Defined Terms Location. Additional Bluebird IP Section 10.7(a) Allowable Expenses Appendix F Allocable Manufacturing Overhead Appendix D Allocable Overhead Appendix F [***] [***] Bluebird Indemnitees Section 11.6(a) Budgeted U.S. Development Costs Section 4.3 Business Acquisition Section 10.4 Business Party Section 10.4 Business Program Section 10.4 CCPS Agreement Term Section 12.1 Celgene Indemnitees Section 11.6(b) CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Defined Terms Location Commercial Supplies Appendix D Competitive Infringement Section 14.1 [***] Cost of Goods Sold or COGS Appendix F [***] Development & U.S. Commercialization Program Section 8.3(a) Distribution Costs Appendix F Elected Candidate Appendix A Fully Burdened Manufacturing Cost Appendix D Gross Profit Appendix F Gross Sales Appendix F Indemnification Claim Notice Section 11.6(c) Indemnified Party Section 11.6(c) Information Request Section 5.6(g) JGC Section 3.1(a) Joint IP Section 12.2 Losses Section 11.6(a) Major EU Countries Section 1.21 Manufacturing and Supply Agreement Section 7.4(b)(ii) Marketing Costs Appendix F Milestone Event Section 11.2(a) Milestone Payment Section 11.2(a) Modified Licensed Product Section 1.24 [***] Operating Profits or Losses Appendix F Other Operating Income/Expense Appendix F Profit & Loss Share Section 11.4 ROW Post-Approval Manufacturing Plan Section 7.3 Sales Costs Appendix F Sales Returns and Allowances Appendix F Solely Owned IP Section 12.1 Specific Patent Section 13.3 Third Party Claims Section 11.6(a) U.S. Administration Liabilities Section 16.8 U.S. Development Costs Appendix F
Appears in 2 contracts
Samples: License Agreement (Bluebird Bio, Inc.), License Agreement (Bluebird Bio, Inc.)
Defined Terms Location. Additional Bluebird Celgene Development & Commercialization Program Section 1.7 Celgene Europe Preamble Celgene Indemnitees Section 9.6(b) Celgene Licensed Product In-License Section 1.8 Celgene Licensed Product In-Licensed IP Section 10.7(a1.9 Celgene Licensed Product IP Section 1.10 Celgene Other In-License Section 1.11 Celgene Regulatory Rights Section 1.12 Celgene Technology Section 1.13 Clinical Study Section 1.14 Combination Product Section 1.30 Commercialization Section 1.15 Commercially Reasonable Efforts Section 1.16 Competitive Infringement Section 7.1 Control Section 1.17 Covers Section 1.18 Elected Candidate Appendix A EU Section 1.19 EU Regulatory Event Section 1.20 Field Section 1.21 First Commercial Sale Section 1.22 First Indication Section 1.23 Fully Burdened Manufacturing Cost Appendix H GAAP Section 1.24 Gene Editing Section 1.25 In-License Payment Section 1.26 Indemnification Claim Notice Section 9.6(c) Allowable Expenses Appendix F Allocable Manufacturing Overhead Appendix D Allocable Overhead Appendix F [***] [***] Bluebird Indemnitees Section 11.6(a) Budgeted U.S. Development Costs Section 4.3 Business Acquisition Section 10.4 Business Indemnified Party Section 10.4 Business Program 9.6(c) Joint IP Section 10.4 CCPS 5.2 License Agreement Preamble License Agreement Effective Date Preamble License Agreement Term Section 12.1 Celgene Indemnitees 10.1 Licensed IP Section 11.6(b1.27 Licensed Product Section 1.28 Litigation Conditions Section 9.6(d)(i) Losses Section 9.6(a) Major EU Countries Section 1.20 Manufacturing Section 1.29 Manufacturing and Supply Agreement Section 2.4(c)(ii) Master Collaboration Agreement Preamble License Agreement CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 19331934, AS AMENDED. Defined Terms Location Commercial Supplies Appendix D Competitive Infringement Section 14.1 [***] Cost of Goods Sold or COGS Appendix F [***] Development & U.S. Commercialization Program Section 