1.1

“Accounting Standards” means GAAP for both Parties, unless a Party elects to change its general accounting principles to IFRS (or any change thereafter between IFRS and GAAP) and provides notice to the other Party of such change in accordance with Section 10.7 (Accounting Standards).

1.2

“Acquiree” has the meaning set forth in Section 2.8.3(b).

1.3

“Acquiror” has the meaning set forth in Section 2.8.3(a).

1.4

“Active Ingredient” means those clinically active materials that provide pharmacological activity in a pharmaceutical or biologic product (excluding [****]).

1.5

“Affiliate” means, with respect to a Person, any other Person that controls, is controlled by, or is under common control with such Person.  For the purpose of this definition only, “control” (including, with correlative meaning, the terms “controlled by” and “under the common control”) means the actual power, either directly or indirectly through one or more intermediaries, to direct or cause the direction of the management and policies of any Person, whether by the ownership of more than 50% of the voting security of such Person, by contract, or otherwise.

1.6

“Agreement” has the meaning set forth in the Preamble.

1.7

“Alliance Manager” has the meaning set forth in Section 3.1 (Alliance Managers).

1.8

“Anti-Corruption Laws” has the meaning set forth in Section 12.1.5 (Representations and Warranties of Each Party).

1.9

“Applicable Law” means collectively all laws, rules, regulations, ordinances, decrees, judicial and administrative orders (and any license, franchise, permit, or similar right granted under any of the foregoing), and any policies and other requirements of any applicable Governmental Authority that govern or otherwise apply to a Party, including all Anti-Corruption Laws.

1.10

“Approved Labeling” means, with respect to a Licensed Product: (a) the Regulatory Authority-approved full prescribing information for such Licensed Product; and (b) the Regulatory Authority-approved labels and other written, printed, or graphic materials on any container, wrapper, or any package insert that is used with or for such Licensed Product.

1.11

“Arbitration Notice” has the meaning set forth in Section 16.3.1 (Rules).

1.12

“Arbitrators” has the meaning set forth in Section 16.3.2 (Selection of Arbitrator).

1.13

“Assigned Collaboration Know-How” means any Collaboration Know-How that [****].

1.14

“Assigned Collaboration Patent Rights” means all Collaboration Patent Rights that Cover Assigned Collaboration Know-How.

1.15

“Assigned Collaboration Technology” means the Assigned Collaboration Know-How and the Assigned Collaboration Patent Rights.

1.16

“Average Patient Cost” means with respect to additional patients enrolled in a Global Clinical Trial for a Licensed Product by a Party [****].

1.17

“BLU-701” means (a) Blueprint’s mutant [****] EGFR inhibitor known as “BLU-701”; (b) its named back-up forms [****] and any other backup form that Blueprint identifies and designates after the Effective Date as a back-up form for BLU-701 in accordance with Blueprint’s then-current business practices; (c) prodrugs that convert to the compounds in (a) and (b); (d) stereoisomers and isotopic variants of the compounds in (a), (b), and (c); (e) [****]; (f) salt forms of the compounds in (a) through (e); and (g) solvates, hydrates, and solid forms (including crystalline, polymorphic, amorphous and co-crystalline forms) of the compounds in (a) through (f).

1.18

[****]

1.19

“BLU-945” means (a) Blueprint’s mutant [****] EGFR inhibitor known as “BLU-945”; (b) its named back-up forms [****] and any other backup form that Blueprint identifies and designates after the Effective Date as a back-up form for BLU-945 in accordance with Blueprint’s then-current business practices; (c) prodrugs that convert to the compounds in (a) and (b); (d) stereoisomers and isotopic variants of the compounds in (a), (b), and (c); (e) [****]; (f) salt forms of the compounds in (a) through (e); and (g) solvates, hydrates, and solid forms (including crystalline, polymorphic, amorphous and co-crystalline forms) of the compounds in (a) through (f).

1.20

[****]

1.21

“Blueprint” has the meaning set forth in the Preamble.

1.22

“Blueprint Collaboration Know-How” means Collaboration Know-How, other than Blueprint/Zai Combination Know-How, developed or invented solely by Blueprint’s or its Affiliates’, licensees’, Sublicensees’, or Subcontractors’ employees, agents, or independent contractors, or any Persons that are contractually required to assign or license such Collaboration Know-How (or Patent Rights Covering such Know-How) to Blueprint or any Affiliate of Blueprint, in each case, in the performance of activities under this Agreement during the Term.

1.23

“Blueprint Collaboration Patent Rights” means all Collaboration Patent Rights that Cover Blueprint Collaboration Know-How.

1.24

“Blueprint Compound” means BLU-701 or BLU-945 and includes [****].

1.25

“Blueprint Identified Rights” has the meaning set forth in Section 2.6.1 (Blueprint Identified Rights).

1.26

“Blueprint Indemnitee(s)” has the meaning set forth in Section 13.1 (By Zai).

1.27

“Blueprint In-Licensed Rights” has the meaning set forth in Section 2.6.3 (Third Party IP Agreements).

1.28

“Blueprint Know-How” means, subject to Section 2.6.5 (Right to Decline Blueprint In-Licensed Rights), all Know-How (excluding Blueprint’s interest in the Blueprint/Zai Combination Know-How and other Joint Collaboration Know-How) that is (a) Controlled by Blueprint or any of its Affiliates as of the Effective Date or during the Term, and (b) necessary or reasonably useful to Develop, perform Medical Affairs for, or Commercialize a Blueprint Compound or a Licensed Product in the Territory, including all Assigned Collaboration Know-How and Blueprint Collaboration Know-How, but expressly excluding Blueprint Manufacturing Know-How.

1.29

“Blueprint Manufacturing Know-How” means all Know-How Controlled by Blueprint or any of its Affiliates as of the Effective Date or during the Term that is actually used for the Manufacture of each Licensed Product in the Field in the Territory.

1.30

“Blueprint Manufacturing Patent Rights” means all Patent Rights Controlled by Blueprint or any of its Affiliates as of the Effective Date or during the Term that are actually practiced for the Manufacture of each Licensed Product in the Field in the Territory.

1.31

“Blueprint Manufacturing Technology” means the Blueprint Manufacturing Know-How and the Blueprint Manufacturing Patent Rights.

1.32

“Blueprint Patent Rights” means, subject to Section 2.6.5 (Right to Decline Blueprint In-Licensed Rights), all Patent Rights (excluding Blueprint’s interest in the Blueprint/Zai Combination Patent Rights and other Joint Collaboration Patent Rights) that are (a) Controlled by Blueprint or any of its Affiliates as of the Effective Date or during the Term, and (b) necessary or reasonably useful (or, with respect to patent applications, would be necessary or reasonably useful if such patent applications were to issue as patents) to Develop, perform Medical Affairs for, or Commercialize a Blueprint Compound or a Licensed Product in the Territory, including all Assigned Collaboration Patent Rights and Blueprint Collaboration Patent Rights, but expressly excluding Blueprint Manufacturing Patent Rights.  Schedule 1.32 (Blueprint Patent Rights) includes the Blueprint Patent Rights that are owned or exclusively licensed by Blueprint in the Territory and that exist as of the Effective Date.

1.33

“Blueprint Publication” has the meaning set forth in Section 11.5.1.

1.34

“Blueprint Specifications” has the meaning set forth in Section 7.2.3 (Specifications).

1.35

“Blueprint Technology” means Blueprint Know-How, Blueprint Patent Rights, and Blueprint’s interest in the Joint Collaboration Technology.

1.36

“Blueprint/Zai Combination” means any Combination Product or Combination Regimen that includes a Blueprint Compound together with any Zai Product.

1.37

“Blueprint/Zai Combination Know-How” means any Collaboration Know-How that (a) [****] relates to any Blueprint/Zai Combination (and not to any Zai Product alone or any other Licensed Product that is not a Blueprint/Zai Combination), including any composition, method of use or method of Manufacturing, in each case, that is specific to a Blueprint/Zai Combination (including any composition, method of use, or method of Manufacturing that is [****]), or any Companion Diagnostic [****] for use with a Blueprint/Zai Combination, and (b) is developed or invented during the Term by a Party’s or its Affiliates’, licensees’, Sublicensees’, or Sublicensees’ employees, agents, or independent contractors, or any Persons that are contractually required to assign or license such Know-How (or Patent Rights Covering such Know-How) to a Party or any Affiliate of a Party, either alone or jointly with the other Party’s or its Affiliates’, licensees’, Sublicensees’, Subcontractors’ employees, agents, or independent contractors, or any Persons that are contractually required to assign or license such Know-How (or Patent Rights Covering such Know-How) to the other Party or any Affiliate of the other Party, in each case, in the performance of activities under this Agreement during the Term.

1.38

“Blueprint/Zai Combination Patent Rights” means all Collaboration Patent Rights that Cover Blueprint/Zai Combination Know-How.  For clarity, Blueprint/Zai Combination Patent Rights do not include any Patent Rights that Cover (a) a Zai Product alone or (b) any other Licensed Product that is not a Blueprint/Zai Combination or a Companion Diagnostic that is for use with a Zai Product alone or any other Licensed Product that is not a Blueprint/Zai Combination.

1.39

“Blueprint/Zai Combination Technology” means the Blueprint/Zai Combination Know-How and the Blueprint/Zai Combination Patent Rights.

1.40

“Breach Notification” has the meaning set forth in Section 15.2.2(a) (Notice and Cure Period).

1.41

“Business Day” means a day other than a Saturday, Sunday, or a day on which banking institutions in Cambridge, Massachusetts or Shanghai, China are required by Applicable Law to remain closed.

1.42

“Buyers” has the meaning set forth in Section 1.136 (Net Sales).

1.43

“Calendar Quarter” means the respective periods of three consecutive calendar months ending on March 31, June 30, September 30, and December 31.

1.44

“Calendar Year” means each 12-month period commencing on January 1.

1.45

“cGMP” means all applicable current Good Manufacturing Practices, including, as applicable, (a) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Parts 4, 210, 211, 601, 610 and 820, (b) European Directive 2003/94/EC and Eudralex 4, (c) the principles detailed in the International Conference on Harmonization’s Q7 guidelines, and (d) the equivalent Applicable Law in any relevant country or region, each as may be amended and applicable from time to time.

1.46

“Change of Control” means, with respect to a Party, that: (a) any Third Party acquires directly or indirectly the beneficial ownership of any voting security of such Party, or if the percentage ownership of such Third Party in the voting securities of such Party is increased through stock redemption, cancellation, or other recapitalization, and immediately after such acquisition or increase such Third Party is, directly or indirectly, the beneficial owner of voting securities representing at least 50% of the total voting power of all of the then outstanding voting securities of such Party; (b) a merger, consolidation, recapitalization, or reorganization of such Party is consummated that would result in shareholders or equity holders of such Party that owned less than 50% of the outstanding voting securities of such Party immediately prior to such transaction, owning at least 50% of the outstanding voting securities of the surviving entity (or its parent entity) immediately following such transaction; or (c) there is a sale or transfer to a Third Party of all or substantially all of such Party’s consolidated assets taken as a whole, through one or more related transactions.

1.47

“Clinical Development” means, with respect to a pharmaceutical or biologic product, Development activities conducted from and after (and including) the filing of an IND for such pharmaceutical or biologic product specifically in connection with (a) Clinical Trials and (b) regulatory activities related to Clinical Trials, including filing of MAAs and obtaining, supporting, or maintaining Regulatory Approvals for such pharmaceutical or biologic product following completion of a Pivotal Trial for such pharmaceutical or biologic product.

1.48

“Clinical Supply Agreement” has the meaning set forth in Section 7.1.1 (Development Supply).

1.49

“Clinical Trial” means any clinical trial in humans that is conducted in accordance with GCP and is designed to generate data in support or maintenance of an IND or MAA, or other similar marketing application, including any Phase I Clinical Trial, Phase II Clinical Trial, Phase III Clinical Trial, or any post-approval clinical trial in humans.

1.50

“CMO” means a contract manufacturing organization.

1.51

“Collaboration Know-How” means any Know-How developed or invented during the Term by a Party’s or its Affiliates’, licensees’, Sublicensees’, or Subcontractors’ employees, agents, or independent contractors, or any Persons that are contractually required to assign or license such Know-How to a Party or any Affiliate of a Party, either alone or jointly with the other Party’s or its Affiliates’, licensees’, Sublicensees’, or Subcontractors’ employees, agents, or independent contractors, or any Persons that are contractually required to assign or license such Know-How (or

1.52

“Collaboration Patent Rights” means any Patent Rights that (a) (i) claim any Invention included in the Collaboration Know-How or (ii) disclose any Collaboration Know-How and (b) have a priority date that is after the Effective Date.

1.53

“Collaboration Technology” means Collaboration Know-How and Collaboration Patent Rights.

1.54

“Combination Product” means a Licensed Product that includes (a) BLU-701 or BLU-945, or both, on the one hand; and (b) another Active Ingredient, on the other hand, sold for a single price.

1.55

“Combination Regimen” means any product or treatment regimen that comprises, or is a combination of (a) a Licensed Product containing a Blueprint Compound, and (b) any other product containing an Active Ingredient other than such Blueprint Compound, where (a) and (b) are labeled for use together either simultaneously or in a separate or sequential administration, whether or not sold for a single price.

1.56

“Commercial Supply Agreement” has the meaning set forth in Section 7.1.2 (Commercial Supply).

1.57

“Commercialization” means any and all activities directed to the marketing, promotion, distribution, pricing, reimbursement, offering for sale, and sale of a pharmaceutical or biologic product and interacting with Regulatory Authorities following receipt of Regulatory Approval in the applicable country or region for such pharmaceutical or biologic product regarding the foregoing, including seeking and maintaining any required Reimbursement Approval, but excluding activities directed to Manufacturing, Development, or Medical Affairs. “Commercialize,” “Commercializing,” and “Commercialized” will be construed accordingly.

1.58

“Commercialization Plan” means, with respect to a Licensed Product, the written [****] strategic and tactical plans for the Commercialization activities for such Licensed Product to be conducted in the Territory that will be prepared and updated by Zai as provided in Section 9.2 (Commercialization Plans).

1.59

“Commercially Reasonable Efforts” means, with respect to the Exploitation of a Blueprint Compound or a Licensed Product by a Party, those efforts and resources, including reasonably necessary personnel, equivalent to the efforts that a reasonable international biopharmaceutical company or a pharmaceutical company[****] based on conditions then prevailing and taking into account all relevant factors [****].  Commercially Reasonable Efforts requires, with respect to an obligation, that the Party: (a) promptly assign responsibility for such obligation to specific employees who are held accountable for progress and monitor such progress on an on-going basis, (b) set and seek to achieve specific and meaningful objectives for carrying out such obligation, and (c) make and implement decisions and allocate resources designed to advance progress with respect to such objectives.  [****]

1.60

[****]

1.61

“Companion Diagnostics” has the meaning set forth in Section 5.18 (Development of Companion Diagnostics).

1.62

“Competitive Activities” has the meaning set forth in Section 2.8.1 (Exclusivity Covenant).

1.63

“Competitive Product” means [****] other than a Licensed Product, that [****].

1.64

“Confidential Information” means (a) Know-How and any technical, scientific, trade, research, manufacturing, business, financial, marketing, product, supplier, intellectual property, and other non-public or proprietary data or information (including unpublished patent applications) that may be disclosed by one Party or its Affiliates to the other Party or its Affiliates pursuant to this Agreement (including information disclosed prior to the Effective Date pursuant to the Confidentiality Agreement), regardless of whether such information is specifically marked or designated as confidential and regardless of whether such information is in written, oral, electronic, or other form, and (b) the terms of this Agreement. Information of a Disclosing Party will not be Confidential Information of such Disclosing Party to the extent that the Receiving Party can demonstrate through competent evidence that such information:

(a)

is known by the Receiving Party or any of its Affiliates without an obligation of confidentiality at the time of its receipt from the Disclosing Party, and not through a prior disclosure by or on behalf of the Disclosing Party, as documented by the Receiving Party’s business records;

(b)

is generally available to the public before its receipt from the Disclosing Party;

(c)

became generally available to the public or otherwise part of the public domain after its disclosure by the Disclosing Party and other than through any act or omission of the Receiving Party or any of its Affiliates or discloses in breach of this Agreement;

(d)

is subsequently disclosed to the Receiving Party or any of its Affiliates without obligation of confidentiality by a Third Party who may rightfully do so and is not under a conflicting obligation of confidentiality to the Disclosing Party; or

(e)

is developed by the Receiving Party or any of its Affiliates independently and without use of or reference to any Confidential Information received from the Disclosing Party, as documented by the Receiving Party’s business records.

1.65

“Confidentiality Agreement” means the Confidential Disclosure Agreement dated [****] by and between the Parties.

1.66

“Continuing Know-How Transfer” has the meaning set forth in Section 4.3 (Continuing Know-How Transfer).

1.67

“Control” or “Controlled” means the possession by a Party (whether by ownership, license, or otherwise other than pursuant to this Agreement) of, (a) with respect to any tangible Know-How, the legal authority or right to physical possession of such tangible Know-How, with the right to provide such tangible Know-How to the other Party on the terms set forth herein, or (b) with respect to Patent Rights, Regulatory Approvals, Regulatory Submissions, intangible Know-How, or other intellectual property rights, the legal authority or right to grant a license, sublicense, access, or right to reference or use (as applicable) to the other Party under such Patent Rights, Regulatory Approvals, Regulatory Submissions, intangible Know-How, or other intellectual property rights on

1.68

“Controlling Party” has the meaning set forth in Section 14.3.2(a)(ii) (Enforcement Rights; Zai First Right).

1.69

“Cover” means, with respect to a particular subject matter at issue and a relevant Patent Right, that the manufacture, use, sale, offer for sale, or importation of such subject matter would fall within the scope of a claim in such Patent Right.

1.70

[****]

1.71

“CRO” means a contract research organization.

1.72

“Data Breach” has the meaning set forth in Section 12.5.2.

1.73

“Debarred/Excluded” means any Person becoming debarred or suspended under 21 U.S.C. §335(a) or (b), the subject of a conviction described in Section 306 of the FD&C Act, excluded, or having previously been excluded, from a federal or governmental health care program, debarred from federal contracting, convicted of or pled nolo contendere to any felony, or to any federal or state legal violation (including misdemeanors) relating to prescription drug products or fraud, the subject to OFAC sanctions or on the OFAC list of specially designated nationals, or the subject of any similar sanction of any Governmental Authority in the Territory.

1.74

“Deficient Site” has the meaning set forth in Section 5.14.2 (Deficient Sublicensees or Sites and Replacement).

1.75

“Development” means all internal and external research, development, and regulatory activities related to pharmaceutical or biologic products, including (a) research, non-clinical testing, toxicology, testing and studies, non-clinical and preclinical activities, and Clinical Trials, (b) preparation, submission, review, and development of data or information (or reports relating thereto and analysis and review of such reports) for the purpose of reviewing the progress and status of the activities under subsection (a) or for the purposes of submission to a Regulatory Authority to obtain authorization to conduct Clinical Trials and to obtain, support, or maintain Regulatory Approval of a pharmaceutical or biologic product, but excluding activities directed to Manufacturing, Medical Affairs, or Commercialization, and (c) the design of future studies, non-

1.76

“Development Milestone Events” has the meaning set forth in Section 10.2.1 (Development Milestone Events and Payments).

