Defined Terms Location. Celgene Licensed Product In-Licensed IP Section 1.9 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) Field Section 1.20 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 Party(ies) Preamble Patent Challenge Section 10.2(b) PHSA Section 7.2(f) Pivotal Study Section 1.30 Regulatory Exclusivity Period Section 1.31 Second Indication Section 1.32 Selling Party Section 1.35 Solely Owned IP Section 5.1 Specific Patent Section 6.3 Sublicensee Section 1.36 Suspension Transition Plan Section 2.4(b)(i)(A) Third Party Claims Section 9.6(a) Valid Claim Section 1.38 Vector Supplies Section 1.40
Appears in 2 contracts
Samples: License Agreement (2seventy Bio, Inc.), License Agreement (Bluebird Bio, Inc.)
Defined Terms Location. Celgene Licensed Product In-Licensed IP Section 1.9 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 EU Regulatory Event Section 2.4(b)(ii)(B) 1.20 Field Section 1.20 1.21 First Commercial Sale Section 1.21 1.22 First Indication Section 1.22 1.23 Fully Burdened Manufacturing Cost Appendix H GAAP Section 1.23 1.24 Gene Editing Section 1.24 Independent Target Antigen Program Section 3.4 1.25 In-License Payment Section 1.25 1.26 Indemnification Claim Notice Section 9.6(c) 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 1.26 1.27 Licensed Product Section 1.27 1.28 Litigation Conditions Section 9.6(d)(i) Losses Section 9.6(a) Major EU Countries Section 1.20 Manufacturing Section 1.28 Manufacturing Party 2.4(b)(i)(E) 1.29 Manufacturing and Supply Agreement Section 2.4(b)(i)(B2.4(c)(ii) Master Collaboration Agreement Preamble Milestone Event Section 4.2 Milestone Payment Section 4.2 Modified Licensed Product Section 1.27 1.28 Net Sales Section 1.29 1.30 Original MCA Preamble Original License Agreement Effective Date Preamble Party(ies) Preamble Patent Challenge Section 10.2(b) PHSA Section 7.2(f) Pivotal Study Section 1.30 1.31 Regulatory Exclusivity Period Section 1.31 1.32 Second Indication Section 1.32 1.33 Selling Party Section 1.35 Solely Owned IP Section 5.1 Specific Patent Section 6.3 Sublicensee Section 1.36 Suspension Transition Plan Section 2.4(b)(i)(A) Third Party Claims Section 9.6(a) Valid Claim Section 1.38 Vector Supplies Section 1.401.34
Appears in 2 contracts
Samples: License Agreement (2seventy Bio, Inc.), License Agreement (Bluebird Bio, Inc.)
Defined Terms Location. Business Party Section 10.4 Business Program Section 10.4 CCPS Agreement Preamble CCPS Agreement Effective Date Preamble CCPS Agreement Term Section 17.1 Celgene Preamble Celgene Corp Preamble Celgene Europe Preamble Celgene Indemnitees Section 16.7(b) Celgene Licensed IP Section 1.9 Celgene Licensed Product In-License Section 1.11 Celgene Licensed Product In-Licensed IP Section 1.9 Celgene Licensed Product IP Section 1.10 1.12 Celgene Other In-License Section 1.11 1.14 Celgene Regulatory Rights Section 1.12 1.15 Celgene Technology Section 1.13 Clinical Data Section 8 1.16 Clinical Study Section 1.14 1.17 Co-Co In Licenses Section 8.1 Combination Product Section 1.29 1.36 Commercialization Section 1.15 1.18 Commercially Reasonable Efforts Section 1.16 1.19 Competitive Infringement Section 7.1 14.1 Control Section 1.17 1.20 Cost of Goods Sold or COGS Appendix F Covers Section 1.18 1.21 Development & U.S. Commercialization Program Section 8.3(a) Distribution Costs Appendix F Elected Candidate Appendix A EU Section 1.19 Eurogentec 1.23 EU Regulatory Event Section 2.4(b)(ii)(B) 1.24 Field Section 1.20 1.25 First Commercial Sale Section 1.21 1.26 First Indication Section 1.22 1.27 Fully Burdened Manufacturing Cost Appendix H I GAAP Section 1.23 1.28 Gene Editing Section 1.24 Independent Target Antigen Program Section 3.4 1.31 Gross Profit Appendix F Gross Sales Appendix F 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 Party(ies) Preamble Patent Challenge Section 10.2(b) PHSA Section 7.2(f) Pivotal Study Section 1.30 Regulatory Exclusivity Period Section 1.31 Second Indication Section 1.32 Selling Party Section 1.35 Solely Owned IP Section 5.1 Specific Patent Section 6.3 Sublicensee Section 1.36 Suspension Transition Plan Section 2.4(b)(i)(A) Third Party Claims Section 9.6(a) Valid Claim Section 1.38 Vector Supplies Section 1.401.32
Appears in 1 contract
Samples: Co Development, Co Promote and Profit Share Agreement (2seventy Bio, Inc.)