8.3(a) Distribution Costs Appendix F Elected Candidate Appendix A Fully Burdened Manufacturing Cost Appendix D Gross Profit Appendix F Gross Sales Appendix F Indemnification Claim Notice Section 11.6(c) Indemnified Party Section 11.6(c) Information Request Section 5.6(g) JGC Section 3.1(a) Joint IP Section 12.2 Losses Section 11.6(a) Major EU Countries Section 1.21 Manufacturing and Supply Agreement Section 7.4(b)(ii) Marketing Costs Appendix F Milestone Event Section 11.2(a) Milestone Payment Section 11.2(a) Modified Licensed Product Section 1.24 [***] Operating Profits or Losses Appendix F Other Operating Income/Expense Appendix F Profit & Loss Share Section 11.4 ROW Post-Approval Manufacturing Plan Section 7.3 Sales Costs Appendix F Sales Returns and Allowances Appendix F Solely Owned IP Section 12.1 Specific Patent Section 13.3 Third Party Claims Section 11.6(a) U.S. Administration Liabilities Section 16.8 U.S. Development Costs Appendix F.
Appears in 1 contract
Defined Terms Location. Additional Bluebird IP Section 10.7(a) Allowable Expenses Appendix F Allocable Manufacturing Overhead Appendix D Allocable Overhead Appendix F [***] [***] Biosimilar Application Section 14.2(f) Bluebird Development Cap Section 4.3(c)(i) Bluebird Indemnitees Section 11.6(a) Budgeted U.S. Development Costs Section 4.3 Business Acquisition Section 10.4 Business Party Section 10.4 Business Program Section 10.4 CCPS Agreement Term Section 12.1 Celgene Indemnitees Section 11.6(b) CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Defined Terms Location Commercial Supplies Appendix D Competitive Infringement Section 14.1 [***] Cost of Goods Sold or COGS Appendix F [***] Development Cost Overage Section 4.3(c)(i) Development & U.S. Commercialization Program Section 8.3(a) Distribution Costs Appendix F Elected Candidate Appendix A Fully Burdened Manufacturing Cost Appendix D Gross Profit Appendix F Gross Sales Appendix F Indemnification Claim Notice Section 11.6(c) Indemnified Party Section 11.6(c) Information Request Section 5.6(g) JGC Section 3.1(a) Joint IP Section 12.2 Losses Section 11.6(a) Major EU Countries Section 1.21 Manufacturing and Supply Agreement Section 7.4(b)(ii) Marketing Costs Appendix F Milestone Event Section 11.2(a) Milestone Payment Section 11.2(a) Modified Licensed Product Section 1.24 [***] Operating Profits or Losses Appendix F Other Operating Income/Expense Appendix F Profit & Loss Share Section 11.4 ROW Post-Approval Manufacturing Plan Section 7.3 Sales Costs Appendix F Sales Returns and Allowances Appendix F Solely Owned IP Section 12.1 Specific Patent Section 13.3 Third Party Claims Section 11.6(a) U.S. Administration Liabilities Section 16.8 U.S. Development Costs Appendix F
Appears in 1 contract
Defined Terms Location. Additional Bluebird Celgene Indemnitees Section 9.6(b) Celgene Licensed Product In-License Section 1.8 Celgene Licensed Product In-Licensed IP Section 10.7(a1.9 Celgene Licensed Product IP Section 1.10 Celgene Other In-License Section 1.11 Celgene Regulatory Rights Section 1.12 Celgene Technology Section 1.13 Clinical Study Section 1.14 Combination Product Section 1.30 Commercialization Section 1.15 Commercially Reasonable Efforts Section 1.16 Competitive Infringement Section 7.1 Control Section 1.17 Covers Section 1.18 Elected Candidate Appendix A EU Section 1.19 EU Regulatory Event Section 1.20 Field Section 1.21 First Commercial Sale Section 1.22 First Indication Section 1.23 Fully Burdened Manufacturing Cost Appendix H GAAP Section 1.24 Gene Editing Section 1.25 In-License Payment Section 1.26 Indemnification Claim Notice Section 9.6(c) Allowable Expenses Appendix F Allocable Indemnified Party Section 9.6(c) Joint IP