control of Xxxxxxx and SB itself becomes the Antibody
Manufacturer pursuant to this Section 9.16 for commercial sale in TERRITORY B or
TERRITORY C, the royalty payable by SB to Xxxxxxx for sales in TERRITORY B or
TERRITORY C, as the case may be, shall thereafter be reduced by [*] of NET SALES
of such PRODUCT, subject to a floor of [*] royalty on such sales in TERRITORY B
and TERRITORY C. In the event a Failure to Supply Unconjugated Antibody by a
Third Party Antibody Manufacturer occurs for reasons within the reasonable
control of Xxxxxxx and SB itself becomes the Antibody Manufacturer pursuant to
this Section 9.16 for commercial sale in TERRITORY B or TERRITORY C, the royalty
payable by SB to Xxxxxxx for sales in TERRITORY B or TERRITORY C, as the case
may be, shall thereafter be reduced by [*] of NET SALES of such PRODUCT, subject
to a floor of [*] royalty on such sales in TERRITORY B and TERRITORY C. For
purposes of this Section 9.16, TERRITORY A shall include Canada and Mexico and
TERRITORY B and TERRITORY C shall exclude such countries.
9.17 CORRECTIVE ACTION FOR SUPPLY OF RADIOLABELED ANTIBODY. In order to
ensure an uninterrupted supply of RADIOLABELED ANTIBODY, the Parties agree that
in the event the JDC makes a good faith determination that the THIRD PARTY
manufacturer and any back-up manufacturer to such THIRD PARTY manufacturer,
which conjugates UNCONJUGATED ANTIBODY to (131)Iodine to create RADIOLABELED
ANTIBODY for DEVELOPMENT or commercial sale in NORTH AMERICA, TERRITORY B
(during the time Xxxxxxx is obligated to supply in TERRITORY B under this
Agreement) or TERRITORY C (during the time Xxxxxxx is obligated to supply in
TERRITORY C under this Agreement) (collectively, the "Radiolabeling
Manufacturer") has been or will be an unreliable supplier (as defined by the
MANUFACTURE AND SUPPLY CHAIN SUBTEAM) of RADIOLABELED ANTIBODY, the Parties
shall meet promptly to work with the then-current Radiolabeling Manufacturer to
attempt to rectify the situation. If such Radiolabeling Manufacturer is unable
to assure the Parties, to their reasonable satisfaction, that it will thereafter
be a reliable supplier of RADIOLABELED ANTIBODY as determined by the JDC, then,
subject to the terms of any applicable PRE-EXISTING THIRD PARTY MANUFACTURE AND
SUPPLY CHAIN AGREEMENTS and/or NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN
AGREEMENTS, the JDC shall either (i) identify another THIRD PARTY manufacturer
to become a new Radiolabeling Manufacturer for RADIOLABELED ANTIBODY in NORTH
AMERICA, TERRITORY B or TERRITORY C, as applicable, or (ii) agree that SB may
supply such RADIOLABELED ANTIBODY in NORTH AMERICA, TERRITORY B or TERRITORY C,
as applicable, upon terms to be agreed to by the Parties. In the event the JDC
elects to use another THIRD PARTY manufacturer to become a new Radiolabeling
Manufacturer for RADIOLABELED ANTIBODY in NORTH AMERICA, TERRITORY B or
TERRITORY C under this Section 9.17, Xxxxxxx shall promptly enter into a
manufacture agreement with such THIRD PARTY. If SB manufactures RADIOLABELED
ANTIBODY for NORTH AMERICA, TERRITORY B or TERRITORY C pursuant to this Section
9.17, Xxxxxxx shall transfer all Xxxxxxx KNOW-HOW reasonably required to permit
SB to manufacture RADIOLABELED ANTIBODY for DEVELOPMENT purposes or commercial
sale in NORTH AMERICA, TERRITORY B or TERRITORY C. For purposes of this Section
9.17, TERRITORY B shall exclude Canada. For purposes of this Section 9.17,
TERRITORY C shall exclude Mexico.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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9.18 EXCHANGE OF INFORMATION. In the event of a transfer of
manufacturing responsibility from Xxxxxxx to SB pursuant to Section 9.6.1, 9.16
or 9.17, the Parties will undertake to exchange and to use COMMERCIALLY
REASONABLE EFFORTS to cause THIRD PARTY manufacturers to exchange, on a regular
basis, all data relating to the manufacture of UNCONJUGATED ANTIBODY and
RADIOLABELED ANTIBODY, provided that such exchange shall in all cases be
consistent with the obligations under any PRE-EXISTING THIRD PARTY MANUFACTURE
AND SUPPLY CHAIN AGREEMENTS and NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN
AGREEMENTS. All information transferred, provided or exchanged under this
Section 9.18 will be subject to the confidentiality requirements set forth in
Article 17.
ARTICLE 10
TRADEMARKS
10.1 SELECTION AND OWNERSHIP OF TRADEMARKS.
10.1.1 TERRITORY A. The Parties agree to use the TRADEMARK
Bexxar(TM) for purposes of CO-PROMOTING the PRODUCT in TERRITORY A, unless the
JCC selects a different TRADEMARK for use in TERRITORY A. SB acknowledges
Xxxxxxx'x ownership of Bexxar(TM) and that Xxxxxxx shall be the owner of any
other TRADEMARK(S) selected and used for purposes of CO-PROMOTING the PRODUCT in
TERRITORY A (collectively, "Territory A Trademark(s)") and agrees that it will
do nothing inconsistent with such ownership. SB further agrees that nothing in
this Agreement shall give SB any right, title or interest in the Territory A
Trademark(s) other than the right to use the Territory A Trademark(s) in
accordance with, and during the term of, this Agreement.
10.1.2 NON-USA TERRITORY. The JCC will select the TRADEMARK(S)
for marketing the PRODUCT in the NON-USA TERRITORY. In the event that the
TRADEMARK(S) selected for use in the NON-USA TERRITORY is one which was
identified by SB to Xxxxxxx prior to the Effective Date as having already
undergone searching by SB, such TRADEMARK(S) shall be owned by SB ("SB
Trademarks"). At the termination of this Agreement, SB shall continue to have
unrestricted ownership of SB Trademarks throughout the NON-USA TERRITORY. In the
event that the TRADEMARK(S) selected for use in the NON-USA TERRITORY is not
such an SB Trademark, such TRADEMARK(S) shall be owned by Xxxxxxx ("Xxxxxxx
Trademarks"). At the termination of this Agreement, Xxxxxxx shall continue to
have unrestricted ownership of such Xxxxxxx Trademarks throughout the TERRITORY,
subject to SB's right to own such TRADEMARK in TERRITORY B and TERRITORY C after
the expiration of the Agreement as provided in Section 13.1.2. SB acknowledges
Xxxxxxx'x ownership of the Xxxxxxx Trademarks, agrees that it will do nothing
inconsistent with such ownership, and agrees that nothing in this Agreement
shall give SB any right, title or interest in the Xxxxxxx Trademarks other than
the right to use the Xxxxxxx Trademarks in accordance with this Agreement.
Xxxxxxx acknowledges SB's ownership of the SB Trademarks, agrees that it will do
nothing inconsistent with such ownership, and agrees that nothing in this
Agreement shall give Xxxxxxx any right, title or interest in the SB Trademarks
other than the right to use the SB Trademarks in accordance with this Agreement.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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10.2 DEVELOPMENT OF TRADEMARKS.
10.2.1 TERRITORY X. Xxxxxxx shall create, search, prosecute,
register and maintain any and all Territory A Trademarks. All OUT-OF-POCKET
COSTS paid by Xxxxxxx after the Effective Date for creating, searching,
registering and maintaining such Territory A Trademarks shall be included in
TRADEMARK COSTS.
10.2.2 NON-USA TERRITORY. SB shall, at its sole expense, create,
search, prosecute, register, and maintain all SB Trademarks developed for the
purposes of this Agreement that will be used in the NON-USA TERRITORY. SB will
further defend such SB Trademarks against any infringement and other claims made
by THIRD PARTIES in the NON-USA TERRITORY. Xxxxxxx shall, at its sole expense,
create, search, prosecute, register, and maintain all Xxxxxxx Trademarks
developed for the purposes of this Agreement that will be used in the NON-USA
TERRITORY. Xxxxxxx will further defend such Xxxxxxx Trademarks against any
infringement and other claims made by THIRD PARTIES in the NON-USA TERRITORY.
10.2.3 DEVELOPMENT OF ADDITIONAL TRADEMARKS IN THE NON-USA
TERRITORY. Xxxxxxx and SB agree that Xxxxxxx may, at its sole discretion and
expense, create, search, prosecute, register and maintain concurrently
TRADEMARKS not confusingly similar to the SB Trademarks, but bearing the same
description of goods, to be used in the NON-USA TERRITORY at the termination of
this Agreement or in the event Xxxxxxx otherwise obtains marketing rights for
PRODUCTS in portions of the NON-USA TERRITORY.
10.3 LICENSE GRANTS.
10.3.1 TERRITORY X. Xxxxxxx hereby agrees to grant to SB an
exclusive (except as to Xxxxxxx), royalty-free license to use the Territory A
Trademark(s) (defined in Section 10.1.1) for the making, use, sale, offer for
sale and importation of the PRODUCT in TERRITORY A for the term of the
Agreement, subject to Xxxxxxx'x right to CO-PROMOTE PRODUCT in TERRITORY A in
accordance with the terms of this Agreement. Such license shall be granted
promptly after each Territory A Trademark is selected in accordance with Section
10.1.1.
10.3.2 NON-USA TERRITORY. Xxxxxxx hereby agrees to grant to SB an
exclusive, royalty-free license to use the Xxxxxxx Trademark(s) (as defined in
Section 10.1.2) for the making, use, sale, offer for sale and importation of the
PRODUCT in the NON-USA TERRITORY for the term of the Agreement, subject to the
use by Xxxxxxx of the Xxxxxxx Trademark for any purpose related to Xxxxxxx'x
supply obligations under this Agreement related to the PRODUCT in the NON-USA
TERRITORY for the term of the Agreement. Such license shall be granted promptly
after each Xxxxxxx Trademark is selected in accordance with Section 10.1.2. SB
hereby agrees to grant to Xxxxxxx a non-exclusive, royalty-free license to use
the SB Trademark(s) (as defined in Section 10.1.2) for any use related to
Xxxxxxx'x supply obligations under this Agreement related to the PRODUCT in the
NON-USA TERRITORY for the term of the Agreement. Such license shall be granted
promptly after each SB Trademark is selected in accordance with Section 10.1.2.
10.3.3 LICENSED TRADEMARKS. The TRADEMARKS to be licensed by the
Parties pursuant to Sections 10.3.1 and 10.3.2 shall be, collectively, the
"Licensed Trademarks."
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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10.4 USE OF TRADEMARKS.
10.4.1 TERRITORY A TRADEMARKS AND XXXXXXX TRADEMARKS. With regard
to Territory A Trademark(s) (as defined in Section 10.1.1) or in the event that
the TRADEMARK for the PRODUCT in the NON-USA TERRITORY is a Xxxxxxx Trademark
(as defined in Section 10.1.2), SB agrees to conform with Xxxxxxx'x customary
guidelines under this Article 10 with respect to manner of use, and to maintain
Xxxxxxx'x quality standards with respect to the goods sold and services provided
in connection with the TRADEMARKS. Further, except when used in accordance with
any usage guidelines provided by Xxxxxxx, XX shall submit to Xxxxxxx any
materials bearing the TRADEMARKS for review and approval prior to the use
thereof and shall make no use of the TRADEMARKS without Xxxxxxx'x written
consent. SB shall execute any documents required in the reasonable opinion of
Xxxxxxx to be entered as a "registered user" or recorded licensee of the
TRADEMARKS, or to be removed as registered user or licensee thereof.
10.4.2 SB TRADEMARKS. In the event that the TRADEMARK for the
PRODUCT in the NON-USA TERRITORY is a SB Trademark (as defined in Section
10.1.2), Xxxxxxx agrees to conform with SB's customary guidelines under this
Article 10 with respect to manner of use, and to maintain SB's quality standards
with respect to the goods sold and services provided in connection with the
TRADEMARKS. Further, except when used in accordance with any usage guidelines
provided by SB, Xxxxxxx shall submit to SB any materials bearing the TRADEMARKS
for review and approval prior to the use thereof and shall make no use of the
TRADEMARKS without SB's written consent. Xxxxxxx shall execute any documents
required in the reasonable opinion of SB to be entered as a "registered user" or
recorded licensee of the TRADEMARKS, or to be removed as registered user or
licensee thereof.
10.4.3 QUALITY MAINTENANCE. SB agrees to cooperate with Xxxxxxx
in facilitating Xxxxxxx'x quality assurance responsibilities by permitting
reasonable inspection of SB's operations as they pertain to the Territory A
Trademarks (as defined in Section 10.1.1) and the Xxxxxxx Trademarks (as defined
in Section 10.1.2) and supplying Xxxxxxx with specimens of use of such
TRADEMARKS upon reasonable request, but in any case no more often than twice
each calendar year. SB will comply with all applicable laws and regulations and
obtain all government approvals pertaining to the sale, distribution and
advertising of PRODUCTS offered in the NON-USA TERRITORY under the Xxxxxxx
Trademarks and covered by this Agreement. Xxxxxxx agrees to cooperate with SB in
facilitating SB's quality assurance responsibilities by permitting reasonable
inspection of Xxxxxxx'x operations as they pertain to the SB Trademarks (as
defined in Section 10.1.2) and supplying SB with specimens of use of the SB
Trademarks upon reasonable request, but in any case no more often than twice
each calendar year.
10.5 INFRINGEMENT OF TRADEMARKS.
10.5.1 TERRITORY A. Each Party shall notify the JCC promptly upon
learning of any actual, alleged or threatened infringement of any Territory A
Trademark or of any unfair trade practices, trade dress imitation, passing off
of counterfeit goods, or like offenses, or any such claims brought by a THIRD
PARTY against a PRODUCT in TERRITORY A (hereinafter "Infringement"). Upon
learning of such Infringement, the JCC shall confer with the Parties
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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regarding strategy and filing of an action to deal with the Infringement. In the
event the JCC determines that an action with regard to such Infringement is
necessary or desirable, Xxxxxxx shall have the first right, but not the
obligation, to institute, prosecute and control any legal proceedings in its own
name and by its own counsel to prevent or restrain such Infringement, and SB
agrees to give Xxxxxxx its reasonable cooperation and assistance. In the event
Xxxxxxx elects not to exercise such first right, SB shall have the right, but
not the obligation, to institute, prosecute and control any legal proceedings in
its own name and by its own counsel to prevent or restrain such Infringement,
and Xxxxxxx agrees to give SB its reasonable cooperation and assistance.
10.5.2 TERRITORY B; TERRITORY C. Each Party shall notify the
other Party promptly upon learning of any actual, alleged or threatened
infringement of any TRADEMARK or of any unfair trade practices, trade dress
imitation, passing off of counterfeit goods, or like offenses, or any such
claims brought by a THIRD PARTY against a PRODUCT in TERRITORY B or TERRITORY C
(hereinafter "Infringement"). If the TRADEMARK involved is an SB Trademark (as
defined in Section 10.1.2), or if the Infringement is otherwise not related to a
Xxxxxxx Trademark (as defined in Section 10.1.2), SB shall be primarily
responsible for instituting, prosecuting and controlling any legal proceedings
in its own name and by its own counsel to prevent or restrain such Infringement,
and Xxxxxxx agrees to give SB its reasonable cooperation and assistance. If the
TRADEMARK involved is a Xxxxxxx Trademark, Xxxxxxx shall be primarily
responsible for instituting, prosecuting and controlling any legal proceedings
in its own name and by its own counsel to prevent or restrain such Infringement,
and SB agrees to give Xxxxxxx its reasonable cooperation and assistance.
10.5.3 STAND-BY RIGHTS. If the Party having the primary right to
institute, prosecute, and control such Infringement action under Sections 10.5.1
or 10.5.2 fails to do so within a period of ninety (90) days after receiving
notice of the Infringement, or if that Party, after initiating an action,
determines to discontinue such action, the other Party shall have the right to
bring and control or take over any such action by counsel of its own choice,
unless prevented from doing so by the laws of the country where the Infringement
occurred or is threatened.
10.6 COSTS RELATED TO INFRINGEMENT.
10.6.1 TERRITORY A. All TRADEMARK COSTS related to TERRITORY A
and all OUT-OF-POCKET COSTS paid to outside counsel and other THIRD PARTIES
which were incurred in bringing, maintaining and prosecuting any action
described in Section 10.5.1 shall be included as part of the determination of
the JOINT P&L as outlined in Section 7.1.14 and any recovery shall be added to
NET SALES in TERRITORY A, provided that such OUT-OF-POCKET COSTS were incurred
after the Effective Date and approved by the JCC.
