Document:

Exhibit

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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Double asterisks denote omissions.
Exhibit 10.1

DEDICATED MANUFACTURING AND COMMERCIAL SUPPLY AGREEMENT
This DEDICATED MANUFACTURING AND COMMERCIAL SUPPLY AGREEMENT (this “Agreement”), effective as of this 3rd day of August, 2018 (the “Effective Date”), between, Spark Therapeutics, Inc., a Delaware corporation with an office at 3737 Market Street, Suite 1300, Philadelphia, PA 19104 (“Customer”), and Brammer Bio MA, LLC, a Delaware limited liability company with offices at 250 Binney Street, Cambridge, MA 02142 (“Brammer”).  Customer and Brammer are referred to herein each as a “Party” and collectively as the “Parties.”
WHEREAS, Brammer provides a full range of viral vector process and analytical development, clinical and commercial manufacturing and supply services to cell and gene therapy companies;
WHEREAS, the Parties have entered into that Development and Manufacturing Services Agreement, dated as of June 30, 2017, between Customer and Brammer (as amended from time to time, the “DMSA”), pursuant to which Brammer performs certain Services (as defined therein) with respect to certain products for Customer, which products may be subject to the manufacture and supply by Brammer on behalf of Customer under this Agreement;
WHEREAS, Customer now desires that Brammer manufacture and supply post Process Performance Qualification (as defined below) certain Products (as defined below) for clinical trial and commercialization purposes pursuant to this Agreement;
WHEREAS, Customer desires Brammer to reserve the Dedicated Capacity (as defined below) in one or more GMP Suite(s) (as defined below) and Non-Dedicated Support Capacity (as defined below) in connection with such manufacture and supply, and Brammer wishes to provide such Dedicated Capacity and Non-Dedicated Support Capacity; and
WHEREAS, in connection with such manufacture and supply, Customer and Brammer shall enter into a Product Addendum (as defined below) for each Product, which shall describe the Program (as defined below) of manufacturing and supply activities that Brammer shall conduct for such Product.
NOW, THEREFORE, in consideration of the mutual covenants contained herein and other good and valuable consideration, the sufficiency and receipt of which are hereby acknowledged, the Parties hereto agree as follows:
1.Definitions. Terms defined elsewhere in this Agreement will have the meanings set forth therein for all purposes of this Agreement unless otherwise specified to the contrary.  The following terms will have the meaning set forth below in this Section 1:
1.1    “Acknowledgement” has the meaning set forth in Section 3.1.
1.2    “Action” means any demand, action, suit, countersuit, arbitration, inquiry, proceeding or investigation by or before any federal, state, local, foreign or international governmental authority or any arbitration or mediation tribunal.

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1.3    “Advanced Payment” has the meaning set forth in Appendix C.
1.4    “Affiliate(s)” means, with respect to either Customer or Brammer, any corporation, company, partnership, joint venture and/or firm which controls, is controlled by or is under common control with Customer or Brammer, as the case may be. As used in the definition of Affiliate, “control” means (a) in the case of corporate entities, direct or indirect ownership of more than fifty percent (50%) of the stock or shares having the right to vote for the election of directors (or such lesser percentage that is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction), and (b) in the case of non-corporate entities, the direct or indirect power to manage, direct or cause the direction of the management and policies of the non-corporate entity or the power to elect more than fifty percent (50%) of the members of the governing body of such non-corporate entity.
1.5    “Agreement” has the meaning set forth in Section 29.
1.6    “Applicable Laws” means all applicable ordinances, rules, regulations, laws, guidelines, guidances, requirements and court orders of any kind whatsoever of any Regulatory Authority applicable to a Party’s activities hereunder, as amended from time to time, including cGMP (if applicable) of the FDA, the EMA, the European Commission, the ICH guidelines and regulations, and other regulatory jurisdictions as agreed to by both Parties.
1.7    “Approved Vendor(s)” has the meaning set forth in Section 9.1.
1.8    “Artwork Change” has the meaning set forth in Section 2.8(i)(c).
1.9    “Batch” means the quantity of Drug Substance, as applicable in the given context, that is intended to have uniform character and quality within specified limits and is produced according to a single cycle of manufacture in accordance with the applicable Batch Record.
1.10    “Batch Documentation” has the meaning set forth in Section 5.1.
1.11    “Batch Pricing” has the meaning set forth in Section 4.1.
1.12    “Batch Record” means the final executed batch production and quality control records, prepared in accordance with cGMP, for each Batch of Product manufactured under this Agreement.
1.13    “Binding Forecast” has the meaning set forth in Section 3.2.
1.14    “BLA” or “Biologics License Application” means, as defined by the FDA, a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2 or any successor regulation thereto), or any equivalent filing in a country or regulatory jurisdiction other than the United States.
1.15    “Brammer” has the meaning set forth in the Background section of this Agreement.
1.16    “Brammer Failure” means, with respect to a Defect, that such Defect was caused by (i) the negligence or willful misconduct of Brammer or any of its Affiliates, or Brammer’s negligence or willful misconduct or failure to follow Customer’s written instructions in managing Approved Vendors, (ii) an act or omission by Brammer or any of its Affiliates in violation of this Agreement, the Quality Agreement or Applicable Laws, (iii) the failure of any applicable GMP Suite or Facility to comply with this Agreement or Applicable Laws, or (iv) a Product Material (inclusive of any Customer-Provided Materials that have been stored and handled incorrectly by or on behalf of Brammer after delivery to Brammer).

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1.17    “Brammer-Funded Equipment” means any equipment used by Brammer or its Affiliates to perform the manufacture and supply activities under this Agreement that do not constitute Customer-Funded Equipment.
1.18    “Brammer IPR” has the meaning set forth in Section 9.4 of the DMSA.
1.19    “Brammer IPR License” has the meaning set forth in Section 9.4 of the DMSA.
1.20    “Brammer Parties” has the meaning set forth in Section 14.1.
1.21    “Brammer Technology” has the meaning set forth in Section 1.10 of the DMSA, with all capitalized terms therein having their meaning set forth in this Agreement.
1.22    “Cancellation Date” has the meaning set forth in Section 3.6.
1.23    “Capacity Access Fee” has the meaning set forth in Appendix C.
1.24    “Certificate of Analysis” means a written certificate certifying that a Batch meets the applicable Specifications, as signed and dated by a duly-authorized representative of Brammer’s quality assurance department, and listing the items tested, manufacturer, specifications, testing methods and test results for a specific Lot.
1.25    “Certificate of Compliance” means a document signed by an authorized representative of Brammer, certifying that a particular Lot was Manufactured in accordance with cGMP (if applicable), all other Applicable Laws and the Specifications.
1.26    “cGMP” means current good manufacturing practices, including the regulations promulgated by the FDA under the United States Food, Drug and Cosmetic Act, 21 C.F.R. Part 210 et seq., as amended from time to time, applicable guidance documents issued by the FDA, EC Directive 2003/94/EC and European Medicines Agency guidance documents, applicable documents developed by the ICH to the extent that they are applicable to the Drug Substance, Drug Product, Product and the Parties hereunder.
1.27    “Change of Control” has the meaning set forth in Section 19.
1.28    “Claims” has the meaning set forth in Section 14.1.
1.29    “Confidential Information” has the meaning set forth in Section 10.1 of the DMSA, with all capitalized terms therein having their meaning set forth in this Agreement.  Customer’s Confidential Information further includes the Product, the Drug Product, the Drug Substance, Customer-Provided Materials, Customer Technology, and New Customer Technology.  Brammer’s Confidential Information includes proprietary technical data, know-how, and trade secrets concerning Brammer’s production and purification methods, Brammer’s equipment specifications, operating parameters and techniques, Brammer’s equipment parameters and techniques, Brammer’s facilities and their design and operation, and Brammer Technology and New Brammer Technology, as well as business, financial and technical data of Brammer.
1.30    “Control” means, with respect to any Technology or Intellectual Property Right, that a Party: (i) owns such Technology or Intellectual Property Right; or (ii) has a license or right to use to such Technology or Intellectual Property Right, in each case of (i) and (ii) with the legal right to grant to the other Party access, a right to use, or a license, or a sublicense (as applicable) to such Technology or Intellectual Property Right without violating the terms of any agreement or other arrangement with any Third Party or creating a payment obligation upon such Party, or knowingly misappropriating the proprietary or trade secret information of a Third Party.

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1.31    “Customer” has the meaning set forth in the Background section of this Agreement.
1.32    “Customer-Funded Equipment” means equipment, if any, identified in the applicable Product Addendum as being provided by Customer or purchased or otherwise acquired by Brammer at Customer’s expense.
1.33    “Customer-Owned Retains” has the meaning set forth in Section 2.10.
1.34    “Customer Parties” has the meaning set forth in Section 14.2.
1.35    “Customer-Provided Materials” means, with respect to a Product, the Product Materials identified in the applicable Product Addendum to be provided by Customer to Brammer hereunder, for use in the manufacture of the Product.
1.36    “Customer Representative” has the meaning set forth in Section 3.7.
1.37    “Customer Technology” means “Spark Technology” as set forth in Section 1.42 of the DMSA, with all capitalized terms therein having their meaning set forth in this Agreement.
1.38    “Dedicated Capacity” means a defined amount of cGMP manufacturing capacity in a GMP Suite, as more specifically described in Appendix C, that is exclusively dedicated to Customer for the manufacture and supply of Products and performance of certain manufacturing and supply activities by Brammer under this Agreement or any Services (as defined in the DMSA) pursuant to the DMSA, during the term corresponding to the periods for which Customer pays the applicable Capacity Access Fee pursuant to Section 4.3.
1.39    “Defect” means, with respect to a Lot of Product post Process Performance Qualification, a defect that causes the Product in such Lot to fail to conform to the Specifications at the time of delivery, or otherwise cannot be used due to the failure of the Lot of Product to meet the requirements of the Quality Agreement, requirements of this Agreement, or Applicable Laws, and which is either (a) discovered by Brammer prior to Delivery or (b) discovered and reported by Customer upon delivery of such Lot at the Delivery Site, or in accordance with Section 5.3, or (d) a Latent Defect.
1.40    “Delinquency Period” has the meaning set forth in Section 4.8.
1.41    “Delivery Site” has the meaning set forth in Section 5.1.
1.42    “Development Services” has the meaning set forth in Section 2.1.
1.43    “Disclosing Party” has the meaning set forth in Section 10.1.
1.44    “Disposition” means a documented decision on the acceptability for use of a specific Batch that is based on a process of reviewing data, Batch Records, and other documentation associated with the production and testing of the Product.
1.45    “DMSA” has the meaning set forth in the Background section of this Agreement.
1.46    “Drug Substance” means the active pharmaceutical ingredient (as defined by ICH Q7) manufactured by Brammer on behalf of Customer and identified in the applicable Product Addendum.
1.47    “Drug Product” means the Product manufactured by Brammer on behalf of Customer, into its final container closure, whether or not labeled.

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1.48    “Effective Date” has the meaning set forth in the Background section of this Agreement.
1.49    “EMA” means the European Medicines Agency, and any successor agency entity thereof having or performing substantially the same function.
1.50    “Estimate” has the meaning set forth in Section 4.5.
1.51    “Facilities” or “Facility” means Brammer’s manufacturing facilities located at 250 Binney Street, Cambridge, MA 02142, and warehouse facilities located at 61 Medford Street, Somerville, MA 02143, unless specifically set forth otherwise on Appendix C with respect to all Products, or on the applicable Product Addendum with respect to a specific Product.
1.52    “Forecast” has the meaning set forth in Section 3.2.
1.53    “Force Majeure Event” has the meaning set forth in Section 18.
1.54    “FDA” means the United States Food and Drug Administration or any successor entity thereof having or performing substantially the same function.
1.55    “GMP Suite” has the meaning set forth in Section 2.3.
1.56    “ICH” means the International Conference on Harmonization.
1.57     “Indemnified Party” has the meaning set forth in Section 14.3.
1.58    “Indemnifying Party” has the meaning set forth in Section 14.3.
1.59    “Intellectual Property Rights” means any and all of the following: (i) Patents, (ii) copyrights in both published and unpublished works, (iii) rights in trade secrets and know-how, whether or not patentable or copyrightable, (iv) trademark and service mark rights, (v) any and all other intellectual property rights, and (vi) any and all registrations and applications for registration of any of the foregoing.
1.60    “JPT” has the meaning set forth in Section 3.7.
1.61    “JSC” has the meaning set forth in Section 3.8.
1.62    “Latent Defect” means a Defect that was not reasonably discoverable within the period specified in Section 5.3 and not attributable to the improper handling or storage of the applicable Lot of Product after Customer takes delivery, but causes such Lot to fail to meet the original Specifications and is identified within [**] after Brammer’s release of a Drug Product Lot, using the analytical testing established for the Process.
1.63    “Launch” shall mean the first sale of a Product that has received Regulatory Approval together with all pricing and reimbursement approvals, from the applicable Regulatory Authority(ies) in a country within the Territory, excluding, however, any sale or other distribution for compassionate use, named patient use or for use in a clinical trial, for test marketing or similar use in a country.
1.64    “Losses” has the meaning set forth in Section 14.1.
1.65    “Lot” means a Batch or a portion of a Batch, or multiple Batches combined to form a filled Drug Product and released under a single alpha-numeric identifier.
1.66    “Manufacturer” means Brammer Bio MA, LLC.

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1.67    “Master Batch Record” means the document containing the instructions for the manufacture of the applicable Product referencing the applicable Specifications for such Product, as such may be amended by the Parties in accordance with the terms hereof.
1.68    “Material Specification” means a document detailing the list of tests, formulations, references to any analytical methods and appropriate acceptance criteria that are numerical limits, ranges or other criteria for tests described, that establishes a set of criteria to which a Product Material should conform to be considered acceptable as per Brammer’s quality requirements.  For the avoidance of doubt, the Parties shall establish Material Specifications for all Product Materials relating to a Product.
1.69    “Minimum Purchase Commitment” has the meaning set forth in Section 3.3.
1.70    “New Brammer Technology” has the meaning set forth in Section 1.27 of the DMSA, with all capitalized terms therein having their meaning set forth in this Agreement.
1.71    “New Customer Technology” means “New Spark Technology” as set forth in Section 1.28 of the DMSA, with all capitalized terms therein having their meaning set forth in this Agreement.
1.72    “Non-Binding Forecast” has the meaning set forth in Section 3.4.
1.73    “Non-Dedicated Support Capacity” means the non-dedicated multi-use cGMP manufacturing capacity at the Facilities provided by Brammer as more specifically described in Appendix C that is non-exclusively dedicated to Customer for the manufacture and supply of the Products and performance of certain Services (as defined in the DMSA) pursuant to the DMSA, and includes multi-use suites for media preparation, downstream processing, and fill-finish, as applicable.  For clarity, the Non-Dedicated Support Capacity may not be a specific physical location within the Facilities, for example, Brammer may qualify [**] fill-finish suites in which Brammer shall prepare the fill-finishing of the Product.
1.74    “Notice of Dispute” has the meaning set forth in Section 13.2(i).
1.75    “Other Customer Product” means any product of Customer which is not a Product under this Agreement.
1.76    “Packaging Information” has the meaning set forth in Section 2.8(i)(a).
1.77    “PAI” has the meaning set forth in Section 6.5.
1.78    “Party” or “Parties” has the meaning set forth in the Background section of this Agreement.
1.79    “Pass-Through Costs” has the meaning set forth in Section 4.4.
1.80    “Patents” means patents and patent applications issued or pending anywhere in the world, together with any and all divisions, renewals, continuations and continuations-in-part thereof, and all patents granted thereon, and all reissues, re-examination certificates, certificates of invention and applications for certificates of invention, revalidations, substitutions, supplementary protection certificates, additions, utility models, and term restorations, extensions and foreign counterparts thereof.
1.81    “Permitted Recipients” has the meaning set forth in Section 10.3.

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1.82    “Person” means an individual, partnership, corporation, limited liability company, joint stock company, unincorporated organization or association, trust or joint venture, or a governmental agency or political subdivision thereof.
1.83    “PPI” has the meaning set forth in Section 4.2.
1.84    “Price” means, with respect to a Product, the price to be charged by Brammer for a Batch of Product manufactured and supplied hereunder as delivered to Customer in accordance with Section 4.1 as set forth on Appendix C, as amended from time to time.
1.85    “Process” means the processes and procedures used to manufacture a Product in accordance with the Master Batch Record, including all protocols and standard operating procedure documents referenced therein, which are provided by Customer to Brammer or developed pursuant to the DMSA.
1.86    “Process Consumables” means media, raw materials, chromatography columns, resins, filters, membranes, disposable analytical test kits, hoses, filter housings, tubing, filling needles, disposable bags, disposable glass/plastic ware, cleaning supplies and other changeover parts used during the manufacture of a Product.
1.87    “Process Performance Qualification” means the collection and evaluation of data, from the Process design stage through repeated production at final scale, which establishes scientific evidence that a manufacturing process is capable of consistently and reproducibly delivering a Product meeting Specifications, as described in the FDA’s Guidance for Industry, Process Validation: General Principles and Practices, January 2011 (Rev. 1), as amended or updated from time to time.
1.88    “Product” means Customer’s product defined in the applicable Product Addendum.
1.89    “Product Addendum” means, with respect to a Product, a written document executed by the Parties that sets forth the following information for such Product: (i) a detailed description of the Program to be conducted for such Product; (ii) the Specifications for the applicable Drug Substance, (iii) Specifications for the Drug Product, (iv) requirements for the final container closure, (v) the Packaging Information, and (vi) any other information specifically relating to such Product and/or the conduct of the Program (e.g., safety stock requirements, etc.), substantially in the form attached hereto as Appendix A.
1.90    “Product Materials” means all the materials identified in the applicable Product Addendum to be consumed (i) in the manufacture and/or testing of the Product or incorporated into the Product or packaging of the Product, including Process Consumables, packaging materials, and components needed for the manufacturing of the Product.
1.91    “Program” means, with respect to a Product, all of the manufacturing, filling, packaging, and other activities to be performed by Brammer or any of its Affiliates in connection with the manufacturing and supply of such Product to Customer pursuant to this Agreement and the applicable Product Addendum, including any mutually agreed and authorized written amendments thereto.
1.92    “Program Manager” has the meaning set forth in Section 3.7.
1.93    “Purchase Order” means a written or electronic order form submitted by Customer in accordance with the terms of this Agreement to Brammer authorizing the manufacture and supply of a Product.
1.94    “Quality Agreement” has the meaning set forth in Section 6.1.
1.95    “Recall” has the meaning set forth in Section 6.6.

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1.96    “Receiving Party” has the meaning set forth in Section 10.1.
1.97    “Regulatory Approval” means in a particular country or regulatory jurisdiction, all approvals and authorizations, including any renewals and amendments thereof, of the applicable Regulatory Authority necessary for the manufacture, packaging, marketing, storage, import, export, transport, distribution, sale and use of a pharmaceutical or biologic product in such country or jurisdiction.
1.98    “Regulatory Authority” means, in a particular country or regulatory jurisdiction, the applicable governmental authority or agency involved in granting any approvals necessary for the manufacture, marketing, importation and sale of a pharmaceutical product (such as a Product) and, to the extent required in such country or regulatory jurisdiction, pricing or reimbursement approval of such pharmaceutical product in such country or regulatory jurisdiction. For illustrative purposes and without limiting the generality of the foregoing, Regulatory Authority includes the FDA, the EMA, or any successor entity or entities thereof having or performing substantially the same function.
1.99    “Renewal Term” has the meaning set forth in Section 17.1.
1.100    “Reprocess” means introducing a Product back into, and repeating appropriate manipulation steps that are part of, the established Process.   
1.101    “Result(s)” means all in-process analytical results, materials, data obtained, and reports developed and/or generated by Brammer in performing its manufacturing and supply activities related to a Product.  Any results, materials or data obtained, developed or generated outside of the conduct of its obligations hereunder or that are not specifically related to the Product or Process will not constitute Results.  For the avoidance of doubt, documents that may be generated or used in the course of performing Brammer’s obligations with respect to a Program, but that are general to Brammer’s business and not specifically related to the Product or Process, such as designs, specifications, and SOPs in connection with the operation of any of its Facility and/or equipment, will not constitute Results.
1.102    “Retained Copies” has the meaning set forth in Section 17.4(i).
1.103    “Retention Period” has the meaning set forth in Section 2.9.
1.104    “Rework” means subjecting a Product to one or more processing steps that are different from the established Process.
1.105    “SOP” means the written standard operating procedures and methods of Brammer, as the same may be amended, in Brammer’s sole discretion, from time to time.
1.106    “Special Waste” means waste or effluent, which is required pursuant to Applicable Laws to be collected in a special container for external disposal.
1.107    “Specifications” means, with respect to a particular Product pursuant to the applicable Product Addendum, the list of tests, references to any analytical methods and appropriate acceptance criteria that are numerical limits, ranges or other criteria for tests described, that establishes a set of criteria to which such Product should conform to be considered acceptable for its intended use. The Specifications for any Product shall be jointly agreed to by the Parties as set forth in the applicable Product Addendum and may be amended or supplemented by mutual written agreement of the Parties. 
1.108    “Storage Guidelines” means, with respect to a Product, the procedures that describe the methods of preserving, monitoring and storing all Product Materials relating to such Product, under conditions as mutually agreed to in writing by Brammer and Customer and included in the applicable Product Addendum.

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1.109    “Technology” has the meaning set forth in Section 1.45 of the DMSA.
1.110    “Term” has the meaning set forth in Section 17.1.
1.111    “Territory” means, with respect to a Product, the countries in the world that are identified in the applicable Product Addendum, together with their respective territories and possessions.
1.112    “Third Party” means any party other than Customer, Brammer and their respective Affiliates.
1.113    “US” means the United States of America and its territories and possessions.
1.114    “Vendor” means any Third Party (a) that supplies any Product Materials, Process Consumables or other products or services to Brammer or its Affiliates; or (b) to which Brammer has subcontracted the performance of any of its obligations under this Agreement.
2.    Overview of Agreement.
2.1    Brammer Manufacturing and Supply Activities; Interpretation.
(i)    Agreement to Supply. During the Term, Brammer shall manufacture and supply Product to Customer for clinical trial and commercial supply purposes and for purposes of Process Performance Qualification pursuant to the provisions of this Agreement, the Quality Agreement and any applicable Product Addendum that are mutually agreed to and executed by the Parties in writing.  The terms of this Agreement shall be deemed to be incorporated into each Product Addendum that may be executed by the Parties.
(ii)    Provision of Services Pursuant to DMSA.  During the Term, Customer may request that Brammer provide certain services related to Products that are outside the scope of Brammer's manufacture and supply obligations under this Agreement, such as the conduct of Process Performance Qualification or services related to Process development in connection with a Product and the like (“Development Services”).  The Parties agree that all Development Services will be set forth in a written Work Order (as defined in Section 1.46 of the DMSA) to the DMSA, shall be considered Services (as defined in Section 1.38 of the DMSA) under the DMSA, shall be governed by all provisions of the DMSA, and shall not be governed by the terms of this Agreement.  In the event that Development Services are inadvertently included in any Product Addendum under this Agreement, the Parties agree that such Product Addendum shall automatically be deemed a Work Order under the DMSA solely with respect to such Development Services and shall be governed by the provisions of the DMSA and not this Agreement. For clarity, other than the performance of manufacturing activities to supply the Product(s) ordered by Customer hereunder following a successful Process Performance Qualification campaign, all other activities or services of Brammer shall be considered “Development Services” for purposes of this Agreement and this Section 2.1(ii).  
(iii)    Manufacture of Product under the DMSA.  Notwithstanding anything to the contrary set forth in this Agreement or the DMSA, in the event Brammer manufactures any Batch of Product under the DMSA on behalf of Customer in the Dedicated Capacity, such Batch shall count towards Customer meeting its then-current Minimum Purchase Commitment, if any, as more specifically described in Section 3.3. 
(iv)    Interpretation.  In the event of a conflict between the terms of this Agreement and the terms set forth in any Product Addendum, the terms of this Agreement shall control, except to the extent that any applicable Product Addendum expressly and specifically states an intent to supersede this Agreement on a specific matter.  Any amendment to the terms of this Agreement shall be effective for all Product Addenda, unless such amendment or any Product Addendum (with respect to such Product Addendum only) expressly and specifically states otherwise.  In the event of a conflict between the terms of this Agreement and the DMSA, 

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the terms of the DMSA shall govern with respect to the performance of the Development Services and all matters relating to intellectual property and confidentiality, and in all other cases, the terms of this Agreement shall govern.
2.2    Use of Facilities.  For each Product, Brammer shall perform all manufacturing and supply activities and all storage activities at the Facilities.  Brammer may not, without the prior written consent of Customer, move the Dedicated Capacity or the Non-Dedicated Supply Capacity to a different facility, site or location without the prior written consent of Customer, which consent will not be unreasonably withheld or delayed (it being understood and agreed that Customer may withhold consent pending satisfactory completion of a quality assurance audit and/or regulatory impact assessment of the new location or additional facility, as the case may be).  In addition, Brammer shall not implement any changes to the Facilities, including the GMP Suites, or any equipment reasonably likely to have an effect on the conduct of the manufacturing and supply activities, storage activities, the Dedicated Capacity or the Non-Dedicated Support Capacity set forth in this Agreement, or the Regulatory Approval of any Product, without Customer’s prior written approval.  Notwithstanding anything to the contrary set forth herein, in the event that any circumstances affect the entire Facility where Dedicated Capacity is located, Brammer shall prioritize reestablishing supply for Customer over customers that do not have Dedicated Capacity
2.3    GMP Suites.  Brammer shall maintain, within the Facilities, GMP manufacturing suite(s) that are exclusively reserved for Dedicated Capacity in a state ready and available for manufacture of Product in accordance with the Product Addenda, which suites are fully equipped, maintained and validated, and which include a sufficient number of qualified and trained staff dedicated to such manufacturing suite to conduct such activities (each, a “GMP Suite”), as provided in Appendix C.  The GMP Suite shall be supported by the Non-Dedicated Support Capacity at the Facilities, as more specifically agreed by the Parties including as described in regulatory filings.  In addition, any Product-specific terms and conditions specific to a GMP Suite reserved for Customer as Dedicated Capacity or used as Non-Dedicated Support Capacity shall be set forth in Appendix C.  All Non-Dedicated Capacity activities shall be conducted in the Facilities as more specifically described in Appendix C.  Brammer shall ensure that the GMP Suites and the Facilities and all equipment used in the manufacture of Products meet Applicable Laws with respect to the manufacture and supply of the Products.  Brammer shall be responsible for properly maintaining the GMP Suites, and for ensuring that all validated Processes are carried out in accordance with the terms of such Processes, all in accordance with Applicable Laws.  Brammer shall obtain and maintain during the Term of this Agreement, at its own expense, any Facility-related regulatory approvals and any other permits necessary for the manufacturing and supply activities conducted by Brammer under this Agreement, excluding obtaining Regulatory Approval for any Product and any other Product-specific approvals (for which Customer shall be responsible as Pass-Through Costs contemplated by Section 4.4).
2.4    Flexible Use of Dedicated Capacity.  During the Term of this Agreement, Customer shall have the right to use Dedicated Capacity to support Customer’s portfolio of various Products, which Brammer will not unreasonably deny or delay.  Accordingly, the Dedicated Capacity and the associated Minimum Purchase Commitment(s) (as defined in Section 3.3 and according to Appendix C) can be used by Customer in support of the supply of one or more Products in Customer’s portfolio that are manufactured by Brammer.  
2.5    Right to Cross-Reference.  Brammer hereby grants to Customer, its Affiliates and its sublicensees, with respect to a Product, a perpetual, irrevocable right to cross-reference Brammer’s regulatory submissions and Facility approvals for the purpose of obtaining and maintaining regulatory approvals (including Regulatory Approvals) with respect to each Product anywhere in the world.  Within [**] after Customer’s written request, Brammer shall deliver to Customer for filing with the FDA or any foreign Regulatory Authority designated by Customer such authorization letters as Customer reasonably deems necessary for the foregoing purpose, which shall be substantially in the form attached hereto as Appendix B, subject to such modifications as may be required by Applicable Laws; provided, however, that if Customer proposes any material modifications 

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to such form, Brammer shall be entitled to an additional [**] for review and approval of the modified form; and provided, further, that Customer shall be responsible for all costs and expenses associated with its request for such cross-reference, and for obtaining any notarization, legalization or apostille that may be required for filing any authorization letter with any foreign Regulatory Authority.  For the avoidance of doubt, Brammer shall not be required to provide directly to Customer any Brammer documents that are general to Brammer’s business, such as a Facility and equipment SOPs unless such documents are expressly requested by a relevant Regulatory Authority or are required by Applicable Laws.  Additionally, if required, at Customer’s request and cost, Brammer shall promptly provide Customer with copies of all granted Regulatory Approvals and any other permits related to the manufacture of any Product.  Customer will have the right to use any and all information contained in such approvals in connection with its own applications for Regulatory Approval and/or commercial development of the Products.
2.6    Annual Capacity.  Brammer shall supply quantities of Product consistent with the Forecasts and accepted Purchase Orders submitted by Customer in accordance with Section 3 below.  Brammer shall have GMP Suites reserved for Dedicated Capacity as provided in Appendix C and otherwise devote the GMP Suites and the Dedicated Capacity and use the Non-Dedicated Support Capacity to perform the activities in accordance with the provisions of this Agreement and any applicable Product Addendum.
2.7    Purchase of Product.  Customer and Brammer agree that: (a) the minimum supply of Products, by year will be as detailed in Appendix C; and (b) Customer and its Affiliates shall purchase from Brammer, and Brammer will be the supplier to Customer and its Affiliates, of the quantity of Products as detailed in the applicable Binding Forecast and accepted Purchase Orders submitted by Customer during the Term that will be no less than the Minimum Purchase Commitment, unless permitted pursuant to Section 3.3 or pursuant to the issuance by Brammer of an acceptance Acknowledgement in accordance with Section 3.1 of this Agreement, respectively.  Notwithstanding anything to the contrary contained herein, nothing contained in this Agreement shall be deemed to limit Customer’s right at any time to qualify a second source supplier for any Drug Substance, Drug Product or Product anywhere in the world at Customer’s sole cost.
2.8    Filling, Finishing and Packaging. Brammer shall be responsible for filling, finishing, vial labeling and primary packaging of any Product for sale in the Territory in accordance with the applicable Product Addendum, Applicable Laws, cGMP, the Quality Agreement, and the Packaging Information.  If secondary packaging is required, the Parties shall agree to negotiate the terms thereof in writing in good faith, substantially as set out below. Notwithstanding anything to the contrary contained herein, nothing contained in this Agreement shall be deemed to limit Customer’s right at any time to appoint a Third Party to conduct any filling, finishing, vial labeling or packaging activities with respect to any Drug Substance, Drug Product or Product.
(i)    Packaging.
a.    Packaging Information.  Customer shall be responsible for the design and delivery of the design of Customer’s artwork, logo, Product marks, Product labels, patient information leaflets and other information (collectively, the “Packaging Information”) for all Product labeling and packaging.  Without limiting the foregoing, Customer shall be solely responsible for all costs and expenses relating to Packaging Information.  The Packaging Information shall be consistent with Applicable Laws and the applicable BLA or Regulatory Approval.  During the term of any the Product Addendum, Customer hereby grants to Brammer a non-transferable and non-sublicensable (other than through one tier to any Affiliates and Approved Vendors performing the applicable packaging activities), royalty-free, non-exclusive license in the Territory specified in such Product Addendum to use such Packaging Information as may be required for Brammer to perform its obligations under this Agreement, which license shall immediately terminate upon the earlier to occur of the expiration or termination of such Product Addendum or this Agreement.