Section 5.2 License Agreement Preamble License Agreement Effective Date Preamble License Agreement Term Section 10.1 Licensed IP Section 1.27 Licensed Product Section 1.28 Litigation Conditions Section 9.6(d)(i) Losses Section 9.6(a) Major EU Countries Section 1.20 Manufacturing Overhead Appendix D Allocable Overhead Appendix F Section 1.29 Manufacturing and Supply Agreement Section 2.4(c)(ii) Master Collaboration Agreement Preamble Milestone Event Section 4.2 Milestone Payment Section 4.2 Modified Licensed Product Section 1.28 [***] [***] Bluebird Indemnitees Section 11.6(a) Budgeted U.S. Development Costs Section 4.3 Business Acquisition Section 10.4 Business Party Section 10.4 Business Program Section 10.4 CCPS Agreement Term Section 12.1 Celgene Indemnitees Section 11.6(b) CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE INDICATES MATERIAL THAT HAS BEEN OMITTED AND REPLACED WITH “[***]”FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. A COMPLETE VERSION OF THIS EXHIBIT ALL SUCH OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 19331934, AS AMENDED. Defined Terms Location Commercial Supplies Appendix D Competitive Infringement Section 14.1 [***] Cost of Goods Sold or COGS Appendix F [***] Development & U.S. Commercialization Program Section 8.3(a) Distribution Costs Appendix F Elected Candidate Appendix A Fully Burdened Manufacturing Cost Appendix D Gross Profit Appendix F Gross Sales Appendix F Indemnification Claim Notice Section 11.6(c) Indemnified Party Section 11.6(c) Information Request Section 5.6(g) JGC Section 3.1(a) Joint IP Section 12.2 Losses Section 11.6(a) Major EU Countries Section 1.21 Manufacturing and Supply Agreement Section 7.4(b)(ii) Marketing Costs Appendix F Milestone Event Section 11.2(a) Milestone Payment Section 11.2(a) Modified Licensed Product Section 1.24 [***] Operating Profits or Losses Appendix F Other Operating Income/Expense Appendix F Profit & Loss Share Section 11.4 ROW Post-Approval Manufacturing Plan Section 7.3 Sales Costs Appendix F Sales Returns and Allowances Appendix F Solely Owned IP Section 12.1 Specific Patent Section 13.3 Third Party Claims Section 11.6(a) U.S. Administration Liabilities Section 16.8 U.S. Development Costs Appendix F.
Appears in 1 contract
Defined Terms Location. Additional Bluebird IP Development Cap Section 10.7(a4.3(c)(i) Allowable Expenses Appendix F Allocable Manufacturing Overhead Appendix D Allocable Overhead Appendix F [***] [***] Bluebird Indemnitees Section 11.6(a16.6(a) Bluebird Licensed IP Section 1.6 Bluebird Regulatory Rights Section 1.7 Bluebird Technology Section 1.8 Budgeted U.S. Development Costs Section 4.3 Business Acquisition Section 10.4 Business Party Section 10.4 Business Program Section 10.4 CCPS Agreement Preamble CCPS Agreement Effective Date Preamble CCPS Agreement Term Section 12.1 17.1 Celgene Preamble Celgene Corp Preamble Celgene Europe Preamble Celgene Indemnitees Section 11.6(b16.6(b) Celgene Licensed IP Section 1.9 Celgene Licensed Product In-License Section 1.10 Celgene Licensed Product In-Licensed IP Section 1.11 Celgene Other In-License Section 1.13 Celgene Regulatory Rights Section 1.14 Celgene Technology Section 1.15 Clinical Study Section 1.16 Combination Product Section 1.32 Commercialization Section 1.17 Commercially Reasonable Efforts Section 1.18 Competitive Infringement Section 14.1 Control Section 1.19 Cost of Goods Sold or COGS Appendix F Covers Section 1.20 Development Cost Overage Section 4.3(c)(i) Development & U.S. Commercialization Program Section 8.3(a) Distribution Costs Appendix F Elected Candidate Appendix A EU Section 1.21 EU Regulatory Event Section 1.22 Field Section 1.23 First Commercial Sale Section 1.24 First