10.6.2 TERRITORY B; TERRITORY C. All OUT-OF-POCKET COSTS paid to
outside counsel and other THIRD PARTIES which were incurred in bringing,
maintaining and prosecuting any action described in Section 10.5.2 shall be
borne by the Party incurring the expense and any recovery shall be kept by the
Party which was responsible for bringing the action.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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10.7 TRADE DRESS.
10.7.1 TERRITORY A. In TERRITORY A, PRODUCT will be packaged in
standard Xxxxxxx packaging, subject to Section 7.1.8. If SB's rights to PRODUCT
are terminated in accordance with this Agreement in TERRITORY A, SB shall not be
permitted to use Xxxxxxx packaging with respect to PRODUCT in such territory.
10.7.2 TERRITORY B AND TERRITORY C. In TERRITORY B and TERRITORY
C, PRODUCT will be packaged in standard SB packaging, subject to Section 7.1.8.
If SB's rights to PRODUCT are terminated in accordance with this Agreement in a
particular country, Xxxxxxx shall not be permitted to use SB packaging with
respect to PRODUCT in such country, and shall not permit its subsequent
licensees to use SB packaging with respect to PRODUCT in such country.
ARTICLE 11
PROSECUTION, MAINTENANCE AND INFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS
11.1 INVENTIONS.
11.1.1 Xxxxxxx shall own all INVENTIONS made solely by its
employees and agents, and all patent applications and patents claiming such
INVENTIONS. SB shall own all INVENTIONS made solely by its employees and agents,
and all patent applications and patents claiming such INVENTIONS. All INVENTIONS
made jointly by employees or agents of Xxxxxxx and employees or agents of SB and
all patent applications and patents claiming such INVENTIONS shall be owned
jointly by Xxxxxxx and SB. All determinations of inventorship under this Section
11.1.1 shall be in accordance with U.S. law. The Parties will seek to negotiate
provisions in agreements with THIRD PARTY manufacturers or suppliers of services
relating to the PRODUCT which provide the Parties with ownership or CONTROL of
any intellectual property relating to the PRODUCT which arises out of such THIRD
PARTY agreements, sufficient for Xxxxxxx or SB to be able to manufacture and
sell PRODUCT throughout the TERRITORY upon expiration of this Agreement and/or
to transfer such intellectual property to a THIRD PARTY supplier. All such
provisions shall be approved in advance by the JDC.
11.1.2 Each Party shall promptly disclose to the other Party the
complete texts of all patent applications filed by the disclosing party after
the Effective Date which relate to ANTI-CD-20 ANTIBODY as well as all
information received after the Effective Date concerning the institution or
possible institution of any interference, opposition, re-examination, reissue,
revocation, nullification or any official proceeding involving PATENT RIGHTS
anywhere in the TERRITORY. The Party reviewing such disclosure shall have the
right to review all such pending applications and other proceedings and make
recommendations concerning them and their conduct. The Parties shall keep each
other promptly and fully informed of the course of patent prosecution or other
proceedings relating to ANTI-CD-20 ANTIBODY including by providing copies of
substantive communications, search reports and THIRD PARTY observations
submitted to or received from patent offices throughout the TERRITORY. The
Parties shall provide such patent consultation at no cost except as otherwise
provided in this Agreement. In addition, SB and
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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Xxxxxxx shall each disclose to the other and discuss any INVENTION relating to
ANTI-CD20 ANTIBODY and the desirability of filing a United States patent
application covering the INVENTION, as well as any foreign counterparts, except
that SB shall have no obligation to disclose to Xxxxxxx [*] other than jointly
with an employee or agent of Xxxxxxx related to [*]. To facilitate such
discussions and any decision-making with respect to jointly-owned INVENTIONS,
each Party will appoint a "patent coordinator," who will have the authority to
participate in such discussions and make such decisions on behalf of such Party.
With respect to INVENTIONS relating to ANTI-CD20 ANTIBODY owned by one Party,
the Party owning the INVENTION shall make the final decision with respect to any
such filings, provided that SB shall have the right, but not the obligation, to
assume responsibility for any XXXXXXX PATENT RIGHT which does not cover a
jointly-owned INVENTION, or any part of such a XXXXXXX PATENT RIGHT, which
Xxxxxxx intends to abandon or otherwise cause or allow to be forfeited (unless
Xxxxxxx has decided to abandon or forfeit such XXXXXXX PATENT RIGHT in order to
preserve other XXXXXXX PATENT Rights or because the substance of such claims are
covered under other XXXXXXX PATENT RIGHTS and SB's patent coordinator has
confirmed that such decision will not diminish the patent protection for
PRODUCT). Xxxxxxx shall give SB reasonable written notice prior to abandonment
or other forfeiture of any XXXXXXX PATENT RIGHT relating to ANTI-CD20 ANTIBODY
or any part of a XXXXXXX PATENT RIGHT relating to ANTI-CD20 ANTIBODY so as to
permit SB to exercise its rights under this Section. With respect to
jointly-owned INVENTIONS, the patent coordinators shall jointly make the final
decision with respect to any such filings, as well as the prosecution and
maintenance of the PATENT RIGHTS which result from such filings. Each Party
shall have the right to select patent counsel and to take such other actions as
are reasonably appropriate to prepare, file, prosecute and maintain patent
protection with respect to its INVENTIONS, consistent with the terms of this
Article 11.
11.2 PROSECUTION AND MAINTENANCE OF PATENT RIGHTS; ALLOCATION OF PATENT
COSTS. Each Party shall be responsible throughout the TERRITORY for prosecuting
and maintaining its own PATENT RIGHTS, subject to Section 11.1.2, and Xxxxxxx
shall be responsible throughout the TERRITORY for prosecuting and maintaining
any jointly-owned INVENTIONS, subject to Section 11.1.2, and all such activity
shall be at the responsible Party's expense except as otherwise provided in this
Article 11. All PATENT COSTS in the TERRITORY arising after the Effective Date
for the XXXXXXX PATENT RIGHTS or the SB PATENT RIGHTS which cover jointly-owned
INVENTIONS shall be shared equally by the Parties. All PATENT COSTS in TERRITORY
A arising after the Effective Date for the XXXXXXX PATENT RIGHTS or the SB
PATENT RIGHTS shall be borne equally by the Parties to the extent that they
relate to ANTI-CD20 ANTIBODY, otherwise they are borne by the Party incurring
such expense. All PATENT COSTS outside of TERRITORY A arising after the
Effective Date for the XXXXXXX PATENT RIGHTS which do not cover jointly-owned
INVENTIONS shall be borne solely by Xxxxxxx. All PATENT COSTS outside of
TERRITORY A arising after the Effective Date for the SB PATENT RIGHTS which do
not cover jointly-owned INVENTIONS shall be borne solely by SB.
11.3 COOPERATION. Each of the Parties shall execute or have executed by
its appropriate employees, representatives, agents, and contractors such
documents as may be necessary to obtain, perfect or maintain any PATENT RIGHTS
filed or to be filed pursuant to this Agreement, and shall cooperate with the
other Party so far as reasonably necessary with respect
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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to furnishing all information and data in its possession reasonably necessary to
obtain or maintain such PATENT RIGHTS.
11.4 INFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS.
11.4.1 RIGHT TO BRING ACTION; TREATMENT OF RECOVERY.
(a) If either Party should become aware of any
infringement or threatened infringement or misappropriation, as the case may be,
in any country of the TERRITORY of any INTELLECTUAL PROPERTY RIGHTS of the other
Party, it shall promptly notify such other Party in writing. As soon as
practicable, the Parties shall confer on the particulars of such infringement or
misappropriation and the possible courses of action to be taken. Subject to
Sections 11.4.3 and 11.4.4, the Party holding the affected INTELLECTUAL PROPERTY
RIGHTS (or, in the case of jointly-owned INVENTIONS, Xxxxxxx) shall have the
first right, but not the obligation, to institute, prosecute and control any
legal proceedings in its own name and by its own counsel to prevent or restrain
such infringement, and the other Party shall have the right to be represented in
such action by its own counsel. If one Party brings any such action or
proceeding, whether under this Section 11.4.1(a) or under Section 11.4.2, the
other Party hereby consents to being joined as a Party plaintiff where necessary
and, in case of joining, such other Party agrees to give the Party bringing such
suit reasonable assistance and authority to file and to prosecute such suit, at
the exercise of the Party bringing such suit. All OUT-OF-POCKET COSTS of any
such action or proceeding in TERRITORY A shall be included as part of the
determination of the JOINT P&L as outlined in Section 7.1.14 to the extent that
such costs relate to ANTI-CD20 ANTIBODY. All OUT-OF-POCKET COSTS of any such
action or proceeding in TERRITORY B or TERRITORY C shall be borne by the Party
incurring such costs.
(b) In the event a Party recovers any damages or other
monetary awards in any proceedings or by way of settlement under Section
11.4.3(b) for infringement or misappropriation of INTELLECTUAL PROPERTY RIGHTS
in TERRITORY A, or royalties as a result of a license grant to a THIRD PARTY in
TERRITORY A under Section 11.4.3(b), (collectively "Recovery") such Recovery
shall be treated as NET SALES for purposes of the JOINT P&L. In the event a
Party recovers any damages or other monetary awards in any proceedings or by way
of settlement under Section 11.4.3(a) for infringement or misappropriation of
INTELLECTUAL PROPERTY RIGHTS in TERRITORY B or TERRITORY C, such recovery shall
be reimbursed first to each Party on a pro-rata basis for any OUT-OF-POCKET
COSTS incurred by such Party pursuant to the last sentence of Section 11.4.1(a)
or Section 11.4.2 and then the excess shall be distributed between the Parties
on a pro-rata basis in proportion to the estimated economic loss incurred by
each of them as a result of the reduction in NET SALES of PRODUCT in TERRITORY B
and TERRITORY C caused by the infringements, provided that the Party bringing
the action shall be entitled to at least one half of such excess, and further
provided that, in the event that SB is the Party bringing the action, in no
event shall the amount of Xxxxxxx'x share exceed the royalties Xxxxxxx would
have received had the sales which were the subject of the action been NET SALES.
11.4.2 If the Party having the primary right to institute,
prosecute, and control such infringement or misappropriation action under
Section 11.4.1(a) fails to do so within a
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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period of ninety (90) days after receiving notice of the infringement or
misappropriation, or if that Party, after initiating an action, determines to
discontinue such action, the other Party shall have the right, but not the
obligation, to the extent related to ANTI-CD20 ANTIBODY, to bring and control or
take over any such action by counsel of its own choice, unless prevented from
doing so by the laws of the country where the infringement or misappropriation
occurred or is threatened, and subject to Sections 11.4.3 and 11.4.4. All
OUT-OF-POCKET COSTS of any such action or proceeding in TERRITORY A shall be
included as part of the JOINT P&L to the extent that such costs relate to
ANTI-CD20 ANTIBODY. All OUT-OF-POCKET COSTS of any such action or proceeding in
TERRITORY B or TERRITORY C shall be borne by the Party incurring such costs.
11.4.3
(a) OUTSIDE TERRITORY A. The Party conducting such
infringement or misappropriation action outside of TERRITORY A shall have full
control over its conduct, including settlement thereof provided that the Parties
shall keep one another informed of the status of and of their respective
activities regarding any litigation or settlement thereof concerning PRODUCT in
the TERRITORY and provided further that no settlement or consent judgment or
other voluntary final disposition of any suit defended or action brought by a
Party pursuant to Section 11.4.1(a) or Section 11.4.2 may be entered into
without the consent of the other Party if such settlement would require the
other Party to be subject to an injunction or to make a monetary payment or
would otherwise adversely affect the other Party's rights under this Agreement.
(b) INSIDE TERRITORY A. In the event that the Parties
decide that it is desirable to grant a license related to any ANTI-CD-20
ANTIBODY to a THIRD PARTY under Xxxxxxx'x INTELLECTUAL PROPERTY RIGHTS in
TERRITORY A, or in the event that the Party controlling the action in TERRITORY
A under Section 11.4.1(a) or Section 11.4.2 desires to settle such action by
granting a license to a THIRD PARTY under Xxxxxxx'x INTELLECTUAL PROPERTY RIGHTS
in TERRITORY A or in the event that the granting of a license to a THIRD PARTY
under Xxxxxxx'x INTELLECTUAL PROPERTY RIGHTS in TERRITORY A is part of a
condition required by a THIRD PARTY as part of the THIRD PARTY'S forbearance to
xxx Xxxxxxx and/or SB and/or any regulatory agency or otherwise forbear to
exercise or agree to waive a legal or administrative or governmental action or
right or impediment against Xxxxxxx and/or SB with respect to preventing Xxxxxxx
and/or SB from lawfully commercializing PRODUCT in TERRITORY A, the Parties will
promptly meet to determine the appropriate and lawful course of action and no
settlement or consent judgment or other voluntary final disposition of any suit
defended or action brought by a Party pursuant to Section 11.4.1(a) or Section
11.4.2 in TERRITORY A which includes the grant of such a license may be entered
into without the consent of the other Party.
11.4.4 In connection with any action taken by either Party
against a THIRD PARTY to protect or enforce any INTELLECTUAL PROPERTY RIGHTS,
the other Party shall, if requested, consult with the Party taking such action,
and make available as witnesses its employees or as evidence any materials,
and/or data as are reasonably necessary for the furtherance of such action. The
OUT-OF-POCKET COSTS in connection with the providing of witnesses and/or the
making available of any materials and/or data shall be borne by the Party
incurring them. If such OUT-OF POCKET COSTS are incurred in TERRITORY A, they
shall be included as part of the JOINT
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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P&L, and if they are incurred in TERRITORY B or TERRITORY C, they shall be borne
by the Party incurring such costs
11.5 DEFENSE AND SETTLEMENT OF THIRD PARTY CLAIMS FOR PRODUCTS IN THE
TERRITORY; OPPOSITION AND REVOCATION PROCEEDINGS.
11.5.1 DEFENSE AND SETTLEMENT OF THIRD PARTY CLAIMS IN TERRITORY
A. If a THIRD PARTY asserts that a patent or other right owned by it is
infringed by the manufacture, use or sale of any PRODUCT in TERRITORY A, the
Party first obtaining knowledge of such a claim shall immediately provide the
other Party notice of such claim and the related facts in reasonable detail. The
JDC or JCC (as appropriate) shall determine how best to control the defense of
any such claim (including the bringing of a declaratory judgment action) with
respect to PRODUCT. In the event the JDC or JCC cannot agree on the defense of
any such claim or whether or not a particular Party shall control the defense,
the Parties shall submit such issue(s) promptly thereafter to an UNAFFILIATED
EXPERT who is a patent attorney. The OUT-OF-POCKET COSTS of engaging such
UNAFFILIATED EXPERT patent attorney for such determination shall be shared
equally by the Parties. The determination of such UNAFFILIATED EXPERT patent
attorney shall be binding on the JDC or JCC. The entity that controls the
defense of a given claim with respect to PRODUCT shall also have the right to
control settlement of such claim; provided, however, that (a) if one Party
controls, no settlement or consent judgment or other voluntary final disposition
of any such claim may be entered into without the consent of the other Party if
such settlement would require the other Party to be subject to an injunction or
to make a monetary payment or would otherwise adversely affect the other Party's
rights under this Agreement, and (b) such Party shall solely bear all
OUT-OF-POCKET COSTS it incurs with respect to such defense which costs did not
receive the prior written approval of the JDC or JCC (as appropriate).
11.5.2 DEFENSE AND SETTLEMENT OF THIRD PARTY CLAIMS OUTSIDE OF
TERRITORY A. If a THIRD PARTY asserts that a patent or other right owned by it
is infringed by the manufacture, use or sale of any PRODUCT outside of TERRITORY
A, the Party first obtaining knowledge of such a claim shall immediately provide
the other Party notice of such claim and the related facts in reasonable detail.
SB shall have the right, but not the obligation, to defend such suit at its own
expense. Xxxxxxx and SB shall provide reasonable assistance to one another and
reasonably cooperate in any such litigation at the other's request without
expense to the requesting party.