1.77

“Development Milestone Payments” has the meaning set forth in Section 10.2.1 (Development Milestone Events and Payments).

1.78

“Development Subcontractor” has the meaning set forth in Section 2.2.3 (Right to Subcontract).

1.79

“Disclosing Party” has the meaning set forth in Section 11.1.1 (Duty of Confidence).

1.80

“Dispute” has the meaning set forth in Section 16.1 (General).

1.81

“Dollar” means the U.S. dollar, and “$” will be interpreted accordingly.

1.82

“Effective Date” has the meaning set forth in the Preamble.

1.83

“EGFR” means epidermal growth factor receptor.

1.84

“Examined Party” has the meaning set forth in Section 10.11 (Financial Records and Audits).

1.85

“Excess Enrollment Reimbursement” has the meaning set forth in Section 5.2.3 (Enrollment of Additional Patients).

1.86

“Executive Officers” has the meaning set forth in Section 3.6.3 (Decisions of the JSC).

1.87

“Exploit” means to make, have made, use, offer to sell, sell, import, export, Develop, Manufacture, perform Medical Affairs activities, or Commercialize. “Exploitation” will be construed accordingly.

1.88

“FD&C Act” means the United States Federal Food, Drug and Cosmetic Act, as amended from time to time, together with any rules, regulations, and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).

1.89

“FDA” means the United States Food and Drug Administration or any successor entity thereto having essentially the same function.

1.90

“Field” means the prevention, treatment, and diagnosis of any indications in humans.

1.91

“First Commercial Sale” means, with respect to any Licensed Product in any country or region, the first sale of such Licensed Product to a Third Party for distribution, use, or consumption in such

1.92

“FTE” means the equivalent of the work of one duly qualified employee of a Party full time for one year (consisting of a total of [****] per year) carrying out Development, Manufacturing, Medical Affairs activities, or other scientific or technical work under this Agreement.  Overtime and work on weekends, holidays, and the like, in each case, will not be counted with any multiplier (e.g., time-and-a-half or double time) toward the number of hours that are used to calculate the FTE contribution.  The portion of an FTE billable by a Party for one individual during a given accounting period will be determined by dividing the number of hours worked directly by such individual on the work to be conducted under this Agreement during such accounting period and the number of FTE hours applicable for such accounting period based on [****] per Calendar Year.

1.93

“FTE Rate” means the amount for an FTE per Calendar Year, which for the Calendar Year ending on December 31, 2021 will be [****].

1.94

“Fully Burdened Manufacturing Cost” means, with respect to any Blueprint Compound, Licensed Product, or any Zai Product (or component thereof), in each case, supplied by or on behalf of the applicable Party to the other Party or its Affiliates hereunder:

(a)

if and to the extent such Blueprint Compound, Licensed Product, or Zai Product (or any precursor or intermediate thereof), as applicable, is Manufactured by a Third Party manufacturer, (i) the actual Third Party costs of such Manufacturing incurred by the supplying Party, including the costs [****]; and

(b)

if and to the extent such Blueprint Compound, Licensed Product, or Zai Product (or any precursor or intermediate thereof), as applicable, is Manufactured by a Party or its Affiliate, the actual, fully burdened costs [****], including the cost of [****]  Such fully burdened costs will be calculated in accordance with applicable Accounting Standards, consistently applied.

1.95

“GAAP” means United States generally accepted accounting principles, consistently applied.

1.96

“GCP” means all applicable good clinical practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of Clinical Trials, including, as applicable (a) as set forth in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Harmonized Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) (the “ICH Guidelines”) and any other guidelines for good clinical practice for trials on medicinal products in the Territory, (b) the Declaration of Helsinki (2004) as last amended at the 52^nd World Medical Association in October 2000 and any further amendments or clarifications thereto, (c) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards), and 312 (Investigational New Drug Application), as may be amended from time to time, and (d) the equivalent Applicable Law in the region in the Territory, each as may be amended and applicable from time to time and in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjects.

1.97

[****]

1.98

“Global Brand Elements” has the meaning set forth in Section 14.9.1 (Global Brand Elements).

1.99

“Global Brand Strategy” has the meaning set forth in Section 9.2 (Commercialization Plan).

1.100

“Global Clinical Trial” means a Clinical Trial for a Licensed Product the data from which, at the time of commencement, is intended to be used to obtain Regulatory Approval both inside the Territory and in any of the following: [****].

1.101

“Global Development Plan” has the meaning set forth in Section 5.1 (Global Development Plan).

1.102

“GLP” means all applicable good laboratory practice standards, including, as applicable, as set forth in the then-current good laboratory practice standards promulgated or endorsed by the U.S. Food and Drug Administration, as defined in 21 C.F.R. Part 58, and the equivalent Applicable Law in the region in the Territory, each as may be amended and applicable from time to time.

1.103

“Governmental Authority” means any federal, national, state, provincial, or local government, or political subdivision thereof, or any multinational organization or any authority, agency, regulatory body, or commission entitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power, or any court or tribunal (or any department, bureau or division of any of the foregoing, or any governmental arbitrator or arbitral body).  Governmental Authorities include all Regulatory Authorities.

1.104

[****]

1.105

“ICC” has the meaning set forth in Section 16.3.1 (Rules).

1.106

“ICH Guidelines” has the meaning set forth in Section 1.96 (GCP).

1.107

“IDL” has the meaning set forth in Section 1.131 (Marketing Authorization Application or MAA).

1.108

“IFRS” means International Financial Reporting Standards, consistently applied.

1.109

“IND” means an Investigational New Drug application required pursuant to 21 C.F.R. Part 312 or any comparable filings outside of the U.S. required to commence human clinical trials in such country or region (such as an application for a Clinical Trial Authorization in the Territory), and all supplements or amendments that may be filed with respect to the foregoing.

1.110

“Indemnified Party” has the meaning set forth in Section 13.3 (Indemnification Procedure).

1.111

“Indemnifying Party” has the meaning set forth in Section 13.3 (Indemnification Procedure).

1.112

“Indication” means [****] that a Licensed Product is [****] in the indication section of the Approved Labeling for such Licensed Product, or that is the subject of a Clinical Trial and where it is [****]

1.113

“Initial Know-How Transfer” has the meaning set forth in Section 4.1 (Initial Know-How Transfer).

1.114

“Invention” means any process, method, composition, article of manufacture, discovery, or finding that is conceived or reduced to practice (whether or not patentable).

1.115

“Joint Collaboration Know-How” means (a) Blueprint/Zai Combination Know-How, and (b) other Collaboration Know-How, excluding any Assigned Collaboration Know-How, developed or invented jointly by a Party’s or its Affiliates’, licensees’, Sublicensees’, or Subcontractors’

1.116

“Joint Collaboration Patent Rights” means all Collaboration Patent Rights that Cover Joint Collaboration Know-How, including Blueprint/Zai Combination Patent Rights.

1.117

“Joint Collaboration Technology” means the Joint Collaboration Know-How and the Joint Collaboration Patent Rights.

1.118

“JPT” has the meaning set forth in Section 3.3 (Joint Project Teams).

1.119

“JPT Chairperson” has the meaning set forth in Section 3.3.1 (Formation; Composition; Meetings).

1.120

“JSC” has the meaning set forth in Section 3.2.1 (Formation).

1.121

“JSC Chairperson” has the meaning set forth in Section 3.2.1 (Formation).

1.122

“Know-How” means any information and materials, including records, discoveries, improvements, modifications, processes, techniques, methods, assays, chemical or biological materials, designs, protocols, formulas, data (including physical data, chemical data, toxicology data, animal data, raw data, clinical data, and analytical and quality control data), dosage regimens, control assays, product specifications, marketing, pricing and distribution costs, Inventions, algorithms, technology, forecasts, profiles, strategies, plans, results in any form whatsoever, know-how and trade secrets (in each case, whether or not patentable, copyrightable or otherwise).

1.123

“Knowledge” means [****] of (a) with respect to Blueprint, [****] and (b) with respect to Zai, [****].

1.124

“Licensed Product” means any product containing a Blueprint Compound as an Active Ingredient, in any form, formulation, dosage form, or method of delivery[****].  [****]

1.125

“Listing Patents” has the meaning set forth in Section 14.6 (Patent Listings).

1.126

“Local Manufacturing Approval” means receipt of all approvals and authorizations necessary for Zai or its Affiliate or their respective CMOs to Manufacture a particular Licensed Product in a particular region in the Territory (including after validation and qualification of Zai’s or such Affiliate’s or CMO’s applicable facilities in the Territory).

1.127

“Losses” means damages, debts, obligations, and other liabilities, losses, claims, taxes, interest obligations, deficiencies, judgments, assessments, fines, fees, penalties, or expenses (including amounts paid in settlement, interest, court costs, costs of investigators, reasonable fees and expenses of attorneys, accountants, financial advisors, consultants, and other experts, and other expenses of litigation).

1.128

“Manufacture” means activities directed to manufacturing, processing, packaging, labeling, filling, finishing, assembly, shipping, storage, or freight of any pharmaceutical or biologic product (or any

1.129

“Manufacturing Technology Transfer” means the transfer of the Blueprint Manufacturing Know-How related to a Blueprint Compound and Licensed Products containing such Blueprint Compound in accordance with the Manufacturing Technology Transfer Plan for such Blueprint Compound, which includes the provision of any technical assistance to enable the Manufacture of such Licensed Products [****].

1.130

“Manufacturing Technology Transfer Plan” means, for each Blueprint Compound, the plan for the transfer to Zai and its designees of Blueprint Manufacturing Know-How for the Licensed Products that include such Blueprint Compound, which plan, among other things, will set forth [****].

1.131

“Marketing Authorization Application” or “MAA” means any new drug application, biologics license application, or other marketing authorization application, in each case, filed with the applicable Regulatory Authority in a country or other regulatory jurisdiction, which application is required to commercially market or sell a pharmaceutical or biologic product in such country or jurisdiction (and any amendments thereto).  In the context of imported drugs, MAA is also known as the Import Drug License (“IDL”) application.

1.132

“Medical Affairs” means activities conducted by a Party’s medical affairs departments (or, if a Party does not have a medical affairs department, the equivalent function thereof), including communications with key opinion leaders, medical education, symposia, advisory boards (to the extent related to medical affairs or clinical guidance), activities performed in connection with patient registries, and other medical programs and communications, including educational grants, research grants (including conducting investigator-initiated studies), and charitable donations to the extent related to medical affairs and not to other activities that do not involve the promotion, marketing, sale, or other Commercialization of the Licensed Products and are not conducted by a Party’s medical affairs (or equivalent) departments.

1.133

“Medical Affairs Plan” means, with respect to a Licensed Product, [****] for the Medical Affairs activities for such Licensed Product to be conducted in the Territory, which plan will include medical information that Zai will provide in the Territory, including [****] that will be prepared and updated by Zai as provided in Section 8.1 (Medical Affairs Plans).

1.134

“Milestone Events” has the meaning set forth in Section 10.2.3(a) (Notification of Milestone Events).

1.135

“Milestone Payments” has the meaning set forth in Section 10.2.3(a) (Notification of Milestone Events).

1.136

“Net Sales” means with respect to a Licensed Product, the gross amount [****] by Zai and its Affiliates and Sublicensees (each of the foregoing, a “Seller”) to independent, unrelated persons (including Third Party Distributors) (“Buyers”) in bona fide arm’s length transactions with respect

(a)

[****]

(b)

[****]

(c)

[****]

(d)

[****]

(e)

[****]

(f)

[****].

1.137

“New Affiliate” has the meaning set forth in Section 2.8.3 (New Affiliate Exception).

1.138

“New Combination” has the meaning set forth in Section 5.9 (New Development Proposed by Zai).

1.139

“New Development Activities” has the meaning set forth in Section 5.9 (New Development Proposed by Zai).

1.140

“New Development Proposal” has the meaning set forth in Section 5.9 (New Development Proposed by Zai).

1.141

“New Indication” has the meaning set forth in Section 5.9 (New Development Proposed by Zai).

1.142

[****]

1.143

“New Territory-Specific Development Activities” has the meaning set forth in Section 5.9.1(a) (JSC Approval).

1.144

“NMPA” means the National Medical Products Administration of the PRC, and local counterparts thereto, and any successor agency or authority thereto having substantially the same function.

1.145

“Non-Clinical Development” means all Development excluding Clinical Development.

1.146

“Non-Funding Party” has the meaning set forth in Section 5.8.1(a) (JSC Approval).

1.147

“NSCLC” means non-small cell lung cancer.

1.148

“OFAC” means the Office of Foreign Assets Control of the United States Department of the Treasury or any successor agency thereto.

1.149

“Other Extensions” has the meaning set forth in Section 14.7 (Patent Term Extensions).

1.150

“Party” or “Parties” has the meaning set forth in the Preamble.

1.151

“Patent Challenge” has the meaning set forth in Section 15.2.3 (Termination for Patent Challenge).

1.152

“Patent Prosecution” means activities directed to (a) preparing, filing, or prosecuting applications (of all types) for any Patent Right, (b) maintaining any Patent Right, or (c) deciding whether to abandon or maintain any Patent Right.

1.153

“Patent Rights” means (a) all patents and patent applications in any country or region, (b) all patent applications filed either from such patents or patent applications or from an application claiming priority from any of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals, and continued prosecution applications, (c) any and all patents that have

1.154

“Patent Term Adjustment” has the meaning set forth in Section 14.7 (Patent Term Extensions).

1.155

“Patent Term Extension” has the meaning set forth in Section 14.7 (Patent Term Extensions).

1.156

“Patient Commitment” has the meaning set forth in Section 5.2.1 (Enrollment in Committed Trials).

1.157

“Paying Party” has the meaning set forth in Section 10.12.2 (Tax Cooperation).

1.158

“Permitted Zai Non-Clinical Development” has the meaning set forth in Section 5.7 (Non-Clinical and Preclinical Studies).

1.159

“Person” means any corporation, limited or general partnership, limited liability company, joint venture, joint stock company, trust, unincorporated association, governmental body, authority, bureau, or agency, or any other entity or body, or an individual.

1.160

“Personal Information” means information related to a reasonably identifiable natural person.

1.161

“Phase I Clinical Trial” means a clinical trial in humans that is generally consistent with 21 C.F.R. § 312.21(a), as amended (or its successor regulation), or, with respect to any other country or region, the equivalent of such a clinical trial in such other country or region.

1.162

“Phase II Clinical Trial” means a clinical trial in humans that is generally consistent with 21 C.F.R. § 312.21(b), as amended (or its successor regulation), or, with respect to any other country or region, the equivalent of such a clinical trial in such other country or region.

1.163

“Phase III Clinical Trial” means a clinical trial in humans of a pharmaceutical or biologic product (including any Combination Regimen) that is generally consistent with 21 C.F.R. § 312.21(c), as amended (or its successor regulation), or, with respect to any other country or region, the equivalent of such a clinical trial in such other country or region.

1.164

“Pivotal Trial” means any (a) [****] or (b) [****] in humans of a pharmaceutical or biologic product (including any Combination Regimen), the results of which, together with prior data and information concerning such product, are [****] in any particular jurisdiction and that is intended to support, or otherwise supports, the filing of an MAA in such jurisdiction (including any bridging study).

1.165

“POC Trial” means a clinical trial [****] in humans of a pharmaceutical or biologic product (including any Combination Regimen) performed to [****] of such product and that [****].

1.166

“PRC” means the People’s Republic of China, which, for purposes of this Agreement, does not include Hong Kong Special Administrative Region, Macau Special Administrative Region, or Taiwan.

1.167

“PRC Submission Estimated Timeline” means, for each Licensed Product, a written timeline setting forth the estimated dates of achievement of key regulatory milestones and submission to

1.168

“Preapproved Subcontractor” means any Subcontractor that the JSC has approved as a Subcontractor that Zai may engage to perform its obligations or exercise its rights under this Agreement as further described in Section 2.2.3 (Right to Subcontract).

1.169

“Privacy Laws” has the meaning set forth in Section 12.5.2.

1.170

“Product Infringement” has the meaning set forth in Section 14.3.1 (Patent Enforcement; Notice).

1.171

“Product Marks” has the meaning set forth in Section 14.9.1 (Global Brand Elements).

1.172

“Proposed Blueprint/Zai Combination” has the meaning set forth in Section 5.8.1 (Proposed Blueprint/Zai Combinations).

1.173

“Prosecuting Party” has the meaning set forth under Section 14.2.3(a) (Blueprint/Zai Combination Technology).

1.174

“Public Official” means (a) any officer, employee or representative of any regional, federal, state, provincial, county or municipal government or government department, agency or other division; (b) any officer, employee or representative of any commercial enterprise that is owned or controlled by a government, including any state-owned or controlled veterinary, laboratory or medical facility; (c) any officer, employee or representative of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank; and (d) any person acting in an official capacity for any government or government entity, enterprise, or organization identified above.

1.175

“Publication” has the meaning set forth in Section 11.5 (Publications).

1.176

“Receiving Party” has the meaning set forth in Section 11.1.1 (Duty of Confidence).

1.177

“Recipient” has the meaning set forth in Section 10.12.2 (Tax Cooperation).

1.178

“Regulatory Approval” means, with respect to a particular country or other regulatory jurisdiction, any approval of an MAA or other approval, product, or establishment license, registration, permit, or authorization of any Regulatory Authority necessary for the commercial marketing or sale of a pharmaceutical or biologic product in such country or other regulatory jurisdiction, excluding, in each case, Reimbursement Approval.

1.179

“Regulatory Authority” means any applicable Governmental Authority with jurisdiction or authority over the Development, Manufacture, Commercialization, or other Exploitation (including Regulatory Approval or Reimbursement Approval) of pharmaceutical or biologic products in a particular country or other regulatory jurisdiction, including the NMPA, and any corresponding national or regional regulatory authorities.

1.180

“Regulatory Exclusivity” means any exclusive marketing rights or data protection or other exclusivity rights conferred by any Regulatory Authority with respect to a pharmaceutical or biologic product in a particular country or other regulatory jurisdiction that prohibits a Person from Commercializing [****].

1.181

[****]

1.182

“Regulatory Submissions” means any filing, application, or submission with any Regulatory Authority in support of Developing, Manufacturing, or Commercializing a pharmaceutical or biologic product (including to obtain, support, or maintain Regulatory Approval from that Regulatory Authority), and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences, or discussions with the relevant Regulatory Authority.  Regulatory Submissions include all INDs, MAAs, and other applications for Regulatory Approval and their equivalents.

