EX-10.1 2 logc-ex101_146.htm EX-10.1 logc-ex101_146.htm

Exhibit 10.1


Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) is the type of information that the registrant treats as private or confidential. Double asterisks denote omissions.

Execution Version

Exclusive Research Collaboration, License and Option Agreement

Between

LogicBio Therapeutics, Inc.

and

CANbridge Care Pharma Hong Kong Limited

 

 

Dated April 26, 2021

 

 

 

 

 



 

 

Schedules and Exhibits

Schedule 1.81 Existing In-License Agreements

Schedule 1.134LB-001 Supply Cost

Schedule 1.153 LogicBio LB-001 Patent Rights

Schedule 1.156 LogicBio Licensed Patent Rights

Schedule 2.2.1Permitted Subcontractors

Schedule 2.3.1In-License Agreement

Schedule 9.2Disclosure Schedule

Schedule 10.9.2Press Release

 

 

Exhibit AResearch Plan

i

  

 

 

 

 

 



 

EXCLUSIVE RESEARCH COLLABORATION, LICENSE AND OPTION AGREEMENT

This Exclusive Research Collaboration, License and Option Agreement (this “Agreement”) is entered into as of April 26, 2021 (the “Effective Date”) by and between CANbridge Care Pharma Hong Kong Limited, a Hong Kong limited liability company, having its registered address at FLAT/RM A 12/F, ZJ300, 300 Lockhart Road, Wan Chai, Hong Kong (“CANbridge”) and LogicBio Therapeutics, Inc., a Delaware corporation having its principal place of business at 65 Hayden Ave., Floor 2, Lexington, MA 02421, United States (“LogicBio”).  CANbridge and LogicBio are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”

RECITALS

WHEREAS, CANbridge is a biopharmaceutical company that is developing and delivering life-changing therapeutics;

WHEREAS, LogicBio is a gene therapy company that is developing novel genetic medicines based on its proprietary technology;

WHEREAS, the Parties wish to jointly Develop Products Directed to the Targets, in accordance with the terms set forth in this Agreement;

WHEREAS, LogicBio desires to grant to CANbridge, and CANbridge desires to receive from LogicBio, an exclusive, worldwide license under the LogicBio Technology to exploit the Products in the CANbridge Field in the Territory, in accordance with the terms set forth in this Agreement; and

WHEREAS¸ LogicBio desires to grant to CANbridge, and CANbridge desires to receive from LogicBio, an exclusive option to obtain an exclusive license to develop and commercialize LB-001 in Greater China, in accordance with the terms set forth in this Agreement.

NOW, THEREFORE, the Parties hereto agree as follows:

Article 1
DEFINITIONS

1.1

Accounting Standards” means United States generally accepted accounting principles or International Financial Reporting Standards, as applicable, which principles or standards are currently used at the relevant time and consistently applied by the applicable Party.

1.2

Acquirer” has the meaning given in Section 2.6.2 (Effect of Change of Control on Exclusivity).

1.3

Acquisition Transaction” has the meaning set forth in Section 2.6.3 (Acquisition of Competing Product).

1.4

Additional Target Option” has the meaning set forth in Section 2.7 (Additional Target Option).

1.5

Additional Target Option Fee” has the meaning set forth in Section 8.2 (Additional Target Option Fee).

1.6

Adverse Event” means any untoward medical occurrence in a human clinical study subject or in a patient who is administered a product, whether or not considered related to such product,

  

 

 

 

 

 



including any undesirable sign (including abnormal laboratory findings of clinical concern), symptom, or disease associated with the use of a product.

1.7

Affiliate” means any Person directly or indirectly controlled by, controlling, or under common control with, a Party, but only for so long as such control continues.  For purposes of this definition, “control” (including, with correlative meanings, “controlled by,” “controlling,” and “under common control with”) will be presumed to exist with respect to a Person in the event of the possession, direct or indirect, of (a) the power to direct or cause the direction of the management and policies of such Person (whether through ownership of securities, by contract, including without limitation, variable interest entity contractual arrangements or otherwise), or (b) more than 50% of the voting securities or other comparable equity interests.  The Parties acknowledge that in the case of certain entities organized under the laws of certain countries outside of the United States, the maximum percentage ownership permitted by law for a foreign investor may be less than 50%, and that in such case, such lower percentage will be substituted in the preceding sentence, provided that such foreign investor has the power to direct or cause the direction of the management and policies of such Person.  Neither of the Parties will be deemed to be an “Affiliate” of the other solely as a result of their entering into this Agreement.

1.8

Agreement Payments” has the meaning set forth in Section 8.11 (Income Tax Withholding).

1.9

Alliance Manager” has the meaning set forth in Section 4.1.1 (Alliance Managers).

1.10

Allowable Overrun” has the meaning set forth in Section 8.4.4 (Allowable Overrun).

1.11

Applicable Law” means applicable laws, statutes, rules, regulations, and other pronouncements having the effect of law of any Governmental Authority that may be in effect from time to time, including disclosure obligations required by any securities exchange or securities commission having authority over a Party and any applicable rules, regulations, guidances, or other requirements of any Regulatory Authority that may be in effect from time to time.

1.12

Applicant” has the meaning set forth in Section 11.9.2 (Access to Confidential Information).

1.13

Applicant Response” has the meaning set forth in Section 11.9.3(b) (Disclosure of Applicant’s Response).

1.14

Assigned Regulatory Submissions” has the meaning set forth in Section 5.1.5(a) (Transfer of Other Assigned Regulatory Submissions).

1.15

Bankruptcy Filing” has the meaning set forth in Section 13.3 (Termination for Insolvency).

1.16

Bayh-Dole Act” means the Patent and Trademark Law Amendments Act of 1980, as amended, codified at 35 U.S.C. §§ 200-212, as well as any regulations promulgated pursuant thereto, including 37 C.F.R. Part 401, and any successor statutes or regulations.

1.17

Biosimilar Application” has the meaning set forth in Section 11.9.1 (Response to Biosimilar Applicants; Notice).

1.18

Biosimilar Product” means, with respect to a Product or LB-001, as applicable, in a country, any gene therapy product or genetic medicine product, as applicable, that is a generic, biosimilar, or interchangeable product with respect to such product sold by a Third Party [**] and that (a) is subject to a license for administration to humans under Section 351(a) or 351(k) of the PHSA and

2

 



(i) contains an active ingredient that is the same as the active ingredient of such product or (ii) is “biosimilar” (as defined in Section 351(i)(2) of the PHSA) or “interchangeable” (as defined in Section 351(i)(3) of the PHSA) to such product (or otherwise bioequivalent, biosimilar, interchangeable, or the like, in each case, to such product under analogous laws for gene therapy products or genetic medicine products), (b) has been licensed as a similar biological medicinal product by EMA pursuant to Directive 2001/83/EC, as may be amended, or any subsequent or superseding law, statute or regulation, or (c) has otherwise received Regulatory Approval as a generic, biosimilar, bioequivalent, or interchangeable product from another applicable Regulatory Authority in such country, including by referencing Regulatory Approvals (or data therein) of such product, or, in each case, (a), (b), or (c), an analogous law, statute, or regulation for gene therapy products or genetic medicine products.

1.19

BPCIA” has the meaning set forth in Section 11.9.1 (Response to Biosimilar Applicants; Notice).

1.20

Breaching Party” has the meaning set forth in Section 13.2.1 (Material Breach and Cure Period).

1.21

Business Day” means any day other than a Saturday, Sunday, or bank or other public holiday in Boston, Massachusetts, the People’s Republic of China or Hong Kong.

1.22

Calendar Quarter” means the respective periods of three consecutive calendar months ending on March 31st, June 30th, September 30th, or December 31st in any Calendar Year; provided, however, that the first Calendar Quarter of the Term will extend from the Effective Date to the end of the first complete Calendar Quarter thereafter and the last Calendar Quarter of the Term will end on the effective date of termination or expiration of the Agreement.

1.23

Calendar Year” means any calendar year beginning on January 1st and ending on December 31st, provided, however, that the first Calendar Year of the Term will begin on the Effective Date and end on December 31 and the last Calendar Year of the Term will end on the effective date of termination or expiration of the Agreement.

1.24

CANbridge” has the meaning set forth in the Preamble.

1.25

CANbridge Background Improvement Know-How” means any Know-How that (a) is Created by or on behalf of either Party or its Affiliates in connection with the performance of activities under this Agreement, (b) constitutes an improvement to CANbridge Background Technology disclosed to LogicBio or its Affiliates in performance of this Agreement and (c) is not LogicBio Background Improvement Technology, in each case to the extent such Know-How relates specifically to a Target or a Product (including any gene therapy construct encapsulated in the Product).

1.26

CANbridge Background Improvement Patent Right” means any Patent Right that claims CANbridge Background Improvement Know-How.

1.27

CANbridge Background Improvement Technology” means collectively, (a) the CANbridge Background Improvement Know-How and (b) CANbridge Background Improvement Patent Rights.

1.28

CANbridge Background Know-How” means all Know-How, other than Joint Collaboration Know-How and CANbridge Collaboration Know-How, that CANbridge or any of its Affiliates Controls as of the Effective Date or that comes into the Control of CANbridge or any of its Affiliates during the Term and that is disclosed to LogicBio or its Affiliate under this Agreement..

3

 



1.29

CANbridge Background Patent Right” means any Patent Right, other than any Joint Collaboration Patent Right or CANbridge Collaboration Patent Right, that CANbridge or any of its Affiliates Controls as of the Effective Date or that comes into the Control of CANbridge or any of its Affiliates during the Term and that is disclosed to LogicBio or its Affiliate under this Agreement.

1.30

CANbridge Background Technology” means (a) the CANbridge Background Know-How and (b) CANbridge Background Patent Rights.

1.31

CANbridge Co-Co Know-How” means any Know-How that (a) CANbridge or any of its Affiliates Control as of the Effective Date or that comes into the Control of CANbridge or any of its Affiliates during the Term and (b) is necessary or useful to Exploit the Products that are the subject of the Co-Development and Co-Commercialization Agreement in the CANbridge Field in accordance with the Co-Development and Co-Commercialization Agreement.

1.32

CANbridge Co-Co Patent Right” means any Patent Right that (a) CANbridge or any of its Affiliates Control as of the Effective Date or that comes into the Control of CANbridge or any of its Affiliates during the Term and (b) claims any CANbridge Co-Co Know-How or is otherwise necessary or useful to Exploit the Products that are the subject of the Co-Development and Co-Commercialization Agreement in the CANbridge Field in accordance with the Co-Development and Co-Commercialization Agreement.

1.33

CANbridge Collaboration Know-How” has the meaning set forth in Section 11.1.2(a) (CANbridge Collaboration Technology).

1.34

CANbridge Collaboration Patent Rights” has the meaning set forth in Section 11.1.2(a) (CANbridge Collaboration Technology).

1.35

CANbridge Collaboration Technology” means (a) the CANbridge Collaboration Know-How and (b) CANbridge Collaboration Patent Rights.

1.36

CANbridge Field” means the treatment, diagnosis or prevention of any and all indications in humans.

1.37

CANbridge House Marks” means CANbridge’s and its Affiliates’ trade names, corporate names and corporate logos.

1.38

CANbridge Indemnitee” has the meaning set forth in Section 12.1 (Indemnification by LogicBio).

1.39

CANbridge Licensed Know-How” means all Know-How that (a) is Controlled by CANbridge or any of its Affiliates as of the Effective Date or during the Term, (b) is not generally known, and (c) is [**] to perform LogicBio’s obligations under this Agreement.

1.40

CANbridge Licensed Patent Right” means any Patent Right that (a) is Controlled by CANbridge or any of its Affiliates as of the Effective Date or during the Term and (b) claims CANbridge Licensed Know-How or is otherwise [**] to perform LogicBio’s obligations under this Agreement.

1.41

CANbridge Licensed Technology” means collectively, (a) the CANbridge Licensed Know-How and (b) CANbridge Licensed Patent Rights.

4

 



1.42

“CANbridge Product Technology” means all Patent Rights and Know-How that (a) are Controlled by CANbridge or its Affiliates on the date of termination of this Agreement and (b) are necessary or otherwise actually used by CANbridge or its Affiliates prior to the date of termination to (i) Exploit any Product in the Territory in the CANbridge Field or (ii) if CANbridge exercises the LB-001 Option prior to the LB-001 Option Deadline, Exploit LB-001 in Greater China in the CANbridge Field.

1.43

CANbridge Response” has the meaning set forth in Section 11.9.3(c) (Preparation of CANbridge Response).

1.44

CANbridge Share” has the meaning set forth in Section 2.3.4 (New In-License Agreement Upfront / Milestones).

1.45

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 more than 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, other than any such transaction that would result in shareholders or equity holders of such Party immediately prior to such transaction owning more than 50% of the outstanding voting securities of the surviving entity (or its parent entity) immediately following such transaction; (c) the shareholders or equity holders of such Party approve a plan of complete liquidation of such Party, or an agreement for the sale or disposition by such Party of all or substantially all of such Party’s assets, other than pursuant to the transaction described above or to an Affiliate; or (d) the sale or transfer to a Third Party of all or substantially all of such Party’s consolidated assets taken as a whole.  Notwithstanding the foregoing, any transaction or series of transactions effected for the purpose of financing the operations of the applicable Party or one or more of its applicable Affiliates (such as a public offering of equity securities to investors) will not be deemed a “Change of Control” for purposes of this Agreement.

1.46

Claim” has the meaning set forth in Section 12.1 (Indemnification by LogicBio).

1.47

Clinical Trial” means any clinical trial in humans that 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 I/II Clinical Trial, Phase II Clinical Trial, Phase III Clinical Trial, Pivotal Clinical Trial, or any post-approval clinical trial in humans.

1.48

CMOmeans a Third Party contract manufacturing organization.

1.49

CMRI” means Children’s Medical Research Institute, an Australian corporation.

1.50

CMRI Agreement” means the License Agreement by and between LogicBio Australia and CMRI, dated as of [**], as the same may be amended from time to time in accordance with this Agreement.

1.51

Co-Development and Co-Commercialization Agreement” has the meaning set forth in Section 2.9.2 (Option Exercise).

1.52

Co-Development and Co-Commercialization Option” has the meaning set forth in Section 2.9.2 (Option Exercise).

5

 



1.53

Co-Owner” has the meaning set forth in the CMRI Agreement.

1.54

Combination Productmeans a product (a) that is sold in the form of a combination that contains or comprises a Product or LB-001 together with one or more other therapeutically active pharmaceutical agents (whether coformulated or copackaged or otherwise sold for a single price), (b) that contains or comprises a Product or LB-001 and is sold for a single invoice price together with any (i) companion diagnostic related to a Product or LB-001, as applicable, or (ii) product, process, service, or therapy other than a Product or LB-001, as applicable (such additional therapeutically active pharmaceutical agent, companion diagnostic, or product, process, service or therapy and each of (a) and (b)(i) or (b)(ii), an “Other Component”), or (c) that contains or comprises a Product or LB-001 and is defined as a “combination product” by the FDA pursuant to 21 C.F.R. §3.2(e) or its foreign equivalent.

1.55

Commercialization” means any and all activities directed to the marketing, promotion, distribution, offering for sale, sale, having sold, importing, having imported, exporting, having exported, or other commercialization of a pharmaceutical or biologic product, but excluding activities directed to Manufacturing, Development, or Medical Affairs. “Commercialize,” “Commercializing,” and “Commercialized” will be construed accordingly.

1.56

Commercialization Plan” has the meaning set forth in Section 6.1.3(e) (Commercialization Plan: Commercialization Reports)

1.57

Commercially Reasonable Efforts” means, with respect to the efforts to be expended, or considerations to be undertaken, by a Party or its Affiliate with respect to any objective or activity to be undertaken hereunder, [**].

1.58

Competing Infringement” has the meaning set forth in Section 11.5.1 (Patent Enforcement; Notice).

1.59

Competing Product” means any [**] other than a Product, that is [**] or [**].

1.60

Confidential Information” means, with respect to a Party subject to Section 10.1.2 (Confidential Information), all Know-How or other information, including proprietary information and materials (whether or not patentable) regarding or embodying such Party’s technology, products, business information, or objectives, that is communicated by or on behalf of such Party (the “Disclosing Party” with respect to such information) to the other Party (the “Receiving Party” with respect to such information) or its permitted recipients, including information disclosed by such Party prior to the Effective Date pursuant to the Confidentiality Agreement, provided that LogicBio Background Improvement Know-How will be the Confidential Information of LogicBio regardless of which Party first disclosed any such LogicBio Background Improvement Know-How to the other Party.

1.61

Confidentiality Agreement” means that certain Confidentiality Agreement, dated as of [**], by and between CANbridge Pharmaceuticals Inc. and LogicBio Therapeutics Inc.

1.62

Control” or “Controlledmeans, with respect to a Party, the possession by a Party or its Affiliates (whether by ownership, license, or otherwise, other than pursuant to this Agreement) of, (a) with respect to any tangible Know-How or Materials, the legal authority or right to physical possession of such tangible Know-How or Materials, with the right to provide such tangible Know-How or Materials to the other Party on the terms set forth herein, (b) with respect to Patent Rights, intangible Know-How, or other intellectual property, the legal authority or right to grant a license,

6

 



sublicense, access, or right to use (as applicable) to the other Party under such Patent Rights, intangible Know-How, or other intellectual property on the terms set forth herein, or (c) with respect to a product or component thereof, the legal authority or right to grant a license, sublicense, access, or right to use (as applicable) to the other Party under Patent Rights that Cover or proprietary Know-How that is incorporated in or embodies such product or component on the terms set forth herein, in each case ((a), (b), and (c)), without breaching or otherwise violating the terms of any arrangement or agreement with a Third Party in existence as of the time such Party or its Affiliates would first be required hereunder to grant the other Party such access, right to use, license, or sublicense; provided that, [**]. Notwithstanding anything in this Agreement to the contrary, a Party and its Affiliates will be deemed to not Control any of the foregoing (a)-(c) that are owned or controlled by a Third Party described in the definition of “Change of Control,” or such Third Party’s Affiliates (other than an Affiliate of such Party prior to the Change of Control) (each, an “Independent Affiliate”), (a) prior to the closing of such Change of Control, except to the extent that any such Patent Rights or Know-How were developed by such Third Party prior to such Change of Control using or incorporating such Party’s or its pre-existing Affiliate’s Know-How or Patent Rights, or (b) after such Change of Control to the extent that such Patent Rights or Know-How are developed or conceived by such Third Party or its Affiliates (other than such Party) after such Change of Control without using or incorporating such Party’s or its pre-existing Affiliate’s Know-How or Patent Rights and are not developed or conceived by personnel who were employees or consultants of such Party or its pre-existing Affiliates.

1.63

Cost Report” has the meaning set forth in Section 8.6.3 (Quarterly True-Up).

1.64

Cover,” “Covering” or “Covered” means, with respect to a particular subject matter at issue and a relevant Patent Right or individual claim in such Patent Right, as applicable, that the manufacture, use, sale, offer for sale, or importation of such subject matter would infringe such Patent Right or, as to a pending claim included in such Patent Right, the making, using, keeping, selling, offering for sale or importation of such compound or product would infringe such Patent Right if such pending claim were to issue in an issued patent without modification.

1.65

Created” means created, made, developed, invented, generated, conceived, or reduced to practice. “Create” and “Creating” have their correlative meanings.

1.66

Cure Period” has the meaning set forth in Section 13.2.1 (Material Breach and Cure Period).

1.67

Debarred” means, with respect to an individual or entity, that such individual or entity has been 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 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.

1.68

Designated CMO” has the meaning set forth in Section 7.1.1(c)(ii) (Subsequent Manufacturing Technology Transfer).

1.69

Development” means all internal and external research, development, and regulatory activities related to pharmaceutical or biologic products, including (a) research, toxicology testing and studies, non-clinical and preclinical testing, studies, and other activities, and Clinical Trials, and (b) preparation, submission, review, and development of data or information for the purpose of submission to a Regulatory Authority to obtain authorization to conduct Clinical Trials and to

7

 



obtain, support, or maintain Regulatory Approval 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, but excluding activities directed to Manufacturing, Medical Affairs, or Commercialization.  Development will include development and regulatory activities for additional forms, formulations, or indications for a pharmaceutical or biologic product after receipt of Regulatory Approval of such product (including label expansion), including Clinical Trials initiated following receipt of Regulatory Approval or any Clinical Trial to be conducted after receipt of Regulatory Approval that was mandated by the applicable Regulatory Authority as a condition of such Regulatory Approval with respect to an approved formulation or indication (such as post-marketing studies, observational studies, in each case, if required by any Regulatory Authority in any region in the Territory to support or maintain Regulatory Approval for a pharmaceutical or biologic product in such region).Develop,” “Developing,” and “Developed” will be construed accordingly.

1.70

Development Milestone Event” has the meaning set forth in Section 8.5.1 (Development Milestones).

1.71

Development Milestone Payment” has the meaning set forth in Section 8.5.1 (Development Milestones).

1.72

Development Plan” has the meaning set forth in Section 6.1.3(b) (Development Plan).

1.73

Directed to” means, with respect to a given gene therapy product and a given Target, that such gene therapy product contains a nucleic acid sequence that encodes such Target, a homolog or ortholog of such Target, or a functional portion of such Target, homolog or ortholog.

1.74

Disclosing Party” has the meaning set forth in Section 1.60 (Confidential Information).

1.75

Dispute” has the meaning set forth in Section 14.1 ([**] Dispute Resolution Mechanism).

1.76

Divest” means, with respect to a Competing Product, the sale, exclusive license or other transfer by the applicable Party and its Affiliates of all of their development and commercialization rights with respect to such Competing Product to a Third Party without the retention or reservation of any development or commercialization obligation, interest or participation rights (other than solely an economic interest or the right to enforce customary terms contained in the relevant agreements effectuating such transaction).

1.77

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

1.78

Effective Date” has the meaning set forth in the preamble.

1.79

EMA” means the European Medicines Agency or any successor agency or authority having substantially the same function.

1.80

Executive Officers” has the meaning set forth in Section 4.2.7(b) (Decisions of the JSC).