11.5.3 RE-EXAMINATION, OPPOSITION AND REVOCATION PROCEEDINGS.
After the Effective Date, in the event either Xxxxxxx or SB believes that
initiating a re-examination, revocation or opposition proceeding against patent
rights held by a THIRD PARTY is necessary or desirable in order to manufacture
or develop or commercialize the PRODUCT anywhere in the TERRITORY, or otherwise
assure that their activities under this Agreement do not infringe the
intellectual property rights of such THIRD PARTY, then the JDC will discuss the
situation in good faith. In the event that the JDC cannot make a unanimous
decision regarding whether or not such revocation or opposition proceeding is
necessary or desirable or whether or not a particular Party shall conduct such
proceeding, the Parties shall submit such issue(s) promptly thereafter to an
UNAFFILIATED EXPERT who is a patent attorney. The OUT-OF-POCKET COSTS of
engaging such UNAFFILIATED EXPERT patent attorney for such determination shall
be shared equally by the
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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Parties. The determination of such UNAFFILIATED EXPERT shall be binding on the
JDC. SB shall have the first right, but not the obligation, to bring such
re-examination, opposition or revocation action outside of TERRITORY X. Xxxxxxx
and SB shall provide reasonable assistance to one another and reasonably
cooperate in any such litigation at the other's request without expense to the
requesting party. All PATENT COSTS inside TERRITORY A related to any such
re-examination, opposition and revocation proceeding brought by a Party in
accordance with this Section 11.5.3 shall be included as part of the JOINT P&L.
All PATENT COSTS outside of TERRITORY A related to any such re-examination,
opposition and revocation proceeding brought by a Party in accordance with this
Section 11.5.3 shall be borne by the Party that incurred such expense.
11.6 ALLOCATION OF EXPENSES. The OUT-OF-POCKET COSTS incurred by either
Party under Section 11.2 shall be allocated between the Parties as provided in
Section 11.2. The OUT-OF-POCKET COSTS incurred by either Party under Section
11.4 shall be allocated between the Parties as provided in Section 11.4. The
OUT-OF-POCKET COSTS incurred by either Party of engaging an UNAFFILIATED EXPERT,
patent defense, settlement and judgments pursuant to Section 11.5 with respect
to PRODUCT in TERRITORY A shall be a shared expense of the Parties. The
OUT-OF-POCKET COSTS of patent defense, settlement and judgments pursuant to
Sections 11.5.1 and 11.5.2 with respect to PRODUCT outside of TERRITORY A shall
be borne by the Party which incurred such expense. The OUT-OF-POCKET COSTS
incurred by either Party of engaging an UNAFFILIATED EXPERT pursuant to Section
11.5.3 shall be a shared expense of the Parties. All PATENT COSTS incurred by a
Party pursuant to Section 11.5.3 shall be allocated between the Parties as
provided in Section 11.5.3.
11.7 ROYALTY REDUCTION IN TERRITORY B or TERRITORY C. If, as a result of
settlement procedures or litigation under Section 11.5, SB is required to pay a
THIRD PARTY a royalty in TERRITORY B or TERRITORY C or make any payment of any
kind for the right to use the Xxxxxxx INTELLECTUAL PROPERTY RIGHTS in a
particular country in TERRITORY B or TERRITORY C, SB may deduct, from the amount
of royalties owed to Xxxxxxx in connection with the country, [*] of the amount
of the royalty or such other amount payable to the THIRD PARTY in respect of the
sale of the allegedly infringing PRODUCT, provided that (i) the balance of such
royalty or other payment obligation shall be included in NON-USA COGS, and (ii)
in any event, the net royalty payable to Xxxxxxx for that country shall not be
reduced to an amount less than [*] of NET SALES in such country or [*] per
Bexxar Therapy (as defined in Section 7.2.5(f)), whichever is greater.
11.8 FORECLOSURE UNDER SECURITY AGREEMENT. In order to xxxxx XX a
security interest in certain collateral, the Parties have executed a Security
Agreement (the "Security Agreement") concurrent with the execution of the LOAN
AGREEMENT. Such collateral includes those XXXXXXX PATENT RIGHTS identified in
the Security Agreement The Parties agree that the following procedures shall
apply in the event of default by Xxxxxxx under the Security Agreement and the
exercise of rights and remedies by SB thereunder. As used in this Section 11.8,
the term "Secured Patents" shall refer to all XXXXXXX PATENT RIGHTS included
within the defined term "Collateral" under the Security Agreement.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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11.8.1 FORECLOSURE NOT A TERMINATION OF THIS AGREEMENT. A default
by Xxxxxxx under the Security Agreement and the exercise of any rights or
remedies by SB thereunder shall not constitute a termination of this Agreement.
Such termination shall occur, if at all, only upon the events specified in
Article 13 or as otherwise provided in this Agreement. So long as this Agreement
remains in effect, the provisions of this Article 11 shall apply to the Secured
Patents, whether title is in the name of Xxxxxxx or SB. Notwithstanding the
above, in the event SB exercises its rights or remedies under the Security
Agreement, and this Agreement remains in effect, SB shall be entitled to one
hundred percent (100%) of all royalties or other remuneration generated as a
result of any license granted by the Parties to a THIRD PARTY in TERRITORY A
under Section 11.4.3(b).
11.8.2 TRANSFER OF SECURED PATENTS.
(a) If SB exercises rights or remedies under the Security
Agreement, then, so long as title to the Secured Patents remains in the name of
Xxxxxxx, Xxxxxxx shall continue to perform prosecution, maintenance, and
enforcement of such PATENT RIGHTS, subject, however, to the terms of this
Article 11, provided that in performing such work, Xxxxxxx shall at all times
keep SB fully informed of its actions with respect to the Secured Patents and
shall follow SB's instructions with respect to such matters to the extent that
they may affects rights within the field of ANTI-CD20 ANTIBODIES.
(b) If SB forecloses on the Secured Patents or otherwise
obtains title thereto, Xxxxxxx shall promptly and fully cooperate in the orderly
transfer of title from Xxxxxxx to SB of such Secured Patents and shall execute
all documents necessary to effect such transfer at its expense. Xxxxxxx shall
make available to SB , at Xxxxxxx'x expense, copies of all its relevant files
regarding the creation, prosecution, maintenance, enforcement and extension of
the Secured Patents.
(c) Any transfer of the Secured Patents to any party other
than SB shall be subject to an agreement by the transferee to take such patents
subject to the terms of this Section 11.8, as if such transferee were SB.
11.8.3 MAINTENANCE OF SECURED PATENTS.
(a) If SB obtains title to the Secured Patents, it shall,
at its expense, prosecute and maintain the Secured Patents, provided that:
(i) SB shall keep Xxxxxxx promptly and fully
informed of the course of patent prosecution and other proceedings including by
providing Xxxxxxx with copies of substantive communications, search reports and
third party observations submitted to or received from patent offices throughout
the TERRITORY or Japan,
(ii) SB will disclose to Xxxxxxx all information
concerning the institution or possible institution of any interference,
opposition, re-examination, reissue, revocation, nullification or any official
proceeding involving a Secured Patent anywhere in the TERRITORY or Japan, and
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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(iii) subject to Section 11.8.3(c), SB shall use
COMMERCIALLY REASONABLE EFFORTS with respect to such prosecution and
maintenance. Notwithstanding the above, Xxxxxxx shall reimburse SB for all costs
it incurs with respect to the prosecution or maintenance of Secured Patents to
the extent that such costs are not related to the field of ANTI-CD20 ANTIBODIES
within thirty (30) days following receipt from SB of an accounting for such
costs, together with a related invoice.
(b) Xxxxxxx shall have the right to review all such
pending applications and other proceedings outlined in Sections 11.8.3(a) and
(b) and make recommendations to SB concerning them and their conduct, provided
that SB shall have sole discretion with respect to all decisions related
thereto, except as otherwise provided in Section 11.8.3(d). Xxxxxxx shall
provide such patent consultation to SB at no cost to SB. Xxxxxxx shall hold all
information disclosed to it under this section as confidential subject to the
provisions of Article 17.
(c) Notwithstanding Section 11.8.3(a)(iii), SB shall have
no obligation to maintain or prosecute any claims contained in the Secured
Patents, and may abandon or otherwise cause or allow such claims to be
forfeited.
(d) If SB determines (i) to abandon any Secured Patents,
or any part of a Secured Patent, (ii) to cause or allow such patent or part
thereof to be forfeited, or (iii) to cease maintaining or prosecuting claims of
the Secured Patents, it shall provide Xxxxxxx at least sixty (60) days prior
notice of such proposed action or event and Xxxxxxx shall have the right, but
not the obligation, to assume responsibility for (a) such Secured Patent or part
thereof which SB intends to abandon or otherwise cause or allow to be forfeited,
or (b) prosecuting or maintaining claims of such Secured Patents, provided that
Xxxxxxx shall bear one hundred percent (100%) of all reasonable expenses
incurred by SB with respect to the prosecution and maintenance of such Secured
Patent or part thereof to be forfeited, whether or not outside the field of
ANTI-CD20 ANTIBODIES from the date Xxxxxxx receives such notice until the date
that either (x) Xxxxxxx assumes such responsibility, or (y) Xxxxxxx notifies SB,
in writing, that Xxxxxxx is not interested in assuming such responsibility.
(e) SB shall have the right but not the obligation to seek
extensions of the terms of any Secured Patents, at SB's expense. SB shall have
sole discretion in making any decisions related to such expenses.
11.8.4 ACTIONS SUBSEQUENT TO TERMINATION. In the event of a
termination of this Agreement at a time when SB has foreclosed on the Secured
Patents (whether such termination occurred before or after such foreclosure),
then:
(a) In the event of the institution of any suit by a THIRD
PARTY against Xxxxxxx, XX, or any sublicensee or distributor of either of them
for patent infringement involving the manufacture, use, sale, distribution or
marketing of PRODUCT anywhere in the TERRITORY or Japan, the Party sued shall
promptly notify the other Party in writing. Each Party shall have the right to
defend itself in such action, at its own expense, and the Parties shall
reasonably cooperate in any such litigation without expense to the requesting
Party.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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(b) In the event that either Party becomes aware of actual
or threatened infringement of a Secured Patent anywhere in the TERRITORY or
Japan, the Party becoming aware of such matter shall promptly inform the other
Party. SB shall have the first right, but not the obligation, to bring, at its
own expense, an infringement action against any such apparent infringer, and if
necessary to name Xxxxxxx as a party in such action, unless the actual or
threatened infringement is exclusively within the scope of Xxxxxxx'x exclusive
license rights under Section 3(a) of the Security Agreement, and the outcome of
such action can not potentially affect the validity or enforceability of such
Secured Patent with respect to the field of ANTI-CD20 ANTIBODIES, in which case
Xxxxxxx shall have the first right to bring such an action and if necessary to
name SB as a party in such action. If the Party with the first right to commence
such an action does not do so within ninety (90) days of delivery or receipt of
the notice of infringement, the other Party, after notifying the first Party in
writing, shall be entitled to bring such infringement action at its own expense.
The Party conducting such action shall have full control over its conduct,
including settlement thereof subject to paragraph (d) below. In any event, the
Parties shall reasonably cooperate in any such litigation without expense to the
requesting Party.
(c) Xxxxxxx and SB shall recover their respective actual
OUT-OF-POCKET COSTS, or equitable proportions thereof, from the proceeds of any
litigation recovery or settlement under this Section 11.8.4. Any amount
recovered in excess of such costs shall be retained by the Party conducting the
action.
(d) The Parties shall keep one another informed of the
status of and their respective activities regarding any litigation or settlement
thereof concerning Secured Patents, provided, however, that no settlement or
consent judgment or other voluntary final disposition of any suit defended or
action brought by a Party pursuant to this Section 11.8 may be entered into
without the consent of the other Party if such settlement would require the
other Party to be subject to an injunction or to make a monetary payment or
would otherwise adversely affect the other Party's rights.
11.8.5 NO REPRESENTATION OR WARRANTY. SB makes no representation
or warranty, express or implied, with respect to any of SB's activities related
to the Secured Patents. Xxxxxxx agrees that SB shall have no liability to
Xxxxxxx with respect to SB's activities related to the Secured Patents provided
that SB follows the procedures outlined in this Section 11.8.
11.9 COVENANT REGARDING EXISTING THIRD PARTY LICENSE AGREEMENTS WITH
[*]. Xxxxxxx covenants that as of the date of mutual execution of this Agreement
by the Parties, it will expeditiously pursue and use COMMERCIALLY REASONABLE
EFFORTS to obtain an amendment(s) of the EXISTING THIRD PARTY LICENSE AGREEMENTS
with [*] (as defined in Section [*]) in order that:
11.9.1 [*] shall waive any right that it has under its EXISTING
THIRD PARTY LICENSE AGREEMENTS with Xxxxxxx to participate in any decisions
regarding the settlement, consent judgment or other voluntary final disposition
of any suit regarding any XXXXXXX PATENT RIGHTS which may be owned by [*]; and
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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11.9.2 the licenses granted to Xxxxxxx by [*] under the first of
the two EXISTING THIRD PARTY LICENSE AGREEMENTS between Xxxxxxx and [*] (as set
forth in Section 1.19(v)) will be consistent in scope with the licenses granted
to Xxxxxxx by [*] under the second of the two EXISTING THIRD PARTY LICENSE
AGREEMENTS between Xxxxxxx and [*] (as set forth in Section 1.19(vi)).
Xxxxxxx agrees to keep SB informed of its efforts to negotiate the amendment(s)
described in Sections 11.9.1 and 11.92. Xxxxxxx provides no assurance to SB that
such amendment(s) will be obtained despite its efforts to do so, provided that
(a) in the event such amendments are not obtained, Xxxxxxx will bear, at its
sole expense, any incremental royalties, licensing fees and legal costs incurred
by the Parties with respect to the making, having made, use or sale of PRODUCT
in the TERRITORY as a result thereof, or (b) in the event such amendment is
obtained, but requires any incremental royalties, licensing fees and legal costs
relating to the making, having made, use or sale of PRODUCT in the TERRITORY,
Xxxxxxx will bear, at its sole expense, any such incremental royalties,
licensing fees and legal costs.
ARTICLE 12
FORCE MAJEURE
Neither Party shall be liable to the other for delay or failure in the
performance of the obligations on its part contained in this Agreement if and to
the extent that such failure or delay is due to circumstances beyond its control
which it could not have avoided by the exercise of reasonable diligence (a
"FORCE MAJEURE OCCURRENCE") including but not limited to: act of God, war or
insurrection; civil commotion; destruction of essential facilities or materials
by earthquake, fire, flood or storm; labor disturbance; epidemic; or other
similar event; provided, however, that the Party so affected shall notify the
other Party promptly should such circumstances arise, giving an indication of
the likely extent and duration thereof, and shall use all COMMERCIALLY
REASONABLE EFFORTS to avoid, remove or alleviate such causes of nonperformance
and shall resume performance of its obligations hereunder with the utmost
dispatch whenever such causes are removed.
ARTICLE 13
TERM AND TERMINATION
13.1 TERM.
13.1.1 Unless earlier terminated as set out in this Agreement,
this Agreement shall expire in TERRITORY A with respect to a particular PRODUCT
upon the termination of the sale of such PRODUCT in TERRITORY A and the
availability of such PRODUCT for the end user, such termination to be determined
by the JCC. Following such expiration, neither Party shall have any rights under
the other Party's INTELLECTUAL PROPERTY RIGHTS in TERRITORY A to make, have
made, use, sell, offer for sale, and import such PRODUCT in TERRITORY A, and,
unless agreed otherwise by the Parties, both Parties shall be precluded from
selling such PRODUCT in TERRITORY A, or from licensing or otherwise enabling any
AFFILIATE or THIRD PARTY to sell such PRODUCT in
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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TERRITORY A. Furthermore, following such expiration, while Xxxxxxx shall retain
all rights to the Territory A Trademarks (as defined in Section 10.1.1) related
to such PRODUCT, unless agreed otherwise by the Parties, Xxxxxxx shall be
precluded from using such Territory A Trademarks in connection with the making,
having made, use, sale, offer for sale, and importation of such PRODUCT or any
other human pharmaceutical therapy in TERRITORY A. This Agreement shall expire
in its entirety in TERRITORY A upon the termination of sale of all PRODUCTS in
TERRITORY A.
