Form 10-Q bluebird bio, Inc. For: Jun 30

 

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Exhibit 10.24

EXECUTION VERSION

Toll Manufacturing and Service Agreement

by and between

bluebird bio, Inc.

and

APCETH Biopharma GmbH

November 18, 2016

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Toll manufacturing and service AGREEMENT

Between

- “BBB” -,

and

- “APCETH” -.

- BBB and APCETH shall also be referred to individually as “Party” and jointly as “Parties” –

and

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Index

 

 

 

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Introduction

 

Against this background the Parties agree:

In this Agreement, the following terms with capitalized initial letter, including any grammatical variations, shall have the meanings as set forth below. Where the context so requires the singular includes the plural and vice versa; this applies in particular with respect to the Product:

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APCETH hereby represents and warrants to BBB by way of an independent warranty according to Article 311 Civil Code (selbstständiges Garantieversprechen i. S. d. § 311 BGB) that,

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BBB hereby represents and warrants to BBB by way of an independent warranty according to Article 311 Civil Code (selbstständiges Garantieversprechen i. S. d. § 311 BGB) that BBB has the full power and right to enter into this Agreement and that there are no obligations, agreements, assignments, licenses, encumbrances or rights of any kind held by other parties, private or public, that are inconsistent with the provisions of this Agreement.

The representations and warranties provided to BBB by APCETH according to Section 10.1 do not exclude or supersede BBB’s warranty rights under Section 9.

[***].

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[***].

Prior to engaging a new Third Party manufacturer [***] (“Minimum Utilization Requirement”). Notwithstanding the foregoing, the Minimum Utilization Requirement shall not apply (i) [***], or (ii) [***].

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Without limiting the foregoing, APCETH will provide BBB and/or the Third Party designated by BBB with the following documentation: [***]. The Parties shall agree in good faith on a schedule and plan for affecting the Technology Transfer. For its assistance in the Technology Transfer, [***].

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APCETH will indemnify BBB, its Affiliates, and its and their respective directors, officers, employees, independent contractors, consultants and agents ( the “BBB Parties”), and defend and hold each of them harmless, from and against any and all losses, damages, liabilities, costs and expenses (including reasonable lawyers’ fees and expenses) in connection with any and all liability suits, investigations, claims or demands (collectively, “Losses”) to the extent such Losses arise out of or result from any claim, lawsuit or other action or threat by a third party arising out of: (a) [***], or (b) [***].

BBB will indemnify APCETH, its Affiliates, and its and their respective directors, officers, employees, independent contractors, consultants and agents (the “APCETH Parties”), and defend and hold each of them harmless, from and against any and all Losses to the extent such Losses arise out of or result from any claim, lawsuit or other action or threat by a Third Party arising out of: (a) [***], or (b) [***].

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BBB is entitled to terminate this Agreement:

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Either Party shall act in full compliance with all Applicable Laws, including all applicable labor, tax and social insurance law and industrial safety regulations with regard to its employees involved in the performance of this Agreement. APCETH shall ensure by appropriate contractual arrangements and supervision that any approved subcontractors act in full compliance with the aforementioned Applicable Laws. APCETH agrees to comply with the reasonable, written instructions of BBB and/or its Affiliates with respect to the Applicable Laws relating to the import, export or re-export of the Supplied Materials and/or Product, provided that where APCETH complies with such instructions, BBB shall be responsible for the import, export or re-export of the Supplied Materials and/or Products.

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bluebird bio Inc.

150 2nd Street, Cambridge, MA 02141,

Attention: Chief Legal Officer

with a copy to [***]

[***]

apceth Biopharma GmbH

Haidgraben 5

D‑85521 Ottobrunn

Germany

Attention: Geschäftsführung

with a copy to [***]

[***]

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Apceth GmbH & Co. KG

 

 

 

 

 

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List of Schedules

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AMENDMENT No. 1 TO THE TOLL MANUFACTURING AND SERVICE AGREEMENT

 

Amendment Agreement No. 1 ("Amendment Agreement No. 1") to the Toll Manufacturing and Service Agreement shall become effective on November 16, 2018 and is entered into by and between:

 

bluebird bio Inc. ("BBB")

having its principal place of business at 60 Binney St., Cambridge, MA 02142, United States of America

 

and,

 

apceth Biopharma GmbH ("APCETH"),

having its principal place of business at Haidgraben 5, 85521 Ottobrunn, Germany.

 

BBB and APCETH hereinafter also each referred to as a "Party" and jointly as the "Parties".

 

Whereas,

 

The Parties entered into a Toll Manufacturing and Service Agreement ("TMSA") effective on January 1, 2017 regarding the clinical and commercial GMP-manufacturing of BBB's Products and related services by APCETH.

 

The Parties entered into an Addendum to the TMSA on May 21, 2018 regarding the European Union's General Data Protection Regulation.

 

The Parties now wish to make certain amendments to the TMSA as detailed herein in this Amendment Agreement No. 1.

 

NOW THEREFORE, the Parties agree as follow:

 

 

"16.2 Indemnification of APCETH

 

BBB will indemnify APCETH, its Affiliates, its approved subcontractors and its and their respective directors, officers, employees, independent contractors, consultants and agents (the “APCETH Parties”), and defend and hold each of them harmless, from and against any and all Losses to the extent such Losses arise out of or result from any claim, lawsuit or other action or threat by a Third Party arising out of: [***].”

 

 

 

 

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IN WITNESS WHEREOF, the Parties have caused this Amendment Agreement No. 1 to be executed and delivered by their respective duly authorized officers

 

 

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[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

Exhibit 10.25

 

EXECUTION VERSION

Clinical and Commercial Supply Agreement

Viral Vector Product

by and between

bluebird bio, Inc.

and

SAFC Carlsbad, Inc.

 

November 27, 2017

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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CLINICAL AND COMMERCIAL SUPPLY AGREEMENT

VIRAL VECTOR PRODUCT

This Clinical and Commercial Supply Agreement (this “Agreement”), executed as of November 27, 2017 and effective as of January 1, 2018 (the “Effective Date”), is entered into by and between:

bluebird bio, Inc., a Delaware corporation, with a place of business located at 60 Binney Street, Cambridge, MA 02142 (“Company”), and

SAFC Carlsbad, Inc., a company incorporated under the laws of the State of California, USA, with its principal offices located at 6211 El Camino Real, Carlsbad, California, 92009 (“SAFC”).  

Company and SAFC are hereinafter sometimes referred to separately as a “Party” or together as the “Parties”.

RECITALS

WHEREAS, Company is engaged in the development of its [***] (each, a “Drug Product” and collectively, the “Drug Products”);

WHEREAS, SAFC develops and manufactures a broad range of viral vectors for viral and gene therapy related products that are active key ingredient(s) for use in biopharmaceutical development, clinical trials and commercial use;

WHEREAS, Company desires to engage SAFC to manufacture and supply the Vector Products (as defined herein) for use by Company in its manufacture, use and sale of its Drug Products;

WHEREAS, this Agreement is for the clinical and commercial manufacture and supply, and any and all related services, including but not limited to, Testing, Process Characterization and Process Performance Qualification (as such terms are defined herein);

WHEREAS, this Agreement supersedes and replaces that certain Production Service Agreement by and between the Parties dated October 30, 2008, as amended (the “Prior Agreement”) and said Prior Agreement is terminated in its entirety as of the Effective Date; and

NOW, THEREFORE, in consideration of the above premises and the mutual covenants, obligations and agreements contained herein, the Parties hereby agree as follows:

1.1“Affiliate” means any entity directly or indirectly controlling, controlled by or under common control with either Party hereto.  For purpose of this definition, “control” shall mean ownership of over fifty percent (50%) of the equity capital, the outstanding voting securities or other ownership interest of an entity, or the right to receive over fifty percent (50%) of the profits or earnings of an entity.  In the case of non-stock organizations, the term “control” shall mean the power to control the distribution of profits.

1.2“Agreement” means, collectively, this Agreement, its Exhibits, any Task Orders, Purchase Orders and any other documents incorporated herein by reference, including without limitation the Quality Agreement(s) (as hereinafter defined); provided, however, the Quality Agreement(s) may be amended and modified separately as a stand-alone document and not require amendment of this Agreement under those circumstances.

1.3“Batch” means a specific quantity of Vector Product produced, tested and released from a single operation of the Manufacturing Process, as described in the Master Batch Record. A “Batch” may be any of the following types as further defined hereinafter and identified on the applicable Task Order [***].

 

 

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1.4“Batch Record” and “Master Batch Record” have the meanings assigned to such terms in the Quality Agreement.

1.5“Cell Bank” means either a master cell bank or a working cell bank, whichever the case may be in its use.

1.6“Certificate of [***]” means a certificate issued by [***].  

1.7“CFR” means the U.S. Code of Federal Regulations.

1.8“Clinical Batch” means a Batch produced by SAFC under cGMP conditions and intended for use by Company for investigational purposes.

 

1.9“Commercial Batch” means a Batch produced by SAFC under cGMP conditions after Company has obtained Regulatory Approval for Sale (as defined herein) of its Drug Product.

 

1.10“Confidential Information” shall mean all technical, business and other information, whether tangible or intangible, including (without limitation) any and all data, techniques, discoveries, inventions, processes, know-how, patent applications, inventor certificates, trade secrets, methods of production and other confidential or proprietary information, that either Party or any Affiliate of a Party has ownership rights to (as either owner, licensee or sub-licensee), or may hereafter obtain ownership rights to, and discloses to the other Party. All Confidential Information disclosed by either Party or its Affiliates to the other Party or its Affiliates pursuant to the Prior Agreement shall be deemed to be the disclosing Party’s Confidential Information hereunder. The Parties agree to either (a) clearly mark the term “Confidential Information” upon written Confidential Information, or (b) in the case of oral disclosure of Confidential Information, to confirm the confidential or proprietary nature of such Confidential Information in a writing prior to such disclosure or within [***] following such disclosure.   Notwithstanding the foregoing, failure to mark or confirm in writing such Confidential Information does not constitute a designation of non-confidentiality when the confidential or proprietary nature would be reasonably recognized by the receiving Party based on the subject matter or type of information disclosed or the circumstances of disclosure, and such information shall be deemed Confidential Information hereunder.

1.11“Consumables” means all single use, regularly replaced or reused materials that are required to perform the Manufacturing Process (including Resins but excluding Plasmid Stocks and Raw Materials).

1.12“Contract Year” means each consecutive twelve (12) month period during the Term, beginning on January 1, 2018 and on each January 1 during the Term thereafter.

1.13“Current Good Manufacturing Practices” or “cGMP” shall mean current good manufacturing practices applicable to the Manufacture of Vector Product, that are promulgated by any applicable governmental or regulatory authority, and as may be set forth in the Quality Agreement.  

1.14“Deviation” shall have the meaning set forth in the Quality Agreement.

1.15“EMA” shall mean the European Medicines Agency of the European Union, and any successor(s) thereto.

1.16“Failure to Supply” shall have the meaning set forth in Section 3.8(a) hereof.

 

 

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1.17“FDA” shall mean the United States Food and Drug Administration, and any successor thereto.

1.18“Manufacture”, “Manufacturing” or “Manufactured” means all activities related to the manufacturing of Vector Product, or any ingredient thereof to be undertaken by SAFC in accordance with the terms and conditions of this Agreement and the Quality Agreement, which may include manufacturing Vector Product or supplies for Company’s commercial sale in and for its Drug Product(s), packaging Vector Product, in-process and final testing and release of Vector Product, or any component or ingredient thereof, quality assurance activities related to manufacturing and release of Vector Product and regulatory activities related to any of the foregoing, as may be more specifically identified in the Quality Agreement, the Specifications, and the applicable Purchase Order.

1.19“Manufacturing Facility” means those parts of the manufacturing facility owned by SAFC Carlsbad, Inc., located at 6219 El Camino Real, Carlsbad, California, 92009, operated by SAFC, validated and made available in accordance with this Agreement.

1.20“Manufacturing Process” shall mean the instructions, Specifications (as well as specifications for raw materials and excipients), formulae, procedures, tests and standards developed, established and mutually agreed in writing by the Parties for Manufacturing the Vector Product.

1.21“Materials Specification” means a document detailing the specifications that are applicable for each Raw Material or Consumable, each as mutually approved in writing by the parties.

1.22“Minimum Lead Time” shall have the meaning set forth in Section 3.3(b) hereof.

1.23“Minimum Purchase Commitment” means Company’s minimum binding purchase commitment to SAFC for a minimum number of Batches of Vector Product during a Contract Year, determined as set forth in Section 3.1(a).

1.24“Out of Specification” or “OOS” shall have the meaning set forth in the Quality Agreement.

1.25“Plasmid Stocks” means any Company proprietary plasmids or reference materials received by SAFC from Company.

1.26“Process Characterization Batch” means a non-cGMP Batch produced by SAFC for the purposes of examination by the Parties as to proposed operational ranges and their individual and/or combined impact on product safety, integrity, strength, purity and quality in an effort to further define the process for commercial manufacturing of the Vector Product.

1.27“Process Performance Qualification Batch” means a cGMP Batch produced by SAFC that confirms the process design and demonstrates consistency of operating within the allowed process parameter ranges.

1.28“Production Records” means all Records (including Batch Records, Master Batch Records, and Specifications) and other documentation, including but not limited to databases or other work product generated by SAFC for Company during and in connection with the Services, whether recorded in writing, electronically, or otherwise.

1.29“Project” means clearly identified portions within a fully-executed Task Order that sets forth specific Services.

 

 

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1.30“Purchase Order” means a document issued by Company to SAFC, which shall include such details as a description, quantities, and agreed upon prices for the Vector Product and/or Services for the applicable Task Order and serves as an ordering acknowledgement mechanism for financial management and invoicing.

1.31“Quality Agreement” means the Quality Agreement between Company and SAFC attached hereto and incorporated herein by reference as Exhibit 1, and as may be amended in accordance with the terms of this Agreement.

1.32“Raw Materials” means all components, reagents and solvents intended for use in the Manufacturing Process for the Vector Product, but excluding any Plasmid Stocks and Consumables, which meet the applicable Materials Specifications.

1.33“Regulations” means any and all laws, rules and regulations applicable to the performance of the Services in the country in which (a) Services are performed, or (b) a regulatory filing including results of Services is intended to be filed. Regulations shall include, without limitation, and where and when applicable; (i) the United States Food, Drug, and Cosmetic Act, as amended and any and all rules, regulations and guidance promulgated thereunder, (ii) all applicable European Union, national and local laws, standards and guidelines, (iii) any and all rules and regulations of the Regulatory Agency or any other federal or state government agency related to the conduct of clinical research studies, and (iv) any applicable guidelines promulgated by the International Conference on Harmonization, including without limitation, the ICH Harmonized Tripartite Guidelines for Good Manufacturing Practice, (v) cGMP, and (vi) cGLP.

1.34“Regulatory Agency” means (a) any regulatory or health authority in the United States or in other countries, including without limitation, the FDA and the EMA, (b) if applicable to a particular Task Order (as hereinafter defined), the relevant government regulatory authority or authorities in countries outside of the United States responsible for the conduct of clinical research studies and/or approval of pharmaceutical products, and (c) any other governmental regulatory authority or authorities identified in the Quality Agreement.

1.35“Regulatory Approval for Sale” means with respect to a country or extra-national territory, any and all approvals (including Biologic License Applications and Marketing Authorization Applications), licenses, registrations or authorizations of any Regulatory Agency necessary in order to commercially distribute, sell or market a  Drug Product in such country or some or all of such extra-national territory, including any pricing or reimbursement approvals that may be required in such country or some or all of such extra-national territory, and not including approvals for sale or distribution under compassionate use, named patient programs, or other expanded access programs.

1.36“Regulatory Filing” means any or all correspondence or petitions, to Regulatory Agencies for the purpose of obtaining or maintaining the Regulatory Approval for Sale of Drug Product or the Manufacturing Process as required by statute, or modifying or supplementing existing filings and subsequent amendments and supplements thereto, including any foreign counterparts thereof and any other filings required by Regulatory Agencies relating to the Manufacture, testing, sale or distribution of Vector Product under this Agreement.

1.37“Resins” means all chromatographic media intended to refine or purify the Vector Product, as specified in the Master Batch Record, all of which meet the applicable Materials Specifications.

1.38“Run Equivalent” shall mean one Batch of Vector Product as counted against the Minimum Purchase Commitment, and the associated Batch production price excluding any Batch testing fees (refer to Exhibit 4, Table 1).