1.81

Existing In-License Agreement” means any agreement set forth in Schedule 1.81 (Existing In-License Agreements), as updated from time to time.

1.82

Exploit” means to make, have made, import, export, distribute, use, have used, keep, sell, have sold, or offer for sale, including to research, Develop, Manufacture, have Manufactured, perform

8

 



or have performed Medical Affairs, Commercialize, register, modify, enhance, improve, or otherwise exploit.Exploitation” and “Exploiting” will be construed accordingly.

1.83

FD&C Act” means the Federal Food, Drug and Cosmetic Act, as the same may be amended or supplemented from time to time.

1.84

FDA” means the U.S. Food and Drug Administration, or any successor agency thereto.

1.85

First Commercial Sale” means, on a country-by-country and product-by-product basis, the first sale of a given Product or LB-001 under this Agreement by CANbridge, its Affiliates, or its Sublicensees to an end user or prescriber for use, consumption, or resale of such product in a country in the Territory (or, with respect to LB-001, in Greater China) in the CANbridge Field where Regulatory Approval and (in the case of countries outside the U.S.) any necessary Pricing and Reimbursement Approval of the product has been obtained and where the sale results in a recordable Net Sale. “First Commercial Sale” will not include: [**].

1.86

Force Majeure” means any event beyond the reasonable control of the affected Party, including embargoes; war or acts of war, including terrorism, insurrections, riots, or civil unrest; strikes, lockouts, or other labor disturbances; pandemics, epidemics, fire, floods, earthquakes, or other acts of nature; or acts, omissions, or delays in acting by any Governmental Authority (including the refusal of the competent Governmental Authorities to issue required Regulatory Approvals due to reasons other than the affected Party’s negligence or willful misconduct or any other cause within the reasonable control of the affected Party); and failure of plant or machinery (provided, in each case, that such event or failure could not have been prevented by the exercise of skill, diligence, and prudence that would be reasonably and ordinarily expected from a skilled and experienced person engaged in the same type of undertaking under the same or similar circumstances). The Parties agree that the effects of the COVID-19 pandemic that is ongoing as of the Effective Date (including related government orders) may be invoked as a Force Majeure for the purposes of this Agreement even though the pandemic is ongoing as of the Effective Date and those effects may be reasonably foreseeable (but are not known for certain) as of the Effective Date.

1.87

FTE” means a qualified full time person, or more than one person working the equivalent of a full-time person, where “full time” is based upon a total of [**] hours per Calendar Year of work carried out by one or more duly qualified employees of a Party or its Affiliates.

1.88

FTE Costs” means, for any period, the [**] in such period.  FTEs will be pro‑rated on a daily basis if necessary.

1.89

FTE Rate” means [**] per annum, subject, in each case, to [**].

1.90

Global Commercialization Plan for LB-001” has the meaning provided in Section 6.2.3 (Global Development and Commercialization of LB-001).

1.91

Global Development Plan for LB-001” has the meaning provided in Section 6.2.3 (Global Development and Commercialization of LB-001).

1.92

Good Laboratory Practices,” “GLP,” or “cGLP” means the then-current standards, practices and procedures promulgated or endorsed by the FDA as set forth in 21 C.F.R. Part 58 (or any successor statute or regulation), including related regulatory requirements imposed by the FDA and comparable regulatory standards, practices and procedures promulgated by the EMA, PMDA, or

9

 



other Regulatory Authority applicable to the Territory, as they may be updated from time to time, including applicable guidelines promulgated under the ICH.

1.93

Good Manufacturing Practices,” “GMP,” or “cGMP” means the then-current and phase appropriate good manufacturing practices required by the FDA, as set forth in the FD&C Act, as amended, and the regulations promulgated thereunder, for the Manufacture and testing of pharmaceutical materials, and comparable Applicable Law related to the manufacture and testing of pharmaceutical materials in jurisdictions outside the United States. “Good Manufacturing Practices,” “GMP,” or “cGMP” also means the quality guidelines promulgated by the International Conference on Harmonization (ICH), including the ICH Q7A, titled “Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients” and the policies promulgated thereunder, in each case, as they may be updated from time to time.

1.94

Governmental Authority” means any court, tribunal, arbitrator, agency, commission, department, ministry, official, authority, or other instrumentality of any nation, state, county, city, or other political subdivision thereof or of any multinational governmental body.

1.95

Greater China” means People’s Republic of China, Hong Kong, Macau and Taiwan.

1.96

IDL” has the meaning set forth in Section 5.2.1 (Responsibility).

1.97

Immediate Patent Infringement Action” has the meaning set forth in Section 11.9.3(d) (Negotiation; LogicBio Rights).

1.98

In-License Agreements” means, collectively, the Existing In-License Agreements and the New In-License Agreements.

1.99

IND” means (a) an Investigational New Drug application as defined in the FD&C Act, as amended, and applicable regulations promulgated thereunder by the FDA, (b) a Clinical Trial authorization application for a product filed with a Regulatory Authority in any other regulatory jurisdiction outside the U.S., the filing of which (in the case of (a) or (b)) is necessary to commence or conduct clinical testing of a pharmaceutical or biologic product in humans in such jurisdiction, or (c) documentation issued by a Regulatory Authority that permits the conduct of clinical testing of a pharmaceutical or biologic product in humans in such jurisdiction.

1.100

IND Effective Date” means, with respect to a Product, the earlier of (a) the date that is [**] following the filing of the first IND for such Product in the U.S. in the CANbridge Field, if the filing Party or its Affiliates has not received any notice of a clinical hold (including any complete or partial clinical hold) or any other administrative delay from the FDA during such [**] period; provided that, if the filing party or its Affiliate does receive a notice of such a clinical hold (including any complete or partial clinical hold) or there is such other administrative delay, then the applicable date under this clause (a) for such Product will be the date on which the FDA lifts such clinical hold or such other administrative delay is otherwise resolved and the FDA first allows such Product to be administered to a human pursuant to such IND, or (b) the date on which such Product is first permitted by the applicable Regulatory Authority in a Major European Market to be administered to a human in the CANbridge Field pursuant to an IND in accordance with Applicable Law.

1.101

Indemnifying Party” has the meaning set forth in Section 12.3.1 (Indemnification Procedure; Notice).

10

 



1.102

Indemnitee” has the meaning set forth in Section 12.3.1 (Indemnification Procedure; Notice).

1.103

Independent Affiliate” has the meaning set forth in Section 1.62 (Control).

1.104

Infringed Patent List” has the meaning set forth in Section 11.9.3(d) (Negotiation; LogicBio Rights).

1.105

Infringement Action” has the meaning set forth in Section 11.5.2(a) ([**]).

1.106

Initial Manufacturing Technology Transfer” has the meaning set forth in Section 7.1.1(c)(i) (Initial Manufacturing Technology Transfer).

1.107

Initial Patent List” has the meaning set forth in Section 11.9.3(a) (Preparation of Initial Patent List).

1.108

Initiating Party” has the meaning set forth in Section 11.5.2(f) (Infringement Actions for Infringements by Third Parties; Procedures).

1.109

Initiation” means, with respect to any Clinical Trial, [**] in such Clinical Trial.

1.110

Intellectual Property” means all Patent Rights, rights to Inventions, copyrights, design rights, trademarks, trade secrets, Know-How, materials, and all other intellectual property rights (whether registered or unregistered) and all applications and rights to apply for any of the foregoing anywhere in the world.

1.111

“Internal Revenue Code” means the United States Internal Revenue Code of 1986, as amended.

1.112

Invention” means any process, method, utility, formulation, composition of matter, article of manufacture, material, creation, discovery or finding, or any improvement thereof, that is conceived, reduced to practice, or otherwise invented, whether patentable or not.

1.113

Joint Collaboration Know-How” has the meaning set forth in Section 11.1.2(c) (Joint Collaboration Technology).

1.114

Joint Collaboration Patent Right” has the meaning set forth in Section 11.1.2(c) (Joint Collaboration Technology).

1.115

Joint Collaboration Technology” means (a) the Joint Collaboration Know-How and (b) Joint Collaboration Patent Rights.

1.116

JSC” has the meaning set forth in Section 4.2.1 (Joint Steering Committee; Formation).

1.117

Know-How” means any (a) proprietary scientific or business information or materials, including records, improvements, modifications, techniques, assays, 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 protectable), and (b) any information embodied in chemical or biological materials or physical embodiments of any of the foregoing.

11

 



1.118

LB-001” means LogicBio’s proprietary clinical-stage genetic medicine product designated as LB-001 on the Effective Date, [**].

1.119

LB-001 Competing Infringement” has the meaning set forth in Section 11.6.1 (Notice).

1.120

LB-001 Development Milestone Event” has the meaning set forth in Section 8.5.2 (Development Milestones for LB-001).

1.121

LB-001 Development Milestone Payment” has the meaning set forth in Section 8.5.2 (Development Milestones for LB-001).

1.122

LB-001 Development Plan” has the meaning set forth in Section 6.2.4(a) (LB-001 Development Plan).

1.123

LB-001 Domain Name” has the meaning set forth in Section 6.2.12(a) (Trademarks and Domain Names).

1.124

LB-001 Infringement Action” has the meaning set forth in Section 11.6.1 (Notice).

1.125

LB-001 JSC” has the meaning set forth in Section 4.4.1 (Formation; General Terms).

1.126

LB-001 Option” has the meaning set forth in Section 2.8.1 (Grant of LB-001 Option).

1.127

LB-001 Option Deadline” means [**].

1.128

LB-001 Option Exercise” has the meaning set forth in Section 2.8.2 (LB-001 Option Exercise).

1.129

LB-001 Option Fee” has the meaning set forth in Section 8.3 (LB-001 Option Fee).

1.130

LB-001 Royalty Period” has the meaning set forth in Section 8.7.2 (LB-001 Royalty Period).

1.131

LB-001 Sales Milestone Event” has the meaning set forth in Section 8.5.4 (Sales Milestones for LB-001).

1.132

LB-001 Sales Milestone Payment” has the meaning set forth in Section 8.5.4 (Sales Milestones for LB-001).

1.133

LB-001 Supply Period” has the meaning set forth in Section 7.2.1 (Manufacturing During LB-001 Supply Period).

1.134

LB-001 Supply Price” means, for LB-001 obtained by LogicBio from a Third Party and supplied to CANbridge, the [**] LogicBio to obtain such quantities of LB-001 [**] and, for LB-001 manufactured by LogicBio and its Affiliates and supplied to CANbridge hereunder, [**] LogicBio and its Affiliates in Manufacturing such quantities of LB-001[**].

1.135

LB-001 Trademark” has the meaning set forth in Section 6.2.12(a) (Trademarks and Domain Names).

1.136

Lead Clinical Candidate” means a research candidate that LogicBio proposes, and CANbridge agrees in writing, is suitable for continued development towards GLP toxicity studies.

12

 



1.137

Lead Product” has the meaning set forth in Section 7.1.1(a) (Supply During LogicBio Manufacturing Period).

1.138

Lead Regulatory Party” has the meaning set forth in Section 5.1.1 (Lead Regulatory Party).

1.139

LogicBio” has the meaning set forth in the Preamble.

1.140

LogicBio Background Improvement Know-How” means any Know-How that (a) is Created by or on behalf of either Party or its Affiliates in connection with the performance of activities under this Agreement and (b) constitutes an improvement to LogicBio Background Technology disclosed to CANbridge or its Affiliate in performance of this Agreement, in each case to the extent such Know-How does not relate specifically to a Target or a Product (including any gene therapy construct encapsulated in the Product).

1.141

LogicBio Background Improvement Patent Right” means any Patent Right that claims LogicBio Background Improvement Know-How.

1.142

LogicBio Background Improvement Technology” means collectively, (a) the LogicBio Background Improvement Know-How and (b) LogicBio Background Improvement Patent Rights.

1.143

LogicBio Background Know-How” means all Know-How, other than Joint Collaboration Know-How and LogicBio Collaboration Know-How, that LogicBio or any of its Affiliates Controls as of the Effective Date or that comes into the Control of LogicBio or any of its Affiliates during the Term.

1.144

LogicBio Background Patent Right” means any Patent Right, other than any Joint Collaboration Patent Right or LogicBio Collaboration Patent Right, that LogicBio or any of its Affiliates Controls as of the Effective Date or that comes into the Control of LogicBio or any of its Affiliates during the Term.

1.145

LogicBio Background Technology” means (a) the LogicBio Background Know-How and (b) LogicBio Background Patent Rights.

1.146

LogicBio CDMO Process Transfer” has the meaning set forth in Section 7.1.1(c)(i) (Initial Manufacturing Technology Transfer).

1.147

LogicBio Collaboration Know-How” has the meaning set forth in Section 11.1.2(b) (LogicBio Collaboration Technology).

1.148

LogicBio Collaboration Patent Rights” has the meaning set forth in Section 11.1.2(b) (LogicBio Collaboration Technology).

1.149

LogicBio Collaboration Technology” means (a) the LogicBio Collaboration Know-How and (b) LogicBio Collaboration Patent Rights.

1.150

LogicBio House Marks” means LogicBio’s and its Affiliates’ trade names, corporate names and corporate logos.

1.151

LogicBio Indemnitee” has the meaning set forth in Section 12.2 (Indemnification by CANbridge).

13

 



1.152

LogicBio LB-001 Know-How” means all Know-How that (a) is Controlled by LogicBio or any of its Affiliates as of the Effective Date or during the Term, (b) is not generally known, and (c) is [**] to Exploit LB-001 in the CANbridge Field in Greater China.

1.153

LogicBio LB-001 Patent Right” means any Patent Right that (a) is Controlled by LogicBio or any of its Affiliates as of the Effective Date or during the Term and (b) claims LogicBio LB-001 Know-How or is otherwise [**] to Exploit LB-001 in the CANbridge Field in Greater China. The LogicBio LB-001 Patent Rights as of the Effective Date are set forth on Schedule 1.153 (LogicBio LB-001 Patent Rights).

1.154

LogicBio LB-001 Technology” means collectively, (a) the LogicBio LB-001 Know-How and (b) LogicBio LB-001 Patent Rights.

1.155

LogicBio Licensed Know-How” means all Know-How that (a) is Controlled by LogicBio or any of its Affiliates as of the Effective Date or during the Term, (b) is not generally known, and (c) is [**] to Exploit any Product in the CANbridge Field, including, to the extent described in clauses (b) and (c), LogicBio’s interest in Joint Collaboration Know-How.

1.156

LogicBio Licensed Patent Right” means any Patent Right that (a) is Controlled by LogicBio or any of its Affiliates as of the Effective Date or during the Term and (b) (i) claims LogicBio Licensed Know-How or (ii) is otherwise [**] to Exploit any Product in the CANbridge Field, including, to the extent described in clauses (a) and (b), LogicBio’s interest in Joint Collaboration Patent Rights.  The LogicBio Licensed Patent Rights as of the Effective Date are set forth on Schedule 1.156 (LogicBio Licensed Patent Rights).

1.157

LogicBio Manufacturing Activities” has the meaning set forth in Section 7.1 (LogicBio Manufacturing Activities).

1.158

LogicBio Manufacturing Know-How” means all LogicBio Licensed Know-How that is related to a method used in Manufacturing any Product or component thereof.

1.159

LogicBio Manufacturing Period” has the meaning set forth in Section 7.1.1(a) (Supply During LogicBio Manufacturing Period).

1.160

LogicBio Product-Specific Licensed Patent Right” means any LogicBio Licensed Patent Right that includes claims that specifically recite the composition of matter, formulation or method of use of a Product or that pertain solely to a Target.

1.161

LogicBio Technology” means collectively, (a) the LogicBio Licensed Know-How and (b) LogicBio Licensed Patent Rights.

1.162

LogicBio’s Knowledge” means the actual knowledge [**], of the following: [**] of LogicBio.

1.163

Losses” has the meaning set forth in Section 12.1 (Indemnification by LogicBio).

1.164

MAA” means any 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), including all Biologics License Applications (BLA) or equivalent submitted to the FDA in the United States in

14

 



accordance with the PHSA or any analogous application or submission with any Regulatory Authority outside of the United States.

1.165

Major European Markets” means [**].

1.166

Major Market Country” means [**].

1.167

Manufacture” means activities directed to manufacturing, manufacturing process development, processing, formulating, packaging, labeling, filling, finishing, assembly, quality assurance, quality control, testing, and release, shipping, or storage of any pharmaceutical or biologic product (or any components or process steps involving any product or any companion diagnostic), placebo, or comparator agent, as the case may be, including process development, qualification, and validation, scale-up, pre-clinical, clinical, and commercial manufacture and analytic development, product characterization, and stability testing, but excluding activities directed to Development, Commercialization, or Medical Affairs. “Manufacturing” will be construed accordingly.

1.168

Manufacturing Committee” has the meaning set forth in Section 4.2.6(a) (Formation).

1.169

Manufacturing Technology Transfer” has the meaning set forth in Section 7.1.1(c)(ii) (Subsequent Manufacturing Technology Transfer).

1.170

Manufacturing Technology Transfer Plan” has the meaning set forth in Section 7.1.1(c)(iii) (Manufacturing Technology Transfer Plan).

1.171

Materials” has the meaning set forth in Section 3.4 (Materials Transfer).

1.172

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, 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 involve the promotion, marketing, sale, or other Commercialization of the Products and are not conducted by a Party’s medical affairs (or equivalent) departments.

1.173

Mono Product” has the meaning set forth in Section 1.174 (Net Sales).

1.174

Net Sales” means the gross amounts invoiced by CANbridge or its Affiliates or Sublicensees (other than Third Party Distributors) (each, a “Selling Party”) under this Agreement to Third Parties (including to Third Party Distributors), for the sale, supply or other disposition of any Product or LB-001, as applicable, less the following deductions actually taken, paid, accrued, allowed, included, or allocated with respect to such sales of such product, and in accordance with the applicable Accounting Standards:

[**].

Notwithstanding the foregoing, [**].

15

 



In the case of any Combination Product sold in a given country in the Territory, Net Sales for the purpose of determining royalties and Sales Milestone Events or LB-001 Sales Milestone Events, as applicable, of the Combination Product in such country will be calculated by [**].

If, on a country-by-country basis, the applicable Mono Product is sold separately in a country, but all of the Other Components in the Combination Product are not sold separately in such country, then Net Sales for the purpose of determining royalties and Sales Milestone Events of the Combination Product for such country will be calculated by [**].

If, on a country-by-country basis, the Product or LB-001, as applicable, included in the Combination Product is not sold separately as a Mono Product in such country, but all of the Other Components included in the Combination Product are sold separately in such country, then Net Sales for the purpose of determining royalties and Sales Milestone Events of the Combination Product for such country will be calculated by [**].

If neither the applicable Mono Product nor the Other Components in a Combination Product are sold separately in a given country, then [**].

1.175

“New In-License Agreement” has the meaning set forth in Section 2.3.2 (New In-License Agreements).

1.176

New License Agreement” has the meaning set forth in Section 2.2.3 (Survival of Sublicenses).

1.177

NMPA” has the meaning set forth in Section 5.2.1 (Responsibility).

1.178

Non-Breaching Party” has the meaning set forth in Section 13.2.1 (Material Breach and Cure Period).

1.179

Option Targetmeans [**].

1.180

Other Committee” has the meaning set forth in Section 4.2.8 (Other Committees).

1.181

Other Component(s)” has the meaning set forth in Section 1.174 (Net Sales).

1.182

Out-of-Pocket Costs” means, with respect to certain activities hereunder, [**].

1.183

Patent Challenge” has the meaning set forth in Section 13.5 (Termination for Patent Challenge).

1.184

Patent Rights” means any and all (a) patents, (b) patent applications, including all provisional and non-provisional applications, patent cooperation treaty (PCT) applications, substitutions, continuations, continuations-in-part, divisions and renewals, and all patent rights granted thereon, (c) all patents-of-addition, reissues, re-examinations and extensions or restorations by existing or future extension or restoration mechanisms, including supplementary protection certificates, patent term extensions, and equivalents thereof, (d) inventor’s certificates, letters patent, or (e) any other substantially equivalent form of government issued right, excluding any rights provided by Regulatory Exclusivity, substantially similar to any of the foregoing described in subsections (a) through (d) above, anywhere in the world.

1.185

Patent Term Extension” has the meaning set forth in Section 11.10 (Patent Term Extensions).

1.186

Per Product Annual Net Sales” has the meaning set forth in Section 8.5.4 (Royalties).

16

 



1.187

Person” means any individual, firm, corporation, partnership, limited liability company, trust, business trust, joint venture, Governmental Authority, association or other entity.

1.188

Pharmacovigilance Agreement” has the meaning set forth in Section 5.1.7 (Pharmacovigilance).

1.189

Phase I Clinical Trial” means a Clinical Trial (or any arm thereof) of a pharmaceutical or biologic product with the endpoint of determining initial tolerance, safety, metabolism, pharmacokinetic or pharmacodynamic information in single dose, single ascending dose, multiple dose, or multiple ascending dose regimens, that satisfies the requirements of U.S. federal regulation 21 C.F.R. § 312.21(a) and its successor regulation or equivalents in other jurisdictions.

1.190

Phase I/II Clinical Trial” means a Clinical Trial (or any arm thereof) of a pharmaceutical or biologic product with the endpoint of determining initial tolerance, safety, metabolism, pharmacokinetic or pharmacodynamic information in single dose, single ascending dose, multiple dose, or multiple ascending dose regimens, and evaluating its effectiveness for a particular indication or indications in one or more specified doses or its short term tolerance and safety, as well as its pharmacokinetic and pharmacodynamic information in patients with the indications under study, that is prospectively designed to generate sufficient data (if successful) to commence a Pivotal Clinical Trial for such product, and that satisfies the requirements of U.S. federal regulation 21 C.F.R. §§ 312.21(a) and (b) and its successor regulation or equivalents in other jurisdictions.