13.1.2 Unless earlier terminated as set out in this Agreement,
this Agreement shall expire in each country of TERRITORY B and TERRITORY C with
respect to a particular PRODUCT on a country-by-country basis, on the [*]
anniversary of the date of FIRST COMMERCIAL SALE of such PRODUCT in such
country. Following such expiration in a particular country of TERRITORY B and
TERRITORY C, each Party shall have a non-exclusive, royalty-free, irrevocable
and perpetual license, under the other Party's INTELLECTUAL PROPERTY RIGHTS in
such country, to make, have made, use, sell, offer for sale, and import such
PRODUCT in such country, except that Xxxxxxx shall have no rights to any
INTELLECTUAL PROPERTY RIGHTS or INVENTIONS or other proprietary know-how of SB
related to the [*] developed [*] the [*]. Furthermore, following such
expiration, SB shall have the exclusive right to use the TRADEMARK used in
connection with such PRODUCT in connection with the making, having made, use,
sale, offer for sale, and importation of the PRODUCT in such country, and if
such TRADEMARK is a Xxxxxxx Trademark (as defined in Section 10.1.2), Xxxxxxx
shall promptly assign all rights and title to such TRADEMARK in such country to
SB. Xxxxxxx warrants and represents that after such expiration, Xxxxxxx shall no
longer use Trademark (whether an SB Trademark (as defined in Section 10.1.2) or
Xxxxxxx Trademark) for any purpose, and shall only be permitted to continue to
sell such PRODUCT under a trademark which is not confusingly similar to
Trademark. This Agreement shall expire in its entirety in a particular country
of TERRITORY B or TERRITORY C upon the termination of the fifteenth anniversary
of the FIRST COMMERCIAL SALE of the last PRODUCT in such country.
13.1.3 With respect to supply of a particular PRODUCT to the
Parties after the expiration of the Agreement in TERRITORY B and TERRITORY C
with respect to such PRODUCT, the Parties shall meet [*] months prior to the
expiration date for the first country under Section 13.1.2 in TERRITORY B, and
again [*] prior to the expiration date for the first country under Section
13.1.2 in TERRITORY C, to discuss an ongoing long-term agreement for the supply
of the relevant UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY from whichever
Party is then manufacturing UNCONJUGATED ANTIBODY and/or RADIOLABELED ANTIBODY
(whether at its own facilities or at a THIRD PARTY manufacturer) to the other
Party in each such TERRITORY. If the Parties are unable to agree on a long-term
supply agreement within six (6) months prior to the first expiration date in any
such TERRITORY, the then supplying Party would be obligated to supply the other
Party with UNCONJUGATED ANTIBODY and/or RADIOLABELED ANTIBODY in such TERRITORY
for [*] following the date of first expiration in such TERRITORY, such supply to
be charged to the receiving Party at the supplying Party's COST OF GOODS plus a
percentage of such Party's COST OF GOODS to be negotiated in good faith between
the Parties, provided in no event shall such percentage exceed [*]. After such
[*], each Party shall be free to contract with any THIRD PARTY manufacturer for
the supply of UNCONJUGATED ANTIBODY and/or RADIOLABELED ANTIBODY, provided that
neither SB nor Xxxxxxx may enter into an exclusivity agreement with a
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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THIRD PARTY manufacturer for the supply of UNCONJUGATED ANTIBODY and/or
RADIOLABELED ANTIBODY which would preclude the other Party from being supplied
by the same manufacturer.
13.2 GENERAL CONDITIONS OF EXPIRATION AND TERMINATION.
13.2.1 The provisions of Sections 8.1, 8.2, 8.3, 8.5, 8.6, 8.7,
9.18, 10.1.1, 10.1.2, 10.2.3, 10.5 (to the extent related to actions which arose
during the term of the Agreement), 10.6 (to the extent related to actions which
arose during the term of the Agreement), 10.7, 11.1, 11.1.2 (with respect to
jointly-owned INVENTIONS), 11.2 (with respect to jointly-owned INVENTIONS), 11.3
(to the extent related to actions which arose during the term of the Agreement),
11.4 (to the extent related to actions which arose during the term of the
Agreement), 11.5 (to the extent related to actions which arose during the term
of the Agreement), 11.6 (to the extent related to actions which arose during the
term of the Agreement), 11.8 and 11.9 and Articles 12, 13, 14, 15, 16, 17, 18
and 19 (excluding Section 19.1) shall survive termination or expiration of this
Agreement.
13.2.2 Termination or expiration of this Agreement shall not
operate to deprive either Party of any rights or remedies either at law or in
equity or to relieve either Party of any of its obligations incurred prior to
the effective date of such termination or expiration.
13.2.3 SB may terminate this Agreement on a country by country
basis by giving Xxxxxxx at least [*] written notice thereof at any time before
SB first markets PRODUCT in such country based on a reasonable determination by
SB, using the same standards SB would use in assessing whether or not to
continue development or commercialization of a PRODUCT of its own making, that
the patent, medical/scientific, technical, regulatory or commercial profile of
PRODUCT does not justify continued development or future commercialization of
PRODUCT in such country. After marketing PRODUCT, SB may terminate this
Agreement on a country by country basis by giving Xxxxxxx at least [*] prior
written notice thereof based on a reasonable determination by SB, using the same
standards SB would use in assessing whether or not to continue development or
commercialization of a PRODUCT of its own making, that the patent,
medical/scientific, technical, regulatory or commercial profile of PRODUCT does
not justify continued marketing of PRODUCT in such country. If SB terminates
this Agreement pursuant to this Section 13.2.3, it shall pay to Xxxxxxx (i) in
the event that Xxxxxxx is continuing with the development or commercialization
of PRODUCT in such country(ies) in which SB is terminating the Agreement, all
sums accrued under this Agreement which are then due and owing by SB to Xxxxxxx
in such country(ies) (less any sums which are then due and owing by Xxxxxxx to
SB in such country(ies)) for [*], as applicable, up to the effective date of
termination, or (ii) in the event that Xxxxxxx determines within such [*] as the
case may be that Xxxxxxx will not continue with the development or
commercialization of PRODUCT in such country(ies) in which SB is terminating the
Agreement, [*] of all unavoidable and noncancellable OUT-OF-POCKET COSTS which
are reasonably associated with winding down the development or commercialization
of PRODUCT in such country(ies). In the event that SB terminates this Agreement
in one or more countries and becomes liable under clause (ii) hereto, then the
Parties shall consult in good faith regarding the costs associated with winding
down such development and commercialization of PRODUCT and
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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the tasks to be undertaken by the Parties, and agree to use COMMERCIALLY
REASONABLE EFFORTS to minimize such costs.
13.2.4 Either Party may terminate this Agreement if, at any time,
the other Party shall file in any court or agency pursuant to any statute or
regulation of any state or country, a petition in bankruptcy or insolvency or
for reorganization or for an arrangement or for the appointment of a receiver or
trustee of the Party or of its assets, or if the other Party proposes a written
agreement of composition or extension of its debts, or if the other Party shall
be served with an involuntary petition against it, filed in any insolvency
proceeding, and such petition shall not be dismissed within sixty (60) days
after the filing thereof, or if the other Party shall propose or be a Party to
any dissolution or liquidation, or if the other Party shall make an assignment
for the benefit of creditors.
13.2.5 Notwithstanding the bankruptcy of Xxxxxxx, or the
impairment of performance by Xxxxxxx of its obligations under this Agreement as
a result of bankruptcy or insolvency of Xxxxxxx, XX shall be entitled to retain
the licenses granted herein, subject to Xxxxxxx'x rights to terminate this
Agreement for reasons other than bankruptcy or insolvency as expressly provided
in this Agreement.
13.2.6 All rights and distribution rights granted under or
pursuant to this Agreement by Xxxxxxx to SB are, and shall otherwise be deemed
to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of
rights to "intellectual property" as defined under Section 101(52) of the U.S.
Bankruptcy Code. The Parties agree that SB, as a licensee of such rights under
this Agreement, shall retain and may fully exercise all of its rights and
elections under the U.S. Bankruptcy Code, subject to performance by SB of its
preexisting obligations under this Agreement. The Parties further agree that, in
the event of the commencement of a bankruptcy proceeding by or against Xxxxxxx
under the U.S. Bankruptcy Code, SB shall be entitled to a complete duplicate of
(or complete access to, as appropriate) any such intellectual property and all
embodiments of such intellectual property, and same, if not already in its
possession, shall be promptly delivered to SB (a) upon any such commencement of
a bankruptcy proceeding upon written request therefor by SB, unless Xxxxxxx
elects to continue to perform all of its obligations under this Agreement, or
(b) if not delivered under (a) above, upon the rejection of this Agreement by or
on behalf of Xxxxxxx upon written request therefor by SB, provided, however,
that upon Xxxxxxx'x (or its successor's) written notification to SB that it is
again willing and able to perform all of its obligations under this Agreement,
SB shall promptly return all such tangible materials to Xxxxxxx, but only to the
extent that SB does not require continued access to such materials to enable SB
to perform its obligations under this Agreement.
13.3 TERMINATION FOR BREACH.
13.3.1 GENERAL. Except as otherwise provided in this Section
13.3.1, either Party may terminate this Agreement for material breach by the
other Party, which breach remains uncured for [*] days in the case of nonpayment
of any amount due and [*] days for all other breaches, each measured from the
date written notice of such breach is given to the breaching Party, or, if such
breach is not susceptible of cure within such [*] day period and the breaching
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
98.
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Party uses diligent good faith efforts to cure such breach, for [*] days after
written notice to the breaching Party, provided that notice of termination must
be given after the date written notice of breach is given and prior to the
expiration of such [*] period and prior to the cure of the breach by the
breaching Party.
13.3.2 BREACH BY SB. If termination is due to a material breach
by SB, all rights granted to SB under this Agreement shall revert to Xxxxxxx and
Xxxxxxx shall automatically be granted an exclusive, worldwide, royalty-free
license, with a right to sublicense, under all INTELLECTUAL PROPERTY RIGHTS held
by SB at the time of termination, to use, sell, offer for sale and import the
PRODUCT in the FIELD in the TERRITORY, but Xxxxxxx shall have no rights under
any INTELLECTUAL PROPERTY RIGHTS or INVENTIONS or other proprietary know-how
held by SB which are related to the [*], and the terms of Section 13.4 shall
apply. Xxxxxxx shall thereafter be free to develop and commercialize the PRODUCT
without limitation or further obligation to SB.
13.4 EARLY TERMINATION LICENSE OF SB'S LICENSE. In the event SB's
license terminates early in one or more countries pursuant to Section 3.2.5(b),
5.4.1(a), 5.4.2(a), 6.7, 7.2.2(a), 7.2.2(b), 9.10.4, 9.10.6, 13.2.3 or 13.3.2
all rights granted to SB under this Agreement in such countries shall revert to
Xxxxxxx and Xxxxxxx shall automatically be granted an exclusive license, with a
right to sublicense, under all INTELLECTUAL PROPERTY RIGHTS held by SB at the
time of termination in such countries, to use, sell, offer for sale and import
the PRODUCT in the FIELD in such countries, except that Xxxxxxx shall have no
rights to any INTELLECTUAL PROPERTY RIGHTS or INVENTIONS or other proprietary
know-how of [*] developed [*] the [*]. In addition, at Xxxxxxx'x election,
either (i) SB will transfer to Xxxxxxx any regulatory filings made by SB or its
permitted sublicensees in such countries or (ii) Xxxxxxx and/or its THIRD PARTY
licensees will have a right of reference to any regulatory filings made by SB or
its permitted sublicensees in such countries to the extent legally permitted.
Xxxxxxx shall thereafter be free to develop and commercialize the Product
without limitation or further obligation to SB in such countries, except as
otherwise provided in this Section 13.4. In addition, SB shall promptly provide
Xxxxxxx, with the SB Transfer Documents (as defined below), which Xxxxxxx may
use as Xxxxxxx sees fit and which Xxxxxxx may provide to a THIRD PARTY licensee
for use in continuing DEVELOPMENT and commercialization of the PRODUCT in the
FIELD in such countries. Xxxxxxx shall reimburse SB for all expenses incurred by
SB in the provision of such Transfer Documents to Xxxxxxx within thirty (30)
days after receipt of SB's invoice therefor.
For purposes of this Section 13.4 and Section 13.5, "SB Transfer Documents"
shall mean [*], including but not limited to the following documents: (i) [*];
(ii) [*]; (iii) [*], and (iv) [*]. Notwithstanding the above, it is understood
that in the event that SB's exclusive license is terminated in less than the
entire European Union, and European Union regulatory or other governmental
regulations require a single company to hold a centralized marketing
authorization license for PRODUCT, SB will still be the marketing authorization
holder of the original centralized license, to which Xxxxxxx and/or its
sublicensee shall have a right of reference, and such original centralized
license will continue to be valid throughout the whole of the European Union,
and Xxxxxxx or its sublicensee will be required to obtain a second centralized
license which will be valid throughout the whole of the European Union, and
neither Xxxxxxx nor its sublicensee will be permitted to market PRODUCT under
the TRADEMARK. However, neither
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
99.
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Xxxxxxx nor its THIRD PARTY licensees shall be permitted to market, sell
or distribute PRODUCT under such second centralized license in those countries
of the European Union in which SB's license remains exclusive, provided that the
foregoing shall not be construed to otherwise limit further sale of PRODUCT put
on sale in those countries of the European Union in which Xxxxxxx and/or its
sublicensee are permitted to market PRODUCT into the other countries of the
European Union.
13.5 NON-EXCLUSIVE LICENSE. In the event SB's license becomes
non-exclusive in one or more countries pursuant to Section 5.4.1(a), 5.4.2(a),
7.2.2(a), 7.2.2(b) or 9.10.4, all rights granted to SB under this Agreement in
such countries shall become non-exclusive and Xxxxxxx shall automatically be
granted a non-exclusive license, with a right to sublicense, under all
INTELLECTUAL PROPERTY RIGHTS held by SB at the time SB's license becomes
non-exclusive in such countries, to use, sell, offer for sale and import the
PRODUCT in the FIELD in such countries, except that Xxxxxxx shall have no rights
to any INTELLECTUAL PROPERTY RIGHTS or INVENTIONS or other proprietary know-how
of SB related to the [*] developed [*] the [*]. In the event SB's license
becomes non-exclusive in one or more countries pursuant to Section 7.2.2(a) or
7.2.2(b), Xxxxxxx may only grant a sublicense under the foregoing license to
sell PRODUCT to a single THIRD PARTY in any given country. In addition, Xxxxxxx
and/or its THIRD PARTY licensees will have a right of reference to any
regulatory filings made by SB or its permitted sublicensees in such countries to
the extent legally permitted. Xxxxxxx shall thereafter be free to develop and
commercialize the Product without limitation or further obligation to SB in such
countries except as otherwise provided in this Section 13.5. In addition, SB
shall promptly provide Xxxxxxx with the SB Transfer Documents (as defined in
Section 13.4), which Xxxxxxx may use as Xxxxxxx sees fit and which Xxxxxxx may
provide to a THIRD PARTY licensee for use in continuing development and
commercialization of the PRODUCT in the FIELD in such countries. Xxxxxxx shall
reimburse SB for all expenses incurred by SB in the provision of such SB
Transfer Documents to Xxxxxxx within [*] after receipt of SB's invoice therefor.
Notwithstanding the above, it is understood that in the event that SB's
exclusive license is converted to a non-exclusive license in less than the
entire European Union, and European Union regulatory or other governmental
regulations require a single company to hold a centralized marketing
authorization license for PRODUCT, SB will still be the marketing authorization
holder of the original centralized license, to which Xxxxxxx and/or its
sublicensee shall have a right of reference, and such original centralized
license will continue to be valid throughout the whole of the European Union,
and Xxxxxxx or its sublicensee will be required to obtain a second centralized
license which will be valid throughout the whole of the European Union, neither
Xxxxxxx nor its sublicensee will be permitted to market PRODUCT under the
Trademark. However, neither Xxxxxxx nor its THIRD PARTY licensees shall be
permitted to market, sell or distribute PRODUCT under such second centralized
license in those countries of the European Union in which SB's license remains
exclusive, provided that the foregoing shall not be construed to otherwise limit
further sale of PRODUCT put on sale in those countries of the European Union in
which Xxxxxxx and/or its sublicensee are permitted to market PRODUCT into the
other countries of the European Union.
13.6 EARLY TERMINATION OF XXXXXXX'X LICENSE. In the event Xxxxxxx'x
rights to CO-PROMOTE PRODUCT terminates early in TERRITORY A pursuant to
Sections 4.2.3, 5.4.1(b), 5.4.2(b) or 7.1.15 (third sentence), all rights
granted to Xxxxxxx under this Agreement in TERRITORY A shall
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
100.