 

 

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1.39“SAFC Technology” means any and all SAFC confidential information, trade secrets and SAFC intellectual property and the like.

1.40“Services” means the services to be performed by SAFC pursuant to a fully-executed Task Order under this Agreement.

1.41“Specifications” shall mean Material, Manufacturing and Vector Product specifications set forth in Exhibit 2 hereto.

1.42“Task Order” means a mutually agreed upon and executed in writing by the Parties that describes the Services to be performed by SAFC for Company, which specifies; (a) Project scope, (b) quantity, (c) delivery dates, (d) shipping instructions and addresses, (e) storage instructions, if any, (f) price and payment schedule, and (g) related Testing. A sample form of a Task Order is attached as Exhibit 3.

1.43“Technology Transfer to SAFC” means the Services related to technology transfer of a Manufacturing Process by Company to SAFC, including any production preparatory, training or related support activities for [***].

1.44“Term” shall have the meaning set forth in Section 10.1 hereof.

1.45“Testing” means a scientific evaluation of the quality, safety and purity of Vector Product through assays performed by a qualified testing facility as more particularly described in a Task Order.

1.46“Third Party Supplier” shall have the meaning set forth in Section 3.8(c)(ii) hereof.

1.47“Vector Product” means the purified active biological ingredient in its final formulation in the applicable closure that results from the Manufacture by SAFC, whether clinical or commercial in nature and as more particularly described in the applicable Specification.

2.1General Conditions of Supply.  During the Term, SAFC shall Manufacture and supply Vector Product to Company, and Company shall purchase Vector Product from SAFC in such quantities as Company may order from time to time, subject to the limitations and requirements set forth herein. In consultation with Company, SAFC shall establish, update as necessary, and reserve sufficient qualitied personnel time, manufacturing resources, equipment and cGMP production capacity to enable SAFC to Manufacture Vector Product in accordance with SAFC’s obligations under this Agreement. All Vector Product Manufactured hereunder shall be Manufactured solely by SAFC in suites exclusively dedicated to Company at the Manufacturing Facility. SAFC may not change the Manufacturing site, location or suites for Vector Product without the prior written approval of Company. SAFC shall perform all maintenance required on equipment within the Manufacturing Facility, including maintenance required according to the equipment manufacturer’s specifications and maintenance required to ensure continued validation of the equipment to cGMP requirements.

 

 

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2.2Control of Plasmid Stocks and Cell Banks; Storage Services.  

(a)SAFC shall maintain all portions of the Plasmid Stocks and Cell Bank that it receives from Company or Company’s agents in safe and secure storage under its control in accordance with the storage guidelines set out in the Quality Agreement and/or Materials Specifications, and SAFC shall not transfer the Plasmid Stocks or Cell Bank to any SAFC Affiliate or to any third party that is not specifically authorized in advance and in writing by Company. SAFC shall comply with all applicable regulatory requirements relating to general safety in handling the Plasmid Stocks and Cell Bank. SAFC shall not use the Plasmid Stocks or Cell Bank for any purpose except as contemplated by this Agreement or as otherwise authorized in writing by Company, and in no event shall SAFC modify or attempt to modify the Plasmid Stocks or Cell Bank. Upon Company’s written request, SAFC shall return all or portions of the Plasmid Stocks and Cell Bank to Company or its designee.  

(b)Storage service fees for [***] shall be contained in an annual Task Order mutually agreed to by the Parties no less than [***] prior to the next Contract Year.

2.3Standard of Performance.  At all times during the Term, SAFC will perform the Services with due care, and in accordance with this Agreement, the Specifications, Quality Agreement and applicable laws and regulations, including and not limited to, Current Good Manufacturing Practices applicable to its facilities and to biologics, it being understood that an immaterial incident or deviation from such standards that does not affect the timing for Manufacture of a Batch (including its production, testing, or release), or delivery of a Batch, shall not by itself be deemed a breach of SAFC’s obligations hereunder and that the parties will work together in good faith to resolve any such incident or deviation pursuant to the Quality Agreement.

2.4Changes to Specifications and Process.  The Specifications shall be amended only as agreed upon in writing by Company and SAFC; provided, however, that the Parties agree to cooperate to amend or supplement the Specifications to the extent reasonably necessary to comply with changes in applicable laws or regulations or the requirements of applicable Regulatory Agencies or as Company may reasonably request from time to time (provided such request is made in good faith).  SAFC shall follow the change control procedures set forth in the Quality Agreement for any proposed changes in the Manufacturing Process.  SAFC acknowledges that any such change(s) shall, in each case, comply with cGMP, this Agreement, all regulatory submissions, and the Quality Agreement.  In the event such amendment (whether as a result of changes in applicable laws or regulations or the requirements of applicable Regulatory Agencies or at Company’s reasonable and good faith request or otherwise) requires additional cost or schedule adjustments for the Manufacture of Vector Product hereunder, Company and SAFC shall agree in good faith on an equitable adjustment to price or schedule or both, as appropriate.  Any such amended Specifications shall be reflected in and attached hereto as an amended and restated Exhibit 2.

2.5Raw Materials and Consumables.

(a)Procurement. SAFC shall be responsible for the procurement of all [***] necessary for the Manufacture of Vector Product. SAFC shall use commercially reasonable efforts to procure all [***], consistent with and having regard to such matters as security and sources of supply, quality of product, volume requirements, terms and conditions of supply and the Manufacturing schedule. The Parties shall use their good faith efforts to identify and establish a list of [***] by [***] and update Exhibit 6, as attached hereto and incorporated herein.

(b)Compliance with Specifications. All [***] hereunder shall comply with the applicable Materials Specifications and the Master Batch Record.

 

 

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(c)Alternate Sources of Supply. SAFC shall be responsible to establish a source or sources of supply for all [***] sufficient to ensure SAFC’s ability to fulfil its obligations to Manufacture Vector Product hereunder in a timely and cost-effective manner, and in accordance with the Quality Agreement. [***].

(d)Sole-Sourced Raw Materials and Consumables. For any sole-sourced [***] that SAFC has provided proper notice to Company in accordance with Section 2.5(c)(i), [***].  

(e)Vendor Audits.  SAFC shall, conduct all necessary audits on vendors and suppliers of Raw Materials, Consumables and Resins to ensure that such vendors and suppliers comply with applicable regulatory and quality requirements.  

(f)Inventory of Materials and Spare Parts. SAFC shall establish, update as necessary and implement, inventory management processes and procedures designed to ensure that SAFC is able to obtain, on a timely basis, all [***] necessary to Manufacture Vector Product hereunder.  SAFC shall ensure that an inventory of spare parts for all equipment it uses to Manufacture Vector Product is maintained consistent with the manufacturers’ recommendations.

(g)Storage and Use of Materials and Vector Product. SAFC shall ensure that all [***] that are in SAFC's control, as well as all Manufacturing Process intermediates and Vector Product in SAFC’s control, are stored in accordance with the terms and conditions of the storage guidelines set out in the Quality Agreement, the Materials Specifications and/or the Master Batch Record (as applicable), or as otherwise mutually agreed to by SAFC and Company in writing.

2.6Quality Control and Release.  The quality control(s) and the release(s) of Vector Product (including documentation) shall be done by SAFC in accordance with the Quality Agreement.  Pursuant to Section 4.3 below, Company shall have the right to reject Vector Product that does not meet the quality control and release testing requirements agreed upon by SAFC and Company in the Specifications.

2.7Access to the Manufacturing Facility

(a)Inspections.  Upon reasonable advance notice, and at mutually agreeable times and dates during normal business hours and in accordance with any requirements of the Quality Agreement, SAFC will permit Company representatives to visit the Manufacturing Facility, discuss the Services with appropriate officials of SAFC, and inspect Production Records, including but not limited to all data, relevant to the Services.  Such Manufacturing Facility visits shall also be permitted during the data retention period described in the Quality Agreement, if any. Company will comply with any and all SAFC safety, security and confidentiality measures for the Manufacturing Facility and other related facilities.

(b)Person-In-Plant. In addition to the foregoing inspection right and audit right otherwise set forth herein, with [***] prior written notice to SAFC, Company may designate an individual from time to time in its discretion (the “Person-In-Plant”), who will be present in the Manufacturing Facility during operating hours and during active Manufacturing, to observe the testing and production phases of the Manufacturing Process, and to consult with SAFC. Company shall cause the Person-In-Plant to (i) not cause any disruption to SAFC’s business activities and (ii) comply with SAFC’s safety, security and confidentiality measures. The duration and activities for Person-In-Plant shall be pre-approved by SAFC in advance of scheduling and entry of such Person-In-Plant.

2.8Documentation.  

(a)General.  Upon completion of Manufacture of each Batch of Vector Product, SAFC shall provide to Company the following documentation related to the Manufacturing of Vector Product in accordance with the Quality Agreement, as applicable: (i) a Certificate of [***], (ii) all Deviations, and (iii) the executed Batch Record.  

 

 

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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(b)Confidential Records.  The Master Batch Records and all documents referred to in Section 2.8(a) shall be Confidential Information of Company and shall not be used or disclosed by SAFC other than for the purposes of permitting SAFC to exercise its rights or fulfil its obligations under this Agreement (including but not limited to, the provision of the Master Batch Record and other documents to Company for quality review) and, where necessary, for disclosure to the relevant Regulatory Agencies in order to comply with regulatory requirements relating to the Manufacturing of Vector Product by SAFC.

(c)Retention of Documentation.  All Production Records related to the Manufacturing of Vector Product shall be owned by Company and archived with SAFC after Manufacturing for a period as stated in the Quality Agreement.

2.9Safety of Vector Product.  In each case in accordance with the Quality Agreement: (i) each Party shall immediately notify the other Party of any unusual health or environmental occurrence relating to the Vector Product; and (ii) each Party shall advise the other Party immediately of any safety or toxicity problems of which it becomes aware regarding the Vector Product.

3.1Minimum Purchase Commitment; Run Equivalents; Additional Batches and Manufacturing Capacity; Support Studies.

(a)During the Term, Company shall purchase the Minimum Purchase Commitment which shall be equal to [***]. In the event Company fails to purchase the Minimum Purchase Commitment [***]. Such payment requirement for the shortfall of Batches shall be invoiced [***].

(b)Notwithstanding Section 3.1(a), in any Contract Year in which [***].

(c)Company may request additional Batches beyond its Minimum Purchase Commitment, provided that Company makes such request upon written notice to SAFC [***].

(d)Company may request support studies related or unrelated to any Batches or Technology Transfer to SAFC under this Agreement, and such support studies shall be incremental to any Minimum Purchase Commitment and shall be under a separate and distinct Task Order outlining the scope of work and cost of such support studies.

 

3.2Forecasts; Change of Vector Product.

(a)In advance of the Effective Date, Company shall determine and provide to SAFC, Company’s initial Contract Year’s forecast, which shall then be updated on a [***] basis. Each [***] update shall include a “rolling” [***] update that includes [***]. Subsequent Contract Year forecasts will be due [***].  Company may update the previous forecast more frequently than on a [***] basis. Forecasting shall not in any way change or affect Company’s Minimum Purchase Commitment obligations.

(b)At Company’s reasonable request in advance, SAFC will review with Company the inventory and lead times for major components of the Manufacturing Process.  Company acknowledges and understands that any forecast will be used by SAFC for planning purposes (including raw material acquisitions and investment in equipment and other resources) in order to make available the production capacity required to Manufacture and supply the forecasted amounts of Vector Product within the time frames agreed to by both Parties.

(c)[***].

 

 

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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3.3Initial Supply; Purchase Orders, Task Orders, Invoicing and Payment.

(a)To initiate SAFC’s Manufacture and supply of Vector Product for the initial Contract Year, SAFC shall issue a Task Order for Company’s review and execution and Company shall then, [***] prior to the first scheduled production start date issue a binding written Purchase Order for its purchase of Vector Product. Both the Task Order and the Purchase Order shall be in accordance with the Minimum Purchase Requirement and may include additional Batches as agreed upon pursuant to Section 3.1(c). The Parties acknowledge, recognize and agree that the Purchase Order is an ordering mechanism for proper financial management and invoicing between the Parties, and has not effect on the terms and conditions of this Agreement, which shall prevail in the event of any other terms and conditions contained in a Purchase Order.

(b)For each subsequent Contract Year following the initial Contract Year, a Task Order for the Contract Year shall be executed between the Parties in writing as above and Company shall issue to SAFC a Purchase Order [***] prior to the start of the Contract Year, or such shorter time period as may be agreed upon by the Parties in writing, for its purchase of Vector Product for such Contract Year.  The minimum number of days between the date of a Purchase Order and the Manufacture start date of Vector Product under this Section 3.3(b) and Section 3.3(a) above shall be referred to hereinafter as the “Minimum Lead Time”.

(c)Within [***] of receipt of a Purchase Order, SAFC shall notify Company in writing of its acceptance of the Purchase Order.  If SAFC fails to respond within such [***] period, the Purchase Order shall be deemed accepted, but only to the extent that any amount ordered is not in excess of the Minimum Purchase Commitment and that the requested delivery date satisfies the Minimum Lead Time.  SAFC, in its sole discretion, may refuse and reject a Purchase Order if the Purchase Order does not accurately reflect the agreed upon Task Order.

(d)If a Purchase Order exceeds the Minimum Purchase Commitment, or does not meet the Minimum Lead Time, SAFC, in its sole and absolute discretion, may (i) accept such Purchase Order, and/or (ii) adjust the price and other related terms taking into consideration the amount of the order that exceeds the Minimum Purchase Commitment and such shorter lead-time. In the event Company wishes not to proceed after such adjustments by SAFC, the Purchase Order shall be deemed to be rejected.

(e)Invoicing and Payment.

(i)[***].

(ii)[***].

(iii)[***].  

3.4Release of Vector Product.  

(a)SAFC shall notify Company when (i) the Manufacture of each Batch of Vector Product is complete, including (ii) all Manufacturing records have been reviewed, (iii) all testing is completed, reviewed, and Vector Product meets Specifications, (iv) all Deviations have been adequately reviewed and approved, and (iv) Vector Product has been released by SAFC, as applicable and in accordance with the Quality Agreement.  

(b)[***].  

3.5Delivery, Title and Risk of Loss.  All Vector Product supplied by SAFC hereunder shall be supplied FCA SAFC’s shipping point within the meaning of [***].  [***].  SAFC may only make delivery in installments with the prior approval of Company, and if approved, all such installments to be separately invoiced and paid for when due per invoice, without regard to subsequent deliveries.  Delay in delivery of any approved installment shall not relieve Company of its obligations to accept any and all remaining deliveries.

 

 

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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3.6Packaging.  SAFC will preserve, package, handle, and pack all Vector Product so as to protect Vector Product from loss or damage, in conformance with the Specifications and the Quality Agreement.

3.7Storage.  SAFC shall hold all Vector Product under the storage conditions established pursuant to the Quality Agreement and in accordance with cGMP.  SAFC, at its own cost, shall store Vector Product for a period not to exceed [***] after Vector Product has been released in accordance with Section 3.4 above.  Any Vector Product held by SAFC beyond the time periods specified above shall be subject to storage charges at SAFC’s current list prices or as mutually agreed to by the Parties in writing.

3.8Delay and Third Party Supplier.

(a)If SAFC is or will be unable for any reason (including an event of Force Majeure under Section 12.18 hereof) to [***].   

(b)[***]

(c)[***]

(i)[***]

(ii)[***]

(iii)[***]

(d)[***].

(e)For the sake of clarity, the remedies provided in this Section 3.8 and the timelines for the completion of any investigation under Section 3.8(b) do not affect (i) any other obligations of SAFC contained herein; (ii) Company’s right to terminate pursuant to Section 10.2(a)(i); (iii) or any other remedies available to Company as provided herein.

4.1Specifications.     In the event of a conflict between the provisions of this Agreement and the provisions of the Quality Agreement, the provisions of the Quality Agreement shall prevail only for all quality related requirements, responsibilities and obligations, otherwise, this Agreement shall prevail. Neither Party shall make changes to the Production Records or the Specifications without the prior written approval of the other party which approval will not be unreasonably withheld. SAFC shall only make changes in the Standard Operating Procedures (SOPs), production equipment, production procedures, or testing methods existing as of the date of this Agreement which materially affect the Services in accordance with the provisions contained in the Quality Agreement. SAFC shall maintain all Production Records and other records as are necessary and appropriate to demonstrate compliance with the Regulations. Company shall be entitled to request SAFC to change the Specifications and the SOPs. SAFC shall use commercially reasonable efforts to accommodate such change; provided that Company will reimburse SAFC the reasonable and necessary costs SAFC incurs in making any such change; provided further that the parties shall engage in good faith negotiations to adjust the costs to reflect the increase or decrease of ongoing costs hereunder resulting from any such change; provided further that if the parties cannot reach agreement to adjust the costs pursuant to this Section 4.1 despite such good faith negotiations, then SAFC shall not be required to change the Specifications or SOPs as requested by Company.