Indication Section 1.25 Fully Burdened Manufacturing Cost Appendix J GAAP Section 1.26 Gene Editing Section 1.27 Gross Profit Appendix F Gross Sales Appendix F In-License Payment Section 1.28 CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 19331934, AS AMENDED. Defined Terms Location Commercial Supplies Appendix D Competitive Infringement Section 14.1 [***] Cost of Goods Sold or COGS Appendix F [***] Development & U.S. Commercialization Program Section 8.3(a) Distribution Costs Appendix F Elected Candidate Appendix A Fully Burdened Manufacturing Cost Appendix D Gross Profit Appendix F Gross Sales Appendix F Indemnification Claim Notice Section 11.6(c) Indemnified Party Section 11.6(c) Information Request Section 5.6(g) JGC Section 3.1(a) Joint IP Section 12.2 Losses Section 11.6(a) Major EU Countries Section 1.21 Manufacturing and Supply Agreement Section 7.4(b)(ii) Marketing Costs Appendix F Milestone Event Section 11.2(a) Milestone Payment Section 11.2(a) Modified Licensed Product Section 1.24 [***] Operating Profits or Losses Appendix F Other Operating Income/Expense Appendix F Profit & Loss Share Section 11.4 ROW Post-Approval Manufacturing Plan Section 7.3 Sales Costs Appendix F Sales Returns and Allowances Appendix F Solely Owned IP Section 12.1 Specific Patent Section 13.3 Third Party Claims Section 11.6(a) U.S. Administration Liabilities Section 16.8 U.S. Development Costs Appendix F.
Appears in 1 contract
Defined Terms Location. Additional Bluebird Celgene Other In-License Section 1.11 Celgene Regulatory Rights Section 1.12 Celgene Technology Section 1.13 Clinical Study Section 1.14 Combination Product Section 1.30 Commercialization Section 1.15 Commercially Reasonable Efforts Section 1.16 Competitive Infringement Section 7.1 Control Section 1.17 Covers Section 1.18 Elected Candidate Appendix A EU Section 1.19 EU Regulatory Event Section 1.20 Field Section 1.21 First Commercial Sale Section 1.22 First Indication Section 1.23 Fully Burdened Manufacturing Cost Appendix H GAAP Section 1.24 Gene Editing Section 1.25 In-License Payment Section 1.26 Indemnification Claim Notice Section 9.6(c) Indemnified Party Section 9.6(c) Joint IP Section 10.7(a) Allowable Expenses Appendix F Allocable Manufacturing Overhead Appendix D Allocable Overhead Appendix F [***] [***] Bluebird Indemnitees Section 11.6(a) Budgeted U.S. Development Costs Section 4.3 Business Acquisition Section 10.4 Business Party Section 10.4 Business Program Section 10.4 CCPS 5.2 License Agreement Preamble License Agreement Effective Date Preamble License Agreement Term Section 12.1 Celgene Indemnitees 10.1 Licensed IP Section 11.6(b1.27 Licensed Product Section 1.28 Litigation Conditions Section 9.6(d)(i) Losses Section 9.6(a) Major EU Countries Section 1.20 Manufacturing Section 1.29 Manufacturing and Supply Agreement Section 2.4(c)(ii) Master Collaboration Agreement Preamble Milestone Event Section 4.2 Milestone Payment Section 4.2 Modified Licensed Product Section 1.28 Net Sales Section 1.30 Original MCA Preamble Party(ies) Preamble Patent Challenge Section 10.2(b) PHSA Section 7.2(f) CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 19331934, AS AMENDED. Defined Terms Location Commercial Supplies Appendix D Competitive Infringement Section 14.1 [***] Cost of Goods Sold or COGS Appendix F [***] Development & U.S. Commercialization Program Section 8.3(a) Distribution Costs Appendix F Elected Candidate Appendix A Fully Burdened Manufacturing Cost Appendix D Gross Profit Appendix F Gross Sales Appendix F Indemnification Claim Notice Section 11.6(c) Indemnified Party Section 11.6(c) Information Request Section 5.6(g) JGC Section 3.1(a) Joint IP Section 12.2 Losses Section 