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revert to SB, and SB shall automatically be granted an exclusive license, with a
right to sublicense, under all INTELLECTUAL PROPERTY RIGHTS held by Xxxxxxx at
the time of termination in TERRITORY A, to use, sell, offer for sale and import
the PRODUCT in the FIELD in TERRITORY A. In addition, SB and/or its THIRD PARTY
licensees will have a right of reference to any regulatory filings made by
Xxxxxxx or its permitted sublicensees in TERRITORY A to the extent legally
permitted. SB shall thereafter be free to commercialize the PRODUCT in TERRITORY
A, and to use the Xxxxxxx Trademark (as defined in Section 10.1.2) in connection
therewith, without limitation or further obligation to Xxxxxxx in TERRITORY A,
except as otherwise provided in this Section 13.6 or Section 7.1.15. In
addition, Xxxxxxx shall promptly provide SB with the Xxxxxxx Transfer Documents
(as defined below) to the extent SB does not already have such Xxxxxxx Transfer
Documents, which SB may use as SB sees fit and which SB may provide to a THIRD
PARTY licensee for use in continuing commercialization of the PRODUCT in the
FIELD in TERRITORY A. SB shall reimburse Xxxxxxx for all expenses incurred by
Xxxxxxx in the provision of such Xxxxxxx Transfer Documents to Sb within thirty
(30) days after receipt of Xxxxxxx'x invoice therefor.
For purposes of this Section 13.6, "Xxxxxxx Transfer Documents" shall
mean all Xxxxxxx KNOW-HOW, including but not limited to the following documents:
(i) a copy of all protocols prepared by Xxxxxxx and regulatory filings made by
Xxxxxxx under this Agreement in TERRITORY A; (ii) a copy of all reports on
non-clinical and clinical studies sponsored by Xxxxxxx in TERRITORY A or for the
benefit of TERRITORY A under this Agreement which have been filed or prepared
for filing with the regulatory authorities; (iii) the data underlying any
non-clinical and clinical database owned by Xxxxxxx in computer-readable form if
readily available in a non-proprietary format, and (iv) a copy of all case
report forms for patients enrolled in clinical studies sponsored by Xxxxxxx for
which no report has been prepared at the time of termination.
13.7 NO LIMIT ON REMEDIES. Nothing herein shall exclude or limit any
remedies or entitlements whatsoever which the law confers to either Party in the
event of a breach of contractual obligations by the other Party.
ARTICLE 14
ASSIGNMENT
14.1 ASSIGNMENT. Neither Party may assign or transfer this Agreement or
any rights or obligations hereunder without the prior written consent of the
other which shall not be unreasonably withheld, except a Party may make such an
assignment without the other Party's consent to Affiliates or to a successor to
substantially all of the pharmaceutical business of such Party, whether in a
merger, sale of stock, sale of assets or other transaction. Any permitted
successor or assignee of rights and/or obligations hereunder shall, in a writing
to the other Party, expressly assume performance of such rights and/or
obligations. Any permitted assignment shall be binding on and inure to the
benefit of the successors of the assigning Party. Any assignment or attempted
assignment by either Party in violation of the terms of this Section 14.1 shall
be null and void and of no legal effect.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
101.
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14.2 PERFORMANCE BY AFFILIATES AND LOCAL OPERATING ENTITIES. Each of
Xxxxxxx and SB acknowledge that obligations under this Agreement may be
performed by AFFILIATES of Xxxxxxx and SB, to the extent permitted by this
Agreement. Each of Xxxxxxx and SB guarantee performance of this Agreement by its
AFFILIATES. In the event of a claim arising under this Agreement with respect to
an AFFILIATE of the other Party, the aggrieved Party may seek a remedy directly
against the other Party and shall not be required to seek a remedy from the
other Party's AFFILIATE. Wherever, as permitted by this Agreement, the Parties
delegate responsibility to local operating entities, the Parties agree that such
entities have no authority to amend the terms of this Agreement or act contrary
to its terms in any way.
ARTICLE 15
INDEMNIFICATION AND INSURANCE
15.1 CROSS INDEMNIFICATION.
15.1.1 INDEMNIFICATION IN THE NON-USA TERRITORY.
(a) With respect to DEVELOPMENT, MANUFACTURE DEVELOPMENT,
manufacture or commercialization of PRODUCT sold or to be sold in TERRITORY B or
TERRITORY C, SB hereby agrees to save, defend and hold Xxxxxxx, its AFFILIATES
and their respective officers, directors, shareholders, representatives, agents,
employees, successors and assigns harmless from and against any and all suits,
claims, actions, demands, liabilities, expenses and/or losses, including
reasonable legal expense and attorneys' fees, brought by a THIRD PARTY or that
arise in connection with any claim brought by a THIRD PARTY with respect to the
PRODUCT ("Losses"), including without limitation, Losses resulting from inherent
defects in the PRODUCT, except to the extent such Losses result from (i) the
negligence or willful misconduct of Xxxxxxx or breach by Xxxxxxx of any
provision of this Agreement, including without limitation, the Xxxxxxx
warranties and representations set forth in Article 16 or (ii) Xxxxxxx'x
manufacture (including its manufacture through THIRD PARTY suppliers) of
UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY which does not comply with GMP or
PRODUCT specifications (as defined in Section 9.4.4), except to the extent such
Losses result from (x) the negligence or willful misconduct of SB or breach by
SB of any provision of this Agreement, including without limitation, the SB
warranties and representations set forth in Article 16 or (y) SB's manufacture
(including its manufacture through THIRD PARTY suppliers) of UNCONJUGATED
ANTIBODY or RADIOLABELED ANTIBODY which does not comply with GMP or PRODUCT
Specifications (as defined in Section 9.4.4).
(b) With respect to DEVELOPMENT, MANUFACTURE DEVELOPMENT,
manufacture or commercialization of PRODUCT sold or to be sold in TERRITORY B or
TERRITORY C Xxxxxxx hereby agrees to save, defend and hold SB, its AFFILIATES
and their respective officers, directors, shareholders, representatives, agents,
employees, successors and assigns harmless from and against any and all Losses
(as defined in Section 15.1.1(a)) with respect to the PRODUCT to the extent such
Losses result from (i) the negligence or willful misconduct of Xxxxxxx or breach
by Xxxxxxx of any provisions of this Agreement, including without limitation,
the SB warranties
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
102.
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and representations set forth in Article 16 or (ii) Xxxxxxx'x manufacture
(including its manufacture through THIRD PARTY suppliers) of UNCONJUGATED
ANTIBODY or RADIOLABELED ANTIBODY which does not comply with GMP or PRODUCT
Specifications (as defined in Section 9.4.4), except to the extent such Losses
result from (x) the negligence or willful misconduct of SB or breach by SB of
any provision of this Agreement, including without limitation, the SB warranties
and representations set forth in Article 16 or (y) SB's manufacture (including
its manufacture through THIRD PARTY suppliers) of UNCONJUGATED ANTIBODY or
RADIOLABELED ANTIBODY which does not comply with GMP or PRODUCT Specifications
(as defined in Section 9.4.4).
15.1.2 INDEMNIFICATION IN TERRITORY A. With respect to
DEVELOPMENT, MANUFACTURE DEVELOPMENT, manufacture or commercialization of
PRODUCT sold or to be sold in TERRITORY A, each Party hereby agrees to save,
defend and hold the other Party, its AFFILIATES and their respective officers,
directors, shareholders, representatives, agents, employees, successors and
assigns harmless from and against any and all Losses (as defined in Section
15.1.1(a)) resulting directly from the manufacture, use, handling, storage, sale
or other disposition of Products throughout Territory A to the extent such
Losses result from (i) the negligence or willful misconduct of the indemnifying
Party or breach by the indemnifying Party of any provision of this Agreement,
including without limitation, the warranties and representations set forth in
Article 16 (ii) a Party's manufacture (including its manufacture through THIRD
PARTY suppliers) of UNCONJUGATED ANTIBODY or RADIOLABELED ANTIBODY which does
not comply with GMP or PRODUCT Specifications (as defined in Section 9.4.4), or
(iii) marketing activities of the indemnifying Party contrary to applicable
governmental regulations or outside the approved labeling of the PRODUCT, except
to the extent such Losses result from (x) the negligence or willful misconduct
of the other Party or breach by the other Party of any provision of this
Agreement, including without limitation, the other Party's warranties and
representations set forth in Article 16 or (y) the other Party's manufacture
(including its manufacture through THIRD PARTY suppliers) of UNCONJUGATED
ANTIBODY or RADIOLABELED ANTIBODY which does not comply with GMP or PRODUCT
Specifications (as defined in Section 9.4.4). Any other Losses resulting
directly from the manufacture, use, handling, storage, sale or other disposition
of PRODUCTS throughout TERRITORY A, including Losses resulting from inherent
defects in the PRODUCT, shall be included as an OTHER OPERATING INCOME/EXPENSE
and included in the JOINT P&L as outlined in Section 7.1.14.
15.2 INDEMNIFICATION PROCEDURE.
15.2.1 In the event Xxxxxxx is seeking indemnification from SB
under Section 15.1.1(a) or 15.1.2, SB shall have no such obligation unless
Xxxxxxx:
(a) gives SB prompt notice of any claim or lawsuit or
other action for which it seeks to be indemnified under this Agreement;
(b) cooperates fully with SB and its agents in defense of
any such claim, complaint, lawsuit or other cause of action; and
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
103.
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(c) SB is granted full authority and control over the
defense, including settlement or other disposition thereof, against such claim
or lawsuit or other action, provided that Xxxxxxx shall have the right to retain
counsel of its choice to participate in the defense of any such claim or lawsuit
at Xxxxxxx'x own expense, provided that such counsel shall not interfere with
SB's full authority and control.
15.2.2 In the event SB is seeking indemnification under Section
15.1.1(b) or Section 15.1.2, Xxxxxxx shall have no such obligation unless SB:
(a) gives Xxxxxxx prompt notice of any claim or lawsuit or
other action for which it seeks to be indemnified under this Agreement;
(b) cooperates fully with Xxxxxxx and its agents in
defense of any such claim, complaint, lawsuit or other cause of action; and
(c) Xxxxxxx is granted full authority and control over the
defense, including settlement or other disposition thereof, against such claim
or lawsuit or other action, provided that SB shall have the right to retain
counsel of its choice to participate in the defense of any such claim or lawsuit
at SB's own expense, provided that such counsel shall not interfere with
Xxxxxxx'x full authority and control.
15.3 INSURANCE. During the term of the Agreement, and for a period of
five (5) years after the expiration or termination of this Agreement or the
earlier termination thereof, each Party shall maintain, respectively, at its
sole cost and expense, and in the case of Xxxxxxx, from insurance companies
having a rating of at least "A-VIII" as published in the most recent edition of
A.M. Best's Insurance Reports, product liability insurance and contractual
liability coverage, in amounts, respectively, which are reasonable and customary
in the U.S. pharmaceutical industry for companies of comparable size and
activities at the respective place of business of each Party. Such product
liability insurance shall insure against all liability, including personal
injury, physical injury, or property damage arising out of the manufacture,
sale, distribution, or marketing of PRODUCT in the countries of the world in
which the Party is permitted to undertake such activities in accordance with
this Agreement. Each Party shall provide written proof of the existence of such
insurance to the other Party upon request. Notwithstanding the foregoing, prior
to FIRST COMMERCIAL SALE each Party shall always maintain product liability
insurance with a minimum of [*] per occurrence (or claim) and annual aggregate
limit of liability, and after FIRST COMMERCIAL SALE each Party shall always
maintain product liability insurance with a minimum of [*] per occurrence (or
claim) and annual aggregate limit of liability. The cost of obtaining and
maintaining such insurance shall not be an allowable expense under the JOINT P&L
described in Section 7.1.14.
ARTICLE 16
WARRANTIES AND REPRESENTATIONS
16.1 Each Party hereby warrants to the other:
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
104.
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16.1.1 that it has full power and authority to execute and
deliver this Agreement, the STOCK PURCHASE AGREEMENT, and the LOAN AGREEMENT and
to perform the obligations on its part under such agreements;
16.1.2 that the execution and delivery by it of this Agreement,
the STOCK PURCHASE AGREEMENT and the LOAN AGREEMENT and the performance of its
obligations under such agreements (i) have been duly approved by all necessary
corporate action and do not require any shareholder action or approval; (ii) do
not and will not conflict with or result in a material breach of any of the
terms and provisions of any THIRD PARTY agreement entered into as of the
Effective Date; and (iii) do not and will not conflict with such Party's
Certificate of Incorporation or By-Laws;
16.1.3 that it has the right to grant the licenses outlined in
this Agreement, and is not aware of any impediment, including without limitation
any THIRD PARTY agreement, which would prevent it from performing its
obligations under this Agreement; and
16.1.4 that it will not enter into any THIRD PARTY agreement
after the Effective Date which, in any way, will limit its ability to perform
all of the obligations undertaken by it hereunder.
16.2 Xxxxxxx warrants and represents that it:
16.2.1 as of the Effective Date will have received any consent
required from Xxxx Xxxxxx Cancer Institute, Inc., a Massachusetts non-profit
corporation, with its principal place of business at 00 Xxxxxx Xxxxxx, Xxxxxx,
Xxxxxxxxxxxxx, 00000 (hereinafter, "Xxxx Xxxxxx"), InterWest Partners V.L.P and
InterWest Investors V (hereinafter collectively, "InterWest Partners"), the
University of Michigan, a constitutional corporation of the State of Michigan,
with offices located at 0000 Xxxxx Xxxxx, Xxxx 0000, Xxx Xxxxx, Xxxxxxxx
00000-0000 (hereinafter, "Michigan") and any other THIRD PARTY to grant the
licenses under Article 5 according to the terms thereof and to perform its
obligations to SB under this Agreement;
16.2.2 as of the Effective Date will have obtained a waiver of
each and every obligation imposed by Xxxx Xxxxxx, InterWest Partners, Michigan
and any other THIRD PARTY (including, without limitation, the United States
Government) to manufacture PRODUCT substantially in the United States of America
consistent with federal law and policy, or in the event that such waivers have
not been obtained by the Effective Date, it will expeditiously pursue, and use
COMMERCIALLY REASONABLE EFFORTS to provide assistance to any THIRD PARTY making
application for, such waivers;
16.2.3 shall pay all royalties or other sums and other payments
which Xxxxxxx may owe to Xxxx Xxxxxx, InterWest Partners, Michigan and any other
THIRD PARTY by virtue of this Agreement (all subject to the cost-sharing
mechanisms set forth in this Agreement), and shall perform and observe all of
the other obligations outlined in all present and future agreements between
Xxxxxxx and Xxxx Xxxxxx, InterWest Partners, Michigan and any other THIRD PARTY
which are in any way related to Xxxxxxx'x ability to grant the rights granted to
SB
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
105.
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under this Agreement or to Xxxxxxx'x ability to perform its obligations to SB
under this Agreement; and
16.2.4 has received no notices that Xxxxxxx is in breach of its
obligations under its agreements with Xxxx Xxxxxx, InterWest Partners, Michigan
or any other THIRD PARTY which are in any way related to Xxxxxxx'x ability to
grant the rights granted to SB under this Agreement or to Xxxxxxx'x ability to
perform its obligations to SB under this Agreement. In the event that Xxxxxxx
receives notice from Xxxx Xxxxxx, InterWest Partners, Michigan or any other
THIRD PARTY that Xxxxxxx has committed a breach of its obligations under any
such agreement, or if Xxxxxxx anticipates such breach, such as may give rise to
a right by such THIRD PARTY to terminate, diminish Xxxxxxx'x ability to grant
rights to SB contemplated by this Agreement, or otherwise diminish Xxxxxxx'x
ability to perform its obligations to SB under this Agreement, Xxxxxxx shall
immediately notify SB of such situation, and Xxxxxxx shall promptly cure such
breach. However, if Xxxxxxx is unable to cure such breach, Xxxxxxx shall, to the
extent possible, permit SB to cure such breach and to negotiate directly with
such THIRD PARTY.
16.3 Xxxxxxx warrants and represents that it has disclosed to SB the
complete texts of all XXXXXXX PATENT RIGHTS as of the Effective Date as well as
all information received by Xxxxxxx as of the Effective Date concerning the
institution or possible institution of any interference, opposition,
reexamination, reissue, revocation, nullification or any official proceeding
involving a XXXXXXX PATENT RIGHT anywhere in the TERRITORY. Xxxxxxx hereby
warrants and represents that it has no present knowledge that the XXXXXXX PATENT
RIGHTS are invalid or unenforceable.
16.4 Xxxxxxx warrants and represents that, to the best of its knowledge,
information related to the PRODUCT it has provided to SB prior to the Effective
Date is up-to-date, timely and accurate in all material respects. Xxxxxxx
further warrants and represents that it has not, up through and including the
Effective Date, omitted to furnish SB with any material information available to
Xxxxxxx concerning the PRODUCT.
16.5 Xxxxxxx warrants and represents that it will not knowingly engage
in any activity regarding DEVELOPMENT or MANUFACTURE DEVELOPMENT or
commercialization of PRODUCT outside of the FIELD, including, but not limited
to, publication of preclinical or clinical data related to PRODUCT, which is or
ought to be recognized by Xxxxxxx as posing a present or potential harm to the
DEVELOPMENT or MANUFACTURE DEVELOPMENT or commercialization of PRODUCT within
the FIELD.