4.2Testing.  If provided for in the applicable Task Order with respect to a Batch, SAFC shall test such Batch to ensure compliance with the Specifications.

 

 

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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4.3Acceptance.  Subject to Section 4.4 below, Company shall have a period of [***] from the date of its (or its designee’s) receipt the Batch Record (which includes the Certificate of [***]) to reject in writing the Vector Product for nonconformity of such Batch with the Specifications. If no written notification is received by SAFC within the [***] period, such Batch is deemed accepted. If Company rejects such shipment in writing within the [***] time period, it shall promptly so notify SAFC and provide sufficient detail of the nonconformity, and the provisions of Section 5.2 below shall apply.

4.4Latent Defects.  If after accepting a shipment of Vector Product, Company subsequently discovers latent material defects [***].

4.5Deviation Report.  If during the Manufacture, including but not limited to the processing, storage, distribution, testing, transport, disposal or other handling, of Vector Product by SAFC an unexpected result arises that [***].

4.6SAFC’s costs shall not include Company’s materials, which include but are not limited to cells, plasmids, equipment, raw materials, consumables or other materials.

5.1Disagreement Concerning Fulfilment of Specifications. In the event of any disagreement between the Parties as to whether Vector Product conforms to the Quality Agreement, the applicable Specifications, or cGMP, the quality assurance representatives of the Parties will attempt in good faith to resolve any such disagreement and the Parties will follow their respective SOPs. If the foregoing discussions do not resolve the disagreement within [***] of Company’s notice pursuant to Section 4.3 or 4.4, a representative sample of such Vector Product and/or relevant documentation will be submitted to an independent testing laboratory (in the case of an alleged failure to meet Specifications) and/or independent cGMP quality or regulatory consultant (in the case of an alleged failure to comply with cGMP), as appropriate, that are mutually agreed upon by the Parties for tests and final determination as to whether such Vector Product conforms with Specifications and/or cGMP quality standards. The laboratory must meet SAFC supplier qualification standards for cGMP test laboratory. The laboratory and consultant, as applicable, must be of recognized standing in the industry, and consent to the appointment of such laboratory and consultant will not be unreasonably withheld or delayed by either Party. Such laboratory will use the test methods contained in the applicable Specifications. The determination of conformance by such laboratory and/or cGMP consultant, as applicable, with respect to all or part of such Vector Product will be final and binding on the Parties, absent manifest error. The fees and expenses of the laboratory and/or consultant, as applicable, incurred in making such determination will be paid by the Party against whom the determination is made.

5.2Remedies for Non-Conforming Product.  

(a)If any Vector Product Manufactured by SAFC fails to conform to Specifications or cGMP (unless the non-conformity is attributable to Company’s negligence or misconduct), SAFC shall [***]. Non-conforming Vector Product shall be disposed of in accordance with the Quality Agreement and at SAFC’s expense (unless the non-conformity is attributable to Company’s negligence or misconduct).  If Company is directed to destroy non-conforming Vector Product, then Company shall provide SAFC a certificate certifying such destruction.

(b)Except as provided for pursuant to any Party’s indemnification obligations for third party claims, the remedy described in this Section 5.2 shall be Company’s sole remedy and SAFC’s only liability for non-conforming Vector Product.

 

 

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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5.3Deviations and OOS.  SAFC and Company shall cooperate in the investigation and response to any Vector Product complaints concerning Deviations and OOS, all in accordance with the Quality Agreement.

6.1Currency.  Except as otherwise expressly indicated, all references to “$” or to “dollars” in this Agreement shall be read as referring to the legal tender of the United States of America.

6.2Pricing. The pricing for Vector Product Manufactured under this Agreement is set forth in the Price and Payment Schedule as more particularly described in Exhibit 4.  [***].  All prices are quoted in United States Dollars.

6.3Invoices and Payments.  SAFC shall invoice Company per Section 3.3(e) and the Price and Payment Schedule in Exhibit 4.  All payments made hereunder are due within [***] from the receipt of the SAFC invoice.  Payments shall be made to SAFC in accordance with the instructions on the invoice.  All payments hereunder shall be made in United States Dollars. In the event Company disputes an invoice or portion thereof, Company shall be required to do so in writing to SAFC within [***] from the receipt of such disputed invoice.

6.4Overdue Payments.  Company shall pay interest on all past-due amounts at a rate of interest equal to the lesser of [***] or the maximum rate permitted by applicable law.  

6.5Annual Price Adjustment.  To reflect changes in the cost of labor and raw materials, SAFC may adjust the Batch production price each Contract Year of the Term following the initial Contract Year in accordance with the following: (a) SAFC shall provide Company with written notice of any [***]; (b) [***].

6.6Taxes.  

(a)If Company must withhold from any payment to SAFC under this Agreement any taxes required to be withheld by Company under the applicable laws of any country, state, territory or jurisdiction, such amount shall be paid to the appropriate taxing authorities.  Upon request, Company shall provide SAFC with sufficient documentation of such withholding as is reasonably available to allow SAFC to verify such withholding and to document such tax withholdings for purposes of claiming tax credits and similar benefits.

(b)Any use tax, sales tax, excise tax, duty, custom, inspection or testing, or any other tax, fee or charge of any nature whatsoever imposed by any governmental authority, on or measured by the transaction between Company and SAFC, but excluding any tax payable on income, revenue, profits or capital of SAFC, shall be paid by Company in addition to any other amounts due hereunder.  If SAFC recovers all or any portion of any tax, fee or charge paid by Company, SAFC shall credit Company with the amount recovered.

6.7SAFC Performance Bonus. Company shall pay SAFC a performance bonus as more particularly described in Exhibit 4 (Section 3) (“Performance Bonus”). Such Performance Bonus shall be invoiced separately by SAFC to Company [***] of the end of the applicable Contract Year.

7.1Recall.

(a)Company shall be responsible for making the determination and for conducting any recall of Drug Product, and SAFC shall co-operate with and give all reasonable and necessary assistance to Company in conducting any such recall to the extent it relates to Vector Product.  Notwithstanding anything herein to the contrary, SAFC shall only bear the cost and expense of a recall directly resulting from [***].  In the event of such recall or similar action, each Party shall use commercially reasonable efforts to mitigate the costs associated therewith.

 

 

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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(b)In the case of a dispute as to the existence or level of non-conforming Vector Product in connection with a recall under Section 7.1(a) above, the matter shall be resolved in accordance with the procedures set forth in Section 5.1.

7.2SAFC Representations and Warranties.  SAFC hereby represents and warrants as follows:

(a)The execution, delivery and performance of this Agreement does not conflict with, violate or breach any agreement to which SAFC is a party or SAFC’s constituent documents, and SAFC is not prohibited or limited by any law or agreement (to which it is a party) from entering into this Agreement and the performance of this Agreement will not create any conflict of interest with any other business or activity engaged in by SAFC;

(b)Vector Product shall be Manufactured and shipped in compliance with cGMP, the Master Batch Record, the Specifications, the Quality Agreement and all other applicable laws, rules and regulations;

(c)SAFC and its Affiliates, approved subcontractors and any person used by SAFC and its Affiliates and subcontractors to perform services under this Agreement (i) have not been debarred and are not the subject of a conviction described in Section 306 of the United States Food, Drug and Cosmetic Act, 21 U.S.C. § 335a; (ii) are not subject to any similar sanction by any government regulatory authority; and (iii) SAFC shall notify Company immediately in writing if SAFC, its Affiliates or any subcontractor or any person used to perform services hereunder, as applicable, is subject to the foregoing, or of any action, suit, claim, investigation or proceeding;  

(d)All Vector Product delivered by SAFC hereunder will conform to the Quality Agreement and the Specifications; and

(e)SAFC will have obtained and maintained in effect all such approvals and permits as may be required under applicable laws, rules, regulations and requirements to operate the Manufacturing Facility for the purposes of Manufacturing Vector Product under the Quality Agreement and under this Agreement. SAFC shall make copies of such registrations and all related documents available for viewing by Company and its designees for inspection, upon prior reasonable request from Company.

7.3Company Representations and Warranties. Company represents and warrants that the execution, delivery and performance of this Agreement does not conflict with, violate or breach any agreement to which Company is a party or Company’s constituent documents; Company is not prohibited or limited by any law or agreement to which it is a party from entering into this Agreement; and the performance of this Agreement will not create any conflict with any other business or activity engaged in by Company.

7.4Disclaimer.  EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, THE PARTIES MAKE NO REPRESENTATIONS OR WARRANTIES OF ANY KIND WHATSOEVER, EITHER EXPRESS OR IMPLIED, WRITTEN OR ORAL, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY, WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE, OR WARRANTY OF NON-INFRINGEMENT, WHETHER ARISING BY LAW, COURSE OF DEALING, COURSE OF PERFORMANCE, USUAGE OF TRADE OR OTHERWISE, ALL OF WHICH ARE EXPRESSLY DISCLAIMED.

7.5Company Indemnification.  Subject to Section 12.5, Company shall indemnify, defend and hold harmless SAFC, its Affiliates and its or their directors, officers and employees from all actions, losses, demands, costs and liabilities arising from any third party claim (including reasonable attorneys’ fees) to which SAFC is or may become subject insofar as they arise out of or are alleged or claimed to arise out of:

(a)[***];

(b)[***];

 

 

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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(c)[***];

(d)[***];

(e)[***];

(f)[***]; or

(g)[***];

(h)in each case except that Company shall have no obligation to indemnify, defend or hold harmless SAFC, its Affiliates and its or their directors, officers and employees for any negligent acts or omissions or willful misconduct by SAFC or its Affiliates and its or their directors, officers, employees, agents or permitted subcontractors associated with its obligations under this Agreement, or for any losses or claims whatsoever to the extent that SAFC has an obligation to indemnify Company with respect to such losses and claims pursuant to Section 7.6 below.

7.6SAFC Indemnification.  Subject to Section 12.5, SAFC shall indemnify, defend and hold harmless Company, its Affiliates and its or their directors, officers and employees from all actions, losses, demands, costs and liabilities arising from any third party claim (including reasonable attorney’s fees) to which Company is or may become subject insofar as they arise out of or are alleged or claimed to arise out of:

(a)[***];

(b)[***];

(c)in each case except that SAFC shall have no obligation to indemnify, defend, or hold harmless Company, its Affiliates and its or their directors, officers and employees for any negligent acts or omissions or willful misconduct by Company or its Affiliates and its or their directors, officers, employees, agents or permitted subcontractors associated with its obligations under this Agreement, or for any losses or claims whatsoever to the extent that Company has an obligation to indemnify SAFC with respect to such losses and claims pursuant to Section 7.5 above.

7.7Indemnification Procedure.  Either Party intending to seek indemnification from the other Party under Sections 7.5 or 7.6 above, as the case may be, shall give the other Party prompt notice of any such claim or lawsuit (including a copy thereof) served upon it and shall fully cooperate with the other Party and its legal representatives in the investigation of any matter which is the subject of indemnification.  Such Party seeking indemnification shall not unreasonably withhold its approval of the settlement of any claim, liability or action covered by the above indemnification provisions.  Notwithstanding the foregoing, the failure to give timely notice to the indemnifying Party shall not release the indemnifying Party from any liability to the Party seeking indemnification to the extent the indemnifying Party is not prejudiced thereby.

7.8Company Insurance.  Without limiting its liability under this Agreement (except as may be otherwise expressly provided in this Agreement), during the Term and for five (5) years after the expiration or termination of this Agreement, Company shall obtain and maintain commercial general liability insurance of [***]. With respect to all insurance coverage required under this Section, (i) Company shall, promptly upon SAFC’s request, furnish SAFC with certificates of insurance evidencing such insurance and (ii) all policies shall include provisions for at least [***] prior written notice of cancellation.  

 

 

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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7.9SAFC Insurance.  Without limiting its liability under this Agreement (except as may be otherwise expressly provided in this Agreement), during the Term and for five (5) years after the expiration or termination of this Agreement, SAFC shall obtain and maintain the following minimum insurance coverages with financial sound and nationally reputable insurers: [***]. Company shall be named as an additional insured (except on policies for workers compensation and professional liability/ errors and omissions) and SAFC will provide Company with a certificate of insurance evidencing such coverages upon Company’s written request. SAFC will provide Company with [***] advance written notice of any material change or cancellation in coverage or limits.

8.1Regulation of Manufacturing Process. If Company, as the Sponsor under the FDA regulations who holds the investigational new drug application or biologics license application is required by the FDA (or the corresponding foreign equivalent required by the EMA or other Regulatory Agency), or any other Regulatory Agency to validate or re-validate Manufacturing Processes that will impact the Manufacturing of Vector Product, Company shall notify SAFC and consult with SAFC regarding the required activities.  SAFC shall only be responsible for the costs of any such validation or re-validation if the validation or re-validation is required due to (i) the non-compliance of the Manufacturing Facility, or (ii) any acts, omissions or deficiencies with respect to the personnel, training or other items within SAFC’s reasonable control; otherwise any and all such costs or expenses shall be the sole responsibility and obligation of Company.    

8.2Regulatory Testing Requirements.   Should, during the course of conducting the Services, regulatory testing requirements covering the Vector Product change such that additional material expense would be incurred by SAFC to satisfy the terms of this Agreement, those expenses will be the responsibility and obligation of Company.

8.3Correspondence.  SAFC will notify Company (pursuant to the Quality Agreement) promptly upon receipt of any correspondence from a Regulatory Agency, which relates to the Vector Product.  In addition, SAFC shall provide to the Regulatory Agencies all documents and information requested by such authority, and shall submit to all inquiries, audits and inspections by the Regulatory Agencies.  

8.4Compliance with Laws; Authorizations.  In performing this Agreement, each Party shall (i) comply with all applicable laws and regulations and (ii) obtain all releases, licenses, permits or other authorization required by any governmental body or authority.

8.5Regulatory Matters

(a)Records.SAFC shall maintain all records required by the Quality Agreement, or as otherwise agreed to in writing by SAFC and Company. SAFC agrees that, in response to any complaint, or in the defense by Company of any litigation, hearing, regulatory proceeding or investigation relating to Vector Product, SAFC shall use reasonable efforts to make available to Company during normal business hours and upon reasonable prior written notice, such SAFC employees and records reasonably necessary to permit the effective response to, defense of, or investigation of such matters, subject to appropriate confidentiality protections. If SAFC incurs costs or expenses with respect to the foregoing attributable to Company’s negligence or willful misconduct, Company shall reimburse SAFC for reasonable costs and expenses incurred by SAFC.

 

 

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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(b)Complaints.Company shall have responsibility for reporting any complaints relating to Vector Product to Regulatory Agencies, including, but not limited to, complaints relating to the Manufacture of Vector Product in accordance with the Quality Agreement, or as otherwise agreed in writing by SAFC and Company. If SAFC incurs costs or expenses with respect to the foregoing attributable to Company’s negligence or willful misconduct, Company shall reimburse SAFC for reasonable costs and expenses incurred by SAFC.

(c)Regulatory Communications and Correspondence. Any and all communications from and to Regulatory Authorities related to Vector Product or to the Manufacture of Vector Product at the Manufacturing Facility shall be handled in accordance with the Quality Agreement, or as otherwise agreed in writing by SAFC and Company.

(d)Regulatory Filings and Maintenance. SAFC shall prepare and maintain all Regulatory Filings and Manufacturing files, certificates, authorizations, data and other records that directly or indirectly pertain to the Manufacture of ABI, as further set forth in the Quality Agreement or as otherwise agreed in writing by SAFC and Company.

(e)Cooperation in Obtaining Government Approvals. As set forth in the Quality Agreement, or as otherwise agreed to in writing by SAFC and Company, at Company’s request, SAFC shall provide Company with such existing documents and information (or copies thereof) held by SAFC to assist Company in securing and maintaining Regulatory Agency approvals for Vector Product. In addition, SAFC shall provide Company with such information as is reasonably requested in writing by Company relating to the Manufacturing Process, the Master Batch Record, SAFC services performed under this Agreement or other ABI-related documentation.

(f)Ownership of Regulatory Filings. Company shall be the sole owner of all Regulatory Filings and all governmental approvals obtained by Company from any Regulatory Agency with respect to Vector Product.