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b.    Legal Requirements for Packaging and Labelling.  Customer shall inform Brammer of any requirements under any Applicable Laws in the Territory relating to packaging or labeling of a Product and shall notify Brammer promptly of any changes to such requirements, so that Brammer can modify or request its Approved Vendors to modify the packaging and labeling.  Brammer shall not be responsible for any delay in the delivery of the applicable Product caused by failure of Customer to notify Brammer of any required modifications in sufficient time for Brammer or its Approved Vendor to make the modifications prior to the required delivery time.  Brammer will implement any changes to the packaging and labeling required by Customer and inform Customer of any delays in the delivery of Product caused thereby.
c.    Changes to Packaging Information.  On advance written notice to Brammer, Customer shall have the right, subject to obtaining any necessary Regulatory Approvals, to change the Packaging Information in which or with which it chooses to have Brammer deliver a Product, any such change being referred to as an “Artwork Change”; provided, however, that (i) any such change occasioned by requirements of Applicable Laws, safety considerations, or the request of any Regulatory Authority shall be implemented as soon as reasonably possible and as required by Applicable Laws, and (ii) for any other Artwork Change, Brammer will use commercially reasonable efforts to accommodate Customer’s time schedule.  In the event that Brammer implements an Artwork Change, all direct out-of-pocket costs and expenses reasonably incurred by Customer or its Affiliates (including any reasonably incurred, direct, out-of-pocket costs of or payable to an Approved Vendor) in connection with such Artwork Change shall be paid by Customer within [**] of the date of an invoice therefor.
d.    Use of the Name of Brammer.  To the extent applicable, all Packaging Information, including Packaging Information resulting from an Artwork Change, which contains the name of Brammer or its Affiliates (other than solely identifying Brammer or its Affiliates or their Approved Vendors as the manufacturer or supplier of the Product) shall be subject to the approval of Brammer.
e.    Limitations. Notwithstanding any other provision of this Agreement, all Product is supplied by Brammer to Customer hereunder solely and exclusively for sale in the Territory set forth in the applicable Product Addendum.
2.9    Record-keeping.  For each Lot of Product manufactured under a Product Addendum, Brammer will keep and maintain records, including all Results produced in the conduct of its obligations hereunder, for a period of [**] after completion of a deliverable, or such longer period as required by the Applicable Laws (the “Retention Period”). For clarity, Brammer will be entitled to retain all original documents relating to a Program and will provide to Customer an electronic and paper copy of all Batch Records, Results and other reports provided under this Agreement.  At the end of the Retention Period, such records and reports shall, at Customer’s option and expense, either be (i) delivered to Customer or to its designee, or (ii) disposed of, but only after giving Customer [**] prior written notice of Brammer’s intent to do so.
2.10    Samples of Product.  Brammer will take and retain, for such period and in such quantities as may be required by cGMP (if applicable) and the applicable Quality Agreement, samples of Product manufactured under this Agreement, including samples required by Customer (“Customer-Owned Retains”). Further, upon Customer’s written request and to the extent consistent with cGMP and Applicable Laws, Brammer will provide to Customer reasonable access to such Customer-Owned Retains or agree that Brammer will perform testing on the Customer-Owned Retains.  Customer acknowledges that Brammer may retain up to [**] units of Drug Product per Batch (at Brammer’s expense for storage) for its legal, regulatory and compliance purposes.
3.    Forecasting and Purchase Orders.
3.1    Purchase Order.  On or before the [**] day of each quarter, Customer shall submit a Purchase Order for all the new quantities of Product ordered by Customer for the immediately succeeding [**] quarters, pursuant to this Section 3, and within [**] following receipt of a Purchase Order, Brammer will issue 

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a written acknowledgement specifying whether it accepts or rejects such Purchase Order (“Acknowledgement”); provided however, that Brammer shall accept such Purchase Order so long as the Purchase Order is consistent with the Minimum Purchase Commitments and this Agreement.
3.2    Binding Forecast.  On or before the date that is [**] after the Effective Date, and on the [**] day of each quarter thereafter, Customer shall submit to Brammer a rolling [**] quarter Batch forecast of Customer’s anticipated demand of Product (each, a “Forecast”).  Subject to Customer’s Minimum Purchase Commitment described in Section 3.3 below, the first [**] quarters of any Forecast shall be binding and non-cancellable by Customer once accepted by Brammer (the “Binding Forecast”).  Purchase Orders will be placed upon submission of the Binding Forecast for any Batches that are not already on order (via one or more previously accepted Purchase Orders).  [**] of the Forecast may be adjusted in subsequent Forecasts, provided that these quarters will not be adjusted by more than +/-[**]% of their values, rounded up to the nearest Batch, in the immediately prior Forecast.  [**] of the Forecast may be adjusted, provided that such adjustment will not be by more than +/- [**]% of their values, rounded up to the nearest Batch, in the immediately prior Forecast. 
3.3    Minimum Purchase Commitment.  Following establishment of the Process for a Product pursuant to the Process Performance Qualification, Customer shall be required to purchase at least the minimum number of Batches of Product per quarter, (the “Minimum Purchase Commitment”) as specified in Appendix C.  If Customer fails to place Purchase Orders at the start of each quarter, sufficient to satisfy the Minimum Purchase Commitment, Customer shall, within [**] of receipt of invoice, pay to Brammer the Batch Pricing for all Batches of Product that would have been manufactured if Customer had placed Purchase Orders sufficient to satisfy the Minimum Purchase Commitment for the first quarter of the Binding Forecast.  Customer and Brammer shall establish, through the JSC, maximum capacity of Batches of a particular Product that can be manufactured in the Dedicated Capacity, taking into account of level-loading the demand and the demonstrated scheduling needs of the Process.
3.4    Non-Binding Forecast.  The remaining portion of each Forecast portion not associated with the Binding Forecast (the “Non-Binding Forecast”) shall be a good faith estimate on the part of Customer as to its expected needs, but shall be non-binding on either Party.
3.5    Brammer’s Cancellation of Purchase Orders. If Customer refuses or fails to timely supply Customer-Provided Materials in accordance with the applicable Product Addendum, Brammer reserves the right to cancel that part of a Purchase Order for which Customer-Provided Materials have not been provided, upon written notice to Customer, and Brammer shall have no further obligations or liability with respect to such part of a Purchase Order. Customer will be responsible for payment for such part of a Purchase Order that cannot be fulfilled due to its failure to provide Brammer with the necessary quantities of Customer-Provided Materials.  Any such cancellation of Purchase Orders shall not constitute a breach of this Agreement by Brammer.
3.6    Customer’s Cancellation of Purchase Orders. Customer may cancel any Purchase Order (in whole or in part) up until the date that is [**] prior to the delivery date specified in such Purchase Order (the “Cancellation Date”).  Customer may also modify the delivery date of a Purchase Order upon the prior written agreement of Brammer, provided that any such modification to the delivery date shall not affect any Binding Forecast.
3.7    Program Manager and Customer Representative. Brammer will appoint a Brammer representative (the “Program Manager”) to be responsible for overseeing the conduct of the manufacturing and supply activities and the completion of each Program by Brammer.  The Program Manager will coordinate performance of manufacturing and supply activities with a representative designated by Customer in writing (the “Customer Representative”), which representative will have responsibility over all matters relating to performance of the manufacturing and supply activities on behalf of Customer.  Unless otherwise mutually agreed to by the Parties, all communications between Brammer and Customer regarding the conduct of a Program under a Product Addendum will be addressed to or copied to the Program Manager and Customer Representative. 

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The Program Manager and the Customer Representative shall be named in each Purchase Order, and Brammer or Customer may, at its option, substitute, respectively, the Program Manager or the Customer Representative during the Term by providing written notice to the other Party.  The Parties will assemble a Joint Project Team (“JPT”) to be responsible for overseeing the conduct of the Programs and the primary day-to-day contact point, which will be comprised of the Program Manager, Customer Representative, and [**] additional employees of each Party.
3.8    Joint Steering Committee.  Within [**] of the Effective Date, the Parties shall establish a Joint Steering Committee (“JSC”), having the respective responsibilities set forth below in this Section 3.8.  The JSC shall be composed of an equal number of appropriate members of Customer’s and Brammer’s respective management teams having appropriate technical credentials, experience, knowledge, and decision-making authority within their respective organizations.  The role of the JSC shall be the overall oversight, review and direction of the ongoing cooperation and communication between the Parties regarding the manufacturing and supply activities under each Product Addendum and the services provided under the DMSA, including:
		
	(a)
	Meeting (i) on a [**] basis in person or by teleconference or videoconference and (ii) on an ad hoc basis as agreed between the Parties from time to time;

		
	(b)
	Monitoring the activities under each Product Addendum, including review of Forecasts, delivery of Products and services, resolution of disputes, assessment of Process improvement opportunities, and review of regulatory needs, among others; and

		
	(c)
	The JSC shall not have the power to take any action under this Agreement or the DMSA to interpret, amend or modify this Agreement or DMSA, or waive compliance therewith.  For clarity, the JSC shall replace the Project Team under the DMSA as the governing body under the DMSA.

4.    Payments.
4.1    Price Per Batch of Product.  For each Product, Customer shall purchase such Product from Brammer at the applicable Price per Batch of Product (“Batch Pricing”) in accordance with the terms of this Agreement and the applicable Product Addendum.  Customer shall pay Brammer for all other fees and expenses of Brammer owing in accordance with the terms of this Agreement.  Such fees and expenses shall be paid within [**] following receipt by Customer of Brammer’s invoice, which invoice shall be submitted to Customer by Brammer as and when Brammer has committed to such fees and expense.
4.2    Annual Price Adjustments. The Price per Batch of Product as set forth in Appendix C shall be subject to increase annually by Brammer, based on the [**] period, provided that Brammer may not increase the Price per Batch of any Product prior to [**], and provided further that the maximum Price increase shall be [**].
4.3    Capacity Access Fee.  Customer shall pay the Capacity Access Fee as provided in Appendix C attached hereto.
4.4    Pass-Through Costs. The Price per Batch of Product does not include amounts payable by Customer for (i) [**]; (ii) [**], if any; (iii) [**]; or (iv) [**]; ((i) through (iv), collectively, “Pass-Through Costs”).  Brammer will invoice Customer for all Pass-Through Costs as incurred by Brammer.  Amounts payable for Customer-Funded Equipment will include the direct cost to acquire, install and qualify the equipment, which will be procured and invoiced in accordance with an applicable Product Addendum.  An administrative fee of [**] percent ([**]%) will be added to all invoices for Pass-Through Costs excluding Customer-Funded Equipment to cover the cost of vendor qualification, vendor management and incoming quality control, inventory management and warehousing.  Customer will pay all such invoices in full within [**] of the date of such 

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invoice, unless Customer notifies Brammer in writing of a disputed invoice amount.  In the case of a disputed amount, the Parties will in good faith discuss the item and seek resolution and Customer will pay all undisputed amounts, if any, included in such invoice.  Notwithstanding anything to the contrary set forth herein, all costs and expenses relating to Brammer-Funded Equipment shall be borne solely by Brammer.
4.5    Estimates for Pass-Through Costs.  Prior to the initiation of commercial manufacturing for a Product and in the [**] before the start of each calendar year, Brammer will prepare and provide to Customer a good-faith itemized estimate (an “Estimate”) of expected costs and expenses to be incurred by Brammer for Process Consumables and services provided by or subcontracted to an Approved Vendor, as applicable, based on the Binding Forecast and the Batch Pricing.  Within [**] of receipt of each Estimate, Customer will either notify Brammer of Customer’s acceptance and agreement of such Estimate, or notify Brammer with reasonable detail of any disputed items set forth in the Estimate.  Failure to so notify Brammer within such [**] period will be deemed to be Customer’s agreement and acceptance of such Estimate.  If Customer disputes any items set forth in the Estimate within such [**] period, the Parties will discuss in good faith the disputed items and Brammer will re-issue an Estimate to Customer and the review and acceptance process set forth above will be applied to such re-issued Estimate.  Following approval of each Estimate, Brammer will proceed, in accordance with the time schedule set forth in the applicable Product Addendum, with the purchase of Process Consumables for the Binding Forecast.
4.6    Reports.  No later than the [**] after each [**], Brammer shall provide a written report to Spark indicating the value of the work performed by Brammer in the previous [**] and in strict accordance with the relevant Purchase Orders, as may be amended pursuant to this Agreement.  The calculation of the work value will be based on the [**] as commonly used in project management and not on work invoiced.  Earned value must be calculated for each identified cost driver indicated in the relevant Purchase Orders.  The format defined as look and feel of the report will be determined and agreed upon by both Parties but the content must be in accordance with the expectations stated herein.  Brammer will use its best effort to ensure that the content of the report be accurate.  Specifically, Brammer will use its best efforts to ensure that the calculations are accurate and in alignment with the relevant Purchase Orders.  Such a report will be in addition to any other report mentioned in this Agreement.
4.7    Taxes. All fees are exclusive of value-added taxes, duties, tariffs, and charges, and Customer is responsible for all such taxes, duties, tariffs, and charges payable on the exportation or importation of Products.  In addition, Customer shall be solely responsible for any taxes including, but not limited to, value-added tax or importation duties, related to Customer-Provided Materials.  Without limiting any of Brammer’s obligations hereunder, Brammer shall cooperate with and assist Customer in all aspects of the shipment, exportation, importation and delivery process in order to ensure the expeditious delivery of the Product to the designated delivery point, including assisting in obtaining any documents that may be required, provided that Customer shall reimburse Brammer for its out-of-pocket costs and expenses incurred in connection therewith as Brammer may invoice to Customer in writing, which invoices shall be payable within [**] following the date thereof.
4.8    Late payments.  Late payments of undisputed amounts under this Agreement will incur an interest charge of the lesser of [**] percent ([**]%) per month or the maximum amount permitted by Applicable Laws.  Brammer reserves the right to suspend the manufacturing and supply activities hereunder in the event of late payments of undisputed amounts after providing Customer written notice of such late payments and allowing Customer a period of [**] to pay the late amounts (any time after such period, the “Delinquency Period”), Brammer reserves the right to refuse receipt of new Customer-Provided Material for manufacture of additional Batches of Product during the Delinquency Period.  Customer will reimburse Brammer for all costs incurred in collecting any late payment of undisputed amounts, including, without limitation, reasonable attorneys’ fees.

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4.9    Payment in US Dollars. All amounts payable to Brammer under this Agreement will be paid in US Dollars, without deduction, and by authenticated and value dated Swift telegraphic transfer for any such payments made from outside the US, quoting invoice numbers of payment to the bank account identified in the applicable invoice or by such other means as Brammer will notify Customer in writing from time to time.
5.    Delivery and Acceptance Procedures.
5.1    Delivery of Product; Risk of Loss.  Brammer shall ship Product ordered by Customer to Customer by the target delivery date specified in the Purchase Order or such other date as may be agreed to in writing by the Parties from time to time.  Each shipment will contain: (i) a packing list if applicable, (ii) an invoice, (iii) the Batch Record, (iii) the Certificate of Compliance, and (v) the Certificate of Analysis (collectively, the “Batch Documentation”).  Brammer shall deliver each Lot of Product [**] (the “Delivery Site”).  Title to each Lot of Product will pass to Customer when Customer or Customer’s designated carrier takes delivery of such Lot at the Delivery Site. All risk of loss or damage to any Lot of Product will pass to Customer when Customer or Customer’s designated carrier takes delivery of such Lot at the Delivery Site, or upon release of a Lot of Product by Brammer if a Lot of Product is, at Customer’s request, stored by Brammer, unless otherwise specified by mutual written agreement of the Parties.  To the extent that Customer requests Brammer to store, pack, or distribute a Lot of Product, the Parties shall negotiate in good faith terms for such shipping, storage, packaging, and distribution services and shall set forth such terms in the applicable Product Addendum.
5.2    Failure to Take Delivery.  If Customer fails to take delivery of any Product Lot on any scheduled delivery date and prior arrangements to store the Product have not been agreed to between the Parties, Brammer shall store such Product as Customer’s agent, and Customer shall be invoiced on the first day of each month following such scheduled delivery for reasonable administration and storage costs.  For each such stored Lot of Product, Customer agrees that: (i) Customer has made a fixed commitment to purchase such Lot of Product; (ii) title and risk of loss for such Lot of Product passes to Customer; (iii) such Lot of Product shall be on a bill and hold basis; and (iv) if no delivery date is determined at the time of billing, Brammer shall have the right to ship such Lot of Product to Customer [**] after billing.
5.3    Acceptance of Product. Upon receipt of each Lot of Product, Customer will:
(i)    inspect the Product and confirm that the quantity of Product received by Customer matches the quantity of Product set forth in the Batch Documentation, and make all the necessary reserves on the delivery receipt related to any shortage in the quantity of Product;
(ii)    inform Brammer, by email to the email address set forth in the Quality Agreement, of any shortage identified through the conduct of the inspection pursuant to Section 5.3(i) within [**] from the date of delivery to Customer of such Lot of Product; and
(iii)    inform Brammer by email of any Defect within [**] from the date of delivery of such Lot of Product at the Delivery Site; provided, however, that Customer may provide notice of rejection of a Lot of Product having a Latent Defect promptly and within [**] upon identification of the Latent Defect.  In the event that a Latent Defect is identified in the Product and it is determined to be a result of a Brammer Failure, then Customer shall have the applicable remedies set forth in this Section 5.
If Customer does not notify Brammer of a shortage or Defect according to the process and timing described above, Customer will be deemed to have accepted the Lot of Product, and to have waived any rights to reject such Lot.
5.4    Lot Defects; Quarantine; Disputes.  Brammer shall not release any Lot of Product for shipment that contains a Defect or does not conform to the warranties set forth in Section 16.1, without the prior written approval of Customer.

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(i)    Quarantine.  In the event any Lot of Product contains a Defect, Brammer shall quarantine and properly tag all such Product. Brammer shall promptly submit to Customer a report detailing the nature of the Defect, including the investigation and testing done and Brammer’s recommended Disposition.
(ii)    Defects Discovered by Customer.  In the event Customer discovers that a Lot of Product contains a Defect, Brammer will work with Customer in good faith to investigate the cause of the Defect.  Customer shall be required to provide Brammer with records that demonstrate that the affected Lot of Product was maintained under proper storage conditions from the time such Lot of Product was delivered to Customer.  The ultimate Disposition of a Product containing a Defect will be the responsibility of Customer’s quality assurance department.  Brammer shall provide any additional information regarding the Defect as may reasonably be requested by Customer.
(iii)    Defects due to Customer Provided Materials.  Customer shall be solely responsible for all costs and expenses incurred in connection with any Lot of Product containing a Defect to the extent any Customer-Provided Material, including that was not incorrectly stored and handled by or on behalf of Brammer, resulted in the Defect, and for all costs and expenses to re-manufacture such Lot of Product.
5.5    Disputes.  In case of any disagreement between the Parties as to whether a Lot of Product contains a Defect exists or whether the Defect is due to a Brammer Failure, then the quality assurance representatives of the parties will attempt in good faith to resolve any such disagreement and Customer and Brammer will follow their respective SOPs to determine the conformity of a Lot of Product contains a Defect and/or the cause of any such Defect.  If the foregoing discussions do not resolve the disagreement in a reasonable time (which will not exceed [**]), then the Parties will promptly select a mutually acceptable, independent, Third Party expert with expertise in the field of gene therapy manufacturing to resolve such disagreement, provided that [**].  The determination by such Third Party expert shall be final and binding on the Parties absent manifest error [**]. For clarity, if Customer has not yet paid the Price for the Lot of Product in question, then Customer’s payment obligations with respect to such Lot of Product shall be stayed until the Third Party expert or laboratory determines that such Lot of Product contains a Defect, and, in the case following establishment of the Process for a Product pursuant to the Process Performance Qualification in accordance with this Agreement and as agreed to by the Parties, that such Defect was caused by a Brammer Failure.
5.6    Drug Substance Non-Compliance and Remedies. If a Lot of Product contains a Defect caused by a Brammer Failure as determined in accordance with Section 5.3, Brammer will at Customer’s election:
(i)    at [**] cost and expense (excluding the cost for the supply of Product Materials that must be replaced therefor) manufacture a new Lot of Drug Substance as soon as practicable, taking into account the availability of Product Materials, or as soon as reasonably possible; or
(ii)    if reasonably possible and acceptable to Customer for its purposes, Reprocess or Rework the Lot of Product, at [**] cost and expense except for the supply of any additional Product Materials that must be replaced therefor, and as soon as practicable, so that the Lot of Product can be deemed to have been manufactured in compliance with cGMP and the Process, and to conform to Specifications.
5.7    Notwithstanding the foregoing, following establishment of the Process for a Product pursuant to the Process Performance Qualification in accordance with this Agreement and as agreed to by the Parties, Brammer shall perform its obligations under Sections 5.6(i) and (ii) only if the Batch of such Product contains a Defect caused by a Brammer Failure.
(i)    Moreover, the Parties will meet to discuss, evaluate and analyze the reasons for and implications of the failure to comply with cGMP (if applicable) manufacturing Process and will decide whether to proceed with or to amend the applicable Product Addendum, or to terminate such Product Addendum.

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(ii)    The sole and exclusive remedies available to Customer with respect to the replacement, Reworking or Reprocessing of a non-conforming Lot of Drug Substance resulting from a Defect caused by a Brammer Failure are set forth in Section 5.6 and this Section 5.7; provided, however, that nothing in Section 5.6 or this Section 5.7 shall limit or otherwise restrict Customer’s other rights and remedies under this Agreement, including with respect to a Brammer breach of the terms of this Agreement.
5.8    Drug Product Non-Compliance and Remedies.  If a Lot of Drug Product contains a Defect caused by a Brammer Failure as determined in accordance with Section 5.3, Brammer will at Customer’s election:
(i)    at [**] cost and expense (excluding (a) [**] percent ([**]%) of the normal cost to manufacture Drug Substance if different Lots of Drug Substance were pooled to manufacture such Lot of Drug Product or [**] percent ([**]%) of the normal cost to manufacture Drug Substance if Batches or Lots of Product were not pooled to manufacture such Lot of Drug Product, and (b) the cost of any additional Product Materials necessary for the supply of any Drug Substance that must be replaced therefor and the cost of any other additional Product Materials necessary for manufacture of the new Lot of Drug Product) and as soon as practicable, manufacture a new Lot of Drug Product, taking into account the availability of Product Materials; or
(ii)    if reasonably possible and acceptable to Customer for its purposes, Reprocess or Rework the Lot of Drug Product, at [**] cost and expense (except for the supply of any additional Product Materials that must be replaced therefor) and as soon as practicable, so that the Lot of Drug Product can be deemed to have been manufactured in compliance with cGMP and the Process, and to conform to Specifications.
The sole and exclusive remedies available to Customer with respect to the replacement, Reworking or Reprocessing of a non-conforming Lot of Drug Product resulting from a Defect caused by a Brammer Failure are set forth in this Section 5.8; provided, however, that nothing in this Section 5.8 shall limit or otherwise restrict Customer’s other rights and remedies under this Agreement, including with respect to a Brammer breach of the terms of this Agreement.
5.9    Other Defects.  Following establishment of the Process for a Product pursuant to the Process Performance Qualification in accordance with this Agreement and as agreed to by the Parties, if a Lot of such Product contains a Defect not caused by a Brammer Failure, then Brammer will at Customer’s cost and expense:
(i)    manufacture a new Batch of Product that conforms to the Specifications as soon as practicable, taking into account the availability of Product Materials; or
(ii)    if reasonably possible and acceptable to Customer for its purposes, Reprocess or Rework the Batch and as soon as practicable, so that the Batch can be deemed to have been manufactured in compliance with cGMP and the Process, and to conform to Specifications.
5.10    Disposition of Non-Conforming Product.  The ultimate Disposition of non-conforming Product will be the responsibility of Customer’s quality assurance department.
5.11    Survival.  The provisions of Sections 5.4-5.11 shall survive termination or expiration of this Agreement, provided that, subsequent to the termination or expiration of this Agreement, Brammer may, in lieu of replacing a Lot of Product that is non-conforming due to a Brammer Failure, elect in its sole discretion to reimburse Customer for Price paid to Brammer (excluding the cost for the supply of Product Materials and Drug Substance, if needed) associated with the supply of such Lot of Product.
6.    Quality, Regulatory and Recalls.