16.6 SB warrants and represents that it has the full right and authority
to enter into this Agreement and that it is not aware of any impediment,
including without limitation any THIRD PARTY agreement, which would prevent it
from performing its obligations under this Agreement.
16.7 SB warrants and represents that it has reviewed the information
furnished to SB by Xxxxxxx regarding PRODUCT before deciding whether to enter
into this Agreement. [*] to [*] the [*] to the [*] to [*].
16.8 EXCEPT FOR THE EXPRESS WARRANTIES AND REPRESENTATIONS CONTAINED IN
THIS AGREEMENT, NEITHER SB NOR XXXXXXX MAKES ANY
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
106.
120
OTHER WARRANTIES OR REPRESENTATIONS, EXPRESS OR IMPLIED, IN FACT OR IN LAW.
ARTICLE 17
CONFIDENTIAL INFORMATION
17.1 INFORMATION. Each Party shall keep all information received from
the other Party (the "Information") confidential and shall not disclose nor use
the Information without the other Party's written consent except to the extent
contemplated by this Agreement. This restriction shall not, however, prevent
disclosure of the Information if and to the extent that disclosure is required
by law, provided that the disclosing Party informs the other Party without delay
of any such requirement, in order to allow such other Party to object to such
disclosure and to seek an appropriate protective order or similar protection
prior to disclosure.
17.2 EXCEPTIONS. The above obligations shall not apply or shall cease to
apply to Information which:
17.2.1 is now, or hereafter becomes, through no act or failure to
act on the part of the receiving Party, generally known or available;
17.2.2 is known by the receiving Party at the time of receiving
such information, as evidenced by its written records;
17.2.3 is hereafter furnished to the receiving Party by a THIRD
PARTY, as a matter of right and without restriction on disclosure;
17.2.4 is independently developed by or for the receiving Party
without any breach of this Article 17; or
17.2.5 is the subject of a written permission to disclose
provided by the disclosing Party.
17.3 PERMITTED DISCLOSURES. Information may be disclosed to employees,
agents or consultants of the receiving Party or its AFFILIATES or sublicensees
or suppliers of LICENSED COMPOUNDS and PRODUCTS, but only to the extent required
to accomplish the purposes of this Agreement and only if the receiving Party
obtains prior agreement from its employees, agents, consultants, sublicensees or
suppliers to whom disclosure is to be made to hold in confidence and not make
use of such Information for any purpose other than those permitted by this
Agreement. Each Party will use at least the same standard of care as it uses to
protect proprietary or confidential information of its own to ensure that such
employees, agents, consultants, sublicensees or suppliers do not disclose or
make any unauthorized use of the Information.
17.4 DISCLOSURE OF AGREEMENT. Neither Xxxxxxx nor SB shall release to
any THIRD PARTY or publish in any way any non-public information with respect to
the terms of this Agreement or concerning their cooperation without the prior
written consent of the other and
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
107.
121
agreement upon the nature and text of such announcement or disclosure, which
consent will not be unreasonably withheld or delayed; provided; however that
either Party may disclose the terms of this Agreement to the extent required to
comply with applicable laws, including without limitation the rules and
regulations promulgated by the Securities and Exchange Commission and the Party
intending to disclose the terms of this Agreement shall provide the
nondisclosing Party an opportunity to review and comment on the intended
disclosure in reasonably sufficient time (such time period to depend on the
urgency of the intended disclosure) prior to public release, and shall provide
the other Party with a written copy thereof, in order to allow such other Party
to comment upon such announcement or disclosure. Each Party agrees that it shall
cooperate fully and in a timely manner with the other with respect to all
disclosures regarding this Agreement to the Securities Exchange Commission and
any other governmental or regulatory agencies, including requests for
confidential treatment of proprietary information of either Party included in
any such disclosure. Notwithstanding any other provision of this Agreement, each
Party may disclose the terms of this Agreement to lenders, investment bankers
and other financial institutions ("Third Party Lender") of its choice solely for
purposes of financing the business operations of such Party either (i) upon the
written consent of the other Party or (ii) if the disclosing Party obtains a
signed confidentiality agreement with such financial institution with respect to
such information, such agreement to contain, at a minimum, the following:
(i) The Third Party Lender shall hold the information
disclosed to it by such Party ("Loan Information") in strict confidence and
shall use diligent efforts, which shall not in any event be less than the Third
Party Lender uses to prevent unauthorized use or disclosure of its own valuable,
confidential information, to prevent any unauthorized use or disclosure of such
Loan Information.
(ii) The Third Party Lender shall not, without the prior
written consent of such Party, use the Loan Information disclosed to it for any
purpose of other than the use for which such Loan Information was disclosed by
such Party.
(iii) Upon completion of the authorized use by such Third
Party Lender and in the absence of any further agreement between the Parties,
the Third Party Lender shall cease all use and make no further use of the Loan
Information and shall, upon written request from such Party, promptly return all
Loan Information to such Party.
17.5 PUBLICITY. Subject to Section 17.4, all publicity, press releases
and other announcements relating to this Agreement or the transaction
contemplated hereby shall be reviewed in advance by, and shall be subject to the
approval of, both Parties.
17.6 PUBLICATION.
17.6.1 The Parties shall cooperate in appropriate publication of
the results of research and development work performed pursuant to this
Agreement, but subject to their predominating interest in obtaining patent
protection for any patentable subject matter. The determination of authorship
for any paper shall be in accordance with accepted scientific practice.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
108.
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17.6.2 Notwithstanding anything in Section 17.6.1 to the
contrary, all publication and presentations of the results of research and
development work performed pursuant to this Agreement must be approved in
advance by both Parties; provided, however, either Party may disclose such
results to the extent required to comply with applicable laws, including without
limitation the rules and regulations promulgated by the Securities and Exchange
Commission and the Party intending to disclose the terms of this Agreement shall
provide the nondisclosing Party an opportunity to review and comment on the
intended disclosure in reasonably sufficient time (such time period to depend on
the urgency of the intended disclosure) prior to public release, and shall
provide the other Party with a written copy thereof, in order to allow such
other Party to comment upon such announcement or disclosure. Each Party agrees
that it shall cooperate fully with the other with respect to all disclosures
regarding this Agreement to the Securities Exchange Commission and any other
governmental or regulatory agencies, including requests for confidential
treatment of proprietary information of either Party included in any such
disclosure. The contribution of each Party shall be noted in all publications
or presentations by acknowledgment or coauthorship, whichever is appropriate.
17.6.3 Nothing in this Agreement shall be construed as preventing
or in any way inhibiting either Party from complying with statutory and
regulatory requirements governing such Party's obligations under this Agreement
regarding the DEVELOPMENT, MANUFACTURE DEVELOPMENT, use and sale or other
distribution of PRODUCT in the FIELD in the TERRITORY in any manner which it
reasonably deems appropriate, including, for example, by disclosing to
regulatory authorities confidential or other information received from the other
Party or THIRD PARTIES.
17.7 PRIOR CONFIDENTIALITY AGREEMENTS. This Agreement, and the
obligation of confidentiality and nondisclosure under this Article 17,
supersedes all prior understandings and agreements relating thereto, including
without limitation, the Confidentiality Agreement between Xxxxxxx and SB dated
April 13, 1995, as extended by letter agreement on May 7, 1997, the
Confidentiality Agreement between Xxxxxxx and SB, dated January 21, 1998 and the
Confidentiality Agreement between Xxxxxxx and SB, dated March 30, 1998
(collectively, the "Prior Confidentiality Agreements"). The Prior
Confidentiality Agreements are null and void and have no further force or
effect.
ARTICLE 18
DISPUTE RESOLUTION
18.1 GENERAL. The Parties recognize that disputes as to certain matters
may from time to time arise during the term of this Agreement which relate to
either Party's rights or obligations hereunder. The Parties have provided in
this Agreement for procedures to facilitate the resolution of disputes arising
under this Agreement in an expedient manner by mutual cooperation and without
resort to litigation. The Parties shall seek to follow the informal dispute
resolution mechanisms set forth in this Agreement prior to pursuing any
administrative or judicial resolution mechanism. In the event no mutually
acceptable resolution of such dispute is achieved in accordance with the
informal dispute resolution mechanisms set forth in this
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
109.
123
Agreement within a reasonable period of time, then either Party shall be
entitled to seek final settlement of such dispute by any administrative or
judicial resolution mechanisms which may be available.
18.2 [*]. [*], either Party may request that a recommendation be
obtained from [*] pursuant to the process set forth in Section 18.3. Such
recommendation, if obtained, shall be [*] or [*]. In the event that neither
Party desires to pursue the process set forth in Section 18.3, the last sentence
of Section 18.1 shall be applicable.
18.3 RECOMMENDATION OF [*]. If requested by either Party [*], the
Parties shall [*] within [*] of the request of the Party invoking this Section
18.3. Each Party shall have [*] after [*] to submit [*] as such Party believes
necessary to resolve the dispute in question, [*]. [*] may then hold [*] on the
issues that need to be resolved. [*] shall promptly thereafter make a
recommendation as to the resolution of the dispute, which recommendation [*].
Each Party shall bear its own expenses in connection with a procedure under this
Section 18.3, and the fees and expenses of [*] shall be borne equally by the
Parties regardless of the ultimate recommendation of such person. The results of
a procedure under this Section 18.3 shall be used by the Parties to [*].
18.4 GOVERNING LAW; JURISDICTION; VENUE. This Agreement shall be
interpreted in accordance with the laws of the State of Delaware, without regard
to the conflict of laws provisions thereof. Any claim or controversy arising out
of or related to this Agreement or any breach hereof which is brought by SB
shall be submitted to a court of competent jurisdiction and venue in [*], and
each Party hereby consents to the jurisdiction and venue of such courts for such
claim or controversy; provided, however, disputes regarding the validity or
enforceability of PATENT RIGHTS or TRADEMARKS shall be submitted to a court of
applicable jurisdiction where the PATENT RIGHT or TRADEMARK was issued. Any
claim or controversy arising out of or related to this Agreement or any breach
hereof which is brought by Xxxxxxx shall be submitted to a court of competent
jurisdiction and venue in [*], and each Party hereby consents to the
jurisdiction and venue of such courts for such claim or controversy; provided,
however, disputes regarding the validity or enforceability of PATENT RIGHTS or
TRADEMARKS shall be submitted to a court of applicable jurisdiction where the
PATENT RIGHT or TRADEMARK was issued.
18.5 ARBITRATION FOR REASONABLE ROYALTY DETERMINATION.
18.5.1 Notwithstanding the other provisions of Article 18 or this
Agreement, in the event that Xxxxxxx loses its rights to CO-PROMOTE PRODUCT in
TERRITORY A in accordance with Sections 4.2.3 or foregoes such rights in
accordance with the third sentence of Section 7.1.15, and the Parties cannot
agree to a commercially reasonable royalty rate within the time periods set
forth in Section 7.1.15, such matters shall be resolved by binding arbitration
in [*] in accordance with the then existent [*]. The payments to Xxxxxxx
provided in Section 7.1.15 pending the resolution of such commercially
reasonable royalty rate shall continue until such matter has been resolved by
such arbitration.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
110.
124
18.5.2 The decision of the Arbitration Tribunal in any
arbitration conducted pursuant to Section 18.5.1 shall be final and not
appealable, and shall be enforceable in any court of competent jurisdiction. No
punitive damages will be recoverable by either Party in such a proceeding. The
Parties agree that the service of any notice in the course of such arbitration
proceeding at their respective addresses as provided for in Section 19.6 below
shall be valid and sufficient. The appointing authority shall be the American
Arbitration Association. Unless agreed otherwise by the Parties, in any
arbitration proceeding hereunder, there shall be one (1) arbitrator, appointed
by the Parties by mutual agreement. The Parties agree that in the event of an
arbitration under this Section 18.5, the arbitrator shall apply the provisions
of Section 10 of the Commercial Arbitration Rules, Revised and Effective July 1,
1996, relating to the conduct of a preliminary hearing. The Parties agree
further that at such preliminary hearing the arbitrator shall require that the
Parties provide at least the following materials related to such arbitration:
(i) the extent and schedule of the production of relevant documents and other
information; (ii) a list of any witnesses to be called, along with a brief
description of the each witness's knowledge; (iii) a list of any experts to be
called, along with a statement of the experts' backgrounds and opinions; and
(iv) a schedule for the delivery of any briefs to be filed with the arbitration
panel. A Party shall not have the right to depose the other Party's witnesses or
experts in preparation for such arbitration, except with such other Party's
consent. The Parties shall jointly share the expenses of the arbitration,
provided that each Party shall solely bear its own legal or other OUT-OF-POCKET
COSTS related to such arbitration.
18.5.3 In the case of an arbitration under Section 18.5.1, (i)
the decision of the arbitrators shall be limited to a determination of a
commercially reasonable royalty rate in the event that Xxxxxxx loses its rights
to CO-PROMOTE PRODUCT in TERRITORY A in accordance with Sections 4.2.3 or
foregoes such rights in accordance with the third sentence of Section 7.1.15,
(ii) the parameters of such determination shall be limited to sales of PRODUCT
in TERRITORY A after the effective date of such loss or relinquishment of rights
to CO-PROMOTE, and (iii) such determination shall be higher than the royalty
rate to be paid by SB to Xxxxxxx on sales of PRODUCT in TERRITORY B but less
than the amount Xxxxxxx would have received had it continued to CO-PROMOTE
PRODUCT in TERRITORY A. Such determination shall be final and binding on the
Parties. The commercially reasonable royalty rate to be paid by SB to Xxxxxxx,
as determined by such arbitrator, shall be retroactively applied to the
effective date of Xxxxxxx'x loss or relinquishment of rights to CO-PROMOTE,
subject to a reconciliation by the arbitrator of the payments made by SB to
Xxxxxxx under Section 7.1.15 pending the resolution of such issue by such
arbitrator.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
111.
125
ARTICLE 19
MISCELLANEOUS
19.1 CONDITIONS TO EFFECTIVENESS. The Parties agree that:
19.1.1 the Effective Date of this Agreement shall be that date
upon which the conditions set forth in this Section 19.1 are satisfied, or
waived by the Parties hereto;
19.1.2 the effectiveness of the Agreement is conditioned upon [*]
the [*]: (i) [*], and (ii) [*] and [*];
19.1.3 [*] as the Parties may mutually agree [*]. [*] if the [*]
and [*] and [*];
19.1.4 [*], SB may waive the conditions to effectiveness set
forth under this Section 19.1 and the date of such waiver shall be the Effective
Date;
19.1.5 in the event that (i) [*] or (ii) [*], this Agreement
shall be null and void and of no further force and effect, and neither Party
shall have any liability to the other arising from the execution of this
Agreement;
19.1.6 [*]; and
19.1.7 [*], all DEVELOPMENT COSTS, MANUFACTURE DEVELOPMENT COSTS,
and MARKETING COSTS incurred by either Party between October 1, 1998 and the
Effective Date under the terms of this Agreement shall be subject to all of the
terms and provisions of this Agreement related thereto, including provisions
related to reimbursement and sharing of such costs. SB shall have no liability
to reimburse or share any costs incurred by Xxxxxxx between October 1, 1998 and
the Effective Date which are not DEVELOPMENT COSTS, MANUFACTURE DEVELOPMENT
COSTS, and MARKETING COSTS.
19.2 NO WAIVER OF CONTRACTUAL RIGHTS. The failure of either Party to
require performance by the other Party of any of that other Party's obligations
hereunder shall in no manner affect the right of such Party to enforce the same
at a later time. No waiver by any Party hereto of any condition, or of the
breach of any provision, term, representation or warranty contained in this
Agreement, whether by conduct or otherwise, in any one or more instances, shall
be deemed to be or construed as a further or continuing waiver of any such
condition or breach, or of any other condition or of the breach of any other
provision, term representation or warranty hereof.
19.3 EXECUTION AND AMENDMENTS.
19.3.1 Each Party shall execute and deliver all such instruments
and perform all such other acts as the other Party may reasonably request in
order to carry out the transactions contemplated by this Agreement.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
112.
126
19.3.2 This Agreement may not be amended or modified except by
written instrument signed by or on behalf of both Parties.
19.4 SEVERABILITY. If a court or other tribunal of competent
jurisdiction should hold any term or provision of this agreement to be
excessive, or invalid, void or unenforceable, the offending term or provision
shall be deemed inoperative to the extent that they may conflict therewith and
shall be deemed to be modified to the extent necessary to conform with such
statute or rule of law, while still preserving, to the extent practicable, the
legitimate aims of the Parties, provided that the remaining portions hereof
shall remain in full force and effect. In the event that the terms and
conditions of this Agreement are materially altered as a result of the above,
the Parties will renegotiate the terms and conditions of this Agreement to
resolve any inequities.