1.191

Phase II Clinical Trial” means a Clinical Trial (or any arm thereof) of a pharmaceutical or biologic product with the endpoint of evaluating its effectiveness for a particular indication or indications in one or more specified doses or its short term tolerance and safety, as well as its pharmacokinetic and pharmacodynamic information in patients with the indications under study, that is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial for such product, and that satisfies the requirements of U.S. federal regulation 21 C.F.R. § 312.21(b) and its successor regulation or equivalents in other jurisdictions.

1.192

Phase III Clinical Trial” means a Clinical Trial (or any arm thereof) of a pharmaceutical or biologic product on a sufficient number of patients, which trial the FDA permits to be conducted under an open IND and is designed to: (a) establish that the pharmaceutical or biologic product is safe and efficacious for its intended use; (b) define warnings, precautions and adverse reactions that are associated with the pharmaceutical or biologic product in the dosage range to be prescribed; and (c) support an MAA by a Regulatory Authority for the pharmaceutical or biologic product, and that satisfies the requirements of U.S. federal regulation 21 C.F.R. § 312.21(c) and its successor regulation or equivalents in other jurisdictions.

1.193

PHSA” has the meaning set forth in Section 11.9.1 (Response to Biosimilar Applicants; Notice).

1.194

Pivotal Clinical Trial” means any (a) Phase III Clinical Trial, or (b) other Clinical Trial (or any arm thereof) of a pharmaceutical or biologic product on a sufficient number of patients, the results of which, together with prior data and information concerning such product, are intended to be or otherwise are sufficient, without any additional Clinical Trial to meet the evidentiary standard for demonstrating the safety, purity, efficacy, and potency of such active substance of such product established by a Regulatory Authority in any particular jurisdiction and that is intended to support, or otherwise supports, the filing of an MAA by a Regulatory Authority in such jurisdiction (including any bridging study). Notwithstanding any provision to the contrary set forth in this Agreement, treatment of patients as part of an expanded access program, compassionate sales or use program (including named patient program or single patient program), or an indigent program,

17

 



in each case, will not be included in determining whether or not a Clinical Trial is a Pivotal Clinical Trial or whether a patient has been dosed thereunder.

1.195

PMDA” means Japan’s Pharmaceuticals and Medical Devices Agency and any successor agency or authority having substantially the same function.

1.196

Pricing and Reimbursement Approval” means the approvals, agreements, determinations, or governmental decisions establishing (a) a price for the applicable Product or LB-001, as applicable, that can be legally charged to consumers and (b) the level of reimbursement for the applicable Product or LB-001, as applicable, that will be reimbursed by Governmental Authorities, in each case ((a) and (b)) if required in a given jurisdiction or country in connection with Commercialization of such Product or LB-001, as applicable, in such jurisdiction or country.

1.197

Product means any gene therapy product resulting from the Research Program, [**] which is Directed to a Target, [**].

1.198

Proposed Biosimilar Product” has the meaning set forth in Section 11.9.1 (Response to Biosimilar Applicants; Notice).

1.199

Proposed CANbridge Response” has the meaning set forth in Section 11.9.3(c) (Preparation of CANbridge Response).

1.200

Proposed Initial Patent List” has the meaning set forth in Section 11.9.3(a) (Preparation of Initial Patent List).

1.201

Proposed Terms” has the meaning set forth in Section 2.9.4 (Third Party Independent Expert).

1.202

Prosecuting Party” means, with respect to any Patent Right, the Party that is responsible for the Prosecution of such Patent Right pursuant to Section 11.4 (Patent Prosecution).

1.203

Prosecution” means the filing, preparation, prosecution (including any interferences, reissue proceedings, reexaminations, oppositions and similar proceedings), post-grant reviews, requests for patent term adjustments, and maintenance of Patent Rights. For clarity, Prosecution excludes any applications or requests for Patent Term Extension. When used as a verb, “Prosecute” means to engage in Prosecution.

1.204

Publishing Party” has the meaning set forth in Section 10.9.3(a) (Publication Rights for Products).

1.205

Receiving Party” has the meaning set forth in Section 1.60 (Confidential Information).

1.206

Redacted Agreement” has the meaning set forth in Section 10.5 (Confidential Treatment).

1.207

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, or authorization of any Regulatory Authority necessary for the Development, Manufacture, Commercialization, or other Exploitation of a pharmaceutical or biologic product in such country or other regulatory jurisdiction, excluding, in each case, Pricing and Reimbursement Approval.

1.208

Regulatory Authority means any applicable Governmental Authority with jurisdiction or authority over the Development, Manufacture, Commercialization, or other Exploitation (including Regulatory Approval, or Pricing and Reimbursement Approval) of pharmaceutical or biologic

18

 



products in a particular country or other regulatory jurisdiction, and any corresponding national or regional regulatory authorities.

1.209

Regulatory Exclusivity” means any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Authority with respect to a Product or LB-001, as applicable in a country or jurisdiction in the Territory (or, with respect to LB-001, Greater China), other than a Patent Right, that prohibits a Person from (a) relying on safety or efficacy data generated by or on behalf of a Party with respect to such product in an application for Regulatory Approval of a Biosimilar Product, or (b) Commercializing a product or a Biosimilar Product, including orphan drug exclusivity or rights similar thereto in other countries or regulatory jurisdictions.

1.210

Regulatory Submissions” means any filing, application, or submission with any Regulatory Authority in support of the Development, Manufacture, Commercialization, or other Exploitation of 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.

1.211

Research Budget” means the budget set forth in the Research Plan, as amended from time to time in accordance with the terms of this Agreement.

1.212

Research Costs” means the FTE Costs and Out-of-Pocket Costs incurred by LogicBio or its Affiliates in the conduct of activities, including Development, regulatory, and Manufacturing activities, under the Research Plan.

1.213

Research Phase” means, with respect to a Target, the period beginning (a) for (i) each Option Target for which CANbridge exercises the Additional Target Option, on the date of the inclusion of such Target under the Research Plan pursuant to Section 2.7 (Additional Target Option) and (ii) any other Target, on the Effective Date, and continuing until (b) [**].

1.214

Research Plan” means the research plan setting forth the activities to be conducted under this Agreement to identify and develop gene therapy products Directed To Targets until the end of the applicable Research Phase, the initial form of which is attached as Exhibit A to this Agreement, as amended from time to time in accordance with the terms of this Agreement.

1.215

Research Program” means the activities conducted under the Research Plan.

1.216

Royalty Period” has the meaning set forth in Section 8.6.2 (Royalty Period).

1.217

Sales Milestone Event” has the meaning set forth in Section 8.5.2 (Sales Milestones).

1.218

Sales Milestone Payment” has the meaning set forth in Section 8.5.2 (Sales Milestones).

1.219

Selling Party” has the meaning set forth in Section 1.174 (Net Sales).

1.220

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 contract research organizations, Third Party Distributors, or CMOs), excluding all Sublicensees.

19

 



1.221

Sublicensees” means any Third Party to whom CANbridge or any of its Affiliates grants a sublicense of its rights hereunder to Exploit Products or, if CANbridge has exercised the LB-001 Option prior to the LB-001 Option Deadline, LB-001, excluding all Subcontractors.

1.222

Subsequent Manufacturing Technology Transfer” has the meaning set forth in Section 7.1.1(c)(ii) (Subsequent Manufacturing Technology Transfer).

1.223

Target” means each of (a) [**], (b) [**], and (c) each Option Target with respect to which CANbridge has exercised an Additional Target Option.

1.224

Taxes” has the meaning set forth in Section 8.11 (Income Tax Withholding).

1.225

Term” has the meaning set forth in Section 13.1 (Term).

1.226

Terminated Target” means any Target with respect to which the Agreement is terminated. If the Agreement is terminated in its entirety, then all Targets will be Terminated Targets.

1.227

Territory” means worldwide.

1.228

Third Party” means any Person other than CANbridge or LogicBio or their respective Affiliates.

1.229

Third Party Distributor” means, with respect to a country, any Third Party that purchases its requirements for Products or LB-001, as applicable, in such country from CANbridge or its Affiliates or Sublicensees and is appointed as a distributor to distribute, market, and resell such product in such country, even if such Third Party is granted ancillary rights to Develop, package, or obtain Regulatory Approval of such product in order to distribute, market, or sell such product in such country.

1.230

Third Party Patent Challenge” has the meaning set forth in Section 11.8.3 (Parties’ Patent Rights).

1.231

Trademark” means all trademarks, service marks, trade names, brand names, sub-brand names, trade dress rights, product configuration rights, certification marks, collective marks, logos, taglines, slogans, designs or business symbols and all words, names, symbols, colors, shapes, designations or any combination thereof that function as an identifier of source or origin or quality, whether or not registered, and all statutory and common law rights therein, and all registrations and applications therefor, together with all goodwill associated with, or symbolized by, any of the foregoing.

1.232

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

1.233

Valid Claim” means, [**], (a) a claim of any issued and unexpired patent [**] whose validity, enforceability, or patentability has not been terminated by any of the following: [**], or (b) a claim within a patent application [**].

20

 



Article 2
LICENSE GRANTS; ADDITIONAL TARGET OPTION; LB-001 OPTION; CO-DEVELOPMENT AND CO-COMMERCIALIZATION OPTION

2.1

License to CANbridge.  Subject to the terms and conditions of this Agreement, LogicBio hereby grants to CANbridge an exclusive (even as to LogicBio, except to the extent necessary or reasonably useful for LogicBio to perform (or have performed) the activities allocated to LogicBio under this Agreement), worldwide, royalty-bearing license, with the right to sublicense through multiple tiers (subject to the provisions of Section 2.2 (Sublicensing by CANbridge; Responsibility)), under LogicBio’s interest in the LogicBio Technology to Exploit the Products in the CANbridge Field.

2.2

Sublicensing and Subcontracting by CANbridge; Responsibility.

 

2.2.1

Sublicensing Rights; Subcontracting.  Subject to Section 2.3 (Existing In-License Agreements) and this Section 2.2 (Sublicensing by CANbridge; Responsibility), and without limiting Section 14.1 (Performance through Affiliates) CANbridge may grant sublicenses under Section 2.1 (License to CANbridge) through multiple tiers to any of its Affiliates or to any Third Party, and may otherwise subcontract the performance of its obligations and the exercise of its rights under this Agreement to any Affiliate or to any Third Party, provided that any such sublicense granted by CANbridge, its Affiliate or its Third Party Sublicensee and any such subcontracting arrangement will be consistent with the terms of this Agreement and will include invention assignment, confidentiality, non-disclosure, non-use and intellectual property provisions at least as restrictive or protective of the Parties as those set forth in this Agreement, except that, in the case of subcontractors, the term of any such confidentiality agreement shall be customary for the nature of the subcontractor. CANbridge will remain responsible for each such Affiliate’s or Third Party Sublicensee’s or subcontractor’s compliance with all obligations under this Agreement applicable to such Affiliate or Third Party Sublicensee or Third Party subcontractor and the grant of any sublicense or subcontract to any Affiliate or any Third Party will not relieve CANbridge of any of its obligations hereunder; provided that any subcontractor’s or Sublicensee’s actions under this Agreement will be attributable to CANbridge in determining whether CANbridge has used Commercially Reasonable Efforts under this Agreement. Notwithstanding the foregoing or anything to the contrary in this Agreement,  neither CANbridge nor its Affiliates will (a) grant sublicenses under the rights granted to CANbridge under this Agreement to any Third Party Sublicensee to conduct activities [**] or (b) subcontract the performance of its obligations or exercise of its rights under this Agreement to a Third Party conducting activities [**], in each case ((a) or (b)) without the prior written consent of LogicBio (not to be unreasonably withheld); provided, however, that LogicBio’s consent is hereby deemed given for CANbridge to subcontract obligations hereunder to any of the entities listed on Schedule 2.2.1.

 

2.2.2

Third Party Sublicensees.  CANbridge will provide LogicBio with written notice of any sublicense granted by CANbridge under Section 2.1 (License to CANbridge) to any Third Party no later than [**] after the effective date thereof (including the identity of the Third Party Sublicensee and the region in which such rights have been sublicensed and a general description of the rights granted). CANbridge or its applicable Affiliate will provide LogicBio with a true and complete copy of each Third Party sublicense agreement, if and as applicable, provided that CANbridge may redact

21

 



 

any confidential or proprietary information contained therein that is not necessary for determining compliance with the terms of this Agreement.

 

2.2.3

Survival of Sublicenses.  Upon termination of this Agreement for any reason, upon the request of any Sublicensee not then in breach of its sublicense agreement or the terms of this Agreement applicable to such Sublicensee, LogicBio hereby automatically grants to each such Sublicensee a direct license on the same terms as this Agreement, taking into account any difference in license scope, territory, and duration of sublicense grant (each a “New License Agreement”).  Within [**] of said termination (or such longer time period as is mutually agreed by LogicBio and such Sublicensee), LogicBio will enter into a confirmatory New License Agreement between LogicBio to such Sublicensee. Under any such New License Agreement between LogicBio and such former Sublicensee, such Sublicensee will be required to pay to LogicBio the same amounts in consideration for such direct grant as LogicBio would have otherwise received from CANbridge pursuant to this Agreement on account of such Sublicensee’s Exploitation of the Products had this Agreement not been terminated. Under such New License Agreement, the Parties agree that LogicBio will not be bound by any grant of rights broader than, and will not be required to perform any obligation other than those rights and obligations contained in, this Agreement and all applicable rights of LogicBio set forth in this Agreement will be included in such New License Agreement.

2.3

In-License Agreements.  

 

2.3.1

Existing In-License Agreements.  Notwithstanding any provision to the contrary in this Agreement, CANbridge acknowledges and agrees that the rights and licenses granted to CANbridge pursuant to Section 2.1 (Licenses to CANbridge) and Section 2.8 (LB-001 Option) are subject to the applicable terms of each Existing In-License Agreement with respect to the LogicBio Technology or LogicBio LB-001 Technology, as applicable, that is being sublicensed thereunder, to the extent such applicable terms have been disclosed to CANbridge or its Affiliates as of the Effective Date.  Any payment obligations arising under the Existing In-License Agreements as a result of the research, Development and Commercialization of a Product by CANbridge, its Affiliates and Sublicensees under this Agreement will be paid solely by LogicBio. Attached as Schedule 2.3.1 are all Existing In-License Agreements as amended as of the Effective Date.

 

2.3.2

New In-License Agreements.  Certain LogicBio Technology or LogicBio LB-001 Technology may be acquired by or licensed to LogicBio during the Term pursuant to an agreement with a Third Party executed after the Effective Date (each, a “New In-License Agreement”).  For any New In-License Agreement pursuant to which LogicBio or its Affiliates would obtain rights to any Know-How or Patent Right that would, if solely-owned and internally developed by LogicBio, be included in the LogicBio Technology or LogicBio LB-001 Technology hereunder, LogicBio will [**].

 

2.3.3

New In-License Agreement Royalties.  CANbridge shall [**] royalties arising under the New In-License Agreement(s) as a result of Net Sales by CANbridge, its Affiliates or Sublicensees of LB-001 or Products. [**].

 

2.3.4

New In-License Agreement Upfront/Milestones.  Any up-front fees or milestone payments arising under any New In-License Agreement shall be [**].

22

 



 

 

2.3.5

Opt-Out.  Notwithstanding the foregoing provisions of this Section 2.3 (In-License Agreements), CANbridge may elect [**] and, thereafter, CANbridge shall have no obligation to [**] under such New In-License Agreement with respect to such Products or LB-001, as applicable, other than any such payments that had accrued prior to such election.

2.4

Licenses to LogicBio.

 

2.4.1

Collaboration License.  Subject to the terms and conditions of this Agreement, CANbridge hereby grants to LogicBio a royalty-free, non-exclusive license, with the right to sublicense solely in accordance with the provisions of Section 2.4.2 (Sublicensing and Subcontracting by LogicBio), under the CANbridge Licensed Technology for the purpose of performing LogicBio’s obligations under this Agreement, including the activities allocated to LogicBio under the Research Plan, in each case in accordance with the terms of this Agreement.

 

2.4.2

Sublicensing and Subcontracting by LogicBio.

 

(a)

LogicBio may grant sublicenses to practice the CANbridge Licensed Technology under Section 2.4.1 (Collaboration License) through multiple tiers to any of its Affiliates or to any Third Party solely as provided in this Section 2.4.2 (Sublicensing and Subcontracting by LogicBio).

 

(b)

LogicBio may enter into subcontracts with Affiliates or Third Parties acting by or for the benefit of LogicBio with respect to the performance of LogicBio’s obligations under this Agreement solely as provided in this Section 2.4.2 (Sublicensing and Subcontracting by LogicBio).

 

(c)

Each sublicense or subcontract entered into by LogicBio pursuant to this Section 2.4.2 (Sublicensing and Subcontracting by LogicBio) will be consistent with the terms of this Agreement and will include invention assignment, confidentiality, non-disclosure, non-use and intellectual property provisions at least as restrictive or protective of the Parties as those set forth in this Agreement, except that the term of any such confidentiality agreement shall be customary for the nature of the sublicensee or subcontractor. No grant of any sublicense or subcontract to a Third Party or an Affiliate will relieve LogicBio of its obligations hereunder. LogicBio will provide CANbridge with written notice of any sublicense granted by LogicBio to a Third Party under Section 2.4 (Licenses to LogicBio) no later than [**] after the effective date thereof (including the identity of the Third Party sublicensee and the territory in which such rights have been sublicensed) and will provide CANbridge with a true and complete copy of each sublicense agreement, except that LogicBio may redact any confidential or proprietary information contained therein that is not necessary for CANbridge to determine compliance with this Agreement.

2.5

No Implied Licenses.  Except as expressly provided in this Agreement, neither Party will be deemed to have granted the other Party any license or other right with respect to any Intellectual Property of such Party.

23

 



2.6

Exclusivity and Restrictions.

 

2.6.1

Exclusivity Covenant.  Subject to Section 2.6.2 (Effect of Change of Control on Exclusivity) and Section 2.6.3 (Acquisition of Competing Product), during the Term neither Party nor its Affiliates will, directly or indirectly, (a) Exploit a Competing Product in the Territory or (b) license, sell, assign or otherwise provide rights to, or jointly develop with, a Third Party to enable such Third Party to Exploit a Competing Product in the Territory.

 

2.6.2

Effect of Change of Control on Exclusivity.  Notwithstanding the provisions of Section 2.6.1 (Exclusivity Covenant), if a Party undergoes a Change of Control during the Term and, as of immediately prior to or following the closing of such Change of Control, any Person that becomes an Independent Affiliate of such Party upon such Change of Control or any of such Person’s Affiliates existing immediately prior to such Change of Control or following such Change of Control other than the applicable Party  or Affiliates of such Party existing prior to such Change of Control (collectively, the “Acquirer”) is Exploiting any Competing Product, then the applicable Party will not be in breach of Section 2.6.1 (Exclusivity Covenant) as a result of such activities with respect to any such Competing Product (provided that, with respect to Competing Products that arise after such Change of Control, the Acquirer does not access or use any intellectual property Controlled by the applicable Party in the conduct of activities related to such Competing Product), and the applicable Party or the Acquirer, as applicable, will, (a) adopt reasonable procedures to segregate all Exploitation of the Competing Product from Exploitation of Products under this Agreement, and conduct any activities under this Agreement separately from all activities relating to the Competing Product, including through the maintenance of separate lab notebooks and records; and (b) establish reasonable firewall protections and safeguards designed to ensure the activities of its personnel under this Agreement are segregated from all activities relating to the Competing Product (except that management personnel may review and evaluate plans and information regarding the Exploitation of products under this Agreement as well as the Competing Product in connection with portfolio decision-making).

 

2.6.3

Acquisition of Competing Product. Notwithstanding the provisions of Section 2.6.1 (Exclusivity Covenant), if a Party or any of its Affiliates acquires rights to Exploit a Competing Product as the result of a merger, acquisition or combination with or of a Third Party other than a Change of Control (each, an “Acquisition Transaction”), such Party will, within [**] after the closing of such Acquisition Transaction, notify the other Party in writing of such acquisition and either:

 

(a)

notify the other Party in writing that such Party or its Affiliate will Divest its rights to such Competing Product, in which case, within [**] after the closing of the Acquisition Transaction, such Party or its Affiliate will Divest such Competing Product; or

 

(b)

notify the other Party in writing that it is ceasing all such Exploitation with respect to the Competing Product, in which case, within [**] after the other Party’s receipt of such notice, such Party and its Affiliates will cease all such activities.

24

 



 

Prior to the time of divestiture pursuant to Section 2.6.3(a) or prior to the termination of activities pursuant to Section 2.6.3(b), as applicable, the relevant Party and its Affiliates will (a) adopt reasonable procedures to segregate all Exploitation of the Competing Product from Exploitation of Products under this Agreement, and conduct any activities under this Agreement separately from all activities relating to the Competing Product, including through the maintenance of separate lab notebooks and records; and (b) establish reasonable firewall protections and safeguards designed to ensure the activities of its personnel under this Agreement are segregated from all activities relating to the Competing Product (except that management personnel may review and evaluate plans and information regarding the Exploitation of products under this Agreement as well as the Competing Product in connection with portfolio decision-making).

 

2.6.4

Non-Solicitation. During the Term, neither Party, nor any Affiliate thereof, will, or will assist any Third Party to, [**].

2.7

Additional Target Option. LogicBio hereby grants to CANbridge, on an Option Target-by-Option Target basis, exclusive options to include each Option Target as a Target under this Agreement in accordance with the terms of this Section 2.7 (Additional Target Option) (each such option with respect to an Option Target, an “Additional Target Option”). [**].

2.8

LB-001 Option.

 

2.8.1

Grant of LB-001 Option. Subject to the terms of this Agreement, LogicBio hereby grants to CANbridge an exclusive option to obtain an exclusive royalty-bearing license, with the right to sublicense through multiple tiers (subject to the provisions of Section 2.8.4 (Sublicensing of LB-001 Rights)), under the LogicBio LB-001 Technology solely to (a) Develop and conduct Medical Affairs with respect to LB-001 in the CANbridge Field in Greater China for the purpose of Commercializing LB-001 in the CANbridge Field in Greater China, and (b) Commercialize LB-001 in the CANbridge Field in Greater China (such option, the “LB-001 Option”).