(g)Company Access to Manufacturing Data and Documentation. Company shall have full access to and the right to use and reference any, correspondence, facility and engineering records and diagrams, validation documentation, lot files, reports, analyses, regulatory requirements and any other data and documentation generated in connection with the Manufacturing activities conducted by SAFC hereunder, and SAFC shall provide Company with copies of the foregoing upon request.

9.1Confidentiality Obligations of SAFC.  In the course of the performance of this Agreement, Company may, from time to time, disclose Confidential Information of Company to SAFC or its Affiliates. Confidential Information of Company shall specifically include but not be limited to the Plasmids, Cell Banks, any documentation relating to the Manufacturing Process provided by Company to SAFC, all elements of the Manufacturing Process provided by Company to SAFC or acquired by Company from SAFC, Vector Product specific unit operations of the Manufacturing Process, the Vector Product, clinical data and information, business plans and regulatory and product strategies and information. Except as expressly permitted otherwise by the terms of this Agreement, SAFC shall:  (i) maintain in confidence and not disclose the Confidential Information of Company to any third party, except on a need-to-know basis to SAFC’s (or its Affiliates’) employees and agents to the extent such disclosure is reasonably necessary in connection with SAFC’s (or its Affiliates’) activities as expressly authorized by this Agreement and upon obligations of confidentiality similar to those set forth herein; and (ii) not use or grant the use of the Confidential Information of Company for any purpose other than the performance of SAFC’s obligations hereunder.

 

 

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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9.2Confidentiality Obligations of Company.  In the course of the performance of this Agreement, SAFC may, from time to time, disclose Confidential Information of SAFC to Company or its Affiliates.  Except as expressly permitted otherwise by the terms of this Agreement, Company shall:  (i) maintain in confidence and not disclose the Confidential Information of SAFC to any third party, except on a need-to-know basis to Company’s (or its Affiliates’) employees and agents to the extent such disclosure is reasonably necessary in connection with Company’s (or its Affiliates’) activities as expressly authorized by this Agreement and upon obligations of confidentiality similar to those set forth herein; and (ii) not use or grant the use of the Confidential Information of SAFC for any purpose other than the performance of Company’s obligations hereunder.

9.3Exceptions.  The provisions of Sections 9.1 and 9.2 above shall not apply to any Confidential Information of the disclosing Party that can be shown by competent evidence by the receiving Party:

(a)To have been known to or in the possession of the receiving Party without any separate obligation of confidentiality before the date of its actual receipt from the disclosing Party;

(b)To be or to have become readily available to the public other than through any act or omission of any Party in breach of any confidentiality obligations owed to the disclosing Party;

(c)To have been disclosed to the receiving Party, other than under an obligation of confidentiality, by a third party which does not have an obligation to the disclosing Party not to disclose such information to others; or

(d)To have been subsequently independently developed by the receiving Party without use of or reference or access to the disclosing Party’s Confidential Information.

9.4License.  During the Term, Company hereby grants to SAFC a royalty-free, non-exclusive license under any know-how, trade secrets, copyrights, designs, databases, discoveries, improvements and inventions (whether patentable or not) related to Vector Product or the Manufacture of Vector Product that are owned or controlled by Company and that are reasonably required for SAFC’s performance of its obligations under this Agreement, but only for such purposes and only to the extent reasonably required for SAFC to perform its obligations under this Agreement.

9.5Proprietary Rights.

(a)Except as expressly set forth in this Agreement each Party owns, and shall continue to own its existing intellectual property, without conferring any interests therein on the other Party. Nothing contained in this Agreement nor any disclosure or provision to SAFC of any Company Confidential Information or other Company information or items shall be deemed to transfer or grant to SAFC or any other person or entity any right to use or exploitation thereof nor to any right, title, interest, or license in, to or under any patent, patent application or other intellectual property, right or asset of Company (including without limitation, any Company Materials, cell banks, specimens, documentation, Production Records, Specifications, raw data, work product, improvements, discoveries, know-how, inventions and other insights), whether patentable or not.

 

 

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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(b)SAFC agrees that all data, information, documents, concepts, ideas, improvements and other insights, exclusive of Process Inventions (defined below), arising from SAFC’s performance of its obligations under this Agreement (collectively “Inventions”), shall promptly be disclosed to Company in writing.  SAFC agrees that all Inventions are the exclusive property of Company. SAFC hereby assigns to Company all right, title and interest, including copyrights and other intellectual property rights, in and to all Inventions which may be developed as a result of SAFC’s performance of the Manufacturing, or by SAFC in the course of performing its obligations under this Agreement.  SAFC will, at no cost to Company, execute (and will ensure that its employees will execute) any and all documents and, at Company’s cost, do any and all things reasonably requested by Company to vest and perfect Company’s interest in the Inventions.

(c) In performing the Manufacturing and in applying SAFC Technology to the Manufacture of the Vector Product, SAFC may develop ideas, know-how, inventions, techniques, improvements and other technology, whether or not patentable or copyrightable, and associated intellectual property that are of general applicability, or are applicable to the conduct of its business (“Process Inventions”). For the sake of clarity, ideas, know-how, inventions, techniques, improvements and other technology arising from the application of Company Confidential Information technology, or that relate exclusively to Vector Product or Manufacturing Process are Inventions and not Process Inventions.

(d)SAFC shall ensure that all of SAFC’s employees, agents and authorized contractors are employed or engaged on terms consistent with this Section.

9.6Company Materials. As between the Parties, Company shall own and retain all rights in and title to the biological materials described [***].

10.1Term. The initial term this Agreement shall commence as of the Effective Date and shall continue in full force and effect [***] (“Initial Term”), unless earlier terminated as provided in Section 10.2. The Initial Term and any duly exercised extension to the Initial Term, may be referred to herein as the “Term”.

10.2Termination. Notwithstanding the provisions of Section 10.1 above,

(a)Either Party may terminate this Agreement as follows:

(i)Termination for Material Breach.  Either Party may terminate this Agreement by written notice at a date set in the notice (allowing at least [***] for cure) in the event of a material breach of this Agreement by the other Party; provided that the breaching Party fails to cure such breach within [***] from the date of such notice, or if the nature of the breach is such as to reasonably require more than [***] to cure, the Party (1) fails to use diligent efforts to cure such material breach, or (2) fails to cure such material breach within an additional [***] period.

(ii)Insolvency. If either Party shall become insolvent or shall make or seek to make an arrangement with, or an assignment for the benefit of creditors, or if proceedings in voluntary or involuntary bankruptcy shall be instituted by, on behalf of or against such Party, that is not dismissed within [***], or if a receiver or trustee of such Party’s assets shall be appointed, or bankruptcy proceedings begin, the other Party may terminate this Agreement, as may be permitted by the applicable laws, with immediate effect.

 

 

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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(iii)Force Majeure; No-Fault Termination. Either Party shall have the right to terminate this Agreement, upon providing written notice thereof to the other Party, such termination to be effective [***] from the effective date of such notice if, as a result of a Force Majeure Event, a Party is unable fully to perform its obligations under this Agreement for any consecutive period of [***], unless the Parties mutually agree in writing upon a shorter time period.

(b)Clinical Trial Failure. Prior to Company’s first Drug Product to receive Regulatory Approval for Sale, Company may terminate this Agreement upon [***] written notice of a clinical trial for a Drug Product is terminated or if Regulatory Approval for Sale is not granted following Company’s submission of an application for Regulatory Approval for Sale.

10.3Rights and Obligations Upon Termination.

(a)Return of Inventory and Confidential Information.  In the event of any termination or expiration, SAFC shall return to Company: (i) all Company property (at Company’s expense, unless Company terminates this Agreement pursuant to Section 10.2(a)(i) or (iii), in which case such property shall be returned at SAFC’s expense), except to the extent required to be retained by law or to comply with such Party’s continuing obligations hereunder; and (ii) all Confidential Information of Company and shall make no further use of such Confidential Information without the prior written consent of Company.  In the event of any termination or expiration of the Term, Company shall return to SAFC all Confidential Information of SAFC and shall make no further use of such Confidential Information without the prior written consent of SAFC; provided, however, that Company may retain a reasonable number of copies to exercise its rights under Section 9, but which shall remain subject to the obligations of non-use and confidentiality set forth in this Agreement.

(b)Payments.  Termination of this Agreement shall not release either Party from the obligation to make payment of all amounts owing to the Party at the time of such termination. Upon termination of this Agreement by SAFC pursuant to Section 10.2, Company shall take delivery and pay for all Vector Product that is subject to an open Purchase Order, pay all monies due and owing pursuant to this Agreement and reimburse SAFC for its costs for all material, work in process, finished Vector Product and all other outstanding inventory (meaning all raw materials that are specifically required and purchased by SAFC for the Manufacture of the Vector Product) to the extent that such items were reasonably acquired by SAFC to meet its obligations hereunder in a timely manner, and make any such other payments to SAFC as required under this Agreement.

(c)Raw Materials and Consumables.  Upon expiration or termination of this Agreement by Company, Company may elect (but shall have no obligation) to purchase from SAFC, at SAFC’s actual cost, all remaining usable Raw Materials and Consumables paid for by SAFC for the Manufacture of Vector Product under this Agreement as of the date of expiration or termination, together with all appropriate documentation related to such quantities of Raw Materials and Consumables.  

(d)Incomplete Task Orders. Upon termination or expiration of this Agreement, SAFC shall make all necessary arrangements to have any open and incomplete Task Orders completed or fulfilled by another contract manufacturer. SAFC’s obligations pursuant to this Section 10.3(d) shall include a technology transfer as may be necessary to a new contract manufacturer selected by Company or Company itself, in accordance with the provisions of Section 3.8(iii); provided, however, unless this Agreement is terminated by Company pursuant to Section 10.2(a), Company shall bear any and all cost of such technology transfer.

 

 

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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11.1Governing Law.  This Agreement shall be governed by, and interpreted and construed in accordance with, the laws of the State of Massachusetts, USA, without regard to its conflict of law provisions.  The U.N. Convention on International Sales of Goods shall not apply to this Agreement.

11.2Dispute Resolution; Venue. In the event that any dispute arises between the Parties out of or in connection with this Agreement, the Parties agree to use good faith efforts in an attempt to resolve such dispute, and if such dispute is not resolved within [***], each Party shall refer such dispute to each such Party’s senior executive officer for further attempts to resolve such dispute for a period of [***]. Any legal action or proceeding concerning the validity, interpretation and enforcement of this Agreement, matters arising out of or related to this Agreement or its making, performance or breach, or related matters will be brought exclusively in the courts of the United States of America for the District of Massachusetts, sitting in Suffolk County, Massachusetts. All parties consent to the exclusive jurisdiction of those courts and waive any objection to the proprietary or convenience of such venue.

12.1Termination of Prior Agreement, Transfer of Task Orders. Effective upon the Effective Date, the Parties hereby terminate the Prior Agreement in its entirety. Notwithstanding the foregoing, all outstanding task orders under the Prior Agreement and as more particularly listed and described in Exhibit 7, shall continue under this Agreement following the Effective Date (the “Transferred Task Orders”), and are hereby incorporated by reference as Task Orders hereunder as of the Effective Date; provided, however, the amounts payable for performance of Services provided pursuant to such Transferred Task Orders shall be in accordance with the amounts set forth on such Transferred Task Orders, and any Batches produced pursuant to such Transferred Task Orders shall not be considered or included for consideration of the Company’s Minimum Purchase Commitment or SAFC’s Performance Bonus.

12.2Financial Records. SAFC will keep accurate financial records of all Services performed under this Agreement including invoice calculations. Company, at its own expense, have access to such financial records upon [***] prior written notice to SAFC, and upon mutually agreeable times and dates during SAFC’s normal business hours for the sole purpose of verifying the correctness of such calculations. All information and materials made available to or otherwise obtained or prepared by or for Company in connection with such an audit shall be SAFC’s Confidential Information. Company may not exercise this right more than once for any Contract Year. Furthermore, in the event that Company is required to capitalize the Manufacturing Facility in accordance with U.S. generally accepted accounting principles and the applicable accounting standards (and any applicable updates or successor accounting guidance promulgated by the Financial Accounting Standards Board), and solely for such purpose, SAFC shall cooperate with Company and shall provide to Company such information reasonably necessary to permit Company to account for this Agreement as a capital lease in Company’s financial statements. Such information provided to Company shall be the Confidential Information of SAFC.

 

 

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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12.3Publicity. Each party shall obtain the prior written approval of the other party, such approval not to be unreasonably withheld, to the content of any written publicity, news release or other public statement or announcement which includes the name of the other party and relates to this Agreement, prior to originating or releasing it. Each party shall advise the other as to whether or not any publicity, news release or other public statement or announcement is approved within [***] after the receipt of the text of the publicity, news release or other public statement or announcement, failing which it shall be deemed to be approved.  If a party advises that it will not approve any publicity, news release or other public statement or announcement, the party that is refusing to approve shall provide the other party with reasons for the refusal. If either party is prevented from complying with the foregoing as a result of the requirements of a securities commission or other regulatory body, the parties shall not be considered to be in breach of this Section or of the confidentiality obligations set forth in Section 9, but shall use reasonable efforts to consult with and keep the other party informed, and shall use reasonable efforts to obtain a protective order.

12.4Use of Names.  SAFC shall not use the name of Company or the names of their employees, or representatives or Affiliates in any advertising materials or in any publication without prior written consent of Company.  Company shall not use the name of SAFC or the names of their employees, or representatives or Affiliates in any advertising materials or in any publication without prior written consent of SAFC.  Notwithstanding the foregoing, Company shall be entitled to identify SAFC as the source of Vector Product in any regulatory submission without SAFC’s prior written consent.

12.5Limitation of Liability and Damages.

(a)NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES (SUCH AS LOST PROFITS), EXCEPT FOR BREACH OF CONFIDENTIALITY OBLIGATIONS OR AS EXPRESSLY PROVIDED IN THIS AGREEMENT, OR ANY SPECIAL OR PUNITIVE DAMAGES ARISING OUT OF THE PERFORMANCE OF THIS AGREEMENT, WHETHER BASED ON CONTRACT, NEGLIGENCE, STRICT LIABILITY, OTHER TORT OR OTHERWISE AND REGARDLESS OF WHETHER ANY PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

(b)THE MAXIMUM AGGREGATE LIABILITY OF SAFC AND ITS AFFILIATES TO COMPANY AND ITS AFFILIATES FOR ANY CAUSE OF ACTION (OR RELATED CAUSES OF ACTION) ARISING OUT OF OR RELATED TO THIS AGREEMENT AND/OR THE MANUFACTURE OR DELIVERY OF THE VECTOR PRODUCT [***] GIVING RISE TO THE LIABILITY.

(c)The foregoing limitations in above shall survive notwithstanding any failure of essential purpose of a limited remedy.

12.6Assignment; Successors; Subcontractors; Third-Party Beneficiaries.  

(a)Neither Party may assign or otherwise transfer any of its rights or obligations under this Agreement without the prior written consent of the other Party, which will not be unreasonably withheld, except that Company may assign, in whole or in part, without such consent any of its rights or obligations under this Agreement (i) to any Affiliate, provided that any such assignment to an Affiliate shall not relieve the assigning Party as the primary obligor hereunder, or (ii) in connection with the merger, consolidation or sale of the stock or substantially all of the assets of the assigning Party’s business responsible for the performance of this Agreement.

 

 

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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(b)Subject to the preceding subsection (a), this Agreement will apply to, be binding in all respects upon, and inure to the benefit of the successors and permitted assigns of the Parties.

(c)SAFC shall not subcontract or otherwise delegate the performance of any of its obligations hereunder to a non-affiliated third party without the prior written approval of Company.  If Company approves any subcontract, SAFC shall: (a) exercise reasonable diligence in the selection of such subcontractors, (b) fully qualify each subcontractor and (c) remain primarily liable for the performance of its obligations hereunder.

(d)Nothing expressed or referred to in this Agreement will be construed to give any person other than the Parties any legal or equitable right, remedy or claim under or with respect to this Agreement or any provision of this Agreement.  This Agreement and all of its provisions and conditions are for the sole and exclusive benefit of the Parties to this Agreement and their successors and assigns.

12.7Transactions Outside Scope of Agreement.  Other than as expressly provided for otherwise in this Agreement, this Agreement shall in no way limit or restrict the ability of either Party or any Affiliate of such Party to offer its products or services to any other person.

12.8No Transfer of Rights.  No transfer, grant or license of rights under any patent or copyright or to any proprietary information or trade secret is made or is to be implied by this Agreement except as may be expressly stated otherwise herein.