1.183

“Reimbursement Approval” means an approval, agreement, determination, or other decision by the applicable Governmental Authority that establishes prices charged to end-users for pharmaceutical or biologic products at which a particular pharmaceutical or biologic product will be reimbursed by the Regulatory Authorities or other applicable Governmental Authorities in the Territory.

1.184

“Replacement Site” has the meaning set forth in Section 5.14.2 (Deficient Sublicensees or Sites and Replacement).

1.185

“Review Period” has the meaning set forth in Section 11.5 (Publications).

1.186

“Royalty Estimate” has the meaning set forth in Section 10.3.4 (Royalty Reports and Payments).

1.187

“Royalty Patent Rights” means the Blueprint Patent Rights, Blueprint Manufacturing Patent Rights, and the Joint Collaboration Patent Rights.

1.188

“Royalty Payments” has the meaning set forth in Section 10.3.1 (Royalty Rates).

1.189

“Royalty Report” has the meaning set forth in Section 10.3.4 (Royalty Reports and Payments).

1.190

“Royalty Term” has the meaning set forth in Section 10.3.2 (Royalty Term).

1.191

“Rules” has the meaning set forth in Section 16.3.1 (Arbitration; Rules).

1.192

“Safety Agreement” has the meaning set forth in Section 6.5.1 (Adverse Events Reporting; Safety Agreements).

1.193

“Sales Milestone Events” has the meaning set forth in Section 10.2.2 (Sales Milestone Events and Payments).

1.194

“Sales Milestone Payments” has the meaning set forth in Section 10.2.2 (Sales Milestone Events and Payments).

1.195

“Scientific Officers” has the meaning set forth in Section 2.8.2 (Competitive Product Disputes).

1.196

“Seller” has the meaning set forth in Section 1.136 (Net Sales).

1.197

“Shared Services Costs” means [****] 1.197 [****].

1.198

[****] has the meaning set forth in Section 5.2.2 [****].

1.199

“Subcontractor” means a Third Party contractor engaged by a Party to perform certain obligations or exercise certain rights of such Party under this Agreement on a fee-for-service basis (including CROs and CMOs).

1.200

“Sublicensee” means any Person, excluding any Subcontractor or Third Party Distributor, (a) with respect to Zai, to whom Zai grants a sublicense of, or other authorization or permission granted under, the rights granted to Zai in Section 2.1 (License Grants to Zai), and (b) with respect to Blueprint, to whom Blueprint grants a sublicense of, or other authorization or permission granted under, the rights granted to Blueprint in Section 2.3 (License Grants to Blueprint).

1.201

“Tax” or “Taxes” means any present or future taxes, levies, imposts, duties, charges, assessments or fees of any nature (including any interest thereon), including value add taxes (“VAT”).

1.202

“Technology Transfer” has the meaning set forth in Section 4.3 (Continuing Know-How Transfer).

1.203

“Term” has the meaning set forth in Section 15.1 (Term).

1.204

“Territory” means the PRC, Hong Kong Special Administrative Region, Macau Special Administrative Region, and Taiwan, each of which will be deemed a separate region for purposes of this Agreement.

1.205

“Territory Sponsor” means, with respect to a Territory-Specific Clinical Trial or a Global Clinical Trial for a Licensed Product to be conducted at sites in the Territory, the Party that holds the IND from the applicable Regulatory Authority in the Territory for such Clinical Trial in its name.

1.206

“Territory-Specific Clinical Trial” means a Clinical Trial for a Licensed Product, the data from which at the time of commencement is intended to be used to obtain, support, or maintain Regulatory Approval in the Territory but not to obtain, support, or maintain Regulatory Approval in any of the following: [****].

1.207

“Territory-Specific Development Plans” has the meaning set forth in Section 5.4 (Territory-Specific Development Plans).

1.208

“Third Party” means any Person other than a Party or an Affiliate of a Party.

1.209

“Third Party Claims” means collectively, any and all Third Party demands, claims, actions, suits, and proceedings (whether criminal or civil, in contract, tort, or otherwise).

1.210

“Third Party Distributor” means any Third Party that purchases Licensed Product from Zai or its Affiliates, or Sublicensees, takes title to such Licensed Product, and distributes such Licensed Product directly to customers, but does not Develop or Manufacture any Blueprint Compound or Licensed Product and does not make any royalty, profit-share, or other payment to Zai or its Affiliates or Sublicensees, other than payment for the purchase of Licensed Products for resale.

1.211

“Third Party IP Agreement” means any agreement with a Third Party entered into by Blueprint or Zai respect to a grant of rights under any Blueprint Identified Rights or Zai Identified Rights.

1.212

“United States” or “U.S.” means the United States of America and its territories and possessions.

1.213

“Upfront Payment” has the meaning set forth in Section 10.1 (Upfront Payment).

1.214

“Valid Claim” means with respect to a particular country or region, a claim in any (a) unexpired and issued Patent Right that has not been irretrievably lapsed or been abandoned, disclaimed, permanently revoked, dedicated to the public, or held invalid, unenforceable, or not patentable by a final non-appealable decision of a court of competent jurisdiction or Governmental Authority in such country or region, or (b) pending patent application that has been pending for [****]; provided that, if a claim ceases to be a Valid Claim by reason of foregoing subclause (b), then such claim would again be deemed a Valid Claim in the event such claim subsequently issues prior to the end of the then-current Royalty Term in such country or region.

1.215

“VAT” has the meaning set forth in Section 1.201 (Tax).

1.216

“VAT Credit” has the meaning set forth in Section 10.13 (VAT Credits).

1.217

“Working Group” has the meaning set forth in Section 3.4 (Working Groups).

1.218

“Zai” has the meaning set forth in the Preamble.

1.219

“Zai Collaboration Know-How” means Collaboration Know-How, other than Blueprint/Zai Combination Know-How or Assigned Collaboration Know-How, developed or invented solely by Zai’s or its Affiliates’, licensees’, Sublicensees’, or Subcontractors’ employees, agents, or independent contractors, or any Persons that are contractually required to assign or license such Collaboration Know-How (or Patent Rights Covering such Know-How) to Zai or any Affiliate of Zai, in each case, in the performance of activities under this Agreement during the Term.

1.220

“Zai Collaboration Patent Rights” means all Collaboration Patent Rights that Cover Zai Collaboration Know-How. For clarity, Zai Collaboration Patent Rights do not include any Blueprint/Zai Combination Patent Rights or Assigned Collaboration Patent Rights.

1.221

“Zai Collaboration Technology” means Zai Collaboration Know-How and Zai Collaboration Patent Rights.

1.222

“Zai Identified General Rights” has the meaning set forth in Section 2.6.2 (Zai Identified Rights).

1.223

“Zai Identified Rights” has the meaning set forth in Section 2.6.2 (Zai Identified Rights).

1.224

“Zai Indemnitee(s)” has the meaning set forth in Section 13.2 (By Blueprint).

1.225

“Zai In-Licensed Rights” has the meaning set forth in Section 2.6.2 (Zai Identified Rights).

1.226

“Zai Know-How” means, subject to Section 2.6.6 (Right to Decline Zai In-Licensed Rights), all Know-How (excluding Zai’s interest in Blueprint/Zai Combination Know-How and other Joint Collaboration Know-How) that is (a) Controlled by Zai or any of its Affiliates as of the Effective Date or during the Term, and (b) used by either Party in the Exploitation of a Blueprint Compound or a Licensed Product, including all Zai Collaboration Know-How.

1.227

“Zai Patent Rights” means, subject to Section 2.6.6 (Right to Decline Zai In-Licensed Rights), all Patent Rights (excluding Zai’s interest in Blueprint/Zai Combination Patent Rights and other Joint Collaboration Patent Rights) that are (a) Controlled by Zai or any of its Affiliates as of the Effective Date or during the Term; and (b) practiced by either Party in the Exploitation of a Blueprint Compound or a Licensed Product, including all Zai Collaboration Patent Rights.

1.228

“Zai Product” means any pharmaceutical or biologic product with respect to which Zai or any of its Affiliates has exclusive rights to Exploit inside the Territory or outside of the Territory, including all forms, modifications, and variants thereof that are Controlled by Zai, in each case, at the time that the JSC agrees in writing to include a Blueprint/Zai Combination containing such Zai Product under this Agreement pursuant to Section 5.8.1 (Proposed Blueprint/Zai Combinations) or Section 5.9 (New Development Proposed by Zai).

1.229

“Zai Publication” has the meaning set forth in Section 11.5.1.

1.230

“Zai Specifications” has the meaning set forth in Section 7.2.3 (Specifications).

1.231

“Zai Technology” means Zai Know-How, Zai Patent Rights, and Zai’s interest in the Joint Collaboration Technology.

1.232

“Zai Third Party IP Agreement” has the meaning set forth in Section 2.6.6(b) (Right to Decline Zai In-Licensed Rights).

2.1

License Grants to Zai.

2.1.1

In the Territory.  Subject to the terms of this Agreement, Blueprint hereby grants to Zai (a) an exclusive, royalty-bearing license, with the right to grant sublicenses solely in accordance with Section 2.2 (Sublicensing and Subcontractors), under the Blueprint Technology to Exploit (other than to conduct or have conducted Non-Clinical Development, or Manufacture or have Manufactured) the Blueprint Compounds and the Licensed Products in the Field in the Territory in accordance with the Territory-Specific Development Plans, Global Development Plans, the Medical Affairs Plans, and the Commercialization Plans or as otherwise expressly permitted by this Agreement and (b) a non-exclusive, royalty-bearing license, with the right to grant sublicenses solely in accordance with Section 2.2 (Sublicensing and Subcontractors), under the Blueprint Technology to [****] in the Field in the Territory. Zai will not practice the Blueprint Technology licensed to Zai under this Section 2.1.1 (In the Territory) except as expressly set forth in the Territory-Specific Development Plans, Global Development Plan, Medical Affairs Plans, and Commercialization Plans or to conduct other activities expressly permitted under this Agreement. Notwithstanding any provision to the contrary set forth in this Agreement, [****].

2.1.2

Manufacturing License. Subject to the terms of this Agreement, effective upon the commencement of the Manufacturing Technology Transfer to Zai for the Manufacture of the Licensed Products in accordance with Section 7.2.2 (Clinical and Commercial Supply), Blueprint hereby grants to Zai [****] in accordance with and subject to the terms of this Agreement, including pursuant to Section 7.2 (Supply by Zai). Zai will not practice the Blueprint Manufacturing Technology licensed to Zai under this Section 2.1.2 (Manufacturing License) until the commencement of the Manufacturing Technology Transfer to Zai for the Manufacture of the Licensed Products in accordance with Section 7.2.2 (Clinical and Commercial Supply).

2.2

Sublicensing and Subcontractors.

2.2.1

Right to Sublicense.  Subject to the terms of this Agreement, Zai will have the right to grant sublicenses of the rights granted under Section 2.1 (License Grants to Zai) to (a) its Affiliates, provided that any such sublicense will automatically terminate if such Person ceases to be an Affiliate of Zai, (b) Development Subcontractors and Third Party Distributors in accordance with this Section 2.2 (Sublicensing and Subcontractors), and (c) subject to Blueprint’s prior written approval, not to be unreasonably withheld, conditioned, or delayed, Third Parties (other than Development Subcontractors and Third Party Distributors).  Notwithstanding the foregoing, Zai will not grant a sublicense to a Third Party of all or substantially all of Zai’s rights or obligations under this Agreement with respect to one or more regions within the Territory without Blueprint’s prior written consent, which consent Blueprint may withhold, condition, or delay in its sole discretion.  Each Sublicensee will hold its rights contingent on the rights licensed to Zai under the terms of this Agreement.  Any termination of the licenses granted to Zai under Section 2.1 (License Grants to Zai) as a result of a termination of this Agreement with respect to one or more Licensed Products or in its entirety will, subject to Section 15.3.11 (Sublicense Survival), cause the Sublicensees to automatically lose the same rights under any sublicense.

2.2.2

Terms of Sublicenses to Third Parties.  Zai will provide prior written notice to Blueprint identifying its intention to grant a sublicense under Section 2.2.1 (Right to Sublicense) to any Third Party (other than a sublicense granted by Zai to a Development Subcontractor or Third Party Distributor; provided that such engagement is otherwise in accordance with Section 2.2.3 (Right to Subcontract)), the purpose of such sublicense, and the identity of the Third Party to whom Zai intends to grant such sublicense.  Each sublicense to a Third Party will be granted under a written agreement that is consistent with the terms of this Agreement and that (a) requires each such Third Party Sublicensee to which Zai grants a sublicense of the rights granted to Zai under Section 2.1 (License Grants to Zai) to comply with the terms of this Agreement that are applicable to such sublicense (including obligations of confidentiality and non-use at least as stringent as those set forth Article 11 (Confidentiality; Publication), as applicable, the Milestone Event and Royalty Payment reporting obligations set forth under Section 10.2 (Milestone Payments) and Section 10.3 (Royalty Payments to Blueprint), the record keeping and audit requirements set forth under Section 5.14 (Clinical Trial Audit Rights), Section 10.11 (Financial Records and Audits), and the intellectual property provisions set forth in Article 14 (Intellectual Property)), and (b) precludes the granting of further sublicenses in contravention with the terms of this Agreement.  Without limiting the generality of the foregoing, each sublicense agreement with such a Third Party entered into after the Effective Date must include (i) [****], (ii) [****], and (iii) [****].

2.2.3

Right to Subcontract.  Zai will not propose the engagement of any Subcontractor that is Debarred/Excluded.  Zai may engage (a) Subcontractors solely to perform Zai’s Development activities with respect to Licensed Products under this Agreement on Zai’s behalf (each a “Development Subcontractor”) or (b) Third Party Distributors to distribute Licensed Products in the Territory on behalf of Zai, in either case, without Blueprint’s prior written consent, but subject to the requirements set forth in the first, the second to last, and the last sentence of this Section 2.2.3 (Right to Subcontract), Section 2.2.4 (Notices of Sublicensing and Subcontractors), Section 2.2.5 (Zai Audits of Sublicensees and Subcontractors), and Section 2.2.6 (Responsibility for Sublicensees and Subcontractors). Prior to Zai’s engagement of the first Subcontractor (other than a Development Subcontractor or Third Party Distributor), Zai will provide to the JSC to review, discuss, and determine whether to approve as Preapproved Subcontractors a list

2.2.4

Notice of Sublicenses and Subcontracts.  Zai will provide Blueprint with a true and complete copy of each sublicense or subcontracting agreement (including all schedules, exhibits, and appendices thereto) with any Third Party (including any Development Subcontractor or Third Party Distributor) within [****] after it becomes effective[****]  Any sublicense granted under this Agreement must either be in English or [****].

2.2.5

Zai Audits of Sublicensees and Subcontractors.  Zai will provide Blueprint with copies of all quality oversight or audit reports from audits that Zai (or its agent) has conducted on any Sublicensees or Subcontractors that Zai engages to perform its obligations or exercise its rights under this Agreement with respect to any Licensed Product, as well as all corrective action plans resulting from any such audits, in each case, to the extent such reports and plans are relevant to such Sublicensees or Subcontractors’ performance of such obligations or exercise of such rights no later than [****].

2.2.6

Responsibility for Sublicensees and Subcontractors.  Zai will require that all Sublicensees and Subcontractors perform the activities that they are sublicensed or engaged to perform (as applicable) in accordance with GLP, cGMP, and GCP, as applicable, and otherwise in compliance with Applicable Law. Notwithstanding any sublicense or subcontracting, Zai will remain primarily liable to Blueprint for the

2.3

License Grants to Blueprint.

2.3.1

Development Activities.  Subject to the terms of this Agreement, Zai hereby grants to Blueprint a worldwide, non-exclusive, royalty-free license, with the right to grant sublicenses through multiple tiers, under the Zai Technology to perform the Development activities for the Blueprint Compounds and the Licensed Products in the Field for which it is responsible under a Global Development Plan, including any Global Clinical Trial for a Licensed Product (including a POC Trial or other Development of any Blueprint/Zai Combination approved by the JSC pursuant to Section 5.8.1 (Proposed Combinations)).

2.3.2

Outside of the Territory.  Subject to the terms of this Agreement, Zai hereby grants to Blueprint a perpetual, irrevocable, royalty-free license, with the right to grant sublicenses through multiple tiers, under the Zai Technology to Exploit the Blueprint Compounds and the Licensed Products in the Field outside of the Territory. Such license under this Section 2.3.2 (Outside of the Territory) will be (a) exclusive under the Zai Collaboration Technology and Zai’s interest in the Joint Collaboration Technology and (b) non-exclusive under all other Zai Technology.

2.4

Retained Rights.  Nothing in this Agreement will be interpreted to grant a Party any rights under any intellectual property rights owned or Controlled by the other Party, including Blueprint Technology, Blueprint Manufacturing Technology, Joint Collaboration Technology, or Zai Technology, in each case, that are not expressly granted herein, whether by implication, estoppel, or otherwise. Any rights not expressly granted to Blueprint by Zai under this Agreement are hereby retained by Zai. Any rights not expressly granted to Zai by Blueprint under this Agreement are hereby retained by Blueprint. In addition, Blueprint expressly retains (a) the exclusive right under the Blueprint Technology (on behalf of itself and its licensees and Sublicensees, other than Zai, Zai’s Affiliates and Zai’s Sublicensees) to conduct Non-Clinical Development involving Blueprint Compounds or Licensed Products anywhere in the world (including in the Territory[****]), (b) the right under the Blueprint Technology to perform Development activities for the Blueprint Compounds and the Licensed Products in the Territory in accordance with this Agreement, including to conduct Development activities under a Global Development Plan as provided hereunder (including in the event that Zai declines, through the JSC, to participate in a Global Clinical Trial proposed by Blueprint under Section 5.11 (New Development Proposed by Blueprint) or fails to satisfy the Patient Commitment with respect to one or more Committed Trials), (c) the right under the Blueprint Technology (on behalf of itself and its licensees and Sublicensees, other than Zai, Zai’s Affiliates and Zai’s Sublicensees) to Manufacture Licensed Products in the Territory itself or through its Affiliates or Third Parties (i) for use by Zai and its authorized Sublicensees in the Territory or (ii) for use by Blueprint, or its licensees, Sublicensees, Affiliates or Third Parties outside of the Territory, (d) the right to perform Blueprint’s other obligations under this Agreement, (e) in the event that Zai does not participate in a Global Clinical Trial for one or more Licensed Products in one or more Indications or with respect to one or more Combination Products or Combination Regimens, the non-exclusive right to Develop Blueprint Compounds and Licensed Products through the use of clinical trial sites, CROs, and other Third Parties in the Territory in connection with the performance of such Global Clinical Trials, and (f) the exclusive right to

2.5

Combination Products Rights.  Notwithstanding any other provision of this Agreement, for purposes of the license grants under Section ‎‎2.1 (License Grants to Zai) or Section 2.3 (License Grants to Blueprint), with respect to any Licensed Product that is a Combination Product or Combination Regimen, such license will only include rights with respect to any Blueprint Compound component of such Combination Product or Combination Regimen and not any other Active Ingredient Controlled by, as applicable, the Party granting such license (e.g., with respect to Zai, any Zai Product or with respect to Blueprint, a compound Controlled by Blueprint other than BLU-701 or BLU-945) or any of its Affiliates except in the event that [****].