11.6(a) Major EU Countries Section 1.21 Manufacturing and Supply Agreement Section 7.4(b)(ii) Marketing Costs Appendix F Milestone Event Section 11.2(a) Milestone Payment Section 11.2(a) Modified Licensed Product Section 1.24 [***] Operating Profits or Losses Appendix F Other Operating Income/Expense Appendix F Profit & Loss Share Section 11.4 ROW Post-Approval Manufacturing Plan Section 7.3 Sales Costs Appendix F Sales Returns and Allowances Appendix F Solely Owned IP Section 12.1 Specific Patent Section 13.3 Third Party Claims Section 11.6(a) U.S. Administration Liabilities Section 16.8 U.S. Development Costs Appendix F.
Appears in 1 contract
Defined Terms Location. Additional Bluebird Celgene Licensed Product In-Licensed IP Section 10.7(a1.9 Celgene Licensed Product IP Section 1.10 Celgene Other In-License Section 1.11 Celgene Regulatory Rights Section 1.12 Celgene Technology Section 1.13 Clinical Data Section 8 Clinical Study Section 1.14 Combination Product Section 1.29 Commercialization Section 1.15 Commercially Reasonable Efforts Section 1.16 Competitive Infringement Section 7.1 Control Section 1.17 Covers Section 1.18 Elected Candidate Appendix A EU Section 1.19 Eurogentec Section 2.4(b)(ii)(B) Allowable Expenses Appendix F Allocable Manufacturing Overhead Appendix D Allocable Overhead Appendix F Field Section 1.20 Certain information indicated with [***] in this document has been omitted from this exhibit because it is both (i) not material and (ii) is the type that the registrant treats as private or confidential. First Commercial Sale Section 1.21 First Indication Section 1.22 Fully Burdened Manufacturing Cost Appendix H GAAP Section 1.23 Gene Editing Section 1.24 Independent Target Antigen Program Section 3.4 In-License Payment Section 1.25 Indemnification Claim Notice Section 9.6(c) Indemnified Party Section 9.6(c) Joint IP Section 5.2 License Agreement Preamble License Agreement Term Section 10.1 Licensed IP Section 1.26 Licensed Product Section 1.27 Litigation Conditions Section 9.6(d)(i) Losses Section 9.6(a) Manufacturing Section 1.28 Manufacturing Party 2.4(b)(i)(E) Manufacturing and Supply Agreement Section 2.4(b)(i)(B) Master Collaboration Agreement Preamble Milestone Event Section 4.2 Milestone Payment Section 4.2 Modified Licensed Product Section 1.27 Net Sales Section 1.29 Original MCA Preamble Original License Agreement Effective Date Preamble Certain information indicated with [***] Bluebird Indemnitees Section 11.6(ain this document has been omitted from this exhibit because it is both (i) Budgeted U.S. Development Costs Section 4.3 Business Acquisition Section 10.4 Business Party Section 10.4 Business Program Section 10.4 CCPS Agreement Term Section 12.1 Celgene Indemnitees Section 11.6(bnot material and (ii) CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDEDis the type that the registrant treats as private or confidential. Defined Terms Location Commercial Supplies Appendix D Competitive Infringement Party(ies) Preamble Patent Challenge Section 14.1 [***] Cost of Goods Sold or COGS Appendix F [***] Development & U.S. Commercialization Program 10.2(b) PHSA Section 8.3(a7.2(f) Distribution Costs Appendix F Elected Candidate Appendix A Fully Burdened Manufacturing Cost Appendix D Gross Profit Appendix F Gross Sales Appendix F Indemnification Claim Notice Pivotal Study Section 11.6(c) Indemnified 1.30 Regulatory Exclusivity Period Section 1.31 Second Indication Section 1.32 Selling Party Section 11.6(c) Information Request Section 5.6(g) JGC Section 3.1(a) Joint IP Section 12.2 Losses Section 11.6(a) Major EU Countries Section 1.21 Manufacturing and Supply Agreement Section 7.4(b)(ii) Marketing Costs Appendix F Milestone Event