Defined Terms Location. Celgene Licensed Product In-Licensed IP Section 1.9 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 1.16 Combination Product Section 1.29 1.32 Commercialization Section 1.15 1.17 Commercially Reasonable Efforts Section 1.16 1.18 Competitive Infringement Section 7.1 14.1 Control Section 1.17 1.19 Cost of Goods Sold or COGS Appendix F Covers Section 1.18 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 1.19 Eurogentec 1.21 EU Regulatory Event Section 2.4(b)(ii)(B) 1.22 Field Section 1.20 1.23 First Commercial Sale Section 1.21 1.24 First Indication Section 1.22 1.25 Fully Burdened Manufacturing Cost Appendix H J GAAP Section 1.23 1.26 Gene Editing Section 1.24 Independent Target Antigen Program Section 3.4 1.27 Gross Profit Appendix F Gross Sales Appendix F In-License Payment Section 1.25 1.28 Indemnification Claim Notice Section 9.6(c16.6(c) Indemnified Party Section 9.6(c16.6(c) Information Request Section 5.6(g) JGC Section 3.1(a) Joint IP Section 5.2 License Agreement Preamble License Agreement Term Section 10.1 12.2 Licensed IP Section 1.26 1.29 Licensed Product Section 1.27 Litigation Conditions Section 9.6(d)(i) 1.30 Losses Section 9.6(a16.6(a) Major EU Countries Section 1.22 Manufacturing Section 1.28 Manufacturing Party 2.4(b)(i)(E) 1.31 Manufacturing and Supply Agreement Section 2.4(b)(i)(B7.4(b)(ii) Marketing Costs Appendix F Master Collaboration Agreement Preamble Milestone Event Section 4.2 11.2(a) 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 Party(ies) Preamble Patent Challenge Section 10.2(b) PHSA Section 7.2(f) Pivotal Study Section 1.30 Regulatory Exclusivity Period Section 1.31 Second Indication Section 1.32 Selling Party Section 1.35 Solely Owned IP Section 5.1 Specific Patent Section 6.3 Sublicensee Section 1.36 Suspension Transition Plan Section 2.4(b)(i)(A) Third Party Claims Section 9.6(a) Valid Claim Section 1.38 Vector Supplies Section 1.4011.2(a)
Appears in 1 contract
Samples: Master Collaboration Agreement (2seventy Bio, Inc.)
Defined Terms Location. Celgene Licensed Product In-Licensed IP Section 1.9 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) Field Section 1.20 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(c16.7(c) Indemnified Party Section 9.6(c16.7(c) Information Request Section 5.6(g) JGC Section 3.1(a) Joint IP Section 5.2 License Agreement Preamble License Agreement Term Section 10.1 12.2 Licensed IP Section 1.26 1.33 Licensed Product Section 1.27 Litigation Conditions Section 9.6(d)(i) 1.34 Losses Section 9.6(a16.7(a) Major EU Countries Section 1.24 Manufacturing Section 1.28 Manufacturing Party 2.4(b)(i)(E) 1.35 Manufacturing and Supply Agreement Section 2.4(b)(i)(B7.4(b)(ii) Marketing Costs Appendix F Master Collaboration Agreement Preamble Milestone Event Section 4.2 11.2(a) Milestone Payment Section 4.2 11.2(a) Modified Licensed Product Section 1.27 1.34 Net Sales Section 1.29 1.36 Operating Profits or Losses Appendix F Original MCA Preamble Original License Agreement Effective Date Preamble Other Operating Income/Expense Appendix F Party(ies) Preamble Patent Challenge Profit & Loss Share Section 10.2(b) PHSA Section 7.2(f) 11.4 Pivotal Study Section 1.30 1.37 Regulatory Exclusivity Period Section 1.31 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 1.32 Selling Party Section 1.35 1.44 Solely Owned IP Section 5.1 12.1 Selling Party Section 1.45 Specific Patent Section 6.3 13.3 Sublicensee Section 1.36 Suspension Transition Plan 1.46 Target Antigen Section 2.4(b)(i)(A) 1.47 Third Party Claims Section 9.6(a16.7(a) U.S. Administration Section 1.48 U.S. Administration Liabilities Section 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 F U.S. Development Plan Section 1.52 U.S. Development & Commercialization Program Section 1.53 Valid Claim Section 1.38 1.54 Vector Supplies Section 1.401.55 Worldwide Commercialization Plan Section 1.56 Worldwide Manufacturing Plan Section 1.57
Appears in 1 contract
Samples: Co Development, Co Promote and Profit Share Agreement (Bluebird Bio, Inc.)