2.6

Third Party In-Licenses.

2.6.1

Blueprint Identified Rights.  Blueprint will remain solely responsible for the payment of all royalties, license fees, milestone payments, and other payment obligations under all agreements entered into by Blueprint prior to the Effective Date.  If, after the Effective Date during the Term, Blueprint intends to obtain Control of any Know-How or Patent Rights from a Third Party (whether by acquisition or license) that may be necessary or useful to Exploit one or more Blueprint Compounds or Licensed Products in the Field anywhere in the world (other than a Change of Control of Blueprint or as a result of the acquisition by Blueprint of a Third Party by merger, acquisition, or similar transaction or series of related transactions) (such Know-How and Patent Rights, “Blueprint Identified Rights”), then Blueprint will notify Zai in writing of such Blueprint Identified Rights and Section 2.6.3 (Third Party IP Agreements) will apply.

2.6.2

Zai Identified Rights.  If Zai determines that a license under any Know-How or Patent Rights controlled by a Third Party is [****] (“Zai Identified Rights”), then Zai will [****]. Blueprint will have the first right to acquire rights to any such Zai Identified Rights from such Third Party (whether by acquisition or license)[****]. If [****], then Blueprint will notify Zai of such intention within [****] and the terms of Section 2.6.3 (Third Party IP Agreements) will apply. If (a) Blueprint [****] within such [****] period or otherwise [****], or (b) [****], then Zai will have the right to acquire rights under such Zai Identified Rights from such Third Party solely for the Territory or any region therein and any such right obtained by Zai will be referred to as “Zai In-Licensed Rights.”

2.6.3

Blueprint In-Licensed Rights.  Prior to executing a Third Party IP Agreement with a Third Party to acquire or license any Blueprint Identified Rights or Zai Identified Rights (together, “Blueprint In-Licensed Rights”), Blueprint will (a) provide Zai an opportunity to review and comment on [****], including any [****] (b) take Zai’s comments into consideration [****] prior to finalizing such Third Party IP Agreement, and (c) ensure that such Third Party IP Agreement includes [****]. Upon execution of such Third Party IP Agreement, Blueprint will notify Zai in writing and will provide [****].

2.6.4

Responsibility for Costs of Blueprint In-Licensed Rights. Subject to Zai’s right to decline a license or sublicense of Blueprint In-Licensed Rights within [****] in accordance with the terms of Section 2.6.5 (Right to Decline Blueprint In-Licensed Rights), following Blueprint’s execution of the applicable Third Party IP Agreement (a) such Blueprint In-Licensed Rights will be included in the Blueprint Know-How or the

2.6.5

Right to Decline Blueprint In-Licensed Rights.  Zai will have the right to decline a license or sublicense (as applicable) from Blueprint under Blueprint In-Licensed Rights under a Third Party IP Agreement by providing written notice to Blueprint [****].  Upon Blueprint’s [****] receipt of such notice declining such a license or sublicense (as applicable) under any Blueprint In-Licensed Rights, Blueprint will not be deemed to Control such Blueprint In-Licensed Rights, the definitions of Blueprint Patent Rights and Blueprint Know-How will exclude such Blueprint In-Licensed Rights, as applicable, and such Blueprint In-Licensed Rights will not be included in the scope of the rights granted to Zai under Section 2.1 (License Grants to Zai).

2.6.6

Right to Decline Zai In-Licensed Rights; Responsibility for Costs.

(a)

Zai In-Licensed Rights. Prior to executing a Third Party IP Agreement with a Third Party to acquire or license any Zai In-Licensed Rights, Zai will (i) provide Blueprint an opportunity to review and comment on [****], including any [****], (ii) take Blueprint’s comments into consideration [****] prior to finalizing such Third Party IP Agreement, and (iii) ensure that such Third Party IP Agreement includes [****]. Upon execution of such Third Party IP Agreement, Zai will notify Blueprint in writing and will provide [****].

(b)

Right to Decline Zai In-Licensed Rights. Blueprint will have the right to decline a license or sublicense (as applicable) from Zai under Zai In-Licensed Rights by providing written notice to Zai [****] (the “Zai Third Party IP Agreement”) [****].  Upon Zai’s [****] receipt of such notice declining such a license or sublicense (as applicable) under any Zai In-Licensed Rights, Zai will not be deemed to Control such Zai In-Licensed Rights, the definitions of Zai Patent Rights and Zai Know-How will exclude such Zai In-Licensed Rights, as applicable, and such Zai In-Licensed Rights will not be included in the scope of the rights granted to Blueprint under Section 2.3 (License Grants to Blueprint).

(c)

Responsibility for Costs of Zai In-Licensed Rights. Subject to Blueprint’s right to decline a license or sublicense of Zai In-Licensed Rights in accordance with the terms of Section 2.6.6(b) (Right to Decline Zai In-Licensed Rights), following Zai’s execution of the applicable Zai Third Party IP Agreement: (i) such Zai In-Licensed Rights will be included in the Zai Know-How or the Zai Patent Rights (as applicable) and licensed or sublicensed (as applicable) to Blueprint under the licenses granted in Section 2.3 (License

2.7

[****]

2.8

Exclusivity.

2.8.1

Exclusivity Covenant.  Subject to Section 2.8.3 (New Affiliate Exception), during the Term neither Party will, and will ensure that its Affiliates and Sublicensees do not, independently or for or with any Third Party, [****] unless agreed in writing by the Parties (the “Competitive Activities”).

2.8.2

Competitive Product Disputes.  If a Party disputes whether a pharmaceutical or biologic product is a Competitive Product, then the Parties will refer the matter to the head of Research & Development of Zai and Blueprint (or, if a Party does not have a head of Research & Development, its most senior employee having the equivalent responsibilities) or their designees (the “Scientific Officers”). The Scientific Officers will meet [****] to discuss and resolve the matter within [****] after referral of such matter to such Scientific Officers.  If the Scientific Officers cannot agree on a resolution to the matter within such [****] period, then the Parties will refer such matter for resolution to an independent Third Party expert agreed upon by the Parties within [****] after the Scientific Officers failed to resolve such matter.  Such independent Third Party expert will be [****], and unless otherwise agreed in writing by the Parties, must not [****].  Such expert will make its determination as to whether the applicable pharmaceutical or biologic product is a Competitive Product [****]. The Party bringing a dispute pursuant to this Section 2.8.2 (Competitive Product Disputes) will [****] engage such expert and the Parties will share the out-of-pocket costs incurred in connection with the engagement of such expert [****]. Within [****] of the engagement of such expert by the disputing Party, such expert will deliver a written decision to the Parties on the matter as to whether such product is a Competitive Product (including a detailed report as to such expert’s rationale for such decision), and such decision will be binding on the Parties.

2.8.3

New Affiliate Exception. Notwithstanding Section 2.8.1 (Exclusivity Covenant), if (1) a Third Party becomes an Affiliate of a Party during the Term through merger, acquisition, consolidation, Change of Control, or other similar transaction (any such Third Party, a “New Affiliate”) and (2) such New Affiliate, as of the execution date of the definitive agreement with respect to such transaction, is engaged in Competitive Activities with respect to one or more Competitive Products, then:

(a)

If such transaction results in a Change of Control of a Party, then such New Affiliate of such Party (the “Acquiror”) and such Party and their respective Affiliates may continue to perform such Competitive Activities after such Change of Control and such Party will not be in violation of its exclusivity obligations set forth in Section 2.8.1 (Exclusivity Covenant), as long as (i) no Confidential Information of the other Party or Blueprint Technology (if the acquired Party is Zai) or Zai Technology (if the acquired Party is Blueprint) is used by or on behalf of such Party, its Acquiror and their respective Affiliates in connection with any such Competitive Activities, and (ii) such Party, its Acquiror and their respective Affiliates institute commercially reasonable [****] safeguards to ensure the requirements set forth in the foregoing clause (i) are met, including by creating “firewalls” between the personnel working on such Competitive Activities and the personnel teams charged with working on the Blueprint Compounds and Licensed Products hereunder or having access to data from activities performed under this Agreement or to the Confidential Information of the other Party.

(b)

If such transaction does not result in a Change of Control of a Party, then such Party (i) will provide to the other Party [****], (ii) unless the Parties agree otherwise in writing, such Party and its New Affiliate (an “Acquiree”) will take one of the following actions set forth below in clauses (A) or (B) and (iii) no later than [****] following the date of consummation of the relevant acquisition transaction, such Party will notify the other Party of which of the actions in the following clauses (A) or (B), it will pursue:  (A) divest, or cause its Acquiree to divest, whether by license or otherwise, its interest in the program of applicable Competitive Activities; or (B) terminate any further Competitive Activities. If such Party notifies the other Party in writing that it intends to divest the program of applicable Competitive Activities or terminate the performance of the applicable Competitive Activities, then such Party or its Acquiree will effect the consummation of such divestiture within [****] (or such other period as may be required to comply with Applicable Law), or effect such termination of the program of applicable Competitive Activities within [****], in each case, after the closing of the relevant transaction and will confirm to the other Party in writing when it completes such divestiture pursuant to clause (A) or termination pursuant to clause (B). Such Party will keep the other Party reasonably informed of its efforts and progress in effecting such divesture or termination until such Party or its Acquiree completes the same. During such [****] or [****] period, as applicable, such Party and its Acquiree’s and their respective Affiliates’ conduct of such Competitive Activities will not constitute a breach by such Party of its exclusivity obligations set forth in Section 2.8.1 (Exclusivity Covenant), as long as during such period, (I) no Confidential Information of the other Party or Blueprint Technology (if the acquiring Party is Zai) or Zai Technology (if the acquiring Party is Blueprint) is used by or on behalf of such acquiring Party, its Acquiree, and their respective Affiliates in connection with any such Competitive Activities, and (II) such acquiring Party, its Acquiree and their respective Affiliates institute commercially reasonable [****] safeguards to ensure the requirements set forth in the foregoing clause (I) are met, including by creating “firewalls” between the personnel working under such Competitive Activities and the personnel teams charged with working on the Blueprint Compounds and Licensed Products hereunder or having access to data from activities performed under this Agreement or Confidential Information of the other Party.

3.1

Alliance Managers.  Each Party will appoint an individual to act as its alliance manager under this Agreement as soon as practicable after the Effective Date (each an “Alliance Manager”).  The Alliance Managers will: (a) serve as the primary points of contact between the Parties for the purpose of providing the other Party with information on the progress of a Party’s activities under this Agreement; (b) be responsible for facilitating the flow of information and otherwise promoting communication, coordination, and collaboration between the Parties, all of which communications between the Parties will be in English; (c) facilitate the prompt resolution of any disputes; and (d) attend JSC, JPT, and Working Group meetings, in each case, as a non-voting member.  An Alliance Manager may also bring any matter to the attention of the JSC, a JPT, or applicable Working Group if such Alliance Manager reasonably believes that such matter warrants such attention.  Each Party will use reasonable efforts to keep an appropriate level of continuity but may replace its Alliance Manager at any time upon written notice to the other Party.

3.2

Joint Steering Committee.

3.2.1

Formation.  No later than [****] after the Effective Date, the Parties will establish a joint steering committee (the “JSC”) to monitor and coordinate the Exploitation of the Blueprint Compounds and the Licensed Products in the Territory.  The JSC will be composed of [****] representatives from each Party (unless otherwise agreed by the Parties) who are fluent in English and who have the appropriate and direct knowledge and expertise and requisite decision-making authority.  Each Party may replace any of its representatives on the JSC and appoint a person to fill the vacancy arising from each such replacement.  A Party that replaces a representative will notify the other Party at least [****] prior to the next scheduled meeting of the JSC.  Both Parties will use reasonable efforts to keep an appropriate level of continuity in representation.  Representatives may be represented at any meeting by another person designated by the absent representative. The JSC will be chaired by one of the representatives (“JSC Chairperson”) and will rotate between the Parties every 12 months during the Term.  The initial JSC Chairperson of the JSC will be a representative of Zai for the period ending [****], and a Blueprint representative will become the JSC Chairperson of the JSC for the next [****] period during the Term. The role of the JSC Chairperson will be to convene and preside at meetings of the JSC and to ensure that the Alliance Managers prepare minutes, but the JSC Chairperson will have no additional powers or rights beyond those held by the other JSC representatives. Each Party’s representatives on the JSC will inform and coordinate within their respective organization to enable each Party to fulfill its obligations as agreed upon between the Parties under this Agreement, including within the time frames set forth hereunder.

3.2.2

Meeting Agendas.  Each Party will disclose to the other Party the proposed agenda items along with appropriate information at least [****] in advance of each meeting of the JSC; provided that under exigent circumstances requiring JSC input, a Party may provide its agenda items to the other Party within a shorter period of time in advance of a meeting, or may propose that there not be a specific agenda for a particular meeting, so long as such other Party consents to such later addition of such agenda items or the absence of a specific agenda for such JSC meeting.

3.2.3

Meetings.  The JSC will hold meetings at such times as it elects to do so, but will meet no less frequently than quarterly, unless otherwise agreed by the Parties.  All meetings

3.2.4

JSC Roles and Responsibilities.  The responsibilities of the JSC will be to:

(b)

review, discuss, and determine whether to approve the initial list of Preapproved Subcontractors and any updates thereto, as described in Section 2.2.3 (Right to Subcontract);

(c)

oversee the JPTs and establish and oversee Working Groups as necessary or advisable to further the purpose of this Agreement and settle any disputes that arise within any JPT or Working Groups, as described in Section 3.6.2 (Resolution of JPT and Working Group Disputes);

(d)

oversee the implementation of, and the coordination between the Parties of activities to be performed under, the Clinical Supply Agreement, the Commercial Supply Agreement, the Safety Agreements, and any other written agreement between the Parties with respect to the subject matter hereof;

(e)

review, discuss, and determine whether to approve each Manufacturing Technology Transfer Plan, as described in Section 4.2 (Manufacturing Technology Transfer);

(f)

review, discuss, and determine whether to approve any change in the scope of Manufacturing activities to be transferred to Zai in connection with the Manufacturing Technology Transfer for any Blueprint Compound and any updates or amendments thereto, as described in Section 4.2 (Manufacturing Technology Transfer);

(g)

review, discuss, and determine whether to approve the [****] PRC Submission Estimated Timeline for each Licensed Product and each update thereto for each Licensed Product, in each case, as described in Section 5.6.2 (Amendments and Obligations);

(h)

review, discuss, and determine whether to approve the initial Territory-Specific Development Plan for each Licensed Product and each update thereto, in each case, as described in Section 5.4 (Territory-Specific Development Plans);

(i)

review and discuss the initial Global Development Plan for each Licensed Product and each update thereto for any Licensed Product, in each case, as described in Section 5.1 (Global Development Plan);

(j)

review, discuss, and determine whether to approve allocation to Zai of any new or additional activities under the Global Development Plan, including any additional Committed Trials proposed by Blueprint, as described in Section 5.1 (Global Development Plan);

(k)

review, discuss, and determine whether to approve for Development under this Agreement [****];

(l)

review, discuss, and determine whether to approve any New Development Proposal, and review, discuss, and determine whether to approve any New Territory-Specific Development Activities, in each case, as described in Section 5.9 (New Development Proposed by Zai);

(m)

review, discuss, and determine whether to approve the regulatory strategy for the Territory with respect to each Licensed Product and each update thereto, as described in Section 6.1 (Regulatory Strategy);

(n)

review and discuss Zai’s plan for undertaking additional regulatory activities for any Licensed Product delegated by Blueprint or the JSC to Zai, as described in Section 6.2.1 (Obtaining and Maintaining Regulatory Approvals);

(o)

review, discuss, and determine matters that may have a material adverse impact upon the regulatory status of the Licensed Products pursuant to Section 6.7 (No Harmful Actions);

(p)

discuss and determine whether to approve [****];

(q)

review, discuss, and determine whether to approve each Medical Affairs Plan and each update thereto, as described in Section 8.1 (Medical Affairs Plans);

(r)

review, discuss, and determine whether to approve each Commercialization Plan and each update thereto, as described in Section 9.2 (Commercialization Plans);

(s)

determine whether a Product Mark is not appropriate for the Territory due to linguistic reasons or market research showing that such Product Mark is not appropriate, and review and comment on any alternative Product Marks selected by Zai, in each case, as described in Section 14.9.2 (Product Marks in the Territory);

(t)

review, discuss, and determine whether to approve any brand strategy for a Licensed Product that is specific to the Territory (or any region therein) and that is inconsistent with the Global Brand Strategy for such Licensed Product, as described in Section 9.2 (Commercialization Plans);

(u)

review, discuss, and determine whether to approve any alternative Licensed Product-specific trademark selected by Zai in accordance with Section 14.9.2 (Product Marks in the Territory); and

(v)

perform such other functions as expressly set forth in this Agreement or allocated to the JSC by the Parties’ written agreement.

3.3

Joint Project Teams.

3.3.1

Formation; Composition; Meetings.  No later than [****], the Parties will form one or more joint project teams to coordinate and oversee the day-to-day performance of the activities and obligations of the Parties under this Agreement related to the Exploitation of each Blueprint Compound and the corresponding Licensed Products (each, a “JPT”).  Each JPT will be composed of representatives from each Party who have direct knowledge and expertise in each of the following functional areas (as applicable depending on the stage of the applicable Licensed Products): clinical, clinical operations, pharmaceutical and biologic product development (including Companion Diagnostics, to the extent applicable), regulatory, safety, manufacturing, intellectual property, marketing, and commercial, in each case, as such functional areas relate to products similar to the applicable Licensed Product.  Initially, only one JPT will be formed for all Licensed Products, but the JPT may during the Term elect to form separate JPTs for one or more Licensed Products.  Each Party may replace any of its representatives on a JPT and appoint a person to fill the vacancy arising from each such replacement.  A Party that replaces a representative will notify the other Party at least [****] prior to the next scheduled meeting of the applicable JPT.  An individual may serve on more than one JPT and each Party will use reasonable efforts to keep an appropriate level of continuity in representation.  Representatives may be represented at any meeting by another person designated by the absent representative.  Each Party’s representatives on the JPT will inform and coordinate within their respective organization to enable each Party to fulfill its obligations within the time frames as agreed upon between the Parties under this Agreement.  Each JPT will be chaired by one of the representatives (“JPT Chairperson”) and will rotate between the Parties every [****] during the Term.  The initial JPT Chairperson of each JPT will be a representative of Blueprint for the period [****] and a Zai representative will become the JPT Chairperson of each JPT for the next [****] period during the Term.  Each JPT will meet as frequently as, and will operate as, the JSC may determine [****]. The role of the JPT Chairperson will be to convene and preside at meetings of the applicable JPT and to ensure that the Alliance Managers prepare minutes, but the JPT Chairperson will have no additional powers or rights beyond those held by the other JPT representatives. The JPTs may meet in person or by means of teleconference, Internet conference, videoconference, or other similar communications method, and the JPT for each Blueprint Compound and corresponding Licensed Products may hold meetings at the same time as one or more other JPTs if agreed by the Parties.  All meetings of each JPT will be held in English.  Each JPT and its activities will be subject to the oversight of, and will report to, the JSC.  In no event will the authority of any JPT exceed the authority of the JSC.  Each Party will be responsible for all of its own costs and expenses of participating in the JPTs.  The Alliance Managers will jointly prepare and circulate minutes for each JPT meeting within [****] after each such meeting and will ensure that such minutes are reviewed and approved by their respective companies within [****] thereafter.