Section 11.2(a) Milestone Payment Section 11.2(a) Modified Licensed Product Section 1.24 [***] Operating Profits or Losses Appendix F Other Operating Income/Expense Appendix F Profit & Loss Share Section 11.4 ROW Post-Approval Manufacturing Plan Section 7.3 Sales Costs Appendix F Sales Returns and Allowances Appendix F 1.35 Solely Owned IP Section 12.1 5.1 Specific Patent Section 13.3 6.3 Sublicensee Section 1.36 Suspension Transition Plan Section 2.4(b)(i)(A) Third Party Claims Section 11.6(a9.6(a) U.S. Administration Liabilities Valid Claim Section 16.8 U.S. Development Costs Appendix F1.38 Vector Supplies Section 1.40
Appears in 1 contract
Defined Terms Location. Additional Bluebird Indemnification Claim Notice Section 16.6(c) Indemnified Party Section 16.6(c) Information Request Section 5.6(g) JGC Section 3.1(a) Joint IP Section 10.7(a12.2 Licensed IP Section 1.29 Licensed Product Section 1.30 Losses Section 16.6(a) Allowable Expenses Major EU Countries Section 1.22 Manufacturing Section 1.31 Manufacturing and Supply Agreement Section 7.4(b)(ii) Marketing Costs Appendix F Allocable Manufacturing Overhead Appendix D Allocable Overhead Master Collaboration Agreement Preamble Milestone Event Section 11.2(a) Milestone Payment Section 11.2(a) Modified Licensed Product Section 1.30 Net Sales Section 1.32 Operating Profits or Losses Appendix F [***] [***] Bluebird Indemnitees Original MCA Preamble Other Operating Income/Expense Appendix F Party(ies) Preamble Profit & Loss Share Section 11.6(a11.4 Pivotal Study Section 1.33 Regulatory Exclusivity Period Section 1.34 ROW Section 1.35 ROW Administration Section 1.36 ROW Development & Commercialization Program Section 1.37 ROW Development Plan Section 1.38 ROW Post-Approval Manufacturing Plan Section 7.3 Sales Costs Appendix F Sales Returns and Allowances Appendix F Second Indication Section 1.39 Solely Owned IP Section 12.1 Selling Party Section 1.40 Specific Patent Section 13.3 Sublicensee Section 1.41 Target Antigen Section 1.42 Third Party Claims Section 16.6(a) Budgeted U.S. Administration Section 1.43 U.S. Administration Liabilities Section 16.8 U.S. Commercialization Budget Section 1.44 U.S. Commercialization Plan Section 1.45 U.S. Development Budget Section 1.46 U.S. Development Costs Appendix F U.S. Development Plan Section 4.3 Business Acquisition Section 10.4 Business Party Section 10.4 Business Program Section 10.4 CCPS Agreement Term Section 12.1 Celgene Indemnitees Section 11.6(b) 1.47 CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 19331934, AS AMENDED. Defined Terms Location Commercial Supplies Appendix D Competitive Infringement Section 14.1 [***] Cost of Goods Sold or COGS Appendix F [***] Development & U.S. Commercialization Program Section 8.3(a) Distribution Costs Appendix F Elected Candidate Appendix A Fully Burdened Manufacturing Cost Appendix D Gross Profit Appendix F Gross Sales Appendix F Indemnification Claim Notice Section 11.6(c) Indemnified Party Section 11.6(c) Information Request Section 5.6(g) JGC Section 3.1(a) Joint IP Section 12.2 Losses Section 11.6(a) Major EU Countries Section 1.21 Manufacturing and Supply Agreement Section 7.4(b)(ii) Marketing Costs Appendix F Milestone Event Section 11.2(a) Milestone Payment Section 11.2(a) Modified Licensed Product Section 1.24 [***] Operating Profits or Losses Appendix F Other Operating Income/Expense Appendix F Profit & Loss Share Section 11.4 ROW Post-Approval Manufacturing Plan Section 7.3 Sales Costs Appendix F Sales Returns and Allowances Appendix F Solely Owned IP Section 12.1 Specific Patent Section 13.3 Third Party Claims Section 11.6(a) U.S. Administration Liabilities Section 16.8 U.S. Development Costs Appendix F.