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6.1    Quality Agreement.  Promptly following the execution of this Agreement, the Parties will negotiate and enter into a detailed document specifying the quality and regulatory procedures and responsibilities of the Parties with respect to the manufacture of Product (the “Quality Agreement”).  In the event of any conflict between the terms and provisions of this Agreement and the terms and provisions of the Quality Agreement, the terms of this Agreement will control, except with respect to matters of Product quality.
6.2    Quality Tests.  Brammer or Approved Vendor shall perform all tests required by the Specifications, the Quality Agreement, and the applicable Product Addendum (except, in each case, as may be specified in the applicable Product Addendum).  Customer shall be responsible for all costs and expenses associated with such tests.
6.3    Change Control.  Brammer shall not unreasonably refuse, or delay with respect to, any written request from Customer to make changes to the Specifications, Process, or Product Materials of a Product and re-validate as necessary, such as those required by an applicable Regulatory Authority or Applicable Laws, but no change to the Process shall be made except by an agreement in writing signed by authorized representatives of the Parties including the cost to implement agreed changes and as specified in the Quality Agreement.  This approach will also govern proposed changes that are requested by Brammer.  All costs for any and all revisions to the Process or Product Materials shall be borne by Customer and shall be mutually agreed in writing by the Parties.
6.4    Regulatory Compliance. Customer shall be solely responsible for obtaining all Regulatory Approvals for the Products, including any applications and amendments in connection therewith.  Brammer will be responsible to maintain all permits and licenses required by any Regulatory Authority with respect to the general cGMP and other non-product specific regulatory site license.  During the Term, Brammer will promptly (but in any event, with respect to information that is available at Brammer, within [**] after the date of Customer’s request, or otherwise within [**] after the date of Customer’s request) assist Customer with all regulatory matters relating to Product manufacturing, at Customer’s request and at Customer’s expense.  Any specific regulatory assistance or support needed with respect to a Product shall be set forth in the applicable Quality Agreement or Change Order.  Each Party intends and commits to cooperate to satisfy all Applicable Laws relating to Product manufacturing.  Quality and regulatory matters shall be handled in accordance with the Quality Agreement as agreed between the Parties.
6.5    Regulatory Body Inspections.  Brammer will support any Pre-Approval Inspections (“PAI”) of Brammer’s Facilities by agreed Regulatory Authorities by preparing for and hosting Regulatory Authorities, as required, and by responding to findings in a timely manner, in consultation with Customer.  Customer [**], however, Customer will not be charged for a routine, general cGMP inspection of the Facilities by any Regulatory Authority.  Brammer shall notify Customer, in accordance with the Quality Agreement, of any inspection of Brammer’s facility proposed or scheduled with the FDA or any other Regulatory Authority that relates to the Product or to general matters at the Facility that affect the Product. Customer will be allowed to have a representative present at any inspection that is specific to the Product, subject to Brammer’s confidentiality requirements with regard to other customers of Brammer. If the FDA or any other Regulatory Authority conducts an inspection at Brammer’s Facility, seizes any Product and/or Product Materials, requests a Recall or field alert be issued for any Product, or otherwise notifies Brammer of any violation or potential violation of any Applicable Laws or of any intended inspection of the Facility, Brammer shall notify Customer, in accordance with the Quality Agreement, of such, and Brammer shall take such actions as may be required under the Quality Agreement.  Brammer will provide Customer with a copy of any report or other written communication received from such Regulatory Authority relating to the Facility (to the extent it relates to or affects the development or manufacture of any Product), a Product, or the Process, within [**] after receipt, and will consult with Customer before responding to each such communication, and shall use commercially reasonable efforts to incorporate any Customer comments in such communications, provided that Brammer may reasonably redact any such reports to protect its Confidential Information (including information regarding 

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products not sold to or systems not used to manufacture Products for Customer).  Brammer will provide Customer with a copy of its final responses within [**] after any submission.  In the event that any such Regulatory Authority requests, but does not seize, a sample of a Product in connection with any such inspection, Brammer, as the case may be (i) shall promptly notify Customer of such request, (ii) if permitted by law, shall satisfy such request only after receiving Customer’s approval, such approval not to be unreasonably withheld or delayed, (iii) shall follow any reasonable procedures instructed by Customer in responding to such request and (iv) shall promptly send a sample of any Product requested by the Regulatory Authority to Customer.  Brammer shall give and permit full access to all or any of its premises at any time to any authorized representative of any Regulatory Authority in connection with its obligations hereunder and shall co-operate fully with any such representative. All information, records, or business information concerning Brammer that is disclosed or made available by Brammer to representatives of Regulatory Authorities in connection with any audit or regulatory process will be deemed to be Confidential Information of Brammer.
6.6    Recalls. In the event Brammer believes a recall, field alert, Product Lot or Batch withdrawal or field correction (“Recall”) may be necessary with respect to any Lot or Batch of Product provided under this Agreement or is contacted by a Regulatory Authority that such Recall is necessary, Brammer shall immediately notify Customer in writing.  Brammer will not act to initiate a Recall without the express prior written approval of Customer, unless otherwise required by Applicable Laws.  In the event Customer believes a Recall may be necessary with respect to any Lot of Product provided under this Agreement, Customer shall immediately notify Brammer in writing and Brammer shall provide all reasonable cooperation and assistance to Customer.  The cost and expenses of any Recall shall be borne by Customer, except if such Recall results from the provision by Brammer of Product that contains a Defect due to a Brammer Failure or that does not conform to the warranties set forth in Section 16.1, or otherwise arises from or relates to the negligence of, willful misconduct of, or failure to follow Customer’s instructions by, Brammer or any of its Affiliates.
7.    Facility Audits and Facility Visits.
7.1    Facility Audits.  Subject to Brammer’s safety procedures, access control SOPs, and confidentiality limitations, Brammer will permit up to [**] Customer representatives, not more frequently than [**] period, during the Term of this Agreement at mutually agreed upon times to audit the Facility for up to [**], as more specifically set forth in the Quality Agreement, provided, however, that Customer may conduct any additional for-cause audits at mutually agreed upon times with reasonable advance notification to Brammer.  Customer will give Brammer reasonable advanced notice of any proposed routine audit but no fewer than [**] prior notice for a for-cause audit, and identify the individuals who will be in attendance; provided that a general quality audit will require a minimum of [**] prior notice.  All routine audits will be during Brammer’s normal business hours on weekdays and conducted in a manner that does not unreasonably interfere with Brammer’s manufacturing and development activities and does not otherwise unreasonably interfere with normal business activities.  All information, records, or business information concerning Brammer that is disclosed or made available by Brammer to Customer’s employees and representatives, or otherwise obtained by such employees and representatives, in connection with any audit and does not constitute Customer Confidential Information will be deemed to be Confidential Information of Brammer.
7.2    Facility Visits.  Subject to Brammer’s safety procedures, access control SOPs, and confidentiality limitations, Brammer will permit Customer’s representatives during the Term of this Agreement, to visit the GMP Suites and Facilities in which manufacturing and supply activities are being conducted at mutually agreed upon times, to provide advice to support technology transfer and/or observe procedures and processes at mutually agreed upon times with reasonable advance notification to Brammer.  Customer will give Brammer reasonable advanced notice of any proposed visit, but no fewer than [**] prior notice and identify the individuals who will be in attendance.  All visits will be during Brammer’s normal business hours on weekdays and conducted consistent with Brammer’s person-in-plant SOPs, and in a manner that does not unreasonably 

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interfere with Brammer’s performance of manufacturing and development activities and does not otherwise unreasonably interfere with normal business activities.
8.    Product Materials.
8.1    Procurement of Product Materials.  Brammer shall order sufficient quantities of all Product Materials (except Customer-Provided Materials) to enable Brammer to manufacture and deliver Product(s) in accordance with Customer’s Binding Forecasts and accepted Purchase Orders.  If requested by Customer, Brammer will order and hold sufficient quantities of Customer-Provided Materials and Customer will pay for these Customer-Provided Materials and hold title to them.  Customer shall be responsible for excess or obsolete Product Materials (including Customer-Provided Materials) purchased by Manufacturer to the extent the excess or obsolescence is caused by any: (i) change to, or cancellation of, a firm Purchase Order, (ii) change to a Binding Forecast, (iii) without limiting this Section 8.1, change to the Specifications or the specifications of such Product Materials after such Product Materials have been purchased by Brammer based upon a Customer firm Purchase Order or a Binding Forecast, as applicable, or (iv) without limiting Section 3, with respect to any Product, reduction in the quantity of such Product as specified in a Binding Forecast relative to the quantity of such Product that was specified in any previous Binding Forecast with respect to the same time period.  Customer shall reimburse Brammer for such excess or obsolescence described in this Section 8.1 on a [**] basis within [**] following receipt of Brammer’s invoice therefor.
8.2    Excess Inventory of Product Materials.  Without limiting the foregoing, at the end of the term of each Product Addendum, as applicable, Customer will purchase any non-cancellable excess inventory of Product Materials, including any Materials used to support production for Customer, and any long lead time items (as specified in the applicable Product Addendum) previously procured by Brammer pursuant to a Binding Forecast that cannot be reasonably used by Brammer in its activities.
8.3    Responsibilities for Procurement of Product Materials; Approved Vendors. Brammer will use commercially reasonable efforts to minimize any delays or disruptions to the manufacturing schedule due to supply of Product Materials (except Customer-Provided Materials) necessary for such manufacturing consistent with the Product Addendum.  The Parties agree that Brammer is responsible for, and shall administer, the procurement of such Product Materials (except Customer-Provided Materials) in accordance with the terms herein, which responsibilities shall include: transporting, inspecting and storing the Product Materials; maintaining systems for material management; maintaining adequate supplies of Product Materials, to the extent required hereunder; and Approved Vendor and logistics management, in each case in accordance with the terms herein.  If there is a failure to perform or supply issue with an Approved Vendor multiple times within the span of [**] consecutive orders, Brammer shall so notify Customer in writing of such supply issue and the Parties shall work together in good faith to identify an Approved Vendor to replace such non-performing Approved Vendor as promptly as possible.  In addition, to the extent that there are any issues with regard to the performance or ability to perform of an Approved Vendor, Brammer shall promptly notify Customer of such issue.  The JSC shall determine a course of action with regard to improving the performance of such Approved Vendor or replacing such Approved Vendor, or if the JSC is unable to promptly agree to such course of action, Customer and Brammer shall mutually agree to a course of action with regard to such Approved Vendor.  Brammer shall promptly, actively and continuously address and manage any delay, non-performance issue or failure to perform by an Approved Vendor, regardless of whether a course of action has been determined by the JSC or the Parties, as applicable, in order to resolve such issue as soon as possible in order to minimize delay or disruption to the manufacturing and supply activities in the Dedicated Capacity and Non-Dedicated Support Capacity set forth hereunder. Brammer shall be solely responsible for all costs and expenses to the extent arising from its negligence or willful misconduct in managing Approved Vendors.
8.4    Customer-Provided Materials.  Customer will provide Brammer with sufficient amounts of the Customer-Provided Materials with which to perform the manufacture and supply of the Product 

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as set forth in the applicable Product Addendum.  Customer will ensure that all documents provided to Brammer, including those related to Customer’s Process and Customer-Provided Materials, are in English.  Customer will be responsible for translating any foreign-language document to English.
(i)    Delivery of Customer-Provided Materials; Risk of Loss.  Customer-Provided Materials will be procured and delivered by Customer to the Facility at no cost to Brammer.  Unless otherwise agreed by the Parties, Customer will deliver the Customer-Provided Material in quantities sufficient to meet the expected requirements of Product manufacturing pursuant to the applicable Product Addendum.  Customer-Provided Materials will remain the sole property of Customer at all times during the Term of this Agreement, but will remain in the possession, control and care of Brammer following delivery of such Customer-Provided Materials by Customer to the Facility. Brammer will use and store the Customer-Provided Materials with due care and in compliance with Storage Guidelines as set forth in the applicable Product Addendum.  Except for losses arising out of the negligence or willful misconduct of Brammer or any of its Affiliates, or Brammer’s negligence or willful misconduct in managing Approved Vendors, or Brammer’s failure to store or handle Customer-Provided Materials correctly or follow the Storage Guidelines, title and risk of loss or damage to such Customer-Provided Materials will at all times remain with Customer, and Brammer will have no liability to Customer for such Customer-Provided Materials.
(ii)    Responsibility for Failure of Customer-Provided Materials.  Customer shall be solely responsible for all costs and expenses to the extent arising from (a) the failure of any Customer-Provided Materials to conform to the applicable Material Specifications therefor at time of delivery to Brammer or (b) Customer’s failure to use, handle or store Customer-Provided Materials in accordance with the Material Specifications, all Applicable Laws, and the Quality Agreement.
(iii)    Material Safety Data Sheets.  Customer will provide accurate and complete Material Safety Data Sheets for all Customer-Provided Materials and for each Product.  Customer will notify Brammer of any unusual adverse health or environmental occurrence relating the Customer-Provided Materials and any Product, including, but not limited to, any claim or complaint by any Customer employee or Third Party.  
(iv)    Brammer Release Testing.  During the Term, if Customer asks Brammer to incorporate a test result into any Brammer Certificate of Analysis, Brammer shall have the ability to audit, upon reasonable written notice and during normal business hours, any site or laboratory used by Customer or its designee in connection with such release testing or result.
8.5    Import, Export, Customs.  For all Product Materials being delivered to Brammer for Customer’s account, Customer will be responsible at its sole cost and expense for satisfying all import, export and customs requirements, including U.S. Export Control Regulations, and Customer will be the importer and exporter of record (or utilize its own customs broker) for any Product Materials being imported and shipped to Brammer and for all Product Materials or Product exported to another country, in each case, for Customer’s account.
9.    Use of Approved Vendors.
9.1    Brammer reserves the right to employ Vendors from time-to-time to undertake certain activities related to this Agreement (for example, for specialty testing, etc.) upon prior written notice to Customer describing the activities to be performed and the prior written consent of Customer, such consent not to be unreasonably withheld or delayed by Customer.  All Vendors must be pre-approved by Customer in writing, such approval not to be unreasonably withheld or delayed by Customer (“Approved Vendors”).  For mutually agreed upon non-routine activities or services provided by Approved Vendors (e.g., activities or services that are developmental in nature or specific to a Product and not, for example, standard specialty testing and waste disposal), each such Approved Vendor will be bound by written confidentiality, nonuse, and quality assurance 

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obligations no less stringent than those set forth in this Agreement, as well as an assignment to Brammer of all inventions or other intellectual property arising in the course of performing such activities and services, as necessary for Brammer to comply with its obligations to Customer under this Agreement.  If a written agreement between Brammer and the Approved Vendor is required specifically for Customer’s Product or for the conduct of activities hereunder by Brammer pursuant to this Agreement, then Brammer shall name Customer as the intended third-party beneficiary of such agreement.
9.2    Subject to the foregoing, Brammer will be responsible to Customer for managing the performance of Approved Vendors.  Brammer will work together with the Approved Vendor, and Customer, if appropriate, to promptly resolve any issues or failures by the Approved Vendor.
10.    Confidential Information/Legal Proceedings/Publicity.
10.1    Term of Confidentiality Obligations.  Except as otherwise provided in this Section 10, during the Term of this Agreement and for a period of [**] after the termination or expiration of this Agreement, each Party (the “Receiving Party”) agrees that it will keep the other Party’s (the “Disclosing Party”) Confidential Information confidential and use it solely to conduct the activities contemplated and to exercise rights under this Agreement, and for no other purpose.  The foregoing notwithstanding, with respect to Confidential Information that constitutes a trade secret, the Receiving Party’s obligations under this Agreement to keep such information confidential will continue for as long as such information remains a trade secret under Applicable Laws.  Nothing in this Agreement shall limit the rights and remedies to which the Parties are entitled under the federal Defend Trade Secrets Act or any other Applicable Laws relating to trade secrets. 
10.2    Confidentiality and Non-Use Obligations.  Each Party agrees that all Confidential Information disclosed to such Party or any of such Party’s Affiliates by or on behalf of the Disclosing Party or an Affiliate of the Disclosing Party (i) will not be used by the Receiving Party or its Permitted Recipients except as authorized under this Agreement and in connection with the activities contemplated by this Agreement or in order to further the purposes of this Agreement and (ii) will be maintained in confidence by the Receiving Party and such Party’s Affiliates, with a degree of care that is not less than the Receiving Party typically exercises with respect to its own Confidential Information and in any case with not less than reasonable care.  Each Party agrees that, in the performance of its obligations under this Agreement, it will not disclose to the other Party any trade secrets except pursuant to the terms of, and procedures set forth in, the DMSA.  The Receiving Party of trade secrets disclosed thereby agrees that it will, upon request, provide to the Disclosing Party a certification that access to and use of such trade secrets is being controlled in accordance with this Agreement.  The Disclosing Party will have, at its sole expense and through a mutually agreed-upon Third Party, subject to confidentiality obligations no less restrictive than those set forth herein, the right to verify the accuracy of such certification through an audit.  Notwithstanding any other provision of this Agreement, disclosure of Confidential Information will not be prohibited to the extent required to comply with Applicable Laws, or with a valid court or administrative order, provided that the Receiving Party will (a) notify the Disclosing Party of any such disclosure requirement or request as soon as practicable; (b) cooperate with and reasonably assist the Disclosing Party (at the Disclosing Party’s cost) if the Disclosing Party seeks a protective order or other remedy in respect of any such disclosure; (c) furnish only that portion of the Confidential Information which is responsive to such requirement or request; and (d) mark any such outgoing communication as “Confidential”.
10.3    Disclosures to Permitted Recipients.  Each Party agrees that such Party and such Party’s Affiliates will provide Confidential Information received from the Disclosing Party or an Affiliate of the Disclosing Party only on a need-to-know basis and only to the Receiving Party’s employees, directors, consultants and advisors, and to the employees, directors, consultants and advisors of the Receiving Party’s Affiliates (collectively, “Permitted Recipients”), solely under conditions of confidentiality and non-use at least as stringent as the conditions imposed by this Agreement, and provided that each Party will remain responsible for any failure by its Permitted Recipients to treat such information and materials as required under Section 

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10.2.  Neither Party shall allow access to the Confidential Information of the other Party to any Permitted Recipient who does not require such access in order to accomplish the purposes of this Agreement.  Receiving Party and its Affiliates will use at least the same standard of care as it uses to protect its own most valuable confidential information, and in any case not less than reasonable care, to ensure that its Permitted Recipients do not disclose or make any unauthorized use or disclosure of the Confidential Information of the Disclosing Party.  For purposes of Section 10.2 and this Section 10.3, with respect to Customer, the purposes of this Agreement shall include the commercialization of Product.
10.4    Exceptions to Confidential Information.  Confidential Information will not include information that:
(i)    was known or used by the Receiving Party or such Party’s Affiliates prior to its date of disclosure to the Receiving Party as demonstrated by appropriate evidence and was not acquired directly or indirectly from the Disclosing Party; or
(ii)    becomes available to the Receiving Party from a Third Party, other than the Disclosing Party, that lawfully has possession of and the right to disclose such Confidential Information without the breach of any contractual, legal or fiduciary obligation to the Disclosing Party or any Third Party; or
(iii)    at the time of disclosure hereunder was generally available to the public;
(iv)    after disclosure hereunder becomes generally available to the public, except through breach of this Agreement by, or other act or omission of, the Receiving Party; or
(v)    is independently developed by or for the Receiving Party without reference to or reliance upon the Confidential Information of the Disclosing Party as demonstrated by competent evidence.
Specific aspects or details of Confidential Information will not be deemed to be within the public domain or in the possession of the Receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the Receiving Party.  Further, any combination of Confidential Information will not be considered in the public domain or in the possession of the Receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the Receiving Party unless the combination and its principles are in the public domain or in the possession of the Receiving Party.
10.5    Responsibility for Compliance with Confidentiality and Nonuse Obligations.
(i)    The Receiving Party will be responsible for any intentional misuse or misappropriation by the Receiving Party, its Affiliates, or its Permitted Recipients of the Disclosing Party’s Confidential Information.
(ii)    The Receiving Party will promptly notify the Disclosing Party in writing of the Receiving Party becoming aware of any actual or threatened disclosure, misappropriation or other violation of the Disclosing Party’s Confidential Information by any other Person.
(iii)    Cooperation.  If at any time the Disclosing Party brings, or investigates the possibility of bringing, any claim against any Person for misappropriation of trade secrets or misuse of Confidential Information, then the Receiving Party, upon the request and at the expense of the Disclosing Party, will reasonably cooperate with and assist the Disclosing Party in the investigation or pursuit of such claim, and provide the Disclosing Party with any information in the possession of the Receiving Party that may be of use to the Disclosing Party in the investigation or pursuit of such claim.

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10.6    Disclosure of Provisions of Agreement.
(i)    To the extent information regarding this Agreement is required to be disclosed by Applicable Laws or by securities exchange listing requirements, each Party shall give the other Party a reasonable opportunity to review those portions of all filings with the United States Securities and Exchange Commission (or any stock exchange, including Nasdaq, or any similar regulatory agency in any country other than the United States) describing the terms of this Agreement (including any filings of this Agreement) prior to submission of such filings, and shall give due consideration to any reasonable comments by the non-filing Party relating to such filing, including the provisions of this Agreement for which confidential treatment should be sought.
(ii)    Each Party agrees to hold as confidential the terms of this Agreement, except that (a) each Party shall have the right to disclose such terms to investors, bona fide potential investors, business partners, Customer’s sublicensee(s) of the License or Other Customer Products License, bona fide potential business partners, lenders, bona fide potential lenders, acquirers, bona fide potential acquirers, and investment bankers in connection with licensing, financing and acquisition activities, and due diligence processes related to such activities, provided that any such Third Party has entered into a written obligation with the Disclosing Party to treat such information and materials as confidential and requiring at least commercially reasonable obligations of confidentiality (and each Party will remain responsible for any failure by any of the foregoing Persons to whom a Receiving Party may disclose Confidential Information) to treat such information as required under Section 10.2 hereof.  Such Party will exercise at least a reasonable standard of care and take commercially reasonable steps to protect Confidential Information of the Disclosing Party and disclose only such portion of Confidential Information of the Disclosing Party, if at all, as is reasonably required to be disclosed.
10.7    Remedies.  The Receiving Party acknowledges that a breach by it of any of the terms of this Agreement would cause irreparable harm to the Disclosing Party for which the Disclosing Party could not be adequately compensated by money damages.  Accordingly, the Receiving Party agrees that, in addition to all other remedies available to the Disclosing Party in an Action at law, in the event of any breach or threatened breach by the Receiving Party of the terms of this Agreement, the Disclosing Party will, without the necessity of proving actual damages or posting any bond or other security, be entitled to seek temporary and permanent injunctive relief, including, but not limited to, specific performance of the terms of this Agreement.
10.8    Non-Solicitation and Non-Hire.  From the Effective Date and for a period of [**] after the termination or expiration of this Agreement, no Party will solicit an employee of another Party who is or has been directly involved in any activity to which this Agreement pertains. Notwithstanding the foregoing, nothing herein will restrict or preclude each Party’s rights to make generalized searches for employees by way of a general solicitation for employment placed in a trade journal, newspaper or website, and which is not designed to target or specifically attract the employees of the other Party.
10.9    Defend Trade Secrets Act Notice.  The Receiving Party acknowledges, and shall inform its Permitted Recipients of, the following notice required by the Defend Trade Secrets Act: An individual will not be held criminally or civilly liable under any federal or state trade secret law for the disclosure of a trade secret that is made in confidence to a federal, state, or local government official or to an attorney solely for the purpose of reporting or investigating a suspected violation of law.  Similarly, an individual will not be held criminally or civilly liable under any federal or state trade secret law for the disclosure of a trade secret that is made in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal.  An individual who files a lawsuit for retaliation by an employer for reporting a suspected violation of law may disclose the trade secret to that individual’s attorney and use the trade secret information in the court proceeding, if the individual files any document containing the trade secret under seal; and does not disclose the trade secret, except pursuant to court order.

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10.10    No Licenses. Except as expressly provided in Section 11 hereof, no right or license, either express or implied, is granted under any Intellectual Property Right or by virtue of the disclosure of Confidential Information under this Agreement, or otherwise. The Parties agree that each Party has and will retain sole and exclusive rights of ownership in and to any Confidential Information of such Party.
10.11    Acknowledgment of Prior Confidentiality Obligations.  The Parties acknowledge that Confidential Information has been provided by the Parties to each other prior to the Effective Date of this Agreement pursuant to the DMSA.  All Confidential Information (as defined in the DMSA) exchanged between the Parties under the DMSA relating to the transactions contemplated by this Agreement will be deemed Confidential Information under this Agreement and will be subject to the terms of this Agreement. All rights and obligations of Customer and Brammer with regard to Confidential Information (as defined in the DMSA) under the DMSA will be unaffected by the execution and effectiveness of this Agreement.
10.12    Data Protection. With respect to its rights and obligations under this Agreement with regard to personal data, each Party shall at all times comply with all Applicable Laws relating to the processing of personal data and privacy and shall not perform any obligation under the Agreement in such a way as to cause either Party to breach any of its obligations under such Applicable Laws.
11.    Intellectual Property.
11.1    Application of DMSA IP Provisions to this Agreement.  Notwithstanding anything to the contrary set forth herein, ownership of, and all right, title and interest in and to, all Customer Technology, New Customer Technology, Brammer Technology, and New Brammer Technology shall, as applicable to or arising from the performance of a Party of its obligations under this Agreement, be governed by Sections 9.1, 9.2 and 9.3 of the DMSA, in their entirety.
11.2    Application of DMSA IP Provisions to DMSA.  The Parties acknowledge that Section 9 of the DMSA, in its entirety, governs all intellectual property matters with regard to the conduct of Services under the DMSA, and that none of the terms and conditions set forth in this Agreement shall amend or supersede such provisions.  All rights and obligations of Customer and Brammer with regard to intellectual property matters under the DMSA will be unaffected by the execution and effectiveness of this Agreement.
11.3    Brammer IPR License. Section 9.4 of the DMSA is hereby incorporated by reference in its entirety, with all capitalized terms therein having their meaning in this Agreement, except that Other Spark Product in Section 9.4 of the DMSA means Other Customer Product as used in this Agreement.  For the avoidance of doubt, there shall be no duplication of any fees owed by Customer in connection with a Brammer IPR License under Section 9.4 of the DMSA and this Section 11.3.
11.4    Technology Transfer to Customer.  Section 9.5 of the DMSA is hereby incorporated by reference in its entirety, with all capitalized terms therein having their meaning set forth in this Agreement
11.5    Confidentiality in Patent Filings. Section 9.6 of the DMSA is hereby incorporated by reference in its entirety, with all capitalized terms therein having their meaning set forth in this Agreement.
11.6    Patent Filings. Section 9.7 of the DMSA is hereby incorporated by reference in its entirety with all capitalized terms therein having their meaning set forth in this Agreement.
11.7    Independent Contractor.  Brammer will perform the activities hereunder as an independent contractor of Customer and will have complete and exclusive control over the Facility, the equipment, and its employees and agents.  Nothing in this Agreement will constitute Brammer, or anyone furnished or used by Brammer in the performance of the activities and services hereunder, as an employee, joint ventures, partner, agent or servant of Customer.  Brammer also agrees that it will not have any rights to receive 

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any employee benefits such as health insurance and accident insurance, sick leave or vacation as are in effect generally for employees of Customer.  Neither Party will enter into any agreements or incur obligations on behalf of the other Party, nor commit the other Party in any other manner without prior written consent from a duly authorized officer or representative of such other Party.
11.8    Third Party Intellectual Property Rights.  The Parties acknowledge that successful completion of a Program under this Agreement may require a Party to obtain a license to Third Party Intellectual Property Rights.  
(i)    If Customer determines that a license to Third Party Intellectual Property Rights is required for Brammer’s use of Customer Technology or New Customer Technology or Customer-Provided Materials in performing its obligations under this Agreement, Customer will be responsible for obtaining and maintaining such license.  In the event either Party is put on notice by a Third Party of alleged infringement of such Third Party’s Intellectual Property Rights arising solely from Customer Technology or New Customer Technology or Customer-Provided Materials, as used by Brammer in performing its obligations under this Agreement, such Party will promptly inform the other Party, including furnishing a copy of such notice (or those portions of the notice directly pertaining to same).  Customer and Brammer together will promptly investigate such notice, and if deemed credible by Customer, seek to resolve the same with such Third Party in a manner that allows for the manufacture of Product.  Customer will assume the costs of resolution, including any license fees and costs associated with litigation, associated with claims of infringement of Third Party Intellectual Rights arising solely from Customer Technology or New Customer Technology.  
(ii)    If Brammer determines that a license to Third Party Intellectual Property Rights is required for Brammer’s use of Brammer IPR in performing its obligations under this Agreement, Brammer will be responsible for obtaining and maintaining such license.  In the event either Party is put on notice by a Third Party of alleged infringement of such Third Party’s Intellectual Property Rights arising solely from Brammer IPR, as used by Brammer in performing its obligations under this Agreement, such Party will promptly inform the other Party, including furnishing a copy of such notice (or those portions of the notice directly pertaining to same).  Brammer and Customer together will promptly investigate such notice, and if deemed credible by Brammer, seek to resolve the same with such Third Party in a manner that allows for the manufacture of Product.  Brammer will assume the costs of resolution, including any license fees and costs associated with litigation, associated with claims of infringement of Third Party Intellectual Rights arising solely from Brammer IPR.
12.    Insurance.
12.1    Customer Insurance.  At all times during the Term of this Agreement and at its own expense, Customer will obtain and maintain certain insurance coverage, with insurers having A.M. Best ratings of A-VII or higher. Customer shall name Brammer an additional insured with respect to: (i) general liability insurance (including liability for property damage, personal injury and contractual liability) with limits not less than $[**] per occurrence/$[**] aggregate and which may be satisfied with a combination of primary and umbrella/excess policies; (ii) Products liability insurance with limits not less than $[**] per occurrence/$[**] aggregate; and (iii) Workers’ Compensation as required by all Applicable Laws.  Additionally, Customer shall obtain and maintain Risk Property Insurance, including transit coverage, covering the Product and Product Materials.  Customer will provide Brammer with reasonable evidence of such coverage within [**] of execution of this Agreement.  If any such policy is replaced, Customer agrees to purchase tail coverage or ensure that the new policy has a retroactive date that is consistent with the start of any work under a Product Addendum and that Customer will continue to be covered on the replacement policy.  Customer will provide Brammer with at least [**] prior written notice of any material change in or cancellation of the insurance coverage.
12.2    Brammer Insurance. At all time during the Term of this Agreement and at its own expense, Brammer shall obtain and maintain certain insurance coverage, with insurers having A.M. Best ratings 