3.3.2

JPT Roles and Responsibilities.  The responsibilities of the JPT will be to:

(a)

oversee the day-to-day performance of the activities and obligations of each Party under this Agreement related to the Exploitation of each Blueprint Compound and Licensed Product;

(b)

discuss and develop the Manufacturing Technology Transfer Plan for each Blueprint Compound, as described in Section 4.2 (Manufacturing Technology Transfer);

(c)

review and discuss updates of any Blueprint Know-How related to any Blueprint Compound or Licensed Product developed by Blueprint or its Affiliates or licensees since the previous meeting, as described in Section 4.3 (Continuing Know-How Transfer);

(d)

review, discuss, and submit to the JSC the [****] PRC Submission Estimated Timeline for each Licensed Product and each update thereto for each Licensed Product, as described in Section 5.6.2 (Amendments and Obligations);

(e)

review, discuss, provide comments on, and submit to the JSC the Territory-Specific Development Plan for each Licensed Product, and each update thereto, as described in Section 5.4 (Territory-Specific Development Plans);

(f)

review, discuss, and determine whether to approve the inclusion of any Non-Clinical Development in the Territory-Specific Development Plan for a Licensed Product, as described in Section 5.7 (Non-Clinical and Preclinical Studies);

(g)

review and discuss the Global Development Plan for each Licensed Product, and each update thereto, as described in Section 5.1 (Global Development Plans);

(h)

discuss, develop, and submit to the JSC the Global Development Plan for any Proposed Blueprint/Zai Combination, as described in Section 5.8.1 (Proposed Blueprint/Zai Combinations);

(i)

review, discuss, provide comments on, and submit to the JSC any update to the Territory-Specific Development Plan for any Licensed Product that includes any New Territory-Specific Development Activities that have been approved by the JSC, as described in Section 5.9.1(a) (JSC Approval);

(j)

discuss, develop, and submit to the JSC the regulatory strategy for the Territory for each Licensed Product, as described in Section 6.1 (Regulatory Strategy);

(k)

review and monitor the Parties’ compliance with the Safety Agreements, as described in Section 6.5.1 (Safety Agreements);

(l)

review and monitor the Parties’ compliance with and performance under the Clinical Supply Agreement, the Commercial Supply Agreement, and any other written agreement between the Parties with respect to the subject matter hereof, and review and discuss Manufacturing of the Licensed Products by each Party for the Territory;

(m)

review, discuss, and comment on the Medical Affairs Plan for each Licensed Product and each update thereto, as described in Section 8.1 (Medical Affairs Plans);

(n)

review and discuss each report provided by Zai of the Medical Affairs activities performed by or on behalf of Zai in the Territory for each Licensed Product, as described in Section 8.3 (Medical Affairs Reports);

(o)

review, discuss, and comment on the Commercialization Plan for each Licensed Product and each update thereto, as described in Section 9.2 (Commercialization Plans);

(p)

review and discuss each report provided by Zai of the Commercialization activities performed by or on behalf of Zai in the Territory for each Licensed Product, as described in Section 9.4 (Commercialization Reports);

(q)

coordinate activities between the Parties with respect to certain Commercialization and Medical Affairs activities for the Licensed Products inside and outside of the Territory, as described in Section 8.4 (Coordination of Medical Affairs Activities) and Section 9.5 (Coordination of Commercialization Activities; Blueprint Support), respectively;

(r)

raise matters for which the JPT is responsible to the JSC for discussion or resolution as appropriate; and

(s)

perform such other functions as expressly set forth in this Agreement or allocated to JPT by the Parties’ written agreement or by the JSC.

3.4

Working Groups.  From time to time, the JSC may establish joint working groups (each, a “Working Group”) on an “as-needed” basis to oversee specific functional areas or activities and coordinate the day-to-day performance of such activities under this Agreement, which establishment of Working Groups will be reflected in the minutes of the meetings of the JSC.  Each such Working Group will have at least two representatives of each Party and will be otherwise constituted, will meet as frequently as, and will operate as the JSC may determine.  Working Groups may meet in person or by means of teleconference, Internet conference, videoconference, or other similar communications method. Each Working Group and its activities will be subject to the oversight of, and will report to, the JSC.  In no event will the authority of any Working Group exceed the authority of the JSC.  Each Party will be responsible for all of its own costs and expenses of participating in any Working Group.  The Alliance Managers will jointly prepare and circulate minutes for each Working Group meeting within [****] after each such meeting and will ensure that such minutes are reviewed and approved by their respective companies within [****] thereafter.

3.5

Non-Member Attendance.  Each Party may from time to time invite a reasonable number of participants, in addition to its representatives, to attend a meeting of the JSC (in a non-voting capacity), a JPT, or any Working Group if such participants have expertise that is relevant to the planned agenda for such JSC, JPT, or Working Group meeting; provided that if either Party intends to have any Third Party (including any consultant) attend such a meeting, then such Party will provide prior written notice to the other Party reasonably in advance of such meeting and will ensure that such Third Party is bound by obligations of confidentiality and non-use at least as stringent as those set forth in Article 11 (Confidentiality; Publication).  Notwithstanding anything to the contrary set forth in this Agreement, if the other Party objects in good faith to the participation of such Third Party in such meeting due to a bona fide concern regarding competitively sensitive information that is reasonably likely to be discussed at such meeting (i.e., a consultant that also provides services to a Third Party with a Competitive Product), then such Third Party will not be

3.6

Decision-Making.

3.6.1

General Process.  The JSC, the JPTs, and any Working Group will only have the powers expressly assigned to it in this Article 3 (Governance) and elsewhere in this Agreement and will not have the authority to: (a) modify or amend the terms of this Agreement; or (b) waive either Party’s compliance with the terms of this Agreement.  All decisions of the JSC, a JPT, and any Working Group will be made by unanimous vote, with each Party’s representatives having one vote (i.e., one vote per Party).  No action taken at any meeting of the JSC or any JPT or Working Group will be effective unless there is a quorum at such meeting, and at all such meetings, a quorum will be reached if two voting representatives of each Party are present or participating in such meeting.  [****]

3.6.2

Resolution of JPT and Working Group Disputes.  The JSC will [****] to resolve all disputes that arise within a JPT or any Working Group within [****] after any such matter is brought to the JSC for resolution.

3.6.3

Decisions of the JSC.  The JSC [****] to promptly resolve any such matter for which it has authority.  If [****] the JSC is unable to resolve any such matter referred to it by the JPT or any Working Group or any matter that is within the scope of the JSC’s authority or any other disagreement between the Parties that may be referred to the JSC, in each case, within a period of [****], then a Party may refer such matter for resolution in accordance with 3.7.1 (Referral to Executive Officers) to the Chief Executive Officer of Blueprint (or an executive officer of Blueprint designated by the Chief Executive Officer of Blueprint who has the power and authority to resolve such matter) and the Chief Executive Officer of Zai (or an executive officer of Zai designated by the Chief Executive Officer of Zai who has the power and authority to resolve such matter) (collectively, the “Executive Officers”).

3.7

Resolution of JSC Disputes.

3.7.1

Referral to Executive Officers.  If a Party makes an election under Section 3.6.3 (Decisions of the JSC) to refer a matter on which the JSC cannot reach a consensus decision for resolution by the Executive Officers, then the JSC will submit in writing the respective positions of the Parties to their respective Executive Officers.  The Executive Officers will [****] to resolve any such matter so referred to them [****], and any final decision that the Executive Officers agree to in writing will be conclusive and binding on the Parties.

3.7.2

Final Decision-Making Authority.  If the Executive Officers are unable to reach agreement on any such matter referred to them [****] after such matter is so referred (or such longer period as the Executive Officers may agree upon), then:

(a)

No Change; Status Quo.  Neither Party will have final decision-making authority [****] and all such matters set forth in the foregoing [****] must be decided by unanimous agreement of the Parties in order to take any action or adopt any change from the then-current status quo.

(b)

Zai Decisions.  Except for any decision listed in Section 3.7.2(a) (No Change; Status Quo), Zai will have final decision-making authority with respect to [****]; provided that:

(i)

[****]; and

(ii)

[****].

(c)

Blueprint Decisions.  Except for any decision listed in Section 3.7.2(a) (No Change; Status Quo), Blueprint will have final decision-making authority with respect to [****] provided that [****].

3.7.3

Limitations on Decision-Making.  Notwithstanding any provision to the contrary set forth in this Agreement, without the other Party’s prior written consent, no decision of the JSC or a Party’s Executive Officer (in the exercise of a Party’s final decision-making authority on any such matters), in each case, may make a decision that could reasonably be expected to (a) result in a [****] in the other Party’s obligations, costs, or expenses under this Agreement, or any Global Development Plan or Territory-Specific Development Plan, unless, in each case, such actions are necessary for Blueprint to comply with Applicable Law as the Territory Sponsor or as the owner and holder of any Regulatory Submission, Regulatory Approval, or Reimbursement Approval, as applicable, for a Licensed Product in the Territory, (b) require the other Party to take any action that such other Party [****] would (i) require such other Party to violate any Applicable Law, the requirements of any Regulatory Authority, or any agreement with any Third Party entered into by such other Party or (ii) require such other Party to infringe or misappropriate any intellectual property rights of any Third Party, (c) conflict with, amend, interpret, modify, or waive compliance under this Agreement, or (d) impose any obligation on either Party that would be in violation of such Party’s written standard operating procedures, written business policies, or written compliance policies or procedures.

3.8

Discontinuation of JSC.  The JSC will continue to exist until the first to occur of (a) the Parties agreeing to disband the JSC, or (b) Blueprint providing written notice to Zai of its intention to disband and no longer participate in the JSC.  Once the JSC is disbanded, the JSC will have no further obligations under this Agreement and, thereafter, the Alliance Managers will be the points of contact for the exchange of information between the Parties under this Agreement and any references in this Agreement to decisions of the JSC will automatically become references to decisions by and between the Parties in writing, subject to the other terms of this Agreement and consistent with the terms of Section 3.7.2 (Final Decision-Making Authority).

4.1

Initial Know-How Transfer.  [****] Blueprint will provide and transfer to Zai copies of Blueprint Know-How (other than Blueprint Manufacturing Know-How, the transfer of which will be performed pursuant to Section 4.2 (Manufacturing Technology Transfer)) that exists on the Effective Date to the extent not previously provided to Zai, including data and results required for Zai to file an IND for the Licensed Products, in each case, in the Territory (the “Initial Know-How Transfer”).  Blueprint may make such Blueprint Know-How available in such reasonable form as Blueprint determines, including, if Blueprint so elects, in the form such Blueprint Know-How is maintained by Blueprint.

4.2

Manufacturing Technology Transfer.

4.2.1

Initiation of Manufacturing Technology Transfer. In addition to the Blueprint Know-How provided to Zai pursuant to the Initial Know-How Transfer, unless otherwise agreed by the Parties, on a Blueprint Compound-by-Blueprint Compound basis, upon [****] commencing [****] and ending no later than [****], Blueprint and Zai will jointly develop a draft Manufacturing Technology Transfer Plan for such Licensed Products containing such Blueprint Compound. Notwithstanding the foregoing, Blueprint will have the right to elect to initiate a Manufacturing Technology Transfer with respect to a Blueprint Compound at any time during the Term by developing a draft Manufacturing Technology Transfer Plan for Licensed Products containing such Blueprint Compound.

4.2.2

Approval of Manufacturing Technology Transfer Plans. Following development thereof, either Party will submit each Manufacturing Technology Transfer Plan to the JPT to review and discuss, and thereafter to the JSC to review, discuss, and determine whether to approve no later than [****] following either Party’s submission to the JPT of each such plan. Blueprint or Zai may propose updates or amendments to any Manufacturing Technology Transfer Plan from time to time, and such updates or amendments will become effective upon approval thereof by the JSC.

4.2.3

Manufacturing Transfer Plan Requirements. Unless otherwise agreed by the JSC, each initial Manufacturing Technology Transfer Plan will contemplate the transfer to Zai of, at minimum, all Manufacturing steps that are necessary for Zai to obtain all applicable Regulatory Approvals (including Local Manufacturing Approvals) required to market and sell a locally-Manufactured version of such Licensed Product in the PRC in the name of Zai or its Affiliate. If transfer of the Manufacture [****] of a Blueprint Compound is not [****] for Zai to obtain all applicable Regulatory Approvals (including Local Manufacturing Approvals) required to market and sell a locally-Manufactured version of such Licensed Product in the PRC in the name of Zai or its Affiliate, and Manufacture [****] is not otherwise transferred to Zai under the initial Manufacturing Technology Transfer Plan for such Blueprint Compound, then, if requested by Zai and agreed to by Blueprint, Blueprint will prepare and submit to the JSC for approval, a Manufacturing Technology Transfer Plan for the transfer of Manufacture to Zai [****] of such Blueprint Compound.

4.2.4

Performance of Manufacturing Technology Transfers. If the Manufacturing Technology Transfer Plan for a Blueprint Compound contemplates the Manufacturing of the applicable Licensed Product from [****], then Blueprint will supply to Zai each of such [****] in accordance with Article 7 (Manufacturing). [****] Blueprint will perform (or cause one or more applicable Third Parties (including any CMO engaged by Blueprint to Manufacture such Licensed Product) to perform) a Manufacturing Technology Transfer for such Licensed Products containing such Blueprint Compound in accordance with such plan. The Parties will [****] complete the Manufacturing Technology Transfer for Licensed Products containing each Blueprint Compound [****] following the approval of the applicable Manufacturing Technology Transfer Plan pursuant to the applicable Manufacturing Technology Transfer Plan, but in any event [****]. Without limiting the foregoing, the Parties will [****] to complete a Manufacturing Technology Transfer with respect to each Licensed Product [****]. Thereafter during the Term, Blueprint (a) will provide Blueprint Manufacturing Know-How as part of the Continuing Know-How Transfer in accordance with Section 4.3 (Continuing Know-How Transfer) and (b) may transfer additional Manufacturing steps with respect to a Blueprint Compound to Zai by

4.3

Continuing Know-How Transfer.  Following the applicable Manufacturing Technology Transfer for each Blueprint Compound and the Licensed Products containing such Blueprint Compound and the Initial Know-How Transfer for each Licensed Product, Blueprint will provide to the JPT in advance of its meeting [****] a summary of any additional Blueprint Manufacturing Know-How and other Blueprint Know-How, in each case, developed by Blueprint or its Affiliates or licensees since the previous quarterly summary that was provided to the JPT. Upon Zai’s reasonable request during the Term, Blueprint will (a) make available to Zai all Blueprint Manufacturing Know-How and other Blueprint Know-How, in each case, in Blueprint’s possession and not previously provided to Zai hereunder and that is necessary or reasonably useful for Zai’s Exploitation of any Blueprint Compound or Licensed Product (as applicable) in accordance with this Agreement, (b) provide a schedule of applicable Blueprint Manufacturing Patent Rights following delivery of a Manufacturing Technology Transfer Plan, (c) transfer any such Blueprint Know-How or Blueprint Manufacturing Know-How, or provide such schedule, to Zai no later than [****] after Zai’s request therefor, and (d) [****] after the Initial Know-How Transfer or Manufacturing Technology Transfer for a Blueprint Compound or Licensed Product (as applicable), provide Zai with reasonable access to Blueprint personnel involved in the Development or Manufacture of such Blueprint Compound or Licensed Product (as applicable) (and the corresponding Blueprint Compound), either in-person at Blueprint’s facility or by teleconference (the “Continuing Know-How Transfer,” and together with the Initial Know-How Transfer and the Manufacturing Technology Transfer, the “Technology Transfers”). Zai may only use the Blueprint Know-How to perform its obligations or exercise its rights under this Agreement and in accordance with the terms hereof. Notwithstanding anything to the contrary set forth in this Agreement, the terms of this Section 4.3 (Continuing Know-How Transfer) will not apply to any data or results of any Global Clinical Trial (including a Global Clinical Trial for a Licensed Product in a New Indication or for a Combination Product or Combination Regimen) unless [****]

4.4

Conduct of Technology Transfer.  Blueprint personnel will not be obligated to travel to Zai’s (or its designee’s) facilities in connection with the performance of any Technology Transfer.  Any materials provided by Blueprint to Zai in connection with the transfer of Blueprint Know-How (including pursuant to any Technology Transfer) will remain the sole property of Blueprint.

4.5

Technology Transfer Costs.  Blueprint will provide consultation and assistance with qualified personnel in connection with the Technology Transfer for each Blueprint Compound and the Licensed Products containing such Blueprint Compound as reasonably requested by Zai, subject to personnel availability. Blueprint will be responsible for the internal costs of up to [****] of such consultation and assistance for each Blueprint Compound.  Zai will reimburse Blueprint for (a) internal costs (at the FTE Rate) in excess of [****] of such consultation and assistance for each Blueprint Compound and (b) all out-of-pocket costs, in each case ((a) and (b)), reasonably incurred by or on behalf of Blueprint in connection with such assistance within [****] after receiving Blueprint’s invoice therefor.

5.1

Global Development Plan.  The global Development of Licensed Products that involves activities both inside and outside of the Territory will be conducted pursuant to a written Development plan (as updated from time to time in accordance with this Section 5.1 (Global Development Plan), the “Global Development Plan”). The initial Global Development Plan has been agreed by the Parties

5.2

Enrollment in Committed Trials.

5.2.1

Enrollment in Committed Trials.  Zai will, in accordance with the Global Development Plan for each Licensed Product, enroll and treat [****].

5.3

Zai Decision to Use a CRO.  If Zai decides to engage a Development Subcontractor to perform one or more Clinical Trials with respect to Licensed Products in the Territory assigned to Zai under the Global Development Plan on Zai’s behalf, then, if applicable, Zai will [****] engaging a local Affiliate of the same contract research organization that Blueprint has engaged or plans to engage, in each case, to perform such Clinical Trials outside of the Territory (including if such Clinical Trial is a Committed Trials).