 

2.8.2

LB-001 Option Exercise. CANbridge may exercise the LB-001 Option at any time prior to the LB-001 Option Deadline by (a) providing written notice thereof to LogicBio and (b) paying the LB-001 Option Fee to LogicBio (such timely exercise of the LB-001 Option, “LB-001 Option Exercise”).

 

2.8.3

[**].

 

2.8.4

Sublicensing of LB-001 Rights. The provisions of Section 2.2 (Sublicensing by CANbridge; Responsibility) will apply, mutatis mutandis, to any sublicense granted by CANbridge or its Affiliates under the licenses and rights granted to CANbridge under Section 2.8.1 (Grant of LB-001 Option).

 

2.8.5

LB-001 Exclusivity and Restrictions. Subject to Section 2.6.2 (Effect of Change of Control on Exclusivity) and Section 2.6.3 (Acquisition of Competing Product), which will apply mutatis mutandis to the restrictions set forth in this Section 2.8.5 (LB-001 Exclusivity and Restrictions), during the Term prior to the LB-001 Option Deadline and, solely if CANbridge exercises the LB-001 Option prior to the LB-001 Option Deadline, during the Term, neither Party nor its Affiliates will, directly or indirectly (i) Exploit any genetic medicine product, other than LB-001, that is intended for use

25

 



 

within the CANbridge Field and is Directed to the same target as LB-001 in Greater China or (ii) license, sell, assign or otherwise provide rights to, or jointly develop with, a Third Party to enable such Third Party to Exploit any such product in Greater China.

 

2.8.6

[**] LB-001 Option for Safety Reasons. Notwithstanding anything to the contrary in this Agreement, (a) in the event that the Development of LB-001 is suspended due to a clinical hold prior to the LB-001 Option Deadline, LogicBio will [**], and (b) if LogicBio or its Affiliate or sublicensee decides to terminate a Clinical Trial of LB-001 and terminate the Development of LB-001 for safety reasons prior to the LB-001 Option Deadline, LogicBio will [**].

2.9

LogicBio Co-Development and Co-Commercialization Option.

 

2.9.1

Development Cost Report. Prior to LogicBio’s exercise of the Co-Development and Co-Commercialization Option, upon request by LogicBio from time to time with respect to any particular Target for which LogicBio has the right to exercise the Co-Development and Co-Commercialization Option, CANbridge will promptly deliver to LogicBio a report of CANbridge’s expenses relating to the Development and Manufacture of Products Directed to such Target as of the date of the request by LogicBio to enable LogicBio to determine whether it desires to exercise the Co-Development and Co-Commercialization Option with respect to such Target.

 

2.9.2

Option Exercise. At any time prior to [**] for the first Product Directed to a Target that is subject to an Additional Target Option under this Agreement, LogicBio will have the option to enter into a worldwide, co-exclusive (with CANbridge) Co-Development and Co-Commercialization Agreement (the “Co-Development and Co-Commercialization Agreement”) for all Products Directed to such Target (the “Co-Development and Co-Commercialization Option”), which option may be exercised  by LogicBio by providing written notice of such exercise to CANbridge identifying the Target that is the subject of the Co-Development and Co-Commercialization Option.

 

2.9.3

Terms of Co-Development and Co-Commercialization Agreement. In the event that LogicBio exercises the Co-Development and Co-Commercialization Option, the Parties will [**] and enter into a Co-Development and Co-Commercialization Agreement [**] the terms and conditions of which agreement [**].

 

2.9.4

Third Party Independent Expert. In the event that the Parties are unable to agree upon the terms of the Co-Development and Co-Commercialization Agreement [**].

 

2.9.5

Economics Upon Execution. Following the execution by both Parties of the Co-Development and Co-Commercialization Agreement, [**].

Article 3
RESEARCH PROGRAM

3.1

Research Plan.  The initial Research Plan is attached as Exhibit A (Research Plan) hereto. Subject to Section 2.7 (Additional Target Option), either Party may propose an amendment to the Research Plan by submitting such proposed amendment in writing to the JSC for review and approval under Section 4.2.4(b) (Responsibilities). Upon the JSC’s approval of such proposed amendment, the Research Plan will be deemed to be amended by such amendment.

26

 



3.2

Performance of Activities under Pre-Clinical Plans.

 

3.2.1

Responsibility; Diligence.  Each Party will have sole responsibility for the conduct of the activities allocated to such Party under the Research Plan. Each Party will [**].

 

3.2.2

Costs of Activities.  CANbridge will pay LogicBio for all Research Costs in accordance with the terms set forth in Section 8.4 (Payment of Research Costs). Except as provided in this Agreement, each Party will be responsible for all costs and expenses incurred by or on behalf of such Party in the performance of all activities allocated to such Party under the Research Plan.

 

3.2.3

Information and Reports.  At each meeting of the JSC, each Party [**].

3.3

Recordkeeping; Audits. Each Party will, and will require its Affiliates and subcontractors to, maintain materially complete, current and accurate hard and electronic (as applicable) copies of records of all work conducted pursuant to its Development,  Manufacturing, Medical Affairs, and Commercialization activities under this Agreement, and all results, data, developments, and Know‑How Created in conducting such activities. Such records will accurately reflect all such work done and results achieved in sufficient detail to verify compliance with its obligations under this Agreement and will be in good scientific manner appropriate for applicable patent and regulatory purposes. With respect to LogicBio, such books and records will record only its Development and Manufacturing activities performed pursuant to this Agreement and will not include or be commingled with records of activities outside the scope of this Agreement. CANbridge will have the right, during normal business hours and upon reasonable advance notice [**] to inspect and copy all records of LogicBio maintained pursuant to this Section 3.3 (Recordkeeping; Audits); provided that CANbridge will maintain any of LogicBio’s Confidential Information in such records in confidence in accordance with Article 10 (Confidentiality).

3.4

Materials Transfer.  In order to facilitate the activities contemplated under the Research Plan, either Party may provide to the other Party certain biological materials or chemical compounds Controlled by the supplying Party to the extent permitted by Applicable Laws (collectively, “Materials”).  Except as otherwise expressly set forth under this Agreement, all such Materials delivered to the other Party will remain the sole property of the supplying Party, will be used only in the performance of activities conducted in accordance with the Research Plan, will not be used or delivered to or for the benefit of any Third Party without the prior written consent of the supplying Party (except for subcontractors performing any activities under the Research Plan), and will be used in compliance with Applicable Law.  Each Party will use the Materials supplied under this Agreement with prudence and appropriate caution in any experimental work as not all of their characteristics may be known. The supplying Party will provide the other Party the most current material safety data sheet for the Materials upon transfer of any Materials. LogicBio will notify CANbridge if any Materials supplied by LogicBio are “Licensed Materials” under the CMRI Agreement, and, without limiting the foregoing, CANbridge’s use of any Materials of LogicBio that are “Licensed Materials” under the CMRI Agreement will be subject to the additional terms and restrictions set forth in the CMRI Agreement with respect thereto. Except as expressly set forth in this Agreement, THE MATERIALS ARE PROVIDED “AS IS” AND WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR ANY PARTICULAR PURPOSE OR ANY WARRANTY THAT THE USE OF THE MATERIALS WILL NOT INFRINGE OR VIOLATE ANY PATENT OR OTHER PROPRIETARY RIGHTS OF ANY THIRD PARTY.

27

 



Article 4
GOVERNANCE

4.1

Alliance Management.

 

4.1.1

Alliance Managers.  As soon as practicable, but no later than [**] following the Effective Date, each Party will appoint a single individual who possesses sufficient alliance management experience and is otherwise suitably qualified and who has the requisite decision-making authority, in each case, to act as its alliance manager under this Agreement to support the collaboration hereunder (the “Alliance Manager”). Each Party may have an additional individual assigned as such Party’s Alliance Manager with respect to LB-001 following LB-001 Option Exercise. Each Party may change the Person designated as its Alliance Manager upon written notice (including via email notification) to the other Party, provided that such new Alliance Manager must possess sufficient alliance management experience and otherwise meet the requirements set forth in this Section 4.1.1 (Alliance Managers). [**].

 

4.1.2

Roles and Responsibilities.  The Alliance Managers will be responsible for (a) facilitating the flow of information and otherwise promoting communication of the day-to-day work under the Research Plan, (b) coordinating the activities under the Research Plan, (c) providing a single point of communication for seeking consensus both internally within the respective Party’s organization and between the Parties regarding key strategy and planning issues, (d) assisting the integration of teams across functional areas, and (e) performing such other functions as requested by the JSC or LB-001 JSC.

4.2

Joint Steering Committee; Other Committees.

 

4.2.1

Formation. As soon as practicable, but no later than [**] after the Effective Date, the Parties will establish a joint steering committee (“JSC”) to oversee the activities under this Agreement other than with respect to LB-001, with solely the functions described below. The JSC will be comprised of an equal number of representatives of CANbridge and of LogicBio, each of whom will have the appropriate authority, experience, and expertise to perform its responsibilities on the JSC. Within [**] after the Effective Date, each Party will designate in writing [**] such representatives for the JSC. The JSC may elect to vary the number of representatives from time to time.  Either Party may replace its representatives with similarly qualified individuals at any time upon prior written notice to the other Party (including via email notification).  If agreed by the JSC on a case-by-case basis (such agreement not to be unreasonably withheld, conditioned, or delayed), the JSC may invite other personnel of either Party from relevant support functions to participate in the discussions and meetings of the JSC, provided that such participants will have no voting authority at the JSC and that any non-employee participants are bound by written obligations of non-use and confidentiality and obligations to assign Intellectual Property that are at least as restrictive or protective of the Parties and their respective Intellectual Property and Confidential Information as those set forth in this Agreement, including those set forth in Article 10 (Confidentiality) and Article 11 (Intellectual Property).

 

4.2.2

JSC Chairperson.  The JSC will have a chairperson who will be a JSC member of [**] from the Effective Date until [**] and then the JSC chairperson will alternate on an annual basis between being a JSC member of CANbridge and a JSC member of

28

 



 

LogicBio. The chairperson will be responsible for calling and convening meetings (subject to Section 4.2.3 (Meetings)), but will have no special authority over the other members of the applicable JSC, and will have no additional voting rights.

 

4.2.3

Meetings.  The first meeting of the JSC will be held [**] after the Effective Date (or such longer period of time as mutually agreed by the Parties) (the “Initial JSC Meeting”). At the Initial JSC Meeting, among other activities, if any, as may be decided by the JSC, the JSC will review, revise as necessary to approve, and determine whether to approve the Initial Research Plan Amendment (as defined below) provided by the JRC (as defined below). The JSC will meet in person (alternating between a site designated by each of LogicBio and CANbridge) or by videoconference or teleconference (a) to discuss matters related to the Research Plan until the conclusion of activities under such Research Plan, [**] and (b) thereafter at least [**], or with such other frequency as the Parties may agree.  Specific meeting dates will be determined by agreement of the Parties. Without limiting the foregoing, either Party may also call a special meeting of the JSC (by videoconference or teleconference) upon at least [**] prior written notice to the other Party if such Party reasonably believes that a significant matter must be addressed before the next regularly scheduled meeting of the JSC, in which case such Party will provide the JSC materials reasonably adequate to enable an informed discussion by its members no later than [**] before the special meeting. LogicBio will organize the Initial JSC Meeting by videoconference or teleconference at a mutually agreeable time no later than [**] after the Effective Date. Each Party will be responsible for its own expenses relating to its attendance at or participation in JSC meetings. The Alliance Managers will jointly prepare and disseminate agendas and presentations no later than [**] in advance of each JSC meeting, unless otherwise agreed to by the Parties in writing. The Alliance Managers will jointly prepare and disseminate proposed minutes for the JSC meeting within [**] after each such meeting and will seek to obtain review and approval of such minutes by their respective companies within [**] thereafter. Such minutes will not be finalized until each representative on the JSC reviews and approves such minutes in writing; provided that any minutes will be deemed approved unless a representative on the JSC objects to the accuracy of such minutes within [**] after the circulation thereof.

 

4.2.4

Responsibilities.  The JSC will, in each case subject to Section 4.2.5 (Decision Making Authority) and Section 4.2.8 (Limits of JSC Decision Making Authority), and in each case other than to the extent included within the responsibilities of the LB-001 JSC:

 

(a)

oversee the activities under the Research Plan;

 

(b)

review and determine whether to approve the Initial Research Plan Amendment, and review and determine whether to approve any other amendment to the Research Plan (including the Research Budget) that is proposed by either Party under Section 3.1 (Research Plan), other than amendments to the Research Plan in connection with the exercise of the Additional Target Option with respect to an Option Target, which amendments must be mutually agreed to by the Parties;

 

(c)

review and discuss all progress reports and data provided by each Party under Section 3.2.3 (Information and Reports) with respect to the Research Plan;

29

 



 

 

(d)

determine whether the advancement criteria for each Product, as set forth in the Research Plan, have been achieved;

 

(e)

determine whether to approve any revision to the Allowable Overrun percentage set forth in Section 8.4 (Payment of Research Costs) with respect to the Research Budget;

 

(f)

oversee the LogicBio Process Development Activities, as described in Section 7.1.1(a) (Supply During LogicBio Manufacturing Period);

 

(g)

determine the date to start the Subsequent Manufacturing Technology Transfer, review and approve the Manufacturing Technology Transfer Plan, and determine whether each Manufacturing Technology Transfer is complete, in each case, as described in and subject to the limitations of Section 7.1.1(b) (Manufacturing Technology Transfer);

 

(h)

oversee the Development of the Products;

 

(i)

review and determine whether to approve each Development Plan and any amendment thereto, as described in Section 6.1.3(b) (Development Plan);

 

(j)

review each Commercialization Plan and any amendment thereto, as described in Section 6.1.3(e) (Commercialization Plan; Commercialization Reports);

 

(k)

coordinate the wind-down of each Party’s efforts under this Agreement, as described in Section 13.8.1(a) (Effects of Termination; Effects of Termination Generally; Wind-Down);

 

(l)

form such Other Committees as the Parties may agree under Section 4.2.8 (Other Committees);

 

(m)

attempt to resolve any disputes on matters within the JSC’s authority or within the authority of any Other Committee formed by the JSC on an informal basis and in good faith prior to the institution of escalation or other formal dispute resolution mechanisms hereunder; and

 

(n)

perform such other functions expressly allocated to the JSC in this Agreement or by the written agreement of the Parties.

 

4.2.5

Joint Research Committee.

 

(a)

Formation.  As soon as practicable, but no later than [**] after the Effective Date (or such longer period of time as mutually agreed by the Parties), the Parties will establish a joint research committee (“JRC”) to draft a proposed amendment to the Research Plan attached hereto as Exhibit A to describe all material aspects of the activities to be conducted under this Agreement to identify and develop gene therapy products Directed To Targets during the applicable Research Phase (the “Initial Research Plan Amendment”). The JRC shall provide the Initial Research Plan Amendment to the JSC within [**] of the Effective Date (or such longer period of time as mutually agreed by the Parties). The JRC will be comprised of an equal number of representatives of

30

 



 

CANbridge and of LogicBio, each of whom will have the appropriate authority, experience, and expertise to perform its responsibilities on the JRC. Within [**] after the Effective Date (or such longer period of time as mutually agreed by the Parties), each Party will designate in writing [**] such representatives for the JRC. The JRC may elect to vary the number of representatives from time to time. Either Party may replace its representatives with similarly qualified individuals at any time upon prior written notice to the other Party (including via email notification). If agreed by the JRC on a case-by-case basis (such agreement not to be unreasonably withheld, conditioned, or delayed), the JRC may invite other personnel of either Party from relevant support functions to participate in the discussions and meetings of the JRC, provided that such participants will have no voting authority at the JRC and that any non-employee participants are bound by written obligations of non-use and confidentiality and obligations to assign Intellectual Property that are at least as restrictive or protective of the Parties and their respective Intellectual Property and Confidential Information as those set forth in this Agreement, including those set forth in Article 10 (Confidentiality) and Article 11 (Intellectual Property).

 

(b)

Meetings.  The JRC will meet by videoconference or teleconference to discuss matters related to the Initial Research Plan Amendment, with such frequency as the Parties may agree, until the Initial Research Plan Amendment is submitted to the JSC. Specific meeting dates will be determined by agreement of the JRC members. [**]. Each Party will be responsible for its own expenses relating to its attendance at or participation in JRC meetings.

 

(c)

Responsibilities.  The JRC will draft the Initial Research Plan Amendment and send said Initial Research Plan Amendment to the JSC within [**] of the Effective Date (or such longer period of time as mutually agreed by the Parties).

 

(d)

Disbandment.  Unless otherwise agreed by the Parties, the JRC will be disbanded following the approval of the Initial Research Plan Amendment in accordance with the terms of this Agreement.

 

4.2.6

Manufacturing Committee.

 

(a)

Formation. As soon as practicable, but no later than [**] after the Effective Date, the Parties will establish a manufacturing committee (the “Manufacturing Committee”) to oversee LogicBio’s Manufacture of the Products under Section 7.1 (Manufacture and Supply of Products), coordinate the Manufacturing Technology Transfers under Section 7.1.1(c) (Manufacturing Technology Transfers) and prepare contingency plans in the event of [**] relating to LogicBio’s Manufacture of the Products under Section 7.1 (Manufacture and Supply of Products). The Manufacturing Committee will be comprised of an equal number of representatives of CANbridge and of LogicBio, each of whom will have the appropriate authority, experience, and expertise to perform its responsibilities on the Manufacturing Committee. Within [**] after the Effective Date, each Party will designate in writing [**] such representatives for the Manufacturing Committee. The Manufacturing Committee may elect to vary the number of representatives from time to time.  Either Party may replace its representatives with similarly qualified

31

 



 

individuals at any time upon prior written notice to the other Party (including via email notification).  If agreed by the Manufacturing Committee on a case-by-case basis (such agreement not to be unreasonably withheld, conditioned, or delayed), the Manufacturing Committee may invite other personnel of either Party from relevant support functions to participate in the discussions and meetings of the Manufacturing Committee, provided that such participants will have no voting authority at the Manufacturing Committee and that any non-employee participants are bound by written obligations of non-use and confidentiality and obligations to assign Intellectual Property that are at least as restrictive or protective of the Parties and their respective Intellectual Property and Confidential Information as those set forth in this Agreement, including those set forth in Article 10 (Confidentiality) and Article 11 (Intellectual Property).

 

(b)

Manufacturing Committee Chairperson.  The Manufacturing Committee will have a chairperson who will be a Manufacturing Committee member of [**] from the Effective Date until [**] and then the Manufacturing Committee chairperson will alternate on an annual basis between being a Manufacturing Committee member of CANbridge and a Manufacturing Committee member of LogicBio. The chairperson will be responsible for calling and convening meetings (subject to Section 4.2.6(c) (Meetings)), but will have no special authority over the other members of the Manufacturing Committee, and will have no additional voting rights.

 

(c)

Meetings. The Manufacturing Committee will meet [**] during the LogicBio Manufacturing Period. Except as set forth in the foregoing sentence, the general terms of Section 4.2.3 (Meetings) will apply to the Manufacturing Committee.

 

(d)

Responsibilities. The Manufacturing Committee will, in each case other than to the extent included within the responsibilities of the JSC or the LB-001 JSC:

 

(i)

oversee LogicBio’s Manufacture of the Products under Section 7.1 (Manufacture and Supply of Products);

 

(ii)

prepare the Manufacturing Technology Transfer Plan and submit to the JSC for approval pursuant to 7.1.1(c) (Manufacturing Technology Transfers);

 

(iii)

coordinate the Manufacturing Technology Transfers under Section 7.1.1(c) (Manufacturing Technology Transfers);

 

(iv)

[**] relating to LogicBio’s Manufacture of the Products under Section 7.1 (Manufacture and Supply of Products); and

 

(v)

perform such other functions expressly allocated to the Manufacturing Committee in this Agreement or by the written agreement of the Parties.

For clarity, except as otherwise agreed by the Parties, the Manufacturing Committee will not have any decision-making authority.

32

 



 

(e)

Disbandment. Unless otherwise agreed by the Parties, the Manufacturing Committee will be disbanded following the completion of the Subsequent Manufacturing Technology Transfer under Section 7.1.1(c) (Manufacturing Technology Transfer).

 

4.2.7

Decision Making.

 

(a)

General Process.  The JSC and any Other Committee established pursuant to this Agreement, if any, will only have the powers expressly assigned to it in this Article 4 (Governance) and elsewhere in this Agreement and except as expressly set forth in this Agreement will not have the authority to: (a) modify or amend the terms and conditions of this Agreement; (b) waive or determine either Party’s compliance with the terms and conditions of this Agreement or the Research Plan; or (c) determine any issue in a manner that would conflict with the express terms and conditions of this Agreement. All decisions of the JSC and any Other Committee 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 Other Committee will be effective unless there is a quorum at such meeting, and at all such meetings, a quorum will be reached if one voting representative of each Party is present or participating in such meeting. Except as otherwise expressly set forth in this Agreement, the phrase “determine,” “select,” “confirm,” “approve,” or “determine whether to approve” by the JSC and any Other Committee and similar phrases used in this Agreement will mean approval in accordance with this Section 4.2.5 (Decision Making), including the escalation and tie‑breaking provisions herein.

 

(b)

Decisions of the JSC.  The JSC will use good faith efforts to promptly resolve any such matter for which it has authority. If, after the use of good faith efforts, the JSC is unable to resolve any matter that is within the scope of the JSC’s authority or any other disagreement between the Parties that the Parties may agree to refer to the JSC, in each case, within a period of [**], then a Party may refer such matter for resolution in accordance with Section 4.2.7(c) (Referral to Executive Officers) to the Chief Executive Officer of LogicBio (or an executive officer of LogicBio designated by the Chief Executive Officer of LogicBio who has the power and authority to resolve such matter) and the Chief Executive Officer of CANbridge (or an executive officer of CANbridge designated by the Chief Executive Officer who has the power and authority to resolve such matter) (collectively, the “Executive Officers”).

 

(c)

Referral to Executive Officers.  If a Party makes an election under Section 4.2.7(b) (Decisions of the JSC) to refer a matter within the scope of the JSC’s authority 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 [**].