19.5 RELATIONSHIP BETWEEN THE PARTIES. Both Parties are independent
contractors under this Agreement. Nothing contained in this Agreement is
intended nor shall be construed so as to constitute Xxxxxxx or SB as partners or
joint venturers with respect to this Agreement. Neither Party shall have the
express or the implied right nor authority to assume or create any obligations
on behalf of or in the name of the other Party, nor to bind the other Party to
any other contract, agreement or undertaking with any THIRD PARTY.
19.6 CORRESPONDENCE AND NOTICES.
19.6.1 Correspondence, reports, documentation, and any other
communication in writing between the Parties in the course of ordinary
implementation of this Agreement (but not including any notice required by this
Agreement) shall be in writing and delivered by hand, sent by facsimile, or by
overnight express mail (e.g., FedEx) to any one (1) member of the JCC or JDC, as
appropriate, appointed by the Party which is to receive such written
communication, or any other way as the JCC or JDC deems appropriate.
19.6.2 Extraordinary notices and communications (including but
not limited to notices of termination, force majeure, material breach, change of
address, or any other notices required by this Agreement) shall be in writing
and sent by prepaid registered or certified air mail or by overnight express
mail (e.g., FedEx), or by facsimile confirmed by prepaid registered or certified
air mail letter or by overnight express mail (e.g., FedEx), and shall be deemed
to have been properly served to the addressee upon receipt of such written
communication.
19.6.3 In the case of Xxxxxxx, the proper address for
communications and for all payments shall be:
Xxxxxxx Pharmaceutical, Inc.
000 Xxxxxxxxxx Xxxxxx, Xxxxx 000
Xxxx Xxxx, Xxxxxxxxxx 00000
XXX
Facsimile: (000) 000-0000
Attn: Chief Financial Officer
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
113.
127
With copies to:
Xxxxxxx Pharmaceutical, Inc.
000 Xxxxxxxxxx Xxxxxx, Xxxxx 000
Xxxx Xxxx, Xxxxxxxxxx 00000
XXX
Facsimile: (000) 000-0000
Attn: Chief Executive Officer
and
Xxxxxxx Pharmaceutical, Inc.
000 Xxxxxxxxxx Xxxxxx, Xxxxx 000
Xxxx Xxxx, Xxxxxxxxxx 00000
XXX
Facsimile: (000) 000-0000
Attn: Vice President, Business Development
and in the case of SB, the proper address for communications and for all
payments shall be:
SmithKline Xxxxxxx Corporation
Xxx Xxxxxxxx Xxxxx (Mail Code FP1930)
X.X. Xxx 0000
Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000
X.X.X.
Attention: Senior Vice President,
Business Development
With copies to:
SmithKline Xxxxxxx Corporation
One Franklin Plaza (Mail Code FP2360)
X.X. Xxx 0000
Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000, X.X.X.
Attention: Corporate Law-U.S.
19.7 COUNTERPARTS. This Agreement may be executed in one or more
counterparts, each of which shall be an original and all of which shall
constitute together the same document.
19.8 WAIVER OF BREACH. Any delay in enforcing a Party's rights under
this Agreement or any waiver as to a particular default or other matter shall
not constitute a waiver of a Party's right to the future enforcement of its
rights under this Agreement, excepting only as to an expressed written and
signed waiver as to a particular matter for a particular period of time. All
rights, remedies, undertakings, obligations and agreements contained in this
Agreement shall be cumulative and except as otherwise expressly provided herein
none of them shall be a limitation of any other remedy, right, undertaking,
obligation or agreement.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
114.
128
19.9 NO INTELLECTUAL PROPERTY RIGHTS GRANTED. No rights or licenses with
respect to a Party's patents, trademarks, know-how, technical information, or
other proprietary rights are granted or deemed granted to the other Party
hereunder or in connection herewith, other than those rights expressly granted
in this Agreement.
19.10 RECORDING. Either Party shall have the right, at any time, to
record, register, or otherwise notify this Agreement in appropriate governmental
or regulatory offices anywhere in the TERRITORY, and the other Party shall
provide reasonable assistance to such Party in effecting such recording,
registering or notifying.
19.11 HEADINGS; INTERPRETATION. Headings in this Agreement are included
for ease of reference only and shall have no legal effect. This Agreement shall
be deemed to comprise the language mutually chosen by the Parties and no rule of
strict construction shall be applied against either Party. In this Agreement,
the singular shall include the plural and vice versa and the word "including"
shall be deemed to be followed by the phrase "without limitation" unless
otherwise specified.
19.12 EXPENSES. Except as otherwise provided in this Agreement, all
expenses incurred by SB in connection with its obligations under this Agreement
will be borne solely by SB and all expenses incurred by Xxxxxxx in connection
with its obligations under this Agreement will be borne solely by Xxxxxxx. Each
Party will be responsible for appointing its own employees, agents and
representatives, who will be compensated by such Party. Each Party will be
responsible for paying any finder's or broker's fee owed to a THIRD PARTY that
such Party incurs based directly or indirectly on negotiating and entering this
Agreement, and shall indemnify the other Party against any obligation to pay
such fee.
19.13 FURTHER ACTIONS. Each Party agrees to execute, acknowledge and
deliver such further instruments, and to do all such other acts, as may be
necessary or appropriate in order to carry out the purposes and intent of this
Agreement.
19.14 OFFICIAL LANGUAGE. The official text of this Agreement and any
appendices, exhibits and schedules hereto, shall be made, written and
interpreted in English. Any notices, accounts, reports, documents, disclosures
of information or statements required by or made under this Agreement, whether
during its term or upon expiration or termination thereof, shall be in English.
In the event of any dispute concerning the construction or meaning of this
Agreement, reference shall be made only to this Agreement as written in English
and not to any other translation into any other language.
19.15 ENTIRE AGREEMENT; TAX AGREEMENT. This Agreement, together with its
Exhibits, the STOCK PURCHASE AGREEMENT, and the LOAN AGREEMENT, constitutes the
entire agreement of the Parties with respect to the subject matter hereof as of
the date of its execution, and supersedes all prior agreements, understandings,
representations and proposals, written or oral, relating thereto. In addition,
upon the request of either Party, the Parties will discuss whether they desire
to enter into an agreement regarding the tax treatment of their activities under
this Agreement. If the Parties mutually agree that such an agreement is
necessary or desirable, they will each bear their own expenses incurred in
connection with the preparation of such an agreement, and
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
115.
129
(unless the Parties otherwise agree in the future), any mutually agreed
OUT-OF-POCKET COSTS incurred in connection with the development of tax
information pursuant to such an agreement shall be shared equally. If only one
Party believes that such an agreement is necessary or desirable, that Party
shall bear the costs of preparing such an agreement, and shall bear the
OUT-OF-POCKET COSTS of developing tax information pursuant to such an agreement.
In any event, each Party shall bear its own internal expenses in connection with
the negotiation and preparation of any such tax agreement and the preparation of
its own tax returns.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
116.
130
IN WITNESS WHEREOF, the Parties, through their authorized officers, have
executed this Agreement on the date first written above, to become effective on
the Effective Date.
SMITHKLINE XXXXXXX CORPORATION XXXXXXX PHARMACEUTICAL, INC.
BY: /s/ Xxxx-Xxxxxx Xxxxxxx BY: /s/ Xxxxxxx X. Xxxxxx
----------------------------- -----------------------------
TITLE: Chief Operating Officer TITLE: President and CEO
-------------------------- ---------------------------
131
EXHIBITS:
EXHIBIT A XXXXXXX PATENT RIGHTS
EXHIBIT B-1 FINANCIAL PLANNING, ACCOUNTING AND REPORTING METHODOLOGIES
EXHIBIT B-2 FTE RATES
EXHIBIT C COUNTRIES IN EUROPE
EXHIBIT D PLANNED CLINICAL TRIALS
EXHIBIT E SB PATENT RIGHTS
EXHIBIT F-1 SB/XXXXXXX BEXXAR PRODUCT TEAM
EXHIBIT F-2 SALES EXPERTISE AND ACTIVITIES TO BE CONTRIBUTED BY EACH PARTY
EXHIBIT G SB FORM OF MARKETING PLAN
EXHIBIT H PHARMACOVIGILANCE RESPONSIBILITIES OF XXXXXXX AND SB
EXHIBIT I PRODUCT-RELATED INQUIRIES
EXHIBIT J PRODUCT RECALL PROCEDURES
132
EXHIBIT A
XXXXXXX PATENT RIGHTS
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[ATTORNEY [SERIAL NO. / [FILED/
DOCKET NO.] PATENT NO.] ISSUED] [TITLE]
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[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
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* Claims priority/effective filing date of earlier application
** ABANDONED in favor of [*]
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
133
EXHIBIT B-1
FINANCIAL PLANNING, ACCOUNTING AND REPORTING METHODOLOGIES
(OPERATING PROFIT OR LOSS)
This EXHIBIT B-1 addresses the financial planning, accounting policies and
procedures to be followed under the Agreement in determining sharing of revenue
and expenses and related sharing of OPERATING PROFIT OR LOSS in TERRITORY A.
Terms not defined in this EXHIBIT B-1 shall have the meanings set forth in the
Agreement.
This Exhibit sets forth the principles for reporting actual results and
budgeted plans of each Party in TERRITORY A for PRODUCT, the frequency of
reporting, [*], the methods of determining payments to the Parties, and auditing
of accounts.
OPERATING PROFIT AND LOSS will be shared by the Parties in accordance
with Section 7.1.13 of the Agreement. Pursuant to Section 7.1.14, only those
costs incurred subsequent to the Effective Date will be included in the
calculation of OPERATING PROFIT AND LOSS. Each Party's OUT-OF-POCKET COSTS that
are SALES COSTS, MARKETING COSTS and other related expenses incurred prior to
commercial launch of PRODUCT will be shared according to Section 7.1.12(a) of
the Agreement.
B.1. PRINCIPLES OF REPORTING
In accordance with Section 7.1.14 of the Agreement, the result of
operations of each Party with respect to PRODUCT in TERRITORY A will be
presented in the following format, with the categories as defined in Section B.3
below:
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
Overhead and FTE allocations are excluded from the calculation of
OPERATING PROFIT AND LOSS except as expressly provided in this Exhibit or the
Agreement.
It is the intention of the Parties that the interpretation of these
definitions will be consistent with generally accepted accounting principles in
the United States ("GAAP").
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
134
B.2. FREQUENCY OF REPORTING
For purposes of the requirements herein, the fiscal year will be [*].
Reporting shall occur in accordance with Section 7.1.14.
B.3. DEFINITIONS
B.3.1 "COST OF GOODS" shall have the meaning set forth in Section 1.11
of the Agreement, subject to Section 7.1.14.
B.3.2 "DISTRIBUTION COSTS" means the OUT-OF-POCKET COSTS specifically
identifiable to the distribution of a PRODUCT including [*].
B.3.3 "MARKETING COSTS" means, consistent with the JOINT MARKETING PLAN,
the OUT-OF-POCKET COSTS of marketing, promotion, advertising, [*],
PRODUCT-related public relations, [*], market research, [*], customer
services, [*], and other similar activities directly related to the
PRODUCT. Such costs will include outside services and expenses [*].
MARKETING COSTS shall also include (a) activities related to obtaining
reimbursement from payers and costs of sales and marketing data and (b)
cost of samples. MARKETING COSTS will specifically exclude (i) the costs
of activities which promote either Party's business as a whole without
being product specific [*] (ii) [*] and (iii) any FTEs associated with
supporting the activities included in the definition of MARKETING COSTS.
B.3.4 "NET SALES" shall have the meaning set forth in Section 1.54 of
the Agreement.
B.3.5 "OPERATING PROFIT OR LOSS" means the consolidated NET SALES for
PRODUCT in TERRITORY A less Xxxxxxx Operating Expenses and SB Operating
Expenses (each as defined in Section 7.1.14) for a given period.
B.3.6 "OTHER OPERATING INCOME/EXPENSE" means other operating income or
expense from or to THIRD PARTIES which is not part of the primary
business activity of the applicable Party, but is related to income or
expense generated from such Party's operations specifically attributable
to its activities under this Agreement, and, unless otherwise mutually
agreed by the Parties, limited to the following:
_ [*]
_ [*]
_ [*]
B.3.7 "PATENT COSTS" shall have the meaning set forth in Section 1.65 of
the Agreement.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
2.
135
B.3.8 "SALES COSTS" means costs incurred consistent with the JOINT
MARKETING PLAN and the annual budget prepared pursuant to such JOINT
MARKETING PLAN and specifically identifiable to the SALES EFFORT (as
defined in Section 7.1.6(a) of the Agreement) in TERRITORY A including
the managed care market. SALES COSTS shall be charged on an FTE basis at
the rate specified in EXHIBIT B-2. The FTE rate shall include [*].
B.3.9 "TRADEMARK COSTS" shall have the meaning set forth in Section 1.95
of the Agreement.
B.4. AUDITS
Either Party shall have the right to conduct audits of the other Party's
books pursuant to Section 8.3 of the Agreement.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
3.
136
EXHIBIT B-2
ANNUAL FTE RATES
Xxxxxxx FTE Rate for Sales Effort Personnel: $[*]
Xxxxxxx FTE Rate for All Other Personnel: $[*]
SB FTE Rate for Sales Effort Personnel: $[*]
SB FTE Rate for All Other Personnel: $[*]
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
137
EXHIBIT C
COUNTRIES IN EUROPE
ANDORRA AUSTRIA BELGIUM BOSNIA
BULGARIA CROATIA CYPRUS CZECH REPUBLIC
DENMARK ESTONIA FINLAND FRANCE
GERMANY GREECE HUNGARY ICELAND
IRELAND ISRAEL ITALY LATVIA
LIECHTENSTEIN LITHUANIA LUXEMBOURG MONACO
NETHERLANDS NORWAY POLAND PORTUGAL
ROMANIA RUSSIA SAN MARINO SERBIA
SLOVAKIA SLOVENIA SPAIN SWEDEN
SWITZERLAND UNITED KINGDOM VATICAN CITY YUGOSLAVIA
138
EXHIBIT D
PLANNED CLINICAL TRIALS
TRIAL NUMBER TRIAL NAME
------------ ----------
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
139
[*] [*]
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
2.
140
EXHIBIT E
SB PATENT RIGHTS
[*]
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
141
EXHIBIT F-1
SB/XXXXXXX BEXXAR PRODUCT TEAM
[*]
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
1.
142
EXHIBIT F-2
SALES EXPERTISE AND ACTIVITIES TO BE CONTRIBUTED BY EACH PARTY
--------------------------------------------------------------------------------
XXXXXXX XX
--------------------------------------------------------------------------------
[*] [*]
[*] [*]
o [*]
o [*] o [*]
o [*] o [*]
o [*] o [*]
[*] o [*]
o [*]
[*] o [*]
o [*]
o [*]
o [*]
[*]
[*]
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
1.
143
EXHIBIT G
[*]
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
1.
144
EXHIBIT H
PHARMACOVIGILANCE RESPONSIBILITIES OF XXXXXXX AND SB
BACKGROUND:
As described in the Agreement, Xxxxxxx retains primary registration
responsibilities in the United States (US), while SB retains primary
registration responsibilities outside of the US. Obligations for reporting
adverse events/reactions to regulatory health authorities for clinical trial
experiences and postmarketing experiences will follow the same divisions of
responsibilities. Xxxxxxx and SB want to share relevant safety information,
within certain time frames, in order to comply with applicable regulatory
reporting requirements.
DEFINITIONS:
The following definitions reflect and are consistent with FDA and ICH
regulations/guidelines.
o ADVERSE EXPERIENCE (AE)
The ICH has defined an AE as "Any untoward medical occurrence in a
patient or clinical investigation subject administered a pharmaceutical
product and which does not necessarily have to have a causal
relationship with this treatment."
o ADVERSE DRUG REACTION (ADR)
In the PRE-APPROVAL clinical experience or in other clinical trial
experiences
The ICH has defined an ADR in clinical trials as "all noxious and
unintended responses to a medicinal product related to any dose."
The phrase "responses to a medicinal product" means that a causal
relationship between a medicinal product and an adverse event is
at least a reasonable possibility, i.e., the relationship cannot
be ruled out.
For MARKETED medical products
The ICH had defined an ADR in marketed medicinal products as "a
response to a drug which is noxious and unintended and which
occurs at doses normally used in man for prophylaxis, diagnosis
or therapy of disease or for modification of physiological
function."
o UNEXPECTED ADR
The ICH has defined an unexpected ADR as "an adverse drug reaction, the
nature or severity of which is not consistent with the applicable
product information (e.g., Investigator Brochure for an unapproved
investigational medicinal product."