5.4

Territory-Specific Development Plans.  Except for the activities allocated to Zai under the Global Development Plan for a Licensed Product pursuant to Section 5.1 (Global Development Plan), all Development of each Licensed Product in the Territory under this Agreement will be conducted pursuant to a written development plan for each such Licensed Product (each, as updated from time to time in accordance with this Section 5.4 (Territory-Specific Development Plans) and Section 3.2 (Joint Steering Committee), a “Territory-Specific Development Plan”).  At least [****] prior to Zai’s planned initiation of any Development activities for a Licensed Product in the Territory that are not contemplated under the Global Development Plan, Zai will provide the applicable JPT with an initial draft of the Territory-Specific Development Plan for such Licensed Product for the JPT’s review and comment.  Each such Territory-Specific Development Plan will contain [****] (a) [****], (b) all major Clinical Development activities for such Licensed Product and all Territory-Specific Clinical Trials and the trial design thereof, in each case, to be conducted solely in furtherance of obtaining Regulatory Approval of such Licensed Product in the Territory (and not outside of the Territory) for the upcoming [****] period, (c) [****] timelines for achieving such activities described in (a) and (b), and (d) [****] key elements involved in obtaining Regulatory Approval of such Licensed Product from all applicable Regulatory Authorities throughout the Territory and the regulatory strategy for each Licensed Product for the Territory approved by the JSC pursuant to Section 6.1 (Regulatory Strategy). Each Territory-Specific Development Plan will include all Clinical Development required to obtain and maintain Regulatory Approval for the applicable Licensed Product in each region of the Territory. Zai will take the applicable JPT’s comments [****] and incorporate such comments where appropriate prior to finalizing the initial Territory-Specific Development Plan for each Licensed Product. From time to time thereafter, [****] to include any New Territory-Specific Development Activities, Zai will propose updates to each Territory-Specific Development Plan in consultation with Blueprint through the applicable JPT and submit each initial Territory-Specific Development Plan and each such proposed updated Territory-Specific Development Plan to the JSC.  The JSC will review, discuss, and determine whether to approve the initial Territory-Specific Development Plan for each Licensed Product and each update thereto.  Once approved by the JSC, each update to a Territory-Specific Development Plan for a Licensed Product will become effective and supersede the then-current Territory-Specific Development Plan for such Licensed Product.

5.5

Development Diligence.  Subject to the terms of this Agreement, Zai will be responsible for and will use Commercially Reasonable Efforts to Develop and obtain Regulatory Approval, and, if applicable, Reimbursement Approval, for [****] each Licensed Product that is the subject of a Territory-Specific Development Plan or Global Development Plan in the Field in the Territory.  Without limiting the generality of the foregoing, Zai will use Commercially Reasonable Efforts to [****].

5.6

PRC Submission Estimated Timeline.

5.6.1

Other Licensed Products. [****] the Parties have finalized the PRC Submission Estimated Timeline [****], in each case, such PRC Submission Estimated Timeline is included in the initial Global Development Plan. In addition, the JPT will develop a PRC Submission Estimated Timeline for any additional Licensed Products at the appropriate

5.6.2

Amendments and Obligations. The JPT will update, and will provide to the JSC to review, discuss, and determine whether to approve, the PRC Submission Estimated Timeline for each Licensed Product annually to include in detail the anticipated key regulatory activities for such Licensed Product [****] in the Territory and the dates on which such activities are estimated to occur. Without limiting the obligations set forth in Section 5.5 (Development Diligence), Zai will use Commercially Reasonable Efforts to: (a) make all Regulatory Submissions to the NMPA pursuant to and in accordance with Section 6.2.1 (Obtaining and Maintaining Regulatory Approvals) for each Licensed Product and in accordance with the applicable PRC Submission Estimated Timeline (as may be amended by the JSC from time to time) [****] and (b) promptly obtain all approvals from the applicable Regulatory Authorities required to dose the first patient with each Licensed Product in Clinical Trials in the Territory.

5.7

Non-Clinical and Preclinical Studies.  Blueprint will be responsible for [****] Non-Clinical Development for all Licensed Products, other than specific Non-Clinical Development for any Licensed Product that (a) is required specifically in support of [****] for such Licensed Product in the Territory, which additional Non-Clinical Development will, subject to approval by the JPT [****] be included under the Territory-Specific Development Plan for such Licensed Product or (b) that the JPT otherwise agrees to include in a Territory-Specific Development Plan, and in each case ((a) or (b)), for which Zai will be responsible (such Non-Clinical Development, “Permitted Zai Non-Clinical Development”).  Notwithstanding any provision to the contrary set forth in this Agreement, in no event will the JPT be permitted to withhold consent to Zai’s performance of any specific Non-Clinical Development in the Territory that is required specifically in support of [****] for such Licensed Product in the Territory, unless[****]. Blueprint will provide support and cooperation as reasonably requested by Zai in connection with any such Permitted Zai Non-Clinical Development.  In addition, Zai will provide support and cooperation as reasonably requested by Blueprint in connection with any Non-Clinical Development for any Blueprint/Zai Combination that is required to support [****] for such product outside of the Territory.  The Party generating data and results (or on whose behalf such data and results are generated) in the course of conducting such Non-Clinical Development for any Licensed Product will provide such data and results to the other Party in accordance with Section 5.17 (Data Exchange and Use).

5.8

Proposed Blueprint/Zai Combination Products.

5.8.1

Proposed Combinations.  If the JPT wishes to include, under the Global Development Plan, Development of any Blueprint/Zai Combination (each, a “Proposed Blueprint/Zai Combination”), then the JPT will develop a Global Development Plan for such Proposed Blueprint/Zai Combination, which plan will include the conduct of a POC Trial for such Proposed Blueprint/Zai Combination and a regulatory strategy for the applicable Proposed Blueprint/Zai Combination and the conduct those Clinical Trials contemplated in such Global Development Plan. Thereafter, the JPT will submit such plans, along with details regarding the scope of intellectual property rights relating to the applicable Active Ingredient Controlled by Zai or its Affiliates that will be licensed or sublicensed (as applicable) to Blueprint (where any license for Blueprint to obtain any right to any Zai Product beyond the conduct of Clinical Trials in accordance with this Section 5.8.1 (Proposed Combinations) will only be as contemplated under an agreement or amendment to this Agreement entered into by the Parties pursuant to Section 5.8.2 (Further

(a)

JSC Approval.  If the JSC approves the Development under this Agreement of the applicable Proposed Blueprint/Zai Combination under the Global Development Plan, then [****].

(b)

No JSC Approval.  If the JSC does not approve the Development under this Agreement of a Proposed Blueprint/Zai Combination, then such Proposed Blueprint/Zai Combination will not be a Blueprint/Zai Combination for purposes of this Agreement and the Parties may not Exploit such Proposed Blueprint/Zai Combination under this Agreement unless and until the JSC approves the Development such Proposed Blueprint/Zai Combination hereunder.

5.8.2

Further Exploitation of Proposed Blueprint/Zai Combinations.  If the JSC determines to approve the conduct of a Pivotal Trial as a Global Clinical Trial for any Blueprint/Zai Combination that was a Proposed Blueprint/Zai Combination approved by the JSC pursuant to Section 5.8.1 (Proposed Blueprint/Zai Combinations), then:

(a)

the JSC will determine which Party will conduct such Pivotal Trial as a Global Clinical Trial;

(b)

following completion [****];

(c)

(i) Zai will not be required to grant any license to Blueprint to seek Regulatory Approval for, or Commercialize the Zai Product included in such Blueprint/Zai Combination, and (ii) Blueprint will not be required to grant any license to Zai to seek Regulatory Approval for, or Commercialize, the Blueprint Compound included in such Blueprint/Zai Combination, in each case ((i) and (ii)), unless the Parties reach agreement on the terms and conditions for such commercial arrangement under this Section 5.8.2 (Further Exploitation of Proposed Blueprint/Zai Combinations);

(d)

notwithstanding any provision to the contrary set forth in this Agreement, no license will be deemed to have been granted to Blueprint or its Affiliates or (sub)licensees to Exploit any Zai Product, except that the license grant to Blueprint under Section 2.3 (License Grants to Blueprint) will include the right to Develop Blueprint/Zai Combinations solely through POC Trials if approved by the JSC pursuant to Section 5.8.1 (Proposed Combinations);

(e)

the Parties will [****] reach agreement on such commercial arrangement prior to commencement of such Pivotal Trial or any further Development of such Blueprint/Zai Combination after completion of the POC Trial for such Blueprint/Zai Combination; and

(f)

neither Party will conduct further Development or other Exploitation of the applicable Blueprint/Zai Combination inside or outside of the Territory, unless and until the Parties enter into a written agreement setting forth such terms as described above in Section 5.8.2(a) through Section 5.8.2(c).

5.9

New Development Proposed by Zai.  Notwithstanding Zai’s final decision-making authority with respect to Development activities for a Licensed Product that are Territory-specific as set forth in Section 3.7.2(b) (Zai Decisions), if [****], then, in either case ((a) or (b)), Zai will present to the JSC to review, discuss, and determine whether to approve, a proposal to add such Development activities for such New Indication or such New Combination to the Territory-Specific Development Plan for the applicable Licensed Product, including the regions in the Territory in which such activities would be conducted (a “New Development Proposal”).  Each New Development Proposal will describe [****] the applicable Non-Clinical Development and Clinical Trials that Zai desires to conduct with respect to such New Indication or such New Combination, including [****] (the “New Development Activities”), as well as [****] anticipated to result from such New Development Activities, and [****].

5.9.1

JSC Decision Regarding New Development Activities.  The JSC will review, discuss, and determine whether to approve a New Development Proposal within [****] after receipt thereof from Zai.

(a)

JSC Approval.  If the JSC approves a New Development Proposal, then upon such an approval, (i) the New Development Activities set forth in such New Development Proposal will be “New Territory-Specific Development Activities” for purposes of this Agreement, and (ii) the JPT will update the Territory-Specific Development Plan for such Licensed Product to include such New Territory-Specific Development Activities for those regions in the Territory agreed by the JSC, including the proposed timelines, in each case, for such New Development Activities set forth in such New Development Proposal (as may be amended by the JSC upon such approval).  Any New Territory-Specific Development Activities included in a Territory-Specific Development Plan pursuant to this Section 5.9.1(a) (JSC Approval) will be Development activities for all purposes under Section 5.5 (Development Diligence).

(b)

No JSC Approval.  If the JSC fails to approve a New Development Proposal, then upon such a failure, the New Development Activities proposed in the New Development Proposal will not be included in any Territory-Specific Development Plan and Zai will not perform any such New Development Activities.

5.10

Standard of Conduct.  Each Party will perform, and will cause its Affiliates, sublicensees (or Sublicensees, as applicable), and subcontractors (or Subcontractors, as applicable) to perform, all Development activities for the Licensed Products under this Agreement (including under each Territory-Specific Development Plan and each Global Development Plan and any New Territory-Specific Development Activities) in good scientific manner, in a timely, professional manner, and in compliance with the applicable Territory-Specific Development Plan or Global Development Plan, as applicable, in accordance with GLP, cGMP, and GCP, as applicable, and in compliance with Applicable Law and with applicable FDA and EMA requirements to the extent necessary for the submission of data generated from such activities in Regulatory Submissions in the U.S. and the European Union. In addition, each Party will conduct its obligations with respect to any Global Clinical Trial under a Global Development Plan or (with respect to Zai) Territory-Specific Clinical Trial under a Territory-Specific Development Plan (as applicable) in strict adherence with the study design set forth in the applicable protocol therefor and as set forth in such Global Development Plan or such Territory-Specific Development Plan, each as may be amended from time to time, and will comply with each statistical analysis plan implemented by the other Party (as applicable) in connection therewith. Zai will not perform any Development of Blueprint Compounds or Licensed

5.11

New Development Proposed by Blueprint.  At anytime during the Term, Blueprint may propose additional Committed Trials in addition to those identified on Schedule 1.60 (Committed Trials) by adding additional Global Clinical Trials for Licensed Products in New Indications or as new Combination Products or Combination Regimens (beyond the Indications, Combination Products, and Combination Regimens contemplated by the then-current Committed Trials) to the Global Development Plan in accordance with Section 5.1 (Global Development Plan).

5.11.1

Zai Election Not to Sponsor. If the JSC does not approve the allocation of responsibility to Zai to serve as the Territory Sponsor or regulatory agent in the Territory for, or to otherwise implement in the Territory, such additional Global Clinical Trials added to the Global Development Plan by Blueprint for a Licensed Product for any New Indication or new Combination Product or Combination Regimen (beyond the Indications, Combination Products, and Combination Regimens contemplated by the then-current Committed Trials), then:

(a)

Not A Committed Trial. The proposed Global Clinical Trial will not be considered a Committed Trial under this Agreement and Zai will not be obligated to implement such Global Clinical Trials in the Territory;

(b)

Right to Develop. Notwithstanding any provision to the contrary set forth in this Agreement (including the terms of Section 2.1 (License Grant to Zai)), Blueprint will have the right to implement such Global Clinical Trials for such Licensed Product for such New Indication or for such new Combination Product or Combination Regimen globally (including in the Territory) [****]; and

(c)

Zai Assistance. Zai will provide reasonable assistance to Blueprint to recruit and enroll patients from the Territory for such Global Clinical Trials [****].

5.11.2

Patient Commitment for Data Access. If Zai wishes to be granted rights with respect to any data or results generated in such Global Clinical Trials for such Licensed Product for such New Indication or for such new Combination Product or Combination Regimen added to the Global Development Plan by Blueprint (beyond the Indications, Combination Products, and Combination Regimens contemplated by the then-current Committed Trials), including pursuant to Section 4.3 (Continuing Know-How Transfer), Section 5.17 (Data Exchange and Use) or Section 6.4 (Right of Reference), then: (a) each Global Clinical Trial for such Licensed Product for such New Indication or such new Combination Product or Combination Regimen will be considered a Committed Trial for all purposes under this Agreement, (b) Zai will be obligated to satisfy the Patient Commitment with respect to all Global Clinical Trials for such Licensed Product for such New Indication or such new Combination Product or Combination Regimen, and (c) the terms of Section 5.2 (Enrollment in Global Clinical Trials) will apply to all Global Clinical Trials for such Licensed Product for such New Indication or for such new Combination Product or Combination Regimen.

5.12

Development of Co-Formulated Products.  Unless otherwise agreed by the Parties, in the course of performing their obligations and exercising their rights under this Agreement, neither Party will (independently or for or with any Third Party) Develop any co-formulated pharmaceutical or biologic product that includes a Blueprint Compound together with any Zai Product.

5.13

Responsibility for Development Costs.

5.13.1

Territory-Specific Development Costs.  Except as otherwise set forth in this Agreement, [****].

5.13.2

Global Development Costs.  Except as otherwise set forth in this Agreement, and otherwise subject to Section 5.1 (Global Development Plan), Zai will be responsible for and will pay (a) all Third Party out-of-pocket costs [****] (b) all other costs and expenses [****], (c) costs of [****], and (d) the internal costs (at the FTE Rate) of Blueprint personnel incurred [****].  Blueprint will invoice Zai quarterly for the foregoing costs incurred by or on behalf of Blueprint in such Calendar Quarter, and Zai will pay the undisputed invoiced amounts within [****] after the date of any such invoice.

5.13.3

Shared Services. Zai will be responsible for and will pay [****] of the Shared Services Costs incurred by Blueprint in connection with any Committed Trials. Blueprint will invoice Zai quarterly for the foregoing costs incurred by or on behalf of Blueprint in each Calendar Quarter, and Zai will pay the undisputed invoiced amounts within [****] after the date of any such invoice.  Blueprint will be responsible for and will pay [****] of the Shared Services Costs incurred by Zai in the performance of any Committed Trials, if any. Zai will invoice Blueprint quarterly for the foregoing costs incurred by or on behalf of Zai in each Calendar Quarter, and Blueprint will pay the undisputed invoiced amounts within [****] after the date of any such invoice.

5.14

Clinical Trial Audit Rights.

5.14.1

Conduct of Audits.  Upon reasonable notification by Blueprint [****], Blueprint or its representatives may conduct an audit of Zai, its Affiliates, or any Sublicensees, Subcontractors, and all Clinical Trial sites engaged by Zai or its Affiliates or Sublicensees to perform Zai’s obligations under any Global Development Plan or Territory-Specific Development Plan, in each case, to ensure that the applicable Global Clinical Trials and Territory-Specific Clinical Trials are conducted in compliance with the applicable Global Development Plan or Territory-Specific Development Plan, GCP, and Applicable Law and meet Blueprint’s global Clinical Trial standards provided by Blueprint from time to time during the Term.  [****] Blueprint will provide Zai with a written summary of Blueprint’s findings of any deficiencies or other areas of remediation that Blueprint identifies during any such audit.  Zai will use Commercially Reasonable Efforts to remediate any such deficiencies within [****] following Zai’s receipt of such report[****].  Without limiting the foregoing, Zai will have the right to be present at any such audit conducted by Blueprint pursuant to this Section 5.14.1 (Conduct of Audits) of any Sublicensees, Subcontractors, or Clinical Trial sites.

5.14.2

Deficient Sites and Replacement.  With respect to any Global Clinical Trial or Territory-Specific Clinical Trial, if either Party reasonably determines that any deficiencies with respect to a Clinical Trial site identified pursuant to Section 5.14.1 (Conduct of Audits) (each, a “Deficient Site”) may cause a Regulatory Authority to reject or otherwise deem deficient the Clinical Trial data from the conduct of any such Global Clinical Trial or Territory-Specific Clinical Trial (as applicable) at such Deficient Site, then such Party will notify the other Party of such Deficient Site and the Parties will discuss and attempt to agree upon a remediation plan for such Deficient Site. If the Parties cannot agree to such a remediation plan for a Deficient Site that is participating in a Global Clinical Trial, then Zai will promptly remove such Deficient Site from the applicable Global Clinical

5.14.3

Zai Audits.  Zai will provide Blueprint with copies of all quality oversight or audit reports prepared in connection with any audit that Zai or its Affiliates or Sublicensees conduct of any Sublicensee, Subcontractor, or Clinical Trial site that Zai or its Affiliates or Sublicensees have engaged or are evaluating to potentially engage to fulfill Zai’s obligations under a Global Development Plan or a Territory-Specific Development Plan no later than [****] after receiving or preparing any such report (as applicable), including English translations thereof.  If Blueprint believes in good faith that any such quality oversight or audit report may be necessary in connection with obtaining, supporting, or maintaining one or more Regulatory Approvals for a Licensed Product or for other communications with Regulatory Authorities outside of the Territory, then upon Blueprint’s request, Zai will provide a certified translation thereof [****].