 

(d)

Resolution of Disputes.  If the Executive Officers are unable to reach agreement on any such matter referred to them within [**] after such matter is so referred (or such other period as the Executive Officers may agree upon),

33

 



 

then, subject to the terms of this Agreement, including Section 4.2.8 (Limits on JSC Decision Making Authority):

 

(i)

No Change; Status Quo.  Neither Party will have final decision-making authority over [**] must be decided by unanimous agreement of the Parties.

 

(ii)

Mutual Agreement. Notwithstanding any provision to the contrary in this Agreement, [**] may only be approved by the JSC by consensus or by mutual written agreement of the Executive Officers.

 

(iii)

LogicBio Decisions.  LogicBio will have the final decision-making authority with respect to [**].

 

(iv)

CANbridge Decisions. Except as set forth [**] CANbridge will have final decision-making authority.

 

4.2.8

Limits on JSC Decision Making Authority. Notwithstanding any provision to the contrary set forth in this Agreement, including Section 4.2.7(d) (Resolution of Disputes), in no event will any Party alone have the power or authority to: (a) modify or amend the terms and conditions of this Agreement (excluding the Research Plan); (b) impose any requirements on the other Party to undertake obligations beyond those for which it is responsible, or to forgo any of its rights, under this Agreement; (c) after the Initial Research Plan Amendment has been approved, make any material changes to the Research Plan, including any material reallocation of activities under the Research Plan or any material amendment to the Research Plan to add activities to the Research Plan, unless such changes [**]; (d) if the decision-making Party is CANbridge, allocate any activity to LogicBio under the Research Plan if the costs of such activity are not reasonably included in the Research Budget; (e) waive such Party’s compliance with the terms and conditions of this Agreement; (f) determine any issue in a manner that would conflict with the express terms and conditions of this Agreement; (g) impose any requirement on the other Party to perform any act that the other Party reasonably believes (i) to be inconsistent with Applicable Law, or (ii) would cause the other Party to infringe or misappropriate any Intellectual Property of any Third Party; (h) make any determination that such Party has fulfilled its obligations under this Agreement or that the other Party has breached this Agreement; or (i) make any decision that is expressly stated to require the mutual agreement of the Parties or approval of the other Party and to not be subject to the decision-making authority of the other Party under Section 4.2.7(d) (Resolution of Disputes).

4.3

Other Committees.  If agreed by the Parties, the JSC may form other committees or working groups as may be necessary or desirable to facilitate the activities under this Agreement (each such committee and the Manufacturing Committee, an “Other Committee”).  A Party may refer any dispute on a matter within an Other Committee’s authority to the JSC for resolution. No such Other Committees’ authority may exceed that specified for the JSC in this Article 4 (Governance).

4.4

LB-001 Joint Steering Committee.

 

4.4.1

Formation; General Terms. Within [**] following LB-001 Option Exercise, the Parties will establish a joint steering committee to oversee the activities under this Agreement with respect to LB-001 (the “LB-001 JSC”), with solely the functions

34

 



 

described below. The general terms of Section 4.2.1 (Formation) through Section 4.2.3 (Meetings) will apply to the LB-001 JSC, mutatis mutandis; provided that (a) the LB-001 JSC chairperson will [**] a LB-001 JSC member from [**] and (b) the LB-001 JSC will meet [**] during the Term following LB-001 Option Exercise.

 

4.4.2

Responsibilities of LB-001 JSC. The JSC will:

 

(a)

subject to LogicBio’s rights under Section 6.2.3 (LB-001 Development Plan) review the LB-001 Development Plan (or any material updates thereto) for the Development of LB-001 in Greater China conducted by or on behalf of CANbridge and the Global Development Plan for LB-001 for the Development of LB-001 outside of Greater China conducted by or on behalf of LogicBio;

 

(b)

review CANbridge’s regulatory activities and strategy for LB-001 in Greater China and the global regulatory strategy for LB-001 outside Greater China;

 

(c)

subject to any other applicable terms of this Agreement, facilitate the exchange of data, information, material or results relating to the Development of LB-001 required to be provided to the LB-001 JSC pursuant to this Agreement;

 

(d)

facilitate the exchange of LogicBio LB-001 Technology that is necessary or useful for CANbridge to Develop and Commercialize LB-001;

 

(e)

review and discuss the LB-001 Commercialization Plan and summaries of LB-001 Commercialization activities undertaken by or on behalf of CANbridge;

 

(f)

review and discuss the Global Commercialization Plan for LB-001, and any updates thereto, provided by LogicBio;

 

(g)

coordinate the wind-down of each Party’s efforts under this Agreement with respect to LB-001, as described in Section 13.8.1(a) (Effects of Termination; Effects of Termination Generally; Wind-Down);

 

(h)

serve as a forum for the discussion of Development and Commercialization activities with respect to LB-001.

 

4.4.3

LB-001 JSC Decision-Making. The LB-001 JSC will be a consultative body and will not have any independent decision-making authority unless otherwise agreed to by the Parties.

Article 5
REGULATORY MATTERS

5.1

Regulatory Matters for Products.

 

5.1.1

Lead Regulatory Party.  On a Target-by-Target basis, (a) prior to [**] for a given Target, LogicBio will be the “Lead Regulatory Party” with respect to all Products Directed to such Target and (b) thereafter, CANbridge will be the “Lead Regulatory Party” with respect to all Products Directed to such Target.

35

 



 

 

5.1.2

Responsibility. Except as otherwise provided in this Agreement or in the Research Plan, the Lead Regulatory Party will be solely responsible for, and will have sole control over, preparing, filing, and maintaining Regulatory Submissions and communicating with Regulatory Authorities in the Territory with respect to each Product within the CANbridge Field [**], provided that, [**]. The Lead Regulatory Party will use [**] to prepare, file, and maintain Regulatory Submissions and communicate with Regulatory Authorities in the Territory with respect to each Product within the CANbridge Field, and to otherwise fulfill its regulatory responsibilities under the Research Plan. Each Party will, and will cause its Affiliates to, reasonably cooperate with the applicable Lead Regulatory Party with respect to all regulatory matters relating to the Products in the CANbridge Field in the Territory, provided that [**].

 

5.1.3

Involvement of Non-Lead Regulatory Party.  The Lead Regulatory Party will:

 

(a)

provide the other Party with (i) reasonable advance notice (and in no event less than [**] advance notice unless impracticable) of substantive meetings with any Regulatory Authority that relate to the applicable Product in the CANbridge Field and that are either scheduled with, or initiated by or on behalf of, the Lead Regulatory Party or its Affiliates, and (ii) an opportunity to have a representative participate in such meetings with any Regulatory Authority, if reasonably practicable and such attendance by the other Party does not limit the number of Lead Regulatory Party representatives at any such meeting;

 

(b)

keep the other Party reasonably informed as to all material interactions with Regulatory Authorities with respect to the applicable Product in the CANbridge Field; and

 

(c)

provide the other Party with a copy of any material documents, information, reports, and correspondence (i) proposed to be submitted to any Regulatory Authority reasonably in advance of such submission and consider in good faith any comments received from the other Party, and (ii) received from any Regulatory Authority as soon as reasonably practicable (including a written summary of any communications in which the other Party did not participate), in each case ((i) and (ii)) to the extent related to such Product in the CANbridge Field.

 

5.1.4

Ownership of Regulatory Submissions.  As between the Parties, all Regulatory Submissions relating to the Products in the Territory within the CANbridge Field will be [**].

 

5.1.5

Transfer of Regulatory Submissions and Data.

 

(a)

Transfer of Regulatory Submissions. On a Target-by-Target basis, within [**], LogicBio will deliver and assign to CANbridge (or a mutually agreed upon Third Party) copies (in electronic or other format) of those Regulatory Submissions, if any, Controlled by LogicBio or its Affiliates at such time that relate to the Development, Commercialization or Manufacture of Products with respect to such Target (the “Assigned Regulatory Submissions”).

36

 



 

(b)

Disclosure of Pre-Clinical Data. On a Target-by-Target basis, in connection with the assignment of Regulatory Submissions provided for in Section 5.1.5(a) (Transfer of Regulatory Submissions), LogicBio will provide to CANbridge (or a mutually agreed upon Third Party) separate copies (in electronic or other format) of the study reports from all studies conducted under the Research Plan that are Controlled by LogicBio and that relate to the Products Directed to such Target (to the extent not previously provided to CANbridge or a mutually agreed upon Third Party).

 

(c)

Cooperation. Subject to the terms and conditions of this Agreement, on a Target-by-Target basis, upon the request of CANbridge, LogicBio will execute and deliver, or will cause to be executed and delivered, to CANbridge (or a mutually agreed upon Third Party) such endorsements, assignments, and other documents as may be reasonably necessary to assign, convey, transfer, and deliver to CANbridge, all of LogicBio’s rights, title, and interests in and to the applicable Assigned Regulatory Submissions, including submitting to the applicable Regulatory Authority a letter or other necessary documentation (with copy to CANbridge) notifying such Regulatory Authority of the transfer of ownership of the relevant INDs assigned to CANbridge pursuant to Section 5.1.5(a) (Transfer of Regulatory Submissions).

 

5.1.6

Safety Database.  CANbridge will own the global safety database with respect to all Products. Except as expressly set forth in Section 5.1.7 (Pharmacovigilance), throughout the Development and Commercialization of each Product, CANbridge will assume responsibility for maintaining the global safety database, and filing of all required safety reports to all Regulatory Authorities in the Territory, including annual safety reports and communication with Regulatory Authorities throughout the Territory regarding all Adverse Events for the Products. Without limiting the foregoing, the Parties will cooperate with regard to the reporting and handling of safety information involving any Product in accordance with Applicable Laws and other regulations on pharmacovigilance and clinical safety.

 

5.1.7

Pharmacovigilance. Not later than the date on which the first IND with respect to a Product is submitted to a Regulatory Authority, the Parties will execute a pharmacovigilance agreement on reasonable and customary terms that will provide, among other things, guidelines and responsibilities for (a) the receipt, investigation, recording, review, communication, reporting, and exchange between the Parties of Adverse Event reports and other safety information relating to the Products, (b) appropriate reconciliation procedures to ensure adequate and compliant exchange of safety data related to the Products, and (c) contact with Regulatory Authorities with respect to the foregoing, in each case ((a)-(c)), in accordance with Applicable Law (each, a “Pharmacovigilance Agreement”). The Pharmacovigilance Agreement will contain terms no less stringent than those required by ICH Guidelines or other applicable guidelines in order to allow the Parties to meet the applicable regulatory and legal requirements regarding the management of safety data under Applicable Law throughout the Territory.

 

5.1.8

Recalls and Voluntary Withdrawals.  CANbridge will use [**] to notify LogicBio promptly, but in no event later than [**], following its determination that any event, incident, or circumstance has occurred that may result in the need for a recall, market suspension, or market withdrawal of a Product in the Territory and will include in such

37

 



 

notice the reasoning behind such determination.  CANbridge will have the [**]. For all recalls, market suspensions, or market withdrawals undertaken pursuant to this Section 5.1.8 (Recalls and Voluntary Withdrawals), CANbridge will be [**].

 

5.1.9

Right of Reference.  Each Party hereby grants to the other Party and its designees a right of reference under all Regulatory Submissions Controlled by said Party or its Affiliates for each Product that pertain solely to the safety of the Product, as reasonably determined by the grantor Party, in the case of LogicBio as the grantee Party, for purposes of obtaining and maintaining approvals for products other than the Products or to Develop products other than the Products anywhere in the world and, in the case of CANbridge as the grantee Party, for purposes of obtaining and maintaining approvals for the Products or to Develop the Products anywhere in the world. Each Party will, and will ensure that its Affiliates will, take actions reasonably necessary to effect such grant of right of reference to the other Party (or its designee), including by providing the other Party with sufficient rights to grant the right of reference described in this Section 5.1.9 (Right of Reference) and making such filings as may be required by Regulatory Authorities to record such grant.

5.2

LB-001 Regulatory Matters. Notwithstanding anything to the contrary in this Agreement, the terms of this Section 5.2 (LB-001 Regulatory Matters) will apply only following LB-001 Option Exercise.

 

5.2.1

Responsibility. Except as otherwise provided in this Agreement, CANbridge will be solely responsible for, and will have sole control over, preparing, filing, and maintaining Regulatory Submissions and communicating with Regulatory Authorities in Greater China with respect to LB-001 within the CANbridge Field [**]. CANbridge will use [**] to prepare, file, and maintain Regulatory Submissions and communicate with Regulatory Authorities in Greater China with respect to LB-001 within the CANbridge Field. LogicBio will, and will cause its Affiliates to, reasonably cooperate with CANbridge with respect to all regulatory matters relating to LB-001 in the CANbridge Field in Greater China.  [**]. CANbridge shall keep LogicBio promptly informed of regulatory developments related to LB-001 in the CANbridge Field in the People’s Republic of China and shall promptly notify LogicBio in writing of any decision by any Regulatory Authority in the People’s Republic of China regarding LB-001.

 

5.2.2

Regulatory Submissions

 

(a)

CANbridge will provide LogicBio with copies of all Regulatory Submissions with respect to LB-001 in Greater China in the form actually submitted to the applicable Regulatory Authority, promptly following receipt or submission of such correspondence, which Regulatory Submissions may be shared with LogicBio’s Third Party licensee’s of rights to LB-001 outside of Greater China if LogicBio has the right to share filings made by such Third Parties with respect to LB-001 as described below. LogicBio will provide to CANbridge copies of all Regulatory Submissions of LogicBio or its Third Party licensees that are in LogicBio’s possession and Control in the form actually submitted to Regulatory Authorities for LB-001 outside Greater China; provided that, with respect to any Regulatory Submission of a Third Party licensee of LogicBio, upon the reasonable request of CANbridge, (i) if LogicBio has the right to receive copies of such Regulatory Submission and to share such copies

38

 



 

with CANbridge under the applicable Third Party license agreement, then LogicBio will [**] to obtain copies of such Regulatory Submission from the applicable Third Party licensee and (ii) if LogicBio does not have the right to receive copies of such Regulatory Submission or to share such copies with CANbridge under the applicable Third Party license agreement, then LogicBio will [**] to (A) obtain copies of such Regulatory Submission from the applicable Third Party licensee and (B) request any required consent from the applicable Third Party licensee to permit LogicBio to disclose such copies to CANbridge.

 

(b)

As part of CANbridge’s updates to the LB-001 JSC pursuant to Section 4.4.2 (Responsibilities of LB-001 JSC), CANbridge will provide LogicBio with a high-level summary of all substantive regulatory activities undertaken by or on behalf of CANbridge with respect to LB-001 in Greater China in the preceding [**], and plans for regulatory matters with respect to LB-001 in Greater China [**], including a high-level summary of all substantive interactions with Regulatory Authorities relating to LB-001. In addition to the foregoing, CANbridge will provide [**] written notice to LogicBio of LB-001 regulatory submissions, regulatory correspondence, regulatory interactions, regulatory approvals, withdrawals, safety-related label changes, and other matters, in each case that are reasonably likely to have a significant effect on LB-001 outside of Greater China. Subject to any confidentiality restrictions applicable to LogicBio, LogicBio will keep CANbridge reasonably informed regarding the status and progress of development activity related to LB-001 outside of Greater China as part of its updates to the LB-001 JSC pursuant to Section 4.4.2 (Responsibilities of LB-001 JSC).

 

(c)

CANbridge will provide LogicBio with advance copies of the first application for Regulatory Approval made in Greater China with respect to LB-001, in each case reasonably in advance of submission to a Regulatory Authority (and, to the extent such copies are not in English, English-language versions thereof). CANbridge will provide LogicBio with a reasonable opportunity to review and comment on such advance copies.

 

5.2.3

Ownership of LB-001 Regulatory Submissions.  As between the Parties, all Regulatory Submissions relating to LB-001 in Greater China within the CANbridge Field will be owned by [**].

 

5.2.4

Regulatory Support. From time to time, upon CANbridge’s request, LogicBio will use [**] to respond to CANbridge’s queries in connection with the Regulatory Approval of LB-001 in Greater China, [**]. provided that LogicBio will not have an obligation to conduct more than [**] activities in the aggregate in response to such queries.

 

5.2.5

LB-001 Right of Reference. LogicBio hereby grants to CANbridge a right of reference under all Regulatory Submissions Controlled by LogicBio or its Affiliates for LB-001 solely to Develop or Commercialize LB-001 in the CANbridge Field in Greater China subject to the terms and conditions of this Agreement. CANbridge hereby grants to (a) LogicBio, (b) its Affiliates and (c)  any current or future licensee of LogicBio with respect to LB-001 who provides equivalent access and a right of reference to all of its Regulatory Submissions pertaining to LB-001 to CANbridge

39

 



 

through LogicBio solely to develop, manufacture or commercialize LB-001 in Greater China in accordance with the terms and conditions of this Agreement, in each case ((a)-(c)) a right of reference under all Regulatory Submissions Controlled by CANbridge or its Affiliates or Sublicensees for LB-001 solely to develop, manufacture or commercialize LB-001 outside Greater China in accordance with the terms and conditions of this Agreement. Each Party will, and will ensure that its Affiliates and, if applicable, Sublicensees will, take actions reasonably necessary to effect such grant of right of reference to the other Party (or its designee), including by making such filings as may be required by Regulatory Authorities to record such grant.

 

5.2.6

LB-001 Safety Database; Pharmacovigilance. LogicBio will own the global safety database with respect to LB-001. LogicBio will be responsible for maintaining the global safety database for LB-001, and for filing of all required safety reports with respect to LB-001 to all Regulatory Authorities, including annual safety reports and communication with Regulatory Authorities regarding all Adverse Events for LB-001 throughout the world.  No later than [**] following LB-001 Option Exercise, the Parties will enter into a pharmacovigilance agreement with respect to LB-001. Each Party will conduct activities designated to such Party under such pharmacovigilance agreement [**].

 

5.2.7

LB-001 Recalls and Voluntary Withdrawals. CANbridge will have the [**] recall and voluntarily withdraw LB-001 solely in Greater China on the terms set forth in Section 5.1.8 (Recalls and Voluntary Withdrawals), mutatis mutandis.

Article 6
CLINICAL DEVELOPMENT AND COMMERCIALIZATION

6.1

Development and Commercialization of Products

 

6.1.1

Clinical Development and Medical Affairs.  On a Target-by-Target basis, following the end of the Research Phase with respect to a Target, CANbridge will have [**] with respect to, the further Development of, and the performance of all Medical Affairs with respect to, all Products Directed to such Target in the CANbridge Field, subject to the terms and conditions of this Agreement and, if applicable, the Co-Development and Co-Commercialization Agreement.

 

6.1.2

Commercialization.

 

(a)

Activities.  Subject to the terms of this Agreement and, if applicable, the Co-Development and Co-Commercialization Agreement, CANbridge will have [**], the Commercialization of all Products, including for each Product: (a) developing and executing a commercial launch and pre-launch plan; (b) marketing and promotion; (c) booking sales and distribution and performance of related services; (d) handling all aspects of order processing, invoicing and collection, inventory, and receivables; (e) publications; (f) providing customer support, including handling medical queries, and performing other related functions; and (g) conforming its practices and procedures in all material respects to Applicable Law relating to the marketing, detailing, and promotion of Products in the CANbridge Field in the Territory.

40

 



 

(b)

Trademarks.  CANbridge will own all Trademarks used in connection with the Exploitation of the Products in the CANbridge Field in the Territory, and have [**], for all matters relating to the selection and use of such trademarks, including the selection, filing, prosecution, maintenance, defense, and enforcement thereof. Throughout the Term and thereafter, LogicBio will not adopt or use, register or attempt to register in the Territory any Trademark, domain name, or similar commercial symbol that includes, or is confusingly similar to, CANbridge’s trademarks used in connection with any Products.

 

6.1.3

Diligence Obligations.

 

(a)

Development Diligence Obligations. Following the end of the Research Phase with respect to a Target, CANbridge, itself or through its Affiliates, Sublicensees, or subcontractors, will use Commercially Reasonable Efforts to Develop and seek Regulatory Approval for one Product directed to such Target in each of [**].

 

(b)

Development Plan.  With respect to each Target, prior to the end of the Research Phase with respect to such Target, CANbridge will deliver to the JSC for review and approval a written plan setting forth [**] planned for the Products Directed to such Target (each such plan approved by the JSC, a “Development Plan”), and from time to time thereafter, CANbridge will deliver proposed amendments to the Development Plans to the JSC for review and approval. The Development Plan shall at all times include activities sufficient for CANbridge to meet its obligation pursuant to Section 6.1.3(a) (Development Diligence Obligations). Except as otherwise set forth in the Research Plan or in this Agreement, neither CANbridge nor its Affiliates or their respective Sublicensees will Develop any Product other than in a manner consistent with the then-current Development Plan with respect to such Product.

 

(c)

Development Reports. With respect to each Target, following the end of the Research Phase with respect to such Target,  CANbridge will, within [**] after the end of each Calendar Year, provide LogicBio with annual written reports summarizing its and its Affiliates’ and Sublicensees’ significant Development activities with respect to such Target hereunder during the preceding Calendar Year, including a summary of the data, timelines, and results of such Development, in each case, to the extent that CANbridge has the right to disclose such information to LogicBio without violating any confidentiality or other obligations to any Third Party. Such reports will be Confidential Information of CANbridge and subject to the terms and conditions set forth in Article 10 (Confidentiality). In addition, the Parties will discuss the status, progress, and results of Development of the Products Directed to each Target conducted by or on behalf of CANbridge [**].

 

(d)

Commercialization Diligence Obligations. Upon receipt of approval of the applicable MAA for a given Product [**] by the applicable Regulatory Authorities, CANbridge, itself or through its Affiliates or Sublicensees, will use Commercially Reasonable Efforts to obtain Regulatory Approval for such Product [**].  Following receipt of Regulatory Approval for a Product in each

41

 



 

country in the Territory, CANbridge will use Commercially Reasonable Efforts to Commercialize such Product in such country.  