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of A-VII or higher. Brammer shall name Customer an additional insured with respect to: (i) general liability insurance (including, without limitation, product liability insurance, liability for property damage, personal injury and contractual liability) with Products at limits not less than $[**] per occurrence/$[**] aggregate; and (ii) Workers’ Compensation as required by all Applicable Laws.  Brammer will provide Customer with reasonable evidence of such coverage within [**] of execution of this Agreement.  If any such policy is replaced, Brammer agrees to purchase tail coverage or ensure that the new policy has a retroactive date that is consistent with the start of any work under a Product Addendum and that Brammer will continue to be covered on the replacement policy.  Brammer will provide Customer with at least [**] prior written notice of any change in or cancellation of the insurance coverage. Without limiting the foregoing, Brammer shall obtain and maintain insurance coverage which covers business interruption.
13.    Dispute Resolution.
13.1    Disputes.  The procedures for discussion, negotiation and mediation set forth in this Section 13 shall apply to all disputes, controversies or claims (whether arising in contract, tort or otherwise) that may arise out of or relate to, or arise under or in connection with this Agreement, or the transactions contemplated hereby, or the commercial or economic relationship of the Parties relating hereto or thereto, between or among Brammer and its Affiliates and Customer and its Affiliates. 
13.2    Dispute Escalation Procedures.  If any dispute or disagreement arises between Brammer and Customer in respect of this Agreement, they shall follow the following procedures in an attempt to resolve the dispute or disagreement:
(i)    The Party claiming that such a dispute exists shall give notice in writing to the other Party of the nature of the dispute (a “Notice of Dispute”).
(ii)    Within [**] of receipt of a Notice of Dispute, the Program Managers shall meet and use reasonable efforts to resolve the dispute.  If the Program Managers are unable to resolve the dispute within [**] of such initial meeting, the Executive Officers (or a designate of the Executive Officer) of each Party shall meet in person or by teleconference and exchange written summaries reflecting, in reasonable detail, the nature and extent of the dispute, and at this meeting, they shall use their reasonable efforts to resolve the dispute.
(iii)    If within [**] the dispute has not been resolved by the Executive Officers, or if, for any reason, the meeting described in Section 13.2(ii) has not been held within [**] of initial receipt of the Notice of Dispute, then, subject to Section 13.5, the Parties agree that either Party may initiate litigation to resolve the dispute.  THE PARTIES HERETO AGREE THAT THEY HEREBY IRREVOCABLY WAIVE AND AGREE TO CAUSE THEIR RESPECTIVE AFFILIATES TO WAIVE THE RIGHT TO TRIAL BY JURY IN ANY ACTION TO ENFORCE OR INTERPRET THE PROVISIONS OF THIS AGREEMENT.
13.3    Survival.  The provisions of this Article 13 shall survive for [**] from the date of termination or expiration of this Agreement.
13.4    Nothing in this Agreement shall limit the right of either Party to seek to obtain in any court of competent jurisdiction any equitable or interim relief or provisional remedy, including injunctive relief.  The dispute resolution of Section 13 is without prejudice to the rights of the Parties to obtain injunctive relief under Section 10.7.
13.5    Unless otherwise agreed in writing, the Parties will continue to provide services and perform activities and honor all other commitments under this Agreement during the course of dispute resolution pursuant to the provisions of Article 13, except to the extent such commitments are the subject of such dispute, controversy or claim.

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14.    Indemnification.
14.1    Customer will defend and indemnify and hold harmless Brammer and its Affiliates and each of its directors, officers, employees, representatives and agents (the “Brammer Parties”) against any and all damages awards, deficiencies, settlement amounts, defaults, assessments, fines, dues, penalties, costs, fees, liabilities, obligations and expenses, including reasonable attorneys’ fees (collectively, “Losses”) in connection with any and all charges, complaints, Actions, suits, proceedings, hearings, investigations, claims and demands of Third Parties (“Claims”) to the extent arising from or resulting from any of the following:
(i)    any breach by Customer of this Agreement or any Product Addendum;
(ii)    any failure to obtain licenses and rights to Third Party technology and/or Intellectual Property Rights as contemplated by Section 11.8;
(iii)    any negligence or willful misconduct of Customer, its employees or agents in the use, handling (after title has passed to Customer), shipment, distribution, marketing or sale of any Product;
(iv)    any injury or death to persons or damage to property resulting from the use and handling by Brammer, in accordance with the applicable Product Addendum any instructions or directions provided by Customer and this Agreement, of any Customer-Provided Material and any Product (before title has passed to Customer);
(v)    any infringement of any Patent or other Intellectual Property Right of a Third Party arising out of Brammer’s use of the Customer-Provided Material in the performance of activities and services in accordance with the terms of this Agreement or any Product Addendum; or
(vi)    any violation of Applicable Laws by a Customer Party;
provided, however, that the foregoing indemnity obligation will not apply to the extent that such Losses arise out of or result from any activities for which Brammer is obligated to indemnify a Customer Party under Section 14.2.
14.2    Brammer will indemnify, defend, and hold harmless Customer and its Affiliates and each of its directors, officers, employees, and agents (the “Customer Parties”) against any and all Losses in connection with any and all Claims to the extent arising from or resulting from any of the following:
(i)    any breach by Brammer of this Agreement or any Product Addendum; or
(ii)    any negligence or willful misconduct of Brammer or any of its Affiliates, or Brammer’s negligence, or willful misconduct or failure to follow Customer’s written instructions in managing Approved Vendors, or agents in the manufacture, storage or handling of Product prior to its delivery to Customer at the Delivery Site; or
a.    any infringement of any Patent or other Intellectual Property Right of a Third Party arising out of Brammer’s use of the Product Material in the performance of services or activities; or
b.    any violation of Applicable Laws by a Brammer Party;
provided, however, that the foregoing indemnity obligation will not apply to the extent that such Losses arise out of or result from any activities for which Customer is obligated to indemnify a Brammer Party under Section 14.1.

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14.3    Upon receipt of notice of any Claim that may give rise to a right of indemnity from the other Party hereto, the Party seeking indemnification (the “Indemnified Party”) will give prompt written notice thereof to the other Party, (the “Indemnifying Party”) of the Claim for indemnity.  Such Claim for indemnity will indicate the nature of the Claim and the basis therefor.  Promptly after a claim is made for which the Indemnified Party seeks indemnity, the Indemnified Party will permit the Indemnifying Party, at its option and expense, to assume the complete defense of such Claim, provided that, (i) the Indemnified Party will have the right to participate in the defense of any such Claim at its own cost and expense; (ii) the Indemnifying Party will conduct the defense of any such Claim with due regard for the business interests and potential related liabilities of the Indemnified Party; and (iii) the Indemnifying Party will, prior to making any settlement, consult with the Indemnified Party as to the terms of such settlement.  The Indemnifying Party will not, in defense of any such Claim, settle or consent to an adverse judgment in any such claim, demand, Action or other proceeding that adversely affects the rights or interests of any Indemnified Party or imposes additional obligations (financial or otherwise) on such Indemnified Party, without the prior express written consent of such Indemnified Party, such consent not to be unreasonably withheld, conditioned or delayed.  After notice to the Indemnified Party of the Indemnifying Party’s election to assume the defense of such Claim, the Indemnifying Party will only be liable to the Indemnified Party for such reasonable legal or other expenses subsequently incurred by the Indemnified Party in connection with the defense thereof at the request of the Indemnifying Party.  As to those Claims with respect to which the Indemnifying Party does not elect to assume control of the defense, the Indemnifying Party will be liable for all reasonable legal or other expenses incurred by the Indemnified Party in connection with the defense thereof and the Indemnified Party will afford the Indemnifying Party an opportunity to participate in such defense at the Indemnifying Party’s own cost and expense, and will not settle or otherwise dispose of any of the same without the consent of the Indemnifying Party, such consent not to be unreasonably withheld, conditioned or delayed.  If requested by the Indemnifying Party, the Indemnified Party agrees to cooperate with the Indemnifying Party and its counsel in contesting any Third Party Claim which the Indemnifying Party defends, or, if (a) appropriate and related to the Third Party Claim in question and (b) reasonable in the judgment of the Indemnifying Party, in making any counterclaim against the Person asserting the Third Party Claim, or any cross complaint against any Person.
15.    Limitations of Liability.
15.1    OTHER THAN FOR A PARTY’S GROSS NEGLIGENCE, WILLFUL MISCONDUCT OR FRAUD, OR FOR BREACH OF SECTION 10 OR 11 OF THIS AGREEMENT, OR A FAILURE OF BRAMMER TO MANUFACTURE PRODUCT IN ACCORDANCE WITH APPLICABLE LAWS (EXCEPT THAT, FOR THE PURPOSES OF THIS SECTION 15.1, GUIDANCES MEANS ONLY GUIDANCES THAT HAVE THE EFFECT OF STATUTORY LAW) RESULTING IN A MATERIAL BREACH HEREUNDER, EACH PARTY’S LIABILITY UNDER THIS AGREEMENT HOWSOEVER ARISING WILL NOT EXCEED [**] DOLLARS ($[**]).  BRAMMER ASSUMES NO LIABILITY FOR THE USE, STORAGE, DISPOSAL, MARKETING, OR SALE OF PRODUCT(S) OR FOR DEFECTS IN PRODUCT(S) RESULTING FROM CUSTOMER-PROVIDED MATERIALS.
15.2    Consequential Damages Waiver.  OTHER THAN FOR A PARTY’S GROSS NEGLIGENCE, WILLFUL MISCONDUCT OR FRAUD, OR FOR BREACH OF SECTION 10 OR 11 OF THIS AGREEMENT, OR A FAILURE OF BRAMMER TO MANUFACTURE PRODUCT IN ACCORDANCE WITH APPLICABLE LAWS (EXCEPT THAT, FOR THE PURPOSES OF THIS SECTION 15.2, GUIDANCES MEANS ONLY GUIDANCES THAT HAVE THE EFFECT OF STATUTORY LAW) RESULTING IN A MATERIAL BREACH HEREUNDER, IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL, PUNITIVE OR EXEMPLARY DAMAGES (INCLUDING, BUT NOT LIMITED TO, DAMAGES BASED UPON LOST PROFITS, BUSINESS INTERRUPTION, LOST BUSINESS, OR LOST SAVINGS) FOR ANY ACTS OR FAILURE TO ACT UNDER THIS AGREEMENT, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBLE EXISTENCE OF SUCH DAMAGES.

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16.    Representations, Warranties and Covenants.
16.1    Brammer Representations, Warranties and Covenants.  Brammer represents, warrants and covenants to Customer that:
(i)    The Facility and all equipment utilized in the manufacture and supply of Product hereunder by Brammer shall, during the Term of this Agreement, be maintained in good operating condition and shall be maintained and operated in accordance with all Applicable Laws, including cGMPs.
(ii)    Brammer shall perform all of its obligations under this Agreement in full compliance with all Applicable Laws in the Territory.  Brammer shall hold during the Term of this Agreement all licenses, permits and similar authorizations required by any Regulatory Authority in the Territory for Brammer to perform its obligations under this Agreement.
(iii)    The Lots of Product furnished by Brammer to Customer under this Agreement:
a.    shall conform to the Specifications;
b.    shall be manufactured, packaged, labeled, handled, stored and shipped in compliance with all Applicable Laws, including cGMPs, and in accordance with the Quality Agreement;
c.    shall be manufactured with Product Materials (other than Customer-Provided Materials as furnished to Brammer hereunder) that conform to the applicable specifications for such Materials;
d.    shall not contain any Product Material or Customer-Provided Materials that has not been used, handled or stored in accordance with the Specifications, Material Specifications, the Storage Guidelines, all Applicable Laws, and the Quality Agreement, provided, however, that the foregoing only applies to the use, handling, and storage of Customer-Provided Materials after such time as they have been delivered to Brammer hereunder; and
e.    shall not be adulterated or misbranded within the meaning of Sections 501 and 502, respectively, of the FD&C Act and any other Applicable Laws and shall comply with the 1913 Virus-Serum-Toxin Act, 21 U.S.C. 151-159 and 21 C.F.R. Parts 101 to 118, as amended by the 1985 Food Security Act (as applicable with respect to veterinary biologics), in each case except to the extent resulting from (i) any Customer-Provided Materials as provided to Brammer hereunder; or (ii) Customer’s specifications for the text (including any logos or other graphics) for any packaging material used in connection with Product.
(iv)    Brammer:
a.    is a limited liability company duly organized, validly existing and in good standing under the laws of the State of Delaware;
b.    has the power and authority to enter into this Agreement;
c.    has power and authority to make, deliver and perform its obligations under this Agreement and has taken all necessary Action to authorize the execution, delivery and performance of this Agreement. No consent of, authorization of, filing with or other act by or in respect of, any Regulatory Authority or any other party is or will be required in respect of Brammer in connection with the execution, delivery, performance, validity or enforceability of this Agreement. This Agreement has been duly executed and delivered on behalf of Brammer. This Agreement constitutes the legal, valid and binding obligations of Brammer enforceable against Brammer in accordance with its terms.

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(v)    Brammer and its Affiliates, subcontractors and vendors (a) have not been debarred and is not subject to a pending debarment pursuant to Section 306 of the U.S. Food, Drug and Cosmetic Act, 21 U.S.C. § 335a, and are not subject to any similar sanction of any other government authority inside or outside of the United States, and neither Brammer nor any of its Affiliates have used, in any capacity, any person who either has been debarred or subject to a pending debarment pursuant to Section 306 of the U.S. Food, Drug and Cosmetic Act, 21 U.S.C. § 335a, and are not subject to any similar sanction of any other government authority inside or outside of the United States; (b) are not disqualified by any Regulatory Authority from performing specific services, and are not subject to a pending disqualification proceeding; and (c) have not been convicted of a criminal offense related to the provision of healthcare items or services and are not subject to any such pending Action.
(vi)    The execution, delivery and performance of this Agreement by Brammer will not violate any agreement or instrument to which Brammer is a party.
16.2    Customer Representations and Warranties.  Customer represents, warrants and covenants to Brammer that:
(i)    Customer shall perform all of its obligations under this Agreement and shall comply with all Applicable Laws in the marketing, distribution and sale of each Product. Customer shall hold during the Term of this Agreement all licenses, permits and similar authorizations required by any Regulatory Authority for Customer to perform its obligations under this Agreement, and to market, distribute and sell each Product in the applicable Territory.
(ii)    The Customer-Provided Materials, as furnished to Brammer under this Agreement, shall have been used, handled and stored by Customer in conformance with the Material Specifications, Storage Guidelines, all Applicable Laws, and the Quality Agreement prior to delivery to Brammer.
(iii)    Customer’s specifications for the text (including any trademarks, logos or other graphics) for all packaging material used in connection with Product, and any such packaging material for the Product provided by Customer or its designee, shall be true and accurate in all material respects, comply with all Applicable Laws and, to its knowledge, not infringe or otherwise violate the Intellectual Property Rights of any Third Party.
(iv)    The Product as manufactured in accordance with the Master Batch Record, the Specifications and the Quality Agreement, including cGMPs, will comply with all Applicable Laws and will not infringe or otherwise violate the Intellectual Property Rights of any Third Party, provided that the foregoing shall not apply with respect to any Brammer IPR used or incorporated in the Product or the Process.
(v)    None of the Customer-Provided Materials as furnished by Customer to Brammer under this Agreement, or Customer’s specifications for the packaging material used in connection with Product shall result in any Product being adulterated or misbranded within the meaning of Sections 501 and 502, respectively, of the FD&C Act and any other Applicable Laws.
(vi)    Customer:
a.    is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware;
b.    has power and authority to conduct its business as currently being conducted and as contemplated herein; and

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c.    has power and authority to make, deliver and perform its obligations under this Agreement and has taken all necessary Action to authorize the execution, delivery and performance of this Agreement. No consent or authorization of, filing with or other act by or in respect of, any Regulatory Authority or any other party is or will be required in respect of Customer in connection with the execution, delivery, performance, validity or enforceability of this Agreement. This Agreement has been duly executed and delivered on behalf of Customer. This Agreement constitutes the legal, valid and binding obligations of Customer enforceable against Customer in accordance with its terms.
(vii)    The Customer-Provided Materials, Customer-Funded Equipment, and Customer’s Product will be provided to Brammer by Customer free of contamination by noxious or toxic agents, infectious agents (including any microbiological or viral agents of infection (e.g., bacteria, fungae, mycoplasmas, prions, and viruses)) and/or corrosive agents. 
(viii)    To the best of Customer’s knowledge, the Customer-Provided Materials and Product(s) are safe and non-hazardous for purposes of the manufacturing activities to be performed hereunder. 
(ix)    The execution, delivery and performance of this Agreement by Customer will not violate any agreement or instrument to which Customer is a party.
16.3    EXCEPT AS SET FORTH HEREIN, EACH PARTY EXPRESSLY DISCLAIMS ALL REPRESENTATIONS AND WARRANTIES, WHETHER EXPRESS OR IMPLIED BY STATUTE, CUSTOM OF THE TRADE OR OTHERWISE, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AND ANY WARRANTIES OF TITLE OR NONINFRINGEMENT.  ANY OTHER REPRESENTATIONS OR WARRANTIES MADE BY ANY PERSON OR ENTITY ON BEHALF OF A PARTY, INCLUDING EMPLOYEES OR REPRESENTATIVES OF A PARTY, THAT ARE INCONSISTENT HEREWITH, WILL BE DISREGARDED AND WILL NOT BE BINDING ON EITHER PARTY.  BRAMMER ASSUMES NO LIABILITY FOR THE MARKETING OR SALE OF PRODUCT(S) BY CUSTOMER.
17.    Term; Termination; Certain Effects of Termination; Amendment to DMSA Term.
17.1    Term. Unless earlier terminated, the term shall commence on the Effective Date and shall continue until March 31, 2026 (the “Term”).  The Term shall automatically renew for successive three (3) year terms (each a “Renewal Term”) unless Customer notifies Brammer of its intention not to renew no less than twenty-four (24) months prior to the expiration of the Term or applicable Renewal Term.
17.2    Termination by Customer.
(i)    Termination for Convenience. Customer may terminate the Agreement for convenience by delivering written notice to Brammer, provided that Customer must provide at least twenty-four (24) months prior notice that is delivered at the end of a calendar quarter and further provided that such notice of termination may not be delivered prior to December 31, 2020.  The economic consequences of termination pursuant to this Section 17.2(i) will be solely as follows: (1) Customer will pay Brammer the Capacity Access Fee during the notice period; (2) Customer will fulfill its purchase obligations pursuant to the Binding Forecast and in any case no less than the Minimum Purchase Commitment through the remaining Term; (3) Customer will purchase all Product manufactured in accordance with this Agreement prior to the effectiveness of termination;  and (4) Customer will pay for any non-cancellable payments made or otherwise due by or from Brammer with respect to Product Materials procured to fulfill Purchase Orders, Product Materials with a long lead time that were procured in accordance with the Binding Forecast, and outsourced services ordered in connection with the Purchase Orders.  For clarity, the Advanced Payment is not refundable.

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(ii)    Market Withdrawal/Clinical Failure.  This Agreement may be terminated after Launch due to market withdrawal of the Product from all licensed markets by Customer or due to the termination of clinical development by Customer by delivering written notice to Brammer, provided that Customer must provide at least twelve (12) months prior notice. The economic consequences of termination pursuant to this Section 17.2(ii) will be as follows: (a) Customer will pay Brammer the Capacity Access Fee during the notice period; (b) Customer will purchase all Product manufactured in accordance with this Agreement prior to the effectiveness of termination; and (c) Customer will pay for any non-cancellable payments made or otherwise due by or from Brammer with respect to Product Materials procured to fulfill Purchase Orders, Product Materials with a long lead time that were procured pursuant to a Binding Forecast, and outsourced services to Approved Vendors ordered in connection with the Purchase Orders, [**]. For clarity, the Advanced Payment is not refundable.
17.3    Termination by Either Party.
(i)    Termination for Material Breach.  Either Party may terminate this Agreement, Product Addendum or any Purchase Order, if the other is in material breach of this Agreement and does not remedy such breach (if such breach is capable of remedy) within [**] for monetary defaults and non-monetary defaults (or such additional time, not to exceed [**], reasonably necessary to cure such non-monetary default) after receipt by the breaching Party of written notice of such default.  The right to terminate this Agreement upon the occurrence of a material breach is in addition to such other rights and remedies which may be available to a Party under Applicable Laws.
a.    The economic consequences of termination of this Agreement by Brammer pursuant to this Section 17.3(i) will be as follows: (i) Customer will pay Brammer the Capacity Access Fee for twenty four (24) months if this notice occurs prior to the December 31, 2020, or twelve (12) months thereafter following the written notice of termination under this Section 17.3; (ii) 2) Customer will fulfill its purchase obligations pursuant to the Binding Forecast and in any case no less than the Minimum Purchase Commitment through the remaining Term; (iii) Brammer will retain all deposit under the Product Addendum; and (iv) Customer will pay for any non-cancellable payments made or otherwise due by or from Brammer with respect to Product Materials procured and outsourced services to Approved Vendors ordered prior to the effectiveness of termination that were incurred in connection with the Binding Forecast and Purchase Orders or otherwise with the consent of Customer.  For clarity, the Advanced Payment is not refundable.
b.    The economic consequences of termination of this Agreement by Customer pursuant to this Section 17.3(i) will be as follows: (a) Customer will pay Brammer for partial Batches of Product and for any completed and released Product; (b) for any non-cancellable payment made or otherwise due by or from Brammer with respect to Product Materials procured or outsourced service to Approved Vendors ordered prior to the effectiveness of termination that were incurred in connection with the Binding Forecast and Purchase Orders, or otherwise with the consent of Customer, and for the return of any Customer-Provided Materials; and (c) Brammer shall refund deposits, if any, for those Stages of the outstanding Product Addendum that have not been initiated and return any cancellable advanced payment.
(ii)    Termination by Insolvency.  Either Party will have the right to terminate this Agreement in its entirety, upon immediate written notice if the other Party (a) applies for or consents to the appointment of, or the taking of possession by, a receiver, custodian, trustee or liquidator of itself or of all or a substantial part of its property, (b) makes a general assignment for the benefit of its creditors, (c) commences a voluntary case under the bankruptcy code of any country, (d) files a petition seeking to take advantage of any Applicable Laws relating to bankruptcy, insolvency, reorganization, winding-up or composition or readjustment of debts, (e) fails to controvert in a timely and appropriate manner, or acquiesce in writing to, any petition filed against it in any involuntary case under the bankruptcy code of any country, (f) takes any corporate action for the purpose of effecting any of the foregoing, (g) has a proceeding or case commenced against it in any court 

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of competent jurisdiction, seeking (1) its liquidation, reorganization, dissolution or winding-up or the composition or readjustment of its debts, (2) the appointment of a trustee, receiver, custodian, liquidator or the like of all or any substantial part of its assets, or (3) similar relief under the bankruptcy code of any country, or an order, judgment or decree approving any of the foregoing is entered, or (h) has an order for relief against it entered in an involuntary case under the bankruptcy code of any country and, in any of (a) through (g) above, the application, assignment, commencement, filing, or corporate action continues unstayed for, and/or is not otherwise discharged or withdrawn on or before, a period of sixty (60) days.
a.    The economic consequences of termination of this Agreement by Brammer pursuant to this Section 17.3(ii) will have the same economic consequences as a termination by Customer pursuant to Section 17.2.
17.4    In addition to the foregoing, in case of expiration or termination of this Agreement for any reason, the following will apply:
(i)    The Receiving Party will promptly return to the other all data and documents in any form comprising or containing any Confidential Information of the Disclosing Party, except that the Receiving Party may retain: (a) one copy of the Disclosing Party’s Confidential Information in secure legal archives for evidentiary purposes only and (b) a copy of computer records or files containing such Confidential Information that have been created pursuant to automatic archiving or back-up procedures that cannot reasonably be deleted (collectively, “Retained Copies”), provided, however, that any such Retained Copies will be kept confidential by the Receiving Party in accordance with the terms and provisions of this Agreement for as long as the Receiving Party is in possession of the Retained Copies.
(ii)    Upon satisfaction of amounts due by Customer, Brammer will deliver to Customer at the Delivery Site any and all quantities of Product manufactured up to the effective date of expiration or termination, except that Brammer may retain up to [**] units of filled Product per Batch for Brammer’s investigational use only.
(iii)    Customer will pay Brammer the amounts set forth in this Agreement, as applicable, and any additional amounts set forth in the relevant Purchase Order.
(iv)    Upon payment of undisputed amounts due by Customer, Brammer will return, ship, or destroy Customer-Provided Materials and Product Materials procured according to the Purchase Order at Customer’s direction and sole expense, including expenses relating to shipping costs, return fees to vendors and any unreimbursed costs on any non-refundable or non-returnable items; provided that Brammer may dispose of Customer-Provided Materials in its discretion, and Customer will have no right to the same, in the event Brammer does not receive direction in accordance with this Section 17.4(iv) within [**] of termination or expiration of this Agreement.
(v)    All Customer-Funded Equipment set forth in a Program Addendum shall be transferred physically to Customer in accordance with a written plan for such transfer mutually agreed to by the JSC.
(vi)    A final Technology Transfer shall be made by Brammer to Customer or Customer’s designee within [**] after the termination or expiration of this Agreement pursuant to a written plan for such transfer mutually agreed to by the JSC.
(vii)    All Results that have not been already delivered by Brammer shall promptly be delivered by Brammer to Customer or Customer’s designee within [**] after the date of termination or expiration of this Agreement; subject that all outstanding undisputed invoices pertaining to the Results have 