Appears in 1 contract
Defined Terms Location. Additional Bluebird IP Section 10.7(a) Allowable Expenses Appendix F Allocable Manufacturing Overhead Appendix D Allocable Overhead Appendix F [***] [***] Bluebird Indemnitees Section 11.6(a) Budgeted U.S. Development Costs Section 4.3 Business Acquisition Section 10.4 Business Party Section 10.4 Business Program Section 10.4 CCPS Agreement Term Section 12.1 Celgene Indemnitees Section 11.6(b) CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Defined Terms Location Commercial Supplies Appendix D Competitive Infringement Section 14.1 [***] Cost of Goods Sold or COGS Appendix F [***] Development & U.S. Commercialization Program Section 8.3(a) Distribution Costs Appendix F Elected Candidate Appendix A Fully Burdened Manufacturing Cost Appendix D Gross Profit Appendix F Gross Sales Appendix F Indemnification Claim Notice Section 11.6(c16.7(c) Indemnified Party Section 11.6(c16.7(c) Information Request Section 5.6(g) JGC Section 3.1(a) Joint IP Section 12.2 Licensed IP Section 1.33 Licensed Product Section 1.34 Losses Section 11.6(a16.7(a) Major EU Countries Section 1.21 1.24 Manufacturing Section 1.35 Manufacturing and Supply Agreement Section 7.4(b)(ii) Marketing Costs Appendix F Master Collaboration Agreement Preamble Milestone Event Section 11.2(a) Milestone Payment Section 11.2(a) Modified Licensed Product Section 1.24 [***] 1.34 Net Sales Section 1.36 Operating Profits or Losses Appendix F Original MCA Preamble Other Operating Income/Expense Appendix F Party(ies) Preamble Profit & Loss Share Section 11.4 Pivotal Study Section 1.37 Regulatory Exclusivity Period Section 1.38 ROW Section 1.40 ROW Administration Section 1.41 ROW Development & Commercialization Program Section 1.42 ROW Development Plan Section 1.43 ROW Post-Approval Manufacturing Plan Section 7.3 Sales Costs Appendix F Sales Returns and Allowances Appendix F Second Indication Section 1.44 Solely Owned IP Section 12.1 Selling Party Section 1.45 Specific Patent Section 13.3 Sublicensee Section 1.46 Target Antigen Section 1.47 Third Party Claims Section 11.6(a16.7(a) CONFIDENTIAL TREATMENT REQUESTED BY BLUEBIRD BIO, INC. [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED Defined Terms Location U.S. Administration Section 1.48 U.S. Administration Liabilities Section 16.8 16.9 U.S. Commercialization Budget Section 1.49 U.S. Commercialization Plan Section 1.50 U.S. Development Budget Section 1.51 U.S. Development Costs Appendix FF U.S. Development Plan Section 1.52 U.S. Development & Commercialization Program Section 1.53 Valid Claim Section 1.54 Vector Supplies Section 1.55 Worldwide Commercialization Plan Section 1.56 Worldwide Manufacturing Plan Section 1.57
Appears in 1 contract
Samples: Share Agreement (Bluebird Bio, Inc.)