12.9Independent Contractors.  The Parties undertake to carry out this Agreement as independent contractors.  No franchise, partnership, joint venture or relationship of principal and agent is intended by this Agreement.  Neither Party is authorized, in the name of or on behalf of the other Party, to incur any obligation, receive any benefit or right or otherwise bind the other Party.  All employees, agents, representatives and contractors of a Party are solely those of such Party and no acts thereof will be binding upon the other Party.

12.10Waiver.  The failure or the delay of any Party hereto to enforce at any time any provision of this Agreement shall not be construed to be a waiver of such provision or of the right of such Party thereafter to enforce such provision.  No waiver of any breach of this Agreement shall be held to constitute a waiver of any other or subsequent breach of this Agreement.

12.11Severability.  Should any provision of this Agreement become void or be cancelled, then the other provisions shall remain in full force and effect.  If a provision of this Agreement should be void or should be declared void, then the Parties will attempt to replace it by another valid provision or will leave the provision unreplaced by mutual consent.  Any provision of this Agreement held invalid or unenforceable only in part or degree will remain in full force and effect to the extent not held invalid or unenforceable.

12.12Exhibits.  All Exhibits attached hereto are hereby incorporated in and made a part of this Agreement as if fully set forth herein.

12.13Entire Agreement.  This Agreement, including all Exhibits, Task Orders, Purchase Orders hereto, contains the final, complete and exclusive agreement of the Parties relative to the subject matter hereof and supersedes all prior and contemporaneous understandings and agreements relating to its subject matter.

 

 

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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12.14Amendment.  This Agreement shall not be deemed or construed to be modified, amended, rescinded, cancelled or waived, in whole or in part, except by written amendment signed by the Parties hereto.

12.15Notices. All notices, consents, waivers and other communications under this Agreement must be in writing and will be deemed to have been duly given when (i) delivered by hand (with written confirmation of receipt), (ii) sent by facsimile (with written confirmation of transmission), (iii) when received by the addressee if sent by registered or certified mail (return receipt requested) or if sent by an internationally recognized overnight delivery service, in each case to the appropriate addresses and facsimile numbers set forth below (or to such other addresses and facsimile numbers as a Party may designate by notice to the other Party):

 

 

12.17Section Headings; Construction.  The headings of Sections in this Agreement are provided for convenience only and will not affect its construction or interpretation.  Unless otherwise expressly provided, the word “including” does not limit the preceding words or terms.

12.18Force Majeure.  Any events that are beyond the reasonable control of the Parties, such as fire, flood, war, strike, civil unrest, terrorism, natural catastrophes, government acts and regulations, national, international or sectoral financial crises and other cases of force majeure beyond a Party’s control (a “Force Majeure Event”), will, except for Company’s payment obligations hereunder, for the duration of the event as it affects the affected Party, suspend the obligations of the affected Party under this Agreement.  As soon as there is an indication of an event of force majeure, the Party affected by it will advise the other Party within [***] or as soon as practical of the effect of such event on this Agreement and about the measures to be taken to mitigate such effect.  The Parties are obligated to use reasonable efforts to mitigate damages and to resume the fulfilment of the contractual obligations as quickly as possible.

12.19Expenses.  Except as otherwise expressly provided in this Agreement, in the Exhibits hereto or in any agreement or other document expressly referenced herein and forming a part hereof, including the Quality Agreement, each Party to this Agreement will bear its respective expenses incurred in connection the performance of its obligations hereunder.  In the event of termination of this Agreement, the obligation of each Party to pay its own expenses will be subject to any rights of a Party arising from a breach of this Agreement by the other.

 

 

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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12.20Counterparts.  This Agreement may be executed in one or more counterparts, each of which will be deemed to be an original copy of this Agreement and all of which, when taken together, will be deemed to constitute one and the same agreement.

12.21Entire Agreement.  This Agreement (including the Exhibits and executed Task Orders or Purchase Orders hereto) constitutes the entire agreement of the parties with respect to the subject matter hereof, and it supersedes all prior oral and written agreements, commitments or understandings with respect to the matters provided for herein, including without limitation the Prior Agreement, any Confidentiality Agreement and any other confidentiality agreement, memorandum of understanding, letter of intent or letter of agreement.

12.22Survival.  Neither expiration nor termination of this Agreement shall terminate those obligations and rights of the parties pursuant to this Agreement which by their terms are intended to survive and such provisions shall survive the expiration or termination of this Agreement.  Without limiting the generality of the foregoing, the following provisions of this Agreement shall survive any expiration or termination hereof: Sections 2.8(b) and (c), 2.9, 7, 9.1, 9.2, 9.3, 9.5, 9.6, 10.3, 11, 12, and all definitions herein required to interpret the foregoing.

IN WITNESS WHEREOF, the Parties intending to be bound by the terms and conditions hereof have caused this Agreement to be signed effective as of the Effective Date by their duly authorized representatives.

 

 

 

 

Index of Exhibits

 

Exhibit 1 – [***]

 

Exhibit 2 – [***]

 

Exhibit 3 – [***]

 

Exhibit 4 – [***]

 

Exhibit 5 – [***]

 

Exhibit 6 – [***]

 

Exhibit 7 – [***]

 

 

 

 

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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Amendment No. 1 to Clinical and Commercial Supply Agreement

 

This Amendment No. 1 to Clinical and Commercial Supply Agreement (this “Amendment”) is made on January 7, 2019 (“Amendment Effective Date”) by and between bluebird bio, Inc., a Delaware corporation (“Company”), and SAFC Carlsbad, Inc., a company incorporated under the laws of the State of California (“SAFC”). Reference is hereby made to that certain Clinical and Commercial Supply Agreement between Company and SAFC dated as of November 27, 2017, having an effective date of January 1, 2018 (as may be amended from time to time, the “Agreement”). Capitalized terms used but not otherwise defined herein shall have the meanings given to such terms in the Agreement.

 

NOW, THEREFORE, in consideration of the mutual covenants contained herein, and for other good and valuable consideration, the amount and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:

 

 

[***]

 

 

Data Privacy. [***]

 

 

This Amendment is binding upon and shall inure to the benefit of the Parties and their respective successors and assigns. The Agreement as modified by this Amendment is the entire agreement between the Parties with respect to the subject matter hereof and supersedes all prior and contemporaneous oral and written agreements and discussions. Except as expressly modified by this Amendment, all terms and provisions of the Agreement remain in full force and effect. In the event of a conflict between the terms and provisions of this Amendment and the Agreement, the terms and provisions of this Amendment shall control. This Amendment may be executed in any number of counterparts, each of which shall be deemed an original, but all of which when taken together shall constitute one and the same instrument.

 

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[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULDLIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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IN WITNESS WHEREOF, the Parties have signed this Amendment as of the Amendment Effective Date.

 

 

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULDLIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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EXHIBIT F

[***]

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULDLIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

 

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

 

Exhibit 10.42

 

Sublease

 

THIS SUBLEASE (this “Sublease”), dated as of April 16, 2019 (the “Effective Date”), between AVENTIS INC., a Pennsylvania corporation, having an address at North American Legal Department, U.S. Corporate, 55 Corporate Drive, Mail Stop 55A-525A, Bridgewater, New Jersey 08807-0977 (“Lessor”) and BLUEBIRD BIO, INC., a Delaware corporation, having an address at 60 Binney Street, Cambridge, Massachusetts 02142, Attn: General Counsel (“Lessee”).

 

W I T N E S S E T H:

 

WHEREAS, by that certain Lease Agreement, dated as of March 25, 2015, as amended by that certain First Amendment to Lease, dated as of October 27, 2015, and as further amended by Agreement Regarding Early Access, Waiver and Related Matters, dated as of June 19, 2017, and as further amended by Second  Amendment to Lease, dated as of June 30, 2018, and as further amended by Acknowledgment of Delivery and Rent Commencement Dates dated as of April 1, 2019 (as heretofore amended, the “Prime Lease”), by and between ARE-MA REGION NO. 40, LLC, a Delaware limited liability company (“Prime Landlord”), as landlord, and Sanofi US Services Inc, as tenant, Prime Landlord leased to Lessor certain premises located in the building located at 50 Binney Street, Cambridge, MA (the “Building”) as such premises are more particularly described in the Prime Lease;

WHEREAS, Sanofi US Services Inc. assigned the Prime Lease to Lessor pursuant to that certain Assignment and Assumption of Lease, dated as of February 14, 2019, by and between Sanofi US Services Inc., as assignor, and Lessor, as assignee;

WHEREAS, Lessee desires to sublease from Lessor certain premises, consisting of the entire Premises under the Prime Lease, on the first through tenth floors of the Building, together with certain areas of the Garage (as defined in the Prime Lease) and all as identified on Exhibit A hereto (the “Subleased Premises”), containing approximately 267,278 rentable square feet in total, upon the terms, covenants and conditions hereinafter set forth.

NOW THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:

 

 

 

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1.Subleased Premises

1.01.Lessor hereby subleases to Lessee, and Lessee hereby subleases and hires from Lessor, the Subleased Premises for the term hereinafter stated on the terms and provisions hereinafter provided or incorporated in this Sublease by reference.  Lessee shall have the right to use such common areas which are appurtenant to or service the Subleased Premises to the extent that such right has been granted to Lessor pursuant to the Prime Lease.  Lessor represents and warrants to Lessee that (i) a true, correct and complete copy of the Prime Lease (excluding redacted terms not relevant to Lessee) is attached here as Exhibit B, (ii) the Prime Lease is in full force and effect, (iii) to Lessor’s knowledge, Lessor is not in default under the Prime Lease, and (iv) Lessor has not received any notice from Prime Landlord that Lessor is in default under the Prime Lease.

1.02.Lessee has examined the Subleased Premises and is fully familiar with the physical condition thereof.  Except as specifically set forth in this Sublease, Lessor has not made and does not make any representations or warranties as to such physical condition, the rentable area of the Subleased Premises, the use to which the Subleased Premises may be put, or any other matter or thing affecting or relating to the Subleased Premises, and Lessee hereby expressly agrees to accept the Subleased Premises in its “as-is” condition, subject to the terms and conditions of this Sublease.  All understandings and agreements heretofore made between the parties hereto are merged in this Sublease which alone fully and completely expresses their agreement, and neither party is relying upon any statement, representation or warranty made by the other not embodied in this Sublease.  

1.03.Lessee shall use and occupy the Subleased Premises solely for technical office use (which includes, as permitted uses and not accessory uses, research and development use, lab use and office use), with permitted accessory uses, all as such use may be permitted in the Prime Lease, and for no other purpose whatsoever.  

2.Term, Prime Landlord Consent, Non-disturbance

2.01.  The term (the “Term”) of this Sublease shall commence on the later to occur of (i) the date Prime Landlord has consented to the subleasing contemplated hereby in accordance with Section 2.02 and (ii) the date Lessor has delivered the Premises to Lessee in accordance with Section 3.01 hereof (the “Commencement Date”), and shall expire at 11:59 pm on December 31, 2030 (the “Expiration Date”).  

2.02.This Sublease shall have no effect until Prime Landlord shall have given its written consent hereto in accordance with the terms of the Prime Lease.  If Prime Landlord has not given its written consent to this Sublease for any reason whatsoever within one hundred twenty (120) days after the date of the execution and delivery of this Sublease by Lessor and Lessee and its delivery to Prime Landlord, then either party hereto may elect to cancel this Sublease by giving notice to the other party within sixty (60) days after the expiration of said one hundred twenty (120)-day period (unless such period shall be extended as hereinafter provided or otherwise by mutual agreement between Lessor and Lessee), but prior to the giving of said

2

 

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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consent by Prime Landlord to this Sublease.  Lessor and Lessee each agree to use all reasonable efforts to obtain such consent.  Lessee acknowledges that it will be required to execute and deliver such consent as a condition precedent to the execution thereof by Prime Landlord and Lessee agrees that it shall promptly execute and deliver to Lessor such consent provided the same does not impose material obligations or liabilities on Subtenant in addition to Subtenant’s obligations and liabilities under this Sublease, or materially reduce Subtenant’s rights as provided under this Sublease.  If either party shall have given notice of termination to the other party in accordance with the provisions of this Section 2.02, then: (i) Lessor shall not be obligated to take any further action to obtain such consent, (ii) Lessor shall refund to Lessee the Security Deposit (as defined herein) and any additional sums paid in relation to this Sublease, all to the extent paid by Lessee and (iii) this Sublease shall thereupon be deemed null and void and of no further force and effect and neither of the parties hereto shall have any rights or claims against the other, except for those provisions which expressly survive the expiration or termination of this Sublease.  Whether or not such consent is granted, Lessor shall pay the out of pocket fees and costs charged by Prime Landlord in connection with the request for its consent to this Sublease in accordance with the applicable provisions of the Prime Lease.

2.03.Except as permitted pursuant to Sections 19 (casualty) and 20 (condemnation) of the Prime Lease, Lessor shall not voluntarily cancel, terminate, amend the material terms of or surrender the Prime Lease without the prior written consent of Lessee, which consent may be withheld in Lessee’s sole discretion, provided, that, Lessee shall not have any right to consent to any of the foregoing if (a) Prime Landlord accepts this Sublease as a direct lease between Prime Landlord and Lessee or (b) any such cancellation, termination, amendment or surrender would not have an adverse effect upon this Sublease.  Notwithstanding anything contained herein, Lessor agrees not to exercise any extension, expansion or contraction options or any further  rights contained in the redacted portions of the Prime Lease, without the written consent of Lessee, which may be withheld in its sole discretion.  Lessor shall deliver to Lessee copies of all executed amendments to the Prime Lease, which copies may be redacted so as to remove from view any confidential information.  Lessor shall not, without Lessee’s prior written consent, cause a default under the Prime Lease that would permit the Prime Landlord to cancel or terminate or surrender the premises demised under the Prime Lease unless Prime Landlord has either agreed or will agree to recognize Lessee’s rights under this Sublease from and after the date of such surrender or termination of the Prime Lease pursuant to a written agreement reasonably acceptable to Lessee.  Lessor shall not take any action under the Prime Lease that would adversely impair the right of Lessee to use and occupy the Subleased Premises for the purposes and as provided under this Sublease.   If the term of the Prime Lease is terminated for any reason prior to the Expiration Date, this Sublease shall thereupon terminate ipso facto without any liability of Lessor to Lessee by reason of such early termination unless such termination is due to (i) Lessor’s violation of its express covenant set forth in this Section 2.03 or (ii) Lessor’s default under the Prime Lease which default was not caused by Lessee.  References in this Sublease to the “termination” of this Sublease include the Expiration Date and any earlier termination thereof pursuant to the provisions of this Sublease, the Prime Lease or by law.  Except as otherwise expressly provided in this Sublease with respect to those obligations of Lessee which by their nature or under circumstances can only be, or under the provisions of this Sublease may be or are required to be, performed after the termination of this Sublease, the Term

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[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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and estate granted hereby shall end at 11:59 PM on the date of termination of this Sublease as if such date were the Expiration Date, and, except as provided herein, neither party shall have any further obligation or liability to the other under this Sublease.  Notwithstanding the foregoing, any liability of Lessor or Lessee to make any payment under this Sublease, which shall have accrued prior to the termination of this Sublease, shall survive the termination of this Sublease.  Notwithstanding anything in this Sublease to the contrary, Lessee shall not be responsible for (i) any default under the Prime Lease unless attributable to a default under this Sublease by Lessee or anyone claiming by through or under Lessee, (ii) conditions at the Subleased Premises, for which the obligation to maintain and repair resides with Prime Landlord under the Prime Lease and/or which existed as of the Commencement Date, (iii) the payment of any charges, fees and other costs imposed by Prime Landlord on Lessor as a result of Lessor’s default under the Prime Lease except if caused by the act or omission of Lessee or anyone claiming by, through or under Lessee, (iv) the removal and/or restoration of any of the Tenant Improvements or any Alterations or Installations existing in the Subleased Premises as of the Commencement Date (except to the extent of any further alterations of the same by Lessee), or (v) making payment of any sums either to Prime Landlord or Lessor in satisfaction of any charges accruing under the Prime Lease (whether denominated as rent, rental, additional rent or otherwise) for any period prior to the Term of this Sublease.  In the event that Lessee desires to terminate this Sublease due to a condemnation or casualty, Lessee shall deliver notice of such termination to Lessor within five (5) days after delivery by Lessor of a copy of the notice delivered by Prime Landlord pursuant to the first sentence of Section 18(b) of the Prime Lease.  In the event of condemnation or casualty, Lessee shall be entitled to abatement of rent only to the extent that Lessor actually receives such abatement of rent from Prime Landlord under Section 18 of the Prime Lease.  Lessor shall have no obligation to provide or attempt to provide to Lessee any substitute space in the event of condemnation or casualty.