5.15

Development Records.  Zai will, and will cause its Affiliates, Sublicensees, and Subcontractors to, maintain reasonably complete, current, and accurate records of all Development activities conducted by or on behalf of Zai, and its Affiliates, Sublicensees, and Subcontractors, respectively, pursuant to this Agreement and all data and other information resulting from such activities consistent with its usual practices, in validated computer systems that are compliant with 21 C.F.R. §11 and in accordance with Applicable Law of both the United States and the Territory. [****]  Zai will maintain all such records relating to the Development of Licensed Products for a period of [****].  Such records will fully and properly reflect all work done and results achieved in the performance of the Development activities for the Licensed Products in good scientific manner appropriate for regulatory and patent purposes.  Zai will document all Non-Clinical Development and Clinical Trials in formal written study reports in accordance with GLP, cGMP, and GCP, as applicable, and in compliance with Applicable Law.  Upon Blueprint’s reasonable request, not more frequently than [****] during which Zai or its Affiliates, Sublicensees, or Subcontractors are performing or having performed Development activities for any Licensed Product, Zai will, and will cause its Affiliates, Sublicensees, and Subcontractors to, allow Blueprint to access, review, and copy such records (including access to relevant databases).  Blueprint will have the right to use the data and results generated by or on behalf of Zai and its Affiliates, Sublicensees, and Subcontractors hereunder to Exploit the Blueprint Compounds and Licensed Products outside of the Territory and to perform Development activities under a Global Development Plan that are allocated to Blueprint thereunder.  Each Party will ensure that all records or other documents that it transmits to the other Party electronically under this Agreement are transmitted over secure systems that include adequate encryption safeguards to prevent unauthorized access and maintain data security.

5.16

Development Reports.  No later than [****] during which Zai is performing, or having performed, Development activities for any Licensed Product, Zai will provide Blueprint[****] with [****] written reports [****] the Development activities performed during the period since the preceding report, the Development activities in process, and the future activities that Zai or its Sublicensees or Subcontractors expect to initiate, including a summary of the data, timelines, and results of such Development activities.  Such reports will be in English.  Zai will also establish a secure link that includes adequate encryption safeguards to provide Blueprint with electronic access to, and secure file transfer of, such information.  Without limiting the foregoing, such reports will contain sufficient detail to enable Blueprint to assess Zai’s compliance with its Development diligence

5.17

Data Exchange and Use.  Subject to Section 5.2.4 (Data Access Criteria) and Section 5.8.1(a) (JSC Approval), in addition to its adverse event and safety data reporting obligations set forth in Section 6.5 (Adverse Events Reporting), each Party will [****] provide the other Party with copies of all data and results and all supporting documentation (e.g., protocols, investigator’s brochures, case report forms, and analysis plans) Controlled by such Party that are generated by or on behalf of such Party or its Affiliates, Sublicensees, or Subcontractors, if applicable, in the Development of each Licensed Product or any Companion Diagnostic, provided, however, that Blueprint may decline to receive copies of data and results of Development of a Blueprint/Zai Combination Product or other Combination Product or Combination Regimen.  Zai will have the right to use and reference such data and results provided by Blueprint for the purpose of obtaining, supporting, and maintaining Local Manufacturing Approvals, Regulatory Approvals, and any Reimbursement Approval, as applicable, of the Licensed Products and Companion Diagnostics in the Territory, without additional consideration.  Blueprint and its designees will have the right to use and reference such data and results provided by Zai for the purpose of obtaining, supporting, or maintaining Regulatory Approval or any Reimbursement Approval, as applicable, of any Licensed Product or Companion Diagnostic (a) outside of the Territory during the Term, or (b) anywhere in the world following termination of this Agreement, in each case ((a) and (b)), without additional consideration.

5.18

Development of Companion Diagnostics.  In connection with the Development or Commercialization of any Licensed Product for which the JSC has approved a Territory-Specific Development Plan (as applicable) contemplating the Development of one or more companion diagnostic products to be used in connection with such Licensed Product (each a “Companion Diagnostic”), Zai may elect to Develop one or more Companion Diagnostics solely in the Territory.  Unless otherwise allocated to Zai under a Global Development Plan for a Licensed Product, Blueprint will be responsible for Developing Companion Diagnostics for Licensed Products if such Companion Diagnostics are to be used with one or more Licensed Products inside and outside of the Territory.  If JSC determines that Zai will Develop a Companion Diagnostic for use with the Commercialization of any Licensed Product in the Territory, then Zai will be responsible [****].  Without limiting Zai’s reimbursement obligations under Section 5.13 (Responsibility for Development Costs) (which obligations pertain to the Development of each Licensed Product, including the cost to purchase Companion Diagnostics [****] to screen patients in connection with the Development of such Licensed Products), Blueprint will be responsible for [****] Notwithstanding Blueprint’s responsibility for [****] if Zai wishes to use any Companion Diagnostic Developed by Blueprint in connection with Zai’s Commercialization of any Licensed Product in the Territory, then Zai will reimburse Blueprint for: (a) [****] that are related to the Development of Companion Diagnostics for use with a Licensed Product solely in the Territory [****] and (b) with respect to [****] that are related to the Development of Companion Diagnostics for use [****] the Territory [****].

6.1

Regulatory Strategy.  [****] the JPT will discuss and develop a regulatory strategy for the Territory for each Licensed Product and will submit the same to the JSC to review, discuss, and determine whether to approve. From time to time the JPT may update the regulatory strategy for the Territory for any Licensed Product and submit the same to the JSC to review, discuss, and determine whether to approve. Once approved by the JSC, each update to a regulatory strategy for such a Licensed Product will become effective and supersede the then-current regulatory strategy for the Territory for such Licensed Product and such approved regulatory strategy will be included in the Territory-Specific Development Plan. The Parties will reasonably coordinate with respect to the implementation of the regulatory strategy for each Licensed Product in the Territory.

6.2

Zai’s Regulatory Responsibilities.

6.2.1

Obtaining and Maintaining Regulatory Approvals. Each Party will keep the other Party informed of regulatory developments related to the Licensed Products in each region in the Territory and will promptly notify the other Party in writing of any decision by any Regulatory Authority in the Territory regarding any Licensed Product.

(a)

In the PRC. Prior to [****], Zai or one of its Affiliates will be responsible for undertaking all regulatory activities and interactions with Regulatory Authorities in the PRC for such Licensed Product in Blueprint’s name as the express and authorized regulatory agent of record for Blueprint in the Territory and will take such actions on behalf of and for the benefit of Blueprint in the PRC in accordance with the applicable regulatory strategy approved by the JSC (including performing any and all regulatory activities assigned to Zai in this Agreement or by the JSC during the Term in connection with the Development or Commercialization of a Licensed Product in the Territory). Following [****] Zai or one of its Affiliates will be responsible for all regulatory activities and interactions with Regulatory Authorities in the PRC leading up to and including obtaining (to the extent not already obtained) and thereafter maintaining, Local Manufacturing Approvals, Regulatory Approvals, and any Reimbursement Approvals, as applicable, for such Licensed Product in the PRC in Zai’s or its Affiliate’s own name in accordance with the applicable regulatory strategy approved by the JSC.  Prior to undertaking any such activities and interactions relating to obtaining and maintaining Local Manufacturing Approvals, Regulatory Approvals, or Reimbursement Approvals for any Licensed Product in the PRC, whether prior to or after [****] for the applicable Licensed Product, Zai will submit a [****] plan for undertaking the same to the JSC for review and discussion.  Following [****] Zai or one of its Affiliates will continue to be responsible for all regulatory activities and interactions with Regulatory Authorities in the PRC with respect to any imported version of such Licensed Product as the express and authorized regulatory agent of record for Blueprint in the PRC and will continue to take such actions with respect to the imported Licensed Product on behalf of and for the benefit of Blueprint in the PRC in accordance with the applicable regulatory strategy approved by the JSC.

(b)

Obtaining and Maintaining Regulatory Approvals outside the PRC. Zai will be responsible for all regulatory activities with respect to Licensed Products leading up to and including obtaining, and thereafter maintaining, Regulatory Approvals and any Reimbursement Approvals in all regions of the Territory other than the

6.2.2

Consultation with NMPA. If Blueprint determines in its reasonable discretion that a consultation meeting with the NMPA may be necessary to conduct any Development of Licensed Products in the Territory contemplated under this Agreement, then at Blueprint’s reasonable request, Zai will request a consultation meeting with the NMPA to discuss such Development in advance of commencing such Development. In such event, the Parties will coordinate with each other regarding the contents of any materials to be shared with the NMPA in connection with such meeting.

6.2.3

Review of Regulatory Submissions.  Zai will provide to Blueprint for review and comment drafts of all Regulatory Submissions in the Territory for the Licensed Products. Zai will incorporate any [****] comments received from Blueprint on such Regulatory Submissions.  In addition, each Party will notify the other Party of any Regulatory Submissions for the Licensed Products and any comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Territory and will provide the other Party with copies thereof as soon as reasonably practicable, but in all events within [****] after submission or receipt thereof (or such longer time period as may be necessary to obtain translations thereof).  If any such Regulatory Submission, comment, or correspondence is not in English, then Zai will provide Blueprint with a certified English translation [****] after receipt of such Regulatory Submission, comment, or correspondence[****].  Blueprint will have the right to review and comment on all such Regulatory Submissions, and Zai will [****] and incorporate such comments [****]

6.2.4

Notice of Meetings.  Each Party will provide the other Party with notice of any meeting or discussion with any Regulatory Authority in the Territory related to any Licensed Product no later than [****] after receiving notice thereof [****]  Zai will lead any such meeting or discussion and Blueprint or its designee will have the right, but not the obligation, to attend and participate in any such meeting or discussion unless prohibited or restricted by Applicable Law or Regulatory Authority.  At Zai’s request, Blueprint will reasonably cooperate with Zai in preparing for any such meeting or discussion.  If Blueprint elects not to attend such meeting or discussion, then Zai will provide to Blueprint a written summary thereof in English [****] following such meeting or discussion.

6.2.5

Zai Responsibility for Costs and Expenses.  Zai will be responsible for all costs and expenses incurred in connection with the performance of all regulatory activities leading up to and including obtaining and thereafter maintaining, Local Manufacturing Approvals, Regulatory Approvals, and any Reimbursement Approvals, as applicable, for each Licensed Product from Regulatory Authorities in the Territory.

6.3

Blueprint’s Regulatory Responsibilities.  Other than with respect to a locally-Manufactured version of a Licensed Product following [****] therefor (if applicable), Blueprint will own and hold all Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals, as applicable, for all Licensed Products in the PRC, and upon Zai’s reasonable request Blueprint will provide Zai with access to and copies of the applicable Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals for such Licensed Products in the PRC.  Following [****] with respect a locally-Manufactured version of a Licensed Product, Zai will own and hold the Local Manufacturing Approvals, Regulatory Submissions, Regulatory Approvals, and

6.4

Right of Reference.  Subject to Section 5.2.4 (Data Access Criteria) and Section 5.8.1(a) (JSC Approval), each Party will grant, and hereby does grant, to the other Party and its Affiliates, licensees, and Sublicensees a right of reference to all Regulatory Submissions pertaining to the Licensed Products in the Field submitted by or on behalf of such Party or its Affiliates, including any Zai Product as necessary in relation to any Blueprint/Zai Combination.  Subject to Section 5.8.1(b) (No JSC Approval), Section 5.8.2 (Further Exploitation of Proposed Additional Blueprint/Zai Combinations that are Blueprint/Zai Combinations), and Section 5.11 (New Development Proposed by Blueprint), Zai and its Affiliates and Sublicensees may use such right of reference to Blueprint’s Regulatory Submissions solely for the purpose of seeking, obtaining, supporting, and maintaining Local Manufacturing Approvals, Regulatory Approvals, and any Reimbursement Approvals, as applicable, for the applicable Licensed Product in the Field in the Territory, as Blueprint’s authorized regulatory agent of record, or on its own behalf for a locally-Manufactured version of a Licensed Product following [****] for such Licensed Product.  Subject to Section 5.8.1(b) (No JSC Approval) and Section 5.8.2 (Further Exploitation of Proposed Additional Blueprint/Zai Combinations that are Blueprint/Zai Combinations), Blueprint and its Affiliates, licensees, and Sublicensees may use such right of reference to Zai’s Regulatory Submissions, if any, solely for the purpose of seeking, obtaining, supporting, and maintaining Regulatory Approval and any Reimbursement Approvals of Licensed Products outside of the Territory.  Each Party will bear its own costs and expenses associated with providing the other Party with the right of reference pursuant to this Section 6.4 (Right of Reference).  Each Party will take such actions as may be reasonably requested by the other Party to give effect to the intent of this Section 6.4 (Right of Reference) and to give the other Party the benefit of the granting Party’s Regulatory Submissions in the other Party’s territory as provided herein.  Such actions may include (a) providing to the other Party copies of correspondence and communications received from the applicable Regulatory Authorities related to such Party’s application for Regulatory Approval of the Licensed Products in the Territory or outside of the Territory, as applicable, or (b) providing the other Party with any underlying raw data or information submitted by the granting Party to the Regulatory Authority with respect to any Regulatory Submissions Controlled by such granting Party or its Affiliates that relates to any Licensed Product.

6.5

Adverse Events Reporting.

6.5.1

Safety Agreements.  [****] the Parties will enter into one or more written agreements setting forth worldwide safety and pharmacovigilance procedures for the Parties with respect to each Licensed Product (each a “Safety Agreement”). Each Safety Agreement

6.5.2

Safety Databases.  Zai will maintain a safety database in English for Clinical Trials for the Licensed Products conducted in the Territory under a Territory-Specific Development Plan[****].  During such time that Blueprint is the holder of Regulatory Approvals and Regulatory Submissions for a Licensed Product in the Territory, Zai will be responsible for, on Blueprint’s behalf: (a) reporting to the applicable Regulatory Authorities in the Territory all quality complaints, adverse events, and safety data related to such Licensed Product for all Territory-Specific Clinical Trials or Global Clinical Trials conducted in the Territory; and (b) responding to safety issues and to all requests of Regulatory Authorities related to such Licensed Product in the Territory.  Zai will provide Blueprint (i) secure, real-time access to Zai’s safety database for the Licensed Products in the Territory, and (ii) upon Blueprint’s request, query results from Zai’s worldwide safety database for each Zai Product solely for the purpose of Developing Blueprint/Zai Combinations.  Blueprint will maintain a global safety database for Global Clinical Trials for the Licensed Products conducted under each Global Development Plan [****].

6.5.3

Notification Obligations. Without limiting the provisions of Section 6.5.1 (Safety Agreements), Zai will be responsible for complying with all Applicable Law governing adverse events (including the reporting thereof) in the Territory and will comply fully with all applicable adverse event reporting recommendations and requirements in all regions in the Territory where Zai intends to Commercialize the applicable Licensed Product. Zai will notify Blueprint on a timely basis of any adverse events related to one or more

6.6

Regulatory Audits.  In addition to its rights to conduct audits pursuant to Section 5.14 (Clinical Trial Audit Rights), upon reasonable notification, Blueprint or its representatives will be entitled to conduct audits of safety and regulatory systems, procedures, or practices of Zai or its Affiliates, Sublicensees, or Subcontractors (including Clinical Trial sites) relating to any Licensed Product.  With respect to any inspection of Zai or its Affiliates, Sublicensees or Subcontractors (including Clinical Trial sites) by any Governmental Authority relating to any Licensed Product, Zai will notify Blueprint of such inspection (a) no later than [****] after Zai receives notice of such inspection [****] or (b) within [****] after the completion of any such inspection of which Zai did not receive prior notice. Zai will promptly provide Blueprint with all information related to any such inspection.  To the extent permitted by Applicable Law, Zai will also permit Governmental Authorities outside of the Territory to conduct inspections of Zai or its Affiliates, Sublicensees, or Subcontractors (including Clinical Trial sites) relating to any Licensed Product, and will ensure that all such Affiliates, Sublicensees, and Subcontractors permit such inspections. Blueprint will have the right, but not the obligation (unless required by Applicable Law or any Governmental Authority), to be present at any such inspection.  Following any such regulatory inspection related to one or more Licensed Products, Zai will provide Blueprint with (i) an unredacted copy of any findings, notice, or report provided by any Governmental Authority related to such inspection (to the extent related to a Licensed Product) within [****] of Zai receiving the same, and (ii) an English translation of any findings, notice, or report of a Governmental Authority related to such inspection (to the extent related to a Licensed Product) within [****] after receiving the same [****].

6.7

No Harmful Actions.  If either Party believes that the other Party is taking or intends to take any action with respect to a Licensed Product in such other Party’s territory that could [****] of any Licensed Product in such Party’s territory, then such Party will have the right to bring the matter to the attention of the JSC and the JSC will [****]. Without limiting the foregoing, unless the Parties otherwise agree (or unless otherwise set forth in this Agreement or in the applicable Global Development Plan), neither Party will communicate with any Regulatory Authority having jurisdiction outside of its respective territory with respect to any Licensed Product, unless for the purpose of seeking Regulatory Approval or so ordered by such Regulatory Authority, in which case, such Party will immediately notify the other Party of such order.

6.8

Notice of Regulatory Action.  If any Regulatory Authority takes or gives notice of its intent to take any regulatory action with respect to any activity of Zai relating to any Licensed Product, then Zai will notify Blueprint of such contact, inspection, notice, or action within [****] after receipt of such notice (or, if action is taken without notice, within [****] of Zai becoming aware of such action).  If any Regulatory Authority takes or gives notice of its intent to take any regulatory action with respect to any activity of Blueprint relating to any Licensed Product that is reasonably likely

6.9

Notice of Other Actions.  In addition, each Party will promptly notify the other of any information that it receives regarding any threatened or pending action, inspection, or communication by or from a Third Party that would reasonably be expected to materially affect the Development of the Licensed Products.

7.1

Supply by Blueprint.

7.1.1

Development Supply.  [****] the Parties will enter into a clinical supply agreement for the supply to Zai of Licensed Products containing each Blueprint Compound (together with the corresponding quality agreement, each a “Clinical Supply Agreement”) pursuant to which Zai will purchase from Blueprint its requirements of each such Licensed Product [****] as necessary for Zai to fulfill its obligations under this Agreement related to the Development of Licensed Products.  [****]  Pursuant to each Clinical Supply Agreement:

(a)

Sole Supply.  Blueprint will, subject to Section 7.2 (Supply by Zai) and any right for Zai to procure its own supply as set forth in such Clinical Supply Agreement, have the sole right to, either by itself or through a CMO, Manufacture and supply to Zai all Blueprint Compounds and Licensed Products containing such Blueprint Compounds, required by Zai for Development use in the Territory as set forth in a Territory-Specific Development Plan and to perform Zai’s Development responsibilities under a Global Development Plan [****].

(b)

Supply Price.  Blueprint will supply the Blueprint Compounds and Licensed Products to Zai pursuant to this Section 7.1.1 (Development Supply) at a transfer price equal to [****], and Zai will pay such invoice, based on a payment schedule to be set forth in the Clinical Supply Agreement and in accordance with Section 7.1.3 (Shipment and Delivery).

7.1.2

Commercial Supply.  [****] the Parties will enter into a commercial supply agreement (together with the corresponding quality agreement, the “Commercial Supply Agreement”), for the supply to Zai of (a) the [****] of each Licensed Product or such other form of such Licensed Product as the JSC may agree, in either case, until [****], and (b) until [****] Licensed Product, pursuant to which Zai will purchase from Blueprint its requirements of the same as necessary for Zai to fulfill its obligations under this

(a)

Sole Supply.  Subject to Section 7.2 (Supply by Zai) and any right for Zai to procure its own supply as set forth in such Commercial Supply Agreement, Blueprint will have the sole right to, either by itself or through an Affiliate, CMO, or licensee, Manufacture and supply to Zai all such Licensed Products as required by Zai for Commercialization in the Territory in accordance with this Agreement.  The Commercial Supply Agreement will [****].