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been paid. Customer shall arrange for the asset transfer of Customer-Funded Equipment within [**] at a mutually agreed to plan and time by JSC.
With the termination of this Agreement, all Purchase Orders shall terminate, unless otherwise agreed to by the Parties.  The termination of any individual Purchase Order will have no effect on the continued existence and enforceability of this Agreement or any other Purchase Order then pending. Except in the event of the expiry of the Term of this Agreement, this Agreement is deemed to continue and apply to any outstanding Purchase Order until the expiry or earlier termination of that Purchase Order.
17.5    The termination of this Agreement for any reason will not affect any accrued rights or obligations of either Party as of the effective date of such termination.  The following provisions will survive any expiration or termination of this Agreement: Sections 2.9, 5.4-5.11, 6.5, 6.6, 7, 10, 11, 13, 14, 15, 16.3, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, the provisions of the applicable Quality Agreement, and any other provision in this Agreement or its Appendices and attachments that by its nature and intent should remain valid after the expiration or termination of the Agreement.
17.6    The Parties hereby agree that notwithstanding anything to the contrary set forth herein or in the DMSA, the DMSA shall continue in full force and effect during the Term of this Agreement.  In addition, the Parties hereby agree that neither Party may terminate the DMSA pursuant to Section 14 of the DMSA prior to the termination or expiration of this Agreement.
18.    Force Majeure.  Either Party will be excused from performing its respective obligations under this Agreement, except for any obligation to make payment under a validly issued invoice, if its performance is delayed or prevented by any event beyond such Party’s reasonable control (each, a “Force Majeure Event”), including acts of God; fire; explosion; severe storms; floods; hurricanes; disease; war; terrorism; insurrection; civil strife; riots; labor dispute and/or strike; government action; contamination of the Facility not due to Brammer’s negligence, willful misconduct and/or failure to exercise commercially reasonable efforts; and unavailability of necessary components or Product Materials for which no suitable replacement is available not due to Brammer’s negligence, willful misconduct and/or failure to exercise commercially reasonable efforts, provided that such performance will be excused only to the extent of and during such disability and provided that financial inability in and of itself will not be a Force Majeure Event.  The Party affected by the Force Majeure Event will use commercially reasonable efforts to resume performance or mitigate the effects of the Force Majeure Event as quickly as practicable. Any time specified for completion of performance in the applicable Product Addendum falling due during or subsequent to the occurrence of any or such events will be automatically extended for a period of time reasonably necessary to recover from such disability.  Brammer will promptly notify Customer if, by reason of any of the events referred to herein, Brammer is unable to meet any such time for performance specified in the applicable Product Addendum.
19.    Assignment; Change of Control of Brammer.  This Agreement may not be assigned or otherwise transferred by either Party without the prior written consent of the other Party; provided, however, Customer may, without such consent, assign this Agreement (i) in connection with the transfer or sale of all or substantially all of the assets of Customer to which this Agreement relates or, in the case of Customer, a Product; (ii) in the event of the merger, reorganization or consolidation of Customer; or (iii) to an Affiliate.  Any purported assignment in violation of the preceding sentence will be void.  Any permitted assignee will assume all obligations of its assignor under this Agreement, provided, however that if either Party assigns this Agreement to an Affiliate, such Party will continue to remain obligated under this Agreement; and, further provided, that, in connection with any assignment to a Third Party described in this Section 19, the permitted assignee will assume in writing all obligations of its assignor under this Agreement.  Except for the indemnification rights under this Agreement of any Brammer Indemnified Party or Customer Indemnified Party in their respective capacities as such (a) the provisions of this Agreement are solely for the benefit of the Parties and are not intended to confer upon any Third Party (including employees of the Parties hereto) except the Parties any rights or remedies hereunder and 

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(b) there are no Third Party beneficiaries of this Agreement and this Agreement shall not provide any Third Party (including employees of the Parties hereto) with any remedy, claim, liability, reimbursement, claim of action or other right in excess of those existing without reference to this Agreement.  Notwithstanding anything to the contrary set forth herein, in the event of a Change of Control of Brammer, (a) Brammer or its successor-in-interest, as applicable, shall continue to perform all of its obligations set forth in this Agreement, including the provision of the GMP Suites, Dedicated Capacity and Non-Dedicated Support Capacity; and (b) Brammer or its successor-in-interest, as applicable, shall continue into Product Addenda in the ordinary course as contemplated by this Agreement.  For purposes of this Agreement, “Change of Control” with respect to Brammer, means (a) the acquisition of beneficial ownership, directly or indirectly, by any Third Party of securities or other voting interest of Brammer (or, if applicable, a parent of Brammer) representing a majority or more of the combined voting power of Brammer’s (or, if applicable, a parent of Brammer) then outstanding securities or other voting interests, (b) any merger, reorganization, consolidation or business combination involving Brammer (or, if applicable, a parent of Brammer) with a Third Party that results in the holders of beneficial ownership of the voting securities or other voting interests of Brammer (or, if applicable, a parent of Brammer) immediately prior to such merger, reorganization, consolidation or business combination ceasing to hold beneficial ownership of more than fifty percent (50%) of the combined voting power of the surviving entity immediately after such merger, reorganization, consolidation or business combination, or (c) any sale, lease, exchange, contribution or other transfer to a Third Party (in one transaction or a series of related transactions) of all or substantially all of the consolidated assets of Brammer to which this Agreement relates.
20.    No Implied Licenses.  No right or license under any Intellectual Property Rights owned or Controlled by a Party of either Party is granted or will be granted by implication.  All such rights or licenses are or will be granted only as expressly provided in this Agreement.
21.    Press Releases, Publicity.  The Parties agree that any initial public announcement of the execution of this Agreement will be in the form of a mutual press release to be agreed upon by the Parties; provided, that the Parties will also agree on the timing of such public announcement. After such press release is published, each Party will be entitled to make or publish any public statement consistent with the contents thereof. Except as set forth in the preceding sentence, no press release, announcement, publicity or other form of public written disclosure related to this Agreement will be permitted by either Party unless the other Party has indicated its consent to the form of the release in writing.  This Section 21 will not apply to any disclosure that is deemed necessary, in the reasonable judgment of the responsible Party, to comply with Applicable Laws or any securities exchange listing requirements.
22.    Use of Names.  Neither Party will make use of the name of the other Party in any advertising or promotional material, or otherwise, in connection with this Agreement or any related agreements, without the prior written consent of such other Party.
23.    Notices.  All notices to be given as required in the Agreement will be in writing and may be delivered by email or delivered personally or mailed either by a reputable overnight carrier with required receipt signature or certified mail, postage prepaid to the Parties at the addresses set forth below or at such other address as either Party may provide by written notice to the other Party in accordance with the provisions of this Section 23.  Such notice will be effective: (i) on the date sent, if delivered personally or by email (receipt of which is confirmed); (ii) the date after delivery if sent by overnight carrier; or (iii) on the date received if sent by certified mail.
If to Customer:
Spark Therapeutics, Inc. 
3737 Market Street, Suite 1300 
Philadelphia, PA 19104

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Attention: 
Head of Manufacturing 
General Counsel
If to Brammer:
Brammer Bio 
Attn: Mark Bamforth, President & CEO 
250 Binney St. 
Cambridge, MA 02142 
Email: [**]
With a copy to (which shall not constitute notice): [**]
24.    Choice of Law; Jurisdiction and Venue.
(i)    This Agreement and any disputes arising out of or relating to this Agreement will be governed by, construed and interpreted in accordance with the internal laws of the State of Delaware, US without regard to any choice of law principle that would require the application of the law of another jurisdiction. The parties expressly reject any application to this Agreement of (a) the United Nations Convention on Contracts for the International Sale of Goods; and (b) the 1974 Convention on the Limitation Period in the International Sale of Goods, as amended by that certain Protocol, done at Vienna on April 11, 1980.
(ii)    Each Party irrevocably submits to the exclusive jurisdiction of the United States District Court for the District of Delaware for the purposes of any suit, Action or other proceeding arising out of this Agreement.  Each Party agrees to commence any such Action, suit or proceeding in the United States District Court for the District of Delaware or if such suit, Action or other proceeding may not be brought in such court for jurisdictional reasons, in the Superior Court of the State of Delaware, Wilmington.  Each Party irrevocably and unconditionally waives any objection to the laying of venue of any such Action, suit or proceeding arising out of this Agreement in the United States District Court for the District of Delaware (or the Superior Court of the State of Delaware, Wilmington, as applicable), and hereby and thereby further irrevocably and unconditionally waives and agrees not to plead or claim in any such court that any such Action, suit or proceeding brought in any such court has been brought in an inconvenient forum.  For the avoidance of doubt, both Parties hereby irrevocably waive any right they may have to a trial by jury arising from any dispute under this Agreement.
25.    Waiver/Severability.  No waiver of any provision of this Agreement, whether by conduct or otherwise, in any one or more instances will be deemed to be or be construed as a further or continuing waiver of any such provision, or of any other provision or condition of this Agreement.  The invalidity of any portion of this Agreement will not affect the validity, force or effect of the remaining portions of this Agreement.  If it is ever held that any provision hereunder is too broad to permit enforcement of such provision to its fullest extent, such provision will be enforced to the maximum extent permitted by law.
26.    Entire Agreement; Modification/Counterparts.  This Agreement, together with the Product Addenda and Appendices attached hereto, sets forth the entire agreement between the Parties hereto with respect to the performance of the Program by Brammer for Customer and as such, supersedes all prior and contemporaneous negotiations, agreements, representations, understandings and commitments with respect thereto and will take precedence over all terms, conditions and provisions of any purchase order form or form of order acknowledgment or other document purporting to address the same subject matter, except for the DMSA.  This Agreement will not be waived, released, discharged, changed or modified in any manner except by an instrument signed by the duly authorized officers of each of the Parties hereto, which instrument will make specific reference to this Agreement and will express the plan or intention to modify same.  This Agreement 

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may be executed in one or more counterparts, each of which will be deemed an original but all of which together will constitute one and the same instrument.  For purposes of execution, facsimile signatures will be deemed originals.
27.    Financial Information.  In the event that Customer is required to capitalize the activities conducted under this Agreement or the Facility in accordance with U.S. Generally Accepted Accounting Principles and the Accounting Standards Codification 840-10 (and any applicable updates or successor accounting guidance promulgated by the Financial Accounting Standards Board), and solely for such purpose, Brammer shall cooperate with Customer and shall provide to Customer information reasonably necessary to permit accounting for this Agreement as a lease (whether operating or capital) in Customer’s financial statements, upon Customer’s reasonable request. Such information provided by Brammer shall be the Confidential Information of Brammer.
28.    Further Documents.  Each Party hereto agrees to execute such further documents and take such further steps as may be reasonably necessary or desirable to effectuate the purposes of this Agreement.
29.    Construction.  Except where the context otherwise requires, wherever used, the singular will include the plural, the plural the singular, the use of any gender will be applicable to all genders and the word “or” is used in the inclusive sense (and/or).  The headings and captions of this Agreement are for convenience of reference only and in no way define, describe, extend or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement.  The term “Agreement” as used herein will mean this Agreement, the Product Addenda, and Appendices attached hereto.  The term “including” as used herein will mean including, without limiting the generality of any description preceding such term.  The term “day” shall mean a calendar day, the term “quarter” shall mean a calendar quarter, and the term “year” shall mean a calendar year.  The language of this Agreement will be deemed to be the language mutually chosen by the Parties and no rule of strict construction will be applied against either Party hereto.  The terms “Work Order” and “Work Statement” are used interchangeably herein.
[Signature Page Follows]

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IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed as of the Effective Date by their duly authorized representatives.
	
		
	BRAMMER BIO MA, LLC
By: /s/ Mark Bamforth    
Name: Mark Bamforth 
Title: President & CEO
	SPARK THERAPEUTICS, INC.
By: /s/ Jeffrey D. Marrazzo    
Name:  Jeffrey D. Marrazzo 
Title:  Chief Executive Officer

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APPENDIX A 
FORM OF PRODUCT ADDENDUM
to Dedicated Manufacturing and Supply Agreement Dated _______________, 2018

Pursuant to the mutual agreement of the Parties, the Product Addendum shall include the following information: (i) a detailed description of the Program to be conducted for such Product; (ii) the Specifications for the applicable Drug Substance, (iii) Specifications for the Drug Product, (iv) requirements for the final container closure, (v) the Packaging Information, and (vi) any other information specifically relating to such Product and/or the conduct of the Program (e.g., safety stock requirements).

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APPENDIX B
FORM OF LETTER AUTHORIZING CROSS-REFERENCING
[Brammer Bio letterhead]
[Date]

[To be addressed to applicable Regulatory Authority holding Customer regulatory submission]

RE: Right of Reference to [identify Brammer regulatory submission]
Dear Sir/Madam:
Brammer Bio MA, LLC, the sponsor of [Brammer regulatory submission], has granted CUSTOMER and its successors and assigns, the right to reference and rely upon all information and data contained in [Brammer regulatory submission] in support of CUSTOMER [identify CUSTOMER regulatory submission].
By this letter, Brammer hereby authorizes the Food and Drug Administration [or Other Regulatory Authority] to cross-reference Brammer’s [Brammer regulatory submission] in its review of CUSTOMER [identify Customer regulatory submission] for the purpose described above.
Please contact [name and telephone number] if you have you any questions regarding this right of reference.
Sincerely,

[Brammer signatory] 
    Title:

cc: [Name, Title]
CUSTOMER ADDRESS

1 If any such letter is to be delivered to a regulatory authority other than the FDA, the Parties acknowledge that appropriate modifications to this form will be necessary. 

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APPENDIX C
DEDICATED CAPACITY AND PURCHASE OF PRODUCT 

Capacity Access Fee
In connection with performing the manufacturing and supply activities under this Agreement, Brammer will provide to Customer at Brammer’s Cambridge, MA facility, Dedicated Capacity for Customer’s exclusive access to an [**] and, when required, a [**], sized and scaled for an annual production calendar of [**], accounting for an annual shutdown of approximately [**] duration.  For clarity, the [**] shall be dedicated at [**] as required to support a campaign needing [**] and is treated as support capacity until that point.  The Parties intend that the Dedicated Capacity will be used by Brammer to carry out its obligations to fulfill Customer’s Forecast for Product (and any subsequent products in Customer’s portfolio that are supplied by Brammer) and will be supported by Brammer’s use of ancillary multi-use suites for media preparation, downstream processing and fill-finish as necessary.
The Dedicated Capacity shall be at an annual cost of [**] US Dollars (US $[**]) (the “Capacity Access Fee”), due and payable in quarterly increments of [**] US Dollars (US $[**]) on the first day of each quarter, i.e., on January 1, April 1, July 1, and October 1.  
Brammer is constructing new suites to support Customer’s supply requirements. Accordingly, the first Capacity Access Fee under this Agreement shall be due and payable by Customer on April 1, 2019. Mechanical completion of the suites is planned to be complete during [**], following which, Brammer will perform commissioning and qualification of the suites with the process equipment installed. Routine GMP manufacturing in the suites is targeted to commence no later than [**]. Brammer will be responsible for all costs associated with mechanical completion and qualification of the suites in preparation for GMP operations. If there is a requirement for Batches to be manufactured during the period in which the suites are being commissioned/qualified, and these are manufactured in other GMP suites elsewhere in the Facility, and Customer is paying the Capacity Access Fee, these Batches will be priced according to this Appendix C, and Brammer will reserve capacity elsewhere in its Facility with identical equipment to manufacture [**] Drug Substance Batches in [**] and no less than [**] Drug Substance batches in [**], provided that Customer submits Purchase Orders for the desired number of Batches for [**] by [**].
The Capacity Access Fee will be subject to adjustment for annual inflation as per the [**], or its successor index, beginning [**].

Payment Terms
In consideration for the reservation of the Dedicated Capacity and the resources being applied to establish such Dedicated Capacity, upon execution of this Agreement, Customer will make an advanced payment of four million US Dollars (US $4,000,000) (“Advanced Payment”).  This payment will be credited at the rate of [**] of the Advanced Payment (or US $[**]) for [**] quarters against each quarterly Capacity Access Fee beginning April 1, 2019, and completing with the [**] Capacity Access Fee payment.  

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Equipment For Dedicated Capacity
Brammer will procure, fund, qualify and maintain equipment for Dedicated Capacity in support of initial process transfer from Brammer’s Alachua facility and set up for [**] (for up to a maximum of [**] US Dollars (US $[**])).  Additional equipment can be procured, qualified and maintained by Brammer as Customer-Funded Equipment and invoiced to Customer as a Pass-Through Cost under a Product Addendum, as appropriate.  Any equipment funded by Customer shall be returned to Customer upon expiration or termination of this Agreement. 

Minimum Number of Batch Starts per annum

	
			
	Year
	Minimum # Batch Starts
	Maximum Capacity

	Pro-rated for 2019
	[**]
	In accordance with Section 3.3

	2020, etc.
	[**]
	 

Batch Pricing for Products with times between Batch starts in the suite between [**] and [**] in Production Bioreactor, provided that if a Product requires less time or additional time, the pricing will be pro rata based on [**]

	
		
	 
	Drug Substance Batch Price

	At Min # Batch Starts
	[**]

	After the Min # Batch Starts
	[**]

Drug Product Fill, QC Release Testing, Product Materials, Approved Vendors, and other Pass-through Costs are additional, but will not be materially different than quotes received by Customer from Brammer for Phase III or commercial manufacturing.

ActiveUS 170335185Exhibit

EXECUTION VERSION

CREDIT AGREEMENT 
 
Dated as of July 3, 2018 
 
 
 
between 
 
 
 
SPARK THERAPEUTICS, INC., 
as the Borrower, 
 
 
 
and 
 
 
 
WELLS FARGO BANK, NATIONAL ASSOCIATION, 
as the Lender 
 
 
 
 
 
 
 
 
 
 
 

TABLE OF CONTENTS
                                                                                                                                     Page

		
	ARTICLE I
	DEFINITIONS AND ACCOUNTING TERMS......................................1

		
	1.01
	Defined Terms..........................................................................................1

		
	1.02
	Other Interpretive Provisions.................................................................18

		
	1.03
	Accounting Terms..................................................................................19

		
	1.04
	Times of Day; Rates...............................................................................19

		
	1.05
	UCC Terms............................................................................................19

		
	ARTICLE II
	COMMITMENTS AND CREDIT EXTENSIONS...............................20

		
	2.01
	Term Borrowing.....................................................................................20

		
	2.02
	Borrowings, Conversions and Continuations of Term Loans................20

		
	2.03
	Prepayments21

		
	2.04
	Termination of Term Commitment.........................................................21

		
	2.05
	Repayment of Term Loans.....................................................................22

		
	2.06
	Interest and Default Rate........................................................................22

		
	2.07
	Fees........................................................................................................22

		
	2.08
	Computation of Interest and Fees..........................................................22

		
	2.09
	Payments Generally............................................................................... 23

		
	2.10
	Cash Collateral.......................................................................................23

		
	ARTICLE III
	TAXES, YIELD PROTECTION AND ILLEGALITY..........................24

		
	3.01
	Taxes..................................................................................................... 24

		
	3.02
	Illegality.................................................................................................24

		
	3.03
	Inability to Determine Rates..................................................................25

		
	3.04
	Increased Costs; Reserves on Eurodollar Rate Loans............................25

		
	3.05
	Compensation for Losses.......................................................................27

		
	3.06
	Survival................................................................................................. 27

		
	ARTICLE IV
	CONDITIONS PRECEDENT TO CREDIT EXTENSIONS.................28

		
	4.01
	Conditions of Initial Credit Extension....................................................28

		
	ARTICLE V
	REPRESENTATIONS AND WARRANTIES........................................30

		
	5.01
	Existence, Qualification and Power........................................................30

		
	5.02
	Authorization; No Contravention...........................................................30

		
	5.03
	Governmental Authorization; Other Consents.......................................30

		
	5.04
	Binding Effect........................................................................................31

		
	5.05
	No Default............................................................................................. 31

		
	5.06
	Margin Regulations; Investment Company Act.....................................31

		
	5.07
	Disclosure..............................................................................................31

		
	5.08
	Sanctions Concerns and Anti-Corruption Laws.....................................32

		
	5.09
	Subsidiaries........................................................................................... 32

		
	ARTICLE VI
	AFFIRMATIVE COVENANTS............................................................32

		
	6.01
	Financial Statements..............................................................................32

TABLE OF CONTENTS
(continued)
                                                                                                                                     Page

		
	6.02
	Certificates; Other Information..............................................................33

		
	6.03
	Notices...................................................................................................34

		
	6.04
	Preservation of Existence.......................................................................35

		
	6.05
	Compliance with Laws...........................................................................35

		
	6.06
	Inspection Rights...................................................................................36

		
	6.07
	Use of Proceeds......................................................................................36

		
	6.08
	Collateral; Further Assurances...............................................................36

		
	ARTICLE VII
	NEGATIVE COVENANTS...................................................................37

		
	7.01
	Change in Nature of Business................................................................37

		
	7.02
	Use of Proceeds......................................................................................37

		
	7.03
	Sanctions; Anti-Corruption Laws...........................................................37

		
	7.04
	Indebtedness.........................................................................................  37

		
	7.05
	Minimum Liquidity................................................................................38

		
	ARTICLE VIII
	EVENTS OF DEFAULT AND REMEDIES..........................................38

		
	8.01
	Events of Default....................................................................................38

		
	8.02
	Remedies upon Event of Default............................................................40

		
	8.03
	Application of Funds..............................................................................41

		
	ARTICLE IX
	MISCELLANEOUS..............................................................................41

		
	9.01
	Amendments, Etc...................................................................................41

		
	9.02
	Notices; Effectiveness; Electronic Communications..............................41

		
	9.03
	No Waiver; Cumulative Remedies; Enforcement..................................43

		
	9.04
	Expenses; Indemnity; Damage Waiver...................................................43

		
	9.05
	Payments Set Aside................................................................................44

		
	9.06
	Successors and Assigns..........................................................................45

		
	9.07
	Treatment of Certain Information; Confidentiality................................46

		
	9.08
	Right of Setoff........................................................................................47

		
	9.09
	Interest Rate Limitation.........................................................................47

		
	9.10
	Counterparts; Integration; Effectiveness................................................47

		
	9.11
	Survival of Representations and Warranties..........................................48

		
	9.12
	Severability............................................................................................48

		
	9.13
	Governing Law; Jurisdiction; Etc..........................................................48

		
	9.14
	Waiver of Jury Trial................................................................................50

		
	9.15
	No Advisory or Fiduciary Responsibility...............................................50

		
	9.16
	Electronic Execution..............................................................................50

		
	9.17
	USA PATRIOT Act Notice.....................................................................51

ii    

SCHEDULES
1.01(a)    Lender’s Office, Certain Addresses for Notices
5.01    Borrower’s Information 
5.09    Subsidiaries
7.04    Existing Indebtedness 

EXHIBITS
Form of

A    Financial Statement Certificate 
B    Loan Notice
C    Notice of Loan Prepayment

CREDIT AGREEMENT
This CREDIT AGREEMENT is entered into as of July 3, 2018, between SPARK THERAPEUTICS, INC., a Delaware corporation (the “Borrower”), and WELLS FARGO BANK, NATIONAL ASSOCIATION, (the “Lender”).
PRELIMINARY STATEMENTS:
WHEREAS, the Borrower has requested that the Lender make a term loan to the Borrower in an aggregate principal amount of $50,000,000.
WHEREAS, the Lender has agreed to make such term loan to the Borrower on the terms and subject to the conditions set forth herein.
NOW THEREFORE, in consideration of the mutual covenants and agreements herein contained, the parties hereto covenant and agree as follows:
ARTICLE I
 
DEFINITIONS AND ACCOUNTING TERMS
1.01    Defined Terms.
As used in this Agreement, the following terms shall have the meanings set forth below:
“Act” has the meaning specified in Section 9.17.
“Additional Secured Obligations” means (a) all obligations arising under Secured Cash Management Agreements and Secured Hedge Agreements and (b) all reasonable documented and out-of-pocket costs and expenses incurred in connection with enforcement and collection of the foregoing, including the reasonable documented and out-of-pocket fees, charges and disbursements of counsel, in each case whether direct or indirect (including those acquired by assumption), absolute or contingent, due or to become due, now existing or hereafter arising and including interest and fees that accrue after the commencement by or against the Borrower of any proceeding under any Debtor Relief Laws naming such Person as the debtor in such proceeding, regardless of whether such interest and fees are allowed claims in such proceeding. 
“Affiliate” means, with respect to a specified Person, another Person that directly, or indirectly through one or more intermediaries, Controls or is Controlled by or is under common Control with the Person specified.
“Agreement” means this Credit Agreement, as amended, amended and restated, supplemented or otherwise modified from time to time.
“Applicable Rate” means a rate per annum equal to (a) in the case of any Eurodollar Rate Loan, 0.65% and (b) in the case of any Base Rate Loan, 0.00 %.

“Approved Cash Collateral” means cash, certificates of deposit, or (solely to the extent agreed to by the Lender and the Borrower pursuant to Section 2.10(b)), other credit support acceptable to the Lender, in each case, which is subject to a first priority, perfected security interest in favor of the Lender.
 “Approved Fund” means any Fund that is administered or managed by (a) the Lender, (b) an Affiliate of the Lender or (c) an entity or an Affiliate of an entity that administers or manages the Lender.
“Assignee Lender” has the meaning specified in Section 9.06.
“Attributable Indebtedness” means, on any date, (a) in respect of any Capitalized Lease of any Person, the capitalized amount thereof that would appear on a balance sheet of such Person prepared as of such date in accordance with GAAP, and (b) in respect of any Synthetic Lease Obligation, the capitalized amount of the remaining lease or similar payments under the relevant lease or other applicable agreement or instrument that would appear on a balance sheet of such Person prepared as of such date in accordance with GAAP if such lease or other applicable agreement or instrument were accounted for as a Capitalized Lease.
“Audited Financial Statements” means the audited Consolidated balance sheet of the Borrower and its Subsidiaries for the fiscal year ended December 31, 2017, and the related Consolidated statements of income (loss) or operations, stockholders’ equity and cash flows for such fiscal year of the Borrower and its Subsidiaries, including the notes thereto.
“Bankruptcy Code” means Title 11 of the United States Code, as amended from time to time. 
“Base Rate” means for any day a fluctuating rate of interest per annum equal to the highest of (a) the Federal Funds Rate plus one-half of one percent (0.50%), (b) the rate of interest in effect for such day as publicly announced from time to time by Wells Fargo as its “prime rate,” and (c) the Eurodollar Rate plus one percent (1.00%); and if the Base Rate shall be less than zero, such rate shall be deemed zero for purposes of this Agreement.  The “prime rate” is a rate set by Wells Fargo based upon various factors including Wells Fargo’s costs and desired return, general economic conditions and other factors, and is used as a reference point for pricing some loans, which may be priced at, above, or below such announced rate.  Any change in such prime rate announced by Wells Fargo shall take effect at the opening of business on the day specified in the public announcement of such change.
“Base Rate Loan” means a Term Loan that bears interest based on the Base Rate.
“Borrower” has the meaning specified in the introductory paragraph hereto.
“Business Day” means any day other than a Saturday, Sunday or other day on which commercial banks are authorized to close under the Laws of, or are in fact closed in, the state where the Lender’s Office is located and, if such day relates to any Eurodollar Rate Loan, means any such day that is also a London Banking Day.

2    

“Capitalized Leases” means all leases that have been or should be, in accordance with GAAP, recorded as capitalized leases.
“Cash Equivalents” means, collectively, (a) marketable direct obligations issued or unconditionally guaranteed by the United States or any agency thereof maturing within one (1) year from the date of acquisition thereof, (b) corporate debt securities maturing no more than one (1) year from the date of creation thereof with a short-term rating of A1/P1 or higher from S&P or Moody’s, respectively, (c) certificates of deposit maturing no more than one (1) year from the date of creation thereof issued by commercial banks incorporated under the laws of the United States, each having combined capital, surplus and undivided profits of not less than $500,000,000 and having a rating of “A” or better by a nationally recognized rating agency; provided that the aggregate amount invested in such certificates of deposit shall not at any time exceed $5,000,000 for any one such certificate of deposit and $10,000,000 for any one such bank unless such certificate of deposit constitutes Approved Cash Collateral, (d) time deposits maturing no more than thirty (30) days from the date of creation thereof with commercial banks or savings banks or savings and loan associations each having membership either in the FDIC or the deposits of which are insured by the FDIC and in amounts not exceeding the maximum amounts of insurance thereunder, or (e) investments, classified in accordance with GAAP as current assets of the Borrower or any of its Subsidiaries, in money market investment programs registered under the Investment Company Act of 1940, which are administered by financial institutions in funds that are rated AAA or Aaa from S&P or Moody’s, respectively.
“Cash Collateral” has the meaning assigned to such term in the Security Agreement.
“Cash Collateralize” means, to pledge and deposit with or deliver to the Lender Cash Collateral (including, without limitation, Approved Cash Collateral) in accordance with Section 2.10 and the provisions of the Security Agreement, as collateral security for the Secured Obligations.
“Cash Collateral Account” has the meaning assigned to such term in the Security Agreement.
“Cash Management Agreement” means any agreement to provide treasury or cash management services, including deposit accounts, overnight draft, credit cards, debit cards, p-cards (including purchasing cards and commercial cards), funds transfer, automated clearinghouse, zero balance accounts, returned check concentration, controlled disbursement services, lockbox, cash pooling, overdraft, account reconciliation and reporting and trade finance services and other cash management services.
“Change in Law” means the occurrence, after the Closing Date, of any of the following:  (a) the adoption or taking effect of any law, rule, regulation or treaty, (b) any change in any law, rule, regulation or treaty or in the administration, interpretation, implementation or application thereof by any Governmental Authority or (c) the making or issuance of any request, rule, guideline or directive (whether or not having the force of law) by any Governmental Authority; provided that notwithstanding anything herein to the contrary, (i) the Dodd-Frank Wall Street Reform and Consumer Protection Act and all requests, rules, guidelines or directives thereunder or issued in connection therewith and (ii) all requests, rules, guidelines or directives promulgated by the Bank for International Settlements, the Basel Committee on Banking Supervision (or any successor or 

3    

similar authority) or the United States or foreign regulatory authorities, in each case pursuant to Basel III, shall in each case be deemed to be a “Change in Law”, regardless of the date enacted, adopted or issued.
“Change of Control” means an event or series of events by which:
(a)    any “person” or “group” (as such terms are used in Sections 13(d) and 14(d) of the Exchange Act, but excluding any employee benefit plan of such person or its subsidiaries, any person or entity acting in its capacity as trustee, agent or other fiduciary or administrator of any such plan) becomes the “beneficial owner” (as defined in Rules 13d-3 and 13d-5 under the Exchange Act, except that a person or group shall be deemed to have “beneficial ownership” of all securities that such person or group has the right to acquire, whether such right is exercisable immediately or only after the passage of time (such right, an “option right”)), directly or indirectly, of fifty (50%) or more of the Equity Interests of Borrower entitled to vote for members of the board of directors or equivalent governing body of the Borrower on a fully-diluted basis (and taking into account all such securities that such “person” or “group” has the right to acquire pursuant to any option right); or
(b)    during any period of twelve (12) consecutive months, a majority of the members of the board of directors or other equivalent governing body of the Borrower cease to be composed of individuals (i) who were members of that board or equivalent governing body on the first day of such period, (ii) whose election or nomination to that board or equivalent governing body was approved by individuals referred to in clause (i) above constituting at the time of such election or nomination at least a majority of that board or equivalent governing body or (iii) whose election or nomination to that board or other equivalent governing body was approved by individuals referred to in clauses (i) and (ii) above constituting at the time of such election or nomination at least a majority of that board or equivalent governing body.
 “Closing Date” means the date hereof.
“Code” means the Internal Revenue Code of 1986.
“Collateral” has the meaning assigned to such term in the Security Agreement.
“Collateral Documents” means, collectively, the Security Agreement and each of the other agreements, instruments or documents that creates or purports to create a Lien on any Collateral in favor of the Lender for the benefit of the Secured Parties.
“Commodity Exchange Act” means the Commodity Exchange Act (7 U.S.C. § 1 et seq.), as amended from time to time, and any successor statute.
“Consolidated” means, when used with reference to financial statements or financial statement items of the Borrower and its Subsidiaries or any other Person, such statements or items on a consolidated basis in accordance with the consolidation principles of GAAP.