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
145
This definition includes an AE/ADR of which the nature, specificity, or
severity is inconsistent with the applicable PRODUCT information. For an
AE/ADR from a clinical trial, the reference document shall be the
Investigator Brochure. For an AE/ADR from a spontaneous report or other
postmarketing source, the reference documents shall be the core PRODUCT
information (PI) or local PI.
o CRITERIA FOR SERIOUS AE OR ADR
A serious AE or ADR is any untoward medical occurrence that:
o results in death,
o is life-threatening (NOTE: The term "life-threatening" in the
definition of "serious" refers to an event in which the patient
was at risk of death at the time of the event; it does not refer
to an event which hypothetically might have caused death if it
were more severe),
o requires inpatient hospitalization or a prolongation of existing
hospitalization,
o results in persistent or significant disability/incapacity, or
o is a congenital anomaly/birth defect.
Medical and scientific judgment should be exercised in deciding whether
expedited reporting is appropriate in other situations, such as
important medical events that may not be immediately life-threatening or
result in death or hospitalization but may jeopardize the patient or may
require intervention to prevent one of the other outcomes listed in the
definition above. These should also usually be considered serious.
(Examples of such events are intensive treatment in an emergency room or
at home for allergic bronchospasm; blood dyscrasias or convulsions that
do not result in hospitalization; or development of drug dependency or
drug abuse.)
o NON-SERIOUS AE
A non-serious AE is any experience which does not meet the definition of
serious as defined above.
Clinical trial experiences which are not considered "serious" include:
hospitalization for a pre-planned/elective procedure for a medical
condition present before treatment started; a pre-existing medical
condition which does not increase in severity or frequency following
treatment; or an experience which is simply a treatment failure
according to the efficacy criteria for the study.
o SPONTANEOUS REPORTS
Reports from any source other than a clinical trial source, including
regulatory agencies, health care professionals, consumers and
literature, shall be classified for reporting purposes as a spontaneous
report.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
3.
146
o REPORTS OF PREGNANCY AND OVERDOSE
While such reports are not AEs or ADRs as defined herein, reports of
pregnancies should be followed up until the outcome of the pregnancy is
known.
PRODUCT has been clinically tested to define the maximally tolerated
dose. "Overdose" will be defined as when the administered dose is >10%
of the prescribed dose or any dose that the reporter of an ADR indicates
as being an overdose for the patient receiving such dose.
o MINIMAL CRITERIA FOR REPORTING
Initial reports should be submitted within the prescribed timelines as
long as the following minimum criteria are met: (1) an identifiable
patient; (2) a suspect medicinal product; (3) an identifiable reporting
source; (4) and an event or outcome.
FOLLOW-UP OF CASES:
The Party who is the initial recipient of an AE/ADR report shall be responsible
for appropriate follow-up of that AE/ADR report and timely transmission of
relevant new information to the other Party.
SAFETY DATABASE:
Xxxxxxx will hold the recognized worldwide safety database for BEXXAR.
Xxxxxxx shall have full access to SB's worldwide safety database to enter, edit,
analyze, and print AE/ADR reports for BEXXAR until such time that the JDC has
determined that (a) Xxxxxxx has established a fully validated safety database
that meets worldwide pharmacovigilance regulatory requirements and (b) a secure
electronic data exchange has been established between the Parties for the
electronic exchange of safety information. The Parties shall agree upon a
process to track any edits or amendments Xxxxxxx makes to the SB worldwide
safety database.
Xxxxxxx will hold the recognized worldwide safety database for PRODUCT other
than BEXXAR ("Additional Product"), except that SB shall hold the recognized
safety database for any Additional Product incorporating SECOND GENERATION
LICENSED COMPOUNDS that arise from SB's research.
DATA EXCHANGE:
o SB will notify Xxxxxxx electronically (or by facsimile if electronic
means is not available) of all serious AE reports (including both
clinical trial and spontaneous AEs) that SB receives within two (2)
calendar days of receipt of such reports by the SB Central Safety
Department in the United Kingdom. When the minimum information required
for reporting can not be transmitted due to translation difficulties, SB
shall notify Xxxxxxx within three (3) working days of initial receipt of
such reports.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
4.
147
o SB will notify Xxxxxxx by facsimile of any fatal or life-threatening
ADRs within twenty four (24) hours of receipt.
o Non-serious spontaneous AE reports received by SB will be submitted to
Xxxxxxx within five (5) working days of receipt of such reports by the
SB Central Safety Department.
x Xxxxxxx will provide SB with CIOMS I forms electronically (or by
facsimile if electronic means is not available) for all U.S. serious AEs
within two (2) calendar days of receipt.
x Xxxxxxx will notify SB by facsimile of any fatal or life-threatening
ADRs within twenty four (24) hours of receipt by Xxxxxxx.
x Xxxxxxx is responsible for receiving and forwarding reports to and from
other Xxxxxxx licensees (if applicable).
o SB is responsible for receiving and forwarding reports to and from other
SB sublicensees (if applicable).
LITERATURE REPORTS:
Each Party shall be responsible for scanning the literature for case reports in
any territory in which it holds registration rights as set forth in this
agreement.
REGULATORY REPORTING:
o Reporting of domestic or foreign cases to the local regulatory
authorities is the responsibility of the local registration holder.
o SB shall be responsible for reporting of domestic cases to the
local regulatory authorities in those countries where SB is the
local registration holder.
x Xxxxxxx shall be responsible for reporting domestic cases to the
FDA in the United States.
x Xxxxxxx will be responsible for reporting IND safety reports to
the FDA.
o Reporting to other regulatory authorities will be the
responsibility of the local registration holder.
INVESTIGATOR NOTIFICATION:
o Notification of submitted alert reports to investigators and to the
local regulatory authorities is the responsibility of the local
registration holder.
x Xxxxxxx shall be responsible for preparing the notifications and
providing a copy to SB for review.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
5.
148
x Xxxxxxx shall be responsible for notification of investigators
in the U.S. and notification of the FDA.
o SB shall be responsible for notification of investigators and the
local regulatory authorities in those countries where SB is the
local registration holder.
PERIODIC PRODUCT SAFETY UPDATE REPORT (PSUR):
The International birth date is the date of first regulatory approval in the
world. This date will determine the anniversary dates for Product Safety Update
Reports (PSURs). Xxxxxxx will produce AE/ADR listings on a semiannual basis
beginning with the International birth date of PRODUCT with consecutive
six-monthly data lock points from that date onward.
On each data lock point date, each Party will provide the other Party with the
most up-to-date available sales or usage figures from their respective
TERRITORIES. Each Party will further supply the other Party with copies of the
safety sections of any "end of study" reports associated with PRODUCT for trials
conducted by that Party. Analysis of the clinical safety information contained
in the PSUR will be done jointly by the Safety Departments of both Parties.
Xxxxxxx is responsible for forwarding the PSURs to other Xxxxxxx licensees (as
applicable) to enable them to meet their local regulatory reporting obligations.
SB is responsible for forwarding the PSURs to other SB sublicensees (as
applicable) to enable them to meet their local regulatory reporting obligations.
Xxxxxxx will be responsible for producing the U.S. Periodic AE Report, with data
provided by SB as required, until such time as the FDA accepts PSURs.
CORE PRODUCT INFORMATION CHANGES:
Safety changes to the core PRODUCT information (PI) or local PI will be made in
consultation between SB and Xxxxxxx. Each Party will then simultaneously amend
their respective package inserts (core and local). Xxxxxxx will be responsible
for communicating such changes to the other Xxxxxxx licensees, as applicable. SB
will be responsible for communicating such changes to other SB sublicensees, as
applicable. The JOINT DEVELOPMENT COMMITTEE will decide the forum in which these
changes are to be decided.
RESPONDING TO SAFETY RELATED OR PRODUCT-RELATED REGULATORY INQUIRIES:
Each Party will keep the other Party informed of any safety-related or
PRODUCT-related regulatory inquiries and cooperate in providing requested
information promptly.
TRAINING OF SALES REPRESENTATIVES:
o The Parties will collaborate in the generation of materials for training
the sales force on safety monitoring and reporting responsibilities.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
6.
149
o SB will provide generic training materials to Xxxxxxx and Xxxxxxx will
provide Product-specific materials to SB.
METHOD FOR REVISING THIS PHARMACOVIGILANCE EXHIBIT:
If either Party desires to revise this Pharmacovigilance Exhibit due to changes
in definitions, regulations, or for any other reason, such Party shall contact
the other Party and the pharmacovigilance Exhibit shall be revised following
written agreement by both Parties.
PHARMACOVIGILANCE CONTACTS IN EACH PARTY:
FOR SB: CONTACT ADDRESS AND NUMBERS
-------------------------------------------------------------------------------------
Primary: [*] SmithKline Xxxxxxx Corporation
Associate Director New Frontiers Science Park (South)
Worldwide Clinical Safety Third Avenue, The Pinnacles
SmithKline Xxxxxxx Xxxxxxxxxxx Xxxxxx, Xxxxx XX00 0XX
E-mail: Tel: [*]
[*]@xxxxxx.xxx Fax: [*]
US Contact: [*] SmithKline Xxxxxxx Corporation
Director, Safety Quality Mgmt. 0000 Xxxxx Xxxxxxxxxxxx Xxxx
SmithKline Xxxxxxx Corporation Xxxxxxxxxxxx, XX 00000-0000
Tel: [*]
E-mail: Fax: [*]
[*]@xxxxxx.xxx
FOR XXXXXXX: CONTACT ADDRESS AND NUMBERS
--------------------------------------------------------------------------------
Primary: [*] Xxxxxxx Pharmaceutical, Inc.
Director, Medical Information and 000 Xxxxxxxxxx Xxxxxx, Xxxxx 000
Xxxxxx Xxxx Xxxx, XX 00000-0000
Xxxxxxx Pharmaceutical, Inc. Tel: [*]
Fax: [*]
E-mail:
[*]@xxxxxxxxxxxx.xxx
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
7.
150
EXHIBIT I
PRODUCT-RELATED INQUIRIES
RESPONSIBILITIES OF XXXXXXX AND SB
BACKGROUND:
As described in the Agreement, Xxxxxxx retains primary registration
responsibilities in the United States (US), while SB retains primary
registration responsibilities outside of the US. Obligations for answering
medical or technical queries will follow the same divisions of responsibilities.
Xxxxxxx and SB want to share relevant PRODUCT information in order to provide
optimal education to individuals inquiring about the PRODUCT.
RESPONDING TO PRODUCT-RELATED INQUIRIES:
For PRODUCT-related inquires from customers who reside in the U.S.
Xxxxxxx will answer all PRODUCT-related inquiries received from customers who
reside in the US. SB shall forward all PRODUCT-related inquires received by it
to Xxxxxxx within 1 business day, unless the urgent nature of the question
necessitates a more rapid response. Members of the SB sales force will forward
PRODUCT-related inquiries directly to Xxxxxxx for response.
For PRODUCT-related inquires from customers who reside outside of the U.S.
SB will answer all PRODUCT-related inquires received from customers who reside
outside of the US. Xxxxxxx shall forward all PRODUCT-related inquires received
by it from countries outside the U.S. to SB's Central Medical Affairs Team
(CMAT) within 1 business day, unless the urgent nature of the question
necessitates a more rapid response.
DATABASE OF RESPONSES:
Xxxxxxx will prepare and maintain a database containing responses to
PRODUCT-related queries. The database, and any updates with new and/or updated
responses to queries will be made available to SB as needed to support the
commercialization of PRODUCT in countries outside of the US.
SB may also prepare a database of responses to PRODUCT-related inquiries
received from customers who reside outside of the U.S. Should SB develop such a
database, it will make the contents and all updates (new or revised responses)
available to Xxxxxxx.
METHOD FOR REVISING THIS PRODUCT-RELATED INQUIRIES EXHIBIT:
If either Party desires to revise this Product-Related Inquiries Exhibit for any
reason, such Party shall contact the other Party and the Product-Related
Inquiries Exhibit shall be revised following written agreement by both Parties.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
1.
151
PRODUCT-RELATED INQUIRY CONTACTS IN EACH PARTY:
FOR SB: CONTACT ADDRESS AND NUMBERS
-------------------------------------------------------------------------------------
Ex-US: [*] SmithKline Xxxxxxx Corporation
[*] New Frontiers Science Park (South)
[*] Xxxxx Xxxxxx, Xxx Xxxxxxxxx
Xxxxxx, Xxxxx XX00 0XX
Tel: [*]
Fax: [*]
E-mail:
[*]
US Contact: [*] SmithKline Xxxxxxx Corporation
[*] FP 1010
[*]
[*] 0 Xxxxxxxx Xxxxx
Xxxxxxxxxxxx, XX 00000
E-mail: Tel: [*]
[*]@xx.xxx Fax: [*]
FOR XXXXXXX: CONTACT ADDRESS AND NUMBERS
------------------------------------------------------------------------------------
Primary: [*] Xxxxxxx Pharmaceutical, Inc.
[*] 000 Xxxxxxxxxx Xxxxxx
[*] Suite 200
[*] Xxxx Xxxx, XX 00000-0000
Tel: [*]
E-mail: Fax: [*]
[*]
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
2.
152
EXHIBIT J
PRODUCT RECALL PROCEDURES
Xxxxxxx shall handle all physical aspects relating to any PRODUCT
recalls in TERRITORY A. SB shall handle all physical aspects relating to any
PRODUCT recalls in TERRITORY B and TERRITORY C. At Xxxxxxx'x request, SB will
assist Xxxxxxx in obtaining and receiving any samples of PRODUCT or
PRODUCT-related items that have been recalled in TERRITORY A. Any PRODUCT or
PRODUCT-related items returned to SB in TERRITORY A shall be shipped by SB to
Xxxxxxx'x facility identified by Xxxxxxx as the point for receiving returned
goods.
SB and Xxxxxxx shall [*] in the direct documented costs incurred by each
of them in TERRITORY A, TERRITORY B and TERRITORY C with respect to
participating in any withdrawal or recall, including without limitation PRODUCT
destruction, except that:
Xxxxxxx shall [*] incurred in connection with such withdrawal or recall
and [*], in cases where such withdrawal or recall was caused by Xxxxxxx by
either of the following circumstances:
(a) a defect in manufacturing (i.e. manufacturing not in
accordance with Specifications and procedures approved by the FDA or other
relevant government/regulatory agencies), including any adulteration,
mislabeling or misbranding of PRODUCT if Xxxxxxx was responsible for that stage
of manufacturing, or a PRODUCT or intermediate thereof failing to meet
applicable regulatory specifications (e.g., the regulations of the FDA and
European Commission Directive 91/356/EEC) or which will not meet applicable
regulatory specifications at the end of shelf life, or
(b) any misrepresentation or willful omission committed by
Xxxxxxx, its employees, officers, directors, agents, representatives or
AFFILIATES in connection with PRODUCT safety or efficacy data or information
submitted or omitted from submission to any regulatory agency.
(c) any misrepresentation made by Xxxxxxx or its employees,
officers, directors, agents, representatives or AFFILIATES in connection with
the promotion of PRODUCT, or
(d) any other negligence or wrongful act committed by Xxxxxxx or
its employees, officers, directors, agents, representatives or AFFILIATES in the
distribution of PRODUCT including, but not limited to, improper storage and/or
handling of PRODUCT.
SB shall [*] incurred in connection with such withdrawal or recall and
[*], in cases where such withdrawal or recall was caused by SB by either of the
following circumstances:
(a) a defect in manufacturing (i.e. manufacturing not in
accordance with Specifications and procedures approved by the FDA or other
relevant government/regulatory agencies), including any adulteration,
mislabeling or misbranding of PRODUCT if SB was responsible for that stage of
manufacturing, or a PRODUCT or intermediate thereof failing to meet
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
1.
153
applicable regulatory specifications (e.g., the regulations of the FDA and
European Commission Directive 91/356/EEC) or which will not meet applicable
regulatory specifications at the end of shelf life;
(b) any misrepresentation or willful omission committed by SB,
its employees, officers, directors, agents, representatives or AFFILIATES in
connection with PRODUCT safety or efficacy data or information submitted or
omitted from submission to any regulatory agency;
(c) any misrepresentation made by SB or its employees, officers,
directors, agents, representatives or AFFILIATES in connection with the
promotion of PRODUCT; or
(d) any other negligence or wrongful act committed by SB or its
employees, officers, directors, agents, representatives or AFFILIATES in the
distribution of PRODUCT including, but not limited to, improper storage and/or
handling of PRODUCT.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
2.