3.Condition of Premises

3.01.Lessee acknowledges and agrees that it is subletting the Subleased Premises in its “as is” condition as of the Commencement Date and that, subject to this Section 3.01, Lessor is not required to perform any work in the Subleased Premises or provide any allowance or other concession to Lessee.  Lessee acknowledges that Lessor will continue to occupy the Subleased Premises from the date of this Sublease until shortly before the Commencement Date and accordingly, there will be some changes to the condition of the Subleased Premises arising out of ordinary use and wear and tear.  Lessor covenants and agrees that, during the period between the date of this Sublease and the Commencement Date, Lessor will maintain and repair the Subleased Premises in a manner consistent with its past practice and in compliance with the terms of the Prime Lease.  Lessor and Lessee shall conduct a walk through immediately prior to the date of this Sublease and immediately prior to the Commencement Date.  In the event of any material change in the condition of the Subleased Premises (excluding ordinary wear and tear) between the date of this Sublease and the Commencement Date arising from the breach by Lessor of its covenant contained in the immediately preceding sentence, Lessee’s sole remedy shall be that Lessor shall either cure such material changes at Lessor’s sole expense or permit Lessee cure such material changes at Lessor’s expense, in which event Lessor shall reimburse Lessee for such costs within thirty (30) days after delivery by Lessee to Lessor of all applicable

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[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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invoices and other reasonable documentation of the costs of cure.  All understandings and agreements heretofore made between the parties hereto are merged in this Sublease which alone fully and completely expresses their agreement, and neither party is relying upon any statement, representation or warranty made by the other not embodied in this Sublease.  Lessor makes no representation concerning, and shall have no liability in connection with, the quantity, quality or condition of any and all services, equipment and supplies given to Lessee; provided, however, Lessor agrees that Lessee shall be entitled to receive all services, utilities, repairs and restorations to be provided by Prime Landlord under the Prime Lease with respect to the Subleased Premises.  Subject to obtaining the approval of Prime Landlord in accordance with Section 2.02 hereof, the parties intend that the Commencement Date shall be July 1, 2021 (“Intended Commencement Date”) and that Lessor shall deliver the Subleased Premises to Lessee on such Intended Commencement Date in accordance with this Section 3.01, provided, however, that Lessor shall have the right, to be exercised upon not less than nine (9) months’ prior written notice to Lessee, to extend the Intended Commencement Date one or more times by up to six (6) months in the aggregate (i.e., to an outside Intended Commencement Date of January 1, 2022).  On the Intended Commencement Date (as extended, if applicable and subject to the approval of Prime Landlord in accordance with Section 2.02 hereof), Lessor shall deliver the Subleased Premises to Lessee in vacant and “broom clean” condition.  In addition, Lessor shall remove all interior signage displaying the name of Lessor or its affiliates.

3.02Promptly following the Commencement Date, Lessor and Lessee shall enter into an agreement in form and substance reasonably satisfactory to Lessor and Lessee confirming the Commencement Date, but the failure to enter into such agreement shall not delay the Commencement Date.  

3.03Not later than one hundred twenty (120) days prior to the expiration of the Term of this Sublease, Lessee shall deliver to Lessor for Lessor’s approval a detailed plan for Lessee’s surrender of the Subleased Premises at the end of the term, including detailed plans relating to the removal of any signage, rooftop equipment and similar long lead items.  Lessor shall have the right to require modifications to such plan to the extent Lessor determines in its sole discretion that such modifications are required in order to effect the timely surrender and vacation of the premises leased under the Prime Lease.  Lessee shall cause all work required to be performed by Lessee in connection with the surrender of the Demised Premises to be performed not later than thirty (30) days prior to the expiration of the Term of this Sublease.  During the one hundred twenty (120) day period prior to the expiration of the Term of this Sublease, Lessor shall have the right to access the Subleased Premises from time to time to perform and inspect work and otherwise to ensure that the premises leased to Lessor under the Prime Lease will be surrendered and vacated in accordance with the terms of the Prime Lease.  Notwithstanding the foregoing, in the event that, prior to the expiration of the Term of this Sublease, Prime Landlord and Lessee enter into a direct lease having a term commencing immediately following the Term of this Sublease and Prime Landlord releases Lessor from all surrender, restoration and similar obligations contained in the Prime Lease relating to the physical condition of the Premises and the compliance of the Premises with applicable laws, then in such event this Section 3.03 shall not be applicable, and Lessee shall be relieved of its surrender and restoration obligations as between Lessor and Lessee under this Sublease.  

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[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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4.Rental

4.01.Lessee shall pay to Lessor rent (“Base Rent”) at the rate of Twenty-Six Million Seven Hundred Fourteen Thousand Four Hundred Thirty-Six and 10/100 Dollars ($26,714,436.10) per annum (i.e., at a rate of Ninety-Nine and 95/100 Dollars ($99.95) per rentable square foot), in equal monthly installments in accordance with the Base Rent schedule attached as Schedule 1 hereto, on the first day of each calendar month, commencing on the Commencement Date, subject to Section 4.03 below.

4.02Base Rent, Additional Rent (as hereinafter defined) and all other costs, charges and sums payable by Lessee hereunder are sometimes herein collectively defined as “Rental”.  If the Rent Commencement Date (as hereinafter defined) falls on any day other than the first of a month, then the Base Rent for such month shall be prorated on a per diem basis, and Lessee agrees to pay the amount thereof for such partial month on the Rent Commencement Date along with any other amounts due Lessor under this Sublease.  The obligation of Lessee to pay Rental and other sums to Lessor and the obligations of Lessor hereunder are independent obligations.  Except as expressly provided in Section 4.03 or Section 4.06, Lessee shall have no right at any time to abate, withhold, reduce or set off any Rental due hereunder.

4.03.Subject to the provisions of this Section 4, Lessee shall (i) not be required to pay the Base Rent for the period commencing on the Commencement Date and ending on the Rent Commencement Date, and (ii) shall not be required to pay the Operating Expense Payment for the period commencing on the Commencement Date and ending on the day that is forty-five (45) days following the Commencement Date (the “Operating Expense Payment Commencement Date”).  Subject to the provisions of this Sublease, the term “Rent Commencement Date” shall mean the date which is the earlier to occur of (i) the date which is ninety (90) days following the Commencement Date and (ii) the date Lessee takes occupancy of all or any portion of the Subleased Premises for the purpose of operating its business.  So long as Lessee is not in default beyond any applicable notice and cure periods, Lessor hereby excuses (y) Lessee’s obligation to pay Base Rent (but not Additional Rent) for the period commencing on the Commencement Date and ending on the Rent Commencement Date, and (z) Lessee’s obligation to pay the Operating Expense Payment for the period commencing on the Commencement Date and ending on the Operating Expense Payment Commencement Date.  Except as expressly set forth in the preceding sentence, there shall be no abatement or excusal of Lessee’s obligation to pay Additional Rent in accordance with this Sublease and Lessee shall pay all Additional Rent, other than the Operating Expense Payment, due hereunder from and after the Commencement Date.

4.04.In addition to the Base Rent, Lessee covenants and agrees to pay Lessor an amount equal to the Operating Expense Payment (as hereinafter defined).  The term “Operating Expense Payment” shall mean one hundred percent (100%) of Lessor’s obligations to make payments to Prime Landlord in accordance with Section 5 of the Prime Lease, it being understood and agreed that such payments contemplated under Section 5 of the Prime Lease include, among other things, (i) Operating Expenses, (ii) Taxes, (iii) Landlord’s Property Management Fee, and (iv) Tenant’s share of Operating Expenses for the Garage, the Project, the Campus and the Premises (each such term, as defined in the Prime Lease).

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[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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4.05Upon receipt by Lessor of statements of Operating Expenses from Prime Lessor under the Prime Lease, Lessor shall deliver copies of the same to Lessee, along with and any other supporting documentation received from Prime Landlord, which statements shall set forth the Additional Rent payable by Lessee.  The Additional Rent shall be payable by Lessee to Lessor in the same manner as the same is payable by Lessor to Prime Landlord, except that, subject to Section 5.02(11) hereof, Lessee shall pay all installments of Additional Rent directly to Lessor at least five (5) business days prior to the respective due dates under the Prime Lease.  As used herein the term “Additional Rent” shall mean the Operating Expense Payment and all other costs, charges and sums payable under this Sublease.  Additionally, Lessee shall be required to pay for any additional charges incurred by Lessee on account of Services (as hereinafter defined) offered at the Building utilized by Lessee or provided at the request of Lessee or supplies requested or utilized by Lessee.  

4.06Lessee shall pay all utility charges as Operating Expenses or otherwise in accordance with the Prime Lease.  For the avoidance of doubt, as of the Effective Date of this Sublease, all utilities are separately metered for the Subleased Premises.  Lessee shall not use or install any fixtures, equipment or machines the use of which in conjunction with other fixtures, equipment and machines in the Subleased Premises would result in an overload of the electrical equipment supplying electric current to the Subleased Premises or would otherwise violate the terms of the Prime Lease.  Lessee shall not permit its use of electric current to exceed the capacity of the then existing feeders, risers, wiring or bus ducts to the Subleased Premises.  In no event shall Lessor be liable or responsible to Lessee for any loss, damage or expense that Lessee sustains or incurs if either the quantity or character of electric service is changed or interrupted or is no longer available or suitable for Lessee’s requirements except to the extent due to the negligence or willful misconduct of Lessor.  To the extent that, for any period during the Term of this Sublease, Lessor actually receives an abatement or set-off of rent under the Prime Lease (and such abatement or set-off of rent is not disputed by Prime Landlord after expiration of all notice and cure periods set forth in the Prime Lease), Lessor shall provide to Lessee an abatement or set-off, as applicable, against the Rental due hereunder in a like amount. Lessor agrees that, if under the Prime Lease any right or remedy of Lessor related to an abatement or set-off is subject to or conditioned upon Lessor making any demand upon Prime Landlord or giving any notice or request to Prime Landlord  then, if Lessee shall so request, Lessor, at Lessee’s expense, shall promptly make such demand or give such notice or request on Lessee’s behalf.  

4.07Lessee shall pay all Rental in lawful money of the United States, when due and payable, without setoff, offset or deduction of any kind whatsoever, except as expressly provided for in this Sublease (including Prime Lease provisions which may be incorporated by reference), and in the event Lessee fails to pay the same when due, Lessor shall have the rights and remedies provided for herein or at law or in equity, in the case of non-payment of Rental.    

4.08.Except as otherwise specifically provided for herein, Rental shall be paid by Lessee to Lessor at the address of Lessor set forth above, or such other place as Lessor may designate in writing, without prior notice or demand therefor and without any abatement, deduction or setoff.

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[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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4.09If any Rental due from Lessee is not received by Lessor when due, Lessee shall pay to Lessor on demand a late payment charge of four percent (4%) of the past-due amount; provided, however, Lessor agrees to waive such late charge one time in any twelve (12) month period, provided that the late payment is made within five (5) days of Lessor’s written notice demanding payment.  Acceptance of any late charge shall not constitute a waiver of Lessee’s default with respect to the overdue amount, or prevent Lessor from exercising any of the other rights and remedies available to Lessor under this Sublease or under applicable law.  In addition to the late charge, Rental not paid when due shall bear interest at the Default Rate from the date due until paid.

4.10At the request of Lessee and at Lessee’s sole cost (except to the extent Prime Landlord is obligated to pay for the same in accordance with Section 5 of the Prime Lease, and Lessor receives such amount from Prime Landlord, which Lessor shall then provide to Lessee for the cost of its Independent Review, as such term is defined in the Prime Lease), Lessor shall exercise the audit rights granted to the Tenant under Section 5 of the Prime Lease.  In the event that Lessee elects to exercise such audit rights, such audit rights shall relate solely to Prime Landlord’s determination of Operating Expenses.  Lessee shall reimburse Lessor within thirty (30) days of Lessor’s written demand for any and all third party out of pocket costs incurred by Lessor in connection with exercising such audit rights and Lessee shall defend, indemnify and hold Lessee harmless from and against any and all claims, damages and liabilities incurred by Lessor in connection with Lessee’s exercise of such audit rights.  Lessor shall have no liability whatsoever in connection with any errors or omissions relating to Prime Landlord’s determination of Operating Expenses or other charges under the Prime Lease.

 

5.Subordination to and Incorporation of Prime Lease; Certain Rights of Lessee

5.01.This Sublease is subordinate to, and Lessee accepts this Sublease subject to (except as modified herein), all of the terms, covenants, provisions, conditions and agreements contained in the Prime Lease and the matters to which the Prime Lease is subject and subordinate.  Lessee acknowledges that a redacted copy of the Prime Lease has been delivered to and examined by Lessee.

5.02.Except as otherwise provided in this Sublease, all of the terms, covenants, conditions, provisions and agreements of the Prime Lease (including, without limitation, definitions and constructions therein contained), except such as by their nature or purport do not relate to the Subleased Premises pursuant to this Sublease or are inconsistent with any of the provisions of this Sublease, are hereby incorporated in and made part of this Sublease with the same force and effect as though set forth at length herein, it being understood and agreed that, for purposes of this Sublease:

(1)references in the Prime Lease to “Landlord” and to “Tenant” shall be deemed to refer to “Lessor” and “Lessee” hereunder (except as otherwise expressly provided in this Sublease);

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[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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(2)references in the Prime Lease to “Rent” shall be deemed to refer to the “Rental” as defined herein;

(3)references in the Prime Lease to “Base Rent” shall be deemed to refer to the “Base Rent” as defined herein;

(4)references in the Prime Lease to “Additional Rent” shall be deemed to refer to the “Additional Rent” as defined herein;

(5)references in the Prime Lease to “this Lease” shall be deemed to refer to this Sublease;

(6)references in the Prime Lease to “Premises” shall be deemed to refer to the “Subleased Premises” as defined herein;

(7)references in the Prime Lease to the “Term” shall be deemed to refer to the “Term” as defined herein;

(8)to the extent that the Prime Landlord reserves the right to enter the Subleased Premises, for purposes of incorporation herein, such right shall inure to the Lessor and to the Prime Landlord;

(9)in any case in the Prime Lease where the consent or approval of Prime Landlord is required pursuant to the terms of the Prime Lease, for purposes of incorporation herein such consent or approval shall include the Lessor and the Prime Landlord;

(10)in any case in the Prime Lease where the Prime Landlord’s architects or engineers have the right to review any plans or specifications of Tenant with respect to alterations, for purposes of incorporation herein, such right shall inure to Lessor, Lessor’s architects and engineers and Prime Landlord and Prime Landlord’s architects and engineers; and

(11)the time limits provided in the provisions of the Prime Lease for the giving of notice, for making demands, for the performance of any act, condition or covenant, or for the exercise of any right, remedy or option, by either party, are amended for the purposes of this Sublease, by lengthening or shortening the same in each instance by one (1) business day, as appropriate, so that notices may be given, demands made, or any act, condition or covenant performed, or any right, remedy or option hereunder exercised, by Lessor or Lessee, as the case may be, within the time limits relating thereto contained in the Prime Lease.  Notwithstanding, the foregoing, if the Prime Lease allows only (i) ten (10) days or fewer for non-monetary obligations, or (ii) five (5) days or fewer for monetary obligations, for Lessor as tenant to perform any act, or to undertake to perform such act, or to correct a failure relating to the Subleased Premises of this Sublease, then, Lessee shall perform or undertake such act and/or correct such failure prior to the expiration of the applicable time limitations set forth in the Prime Lease.

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[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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5.03.The following sections of the Prime Lease shall not be incorporated herein by reference:

 

For the avoidance of doubt, (i) in no event shall Lessee be responsible for any redacted provisions of the Prime Lease and (ii) though the same are incorporated herein by reference, the parties agree that as between Lessor and Lessee, in no event shall Lessor have any obligations or liabilities to Lessee under the final grammatical paragraph of Section 5, Section 10(a), Section 10(b), or Sections 16(b), 27, 30 or 36 and Exhibit H of the Prime Lease.  