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“Consolidated Senior Indebtedness” means, as of any date of determination with respect to the Borrower and its Subsidiaries on a Consolidated basis without duplication, the sum of (a) all Indebtedness of the Borrower and its Subsidiaries minus (b) all Subordinated Indebtedness of the Borrower and its Subsidiaries.
“Contractual Obligation” means, as to any Person, any provision of any security issued by such Person or of any agreement, instrument or other undertaking to which such Person is a party or by which it or any of its property is bound.
“Control” means the possession, directly or indirectly, of the power to direct or cause the direction of the management or policies of a Person, whether through the ability to exercise voting power, by contract or otherwise.  “Controlling” and “Controlled” have meanings correlative thereto. 
“Debtor Relief Laws” means the Bankruptcy Code, and all other liquidation, conservatorship, bankruptcy, assignment for the benefit of creditors, moratorium, rearrangement, receivership, insolvency, reorganization, or similar debtor relief Laws of the United States or other applicable jurisdictions from time to time in effect.
“Default” means any event or condition that constitutes an Event of Default or that, with the giving of any notice, the passage of time, or both, would be an Event of Default.
“Default Rate” means (a) with respect to any past due Obligation for which a rate is specified, a rate per annum equal to two percent (2%) in excess of the rate otherwise applicable thereto and (b) with respect to any past due Obligation for which a rate is not specified or available, a rate per annum equal to the Base Rate plus the Applicable Rate for Base Rate Loans plus two percent (2%), in each case, to the fullest extent permitted by applicable Law.
“Designated Account” has the meaning specified in Section 2.09(b).
“Designated Jurisdiction” means any country or territory to the extent that such country or territory is the subject of any Sanction.
“Disqualified Equity Interests” means any Equity Interests that, by their terms (or by the terms of any security or other Equity Interest into which they are convertible or for which they are exchangeable) or upon the happening of any event or condition, (a) mature or are mandatorily redeemable (other than solely for Qualified Equity Interests), pursuant to a sinking fund obligation or otherwise (except as a result of a change of control or asset sale so long as any rights of the holders thereof upon the occurrence of a change of control or asset sale event shall be subject to the prior repayment in full of the Loans and all other Obligations that are accrued and payable), (b) are redeemable at the option of the holder thereof (other than solely for Qualified Equity Interests) (except as a result of a change of control or asset sale so long as any rights of the holders thereof upon the occurrence of a change of control or asset sale event shall be subject to the prior repayment in full of the Loans and all other Obligations that are accrued and payable), in whole or in part, (c) provide for the scheduled payment of dividends in cash or (d) are or become convertible into or exchangeable for Indebtedness or any other Equity Interests that would constitute Disqualified 

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Equity Interests, in each case under any of clauses (a) through (d), prior to the date that is 91 days after the Maturity Date.
“Dollar” and “$” mean lawful money of the United States.
“Environmental Laws” means any and all federal, state, local, and foreign statutes, laws, regulations, ordinances, rules, judgments, orders, decrees, permits, concessions, grants, franchises, licenses, agreements or governmental restrictions relating to pollution and the protection of the environment or the release of any Hazardous Materials into the environment, including those related to hazardous substances or wastes, air emissions and discharges to waste or public systems.
“Environmental Liability” means any liability, contingent or otherwise (including any liability for damages, costs of environmental remediation, fines, penalties or indemnities), of the Borrower or any of its Subsidiaries resulting from or based upon (a) violation of any Environmental Law, (b) the generation, use, handling, transportation, storage, treatment or disposal of any Hazardous Materials, (c) exposure to any Hazardous Materials, (d) the release or threatened release of any Hazardous Materials into the environment or (e) any contract or agreement pursuant to which liability is assumed or imposed with respect to any of the foregoing.
“Equity Interests” means, with respect to any Person, all of the shares of capital stock of (or other ownership or profit interests in) such Person, all of the warrants, options or other rights for the purchase or acquisition from such Person of shares of capital stock of (or other ownership or profit interests in) such Person, all of the securities convertible into or exchangeable for shares of capital stock of (or other ownership or profit interests in) such Person or warrants, rights or options for the purchase or acquisition from such Person of such shares (or such other interests), and all of the other ownership or profit interests in such Person (including partnership, member or trust interests therein), whether voting or nonvoting, and whether or not such shares, warrants, options, rights or other interests are outstanding on any date of determination.
 “ERISA” means the Employee Retirement Income Security Act of 1974, as amended from time to time.
“ERISA Affiliate” means any trade or business (whether or not incorporated) under common control with the Borrower within the meaning of Section 414(b) or (c) of the Code (and Sections 414(m) and (o) of the Code for purposes of provisions relating to Section 412 of the Code).
“ERISA Event” means (a) a Reportable Event with respect to a Pension Plan; (b) the withdrawal of the Borrower or any ERISA Affiliate from a Pension Plan subject to Section 4063 of ERISA during a plan year in which such entity was a “substantial employer” as defined in Section 4001(a)(2) of ERISA or a cessation of operations that is treated as such a withdrawal under Section 4062(e) of ERISA; (c) a complete or partial withdrawal by the Borrower or any ERISA Affiliate from a Multiemployer Plan or notification that a Multiemployer Plan is in reorganization; (d) the filing of a notice of intent to terminate a Pension Plan or the treatment of a Pension Plan amendment as a termination under Section 4041 or 4041A of ERISA; (e) the institution by the PBGC of proceedings to terminate a Pension Plan; (f) any event or condition which constitutes grounds under Section 4042 of ERISA for the termination of, or the appointment of a trustee to 

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administer, any Pension Plan; (g) the determination that any Pension Plan is considered an at-risk plan or a plan in endangered or critical status within the meaning of Sections 430, 431 and 432 of the Code or Sections 303, 304 and 305 of ERISA; (h) the imposition of any liability under Title IV of ERISA, other than for PBGC premiums due but not delinquent under Section 4007 of ERISA, upon  the Borrower or any ERISA Affiliate; or (i)  the failure by the Borrower or any ERISA Affiliate to make any required contribution to a Multiemployer Plan.
“Eurodollar Rate” means:
(a)    for any Interest Period with respect to a Eurodollar Rate Loan, the rate per annum equal to the London Interbank Offered Rate (“LIBOR”), or a comparable or successor rate which rate is approved by the Lender, as published on the applicable Bloomberg screen page (or such other commercially available source providing such quotations as may be designated by the Lender from time to time) (in such case, the “LIBOR Rate”) at or about 11:00 a.m., London time, two (2) Business Days prior to the commencement of such Interest Period, for Dollar deposits (for delivery on the first day of such Interest Period) with a term equivalent to such Interest Period; and
(b)    for any interest calculation with respect to a Base Rate Loan on any date, the rate per annum equal to the LIBOR Rate, at or about 11:00 a.m., London time, two (2) Business Days prior to such date for Dollar deposits with a term of one (1) month commencing that day;
provided that (i) to the extent a comparable or successor rate is approved by the Lender in connection herewith, the approved rate shall be applied in a manner consistent with market practice; provided, further that to the extent such market practice is not administratively feasible for the Lender, such approved rate shall be applied in a manner as otherwise reasonably determined by the Lender and (ii) if the Eurodollar Rate shall be less than zero, such rate shall be deemed zero for purposes of this Agreement.
“Eurodollar Rate Loan” means a Term Loan that bears interest at a rate based on clause (a) of the definition of “Eurodollar Rate.”
“Event of Default” has the meaning specified in Section 8.01.
“Exchange Act” means the Securities Exchange Act of 1934, as amended from time to time.
 “Excluded Taxes” means any of the following taxes imposed on or with respect to a Lender or required to be withheld or deducted from a payment to a Lender, (a) taxes imposed on or measured by net income (however denominated) or that are franchise taxes or branch profits taxes as a result of a present or former connection between such Lender and the jurisdiction imposing such tax (other than connections arising from such Lender having executed, delivered, become a party to, performed its obligations under, received payments under, received or perfected a security interest under, engaged in any other transaction pursuant to or enforced any Loan Document, or sold or assigned an interest in any Loan or Loan Document), (b) in the case of a Lender, United States federal withholding taxes imposed on amounts payable to or for the account of such Lender with respect 

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to an applicable interest in a Loan pursuant to a law in effect on the date on which (i) such Lender acquires such interest in the Loan, or (ii) such Lender changes its lending office, except in each case to the extent that amounts with respect to such taxes were payable either to such Lender's assignor immediately before such Lender became a party hereto or to such Lender immediately before it changed its lending office, (c) in the case of any Lender that is entitled to an exemption from or reduction of withholding tax with respect to payments made under any Loan Document, any tax attributable to the failure of such Lender to deliver to the Borrower, at the time or times reasonably requested by the Borrower, such properly completed and executed documentation reasonably requested by the Borrower as will permit such payments to be made without withholding or at a reduced rate of withholding, and (d) any amended or successor version of Sections 1471 through 1474 of the Code that is substantively comparable and not materially more onerous to comply with, any future regulations or official interpretations thereof, any future agreement entered into pursuant to Section 1471(b)(1) of the Code, and any future “intergovernmental agreements” with respect to the foregoing.
“Facility Termination Date” means the date as of which all of the following shall have occurred:  (a) the Term Commitment has terminated, and (b) all Secured Obligations have been paid in full (other than Unasserted Obligations).
“FASB ASC” means the Accounting Standards Codification of the Financial Accounting Standards Board.
“FDA” means the United States Food and Drug Administration, or any successor Governmental Authority performing a similar function.
“FDIC” means the Federal Deposit Insurance Corporation.
“Federal Funds Rate” means, for any day, the rate per annum equal to the weighted average of the rates on overnight federal funds transactions with members of the Federal Reserve System, as published by the Federal Reserve Bank of New York on the Business Day next succeeding such day; provided that (a) if such day is not a Business Day, the Federal Funds Rate for such day shall be such rate on such transactions on the immediately preceding Business Day as so published on the next succeeding Business Day, and (b) if no such rate is so published on such next succeeding Business Day, the Federal Funds Rate for such day shall be the average rate (rounded upward, if necessary, to a whole multiple of 1/100 of 1%) charged to Wells Fargo on such day on such transactions as determined by the Lender.
“Fee Letter” means that certain Fee Letter dated as of July 3, 2018, by and between the Borrower and the Lender.
“Financial Statement Certificate” means a certificate substantially in the form of Exhibit A.
“FRB” means the Board of Governors of the Federal Reserve System of the United States.

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“Fund” means any Person (other than a natural Person) that is (or will be) engaged in making, purchasing, holding or otherwise investing in commercial loans and similar extensions of credit in the ordinary course of its activities. 
“Funding Indemnity Letter” means a funding indemnity letter in form and substance reasonably acceptable to the Lender.
“GAAP” means generally accepted accounting principles in the United States set forth from time to time in the opinions and pronouncements of the Accounting Principles Board and the American Institute of Certified Public Accountants and statements and pronouncements of the Financial Accounting Standards Board (or agencies with similar functions of comparable stature and authority within the accounting profession) including, without limitation, the FASB ASC, that are applicable to the circumstances as of the date of determination, consistently applied and subject to Section 1.03.
“Governmental Authority” means the government of the United States or any other nation, or of any political subdivision thereof, whether state or local, and any agency, authority, instrumentality, regulatory body, court, central bank or other entity exercising executive, legislative, judicial, taxing, regulatory or administrative powers or functions of or pertaining to government (including, without limitation, any supra-national bodies such as the European Union or the European Central Bank).
“Guarantee” means, as to any Person, (a) any obligation, contingent or otherwise, of such Person guaranteeing or having the economic effect of guaranteeing any Indebtedness of the kind described in clauses (a) through (g) of the definition thereof or other obligation payable or performable by another Person (the “primary obligor”) in any manner, whether directly or indirectly, and including any obligation of such Person, direct or indirect, (i) to purchase or pay (or advance or supply funds for the purchase or payment of) such Indebtedness or other obligation, (ii) to purchase or lease property, securities or services for the purpose of assuring the obligee in respect of such Indebtedness or other obligation of the payment or performance of such Indebtedness or other obligation, (iii) to maintain working capital, equity capital or any other financial statement condition or liquidity or level of income or cash flow of the primary obligor so as to enable the primary obligor to pay such Indebtedness or other obligation, or (iv) entered into for the purpose of assuring in any other manner the obligee in respect of such Indebtedness or other obligation of the payment or performance thereof or to protect such obligee against loss in respect thereof (in whole or in part), or (b) any Lien on any assets of such Person securing any Indebtedness of the kind described in clauses (a) through (g) of the definition thereof or other obligation of any other Person, whether or not such Indebtedness or other obligation is assumed or expressly undertaken by such Person (or any right, contingent or otherwise, of any holder of such Indebtedness to obtain any such Lien).  The amount of any Guarantee shall be deemed to be an amount equal to the stated or determinable amount of the related primary obligation, or portion thereof, in respect of which such Guarantee is made or, if not stated or determinable, the maximum reasonably anticipated liability in respect thereof as determined by the guaranteeing Person in good faith.  The term “Guarantee” as a verb has a corresponding meaning.

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“Hazardous Materials” means all explosive or radioactive substances or wastes and all hazardous or toxic substances, wastes or other pollutants, including petroleum or petroleum distillates, natural gas, natural gas liquids, asbestos or asbestos-containing materials, polychlorinated biphenyls, radon gas, infectious or medical wastes and all other substances, wastes, chemicals, pollutants, contaminants or compounds of any nature in any form regulated pursuant to any Environmental Law.
“IFRS” means international accounting standards within the meaning of IAS Regulation 1606/2002 to the extent applicable to the relevant financial statements delivered under or referred to herein.
“Indebtedness” means, as to any Person at a particular time, without duplication, all of the following, whether or not included as indebtedness or liabilities in accordance with GAAP:
(a)    all obligations of such Person for borrowed money and all obligations of such Person evidenced by bonds, debentures, notes, loan agreements or other similar instruments;
(b)    all direct or contingent obligations of such Person arising under letters of credit (including standby and commercial), bankers’ acceptances, bank guaranties, surety bonds and similar instruments;
(c)    net obligations of such Person under any Swap Contract;
(d)    all obligations (including, without limitation, earnout obligations) of such Person to pay the deferred purchase price of property or services (other than trade accounts payable in the ordinary course of business and not past due for more than one hundred twenty (120) days after the date on which such trade account payable was created (unless being contested in good faith as to which adequate reserves required by GAAP have been established and are being maintained and as to which no encumbrance has been placed on any property of such Person));
(e)    indebtedness (excluding prepaid interest thereon) secured by a Lien on property owned or being purchased by such Person (including indebtedness arising under conditional sales or other title retention agreements), whether or not such indebtedness shall have been assumed by such Person or is limited in recourse;
(f)    all Attributable Indebtedness in respect of Capitalized Leases and Synthetic Lease Obligations of such Person;
(g)    all obligations of any such Person in respect of Disqualified Equity Interests; and
(h)    all Guarantees of such Person in respect of any of the foregoing.
For all purposes hereof, the Indebtedness of any Person shall include the Indebtedness of any partnership or joint venture (other than a joint venture that is itself a corporation or limited 

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liability company) in which such Person is a general partner or a joint venturer, unless such Indebtedness is expressly made non-recourse to such Person.  The amount of any net obligation under any Swap Contract on any date shall be deemed to be the Swap Termination Value thereof as of such date.  The amount of any Capitalized Lease or Synthetic Lease Obligation as of any date shall be deemed to be the amount of Attributable Indebtedness in respect thereof as of such date.
“Indemnitees” has the meaning specified in Section 9.04(b).
“Information” has the meaning specified in Section 9.07.
“Interest Payment Date” means, the last Business Day of each calendar month.
“Interest Period” means, as to each Eurodollar Rate Loan, the period commencing on the date such Eurodollar Rate Loan is disbursed or converted to or continued as a Eurodollar Rate Loan and ending on the date one (1), two (2), three (3), six (6) or twelve (12) months thereafter (in each case, subject to availability), as selected by the Borrower in its Loan Notice; provided that:
(a)    any Interest Period that would otherwise end on a day that is not a Business Day shall be extended to the next succeeding Business Day unless such Business Day falls in another calendar month, in which case such Interest Period shall end on the next preceding Business Day;
(b)    any Interest Period that begins on the last Business Day of a calendar month (or on a day for which there is no numerically corresponding day in the calendar month at the end of such Interest Period) shall end on the last Business Day of the calendar month at the end of such Interest Period; and
(c)    no Interest Period shall extend beyond the Maturity Date of the Term Facility.
“Laws” means, collectively, all international, foreign, federal, state and local statutes, treaties, rules, guidelines, regulations, ordinances, codes and administrative or judicial precedents or authorities, including the interpretation or administration thereof by any Governmental Authority charged with the enforcement, interpretation or administration thereof, and all applicable administrative orders, directed duties, requests, licenses, authorizations and permits of, and agreements with, any Governmental Authority, in each case whether or not having the force of law.
“Lender” means Wells Fargo Bank, National Association (including any of its branch offices) and its successors and assigns (including each Assignee Lender).
“Lender’s Office” means the Lender’s address and, as appropriate, account as set forth on Schedule 1.01(a), or such other address or account as the Lender may from time to time notify the Borrower; which office may include any Affiliate of the Lender or any domestic or foreign branch of the Lender or such Affiliate.
“LIBOR” has the meaning specified in the definition of Eurodollar Rate.

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“Lien” means any mortgage, pledge, hypothecation, assignment, deposit arrangement, encumbrance, lien (statutory or otherwise), charge, or preference, priority or other security interest or preferential arrangement in the nature of a security interest of any kind or nature whatsoever (including any conditional sale or other title retention agreement, any easement, right of way or other encumbrance on title to real property and any financing lease having substantially the same economic effect as any of the foregoing).
“Liquidity Ratio” means, as of any date of determination, the ratio of (a) Consolidated unrestricted and unencumbered (other than in favor of the Lender) cash and Cash Equivalents of the Borrower and its Subsidiaries as of such date to (b) Consolidated Senior Indebtedness as of such date.
“Loan” means an extension of credit by the Lender to the Borrower under Article II in the form of a Term Loan.
“Loan Documents” means, collectively, (a) this Agreement, (b) the Collateral Documents, (c) the Fee Letter, (d) the Funding Indemnity Letter and (e) all other certificates, agreements, documents and instruments executed by the Borrower pursuant to the foregoing (but specifically excluding any Secured Hedge Agreement or any Secured Cash Management Agreement).
“Loan Notice” means a notice of (a) a Term Borrowing, (b) a conversion of Term Loans from one Type to the other, or (c) a continuation of Eurodollar Rate Loans, pursuant to Section 2.02(a), which, if in writing, shall be substantially in the form of Exhibit B or such other form as may be approved by the Lender (including any form on an electronic platform or electronic transmission system as shall be approved by the Lender), appropriately completed and signed by a Responsible Officer of the Borrower.
“London Banking Day” means any day on which dealings in Dollar deposits are conducted by and between banks in the London interbank eurodollar market.
“Master Agreement” has the meaning set forth in the definition of “Swap Contract.”
“Material Adverse Effect” means (a) a material adverse change in, or a material adverse effect on, the operations, business, assets, properties, liabilities (actual or contingent), or financial condition of the Borrower and its Subsidiaries, taken as a whole; (b) a material impairment of the rights and remedies of the Lender under any Loan Document, or of the ability of the Borrower to perform its obligations under the Loan Documents, taken as a whole; or (c) a material adverse effect upon the legality, validity, binding effect or enforceability against the Borrower of any Loan Document.
“Maturity Date” means July 3, 2023; provided, however, that if such date is not a Business Day, the Maturity Date shall be the immediately preceding Business Day.
“Maximum Rate” has the meaning specified in Section 9.09.

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“Medicaid” means that government-sponsored entitlement program under Title XIX, P.L. 89-97 of the Social Security Act, which provides federal grants to states for medical assistance based on specific eligibility criteria, as set forth on Section 1396, et seq. of Title 42 of the United States Code.
“Medicare” means that government-sponsored insurance program under Title XVIII, P.L. 89-97, of the Social Security Act, which provides for a health insurance system for eligible elderly and disabled individuals, as set forth at Section 1395, et seq. of Title 42 of the United States Code.
“Minimum Collateral Amount” means, at any time, Approved Cash Collateral in an amount equal to the greater of (a) 100% of the Outstanding Amount of the Term Loan at such time plus 100% of the Additional Secured Obligations and (b) such other amount as may be mutually agreed to in writing by Borrower and the Lender.
“Moody’s” means Moody’s Investors Service, Inc. and any successor thereto.
“Multiemployer Plan” means any employee benefit plan of the type described in Section 4001(a)(3) of ERISA, to which the Borrower or any ERISA Affiliate makes or is obligated to make contributions, or during the preceding five (5) plan years, has made or been obligated to make contributions.
“Multiple Employer Plan” means a Plan which has two or more contributing sponsors (including the Borrower or any ERISA Affiliate) at least two of whom are not under common control, as such a plan is described in Section 4064 of ERISA.
“Notice of Loan Prepayment” means a notice of prepayment with respect to a Term Loan, which shall be substantially in the form of Exhibit C or such other form as may be approved by the Lender (including any form on an electronic platform or electronic transmission system as shall be approved by the Lender), appropriately completed and signed by a Responsible Officer of the Borrower.
“Obligations” means (a) all advances to, and debts, liabilities, obligations, covenants and duties of, the Borrower arising under any Loan Document or otherwise with respect to the Term Loan and (b) all costs and expenses incurred in connection with enforcement and collection of the foregoing, including the fees, charges and disbursements of counsel, to the extent provided for and subject to the limitations contained in Section 9.04, in each case whether direct or indirect (including those acquired by assumption), absolute or contingent, due or to become due, now existing or hereafter arising and including interest and fees that accrue after the commencement by or against the Borrower pursuant to any proceeding under any Debtor Relief Laws naming such Person as the debtor in such proceeding, regardless of whether such interest and fees are allowed claims in such proceeding.
“OFAC” means the Office of Foreign Assets Control of the United States Department of the Treasury.

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“Organization Documents” means, (a) with respect to any corporation, the certificate or articles of incorporation and the bylaws (or equivalent or comparable constitutive documents with respect to any non-U.S. jurisdiction); (b) with respect to any limited liability company, the certificate or articles of formation or organization and operating agreement or limited liability company agreement (or equivalent or comparable documents with respect to any non-U.S. jurisdiction); (c) with respect to any partnership, joint venture, trust or other form of business entity, the partnership, joint venture or other applicable agreement of formation or organization (or equivalent or comparable documents with respect to any non-U.S. jurisdiction) and (d) with respect to all entities, any agreement, instrument, filing or notice with respect thereto filed in connection with its formation or organization with the applicable Governmental Authority in the jurisdiction of its formation or organization (or equivalent or comparable documents with respect to any non-U.S. jurisdiction).
“Outstanding Amount” means with respect to Term Loans on any date, the aggregate outstanding principal amount thereof after giving effect to any borrowings and prepayments or repayments of Term Loans occurring on such date.
“Participant Register” has the meaning set forth in Section 9.06(c). 
“PBGC” means the Pension Benefit Guaranty Corporation.
“Pension Plan” means any employee pension benefit plan (including a Multiple Employer Plan or a Multiemployer Plan) that is maintained or is contributed to by the Borrower or any ERISA Affiliate and is either covered by Title IV of ERISA or is subject to the minimum funding standards under Section 412 of the Code.
“Permitted Lien” means each of the following Liens, solely to the extent such Liens (x) are non-consensual Liens arising only as a matter of Law and (y) could not have priority over the Liens of the Lender on the Collateral securing the Secured Obligations:
(a)    Liens imposed by Law for taxes, assessments or governmental charges or levies not yet due or which are being contested in good faith by appropriate proceedings diligently conducted (which effectively stay the enforcement of any such Liens) and with respect to which adequate reserves are being maintained in accordance with GAAP;
(b)    statutory Liens such as landlord’s, carriers’, warehousemen’s, mechanics’, materialmen’s, repairmen’s or other like Liens arising in the ordinary course of business which are not overdue for a period of more than thirty (30) days or which are being contested in good faith and by appropriate proceedings diligently conducted (which effectively stay the enforcement of any such Liens) and with respect to which adequate reserves are being maintained in accordance with GAAP; and
(c)    Liens securing judgments for the payment of money (or appeal or other surety bonds relating to such judgments) not constituting an Event of Default under Section 8.01(h).