 

(e)

Commercialization Plan; Commercialization Reports. [**] in advance of the anticipated date of the first Regulatory Approval for a Product, CANbridge will deliver to the JSC for review a written plan setting forth in reasonable detail the major Commercialization activities planned for such Product (each such plan, a “Commercialization Plan”). The Commercialization Plan shall at all times include activities sufficient for CANbridge to meet its obligation pursuant to Section 6.1.3(d) (Commercialization Diligence Obligations). From time to time thereafter, CANbridge will deliver proposed amendments to the Commercialization Plans to the JSC for review. Except as otherwise set forth in this Agreement, neither CANbridge nor its Affiliates or their respective Sublicensees will Commercialize any Product other than in a manner consistent with the then-current Commercialization Plan with respect to such Product. On an annual basis after approval of the applicable Commercialization Plan, CANbridge will, within [**] after the end of each Calendar Year, provide LogicBio with written reports summarizing its and its Affiliates’ and Sublicensees’ significant Commercialization activities with respect to Products hereunder during the preceding Calendar Year and any updates to its planned Commercialization activities, to the extent that CANbridge has the right to disclose such information to LogicBio without violating any confidentiality or other obligations to any Third Party. CANbridge agrees and acknowledges that, notwithstanding any provision to the contrary in this Agreement, LogicBio may disclose any Commercialization plan or report provided under this Section 6.1.3(e) (Commercialization Plan; Commercialization Reports) to CMRI under the obligations of confidentiality and non-use set forth in the CMRI Agreement.

6.2

Development and Commercialization of LB-001

 

6.2.1

Development and Medical Affairs. Following LB-001 Option Exercise, as between the Parties, CANbridge will have [**], the further Development of, and the performance of all Medical Affairs with respect to, LB-001 in the CANbridge Field in Greater China, subject to the terms and conditions of this Agreement.

 

6.2.2

Technology Transfer after LB-001 Option Exercise. Within [**] following LB-001 Option Exercise (or such longer time period as mutually agreed by the Parties), LogicBio will transfer to CANbridge or its designated Affiliate a copy of all LogicBio LB-001 Know-How in its possession or Control as of the date of LB-001 Option Exercise, including all such LB-001 Know-How that LogicBio [**] for CANbridge to Exploit LB-001, and including any documentation (whether held in paper or electronic format) or similar removable media, at CANbridge’s cost and expense.

 

6.2.3

Global Development and Commercialization of LB-001. Notwithstanding anything to the contrary in this Agreement, the terms of this Section 6.2.3 (Global Development and Commercialization of LB-001) will only apply following LB-001 Option Exercise.

 

(a)

Global Development Plan.  Following LB-001 Option Exercise, LogicBio will prepare a written plan setting forth the major Development activities planned for LB-001 to achieve Regulatory Approval for LB-001 [**] (such

42

 



 

plan, as may be updated from time to time in accordance with this Section 6.2.3(a) (Global Development Plan), the “Global Development Plan for LB-001”).  LogicBio will deliver a draft of the Global Development Plan for LB-001 to the LB-001 JSC for review at the first LB-001 JSC meeting and shall thereafter provide the LB-001 JSC with updates, if any, to the Global Development Plan for LB-001 no less frequently than [**].  The LB-001 JSC shall have no right to approve the Global Development Plan for LB-001 or any update thereto but LogicBio shall take any comments provided by the LB-001 JSC into good faith consideration. [**].

 

(b)

Global Development Reports. LogicBio will, within [**] after the end of each Calendar Year after LB-001 Option Exercise, provide the LB-001 JSC with [**] written reports summarizing its and its Affiliates’ and sublicensees’ significant Development activities with respect to LB-001 during [**], including a summary of the data, timelines, and results of such Development. Such reports will be Confidential Information of LogicBio and subject to the terms and conditions set forth in Article 10 (Confidentiality). In addition, the Parties will discuss the status, progress, and results of Development of LB-001 conducted by or on behalf of LogicBio and its Affiliates and sublicensees [**].

 

(c)

Global Commercialization Plan. Following LB-001 Option Exercise, reasonably in advance of the anticipated date of the first Regulatory Approval for LB-001 [**], LogicBio will deliver to the LB-001 JSC for review a written plan setting forth [**] planned for LB-001 outside of Greater China, as appropriate given the stage of Development of LB-001 at such time (such plan, as may be amended from time to time in accordance with this Section 6.2.3(c) (Global Commercialization Plan), the “Global Commercialization Plan for LB-001”). From time to time thereafter, LogicBio will deliver proposed amendments to the Global Commercialization Plan for LB-001 to the LB-001 JSC for review. The LB-001 JSC shall have no right to approve the Global Development Plan for LB-001 but LogicBio shall take any comments provided by the LB-001 JSC into good faith consideration. [**].

 

(d)

LogicBio Obligations to Third Party Partners. Notwithstanding anything to the contrary in this Agreement, including in Section 6.2.3 (Global Development and Commercialization of LB-001), LogicBio’s obligation to include information in any of the Global Development Plan for LB-001, the Global Commercialization Plan for LB-001, or any updates to the foregoing or reports related to the Development or Commercialization of LB-001 will in each case be subject to LogicBio’s obligations of confidentiality to any Third Party licensee that has rights to Develop or Commercialize LB-001 outside Greater China.

 

6.2.4

LB-001 Development Plan.

 

(a)

Within [**] following LB-001 Option Exercise (or such longer time period as mutually agreed by the Parties), CANbridge will provide to LogicBio a copy of a written plan setting forth [**] for LB-001 in Greater China, which written plan shall at all times include [**] that are intended to support Regulatory Approval of LB-001 in Greater China (the “LB-001 Development Plan”). The LB-001 Development Plan shall at all times include activities sufficient for

43

 



 

CANbridge to meet its obligation pursuant to Section 6.2.7 (LB-001 Development Diligence) and will be consistent with the then-current Global Development Plan for LB-001 provided to CANbridge under Section 6.2.3(a) (Global Development Plan). CANbridge will promptly provide to LogicBio any material updates to the LB-001 Development Plan. The LB-001 Development Plan and any proposed material updates to the LB-001 Development Plan will be in sufficient detail to permit LogicBio to assess whether Development activities with respect to LB-001 in Greater China would be likely to [**] on the development or commercialization of LB-001 outside of Greater China. Without limiting the foregoing, for purposes of this Section 6.2.4(a), a “material update” will include [**].

 

(b)

Neither CANbridge nor its Affiliates nor their respective Sublicensees will Develop LB-001 in any manner that [**]. Without limiting the foregoing, neither CANbridge nor its Affiliates nor their respective Sublicensees will undertake any Development activities for LB-001 set forth in the LB-001 Development Plan or an update to the LB-001 Development Plan prior to the later of (i) [**] following LogicBio’s receipt of the LB-001 Development Plan or update under Section 6.2.4(a) and (ii) if there is a LB-001 Development Dispute with respect to the LB-001 Development Plan or update, [**] in accordance with Section 6.2.5 (LB-001 Development Dispute).

 

6.2.5

LB-001 Development Dispute. If LogicBio determines, in its reasonable discretion, that any Development activity proposed to be conducted by or on behalf of CANbridge or its Affiliates or their respective Sublicensees with respect to LB-001, as set forth in the LB-001 Development Plan or any update thereto, [**] and would be likely to [**] (an “LB-001 Development Dispute”), then LogicBio will notify CANbridge and the LB-001 JSC of such LB-001 Development Dispute within [**] of LogicBio’s receipt of the LB-001 Development Plan or update, as applicable, and at the request of either Party, such LB-001 Development Dispute will be submitted to the Parties’ Executive Officers for resolution. If LogicBio does not provide notice of an LB-001 Development Dispute in accordance with the preceding sentence [**]. The Executive Officers will meet (in person or by teleconference) to attempt in good faith to resolve such matter through discussions promptly following submission thereof, and in any event within [**] thereafter, unless otherwise mutually agreed upon by the Executive Officers. In the event that the Executive Officers are unable to resolve such issue within [**] of the issue being presented to them, [**], but will only exercise such right in good faith after full consideration of the positions of both Parties and will communicate its decision with respect to such LB-001 Development Dispute to [**] in writing within [**] after referral of such LB-001 Development Dispute to the Executive Officers. [**] to conduct the Development activity that is the subject of the LB-001 Development Dispute, CANbridge and its Affiliates and their respective sublicensees will have the right to conduct such Development activity solely in accordance with the LB-001 Development Plan or update that is the subject of such LB-001 Development Dispute, without further objection by LogicBio. For clarity, if CANbridge further updates the LB-001 Development Plan regarding any Development activity that has been previously approved by LogicBio under this Section 6.2.5 (LB-001 Development Dispute), LogicBio will have the right to review and object to such update to the LB-001 Development Plan pursuant to this Section 6.2.5 (LB-001 Development Dispute).

44

 



 

 

6.2.6

Reports of LB-001 Development Activities. Following LB-001 Option Exercise, each Party will report on any and all Development activities undertaken by or on behalf of such Party or its Affiliates with respect to LB-001 in Greater China or outside Greater China, as applicable, in connection with meetings of the LB-001 JSC; provided that, LogicBio’s obligation to provide such report will be subject to any Third Party confidentiality obligations.

 

6.2.7

LB-001 Development Diligence. Following LB-001 Option Exercise, CANbridge, itself or through its Affiliates, Sublicensees, or subcontractors, will use Commercially Reasonable Efforts to Develop and seek Regulatory Approval for LB-001 [**] in Greater China.

 

6.2.8

LB-001 Commercialization Activities. Subject to the terms of this Agreement, following LB-001 Option Exercise, CANbridge will [**], the Commercialization of LB-001 in Greater China, including: (a) developing and executing a commercial launch and pre-launch plan; (b) marketing and promotion; (c) booking sales and distribution and performance of related services; (d) handling all aspects of order processing, invoicing and collection, inventory, and receivables; (e) publications; (f) providing customer support, including handling medical queries, and performing other related functions; and (g) conforming its practices and procedures in all material respects to Applicable Law relating to the marketing, detailing, and promotion of LB-001 in the CANbridge Field in the Territory.

 

6.2.9

LB-001 Commercialization Diligence Obligations. Following LB-001 Option Exercise, upon receipt of approval of the applicable MAA for LB-001 [**] in Greater China by the applicable Regulatory Authorities, CANbridge, itself or through its Affiliates or Sublicensees, will use Commercially Reasonable Efforts to obtain Regulatory Approval for LB-001 [**]. Following receipt of Regulatory Approval for LB-001 [**] in Greater China, CANbridge will use Commercially Reasonable Efforts to Commercialize LB-001 [**].

 

6.2.10

LB-001 Commercialization Plan; Commercialization Reports. Following LB-001 Option Exercise, reasonably in advance of [**], CANbridge will deliver to LogicBio a written plan setting forth [**] planned for LB-001 in Greater China. Such plan shall at all times include activities sufficient for CANbridge to meet its obligation pursuant to Section 6.2.9 (LB-001 Commercialization Diligence Obligations). On [**] thereafter, (a) CANbridge will within [**] after the end of [**], provide LogicBio with written reports summarizing its and its Affiliates’ and Sublicensees’ significant Commercialization activities with respect to LB-001 in Greater China during [**] and any updates to its planned Commercialization activities, to the extent that CANbridge has the right to disclose such information to LogicBio without violating any confidentiality or other obligations to any Third Party and (b) LogicBio will provide CANbridge with its then-current global brand strategy with respect to LB-001, to the extent that LogicBio has the right to disclose such information to CANbridge without violating any confidentiality or other obligations to any Third Party.

 

6.2.11

Diversion. Neither Party nor its Affiliates will, and each Party will take reasonable measures to ensure that its Third Party sublicensees and subcontractors do not, either directly or indirectly, promote, market, distribute, import, sell, or have sold LB-001 [**].

45

 



 

6.2.12

LB-001 Trademarks and Domain Names.

 

(a)

Trademarks and Domain Names. LB-001 will be Commercialized in Greater China solely under those Trademarks and solely using those domain names that have been approved by the Parties in accordance with Section 6.2.12 (LB-001 Trademarks and Domain Names), after [**] consultation with the Parties’ intellectual property counsel (each such approved Trademark, other than CANbridge House Marks or LogicBio House Marks, an “LB-001 Trademark” and each such approved domain name, other than those containing a CANbridge House Mark or LogicBio House Mark, an “LB-001 Domain Name”).

 

(b)

Ownership. Except as otherwise agreed by the Parties, [**] will own all LB-001 Trademarks and LB-001 Domain Names, subject to the license granted to [**] herein, and is responsible for the filing, prosecution, registration and maintenance of such LB-001 Trademarks and the registration and maintenance of such LB-001 Domain Names. If the Party that owns an LB-001 Trademark or LB-001 Domain Name decides not to file or continue to prosecute, register or maintain such LB-001 Trademark or obtain or maintain such LB-001 Domain Name in Greater China, it will give the other Party [**] notice to that effect sufficiently in advance of any deadline for any filing with respect to such LB-001 Trademark or LB-001 Domain Name in Greater China to permit the other Party to carry out such activity. After such notice, the other Party may undertake such activity on behalf of and in the name of the first Party. The expenses of the selection, filing, prosecution and maintenance of the LB-001 Trademarks and obtaining and maintaining the LB-001 Domain Names in Greater China will be borne [**]. Each Party will keep the other Party regularly apprised of the status of its activities under this Section 6.2.12(b) (Ownership) and will consult with such other Party [**] prior to taking any material action with respect to any such LB-001 Trademark or LB-001 Domain Name.

 

(c)

Trademark and Domain Name Use. The manner of use of the LB-001 Trademarks and the LB-001 Domain Names will be subject to periodic review by the Parties. CANbridge will not use the LB-001 Trademarks in a way that is inconsistent with the trademark usage guidelines and the usage instructions approved by the Parties pursuant to Section 6.2.12 (LB-001 Trademarks and Domain Names). Neither Party will use a Trademark confusingly similar to any of the LB-001 Trademarks with any of its other products in Greater China or, except as otherwise provided herein, use the LB-001 Trademarks in combination with its other Trademarks in Greater China in a manner which would create a composite or combination marks. The Parties will utilize the LB-001 Trademarks and the LB-001 Domain Names within Greater China only in accordance with this Agreement and for no other product in Greater China. LogicBio may utilize the LB-001 Trademarks and the LB-001 Domain Names outside of Greater China, provided that such use is not reasonably likely to cause confusion or devalue the LB-001 Trademark or LB-001 Domain Name, as applicable, in Greater China.

 

(d)

[**]. Upon LB-001 Option Exercise, [**], to use and display the LB-001 Trademarks and to use the LB-001 Domain Names in connection with the Commercialization of LB-001 in Greater China in accordance with the terms

46

 



 

of this Agreement. All goodwill arising from the use of such LB-001 Trademarks and LB-001 Domain Names will inure to the benefit of [**].

 

(e)

Dispute Resolution. In the event that the Parties do not reach mutual agreement with respect to any matter under Section 6.2.12 (LB-001 Trademarks and Domain Names) that requires mutual agreement of the Parties within [**] after such matter has been submitted to the Parties, either Party may submit the dispute to the Executive Officers. The Executive Officers will meet (in person or by teleconference) to attempt in good faith to approve such matter through discussions promptly following submission thereof, and in any event within [**] thereafter, unless otherwise mutually agreed upon by the executives or their designees. In the event that such individuals are unable to resolve such issue within such [**] period, the matter will not be approved and may be resolved by the Parties pursuant to the dispute resolution provisions in this Agreement.

Article 7
MANUFACTURING

7.1

Manufacture and Supply of Products.

 

7.1.1

Manufacture of Products; Manufacturing Technology Transfers.

 

(a)

Supply During LogicBio Manufacturing Period.  Subject to the oversight of the JSC, on a Product-by-Product basis, during the LogicBio Manufacturing Period with respect to a Product, LogicBio will have sole responsibility for all Manufacturing activities, including manufacturing process development activities and the selection of a mutually agreeable Third Party CMO for the conduct of Manufacturing activities, for such Product under the Agreement, and CANbridge will reimburse LogicBio for its costs and expenses incurred in connection with such Manufacture in accordance with the Research Budget pursuant to Section 8.6 (Payment of Research Costs).  As of the Effective Date, the Parties agree that [**] is the Third Party CMO. LogicBio will perform its obligations set forth under this Section 7.1.1(a) (Supply During LogicBio Manufacturing Period) (“LogicBio Manufacturing Activities”) as set forth in and in accordance with the Research Plan. The “LogicBio Manufacturing Period” means, on a Product-by-Product basis, the period that will commence on the Effective Date and [**].

 

(b)

Supply After LogicBio Manufacturing Period.  On a Product-by-Product basis, following the LogicBio Manufacturing Period with respect to a Product, CANbridge will have sole responsibility for, and sole decision-making authority with respect to, all Manufacturing activities, [**] for the Manufacture of such Product.

 

(c)

Manufacturing Technology Transfers.

 

(i)

Initial Manufacturing Technology Transfer. [**] following the initiation of the transfer of the [**] with respect to the Lead Product to LogicBio’s then-current CDMO for the Lead Product (the “LogicBio CDMO Process Transfer”), LogicBio will notify

47

 



 

CANbridge thereof and [**] with respect to the Lead Product as determined by the Manufacturing Committee, [**] (the “Initial Manufacturing Technology Transfer”), and [**]. Notwithstanding the foregoing, the Parties will use [**] to conduct the Initial Manufacturing Technology Transfer [**] with the LogicBio CDMO Process Transfer to the extent [**] to the Development timeline for the Lead Product under the Research Plan.

 

(ii)

Subsequent Manufacturing Technology Transfer. During the applicable period approved by the JSC, in anticipation of the conclusion of the LogicBio Manufacturing Period with respect to the Lead Product, LogicBio and CANbridge will [**] (each, a “Designated CMO”) [**] is [**] to enable the Manufacture of the Lead Product, to the extent not previously [**] (the “Subsequent Manufacturing Technology Transfer,” and, together with the Initial Manufacturing Technology Transfer, each a “Manufacturing Technology Transfer”), and [**].

 

(iii)

Manufacturing Technology Transfer Plan. The Manufacturing Technology Transfers will be conducted pursuant to and will be subject to a written plan prepared by the Manufacturing Committee and approved by the JSC in good faith prior to the anticipated commencement of the Initial Manufacturing Technology Transfer (the “Manufacturing Technology Transfer Plan”), [**]. The Parties will use [**] efforts to agree upon the Manufacturing Technology Transfer Plan within [**] following the Effective Date. Without limiting the foregoing, in connection with the development of the Manufacturing Technology Transfer Plan, LogicBio will use [**]. For each Manufacturing Technology Transfer, each Party will use [**] to effect the full Manufacturing Technology Transfer as soon as possible following the commencement of such technology transfer activities. If requested by CANbridge, LogicBio will use [**].

 

7.1.2

[**].  If LogicBio is performing the LogicBio Manufacturing Activities through any Designated CMO, then, in connection with the Subsequent Manufacturing Technology Transfer, the Parties will discuss [**].

7.2

Manufacture and Supply of LB-001.

 

7.2.1

Manufacturing During LB-001 Supply Period. Following LB-001 Option Exercise, as between the Parties, LogicBio will have [**] (such period, the “LB-001 Supply Period”). Promptly following LB-001 Option Exercise, the Parties will negotiate [**] and enter into a clinical supply agreement [**] for the supply of LB-001 by LogicBio to CANbridge in Greater China at the LB-001 Supply Price during the LB-001 Supply Period, and a related quality agreement, which agreements will govern the terms and conditions of Manufacturing LB-001 for CANbridge’s and its Affiliates’ and Sublicensees’ Development activities in Greater China during the LB-001 Supply Period. Prior to any commercial supply of LB-001 to CANbridge during the LB-001 Supply Period, the Parties will negotiate [**] a commercial supply agreement pursuant to which LogicBio will supply LB-001 to CANbridge for commercial use during the LB-001 Supply Period.

48

 



 

7.2.2

Manufacturing Post-LB-001 Supply Period. After the LB-001 Supply Period, LogicBio will, [**] either [**] LogicBio will have the right, during normal business hours, [**] CANbridge shall cooperate with LogicBio in the conduct of such inspection. [**].

Article 8
PAYMENTS AND ROYALTIES

8.1

Upfront Payment.  Within [**] after the Effective Date, [**], CANbridge will pay LogicBio a onetime, nonrefundable, noncreditable upfront payment of Ten Million Dollars ($10,000,000).

8.2

Additional Target Option Fee. With respect to each Option Target for which CANbridge exercises the Additional Target Option, CANbridge will pay LogicBio a one‑time, non‑refundable, non‑creditable payment of [**] Dollars ($[**]) within [**] of providing LogicBio written notice of its exercise of the Additional Target Option (the “Additional Target Option Fee”).

8.3

LB-001 Option Fee. CANbridge will pay LogicBio a one‑time, non‑refundable, non‑creditable payment of [**] Dollars ($[**]) within [**] of providing LogicBio written notice of its exercise of the LB-001 Option (the “LB-001 Option Fee”).

8.4

Payment of Research Costs. CANbridge will reimburse LogicBio for [**] Research Costs incurred by LogicBio or its Affiliates in accordance with the Research Budget and the terms set forth in this Section 8.4 (Payment of Research Costs).

 

8.4.1

Upfront Payment of Research Costs. Within [**] after the Effective Date, CANbridge will pay LogicBio a one-time, non-refundable payment of Eight Hundred Seventy-Seven Thousand Five Hundred Dollars ($877,500), which amount will be credited against the payment of Research Costs under Section 8.4.2 (Quarterly Estimated Invoice).

 

8.4.2

Quarterly Estimated Invoice. Within [**] prior to the beginning of each Calendar Quarter after the first Calendar Quarter and until the completion of activities under the Research Plan, LogicBio will submit to CANbridge an invoice, which must include in [**] in such Calendar Quarter (each, a “Quarterly Estimated Invoice”). CANbridge will pay the amount set forth in each Quarterly Estimated Invoice within [**] after its receipt thereof; provided that CANbridge may credit the upfront amount paid under Section 8.4.1 (Upfront Payment of Research Costs) against payments by CANbridge under this Section 8.4.2 (Quarterly Estimated Invoice) and will only need to pay amounts set forth in any Quarterly Estimated Invoice starting with the Calendar Quarter in which the aggregate amounts in all Quarterly Estimated Invoices delivered prior to and for such Calendar Quarter exceed such upfront amount.

