set
forth in the section of this Agreement indicated below:
DEFINITION
SECTION
2010 Agreement
Introduction AAA
15.1(b) Accounting Standards
Exhibit E
Acquired Party
15.4(b) Acquired Party Activity
15.4(c) Acquired Third
Party
15.4(c) Acquirer
15.4(b) Acquisition
15.4(b) Additional
Development Activities
3.3 Additional Development Opt-In Date
3.3(e)(i)
Additional Development Opt-In Notice
3.3(e) Additional Development Proposal
3.3(a) Additional Development Party
3.3(c) Additional Revenue
Exhibit E
Advertising and Market Research Expenses
Exhibit E AGI-23088 ROW Agreement
Recitals Agios
Preamble Agios Clinical-Scale Manufacturing Responsibilities
4.1(a) Agios Commercial-Scale Manufacturing Responsibilities
4.1(a) Agios
Indemnified Parties
13.1(a) Agios Opt-Out Notice
2.12(a) Agios Opt-Out
Date
2.12(a) Agreement
Preamble AIS
Recitals Alliance Manager
2.6
Annual Net Sales
Exhibit E Arbitrable Matters
15.1(b) Audit Team
9.8(a)
Audit Rights Holder
9.8(f) Auditee
9.8(f) Bankruptcy Code
8.8 Breaching
Party
14.2(b)(i) CA 23088 US Partnership
15.16 Celgene
Preamble Celgene
Controlled Agios Patent Rights
10.2(b) Celgene Indemnified Parties
13.2(a)
Celgene Manufacturing Responsibilities
4.1(c) Challenge
10.8(a) Change of
Control
15.5(c) CIS II
Recitals Combination Product
Exhibit E
Commercialization Expenses
Exhibit E Commercialization Budget
6.2(a)(i)
Commercialization Plan
6.2(a)(i) Committee
2.1(a)
- 11 -
DEFINITION
SECTION
Competitive Infringement
10.3(b) Cooperating Party
11.3(b)(iii) CPI
Exhibit E CREATE Act Patent
10.7 Development Budget
3.1(a) Development
Costs
Exhibit E Disclosing Party
11.1 Dispute
15.1(a) Distribution
Costs
Exhibit E DOJ
15.17(c)(i) [**] Agreement
Exhibit D Earlier Patent
10.7 Effective Date
Preamble Excess Amounts
9.2(b) Expert
15.1(b)(i)
Finance Working Group
2.1(a) Financial Exhibit
2.9(b) FTC
15.17(c)(ii)
FTE
Exhibit E FTE Costs
Exhibit E FTE Rate
Exhibit E Global Safety
Database
5.3 Health Care Reform Fees
Exhibit E [**]
15.12 HSR Act
15.17(c)(iii) Initial Enforcement Party
10.3(b) Invalidity Claim
10.4(b)
JCC
2.1(a) JDC
2.1(a) Joint Inventions
10.1(c) Joint Patents
10.1(c)
JPC
2.1(a) JPC Designee
2.8(e) JSC
2.1(a) Manufacturing Costs
Exhibit E Manufacturing Scale-Up Costs
Exhibit E Marketing Activities
6.3(a) Marketing Expenses
Exhibit E Marketing Management Expenses
Exhibit
E Medical Education Expenses
Exhibit E Net Sales
Exhibit E Non-Additional
Development Party
3.3(c) Non-Breaching Party
14.2(b)(i) Objecting Party
6.1(b) Other Commercialization Costs
Exhibit E
- 12 -
DEFINITION
SECTION
Out-of-Pocket Costs
Exhibit E Patent and Trademark Prosecution and
Enforcement Costs
Exhibit E Patent Prosecution Expenses
10.2(e) Payments
9.9(a) Pharmacovigilance Agreement
5.3 Phase IV Trial Expenses
Exhibit
E PPACA
Exhibit E Product Liabilities
Exhibit E Product Trademarks
6.4(a) Proposing Party
6.1(b) Prosecuting Party
10.2(f)(i) Recall Expenses
Exhibit E Receiving Party
11.1 Reconciliation Procedures
2.9(b)
Redacted Version
11.3(b)(i) Regulatory Interactions
5.1(b) Regulatory
Expenses
Exhibit E Regulatory Maintenance Costs
Exhibit E Requesting Party
11.3(b)(iii) Royalty Term
9.5(b) Selling Expenses
Exhibit E Step-In
Enforcement Party
10.3(d) Term
14.1 Third Party Activity
15.4(b) Third
Party Contractors
8.2(a)(ii) Third Party Infringement
10.3(a) Third Party
Infringement Action
10.4(a) Third Party Patent Costs
Exhibit E Third Party
Products Liability Action
13.4(a) US Territory Loss
Exhibit E US Territory
Profit
Exhibit E US Territory Profit or Loss
Exhibit E
Article II
Governance; Collaboration
Section 2.1 General.
(a) Governance Committees. The Parties hereby establish (i) a Joint Steering
Committee ("JSC") to oversee and coordinate the overall conduct of all further
activities concerning the Collaboration