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“Person” means any natural person, corporation, limited liability company, trust, joint venture, association, company, partnership, Governmental Authority or other entity.
“Plan” means any employee benefit plan within the meaning of Section 3(3) of ERISA (including a Pension Plan), maintained for employees of the Borrower or any ERISA Affiliate or any such Plan to which the Borrower or any ERISA Affiliate is required to contribute on behalf of any of its employees.
“Qualified Equity Interests” means any Equity Interests that are not Disqualified Equity Interests.
“Register” has the meaning set forth in Section 9.06(b).
“Related Parties” means, with respect to any Person, such Person’s Affiliates and the partners, directors, officers, employees, agents, trustees, administrators, managers, advisors and representatives of such Person and of such Person’s Affiliates.
“Reportable Event” means any of the events set forth in Section 4043(c) of ERISA, other than events for which the thirty (30) day notice period has been waived.
“Responsible Officer” means the chief executive officer, president, chief financial officer, chief business officer, treasurer, assistant treasurer or controller of the Borrower, solely for purposes of the delivery of incumbency certificates pursuant to Section 4.01, the secretary or any assistant secretary of the Borrower and, solely for purposes of notices given pursuant to Article II, any other officer or employee of the Borrower so designated by any of the foregoing officers in a notice to the Lender or any other officer or employee of the Borrower designated in or pursuant to an agreement between the Borrower and the Lender. Any document delivered hereunder that is signed by a Responsible Officer of the Borrower shall be conclusively presumed to have been authorized by all necessary corporate, partnership and/or other action on the part of the Borrower and such Responsible Officer shall be conclusively presumed to have acted on behalf of the Borrower. To the extent requested by the Lender, each Responsible Officer will provide an incumbency certificate and to the extent requested by the Lender, appropriate authorization documentation, in form and substance satisfactory to the Lender.
“S&P” means Standard & Poor’s Financial Services LLC, a part of McGraw-Hill Financial and any successor thereto.
“Sanction(s)” means any sanction administered or enforced by the United States Government (including, without limitation, OFAC), the United Nations Security Council, the European Union, Her Majesty’s Treasury (“HMT”) or other relevant sanctions authority.
“SEC” means the Securities and Exchange Commission, or any Governmental Authority succeeding to any of its principal functions.
“Secured Cash Management Agreement” means any Cash Management Agreement between the Borrower or any of its Subsidiaries and the Lender or an Affiliate of the Lender.    It is understood 

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and agreed that each Secured Cash Management Agreement shall be entered into in the sole and absolute discretion of the Lender and/or its Affiliates.
“Secured Hedge Agreement” means any Swap Contract between the Borrower or any of its Subsidiaries and the Lender or an Affiliate of the Lender.  It is understood and agreed that each Secured Hedge Agreement shall be entered into in the sole and absolute discretion of the Lender and/or its Affiliates.  
“Secured Obligations” means all Obligations and all Additional Secured Obligations.
“Secured Parties” means, collectively, the Lender, each Affiliate of the Lender party to any Secured Cash Management Agreement or Secured Hedge Agreement and the Indemnitees.
“Securities Act” means the Securities Act of 1933, as amended from time to time.
“Security Agreement” means the Cash Collateral Agreement, dated as of the Closing Date, executed in favor of the Lender by the Borrower, as amended, amended and restated, supplemented or otherwise modified from time to time.
“Social Security Act” means the Social Security Act of 1965.
“Subordinated Indebtedness” means Indebtedness of the Borrower that is subordinated in right and time of payment to the Obligations on terms and conditions satisfactory to the Lender, and if such Subordinated Indebtedness is convertible into Equity Interests of the Borrower, such Subordinated Indebtedness shall qualify as Subordinated Indebtedness only to the extent such Equity Interests do not constitute Disqualified Equity Interests.
“Subsidiary” of a Person means a corporation, partnership, joint venture, limited liability company or other business entity of which a majority of the shares of Voting Stock is at the time beneficially owned, or the management of which is otherwise controlled, directly, or indirectly through one or more intermediaries, or both, by such Person.  Unless otherwise specified, all references herein to a “Subsidiary” or to “Subsidiaries” shall refer to a Subsidiary or Subsidiaries of the Borrower.
“Swap Contract” means (a) any and all rate swap transactions, basis swaps, credit derivative transactions, forward rate transactions, commodity swaps, commodity options, forward commodity contracts, equity or equity index swaps or options, bond or bond price or bond index swaps or options or forward bond or forward bond price or forward bond index transactions, interest rate options, forward foreign exchange transactions, cap transactions, floor transactions, collar transactions, currency swap transactions, cross-currency rate swap transactions, currency options, spot contracts, or any other similar transactions or any combination of any of the foregoing (including any options to enter into any of the foregoing), whether or not any such transaction is governed by or subject to any master agreement, and (b) any and all transactions of any kind, and the related confirmations, which are subject to the terms and conditions of, or governed by, any form of master agreement published by the International Swaps and Derivatives Association, Inc., any International Foreign Exchange Master Agreement, or any other master agreement (any such master agreement, 

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together with any related schedules, a “Master Agreement”), including any such obligations or liabilities under any Master Agreement.
“Swap Termination Value” means, in respect of any one or more Swap Contracts, after taking into account the effect of any legally enforceable netting agreement relating to such Swap Contracts, (a) for any date on or after the date such Swap Contracts have been closed out and termination value(s) determined in accordance therewith, such termination value(s), and (b) for any date prior to the date referenced in clause (a), the amount(s) determined as the mark-to-market value(s) for such Swap Contracts, as determined based upon one or more mid-market or other readily available quotations provided by any recognized dealer in such Swap Contracts (which may include the Lender or any Affiliate of the Lender).
 “Synthetic Lease Obligation” means the monetary obligation of a Person under (a) a so-called synthetic, off-balance sheet or tax retention lease, or (b) an agreement for the use or possession of property, in each case, creating obligations that do not appear on the balance sheet of such Person but which, upon the application of any Debtor Relief Laws to such Person, would be characterized as the indebtedness of such Person (without regard to accounting treatment).
“Term Borrowing” means a borrowing consisting of simultaneous Term Loans of the same Type and, in the case of Eurodollar Rate Loans, having the same Interest Period made by the Lender pursuant to Section 2.01.
“Term Commitment” means the Lender’s obligation to make Term Loans to the Borrower pursuant to Section 2.01(a).  The Term Commitment on the Closing Date is $50,000,000.
“Term Facility” means, at any time, (a) on or prior to the Closing Date, the aggregate amount of the Term Commitment at such time and (b) thereafter, the aggregate principal amount of the Term Loans outstanding at such time.
“Term Loan” means an advance made by the Lender under the Term Facility.
“Threshold Amount” means $5,000,000.
“Type” means, with respect to a Term Loan, its character as a Base Rate Loan or a Eurodollar Rate Loan.
“UCC” means the Uniform Commercial Code as in effect in the State of New York; provided that, if perfection or the effect of perfection or non-perfection or the priority of any security interest in any Collateral is governed by the Uniform Commercial Code as in effect in a jurisdiction other than the State of New York, “UCC” means the Uniform Commercial Code as in effect from time to time in such other jurisdiction for purposes of the provisions hereof relating to such perfection, effect of perfection or non-perfection or priority.
“Unasserted Obligations” means, at any time, (a) contingent indemnification obligations in respect of which no claim or demand for payment has been made or asserted at such time,  and (b) Secured Obligations under Secured Cash Management Agreements and Secured Hedge Agreements 

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for which the Borrower and/or its Subsidiaries shall have made arrangements satisfactory to (and for the benefit of), as applicable, the Lender and each Affiliate of the Lender party to such Secured Cash Management Agreements and/or Secured Hedge Agreements (including, without limitation, arrangements for replacement collateral), in each case, in respect of such Secured Obligations thereunder.
“United States” and “U.S.” mean the United States of America.
 “Voting Stock” means, with respect to any Person, Equity Interests issued by such Person the holders of which are ordinarily, in the absence of contingencies, entitled to vote for the election of directors (or other governing body performing similar functions) of such Person, even though the right to so vote has been suspended by the happening of such contingency.
“Wells Fargo” means Wells Fargo Bank, National Association and its successors.
1.02    Other Interpretive Provisions.
With reference to this Agreement and each other Loan Document, unless otherwise specified herein or in such other Loan Document:
(a)    The definitions of terms herein shall apply equally to the singular and plural forms of the terms defined.  Whenever the context may require, any pronoun shall include the corresponding masculine, feminine and neuter forms.  The words “include,” “includes” and “including” shall be deemed to be followed by the phrase “without limitation.”  The word “will” shall be construed to have the same meaning and effect as the word “shall.”  Unless the context requires otherwise, (i) any definition of or reference to any agreement, instrument or other document (including the Loan Documents and any Organization Document) shall be construed as referring to such agreement, instrument or other document as from time to time amended, amended and restated, modified, extended, restated, replaced or supplemented from time to time (subject to any restrictions on such amendments, restatements, supplements, extensions or modifications set forth herein or in any other Loan Document), (ii) any reference herein to any Person shall be construed to include such Person’s successors and assigns, (iii) the words “hereto,” “herein,” “hereof” and “hereunder,” and words of similar import when used in any Loan Document, shall be construed to refer to such Loan Document in its entirety and not to any particular provision thereof, (iv) all references in a Loan Document to Articles, Sections, Preliminary Statements, Exhibits and Schedules shall be construed to refer to Articles and Sections of, and Preliminary Statements, Exhibits and Schedules to, the Loan Document in which such references appear, (v) any reference to any law shall include all statutory and regulatory rules, regulations, orders and provisions consolidating, amending, replacing or interpreting such law and any reference to any law or regulation shall, unless otherwise specified, refer to such law or regulation as amended, modified, extended, restated, replaced or supplemented from time to time, and (vi) the words “asset” and “property” shall be construed to have the same meaning and effect and to refer to any and all tangible and intangible assets and properties, including cash, securities, accounts and contract rights.

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(b)    In the computation of periods of time from a specified date to a later specified date, the word “from” means “from and including;” the words “to” and “until” each mean “to but excluding;” and the word “through” means “to and including.”
(c)    Section headings herein and in the other Loan Documents are included for convenience of reference only and shall not affect the interpretation of this Agreement or any other Loan Document.
1.03    Accounting Terms.
(a)    Generally.  All accounting terms not specifically or completely defined herein shall be construed in conformity with, and all financial data (including financial ratios and other financial calculations) required to be submitted pursuant to this Agreement shall be prepared in conformity with, GAAP applied on a consistent basis, as in effect from time to time, applied in a manner consistent with that used in preparing the Audited Financial Statements, except as otherwise specifically prescribed herein.
(b)    Changes in GAAP.  If at any time any change in GAAP (including the adoption of IFRS) would affect any requirement set forth in any Loan Document, and either the Borrower or Lender shall so request, the Lender and the Borrower shall negotiate in good faith to amend such requirement to preserve the original intent thereof in light of such change in GAAP; provided that, until so amended, (i) such requirement shall continue to be computed in accordance with GAAP prior to such change therein and (ii) the Borrower shall provide to the Lender financial statements and other documents required under this Agreement or as reasonably requested hereunder setting forth a reconciliation between calculations of such requirement made before and after giving effect to such change in GAAP.
1.04    Times of Day; Rates.
Unless otherwise specified, all references herein to times of day shall be references to Eastern time (daylight or standard, as applicable).
The Lender does not warrant, nor accept responsibility, nor shall the Lender have any liability with respect to the administration, submission or any other matter related to the rates in the definition of “Eurodollar Rate” or with respect to any comparable or successor rate thereto.
1.05    UCC Terms.
Terms defined in the UCC in effect on the Closing Date and not otherwise defined herein shall, unless the context otherwise indicates, have the meanings provided by those definitions.  Subject to the foregoing, the term “UCC” refers, as of any date of determination, to the UCC then in effect.
ARTICLE II 
 
COMMITMENTS AND CREDIT EXTENSIONS

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2.01    Term Borrowing.
Subject to the terms and conditions set forth herein, the Lender agrees to make a single loan to the Borrower, in Dollars, on the Closing Date in an amount not to exceed the Term Facility.  The Term Borrowing shall consist of Term Loans made by the Lender.  Term Loans repaid or prepaid may not be reborrowed.  Term Loans may be Base Rate Loans or Eurodollar Rate Loans, as further provided herein; provided, however, any Term Borrowing made on the Closing Date shall be made as Base Rate Loans unless the Borrower delivers a Funding Indemnity Letter not less than two (2) Business Days prior to the Closing Date.
2.02    Borrowings, Conversions and Continuations of Term Loans.
(a)    Notice of Borrowing.  Each Term Borrowing, each conversion of Loans from one Type to the other, and each continuation of Eurodollar Rate Loans shall be made upon the Borrower’s irrevocable notice to the Lender, which may be given by (i) telephone or (ii) a Loan Notice; provided that any telephonic notice must be confirmed immediately by delivery to the Lender of a Loan Notice.  Each such notice must be received by the Lender not later than 11:00 a.m. (A) two (2) Business Days prior to the requested date of any Term Borrowing of, conversion to or continuation of Eurodollar Rate Loans or of any conversion of Eurodollar Rate Loans to Base Rate Loans, and (B) on the requested date of any Term Borrowing of Base Rate Loans; provided, however, that if the Borrower wishes to request Eurodollar Rate Loans having an Interest Period of twelve (12) months in duration as provided in the definition of “Interest Period”, the applicable notice must be received by the Lender not later than 11:00 a.m. four (4) Business Days prior to the requested date of such Term Borrowing, conversion or continuation.  Not later than 11:00 a.m., two (2) Business Days before the requested date of such Term Borrowing, conversion or continuation, the Lender shall notify the Borrower (which notice may be by telephone) whether or not the requested Interest Period is available.  Each Term Borrowing of, conversion to or continuation of Eurodollar Rate Loans shall be, unless otherwise agreed by Lender, in a principal amount of $5,000,000 or a whole multiple of $1,000,000 in excess thereof (or, in connection with any conversion or continuation of a Term Loan, if less, the entire principal thereof then outstanding).  Each Term Borrowing of or conversion to Base Rate Loans shall be, unless otherwise agreed by Lender, in a principal amount of $500,000 or a whole multiple of $100,000 in excess thereof (or, in connection with any conversion or continuation of a Term Loan, if less, the entire principal thereof then outstanding).  Each Loan Notice (whether telephonic or written) shall specify (1) whether the Borrower is requesting a Term Borrowing, a conversion of Term Loans from one Type to the other, or a continuation of Term Loans, as the case may be, (2) the requested date of the Term Borrowing, conversion or continuation, as the case may be (which shall be a Business Day), (3) the principal amount of Term Loans to be borrowed, converted or continued, (4) the Type of Loans to be borrowed or to which existing Term Loans are to be converted, and (5) if applicable, the duration of the Interest Period with respect thereto.  If the Borrower fails to specify a Type of Term Loan in a Loan Notice or if the Borrower fails to give a timely notice requesting a conversion or continuation, then the applicable Term Loans shall be made as, or converted to, Base Rate Loans.  Any such automatic conversion to Base Rate Loans shall be effective as of the last day of the Interest Period then in effect with respect to the applicable Eurodollar Rate Loans.  If the Borrower requests a Term Borrowing of, conversion to, 

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or continuation of Eurodollar Rate Loans in any such Loan Notice, but fails to specify an Interest Period, it will be deemed to have specified an Interest Period of one (1) month. 
(b)    Advances.  On the Closing Date, following receipt of a Loan Notice, upon satisfaction of the applicable conditions set forth in Section 4.01, the Lender shall make the requested funds available to the Borrower either by (i) crediting the account of the Borrower on the books of Wells Fargo with the amount of such funds or (ii) wire transfer of such funds, in each case in accordance with instructions provided to (and reasonably acceptable to) the Lender by the Borrower.
(c)    Eurodollar Rate Loans.  Except as otherwise provided herein, a Eurodollar Rate Loan may be continued or converted only on the last day of an Interest Period for such Eurodollar Rate Loan.  During the existence of an Event of Default, no Loans may be requested as, converted to or continued as Eurodollar Rate Loans without the consent of the Lender.
(d)    Interest Periods. After giving effect to all Term Borrowings, all conversions of Term Loans from one Type to the other, and all continuations of Term Loans as the same Type, there shall not be more than five (5) Interest Periods in effect in respect of the Term Facility.
2.03    Prepayments.
The Borrower may, upon notice to the Lender pursuant to delivery to the Lender of a Notice of Loan Prepayment, at any time or from time to time voluntarily prepay Term Loans in whole or in part without premium or penalty subject to Section 3.05; provided that, unless otherwise agreed by the Lender (a) such notice must be received by Lender not later than 11:00 a.m. (1) three (3) Business Days prior to any date of such prepayment; (b) any prepayment shall be in a principal amount of $5,000,000 or a whole multiple of $1,000,000 in excess thereof or, if less, the entire principal amount thereof then outstanding and shall, if applicable, be applied, in inverse order of maturity, to the remaining outstanding principal installments of the Term Loan.  Each such notice shall specify the date and amount of such prepayment and the Type(s) of Loans to be prepaid and, if Eurodollar Rate Loans are to be prepaid, the Interest Period(s) of such Loans.  If such notice is given by the Borrower, the Borrower shall make such prepayment and the payment amount specified in such notice shall be due and payable on the date specified therein.  Any prepayment of principal shall be accompanied by all accrued interest on the amount prepaid, together with any additional amounts required pursuant to Section 3.05. Each prepayment of the outstanding Term Loans pursuant to this Section 2.03 shall be applied to the aggregate principal amount of the Term Loans outstanding on such date.
2.04    Termination of Term Commitment.
The aggregate Term Commitment shall be automatically and permanently reduced to zero on the Closing Date upon the Term Borrowing.
2.05    Repayment of Term Loans.
The Borrower shall pay to the Lender the principal amount of the Term Loans in consecutive quarterly installments in the amount of $1,500,000 on the last day of each of March, June, September 

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and December, commencing June 30, 2019.  If not sooner paid, the Term Loans shall be paid in full, together with accrued interest thereon, on the Maturity Date.
2.06    Interest and Default Rate.
(a)    Interest.  Subject to the provisions of Section 2.06(b), (i) each Eurodollar Rate Loan shall bear interest on the outstanding principal amount thereof for each Interest Period from the applicable borrowing date at a rate per annum equal to the Eurodollar Rate for such Interest Period plus the Applicable Rate; and (ii) each Base Rate Loan shall bear interest on the outstanding principal amount thereof from the applicable borrowing date at a rate per annum equal to the Base Rate plus the Applicable Rate.  To the extent that any calculation of interest or any fee required to be paid under this Agreement shall be based on (or result in) a rate that is less than zero, such rate shall be deemed zero for purposes of this Agreement.
(b)    Default Rate.
(i)    If any amount payable by the Borrower under any Loan Document is not paid when due (without regard to any applicable grace periods), whether at stated maturity, by acceleration or otherwise, then such amount shall thereafter bear interest at a fluctuating interest rate per annum at all times equal to the Default Rate to the fullest extent permitted by applicable Laws.
(ii)    Accrued and unpaid interest on past due amounts (including interest on past due interest) shall be due and payable upon demand.
(c)    Interest Payments.  Interest on each Loan shall be due and payable in arrears on each Interest Payment Date, the Maturity Date and at such other times as may be specified herein.  Interest hereunder shall be due and payable in accordance with the terms hereof before and after judgment, and before and after the commencement of any proceeding under any Debtor Relief Law.
2.07    Fees.
The Borrower shall pay to the Lender such fees specified in the Fee Letter and such other fees as shall have been separately agreed upon in writing, in each case, in the amounts and at the times so specified in the Fee Letter or, as applicable, in any such separate agreement.  Such fees shall be fully earned when paid and shall not be refundable for any reason whatsoever.
2.08    Computation of Interest and Fees.
All computations of interest for Base Rate Loans (including Base Rate Loans determined by reference to the Eurodollar Rate) shall be made on the basis of a year of 365 or 366 days, as the case may be, and actual days elapsed.  All other computations of fees and interest shall be made on the basis of a 360-day year and actual days elapsed (which results in more fees or interest, as applicable, being paid than if computed on the basis of a 365-day year).  Interest shall accrue on each Loan for the day on which the Loan is made, and shall not accrue on a Loan, or any portion thereof, for the day on which the Loan or such portion is paid, provided that any Loan that is repaid 

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on the same day on which it is made shall, subject to Section 2.09, bear interest for one (1) day.  Each determination by the Lender of an interest rate or fee hereunder shall be conclusive and binding for all purposes, absent manifest error.
2.09    Payments Generally.
(a)    General Payment Terms.  All payments to be made by the Borrower shall be made free and clear of and without condition or deduction for any counterclaim, defense, recoupment or setoff.  Except as otherwise expressly provided herein, all payments by the Borrower hereunder shall be made to the Lender at the Lender’s Office in Dollars and in immediately available funds not later than 2:00 p.m. on the date specified herein.  All payments received by the Lender after 2:00 p.m. shall be deemed received on the next succeeding Business Day and any applicable interest or fee shall continue to accrue.  Except as otherwise specifically provided for in this Agreement, if any payment to be made by the Borrower shall come due on a day other than a Business Day, payment shall be made on the next following Business Day, and such extension of time shall be reflected in computing interest or fees, as the case may be.
(b)    Direct Debit.  The Borrower agrees that on the due date of any amount due under this Agreement or the other Loan Documents, the Lender will debit the amount due from a deposit account owned by the Borrower and as designated in writing by the Borrower (the “Designated Account”). The Borrower shall at all times during the term of this Agreement maintain such direct debit arrangements with the Lender or with another financial institution reasonably acceptable to Lender, and maintain sufficient funds in the Designated Accounts to pay amounts due under this Agreement or the other Loan Documents.  Without in any way derogating from the obligations of the Borrower hereunder, should there be insufficient funds in the Designated Account to pay all such sums when due, the full amount of such deficiency shall be immediately due and payable by the Borrower in accordance with the terms of this Agreement.      
2.10    Cash Collateral.
(a)    The Borrower shall at all times during the term of this Agreement maintain Approved Cash Collateral pursuant to the terms of the Security Agreement in an amount not less than the Minimum Collateral Amount. All Collateral shall be subject to a first priority, perfected security interest in favor of the Lender and shall secure all of the Secured Obligations.  All Cash Collateral shall be maintained in one or more blocked, interest bearing collateral accounts at Wells Fargo.  The Borrower shall promptly (but in any event within three (3) Business Days) following written demand therefor from time to time pay all customary account opening, activity and other administrative fees and charges in connection with the maintenance and disbursement of Cash Collateral.
(b)    Each of the Borrower and the Lender agrees to consider the appropriateness of a change in the type of Approved Cash Collateral on a periodic basis throughout the term of this Agreement; provided that any such change to the type of such Approved Cash Collateral shall be made only upon Lender’s and Borrower’s consent (it being acknowledged that the consent of the Lender may be withheld in the Lender’s sole and absolute discretion).

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ARTICLE III
 
TAXES, YIELD PROTECTION AND ILLEGALITY
3.01    Taxes.
If any payments to the Lender under this Agreement are made from outside the United States, the Borrower shall not deduct any foreign taxes from any payments it makes to the Lender.  If any such taxes are imposed on any payments made by the Borrower (including payments under this paragraph), the Borrower will pay the taxes and will also pay to the Lender, at the time interest is paid, any additional amount which the Lender specifies as necessary to preserve the after-tax yield the Lender would have received if such taxes had not been imposed.  As soon as practicable after any payment of taxes by the Borrower to a Governmental Authority, as provided in this Section 3.01, the Borrower will deliver to the Lender the original or a certified copy of a receipt issued by such Governmental Authority evidencing such payment, a copy of any return reporting such payment or other evidence of such payment reasonably satisfactory to the Lender.
The Borrower will confirm that it has paid the foregoing taxes by giving the Lender official tax receipts (or notarized copies) within thirty (30) days after the due date.
3.02    Illegality.
If the Lender determines that any Law has made it unlawful, or that any Governmental Authority has asserted that it is unlawful, for the Lender or its Lender’s Office to perform any of its obligations hereunder or to make, maintain or fund or charge interest with respect to any Term Loan or to determine or charge interest rates based upon the Eurodollar Rate, or any Governmental Authority has imposed material restrictions on the authority of the Lender to purchase or sell, or to take deposits of, Dollars in the London interbank market, then, on notice thereof by the Lender to the Borrower, (a) any obligation of the Lender to issue, make, maintain, fund or charge interest with respect to any such Term Loan or continue Eurodollar Rate Loans or to convert Base Rate Loans to Eurodollar Rate Loans shall be suspended, and (b) if such notice asserts the illegality of the Lender making or maintaining Base Rate Loans the interest rate on which is determined by reference to the Eurodollar Rate component of the Base Rate, the interest rate on which Base Rate Loans of the Lender shall, if necessary to avoid such illegality, be determined by the Lender without reference to the Eurodollar Rate component of the Base Rate, in each case until the Lender notifies the Borrower that the circumstances giving rise to such determination no longer exist.  Upon receipt of such notice, (i) the Borrower shall, upon demand from the Lender, prepay or, if applicable, convert all Eurodollar Rate Loans to Base Rate Loans (the interest rate on which Base Rate Loans shall, if necessary to avoid such illegality, be determined by the Lender without reference to the Eurodollar Rate component of the Base Rate), either on the last day of the Interest Period therefor, if the Lender may lawfully continue to maintain such Eurodollar Rate Loans to such day, or immediately, if the Lender may not lawfully continue to maintain such Eurodollar Rate Loans and (ii) if such notice asserts the illegality of the Lender determining or charging interest rates based upon the Eurodollar Rate, the Lender shall during the period of such suspension compute the Base Rate without reference to the Eurodollar Rate component thereof until it is no longer illegal for the Lender to determine 

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or charge interest rates based upon the Eurodollar Rate.  Upon any such prepayment or conversion, the Borrower shall also pay accrued interest on the amount so prepaid or converted.
3.03    Inability to Determine Rates.
If in connection with any request for a Eurodollar Rate Loan or a conversion to or continuation thereof, the Lender determines that (a) Dollar deposits are not being offered to banks in the London interbank eurodollar market for the applicable amount and Interest Period of such Eurodollar Rate Loan, (b) adequate and reasonable means do not exist for determining the Eurodollar Rate for any requested Interest Period with respect to a proposed Eurodollar Rate Loan or in connection with an existing or proposed Base Rate Loan, or (c) the Eurodollar Rate for any requested Interest Period with respect to a proposed Eurodollar Rate Loan does not adequately and fairly reflect the cost to the Lender of funding such Eurodollar Rate Loan, the Lender will promptly so notify the Borrower.  Thereafter, (i) the obligation of the Lender to make or maintain Eurodollar Rate Loans shall be suspended (to the extent of the affected Eurodollar Rate Loans or Interest Periods), and (ii) in the event of a determination described in the preceding sentence with respect to the Eurodollar Rate component of the Base Rate, the utilization of the Eurodollar Rate component in determining the Base Rate shall be suspended, in each case until the Lender revokes such notice.  Upon receipt of such notice, the Borrower may revoke any pending request for a Term Borrowing of, conversion to or continuation of Eurodollar Rate Loans (to the extent of the affected Eurodollar Rate Loans or Interest Periods) or, failing that, will be deemed to have converted such request into a request for a Term Borrowing of Base Rate Loans in the amount specified therein. Notwithstanding the foregoing, in the case of such pending request, the Lender, in consultation with the Borrower, may establish an alternative interest rate for funding Term Loans in the applicable amount, and with the same Interest Period as the Term Loan requested to be made, converted or continued, as the case may be in which case, such alternative rate of interest shall apply with respect to such Term Loans.
3.04    Increased Costs; Reserves on Eurodollar Rate Loans.
(a)    Increased Costs Generally.  If any Change in Law shall:
(i)    impose, modify or deem applicable any reserve, special deposit, compulsory loan, insurance charge or similar requirement against assets of, deposits with or for the account of, or credit extended or participated in by, the Lender (except any reserve requirement contemplated by Section 3.04(d));
(ii)    subject the Lender to any taxes (other than Excluded Taxes) on its loans, loan principal, letters of credit, commitments, or other obligations, or its deposits, reserves, other liabilities or capital attributable thereto; or
(iii)    impose on the Lender or the London interbank market any other condition, cost or expense (other than taxes) affecting this Agreement or Eurodollar Rate Loans made by the Lender;
and the result of any of the foregoing shall be to increase the cost to the Lender of making, converting to, continuing or maintaining any Term Loan (or of maintaining its obligation 

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to make any such Term Loan), or to reduce the amount of any sum received or receivable by the Lender hereunder (whether of principal, interest or any other amount) then, upon request of the Lender, the Borrower will pay to the Lender such additional amount or amounts as will compensate the Lender for such additional costs incurred or reduction suffered.
(b)    Capital Requirements.  If the Lender determines that any Change in Law affecting the Lender or the Lender’s Office or the Lender’s holding company, if any, regarding capital or liquidity requirements has or would have the effect of reducing the rate of return on the Lender’s capital or on the capital of the Lender’s holding company, if any, as a consequence of this Agreement, the Term Commitment of the Lender or the Term Loans made by the Lender, to a level below that which the Lender or the Lender’s holding company could have achieved but for such Change in Law (taking into consideration the Lender’s policies and the policies of the Lender’s holding company with respect to capital adequacy), then from time to time the Borrower will pay to the Lender such additional amount or amounts as will compensate the Lender or the Lender’s holding company for any such reduction suffered.
(c)    Certificates for Reimbursement.  A certificate of the Lender setting forth the amount or amounts necessary to compensate the Lender or its holding company, as the case may be, as specified in subsection (a) or (b) of this Section and delivered to the Borrower shall be conclusive absent manifest error.  The Borrower shall pay the Lender the amount shown as due on any such certificate within ten (10) days after receipt thereof.
(d)    Reserves on Eurodollar Rate Loans.  The Borrower shall pay to the Lender, (i) as long as the Lender shall be required to maintain reserves with respect to liabilities or assets consisting of or including eurocurrency funds or deposits (currently known as “Eurocurrency liabilities”), additional interest on the unpaid principal amount of each Eurodollar Rate Loan equal to the actual costs of such reserves allocated to such Term Loan by the Lender (as determined by the Lender in good faith, which determination shall be conclusive absent manifest error), and (ii) as long as the Lender shall be required to comply with any reserve ratio requirement or analogous requirement of any central banking or financial regulatory authority imposed in respect of the maintenance of the Term Commitment or the funding of the Term Loans, such additional costs (expressed as a percentage per annum and rounded upwards, if necessary, to the nearest five decimal places) equal to the actual costs allocated to such Term Commitment or Term Loan by the Lender (as determined by the Lender in good faith, which determination shall be conclusive absent manifest error), which in each case shall be due and payable on each date on which interest is payable on such Term Loan, provided the Borrower shall have received at least ten (10) days’ prior notice of such additional interest or costs from the Lender.  If the Lender fails to give notice ten (10) days prior to the relevant Interest Payment Date, such additional interest shall be due and payable ten (10) days after the Borrower’s receipt of such notice.
(e)    Delay in Requests.  Failure or delay on the part of the Lender to demand compensation pursuant to the foregoing provisions of this Section 3.04 shall not constitute a waiver of the Lender’s right to demand such compensation, provided that the Borrower shall not be required to compensate the Lender pursuant to the foregoing provisions of this Section for any increased costs incurred or reductions suffered more than nine (9) months prior to the date that the Lender notifies the Borrower 