Defined Terms Location. Celgene Indemnitees Section 9.6(b) Celgene Licensed Product In-License Section 1.8 Celgene Licensed Product In-Licensed IP Section 1.9 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 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 Eurogentec EU Regulatory Event Section 2.4(b)(ii)(B) 1.20 Field Section 1.20 1.21 First Commercial Sale Section 1.21 1.22 First Indication Section 1.22 1.23 Fully Burdened Manufacturing Cost Appendix H GAAP Section 1.23 1.24 Gene Editing Section 1.24 Independent Target Antigen Program Section 3.4 1.25 In-License Payment Section 1.25 1.26 Indemnification Claim Notice Section 9.6(c) 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 1.26 1.27 Licensed Product Section 1.27 1.28 Litigation Conditions Section 9.6(d)(i) Losses Section 9.6(a) Major EU Countries Section 1.20 Manufacturing Section 1.28 Manufacturing Party 2.4(b)(i)(E) 1.29 Manufacturing and Supply Agreement Section 2.4(b)(i)(B2.4(c)(ii) 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 Party(ies) Preamble Patent Challenge Section 10.2(b) PHSA Section 7.2(f) Pivotal Study Section 1.30 Regulatory Exclusivity Period Section 1.31 Second Indication Section 1.32 Selling Party Section 1.35 Solely Owned IP Section 5.1 Specific Patent Section 6.3 Sublicensee Section 1.36 Suspension Transition Plan Section 2.4(b)(i)(A) Third Party Claims Section 9.6(a) Valid Claim Section 1.38 Vector Supplies Section 1.401.28
Appears in 1 contract
Defined Terms Location. Celgene Licensed Product In-Licensed IP Section 1.9 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) Field Section 1.20 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(c16.7(c) Indemnified Party Section 9.6(c16.7(c) Information Request Section 5.6(g) JGC Section 3.1(a) Joint IP Section 5.2 License Agreement Preamble License Agreement Term Section 10.1 12.2 Licensed IP Section 1.26 1.33 Licensed Product Section 1.27 Litigation Conditions Section 9.6(d)(i) 1.34 Losses Section 9.6(a16.7(a) Major EU Countries Section 1.24 Manufacturing Section 1.28 Manufacturing Party 2.4(b)(i)(E) 1.35 Manufacturing and Supply Agreement Section 2.4(b)(i)(B7.4(b)(ii) Marketing Costs Appendix F Master Collaboration Agreement Preamble Milestone Event Section 4.2 11.2(a) Milestone Payment Section 4.2 11.2(a) Modified Licensed Product Section 1.27 1.34 Net Sales Section 1.29 1.36 Operating Profits or Losses Appendix F Original MCA Preamble Original License Agreement Effective Date Preamble Other Operating Income/Expense Appendix F Party(ies) Preamble Patent Challenge Profit & Loss Share Section 10.2(b) PHSA Section 7.2(f) 11.4 Pivotal Study Section 1.30 1.37 Regulatory Exclusivity Period Section 1.31 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 1.32 Selling Party Section 1.35 1.44 Solely Owned IP Section 5.1 12.1 Selling Party Section 1.45 Specific Patent Section 6.3 13.3 Sublicensee Section 1.36 Suspension Transition Plan 1.46 Target Antigen Section 2.4(b)(i)(A) 1.47 Third Party Claims Section 9.6(a) Valid Claim Section 1.38 Vector Supplies Section 1.4016.7(a)
Appears in 1 contract
Samples: Co Development, Co Promote and Profit Share Agreement (2seventy Bio, Inc.)