 

8.4.3

Quarterly True-Up. Within [**] after the end of each Calendar Quarter for which LogicBio submits to CANbridge a Quarterly Estimated Invoice, LogicBio will submit to CANbridge a report of Research Costs, if any, actually incurred by LogicBio or its Affiliates during such Calendar Quarter, or, if not included in a preceding Cost Report, Research Costs incurred by LogicBio or its Affiliates during a prior Calendar Quarter (each, a “Cost Report”). If the total amount set forth in the Cost Report for a given Calendar Quarter exceeds the total amount set forth in the Quarterly Estimated Invoice for such Calendar Quarter, then CANbridge will pay LogicBio the difference within [**] after its receipt of the applicable Cost Report. If the total amount set forth in the

49

 



 

Quarterly Estimated Invoice for a given Calendar Quarter exceeds the total amount set forth in the Cost Report for such Calendar Quarter, then the difference will be credited toward any subsequent payment made by CANbridge under Section 8.4.2 (Quarterly Estimated Invoice) or, if such Calendar Quarter is the last Calendar Quarter during which the Parties are conducting activities under the Research Plan, then the difference will be credited toward any subsequent payment by CANbridge under Section 8.5 (Milestone Payments) or Section 8.6 (Royalties for Products).

 

8.4.4

Allowable Overrun. Notwithstanding the foregoing or any provision to the contrary in this Section 8.4 (Payment of Research Costs), CANbridge will only reimburse LogicBio for the Research Costs incurred by LogicBio or its Affiliates in accordance with the Research Budget, provided, however, that if the Research Costs exceed the Research Budget for a given Calendar Year, then LogicBio may include such excess costs in a Quarterly Estimated Invoice and Cost Report, and CANbridge will reimburse such excess costs to the extent such excess costs do not exceed [**] (such amount, the “Allowable Overrun”), but will have no obligation to reimburse LogicBio beyond the Allowable Overrun.

 

8.4.5

Adjustments to Research Budgets. In the event that LogicBio, in its reasonable discretion, determines that Research Costs that are anticipated in a certain Calendar Year in the Research Budget will be incurred in a different Calendar Year, then (a) LogicBio will [**] notify CANbridge of such timing issue and (b) [**].

8.5

Milestone Payments.

 

8.5.1

Development Milestones for Products.  On a Target-by-Target basis, within [**] after the first achievement of each milestone event set forth in this Section 8.5.1 (Development Milestones for Products) (each, a “Development Milestone Event”) for the first Product Directed to a Target by or on behalf of CANbridge, any of its Affiliates or any Sublicensee, CANbridge will notify LogicBio in writing of the achievement of such Development Milestone Event and, within [**] of CANbridge’s receipt of an invoice for such payment, CANbridge will make a non‑refundable and non‑creditable milestone payment to LogicBio in the amount set forth in this Section 8.5.1 (Development Milestones for Products) corresponding to such Development Milestone Event (each, a “Development Milestone Payment”). Each Development Milestone Payment will be payable [**].

TABLE 8.5.1 – Development Milestones for Products

Development Milestone Event

Development Milestone Payment

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

 

[**].

50

 



 

8.5.2

Development Milestones for LB-001. Following LB-001 Option Exercise, within [**] after the first achievement of each milestone event set forth in this Section 8.5.2 (Development Milestones for LB-001) (each, an “LB-001 Development Milestone Event”) for LB-001, the Party that achieves an LB-001 Development Milestone will notify the other Party in writing of the achievement of such LB-001 Development Milestone Event and, within [**] of CANbridge’s receipt of an invoice for such payment, CANbridge will make a non‑refundable and non‑creditable milestone payment to LogicBio in the amount set forth in this Section 8.5.2 (Development Milestones for LB-001) corresponding to such LB-001 Development Milestone Event (each, an “LB-001 Development Milestone Payment”). [**].

TABLE 8.5.2 – Development Milestones for LB-001

LB-001 Development Milestone Event

LB-001 Development Milestone Payment

[**]

[**]

[**]

[**]

 

[**].

 

8.5.3

Sales Milestones for Products. Within [**] after the first achievement of each milestone event set forth in this Section 8.5.3 (Sales Milestones for Products) (each, a “Sales Milestone Event”) for each Product by or on behalf of CANbridge, any of its Affiliates or any Sublicensee, CANbridge will notify LogicBio in writing of the achievement of such Sales Milestone Event and, within [**] of CANbridge’s receipt of an invoice for such payment, CANbridge will make a non‑refundable and non‑creditable milestone payment to LogicBio in the amount set forth in this Section 8.5.3 (Sales Milestones for Products) corresponding to such Sales Milestone Event (each, a “Sales Milestone Payment”). [**].

TABLE 8.5.2 – Sales Milestones for Products

Sales Milestone Event

Sales Milestone Payment

[**]

[**]

[**]

[**]

[**]

[**]

 

 

8.5.4

Sales Milestones for LB-001.  Following LB-001 Option Exercise, within [**] after the first achievement of each milestone event set forth in this Section 8.5.4 (Sales Milestones for LB-001) (each, an “LB-001 Sales Milestone Event”) by or on behalf of CANbridge, any of its Affiliates or any sublicensee, CANbridge will notify LogicBio in writing of the achievement of such LB-001 Sales Milestone Event and, within [**] of CANbridge’s receipt of an invoice for such payment, CANbridge will make a non‑refundable and non‑creditable milestone payment to LogicBio in the amount set forth in this Section  8.5.4 (Sales Milestones for LB-001) corresponding to such Sales Milestone Event (each, an “LB-001 Sales Milestone Payment”). [**].

TABLE 8.5.4 – Sales Milestones for LB-001

51

 



Sales Milestone Event

Sales Milestone Payment

The Net Sales of LB-001 in Greater China in a Calendar Year reaches $[**]

[**]

The Net Sales of LB-001 in Greater China in a Calendar Year reaches $[**]

[**]

The Net Sales of LB-001 in Greater China in a Calendar Year reaches $[**]

[**]

 

8.6

Royalties for Products.

 

8.6.1

Royalty Payments.  On a Product‑by‑Product and country‑by‑country basis, during the Royalty Period of a Product in a country in the Territory, CANbridge will pay to LogicBio tiered royalties on the Net Sales of such Product in the CANbridge Field during each Calendar Year at the following rates:

TABLE 8.6.1 – Royalty Payments

Net Sales of Product in the CANbridge Field in the Territory During the Relevant Calendar Year (“Per Product Annual Net Sales”)

Marginal Royalty Rate

Global Net Sales of the Product in the CANbridge Field in a Calendar Year of up to $[**]

 

[**]

The portion of global Net Sales of the Product in the CANbridge Field in a Calendar Year which is in excess of $[**] but less than or equal to $[**]

 

[**]

The portion of global Net Sales of the Product in the CANbridge Field in a Calendar Year which is in excess of $[**] but less than or equal to $[**]

 

[**]

The portion of global Net Sales of the Product in the CANbridge Field in a Calendar Year which is in excess of $[**]

 

[**]

 

Each marginal royalty rate set forth in Table 8.6.1 (Royalty Payments) above will apply only to that portion of Per Product Annual Net Sales that falls within the indicated range. For example, if there is $[**] in Per Product Annual Net Sales for a Product, after conversion to U.S. Dollars of the Net Sales in each country in the Territory, then CANbridge would owe a royalty payment under this Section 8.6.1 (Royalty Payments) of [**].

 

8.6.2

Royalty Period.  On a Product-by-Product and country-by-country basis, CANbridge’s obligation to pay royalties for a Product in a country will begin upon the first sale of such Product in such country that results in a recordable Net Sale and will expire upon the last to occur of (a) the expiration of the last to expire Valid Claim within the LogicBio Technology Covering the manufacture, use or sale of such Product in such country in the CANbridge Field, (b) the expiration of all Regulatory Exclusivity, if any, for such Product in such country, and (c) 10 years after First Commercial Sale

52

 



 

of such Product in such country (the “Royalty Period”). Upon expiration of the Royalty Period for a given Product in a given country (i) no further Royalties will be payable in respect of sales of such Product in such country, and (ii) the licenses granted to CANbridge under Section 2.1 (License to CANbridge) with respect to the Exploitation of such Product in such country will automatically become, fully paid-up, perpetual, irrevocable, and royalty free. For clarity, only a single royalty will be payable as a result of one or more Valid Claims within the LogicBio Technology Covering the manufacture, use or sale of such Product in such country during the applicable Royalty Period.

 

8.6.3

Royalty Reports; Payments.

 

(a)

Flash Reports. No later than [**] after the end of each Calendar Quarter during which any Royalties are owed, CANbridge will submit to LogicBio a written flash report of CANbridge’s reasonable, good faith estimate of (i) Net Sales of Products sold, in the currency for which such Products were sold, by or on behalf of CANbridge and its Affiliates and Sublicensees during such Calendar Quarter, and (ii) the royalties payable on such Net Sales.

 

(b)

Royalty Reports.  No later than [**] after the end of each Calendar Quarter during which any Royalties are owed, CANbridge will submit to LogicBio a written report of Net Sales of Products sold, in the currency for which such Products were sold, by or on behalf of CANbridge and its Affiliates and Sublicensees during such Calendar Quarter, and the royalties payable on such Net Sales [**] paid hereunder.

 

(c)

Royalty Payments.  Royalties will be payable on a Calendar Quarter basis and CANbridge will make any such payments within [**] after the end of the Calendar Quarter during which the applicable Net Sales of Products occurred.

 

8.6.4

Payment Adjustments.

 

(a)

Expiration of Valid Claims and Regulatory Exclusivity.  On a Product-by-Product and country-by-country basis, if during the Royalty Period for a Product in a given country, there is no Valid Claim within the LogicBio Technology Covering the manufacture, use or sale of such Product in such country and no Regulatory Exclusivity with respect to such Product in such country, then commencing in the [**] after the date on which this Section 8.6.4(a) (Expiration of Valid Claims) applies and for the remainder of the Royalty Period for such Product in such country during which there remains no Valid Claim within the LogicBio Technology Covering the manufacture, use or sale of such Product in such country and no Regulatory Exclusivity with respect to such Product in such country, the royalty rates set forth in Table 8.6.1 (Royalty Payments) with respect to such Product in such country will be reduced by [**] for the purposes of determining the royalties payable under Section 8.6.1 (Royalty Payments), subject to Section 8.6.4(d) (Maximum Payment Adjustments).

 

(b)

Biosimilar Competition. If during any Calendar Quarter during the Royalty Period for a Product in a given country, [**] and such Product sold in such Calendar Quarter in such country (as determined by data obtained from a

53

 



 

mutually agreed upon Third Party source), then the percentage royalty payable on Net Sales of such Product in such country will be reduced by [**] for such Calendar Quarter.

 

(c)

Third Party Payments.  If CANbridge makes a royalty payment under any agreement with a Third Party pursuant to which CANbridge obtains a license or other rights under a Patent Right(s) owned or controlled by such Third Party (whether by acquisition or license) that is necessary to Exploit one or more Products in the CANbridge Field, then CANbridge may offset against the royalties due to LogicBio for such Products an amount equal to [**] of the royalties paid to such Third Party under such agreement in connection with the Exploitation of Products, in all cases, subject to Section 8.6.4(d) (Maximum Payment Adjustments).

 

(d)

Maximum Payment Adjustments. In no event will the royalty rate applicable to any Product in a given Calendar Quarter be less than [**] as a result of the aggregate reductions permitted pursuant to Section 8.6.4(a) (Expiration of Valid Claims), Section 8.6.4(b) (Biosimilar Competition) and Section 8.6.4(c) (Third Party Payments).

8.7

Royalties for LB-001.

 

8.7.1

LB-001 Royalty Payments. Following LB-001 Option Exercise, during the LB-001 Royalty Period in a country in Greater China, CANbridge will pay to LogicBio tiered royalties on the Net Sales of LB-001 in the CANbridge Field in Greater China during each Calendar Year at the following rates:

TABLE 8.7.1 – LB-001 Royalty Payments

Net Sales of LB-001 in the CANbridge Field in Greater China During the Relevant Calendar Year

Marginal Royalty Rate

Net Sales of LB-001 in the CANbridge Field in Greater China in a Calendar Year of up to $[**]

 

[**]

The portion of Net Sales of LB-001 in the CANbridge Field in Greater China in a Calendar Year which is in excess of $[**] but less than or equal to $[**]

 

[**]

The portion of Net Sales of LB-001 in the CANbridge Field in Greater China in a Calendar Year which is in excess of $[**] but less than or equal to $[**]

 

[**]

The portion of Net Sales of LB-001 in the CANbridge Field in Greater China in a Calendar Year which is in excess of $[**]

 

[**]

 

Each marginal royalty rate set forth in Table 8.7.1 (LB-001 Royalty Payments) above will apply only to that portion of LB-001 annual Net Sales in the CANbridge Field in Greater China that falls within the indicated range. For example, if there is $[**] of LB-001 annual Net Sales in the CANbridge Field in

54

 



Greater China, after conversion to U.S. Dollars of the Net Sales in each country in Greater China, then CANbridge would owe a royalty payment under this Section 8.7.1 (LB-001 Royalty Payments) of [**].

 

8.7.2

LB-001 Royalty Period. Following LB-001 Option Exercise, on a country-by-country basis, CANbridge’s obligation to pay royalties for LB-001 in a country will begin upon the first sale of LB-001 in such country that results in a recordable Net Sale and will expire upon the last to occur of (a) the expiration of the last to expire Valid Claim within the LogicBio LB-001 Technology Covering the manufacture, use or sale of LB-001 in such country in the CANbridge Field, (b) the expiration of all Regulatory Exclusivity, if any, for LB-001 in such country, and (c) 10 years after First Commercial Sale of LB-001 in such country (the “LB-001 Royalty Period”). Upon expiration of the LB-001 Royalty Period in a given country following LB-001 Option Exercise (i) no further royalties will be payable under this Agreement in respect of sales of LB-001 in such country, and (ii) the licenses granted to CANbridge under Section 2.8 (LB-001 Option) with respect to the Exploitation of LB-001 in such country will automatically become, fully paid-up, perpetual, irrevocable, and royalty free. For clarity, only a single royalty will be payable as a result of one or more Valid Claims within the LogicBio LB-001 Technology Covering the manufacture, use or sale of LB-001 in such country during the applicable LB-001 Royalty Period.

 

8.7.3

Royalty Reports; Payments; Payment Adjustments. Following LB-001 Option Exercise, the terms of Section 8.6.3 (Royalty Reports; Payments) and Section 8.6.4 (Payment Adjustments) will apply to royalty payments under Section 8.7 (Royalties for LB-001), mutatis mutandis; provided, however, that in no event will the royalty rate applicable to LB-001 in a given Calendar Quarter be less than [**] as a result of the aggregate reductions permitted pursuant to this Agreement.

8.8

Payment Method.  All payments to be made between the Parties under this Agreement will be made in Dollars and may be paid by wire transfer in immediately available funds to a bank account designated by the receiving Party.

8.9

Currency Exchange.  The rate of exchange to be used in computing the amount of currency equivalent in U.S. Dollars owed to a Party under this Agreement will be the monthly average exchange rate between each currency of origin and U.S. Dollars as reported by [**] or an equivalent resource as agreed by the Parties.

8.10

Late Payments.  If a Party does not receive payment of any sum due to it on or before the due date, simple interest will thereafter accrue on the sum due to such Party until the date of payment at the per annum rate equal to [**].

8.11

Income Tax Withholding.  Except as otherwise provided in this Section 8.11 (Income Tax Withholding), each Party will pay all income and other taxes (including interest) imposed on or measured with respect to its own income accruing to it under this Agreement (“Taxes”). If Applicable Laws require the withholding of Taxes from any payments made by CANbridge under this Agreement (“Agreement Payments”), CANbridge will make such withholding payments and will subtract from the applicable Agreement Payments the lesser of [**] provided, however, [**]. CANbridge will timely remit any amounts withheld under this provision to the appropriate Governmental Authority and will submit to LogicBio appropriate proof of payment of the withheld Taxes as well as the official receipts within a reasonable period of time. If CANbridge determines that any withholding in respect of Tax is required with respect to an Agreement Payment, CANbridge will provide reasonable advance notice to LogicBio of such required withholding and

55

 



will cooperate with and provide to LogicBio reasonable assistance in order to allow LogicBio to eliminate or mitigate any such withholding Tax obligations with respect to Agreement Payments, including obtaining the benefit of any present or future treaty against double taxation which may apply to the Agreement Payments.

8.12

Foreign-Derived Deduction Eligible Income Reporting.  CANbridge will obtain and deliver to LogicBio, reasonably promptly following LogicBio’s request to provide, information as reasonably requested by LogicBio to meet any documentation requirements imposed by regulations issued under Section 250 of the Internal Revenue Code for the treatment of an appropriate portion of such amounts as “foreign-derived deduction eligible income” within the meaning of Section 250 of the Internal Revenue Code and the regulations thereunder.

8.13

Value Added Tax.  It is understood and agreed between the Parties that any payments made by any Party under this Agreement are exclusive of any value added tax or similar tax imposed upon such payments. Where such tax is properly chargeable in respect of any supply of goods or services made under this Agreement, [**].

8.14

Record Retention; Audits. Each Party will maintain and will cause its Affiliates and all Sublicensees to maintain, complete and accurate records in sufficient detail to permit the other Party to confirm the accuracy of the calculation of payments under this Agreement. Upon prior notice of at least [**], but not more than [**], such records will be available during regular business hours for a period of [**] from the end of the Calendar Year to which they pertain for examination at the expense of the requesting Party by an independent certified public accountant selected by the requesting Party  (or, if LogicBio is the requesting Party, CMRI) and reasonably acceptable to the other Party, for the sole purpose of verifying the accuracy of the financial reports and correctness of the payments furnished by the other Party pursuant to this Agreement. Any such auditor will not disclose the other Party’s Confidential Information, except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by the other Party or the amount of payments due by the other Party under this Agreement. The accountant’s report will be disclosed simultaneously to both Parties, and such report will be the Confidential Information of each Party (with both Parties being deemed the Receiving Party with respect thereto) and subject to the terms Article 10 (Confidentiality); provided that, if LogicBio is the requesting Party, the Parties may disclose each such report to CMRI under the obligations of confidentiality and non-use set forth in the CMRI Agreement. Any amounts shown to be owed but unpaid will be paid within [**] after the date of the accountant’s report.  Any amounts shown to have been overpaid will be refunded within [**] after the date of the accountant’s report. The requesting Party will [**] of such audit unless such audit discloses an underpayment by the other Party of more than the greater of (a) [**] of the amount due and (b) $[**]. The audit rights in this Section 8.14 (Record Retention; Audits) will survive the Term for [**] following the effective date of any termination or expiration of this Agreement.

Article 9
REPRESENTATIONS, WARRANTIES, AND COVENANTS

9.1

Mutual Representations and Warranties of the Parties.  Each Party represents and warrants to the other Party as of the Effective Date that:

 

9.1.1

Organization.  It is a corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction of its organization, and has all requisite power and authority, corporate or otherwise, to execute, deliver, and perform this Agreement.

56

 



 

9.1.2

Binding Agreement.  This Agreement is a legal and valid obligation binding upon such Party and enforceable in accordance with its terms, subject to the effects of bankruptcy, insolvency, or other laws of general application affecting the enforcement of creditor rights, judicial principles affecting the availability of specific performance, and general principles of equity (whether enforceability is considered a proceeding at law or equity).

 

9.1.3

Authorization. The execution, delivery, and performance of this Agreement by such Party has been duly authorized by all necessary corporate action and does not conflict with any agreement, instrument, or understanding, oral or written, to which it is a party or by which it is bound, nor violate any Applicable Law or any order, writ, judgment, injunction, decree, determination, or award of any court or governmental body, or administrative or other agency presently in effect applicable to such Party.

 

9.1.4

No Further Approval.  It is not aware of any government authorization, consent, approval, license, exemption, or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any Applicable Law, currently in effect, necessary for, or in connection with, the transactions contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other agreements (except for Regulatory Approvals, Pricing and Reimbursement Approvals, and similar authorizations from Governmental Authorities necessary for the Exploitation of Products as contemplated hereunder).

 

9.1.5

No Inconsistent Obligations.  It is not under any obligation, contractual or otherwise, to any Person that conflicts with or is inconsistent in any material respect with the terms of this Agreement, or that would impede the diligent and complete fulfillment of its obligations hereunder.

 

9.1.6

No Debarment.  Neither it nor any of its respective Affiliates has been Debarred by the FDA, is not subject to any similar sanction of other Governmental Authorities in the Territory, and, to its knowledge, neither it nor any of its respective Affiliates has used or engaged, in any capacity, in connection with this Agreement or any ancillary agreements (if any), any Person who either has been Debarred by such a Regulatory Authority.