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[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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5.04.Alterations.  The provisions of this Section 5.04 are in addition to and not in substitution for the provisions of Section 12 of the Prime Lease.  Lessor shall have the right to reasonably approve Lessee’s contractors for work having a value of more than $100,000.  Lessor and Prime Landlord shall be named as additional insured in each contractor’s builder’s risk policy (if applicable) and liability policies for each construction project.  Any alterations, decorations and installations made by Lessee, or any assignee or subtenant of Lessee shall be removed by Lessee prior to the expiration of the Term if Prime Landlord or Lessor requires such removal or if required under the Prime Lease.  Lessee shall indemnify, defend and hold harmless Lessor against any and all loss, cost, liability, claim, damage and expenses, including, without limiting the generality of the foregoing, reasonable attorneys’ fees and expenses, court costs, penalties and fines incurred in connection with or arising from any such changes, alterations and improvements.  Lessee shall not be obligated to remove or restore any alterations or improvements existing in the Subleased Premises on the Commencement Date unless Prime Landlord and Lessee enter into a direct lease having a term commencing immediately following the Term of this Sublease and Prime Landlord releases Lessor from all surrender, restoration and similar obligations under the Prime Lease.

6.Services; Disputes with Prime Landlord. Notwithstanding anything to the contrary contained herein, the only services, utilities, repairs, access, and equipment (collectively, together with similar rights, “Services”) to which Lessee is entitled are only those to which Lessor is entitled under the Prime Lease.  Lessee acknowledges and understands that the Services provided by Prime Landlord are not comprehensive and do not include all repair, maintenance or management services necessary or customary for the operation of the Subleased Premises and that Lessee will be responsible at its sole cost for contracting with Prime Landlord or its affiliate to provide such services, provided that, if Prime Landlord or its affiliate is not willing to provide such services (or is not willing to provide them on commercially reasonable market terms) then Lessee shall contract with a reputable third party property management company to provide such services, which third party management company is in the business of providing property management services to tenants in buildings comparable to the Building in Cambridge, Massachusetts.  Lessee acknowledges and agrees that all Services shall be provided solely by Prime Landlord, and Lessor shall not have any obligation during the term of this Sublease to provide any Services (but Lessee shall be permitted to use such services in accordance with and subject to the terms hereof).  Lessor shall in no event be liable to Lessee nor shall the obligations of Lessee hereunder be impaired or the performance thereof excused because of any failure or delay on Prime Landlord’s part in furnishing such Services unless such failure or delay is caused by Lessor’s negligent acts or misconduct or its default under the Prime Lease or this Sublease and such default is not caused by Lessee.  If, at any time during the Term, Prime Landlord shall default in any of its obligations to furnish Services to the Subleased Premises, then, if Lessee is not in then in breach of any of its obligations under this Sublease beyond applicable notice and cure periods, upon Lessor’s receipt of a written notice from Lessee specifying such default, Lessor shall, at Lessee’s sole cost and expense, promptly use its reasonable efforts to cause Prime Landlord to cure such default.  Lessor agrees, upon Lessee’s request, to use reasonable efforts (excluding litigation), at Lessee’s expense to cause Prime Landlord to provide the services and utilities described in Section 11 of the Prime Lease or to make the repairs or restorations described in Sections 13 or 18 of the Prime Lease, as applicable.  Lessor agrees that, if under the Prime Lease any right or remedy of Lessor or any duty or obligation of Prime Landlord is subject to or conditioned upon Lessor making any demand upon Prime Landlord or giving any notice or request to Prime Landlord  then, if Lessee shall so request, Lessor, at Lessee’s expense, shall make such demand or give such notice or request on Lessee’s behalf.    

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[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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7.Insurance. Lessee, at Lessee’s sole expense, shall maintain such policies of insurance as required of Lessor under the Prime Lease with respect to the Subleased Premises, in the manner set forth therein, listing Prime Landlord and Lessor as additional insureds and Lessee shall cause its insurance carrier to include any clauses or endorsements in favor of both Lessor and the Prime Landlord which Lessor is required to provide pursuant to the provisions of the Prime Lease.

 

8.Breach of Prime Lease. Lessee shall not do or permit to be done anything which would constitute a violation or breach of any of the terms, conditions or provisions of the Prime Lease or which would cause the Prime Lease to be terminated or forfeited by virtue of any rights of termination or forfeiture reserved by or vested in Prime Landlord.  Lessee shall comply with all Rules and Regulations of the Building now or hereafter in effect.  In addition, Lessee agrees to indemnify and hold harmless Lessor from and against any and all liability, loss, damage, claim or expense (including reasonable attorneys’ fees) of any kind whatsoever in any way arising out of or connected with any breach, default or failure to perform on the part of the Lessee, as the case may be, under this or any other section of this Sublease.  Lessor shall indemnify and hold harmless Lessee from and against any and all liability, loss, damage, claim or expense (including reasonable attorneys’ fees) of any kind whatsoever in any way arising out of or in connection with any breach, default or failure to perform on the part of Lessor, as the case may be, under this or any other section of this Sublease.  The indemnity obligations under this section shall survive the expiration or sooner termination of this Sublease.  Lessee acknowledges and agrees that, in the event that Lessor becomes liable for any failure by Lessee to manage or maintain the Subleased Premises in accordance with the requirements of the Prime Lease, Lessee shall be solely responsible at its sole expense for all costs, claims, damages and liabilities associated with such failure.

 

9.Assignment and Subletting

9.01.Lessor shall have all of the rights of the Prime Landlord under Section 22 of the Prime Lease as though Lessor were the Prime Landlord and Lessee were the Tenant.  The provisions of this Section 9.01 are in addition to and not in substitution for the provisions of Section 22 of the Prime Lease.

9.02Lessee shall not have the right to sublease, assign, transfer, pledge, mortgage (or otherwise encumber) or allow the Subleased Premises to be occupied by anyone other than Lessee without the consent of (a) Prime Landlord, to the extent required under the Prime Lease and subject to any other rights of Landlord set forth therein with respect to subleases or assignments and (b) Lessor, to the same extent that Prime Landlord’s consent is required under the Prime Lease.  No assignment or subletting or any Permitted Assignment (as defined in the Prime Lease) shall release Lessee from its obligations hereunder and Lessee shall provide all such notices and other deliveries to Lessor in connection with any of the foregoing as and when required under the Prime Lease. Subject to the consent of the Prime Landlord and/or Lessor pursuant to the terms hereof and the terms of the Prime Lease, in the event of an assignment of this Sublease or a further sublet of all or a portion of the Subleased Premises, or other transfer or transaction involving this Sublease pursuant to which Lessee is entitled to receive consideration in excess of the Rental payable by Lessee hereunder to Lessor, after first deducting such actual and reasonable third party expenses such as tenant improvement costs, brokerage fees, legal costs and any design or construction fees directly related to and required pursuant to the terms of any such sublease or assignment (“Excess Sublease Rent”), then Lessee shall pay Sixty-Six and Two-Thirds Percent (66 2/3%) of such Excess Sublease Rent to Lessor in accordance with Section 22 of the Prime Lease as incorporated herein.

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9.03In addition to Lessee’s rights to a permitted transfer pursuant to Section 22(b) of the Prime Lease, Lessee shall have the right to assign this Lease, upon not less than 30 days’ advance notice to Lessor but without obtaining Lessor’s consent, to a corporation or other entity which is a successor in interest to Tenant by way of merger, consolidation or corporate reorganization, or by the purchase of all or substantially all of the ownership interests or assets of  Lessee, provided that (i) the proposed assignee’s Net Worth (as such term is defined in Section 43(b) of the Prime Lease with references to Tenant being references to the proposed assignee) is no less than an amount equal to the Net Worth of the Lessee immediately prior to the effectiveness of such assignment, merger, consolidation, corporate reorganization or purchase of all or substantially all of the ownership interests or assets of Lessee, as evidenced by a certification from the Chief Financial Officer of such assignee of such assignee’s Net Worth in the form of the Required Net Worth Certification a balance sheet attached as Exhibit C hereof and (ii) such assignee shall agree in writing to assume all of the terms, covenants and conditions of this Lease arising after the effective date of the assignment.  For purposes hereof, “Net Worth” shall mean the excess of the Lessee’s total assets (less intangible assets) over Lessee’s liabilities.  

9.04In the event of termination, re-entry or dispossession of Lessor by Prime Landlord under the Prime Lease, Prime Landlord may, at its option, take over all of the right, title and interest of Lessor, as sublessor under this Sublease, and Lessee, at Prime Landlord’s option, shall attorn to Prime Landlord pursuant to the then executory provisions of this Sublease, except that Prime Landlord shall not be: (i) liable for any act or omission of Lessor under this Sublease, (ii) subject to any defense or offsets which Lessee may have against Lessor, except for offset rights to which Lessee is entitled pursuant to this Sublease; (iii) bound by any previous payment which Lessee may have made to Lessor more than one (1) month in advance of the date upon which such payment was due, unless previously approved by Prime Landlord; (iv) bound by any obligation to make any payment to or on behalf of Lessee; (v) bound by any obligation to perform any work or to make improvements to the Premises (as such term is defined in the Prime Lease) or the Subleased Premises, provided the foregoing shall not relieve the Prime Landlord from the continuing obligations required of the Landlord under the Prime Lease; (vi) bound by any amendment or modification of this Sublease made without Prime Landlord’s consent; or (vii) bound to return Lessee’s security deposit, if any, until such deposit has come into its actual possession and Lessee would be entitled to such security deposit pursuant to the terms of this Sublease.  Notwithstanding anything to the contrary contained herein, nothing contained shall limit Lessee’s rights, defenses or remedies for any default by a prior sublandlord (including Lessor) under this Sublease which remains uncured following the time Prime Landlord succeeds to the interest of Lessor under the Sublease, nor relieve Prime Landlord of the obligation to cure ongoing defaults that are continuing following the date that Prime Landlord succeeds in the interest of Lessor under this Sublease, provided that Prime Landlord is given written notice of such default and thereafter fails to cure the same within the cure period provided for in this Sublease.  

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9.05 Notwithstanding anything to the contrary contained in the Prime Lease, excluding any such Permitted Assignment pursuant to Section 22(b) or (c) of the Prime Lease, if at any time or from time to time during the period excluding the final thirty-six (36) months of the Term, Lessee desires to (i) assign this Sublease or its entire interest under this Sublease, or (ii) sublet (y) greater than one-hundred eighty thousand (180,000) rentable square feet of the Subleased Premises (in one or more transactions, whether or not related), or (z) any portion of the Subleased Premises for substantially the remainder of the Term (such proposed transfer in (i) and (ii) being considered a “Recapture Event”), then at least fifteen (15) days prior to the date when Lessee desires the assignment or subletting to be effective (the “Transfer Date”), Lessee shall deliver a notice to Lessor (the “Notice”) which shall set forth the name, address and business of the proposed assignee or sublessee, information (including financial statements) concerning the character of the proposed assignee or sublessee, a detailed description of the space proposed to be assigned or sublet, which must be a single, self-contained unit or have the ability to be demised into a single, self-contained unit (the “Space”), any rights of the proposed assignee or sublessee to use Lessee’s improvements and the like, the Transfer Date, and the fixed rent and/or other consideration and all other material terms and conditions of the proposed assignment or subletting, all in such detail as Lessor may reasonably require.  If Lessor requests additional detail, the Notice shall not be deemed to have been received until Lessor receives such additional detail.  In the event of a Recapture Event, Lessor shall have the option, exercisable by giving notice to Lessee at any time within fifteen (15) days after Lessor’s receipt of the Notice (“Recapture Notice”), to terminate this Sublease as to the Space as of the Transfer Date, in which event Lessee shall be relieved of all further obligations hereunder as to the Space.  If Lessor exercises its option to recapture the Space, then Lessor shall install a demising wall separating the Space from the balance of the Subleased Premises and shall separate utility lines to the extent required, at Lessor’s sole cost and expense.  No failure of Lessor to exercise its recapture right with respect to the Space shall be deemed to be Lessor’s consent to the assignment or subletting of all/or any portion of the Space.  Provided Lessor has consented to such assignment or subletting, Lessee may assign or sublet the Space to the transferee named in the Notice in accordance with the terms and conditions of the Prime Lease.  For the avoidance of doubt, during the final thirty-six (36) months of the Term, the recapture conditions of this Section 9.05 shall no longer apply.

9.06If (a) Lessee desires to enter into a transaction to sublease a portion of the Subleased Premises and (b) the number of rentable square feet then contemplated to be subleased by Lessee, when aggregated with the number of rentable square feet of the Subleased Premises previously subleased by Lessee, exceeds one hundred eighty thousand (180,000) rentable square feet of space, a Recapture Event shall be deemed to have occurred with respect to the current proposed subleased space as well as all previously subleased space and Lessee shall deliver a Notice to Lessor identifying all of the space that is the subject of the Recapture Event, together with true and correct copies of all applicable subleases.  In such event, Lessor shall have (i) the rights set forth in Section 9.05 with respect to the space that Lessee then currently proposes to sublease and (ii) as to the remainder of the space that is the subject of earlier subleases, Lessor shall have the right (which shall be contained in all subleases entered into by Lessee) to terminate the sublease between Lessee and the subtenant in which event Lessor shall recognize the sublease as a direct lease between Lessor and the subtenant until the end of the applicable sublease term.

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10.Indemnification; Damage.  

10.01Subject to any applicable waiver of subrogation and/or release provisions applicable to the parties, and except to the extent resulting from the negligence or willful misconduct of Lessor or any of Lessor’s employees, agents, contractors or invitees, Lessee shall indemnify, defend and hold harmless Lessor and its employees and agents from and against any and all loss, cost, liability, claim, damage and expense, including, without limiting the generality of the foregoing, reasonable attorneys’ fees and expenses and court costs, penalties and fines incurred in connection with or arising from any injury, damage or loss (by theft or otherwise) occurring in or about the Subleased Premises or the Building and arising from any acts, omissions or negligence of Lessee, its employees, licenses or agents.  Subject to any applicable waiver of subrogation and/or release provisions applicable to the parties, and except to the extent resulting from the negligence or willful misconduct of Lessee or any of Lessee’s employees, agents, contractors or invitees, Lessor shall indemnify, defend and hold harmless Lessee and its employees and agents, from and against any and all loss, cost, liability, claim, damage and expense, including, without limiting the generality of the foregoing, reasonable attorneys’ fees and expenses and court costs, penalties and files incurred in connection with or arising from any negligence or willful misconduct of Lessor or Lessor’s employees, agents, contractors or invitees.

10.02  Notwithstanding any other provision of this Sublease or the Prime Lease to the contrary, except to the extent resulting from Lessor’s negligence or willful misconduct, Lessor shall not be liable to Lessee, or to Lessee’s employees, agents, subtenants, licensees, invitees, or visitors, or to any other person whomever, for any loss, or any damage to or loss of any property or death or injury to any person occasioned by or arising out of (a) the condition or design of or any defect in or failure to repair the Subleased Premises or the Building or any part or component thereof (including without limitation any mechanical, electrical, plumbing, heating, air conditioning or other systems or equipment); or (b) acts or omissions of Prime Landlord, other tenants or occupants in the Building or of any other persons whomever; or (c) burglary, theft, vandalism, malicious mischief, fire, act of God, public enemy, criminal conduct, court order or injunction, riot, strike, insurrection, war, requisition or order of governmental authority, or any other matter beyond the reasonable control of Lessor; (d) repair or alteration of any part of the Subleased Premises or Building; or (e) violation or default by Prime Landlord under the Prime Lease (including without limitation slowdown, interruption, failure or cessation of any service to be provided by Prime Landlord).

11.Consents and Approvals. In any instance when Lessor’s consent or approval is required under this Sublease, Lessor’s refusal to consent to or approve any matter or thing shall be deemed reasonable if, inter alia, such consent or approval has not been obtained from Prime Landlord (if required under the Prime Lease).  In the event that Lessee shall seek the approval by or consent of Lessor and Lessor shall fail or refuse to give such consent or approval, Lessee shall not be entitled to any damages for any withholding or delay of such approval or consent by Lessor, it being intended that Lessee’s sole remedy shall be an action for injunction or specific performance and that said remedy of any action for injunction or specific performance shall be available only in those cases where Lessor shall have expressly agreed not unreasonably to withhold or delay its consent.  Notwithstanding anything to the contrary contained herein, in the event Prime Landlord agrees to provide its consent where necessary pursuant to the Prime Lease, Lessor agrees it shall not unreasonably withhold, condition or delay its consent hereunder.  