(b)

Supply Price.  Blueprint will supply to Zai pursuant to this Section 7.1.2 (Commercial Supply) each Licensed Product (or Active Ingredient thereof, as applicable) at a transfer price equal to [****].  Blueprint will invoice Zai for such Licensed Products, and Zai will pay such invoice, based on a payment schedule to be set forth in the Commercial Supply Agreement and in accordance with Section 7.1.3 (Shipment and Delivery).

7.1.3

Shipment and Delivery.  Delivery of all Blueprint Compounds and Licensed Products supplied by Blueprint under any Clinical Supply Agreement or Commercial Supply Agreement will take place [****].

7.2

Supply by Zai.

7.2.1

Restriction on Manufacturing by Zai.  Zai will not Manufacture or have Manufactured any Blueprint Compound or any Licensed Product that contains such Blueprint Compound until the completion of a Manufacturing Technology Transfer for the applicable Blueprint Compound in accordance with Section 4.2 (Manufacturing Technology Transfer).  Notwithstanding any provision to the contrary in this Agreement, unless otherwise subsequently agreed by Blueprint in a Clinical Supply Agreement or Commercial Supply Agreement, or otherwise in writing, in no event will Zai perform any step in the Manufacturing process for any Licensed Product [****].

7.2.2

Clinical and Commercial Supply.  Following [****], Zai will Manufacture locally-Manufactured Licensed Products in the Territory for Development purposes or commercial use, as applicable, and will be responsible for all Manufacturing steps transferred to Zai under a Manufacturing Technology Transfer Plan, in each case, in the Territory [****]. Zai agrees that Zai’s Manufacturing process with respect to each locally-Manufactured Licensed Product will at all times be in accordance with the Zai Specifications for such Licensed Product approved by Blueprint pursuant to Section 7.2.3 (Specifications) and cGMP and ICH Guidelines, and in compliance with Applicable Law.

7.2.3

Specifications.  Unless the JSC determines that Zai will be granted rights only to package and label, but not otherwise Manufacture, a particular Licensed Product for Development or Commercialization purposes in the Territory, as part of the Manufacturing Technology Transfer for each Blueprint Compound and the Licensed Products containing such Blueprint Compound, Blueprint will provide Zai with Blueprint’s written process and

7.2.4

Second Source of Supply. Blueprint will have the right at any time during the Term to request that Zai serve as a back-up supplier of one or more Licensed Products for use by Blueprint inside or outside of the Territory. Upon Blueprint’s request, and Zai’s agreement, following completion of the Manufacturing Technology Transfer with respect to a Blueprint Compound and the Licensed Products containing such Blueprint Compound, Zai will supply such Licensed Products to Blueprint for Blueprint’s Exploitation of such Licensed Products outside of the Territory, as a second source of supply, at a price equal to [****].

7.3

Product Tracking in the Territory.  Zai will, and will ensure that its Affiliates and Sublicensees, maintain adequate records to permit the Parties to trace the distribution, sale, and use of all Licensed Products to hospitals and pharmacies in the Territory.

8.1

Medical Affairs Plans.  [****] Zai will develop and provide an initial draft of the Medical Affairs Plan for such Licensed Product to the JPT for its review and discussion.  The Medical Affairs Plan for a Licensed Product will contain a [****] of the major Medical Affairs activities to be undertaken for such Licensed Product in the Territory and the estimated timelines for performing such activities, including all key opinion leaders that Zai plans to engage.  The JPT will have the right to comment on each such Medical Affairs Plan and each update thereto, and Zai will consider such comments [****] and incorporate such comments [****] prior to finalizing each such Medical Affairs Plan (or any update thereto).  Thereafter, from time to time, [****] Zai will propose updates to the Medical Affairs Plan for each Licensed Product in consultation with the JPT to reflect changes in such plans, including to account for relevant factors that may influence such plan and the Medical Affairs activities set forth therein. Zai submit each initial Medical Affairs Plan and each such proposed updated Medical Affairs Plan to the JSC.  The JSC will review, discuss, and determine whether to approve each initial Medical Affairs Plan for each Licensed Product and each update thereto.  Once approved by the JSC, each update to a Medical Affairs Plan for a Licensed Product will become effective and supersede the then-current Medical Affairs Plan for such Licensed Product.

8.2

Conduct of Medical Affairs Activities.  Zai will conduct all Medical Affairs activities for Licensed Products in the Territory in accordance with the applicable Medical Affairs Plan. Zai will not conduct any Medical Affairs activities with respect to Licensed Products except for those activities set forth in an applicable Medical Affairs Plan. Zai will, subject to Applicable Laws, conduct such activities in compliance with its internal policies on engaging and sponsoring healthcare providers.

8.3

Medical Affairs Reports.  For each Calendar Year following the first Regulatory Approval for a Licensed Product in the Territory, [****] Zai will provide to Blueprint a report (by means of a slide presentation or otherwise) summarizing the Medical Affairs activities performed by or on behalf of Zai and its Affiliates and Sublicensees in the Territory for each Licensed Product in each region in the Territory since the prior report provided by Zai.  Such reports will be Confidential Information of Zai and subject to the terms of Article 11 (Confidentiality; Publication).  Zai will provide [****] updates [****] to any such report at each meeting of the JSC, JPT, and any Working Group established by the JSC to oversee Medical Affairs activities under this Agreement.

8.4

Coordination of Medical Affairs Activities.  The Parties recognize that each Party may benefit from the coordination of certain Medical Affairs activities for the Licensed Products inside and outside of the Territory. Accordingly, the Parties will coordinate such activities through the JPT where appropriate, including to ensure that medical information provided by each Party in their respective territories is consistent inside and outside of the Territory.  Upon Zai’s request, Blueprint will provide an update on Blueprint’s material planned key Medical Affairs activities with respect to the Licensed Products outside the Territory at regularly scheduled meetings of the JSC.

9.1

Commercialization Diligence Obligations.  Zai will be solely responsible for and will use Commercially Reasonable Efforts to Commercialize each Licensed Product in each region in the Territory after receiving Regulatory Approval and, if applicable, Reimbursement Approval for such Licensed Product in such region.  Zai will conduct all Commercialization of each Licensed Product in the Territory in accordance with the Commercialization Plan for such Licensed Product, at its sole cost and expense. [****]

9.2

Commercialization Plans.  [****] Zai will develop and provide an initial draft of the Commercialization Plan for such Licensed Product to the JPT for its review and discussion.  The Commercialization Plan for a Licensed Product will contain [****] Commercialization activities to be undertaken (including [****]) for such Licensed Product in the Territory and the estimated timelines for achieving such activities.  The JPT will have the right to comment on each such Commercialization Plan and Zai will consider such comments [****] and incorporate such comments [****] prior to finalizing each such Commercialization Plan. Thereafter, from time to time, [****] Zai will propose updates to the Commercialization Plan for each Licensed Product in consultation with the JPT to reflect changes in such plans, including those in response to changes in the marketplace, relative commercial success of the applicable Licensed Product, and other relevant factors that may influence such plan and the Commercialization activities set forth therein.  Zai will submit each proposed updated Commercialization Plan for a Licensed Product to the JPT for review and discussion and will consider [****] and incorporate [****] any comments thereon provided by the JPT before finalizing any such update. Zai submit each initial Commercialization Plan and each such proposed updated Commercialization Plan to the JSC.  The JSC will review, discuss, and determine whether to approve each initial Commercialization Plan for each Licensed Product and each update thereto.  Once approved by the JSC, each update to a Commercialization Plan for a Licensed Product will become effective and supersede the then-current Commercialization Plan for such Licensed Product. Each Commercialization Plan for a Licensed Product (including each update thereto) must be consistent with Blueprint’s global brand strategy and global key messaging, and Global Brand Elements for such Licensed Product (each, a “Global Brand Strategy”), if and as provided to Zai by Blueprint from time to time during the Term; provided, however, that if the JSC agrees upon brand strategy for a Licensed Product that is specific to the Territory (or any region therein) and that is inconsistent with the Global Brand Strategy for such Licensed Product (including any product positioning or messaging for the Territory or any region therein), then Zai will have the right to implement such Territory-specific brand strategy within the Territory and to incorporate such inconsistent strategies in the Commercialization Plan for such Licensed Product.

9.3

Conduct of Commercialization Activities.  Zai will conduct all Commercialization of Licensed Products in the Territory in accordance with the applicable Commercialization Plan. Zai will not conduct any Commercialization activities with respect to Licensed Products except for those activities set forth in an applicable Commercialization Plan.

9.4

Commercialization Reports.  For each Calendar Year following the first Regulatory Approval for a Licensed Product in the Territory, [****] Zai will provide to Blueprint a report [****] summarizing the Commercialization activities performed by or on behalf of Zai and its Affiliates and Sublicensees in the Territory for each Licensed Product in each region in the Territory since the prior report provided by Zai.  Each such report will contain sufficient detail to enable Blueprint to assess Zai’s compliance with its Commercialization diligence obligations set forth in Section 9.1 (Commercialization Diligence Obligations).  Such reports will be Confidential Information of Zai and subject to the terms of Article 11 (Confidentiality; Publication).  Zai will provide updates to any such report at each meeting of the JSC, JPT, and any Working Group established by the JSC to oversee Commercialization activities under this Agreement.

9.5

Coordination of Commercialization Activities.  The Parties recognize that each Party may benefit from the coordination of certain Commercialization activities for the Licensed Products inside and outside of the Territory (other than pricing for the Licensed Products inside and outside of the Territory, the responsibilities for which are set forth in Section 9.6 (Pricing; Reimbursement Approvals)). Accordingly, the Parties will coordinate such activities through the JPT where appropriate, which coordination may include communications regarding product positioning.

9.6

Pricing; Reimbursement Approvals.  Notwithstanding any provision to the contrary set forth in this Agreement, each Party will have the right to determine the price of the Licensed Products sold in its territory and neither Party will have the right to direct, control, or approve the pricing of the Licensed Products in the other Party’s territory.  Zai will keep Blueprint timely informed on (a) any [****] changes to the [****] pricing strategies with respect to any Licensed Product in the Territory, and (b) the status of any application for Reimbursement Approval for a Licensed Product in the Territory, including any discussion with any Regulatory Authority with respect thereto.

9.7

Diversion.  Each Party agrees that it will not, and will ensure that its Affiliates and licensees and subcontractors (or Sublicensees and Subcontractors, as applicable) will not, either directly or indirectly, promote, market, distribute, import, sell, or have sold any Licensed Products to any Third Party or to any address or Internet Protocol address or the like outside of such Party’s respective territory, including via the Internet or mail order.  Neither Party will engage, and each Party will not permit its Affiliates or Sublicensees to engage, in any advertising or promotional activities relating to any Licensed Products for use directed primarily to customers or other buyers or users of the Licensed Products located in any country or jurisdiction outside of such Party’s respective territory, or solicit orders from any prospective purchaser located in any country or jurisdiction outside of such Party’s respective territory.  If either Party or its respective Affiliates or licensees (or Sublicensees, as applicable) receives any order for any Licensed Products from a prospective purchaser located in a country or jurisdiction outside of such Party’s respective territory, then such Party will immediately refer that order to the other Party and will not accept any such orders.  Neither Party will, and neither Party will permit its Affiliates, licensees (or Sublicensees, as applicable), or subcontractors (or Subcontractors, as applicable) to, deliver or tender (or cause to be delivered or tendered) any Licensed Products to Third Parties for use outside of such Party’s respective territory, except in accordance with a Global Development Plan or Territory-Specific Development Plan, or except in connection with a Manufacturing Technology Transfer pursuant to Section 4.2 (Manufacturing Technology Transfer) and Article 7 (Manufacturing). For purposes of this Section 9.7 (Diversion), (a) Zai’s territory will be the Territory and (b) Blueprint’s territory will be worldwide except for the Territory.

10.1

Upfront Payment.  Within [****] after the Effective Date, Zai will pay to Blueprint by wire transfer of immediately available funds a non-refundable, non-creditable upfront payment of $25,000,000 in U.S. Dollars (the “Upfront Payment”).

10.2

Milestone Payments.

10.2.1

Development Milestone Events and Payments.  No later than [****] after the earliest achievement of each development milestone event set forth below [****], Zai will pay to Blueprint the corresponding non-refundable, non-creditable development milestone payment set forth below (the development milestone events set forth in Table 10.2.1 the “Development Milestone Events” and the development milestone payments set forth in Table 10.2.1 the “Development Milestone Payments”).

10.2.2

Sales Milestone Events and Payments.  On a Licensed Product-by-Licensed Product basis, no later than [****] after the end of the first Calendar Quarter in which each sales milestone event set forth below for such Licensed Product is achieved, Zai will pay to Blueprint with respect to each Licensed Product the corresponding non-refundable, non-creditable sales milestone payment set forth below in Table 10.2.2 (the sales milestone events set forth in Table 10.2.2, the “Sales Milestone Events” and the sales milestone payments set forth in Table 10.2.2, the “Sales Milestone Payments”).  If in a given Calendar Year more than one of the Sales Milestone Events set forth in Table 10.2.2 below is achieved with respect to a particular Licensed Product, then Zai will pay to Blueprint a separate Sales Milestone Payment with respect to each such Sales Milestone Payment that is achieved for the first time in such Calendar Year. For purposes of this Section 10.2.2 (Sales Milestone Events and Payments), (a) Licensed Products containing [****] and (b) Combination Products containing [****].

10.2.3

Milestone Conditions.

(a)

Notification of Milestone Events.  Zai will promptly notify Blueprint in writing, but in no event later than (i) [****] after the achievement of each Development Milestone Event and (ii) [****]after the end of the Calendar Quarter in which each Sales Milestone Event is achieved (together with the Development Milestone Events, the “Milestone Events”).  However, in no event will a failure by Zai to deliver such notice of achievement of a Milestone Event relieve Zai of its obligation to pay Blueprint the corresponding Development Milestone Payment or Sales Milestone Payment (collectively, the “Milestone Payments”).

(b)

Skipped Milestone Events.  If Zai achieves any of the Development Milestone Events for a particular Licensed Product [****] but without the prior achievement of any corresponding earlier listed Development Milestone Events for such Licensed Product [****], then Zai will pay to Blueprint the applicable Milestone Payment to be made with respect to such earlier Development Milestone Events for such Licensed Product [****] at the same time as Zai pays the applicable Development Milestone Payment due upon achievement of such Development Milestone Event.  For example, [****].

(c)

Maximum Milestone Payment Example. For example: [****].

10.3

Royalty Payments to Blueprint.

10.3.1

Royalty Rates.  Subject to the remainder of this Section 10.3 (Royalty Payments to Blueprint), Zai will make non-refundable royalty payments to Blueprint, on a Licensed Product-by-Licensed Product basis for Licensed Products sold in the Territory during the applicable Royalty Term, calculated by multiplying the applicable royalty rate set forth below in Table 10.3.1 by [****]. The royalty payments due with respect to Net Sales of each Licensed Product pursuant to this Section 10.3 (Royalty Payments to Blueprint), collectively the “Royalty Payments.” For purposes of this Section 10.3 (Royalty Payments to Blueprint), (a) Licensed Products [****] and (b) Combination Products [****].

10.3.2

Royalty Term.  Zai will pay to Blueprint the Royalty Payments on a Licensed Product-by-Licensed Product and region-by-region basis beginning on the date of the First Commercial Sale of such Licensed Product in such country or region and lasting until the later of: (a) [****] (b) [****] and (c) [****] (“Royalty Term”).

10.3.3

Royalty Reductions.

(a)

Expiration of Valid Claims.  Subject to Section 10.3.3(c) (Cumulative Reductions Floor), on a Licensed Product-by-Licensed Product and region-by-region basis, if there is no Valid Claim of a Royalty Patent Right that Covers the Licensed Product [****] in such region, then, commencing [****] after the date on which this Section 10.3.3(a) (Expiration of Valid Claims) applies and for all [****] thereafter during which this Section 10.3.3(a) (Expiration of Valid Claims) applies, the applicable royalty rate that would otherwise be owed on such Net Sales of such Licensed Product in such region under Section 10.3.1 (Royalty Payments to Blueprint) will be [****]; provided that if such Licensed Product [****] subsequently becomes Covered by a Valid Claim within the Royalty Patent Rights in such region prior to [****], then the applicable royalty rate that would otherwise be owed on such Net Sales of such Licensed Product in such region will no longer be subject to the aforementioned reduction beginning at [****].

(b)

Offset For Third Party Licensing Payments.  Subject to Section 2.6 (Third Party In-Licenses) and Section 10.3.3(c) (Cumulative Reductions Floor), Zai will be entitled to, on a country-by-country basis, credit against the royalties due to Blueprint upon Net Sales of a Licensed Product in such country an amount equal to [****]of the total royalties paid by Zai to Third Parties with respect to license rights to Patent Rights, or Patent Rights together with Know-How, controlled by Third Parties that are necessary to avoid infringement of such Third Party rights in the Territory (i) [****] or (ii) [****].

(c)

Cumulative Reductions Floor.  In no event will the aggregate amount of Royalty Payments due to Blueprint for a Licensed Product in a region in the Territory in any given [****] during the Royalty Term for such Licensed Product in such region be reduced to less than [****] of the amount that otherwise would have been due and payable to Blueprint in such [****] for such Licensed Product in such region but

10.3.4

Royalty Reports and Payments.  Commencing with the [****] during which the First Commercial Sale of a Licensed Product is made anywhere in the Territory, [****] Zai will provide Blueprint with [****] the amount of royalties payable by Zai for the applicable [****], on a Licensed Product-by-Licensed Product and region-by-region basis (each, a “Royalty Estimate”). [****] Zai will provide Blueprint with a detailed report for the applicable [****], on a Licensed Product-by-Licensed Product and region-by-region basis (each, a “Royalty Report”) containing: (a) the amount of gross sales and Net Sales of each Licensed Product sold by Zai and its Affiliates and Sublicensees in each region and all deductions used to determine such Net Sales of each such Licensed Products for such [****], (b) a calculation of the Royalty Payment due on such Net Sales of each Licensed Product in each region, including any royalty reduction made in accordance with Section 10.3.3(a) (Expiration of Valid Claims) and Section 10.3.3(b) (Offset For Third Party Licensing Payments), (c) the exchange rate used for converting any Net Sales recorded in a currency other than Dollars, (d) any withholding taxes required to be made from such Royalty Payments, and (e) the quantity and description of each Licensed Product sold by Zai or its Affiliate or Sublicensee in each region in the Territory during such [****] comprising such Net Sales, including detailed sales reports for each Licensed Product for [****] in each region in the Territory. Concurrent with the delivery of the applicable Royalty Report, [****], Zai will pay the amount of the Royalty Payments set forth in the applicable Royalty Report to Blueprint in Dollars.  If requested by Blueprint, the Parties will seek to resolve any