9.2

Additional Representations and Warranties of LogicBio.  LogicBio represents and warrants to CANbridge as of the Effective Date and, with respect to LB-001, also as of the date CANbridge exercises the LB-001 Option (except as set forth in a disclosure schedule provided by LogicBio to CANbridge within [**] following the date of the LB-001 Option Exercise), that, in each case except as otherwise set forth in Schedule 9.2 (Disclosure Schedule):

 

9.2.1

it has the full right, power, and authority to grant all of the licenses and rights granted to CANbridge under this Agreement;

 

9.2.2

LogicBio’s rights, title, and interests to all the LogicBio Technology and LogicBio LB-001 Technology are free of any lien, encumbrance, charge, security interest, mortgage, or liability;

 

9.2.3

(a) Schedule 1.156 (LogicBio Licensed Patent Rights) sets forth a complete and accurate list of all Patent Rights existing as of the Effective Date that are owned or

57

 



 

otherwise Controlled by LogicBio or any of its Affiliates and that claim any LogicBio Licensed Know-How, other than any such Patent Right that is a provisional patent application that claims any LogicBio Licensed Know-How that is necessary or useful for the Manufacture of Products (the “LogicBio Licensed Patent Rights Exception”); (b) LogicBio owns or otherwise Controls all Patent Rights listed on Schedule 1.156 (LogicBio Licensed Patent Rights); and (c) except as otherwise noted on Schedule 1.156 (LogicBio Licensed Patent Rights), LogicBio either exclusively owns all rights, title, and interests in and to such Patent Rights, or where LogicBio does not exclusively own any such Patent Right, Schedule 1.156 (LogicBio Licensed Patent Rights) identifies the Third Party that, to LogicBio’s Knowledge, Controls such Patent Rights and the agreement pursuant to which LogicBio Controls such Patent Right;

 

9.2.4

(a) Schedule 1.153 (LogicBio LB-001 Patent Rights) sets forth a complete and accurate list of all Patent Rights in Greater China existing as of the Effective Date that are owned or otherwise Controlled by LogicBio or any of its Affiliates and that claim any LogicBio LB-001 Know-How; (b) LogicBio owns or otherwise Controls all Patent Rights listed on Schedule 1.153 (LogicBio LB-001 Patent Rights); and (c) except as otherwise noted on Schedule 1.153 (LogicBio LB-001 Patent Rights), LogicBio exclusively owns all rights, title, and interests in and to such Patent Rights, and where LogicBio does not exclusively own any such Patent Right, Schedule 1.153 (LogicBio LB-001 Patent Rights) identifies the Third Party that, to LogicBio’s Knowledge, Controls such Patent Rights and the agreement pursuant to which LogicBio Controls such Patent Right;

 

9.2.5

(a) all LogicBio Licensed Patent Rights and LogicBio LB-001 Patent Rights, in each case that are owned by LogicBio, are being diligently prosecuted in the respective patent offices in accordance with Applicable Law; (b) to LogicBio’s knowledge, the inventorship of the LogicBio Licensed Patent Rights and LogicBio LB-001 Patent Rights is properly identified on each issued patent or patent application in the LogicBio Licensed Patent Rights; and (c) all fees required to be paid by LogicBio in any jurisdiction in order to maintain the LogicBio Licensed Patent Rights and LogicBio LB-001 Patent Rights have been timely paid and the LogicBio Licensed Patent Rights and LogicBio LB-001 Patent Rights are subsisting, and to LogicBio’s Knowledge, valid and enforceable;

 

9.2.6

there is no pending litigation, or [**], litigation that has been threatened against LogicBio in writing, that alleges, or any written communication received by LogicBio alleging, that LogicBio’s practice of the LogicBio Technology or LogicBio LB-001 Technology prior to the Effective Date has infringed, misappropriated, or otherwise violated the Intellectual Property of any Third Party;

 

9.2.7

there are no claims, judgments, or settlements against or pending with respect to the LogicBio Technology or LogicBio LB-001 Technology or amounts with respect thereto, owed by LogicBio or any of its Affiliates, and LogicBio has not received written notice threatening any such claims, judgments, or settlements;

 

9.2.8

[**], no Third Party has challenged the ownership, scope, duration, validity, enforceability, priority, or right to use any LogicBio Licensed Patent Rights or LogicBio LB-001 Patent Rights (including, by way of example, through the institution of or written threat of institution of interference, inter partes review, reexamination,

58

 



 

protest, opposition, nullity, or similar invalidity proceeding before the United States Patent and Trademark Office or any foreign patent authority or court);

 

9.2.9

[**], no Third Party is infringing, misappropriating, or otherwise violating, or threatening to infringe, misappropriate, or otherwise violate the LogicBio Technology or LogicBio LB-001 Technology;

 

9.2.10

LogicBio has not previously assigned, transferred, conveyed, or granted any license or other rights under the LogicBio Technology or LogicBio LB-001 Technology;

 

9.2.11

to the extent permissible under Applicable Law, all employees, agents, advisors, consultants, contractors or other representatives of LogicBio or its Affiliates performing activities under this Agreement are and will be under an obligation to assign all rights, title, and interests in and to their Inventions and other Know-How, whether or not patentable, and Intellectual Property therein, to LogicBio or its Affiliates as the sole owner thereof, and CANbridge will have no obligation to contribute to any remuneration of any inventor employed or previously employed by LogicBio or any of its Affiliates in respect of any such Inventions and other Know-How and Intellectual Property therein that are so assigned to LogicBio or its Affiliate(s);

 

9.2.12

Other than the Existing In-License Agreements, there are no Third Party agreements pursuant to which LogicBio Controls any of the LogicBio Technology or LogicBio LB-001 Technology;

 

9.2.13

no written notice of default or termination has been received or given under any agreement pursuant to which LogicBio Controls any LogicBio Technology or LogicBio LB-001 Technology;

 

9.2.14

LogicBio and its Affiliates have taken [**] consistent with industry practices to protect the secrecy, confidentiality, and value of all LogicBio Licensed Know-How and LogicBio LB-001 Know-How that constitutes trade secrets under Applicable Law (including requiring all employees, consultants, and independent contractors to execute binding and enforceable agreements requiring all such employees, consultants, and independent contractors to maintain the confidentiality of such LogicBio Licensed Know-How and LogicBio LB-001 Know-How);

 

9.2.15

except as expressly set forth on Schedule 9.2.15, the LogicBio Technology and LogicBio LB-001 Technology has not been created pursuant to, and is not subject to, any funding agreement with any Governmental Authority or any Third Party, and is not subject to the requirements of the Bayh-Dole Act or any similar provision of any Applicable Law; LogicBio and its Affiliates have complied [**] with all reporting requirements under Applicable Law with respect to those Inventions and Patent Rights identified on Schedule 9.2.15;

 

9.2.16

LogicBio has provided to CANbridge true, complete, and correct (redacted) copies of all agreements relating to the Manufacture or supply of the Products and components thereof that are in effect as of the Effective Date (excluding any agreements for the purchase of ordinary course components or materials acquired by purchase order or without a supply agreement), a complete list of which appears on Schedule 9.2.16; there are no exclusivity provisions or any other restrictions in any agreement between

59

 



 

LogicBio or its Affiliates, on the one hand, and any Third Party relating to the Manufacture or supply of the Products and components thereof to LogicBio, on the other hand, that would limit CANbridge’s ability to Manufacture, or have the Products and components thereof Manufactured;

 

9.2.17

all works of authorship and all other materials subject to copyright protection included in LogicBio Licensed Know-How or LogicBio LB-001 Know-How are original and were either created by employees of LogicBio or its Affiliates within the scope of their employment or are otherwise works made for hire, or all right, title, and interest in and to such materials have been legally and fully assigned and transferred to LogicBio or such Affiliate, and all rights in all Inventions and discoveries, developed or invented by any employee or independent contractor of LogicBio or such Affiliate during the course of their employment (or other retention) by LogicBio or such Affiliate, and included in LogicBio Licensed Know-How or LogicBio LB-001 Know-How, or that are the subject of one or more LogicBio Licensed Patent Rights or LogicBio LB-001 Patent Rights, have been assigned in writing to LogicBio or its Affiliate; and

 

9.2.18

None of the LogicBio Licensed Patent Rights Exceptions are specifically related to the Target, Option Target or the Products.

9.3

Covenants of LogicBio.

 

9.3.1

LogicBio covenants to CANbridge that LogicBio will not, and will cause its Affiliates not to license, sell, assign, or otherwise transfer to any Person any LogicBio Technology (or agree to do any of the foregoing).

 

9.3.2

LogicBio covenants to CANbridge that, (i) prior to the LB-001 Option Deadline and (ii) if CANbridge exercises the LB-001 Option prior to the LB-001 Option Deadline, then during the Term of this Agreement, LogicBio will not, and will cause its Affiliates not to license, sell, assign, or otherwise transfer to any Person any LogicBio LB-001 Technology (or agree to do any of the foregoing).

 

9.3.3

LogicBio will (a) maintain Control of all LogicBio Licensed Know-How and LogicBio LB-001 Know-How; (b) not breach or be in default under any  In-License Agreements in a manner that would give rise to a right of termination under any such agreement; and (c) not terminate or amend any In-License Agreements in a manner that adversely affects CANbridge’s rights under this Agreement with respect to the Products, Targets, Option Targets or LB-001, without CANbridge’s prior written consent.  If LogicBio receives notice of any alleged [**] breach under any In-License Agreement, then LogicBio will promptly, but in no event less than [**] thereafter, provide written notice thereof to CANbridge and grant CANbridge the right (but not the obligation) to cure any such alleged breach.

9.4

Mutual Covenants.

 

9.4.1

Neither Party nor its Affiliates will use or engage, in any capacity, in connection with this Agreement or any ancillary agreements (if any), any Person who either has been Debarred by a Regulatory Authority.  Each Party will inform the other Party in writing promptly if it or any Person engaged by it or any of its Affiliates who is performing services under this Agreement or any ancillary agreements (if any) is Debarred, or if any action, suit, claim, investigation, or legal or administrative proceeding is pending

60

 



 

or, to such Party’s knowledge (or LogicBio’s Knowledge in the case of LogicBio), is threatened, relating to the debarment or conviction of such Party, any of its Affiliates or any such Person performing services hereunder or thereunder.

 

9.4.2

Each Party and its Affiliates will comply [**] with all Applicable Laws (including all anti-bribery laws and export control laws) in the Exploitation of the Products and performance of its obligations and exercise of its rights under this Agreement.

 

9.4.3

Each Party and its Affiliates will, and will cause their respective contractors and consultants to, conduct all Development of Products and components thereof in accordance with GLP, GCP, as applicable and, in each case, as appropriate to the phase or stage of the relevant Development efforts, and other Applicable Law.

 

9.4.4

Each Party will, and will ensure that its Affiliates, Sublicensees, and Subcontractors obtain written agreements from any and all Persons involved in or performing any activities under this Agreement by or on behalf of such Party that assign such Persons’ rights, title, and interests in and to any Know-How or Inventions prior to any such Persons performing such activities.

 

9.4.5

Neither Party will [**] transfer to the other Party any goods, software, technology, or services that are (a) controlled at a level other than EAR99, or for reasons other than anti-terrorism, under the U.S. Export Administration Regulations; (b) controlled under the U.S. International Traffic in Arms Regulations; (c) specifically identified as an E.U. Dual Use Item; or (d) on an applicable export control list of a jurisdiction within the Territory.

9.5

Transparency Reporting.  Each Party will be responsible for tracking and reporting transfers of value initiated and controlled by its and its Affiliates’ employees, contractors, and agents pursuant to the requirements of the transparency or marketing reporting laws of any Governmental Authority in the Territory, including Section 6002 of the ACA, commonly referred to as the “Sunshine Act.”

9.6

DISCLAIMER OF WARRANTIES.  EXCEPT AS OTHERWISE EXPRESSLY SET FORTH HEREIN, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTIES OF TITLE, NON-INFRINGEMENT, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE. IN PARTICULAR, NEITHER PARTY MAKES ANY REPRESENTATION NOR EXTENDS ANY WARRANTY THAT THE DEVELOPMENT CANDIDATES OR PRODUCTS WILL BE SUCCESSFULLY DEVELOPED OR COMMERCIALIZED HEREUNDER.

9.7

LIMITATION OF LIABILITY.  EXCEPT FOR DAMAGES RESULTING FROM BREACHES OF [**]  AND WITHOUT LIMITING EITHER PARTY’S OBLIGATIONS IN RESPECT OF [**], IN NO EVENT WILL EITHER PARTY HAVE ANY CLAIMS AGAINST OR LIABILITY TO THE OTHER PARTY WITH RESPECT TO ANY INDIRECT, PUNITIVE, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES, OR ANY CLAIMS FOR LOST PROFITS OR REVENUES, ARISING UNDER OR IN CONNECTION WITH THIS AGREEMENT UNDER ANY THEORY OF LIABILITY, EVEN IF SUCH PARTY HAS BEEN INFORMED OR SHOULD HAVE KNOWN OF THE POSSIBILITY OF SUCH DAMAGES.

61

 



Article 10
CONFIDENTIALITY

10.1

Confidential Information.  It is understood and agreed by the Parties that:

 

10.1.1

The terms and conditions, but not the existence, of this Agreement will be considered Confidential Information of both Parties and kept confidential by each of the Parties in accordance with this Article 10 (Confidentiality).

 

10.1.2

The Know-How and Patent Rights Controlled by a Party and all reports, information, and data provided by a Party to the other Party or its Affiliates or representatives hereunder will be considered such owning, Controlling or providing Party’s Confidential Information, as applicable, except that, (a) in addition to any information that is expressly designated herein as the Confidential Information of both Parties, any findings in respect of any audit or inspection performed under this Agreement will also be the Confidential Information of both Parties, unless expressly identified as the Confidential Information of a single Party hereunder, and (b) any Know-How or Patent Rights assigned by one Party to the other pursuant to the terms of this Agreement will be considered Confidential Information of the Party to whom such Know-How or Patent Rights are assigned.

10.2

Non-Disclosure and Non-Use Obligation.  Except as otherwise expressly set forth herein, the Receiving Party will, during the Term and for a period of [**] thereafter, keep the Confidential Information of the Disclosing Party confidential using at least the same degree of care with which the Receiving Party holds its own Confidential Information [**] and will not (a) disclose such Confidential Information to any Person without the prior written approval of the Disclosing Party, except, solely to exercise its rights or perform its obligations under this Agreement, to its employees, Affiliates, Sublicensees, and Subcontractors, consultants, or agents who have a need to know such Confidential Information, all of whom will be similarly bound by confidentiality, non-disclosure, and non-use provisions at least as restrictive or protective of the Parties as those set forth in this Agreement and for whom the Disclosing Party will be responsible, or (b) use such Confidential Information for any purpose other than for the purposes contemplated by this Agreement. The Receiving Party will use [**] to cause the foregoing Persons to comply with the restrictions on use and disclosure set forth in this Section 10.2 (Non-Disclosure and Non-Use Obligation) and will be responsible for ensuring that such Persons maintain the Disclosing Party’s Confidential Information in accordance with this Article 10 (Confidentiality). Each Party will promptly notify the other Party of any misuse or unauthorized disclosure of the other Party’s Confidential Information.

10.3

Exemptions.  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 already in the possession of the Receiving Party at the time of its receipt from the Disclosing Party and not through a prior disclosure by or on behalf of the Disclosing Party, (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 disclosees in breach of this Agreement, including pursuant to Section 10.9.3 (Publication Rights), (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 independently by employees, Subcontractors, consultants or agents of the Receiving Party or any of its Affiliates

62

 



without use of or reliance upon the Disclosing Party’s Confidential Information. No combination of features or disclosures will be deemed to fall within the foregoing exclusions merely because individual features are published or available to the general public or in the rightful possession of the Receiving Party unless the combination itself and principle of operation are published or available to the general public or in the rightful possession of the Receiving Party.

10.4

Permitted Disclosures.  In addition to the exceptions contained in Section 10.2 (Non-Disclosure and Non-Use Obligation) and Section 10.3 (Exemptions), the Receiving Party may disclose Confidential Information of the Disclosing Party to the extent (and solely to the extent) that such disclosure is reasonably necessary in the following instances:

 

10.4.1

(a) the Prosecution of Patent Rights as contemplated by this Agreement; or (b) Regulatory Submissions and other filings with Governmental Authorities (including Regulatory Authorities), as necessary for the Exploitation of a Product;

 

10.4.2

disclosure of the existence and applicable terms of this Agreement, the status and results of Exploitation of one or more Products to actual or bona fide potential investors, acquirors, Sublicensees, lenders, and other financial or commercial partners, and their respective attorneys, accountants, banks, investors, and advisors, solely for the purpose of evaluating or carrying out an actual or potential investment, acquisition, sublicense, debt transaction, or collaboration; provided that, in each such case, (a) such Persons are bound by obligations of confidentiality, non-disclosure, and non-use provisions at least as restrictive or protective of the Parties as those set forth in this Agreement or otherwise customary for such type and scope of disclosure, (b) that any such disclosure is limited to the maximum extent practicable for the particular context in which it is being disclosed, and (c) notwithstanding the foregoing (a) and (b), that the term of such confidentiality obligation must be consistent with industry standards, but in all cases at least [**];

 

10.4.3

if required by Applicable Law, including as may be required in connection with any filings made with, or by the disclosure policies of a securities exchange (as set forth in additional detail in Section 10.5 (Confidential Treatment)); provided that the Party seeking to disclose the Confidential Information of the other Party: (a) use all reasonable efforts to inform the other Party prior to making any such disclosures and cooperate with the other Party in seeking a protective order or other appropriate remedy (including redaction); and (b) whenever possible, request confidential treatment of such information in accordance with Section 10.5 (Confidential Treatment);

 

10.4.4

to prosecute or defend litigation so long as there is [**] prior written notice given by the Receiving Party before filing, and to enforce Patent Rights in connection with the Receiving Party’s rights and obligations pursuant to this Agreement; and

 

10.4.5

to allow the Receiving Party to exercise its rights and perform its obligations hereunder, provided that such disclosure is covered by terms of confidentiality and non-use at least as restrictive as those set forth herein.

If and whenever any Confidential Information is disclosed in accordance with this Section 10.4 (Permitted Disclosures), such disclosure will not cause any such information to cease to be Confidential Information except to the extent that such disclosure results in a public disclosure of such information (other than by breach of this Agreement).

63

 



10.5

Confidential Treatment.  Notwithstanding any provision to the contrary set forth in this Agreement, if a Party is required to make a disclosure of the other Party’s Confidential Information pursuant to Section 10.4.3 and Section 10.4.4, then it will, to the extent not prohibited by Applicable Law or judicial or administrative process, except where impracticable, give reasonable advance notice to the other Party of such proposed disclosure and use reasonable efforts to secure confidential treatment of such information and will only disclose that portion of Confidential Information that is legally required to be disclosed as advised by its legal counsel.  In any event, each Party agrees to take all reasonable action to avoid disclosure of Confidential Information of the other Party hereunder.  In addition, the Parties acknowledge that either or both Parties may be obligated to file a copy of this Agreement (or portions of this Agreement or an abstract of the terms of this Agreement) with the SEC or other Governmental Authorities.  Each Party will be entitled to make such a required filing, provided that it initially files a redacted copy of this Agreement (or portions of this Agreement or an abstract of the terms of this Agreement) (“Redacted Agreement”) and requests confidential treatment of the terms redacted from this Agreement for a reasonable period of time.  In the event of any such filing, each Party will (a) permit the other Party to review and comment upon such request for confidential treatment [**] reasonably in advance of its submission to the SEC or such other Governmental Authorities, and (b) [**] the other Party’s comments thereon to the extent consistent with the then-current legal requirements governing redaction of information from material agreements that must be publicly filed in the applicable country.  Each Party will be responsible for its own legal and other external costs in connection with any such filing, registration, or notification.

10.6

Relationship to Confidentiality Agreement.  This Agreement supersedes the Confidentiality Agreement; provided, however, that all “Confidential Information” disclosed or received by the Parties and their Affiliates thereunder will be deemed the Confidential Information of the originally disclosing Party hereunder and will be subject to the terms and conditions of this Agreement.

10.7

Equitable Relief.  Given the nature of the Confidential Information and the competitive damage that could result to a Party upon unauthorized disclosure, use, or transfer of its Confidential Information to any Third Party, the Parties agree that monetary damages may not be a sufficient remedy for any breach of this Article 10 (Confidentiality).  In addition to all other remedies, a Party will be entitled to seek specific performance and injunctive and other equitable relief as a remedy for any breach or threatened breach of this Article 10 (Confidentiality).

10.8

Use of Name and Logo. Subject to Section 10.9.2 (Announcement), neither LogicBio nor CANbridge will use the other Party’s or its Affiliates’ (or, if the other Party is LogicBio, CMRI’s or any Co-Owner’s) name or logo in any label, press release, or product advertising, or for any other promotional purpose, without first obtaining the other Party’s written consent.

10.9

Publications.

 

10.9.1

Coordination.  LogicBio and CANbridge will, from time to time and at the request of the other Party, discuss the general information content relating to this Agreement that may be publicly disclosed.  All publications will be made in accordance with the process set forth in Section 10.9.3 (Publication Rights).

 

10.9.2

Announcements. Except as may be expressly permitted under Section 10.4 (Permitted Disclosures) or Section 10.9.1 (Coordination), neither Party will make any public announcement regarding this Agreement without the prior written approval of the other Party, except for either Party’s references to the other as the licensor or licensee (as applicable) or a collaboration partner under this Agreement. The Parties may issue a

64

 



 

press release regarding the signing of this Agreement after the Effective Date. Each Party will be permitted to issue press releases indicating the payment of a milestone or the achievement of the milestone event corresponding to the payment, in each case upon the prior written consent of the other Party (consent not to be unreasonably withheld, conditioned or delayed). The press release to be issued by the Parties on or following the Effective Date will be substantially in the form of press release set forth on Schedule 10.9.2 (Press Release). After the issuance of such press release or other permitted public disclosure by a Party, either Party may make subsequent public disclosures reiterating such information without having to obtain the other Party’s prior consent and approval so long as the information in such press release or other public announcement remains true, correct, and the most current information with respect to the subject matters set forth therein.  For clarity, nothing in this Agreement will prevent CANbridge from making any scientific publication or public announcement concerning CANbridge’s Development, Manufacture or Commercialization activities with respect to LB-001 or any Product under this Agreement; provided, however, that, except as permitted under Section 10.4 (Permitted Disclosures), CANbridge will not disclose any such publication or announcement without obtaining LogicBio’s prior written consent (consent not to be unreasonably withheld, conditioned or delayed).

 

10.9.3

Publication Rights.  

 

(a)

Publication Rights for Products. Except as set forth in Section 10.9.3(b) (Publication Rights), each Party may, in its sole discretion, publish results of Development activities conducted by or on behalf of such Party with respect to a Product, provided, however, that the other Party will have the right to review all proposed publications prior to submission of such publication, in accordance with the procedures set forth in this Section 10.9.3