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12.Brokerage. Lessee represents that it dealt with no broker in connection with this Sublease other than Jones Lang LaSalle.  Lessee shall indemnify, defend and hold Lessor harmless against liability arising out of any inaccuracy or alleged inaccuracy of the foregoing representation of Lessee.  Lessor represents that it dealt with no broker in connection with this Sublease other than Zell Partnership, Inc. Lessor shall indemnify, defend and hold Lessee harmless against liability arising out of any inaccuracy or alleged inaccuracy of the foregoing representation of Lessor.  Lessor shall be responsible for paying any commissions due to Jones Lang LaSalle and Zell Partnership, Inc. arising out of the execution of this Sublease pursuant to separate agreements.  Lessor shall have no liability for brokerage commissions arising out of a sublease or assignment by Lessee and Lessee shall and does hereby indemnify Lessor against all liability for brokerage commissions arising out of any such sublease or assignment.  The provisions of this Section 12 shall survive the expiration or earlier termination of this Sublease.

13.Notices

13.01.All rent and other payments required to be made by Lessee shall be payable to Lessor at Lessor’s address set forth on the first page hereof or at such other address as Lessor may specify from time to time by Notice (as hereinafter defined) to Lessee.  Whenever this Sublease requires or permits any consent, approval, notice, request or demand from one party to the other (collectively, “Notice”), such Notice must be in writing to be effective and shall be effective on the date of actual receipt of such Notice by the addressee or when the attempted initial delivery is refused or when it cannot be made because of a change of address of which the sending party has not been notified.  The following shall, without limitation, be prima facia evidence of actual receipt of Notice by the addressee:  (a) if mailed, by a United States certified mail return receipt, signed by the addressee or the addressee’s agent or representative, (b) if sent by overnight courier with receipt signed by the addressee or the addressee’s agent or representative; or (c) if hand delivered, by a delivery receipt signed by the addressee or the addressee’s agent or representative.  All notices or other communications required or desired to be given hereunder to Lessor shall be delivered to the address set forth in the preamble, Attn: Head of Real Estate, with a copy to: Aventis Inc., North American Legal Department, U.S. Corporate, 55 Corporate Drive, Bridgewater , New Jersey 08807-0977, Attn: General Counsel, North America and with a copy to; and with a copy to Arnold & Porter, 601 Massachusetts Avenue NW, Washington, DC 20001, Attn: Kenneth Schwartz.  All such notices or other communications to Lessee shall be delivered to BLUEBIRD BIO, INC., a Delaware corporation, 60 Binney Street, Cambridge, Massachusetts 02142, Attn: General Counsel.

13.02Any notices, approvals, consents or other communications under this Sublease shall be in writing and sent by either (a) certified mail, return receipt requested, postage prepaid, (b) personal delivery or (c) nationally recognized overnight courier service to the parties at their respective addresses set forth in this Sublease.  Any notice, approval, consent or other communication shall be deemed given if sent by certified mail, return receipt requested on the third business day following the date mailed, if sent by personal delivery on the date delivered or if sent by nationally recognized overnight courier service on the next business day after the date delivered to such courier service.

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14.Confidentiality.  Except as otherwise required by law, neither Lessor nor Lessee shall disclose the terms of this Sublease to any other person.  Notwithstanding the foregoing,  Lessor and Lessee shall have the right to disclose the terms of this Sublease to their respective (i) members, partners, shareholders, directors, officers, employees and agents of each of their constituent entities and (ii) their respective legal counsel and advisors.  All persons described in the foregoing clauses (i) and (ii) shall be informed by Lessor or Lessee, as applicable, of the confidential nature of such information and shall be directed to keep such information confidential.   Notwithstanding the foregoing, each of Lessor and Lessee acknowledges that the rules and regulations promulgated by the United States Securities and Exchange Commission (the “SEC”) may require the other party to disclose certain basic information concerning this Sublease and the transactions contemplated herein in documents to be filed with the SEC.  The parties agree that Lessor and Lessee shall be permitted to make such disclosures and that such disclosures shall not constitute a breach or a violation of this Section 14 or any other confidentiality or non-disclosure agreement executed by the parties (or any of their respective affiliates).  

15.Representations

15.01.Lessor’s Representations.  To induce Lessee to enter into this Sublease, Lessor hereby represents, warrants and covenants to Lessee that:

(a)Lessor holds the entire tenant’s interest under the Prime Lease;

(b)Lessor has not sublet the Subleased Premises or any portion of the Subleased Premises; and

(c)Lessor is a duly formed and validly existing Delaware corporation.  This Sublease has been duly authorized, executed and delivered by Lessor.

15.02.Lessee's Representations.   To induce Lessor to enter into this Sublease, Lessee hereby represents, warrants and covenants to Lessor that:

(a)Lessee is a duly formed and validly existing Delaware corporation; and

(b)This Sublease has been duly authorized, executed and delivered by Lessee.

16.Lessor’s Liability.  Lessor, its partners, officers, directors, shareholders and principals, disclosed or undisclosed, shall have no personal liability under this Sublease.  If Lessor shall fail to perform any covenant, term or condition of this Sublease upon Lessor’s part required to be performed, or if Lessee shall make any claim arising out of Lessee’s occupancy or use of the Subleased Premises, Lessor’s liability from and after the date of this Sublease shall not exceed the Rental payable hereunder, and in no event shall Lessor’s partners, officers, directors, shareholders or principals, disclosed or undisclosed, be subject to lien, levy, execution or other enforcement procedure for the satisfaction of Lessee’s remedies under or with respect to this Sublease, the relationship of Lessor and Lessee hereunder or Lessee’s use or occupancy of the Subleased Premises.  If Lessee shall acquire a lien on such other property or assets by judgment or otherwise, Lessee shall promptly release such lien by executing and delivering to Lessor any instrument, prepared by Lessor, required for such lien to be released.  This paragraph shall inure to the benefit of Lessor and its successors and assigns and shall survive the expiration or sooner termination of this Sublease.

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17. No Renewals.  Lessee shall have no renewal or extension rights hereunder and, notwithstanding anything herein to the contrary, no rights of Lessor to renewals under the Prime Lease shall be incorporated herein, provided, however, that if requested by Lessee, Lessor shall work in good faith with Lessee to obtain renewal rights for Lessee directly from Prime Landlord.

18. Parking; Signage.  

18.01Lessee and its employees and invitees shall have the right to use Two Hundred  Sixteen (216) parking spaces in the Garage at market monthly rates, subject to the terms and conditions for the use thereof set forth in the Prime Lease.  Lessee shall be solely responsible for  paying directly to Prime Landlord or the Garage operator for all of such parking spaces at the monthly market rate designated by Prime Landlord pursuant to and in accordance with the terms of Section 10(b) of the  Prime Lease.  In addition, Lessee shall be obligated to pay Lessee’s Share of Operating Expenses for the Garage as additional rent hereunder.  Notwithstanding anything to the contrary contained in Sections 10(a) and 10(b) of the Prime Lease, as between Lessor and Lessee, Lessor shall have no obligations or liabilities to Lessee relating in any way to Lessee’s rights to park in the Garage.

18.02 On or prior to the Commencement Date, Lessor shall request that Prime Landlord replace Lessor’s name with that of Lessee on the monument sign located on the exterior of the Building, all of which shall be at the sole cost of Lessee.  Lessee shall have no other exterior signage rights granted under the Prime Lease to Lessor or otherwise.  

19. Cleaning. Notwithstanding anything herein or in the Prime Lease to the contrary, Lessee shall be responsible, at its sole cost and expense, for performing all services for the Premises in accordance with first class standards and otherwise as required under the Prime Lease.

20.Security.  Lessor shall have no responsibility or liability for the security of the Building, the Subleased Premises or the safety of any of Lessee’s employees, agents or contractors and Lessee hereby waives any right to make any claims against Lessor with regard to any such security matters.  Lessee shall have the right to provide security in accordance with Section 33 of the Prime Lease.  

21. Security Deposit.

21.01Not later than five (5) business days following delivery by Prime Landlord of its written consent to this Sublease, Lessee shall deliver to Lessor the sum of Forty Million Seventy One Thousand Six Hundred Fifty Four and 15/100 Dollars ($40,071,654.15) (the “Security Deposit”) in the form of a letter of credit (“Letter of Credit”) in accordance with the requirements set forth below. Such Security Deposit shall be security for the payment and performance by Lessee of all obligations, covenants, conditions and agreements under this Sublease, and Lessor shall have the right, but shall not be obligated, to apply all or any portion of the Security Deposit to cure any monetary Default or material non-monetary Default under this Sublease by Lessee, in which event Lessee shall be obligated to promptly deposit with Lessor the amount necessary (or deliver an amendment to the Letter of Credit) to restore the Security

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Deposit to its original amount within fifteen (15) days.  In the event a monetary Default or material non-monetary Default occurs and is continuing, said Security Deposit shall not be deemed liquidated damages and Lessor may apply that portion of the Security Deposit to cure the monetary Default or material non-monetary Default on Lessee’s behalf, and such application shall not preclude Lessor from recovering from Lessee all additional damages incurred by Lessor.  In the event Lessee fully and faithfully complies with all terms, covenants, and conditions of this Sublease, the Letter of Credit shall be returned to Lessee within forty-five (45) days following the expiration or earlier termination hereof and Lessee’s surrender of the Subleased Premises in accordance with the terms of this Sublease.  Lessor shall transfer at its sole cost and expense the Letter of Credit to any purchaser or other successor or assignee of its interest hereunder and upon such transfer, Lessor shall be discharged and released from all further liability with respect to the Security Deposit and Lessee agrees to look solely to the successor or assignee for the return thereof.  The Letter of Credit shall be an unconditional, irrevocable Letter of Credit in a form and from a financial institution reasonably acceptable to Lessor and shall have a term equal to the period expiring on the sixtieth (60^th) day following the expiration of the Term or, at Lessee’s option, shall have a term equal to the period expiring on an earlier date, which shall be no less than the first anniversary of the date of issuance thereof, in which event Lessee covenants that a renewal or replacement shall be delivered to Lessor by that date which is thirty (30) days prior to the expiration date of such Letter of Credit.  If Lessee fails to so timely renew (or so replace) and deliver said Letter of Credit, Lessor may draw upon the Letter of Credit then in effect without the necessity of any other notice, in which event the proceeds thereof shall be held by Lessor until Lessee delivers a renewal or replacement. Said Letter of Credit shall provide that Lessor shall be permitted to draw on same following its declaration that it is permitted to so draw pursuant to the terms of this Sublease without requiring any additional certifications or evidence of Default.  In the event said Letter of Credit would expire during the pendency of any litigation and Lessee does not renew or replace the same at least thirty (30) days prior to the expiration date of such Letter of Credit, Lessor may draw upon said Letter of Credit after a Default by Lessee and hold the proceeds thereof as a Security Deposit hereunder.  Said Letter of Credit shall provide that Lessor be permitted to draw on same either by presentation (i) in person at a location in the United States of America or (ii) by overnight courier service, or (iii) by facsimile.  The use, application or retention of the proceeds of the Letter of Credit, or any portion thereof, by Lessor shall not prevent Lessor from exercising any other right or remedy provided by this Sublease or by law, and shall not limit any recovery to which Lessor may otherwise be entitled.  Notwithstanding anything to the contrary contained in this Sublease, Lessee acknowledges and agrees that if Lessee fails to timely make any payment required to be made by Lessee under that certain Purchase Agreement by and between Lessor and Lessee dated as of the date hereof relating to certain FF&E, and Lessee fails thereafter to make such payment within three (3) business days after written notice from Lessor, then failure to make such payment shall constitute an immediate Default under this Sublease without any further cure right on the part of Lessee.

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21.02If, on each of the anniversaries of the Commencement Date (each, an “Anniversary Date”), Lessee meets or exceeds the requirements that (i) Lessee’s working capital shall be at least $1,000,000,000, with such “working capital” defined as total current assets plus any other marketable securities that are readily convertible into cash minus the total current liabilities of Lessee as reported in Lessee’s SEC filings, and (ii) no Default by Lessee under this Sublease shall have occurred and be continuing (collectively, the “Reduction Requirements”, and each a Reduction Requirement”), then as provided below in this Section, the Security Deposit shall be reduced by the amounts set forth in the table below.  

 

 

The “Reduced Security Deposit” shall mean the amount of the Security Deposit required to be held by Lessor under this Sublease as of the Reduction Date, less the Reduction Amount.  If Lessee provides Lessor with written evidence reasonably satisfactory to Lessor that Lessee has met all of the Reduction Requirements, then Lessor shall return the unapplied portion of the Security Deposit then held by Lessor, less the Reduced Security Deposit, to Lessee within fifteen (15) days of Lessee’s delivery of such written evidence.  If Lessor returns to Lessee any portion of the Security Deposit in accordance with this Section, then from and after the date such monies are returned to Lessee, the “Security Deposit” shall be deemed the Reduced Security Deposit for all purposes of this Sublease.  

22.Miscellaneous.  

22.01In the event of any action or proceeding brought by either party under this Sublease against the other party hereto, the prevailing party shall be entitled to recover from the other party all costs and expenses, including reasonable attorneys’ fees, in such action or proceeding.

22.02Submission of this Sublease to Lessee for signature does not constitute a reservation of space or an option to Sublease.  This Sublease is not effective until execution by and delivery to both Lessor and Lessee.

22.03 If any provision of this Sublease or the application thereof to any person or circumstances shall be invalid or unenforceable to any extent, the remainder of this Sublease and the application of such provisions to other persons or circumstances shall not be affected thereby and shall be enforced to the greatest extent permitted by law.

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22.04This Sublease shall be binding upon and inure to the benefit of Lessor and Lessee and their respective heirs, personal representatives, successors and assigns (subject to any other express provisions addressing subleasing and assignment).

22.05The captions appearing in this Sublease are for convenience only and in no way define, limit, construe or describe the scope or intent of any Section.  The laws of the Commonwealth of Massachusetts and applicable United States federal law shall govern the validity, performance and enforcement of this Sublease.  This Sublease shall not be construed more or less favorably with respect to either party as a consequence of the Sublease or various provisions hereof having been drafted by one of the parties hereto.

22.06This Sublease may not be altered, waived, amended or extended except by an instrument in writing signed by Lessor and Lessee.

22.07LESSOR AND LESSEE EXPRESSLY AGREE THAT THERE ARE AND SHALL BE NO IMPLIED WARRANTIES OF MERCHANTABILITY, SUITABILITY, HABITABILITY, FITNESS FOR A PARTICULAR PURPOSE OR OF ANY OTHER KIND ARISING OUT OF THIS SUBLEASE, AND THERE ARE NO WARRANTIES WHICH EXTEND BEYOND THOSE EXPRESSLY SET FORTH IN THIS SUBLEASE.

22.08Lessee represents and warrants that the financial statements that it provided to Lessor prior to the execution of this Sublease truly, accurately and fairly represent the financial results, cash flows and financial condition of Lessee as of the date of such statements and do not misstate any material fact or omit any material information or contingent liability.

22.09This Sublease may be executed in counterparts.

 

 

(Remainder of page intentionally left blank; signature page follows.)

 

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IN WITNESS WHEREOF, Lessor and Lessee have executed this Sublease as of the day and year first above written.

 

 

 

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SCHEDULE 1

 

[***]

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EXHIBIT A

 

[***]

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EXHIBIT B

 

[***]

 

 

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EXHIBIT C

 

[***]

 

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

Exhibit 10.43

 

Amendment to Sublease

 

Reference is made to that certain Sublease (the “Agreement”), dated April 16, 2019, between bluebird bio, Inc. (“bluebird bio”) and Aventis Inc. (“Seller”).  

 

This is an amendment (“Amendment”) to the Agreement. To the extent any provision of this Amendment conflicts with any of the provisions of the Agreement, the provisions of this Amendment shall govern.  Capitalized terms but not otherwise defined herein shall have the respective meanings ascribed to such terms in the Agreement, as applicable.  Except for the amendments made hereby, the above referenced Agreement remains in full force and effect.  This Amendment is effective as of April 19, 2019 (the “Amendment Effective Date”).

 

 

 

 

[signature page follows]

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The parties, acting through their duly authorized representatives, have executed this Amendment as of the Amendment Effective Date.

 

 

 

Exhibit 31.1

CERTIFICATIONS

I, Nick Leschly, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of bluebird bio, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15(d)-15(f)) for the registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

 

 

 

Exhibit 31.2

CERTIFICATIONS

I, Chip Baird, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of bluebird bio, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15(d)-15(f)) for the registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

 

 

Exhibit 32.1

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report on Form 10-Q of bluebird bio, Inc. (the “Company”) for the period ended June 30, 2019 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), each of the undersigned officers of the Company hereby certifies, pursuant to 18 U.S.C. Section 1350, that to his or her knowledge:

(1) the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

 

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