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of the Change in Law giving rise to such increased costs or reductions and of the Lender’s intention to claim compensation therefor (except that, if the Change in Law giving rise to such increased costs or reductions is retroactive, then the nine (9) month period referred to above shall be extended to include the period of retroactive effect thereof).
3.05    Compensation for Losses.
Upon demand of the Lender from time to time, the Borrower shall promptly compensate the Lender for and hold the Lender harmless from any loss, cost or expense incurred by it as a result of:
(a)    any continuation, conversion, payment or prepayment of any Term Loan other than a Base Rate Loan on a day other than the last day of the Interest Period for such Loan (whether voluntary, mandatory, automatic, by reason of acceleration, or otherwise); or
(b)    any failure by the Borrower (for a reason other than the failure of the Lender to make a Loan) to prepay, borrow, continue or convert any Term Loan other than a Base Rate Loan on the date or in the amount notified by the Borrower;
including any loss of anticipated profits and any loss or expense arising from the liquidation or reemployment of funds obtained by it to maintain such Term Loan or from fees payable to terminate the deposits from which such funds were obtained.  The Borrower shall also pay any reasonable and customary administrative fees charged by the Lender in connection with the foregoing.
For purposes of calculating amounts payable by the Borrower to the Lender under this Section 3.05, the Lender shall be deemed to have funded each Eurodollar Rate Loan made by it at the Eurodollar Rate for such Loan by a matching deposit or other borrowing in the London interbank eurodollar market for a comparable amount and for a comparable period, whether or not such Eurodollar Rate Loan was in fact so funded.
3.06    Survival.
All of the Borrower’s obligations under this Article III shall survive termination of the Term Commitment and repayment of all other Obligations hereunder.
ARTICLE IV 
 
CONDITIONS PRECEDENT TO CREDIT EXTENSIONS
4.01    Conditions of Initial Credit Extension.
The obligation of the Lender to make the Term Loan hereunder is subject to satisfaction of the following conditions precedent:
(a)    Execution of Credit Agreement; Loan Documents.  The Lender shall have received (i) counterparts of this Agreement, executed by a Responsible Officer of the Borrower, (ii) counterparts of the Security Agreement, and each other Collateral Document, executed by a 

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Responsible Officer of the Borrower and a duly authorized officer of each other Person party thereto, as applicable and (iii) counterparts of any other Loan Document, executed by a Responsible Officer of the Borrower and a duly authorized officer of each other Person party thereto.
(b)    Cash Collateral.  The Lender shall have received Approved Cash Collateral in an amount at least equal to Minimum Collateral Amount, which Approved Cash Collateral shall be maintained in the Cash Collateral Account.
(c)    Officer’s Certificate.  The Lender shall have received a certificate of a Responsible Officer of the Borrower dated the Closing Date, certifying (i) as to the Organization Documents of the Borrower (which, to the extent filed with a Governmental Authority, shall be certified as of a recent date by such Governmental Authority), the resolutions of the governing body of the Borrower, the good standing, existence or its equivalent of the Borrower and of the incumbency (including specimen signatures) of the Responsible Officers of the Borrower, (ii) as to the accuracy of the representations and warranties of the Borrower contained in Article II, Article V and in the other  Loan Documents, (iii) that no Default exists, or would result from the proposed Term Borrowing on the Closing Date or from the application of the proceeds thereof, (iv) that since the date of the Audited Financial Statements no event or condition has occurred that has had or would be reasonably expected, either individually or in the aggregate, to have a Material Adverse Effect, and (v) that no actions, suits, proceedings, claims or disputes are pending or, to the knowledge of the Borrower, threatened in writing, at law, in equity, in arbitration or before any Governmental Authority, by or against the Borrower or any Subsidiary or against any of their properties or revenues that (A) purport to affect or pertain to this Agreement or any other Loan Document or any of the transactions contemplated hereby or (B) either individually or in the aggregate would reasonably be expected to have a Material Adverse Effect.
(d)    Legal Opinions of Counsel.  The Lender shall have received an opinion or opinions of counsel for the Borrower, dated the Closing Date and addressed to the Lender, in form and substance reasonably acceptable to the Lender.
(e)    Personal Property Collateral.  The Lender shall have received, in form and substance reasonably satisfactory to the Lender:
(i)    (A) searches of UCC filings in the jurisdiction of incorporation or formation, as applicable, of the Borrower or where a filing would need to be made in order to perfect the Lender’s security interest in the Collateral, copies of the financing statements on file in such jurisdictions and (B) tax lien, judgment and bankruptcy searches reasonably requested by Lender, the results of which searches shall be reasonably satisfactory to the Lender; and
(ii)    completed UCC financing statements for each appropriate jurisdiction as is necessary, in the Lender’s sole discretion, to perfect the Lender’s security interest in the Collateral.
(f)    Loan Notice.  The Lender shall have received a Loan Notice with respect to the Term Loan to be made on the Closing Date.

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(g)    Consents.  The Lender shall have received a certificate of a Responsible Officer of the Borrower either (i) attaching copies of all consents, licenses and approvals required in connection with the consummation by the Borrower of the transactions contemplated by the Loan Documents and the execution, delivery and performance by the Borrower and the validity against the Borrower of the Loan Documents to which it is a party, and such consents, licenses and approvals shall be in full force and effect, or (ii) stating that no such consents, licenses or approvals are so required.
(h)    Material Adverse Effect.  The Lender shall be satisfied that there shall not have occurred since the date of the Audited Financial Statements any event or condition that has had or would be reasonably expected, either individually or in the aggregate, to have a Material Adverse Effect.
(i)    Fees and Expenses.  (i) All fees required to be paid to the Lender on or before the Closing Date shall have been paid and (ii) unless waived by the Lender, the Borrower shall have paid all expenses (including, the fees, charges and disbursements of counsel to the Lender (directly to such counsel if requested by the Lender), plus such additional amounts of such fees, charges and disbursements as shall constitute its reasonable estimate of such fees, charges and disbursements incurred or to be incurred by it through the closing proceedings (provided that such estimate shall not thereafter preclude a final settling of accounts between the Borrower and the Lender)) of the Lender payable pursuant to the Loan Documents, in each case, to the extent invoiced two (2) Business Days prior to the Closing Date (or such later date as may be agreed to by the Borrower).
(j)    Due Diligence.  The Lender shall have completed a due diligence investigation of the Borrower and its Subsidiaries in scope, and with results, satisfactory to the Lender, including, without limitation, OFAC, the United States Foreign Corrupt Practices Act of 1977 and “know your customer” due diligence.  The Borrower shall have provided to the Lender the documentation and other information requested by the Lender in order to comply with applicable Law, including, without limitation, the Act.
(k)    Other Documents.  All other documents provided for herein or which the Lender may reasonably request or require.
(l)    Additional Information.  Such additional information and materials which the Lender shall reasonably request or require.
ARTICLE V 
 
REPRESENTATIONS AND WARRANTIES
The Borrower represents and warrants to the Lender that:
5.01    Existence, Qualification and Power.
The Borrower and each of its Subsidiaries (a) is duly organized or formed, validly existing and, as applicable, in good standing under the Laws of the jurisdiction of its incorporation or organization, (b) has all requisite power and authority and all requisite governmental licenses, 

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authorizations, consents and approvals to (i) own or lease its assets and carry on its business and (ii) execute, deliver and perform its obligations under the Loan Documents to which it is a party, and (c) is duly qualified and is licensed and, as applicable, in good standing under the Laws of each jurisdiction where its ownership, lease or operation of properties or the conduct of its business requires such qualification or license; except in each case referred to in clause (a) (solely with respect to any Subsidiary of the Borrower), (b)(i) or (c), to the extent that failure to do so would not reasonably be expected to have a Material Adverse Effect.  Schedule 5.01 sets forth as of the Closing Date the Borrower’s exact legal name, the jurisdiction of its incorporation, the address of its principal place of business and its U.S. taxpayer identification number.  The copy of the Organization Documents of the Borrower provided to the Lender pursuant to the terms of this Agreement is a true and correct copy of each such document, each of which is valid and in full force and effect on the Closing Date.
5.02    Authorization; No Contravention.
The execution, delivery and performance by the Borrower of each Loan Document have been duly authorized by all necessary corporate or other organizational action, and do not and will not (a) contravene the terms of any of the Borrower’s Organization Documents; (b) result in the imposition or the creation of (or requirement to create) any Lien on any asset of the Borrower; (c) conflict with or result in any breach or contravention of or require any payment (other than in any immaterial amount) to be made under (i) any Contractual Obligation to which the Borrower is a party or affecting the Borrower or its properties or any of its Subsidiaries or (ii) any order, injunction, writ or decree of any Governmental Authority or any arbitral award to which the Borrower or its property is subject; or (c) violate in any Law; except in each case referred to in clauses (c) or (d) above, to the extent that such conflict, breach, contravention or violation would not reasonably be expected to have a Material Adverse Effect.
5.03    Governmental Authorization; Other Consents.
No approval, consent, exemption, authorization, or other action by, or notice to, or filing with, any Governmental Authority or any other Person is necessary or required in connection with (a) the execution, delivery or performance by, or enforcement against, the Borrower of this Agreement or any other Loan Document, (b) the grant by the Borrower of the Liens granted by it pursuant to the Collateral Documents, (c) the perfection or maintenance of the Liens created under the Collateral Documents (including the first priority nature thereof) or (d) the exercise by the Lender of its rights under the Loan Documents or the remedies in respect of the Collateral pursuant to the Collateral Documents, other than (i) authorizations, approvals, actions, notices and filings which have been duly obtained and (ii) filings to perfect the Liens created by the Collateral Documents.
5.04    Binding Effect.
This Agreement has been, and each other Loan Document, when delivered hereunder, will have been, duly executed and delivered by the Borrower.  This Agreement constitutes, and each other Loan Document when so delivered will constitute, a legal, valid and binding obligation of the Borrower, enforceable against the Borrower in accordance with its terms, subject to applicable 

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bankruptcy, insolvency, reorganization, moratorium or other laws affecting creditors’ rights generally and subject to general principles of equity, regardless of whether considered in proceedings in equity or at law.
5.05    No Default.
Neither the Borrower nor any Subsidiary thereof is in default under or with respect to, or a party to, any Contractual Obligation that would, either individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.  No Default has occurred and is continuing or would result from the consummation of the transactions contemplated by this Agreement or any other Loan Document.
5.06    Margin Regulations; Investment Company Act.
(a)    Margin Regulations.  The Borrower is not engaged and will not engage, principally or as one of its important activities, in the business of purchasing or carrying margin stock (within the meaning of Regulation U issued by the FRB), or extending credit for the purpose of purchasing or carrying margin stock.  Following the application of the proceeds of each Term Borrowing, not more than twenty-five percent (25%) of the value of the assets (either of the Borrower only or of the Borrower and its Subsidiaries on a consolidated basis) subject to any restriction contained in any agreement or instrument between the Borrower and the Lender or any Affiliate of the Lender relating to Indebtedness and within the scope of Section 8.01(e) will be margin stock.
(b)    Investment Company Act.  Neither the Borrower nor any Subsidiary is or is required to be registered as an “investment company” under the Investment Company Act of 1940.
5.07    Disclosure.
The (a) Form 10-Q of the Borrower prepared for the fiscal quarter ended March 31, 2018, and (b) Form 10-K of the Borrower prepared for the fiscal year ended December 31, 2017, when each was filed with the SEC or amended, conformed in all material respects to the requirements of the Securities Act or the Exchange Act, as applicable.  No report, financial statement, certificate or other information furnished in writing by the Borrower to the Lender in connection with the transactions contemplated hereby and the negotiation of this Agreement or delivered hereunder or under any other Loan Document (in each case as modified or supplemented by other information so furnished), when taken as a whole, contains any untrue statement of a material fact or omits to state a material fact necessary in order to make the statements made, in the light of the circumstances under which they were made, not misleading; provided that, with respect to projected financial information, the Borrower represents only that such information was prepared in good faith based upon assumptions believed to be reasonable at the time (it being understood that projections and forecasts are not a guarantee of financial performance and actual results may vary materially from the projections and forecasts).

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5.08    Sanctions Concerns and Anti-Corruption Laws.
(a)    Sanctions Concerns. Neither the Borrower, nor any Subsidiary, nor, to the knowledge of the Borrower and its Subsidiaries, any director, officer, employee, agent, affiliate or representative thereof, is an individual or entity  that is, or is owned or controlled by any individual or entity that is (i) currently the subject or target of any Sanctions, (ii) included on OFAC’s List of Specially Designated Nationals, HMT’s Consolidated List of Financial Sanctions Targets and the Investment Ban List, or any similar list enforced by any other relevant sanctions authority or (iii) located, organized or resident in a Designated Jurisdiction.
(b)    Anti-Corruption Laws.  The Borrower and its Subsidiaries have conducted their business in compliance with the United States Foreign Corrupt Practices Act of 1977, the UK Bribery Act 2010 and other similar anti-corruption legislation in other jurisdictions, and have instituted and maintained policies and procedures designed to promote and achieve compliance with such laws.
5.09    Subsidiaries.  Each Subsidiary of the Borrower as of the Closing Date is listed on Schedule 5.09.  
ARTICLE VI 
 
AFFIRMATIVE COVENANTS
The Borrower hereby covenants and agrees that on the Closing Date and thereafter until the Facility Termination Date, the Borrower shall, and shall cause each of its Subsidiaries to:
6.01    Financial Statements.
Deliver to the Lender, in form and detail reasonably satisfactory to the Lender:
(a)    Audited Financial Statements.  As soon as available, but in any event within one hundred twenty (120) days after the end of each fiscal year of the Borrower, a Consolidated balance sheet of the Borrower and its Subsidiaries as at the end of such fiscal year, and the related Consolidated statements of income (loss) or operations, changes in stockholders’ equity and cash flows for such fiscal year, setting forth in each case in comparative form the figures for the previous fiscal year, all in reasonable detail and prepared in accordance with GAAP, audited and accompanied by a report and opinion of an independent certified public accountant of nationally recognized standing reasonably acceptable to the Lender, which report and opinion shall be prepared in accordance with generally accepted auditing standards and, shall not be subject to any “going concern” or like qualification or exception or any qualification or exception as to the scope of such audit.
(b)    Quarterly Financial Statements.  As soon as available, but in any event within sixty (60) days after the end of each of the first three (3) fiscal quarters of each fiscal year of the Borrower, a Consolidated balance sheet of the Borrower and its Subsidiaries as at the end of such fiscal quarter, and the related Consolidated statements of income (loss) or operations, statements of stockholders’ equity and cash flows for such fiscal quarter and for the portion of the Borrower’s fiscal year then 

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ended, setting forth in each case in comparative form the figures for the corresponding fiscal quarter of the previous fiscal year and the corresponding portion of the previous fiscal year, all in reasonable detail and prepared in accordance with GAAP certified by the chief executive officer, chief financial officer, treasurer or controller who is a Responsible Officer of the Borrower as fairly presenting in all material respects the financial condition, results of operations, stockholders’ equity and cash flows of the Borrower and its Subsidiaries, subject only to normal year-end audit adjustments and the absence of footnotes.
(c)    Annual Budget.  As soon as available, but in any event within ninety (90) days after the end of each fiscal year of the Borrower, an annual budget of the Borrower and its Subsidiaries on a Consolidated basis, prepared by management of the Borrower and approved by the Borrower’s board of directors, in form reasonably satisfactory to the Lender, consisting of Consolidated balance sheets and statements of income or operations and cash flows of the Borrower and its Subsidiaries on a quarterly basis for the immediately following fiscal year.
6.02    Certificates; Other Information.
Deliver to the Lender, in form and detail reasonably satisfactory to the Lender:
(a)    Financial Statement Certificate.  Concurrently with the delivery of the financial statements referred to in Section 6.01(a) and (b) a duly completed Financial Statement Certificate signed by the chief executive officer, chief financial officer, treasurer or controller which is a Responsible Officer of the Borrower.  Unless the Lender requests executed originals, delivery of the Financial Statement Certificate may be by electronic communication including fax or email and shall be deemed to be an original and authentic counterpart thereof for all purposes.
(b)    [Reserved].
(c)    Annual Reports; Etc.  Promptly after the same are available, copies of each annual report, proxy or financial statement or other material report or communication sent to the stockholders of the Borrower, and copies of all annual, regular, periodic and special reports and registration statements which the Borrower may file or be required to file with the SEC under Section 13 or 15(d) of the Exchange Act, or with any national securities exchange, and in any case not otherwise required to be delivered to the Lender pursuant hereto.
(d)    Debt Securities Statements and Reports.  Promptly, but in any event within five (5) Business Days after receipt thereof by the Borrower or any Subsidiary thereof, copies of all notices, requests and other documents (including amendments, waivers and other modifications) so received under or pursuant to any instrument, indenture, loan or credit or similar agreement (on account of Indebtedness in excess of the Threshold Amount) regarding or related to any event of default or other material breach by the Borrower.
(e)    Reserved. 
(f)    FDA Notices.  Promptly, and in any event within fifteen (15) Business Days after receipt thereof by the Borrower or any of its Subsidiaries, copies of each material notice from the 

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FDA (or comparable agency in any applicable non-U.S. jurisdiction or state or local Governmental Authority) concerning any material investigation or other adverse material inquiry, or material and adverse finding or material determination with respect to any product developed, manufactured, sold or distributed by the Borrower or any of its Subsidiaries (including any notification seeking a recall, removal or corrective action affecting the products developed, manufactured, sold or distributed by the Borrower or such Subsidiary), including, without limitation, the receipt by the Borrower or any of its Subsidiaries of any so called “warning letter”, “untitled letter”, FDA Form 483 or similar notification, in each case, from the FDA (or analogous foreign, state or local Governmental Authority) to the extent material to the Borrower and its Subsidiaries taken as a whole.
(g)    Additional Information.  Promptly, such additional information regarding the business, financial, legal (excluding information that Borrower determines is reasonably necessary to preserve attorney-client privilege) or corporate affairs of the Borrower or any Subsidiary thereof, or compliance with the terms of the Loan Documents, as the Lender may from time to time reasonably request.
Documents required to be delivered pursuant to Section 6.01(a) or (b) or Section 6.02(c) (to the extent any such documents are included in materials otherwise filed with the SEC) may be delivered electronically and if so delivered, shall be deemed to have been delivered on the date (a) on which the Borrower posts such documents, or provides a link thereto on the Borrower’s website on the Internet at the website address listed on Schedule 1.01(a) or on which such financial statements and/or other documents are posted on the SEC’s website on the Internet at www.sec.gov; or (b) on which such documents are posted on the Borrower’s behalf on an Internet or intranet website, if any, to which the Lender has access (whether a commercial, third-party website or whether sponsored by the Lender); provided that, the Borrower shall deliver paper copies of such documents to the Lender upon its reasonable request to the Borrower to deliver such paper copies until a written request to cease delivering paper copies is given by the Lender.
6.03    Notices.
Promptly, but in any event within three (3) Business Days, upon any Responsible Officer of the Borrower becoming aware of such event (or, if earlier, the date that any Responsible Officer of the Borrower should have been aware of such event), notify the Lender:
(a)    of the occurrence of any Default;
(b)    of any matter that has resulted or could reasonably be expected to result in a Material Adverse Effect, including (i) breach or non-performance of, or any default under, a Contractual Obligation of the Borrower or any Subsidiary; (ii) any dispute, litigation, investigation, proceeding or suspension between the Borrower or any Subsidiary and any Governmental Authority; or (iii) the commencement of, or any material development in, any litigation or proceeding affecting the Borrower or any Subsidiary, including pursuant to or involving any applicable Environmental Laws; 
(c)    of the occurrence of any ERISA Event; and

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(d)    incurrence of Indebtedness in an amount equal to or greater than $10,000,000.
Each notice pursuant to this Section 6.03 shall be accompanied by a statement of a Responsible Officer of the Borrower setting forth details of the occurrence referred to therein and to the extent applicable, stating what action the Borrower has taken and proposes to take with respect thereto.  Each notice pursuant to Section 6.03(a) shall describe with particularity any and all provisions of this Agreement and any other Loan Document that have been breached, if applicable.
6.04    Preservation of Existence.
(a) Preserve, renew and maintain in full force and effect its legal existence and good standing under the Laws of the jurisdiction of its organization except, solely with respect to any Subsidiary of the Borrower,  to the extent that failure to do so would not reasonably be expected to have a Material Adverse Effect; (b) maintain all material rights, properties, privileges, permits, licenses and franchises necessary in the normal conduct of the business of the Borrower or any Subsidiary (except to the extent the maintenance thereof is no longer desirable in the conduct of the business of the Borrower and its Subsidiaries and that the loss thereof is not disadvantageous in any material respect to the Lender and the other Secured Parties); and (c) preserve or renew all of its registered patents, trademarks, trade names and service marks that are material to the business of the Borrower and its Subsidiaries, taken as a whole (provided that clauses (b) and (c) shall not restrict the ability of the Borrower or any of its Subsidiaries to abandon intellectual property rights which are uneconomical, negligible, obsolete or otherwise not material in the conduct of the business of the Borrower and its Subsidiaries, taken as a whole).
6.05    Compliance with Laws.
(a)    Comply in all material respects with the requirements of all Laws and all orders, writs, injunctions and decrees applicable to it or to its business or property, except in such instances in which (i) such requirement of Law or order, writ, injunction or decree is being contested in good faith by appropriate proceedings diligently conducted; or (ii) the failure to comply therewith would not reasonably be expected to have a Material Adverse Effect.
(b)    Conduct its business in compliance with the United States Foreign Corrupt Practices Act of 1977, the UK Bribery Act 2010 and other similar anti-corruption legislation in other jurisdictions and maintain policies and procedures designed to promote and achieve compliance with such laws.
6.06    Inspection Rights.
Upon two (2) Business Days prior notice, permit representatives, agents and independent contractors of the Lender to visit and inspect any of its properties, to examine its corporate, financial and operating records, and make copies thereof or abstracts therefrom, and to discuss its affairs, finances and accounts with its directors, officers, and independent public accountants (provided that, with respect to such independent public accountants, a Responsible Officer of the Borrower is present) at such reasonable times during normal business hours and  upon reasonable advance notice to the Borrower; provided, however, that (a) except during the occurrence and continuance 

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of an Event of Default (i) the Borrower shall not be required to reimburse the Lender for the charges, costs and expenses in connection with more than one such visit per year and (ii) the Lender shall not exercise its rights under this Section 6.06 more than one (1) time per fiscal year and (b) when an Event of Default exists the Lender (or any of its representatives, agents or independent contractors) may do any of the foregoing at the expense of the Borrower at any time during normal business hours and without advance notice.
6.07    Use of Proceeds.
Use the proceeds of the Term Borrowings solely for working capital and general corporate purposes not in contravention of any Law or of any Loan Document and not use such Loan proceeds, directly or indirectly, immediately, incidentally or ultimately, to purchase or carry margin stock (within the meaning of Regulation U of the FRB) or to extend credit to others for the purpose of purchasing or carrying margin stock or to refinance or refund indebtedness originally incurred for such purpose.
6.08    Collateral; Further Assurances.
(a)    Maintain all Collateral free and clear of all Liens (other than the Lien of the Lender securing the Secured Obligations and Permitted Liens); and
(b)    Promptly upon request by the Lender, (i) correct any material defect or error that may be discovered in any Loan Document or in the execution, acknowledgment, filing or recordation thereof, and (ii) do, execute, acknowledge, deliver, record, re-record, file, re-file, register and re-register any and all such further acts, deeds, certificates, assurances and other instruments as the Lender may reasonably require from time to time in order to (A) carry out more effectively the express purposes of the Loan Documents, (B)  perfect and maintain the validity, effectiveness and priority of any of the Collateral Documents and any of the Liens intended to be created thereunder (including, without limitation, promptly executing and delivering any and all further instruments and documents and taking all such other action as the Lender may deem reasonably necessary to maintain in favor of the Lender, for the benefit of the Secured Parties, Liens on the Collateral that are duly perfected in accordance with the requirements of, or the obligations of the Borrower under, the Loan Documents and all applicable Laws) and (C) assure, convey, grant, assign, transfer, preserve, protect and confirm more effectively unto the Secured Parties the rights granted or now or hereafter intended to be granted to the Secured Parties under any Loan Document or under any other instrument executed in connection with any Loan Document to which the Borrower or any of its Subsidiaries is or is to be a party, and cause each of its Subsidiaries to do so.
ARTICLE VII 
 
NEGATIVE COVENANTS
The Borrower hereby covenants and agrees that on the Closing Date and thereafter until the Facility Termination Date, the Borrower shall not, nor shall it permit any Subsidiary to, directly or indirectly:

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7.01    Change in Nature of Business.
(a) Engage in any material line of business substantially different from those lines of business conducted by the Borrower and its Subsidiaries on the date hereof or any business substantially related, complementary or incidental thereto or a reasonable extension thereof (and non-core incidental businesses acquired in connection with any acquisition or investment or other immaterial businesses) or (b) suspend operating or cease to operate a substantial portion of its or their business as conducted by the Borrower and its Subsidiaries on the date hereof; provided, however, for the avoidance of doubt nothing herein shall prohibit (x) the Borrower or any Subsidiary from changing its focus to a different therapeutic area(s) or disease target(s) or (y) the Borrower from dissolving, liquidating or winding up any Subsidiary outside of any insolvency or bankruptcy proceeding.
7.02    Use of Proceeds.
Use the proceeds of the Term Loans, whether directly or indirectly, and whether immediately, incidentally or ultimately, to purchase or carry margin stock (within the meaning of Regulation U of the FRB) or to extend credit to others for the purpose of purchasing or carrying margin stock or to refund indebtedness originally incurred for such purpose.
7.03    Sanctions; Anti-Corruption Laws.
(a)    Use the Term Loans or the proceeds of any Term Loan, or lend, contribute or otherwise make available such Term Loan or the proceeds of any Term Loan to any Person, to fund any activities of or business with any Person, or in any Designated Jurisdiction, that, at the time of such funding, is the subject of Sanctions, or in any other manner that will result in a violation by any Person of Sanctions.
(b)    Use any Term Loan or the proceeds of any Term Loan for any purpose which would breach the United States Foreign Corrupt Practices Act of 1977, the UK Bribery Act 2010 and other similar anti-corruption legislation in other jurisdictions.
7.04    Indebtedness.  
Create, incur, assume or permit to exist any Indebtedness resulting from borrowings, loans or advances, whether secured or unsecured, matured or unmatured, liquidated or unliquidated, joint or several, except (a) Indebtedness of the Borrower to the Lender, (b) Indebtedness (contingent or otherwise) existing or arising under any Swap Contract, provided that such obligations are (or were) entered into by such Person in the ordinary course of business for the purpose of directly mitigating risks associated with fluctuations in interest rates or foreign exchange rates, (c) any other Indebtedness of Borrower existing as of, and disclosed to Bank prior to, the date hereof and set forth on Schedule 7.04, in each case, any refinancings, refundings, renewals or extensions thereof; provided that the amount of such Indebtedness is not increased at the time of such refinancing, refunding, renewal or extension, (d) Subordinated Indebtedness; provided, that both before and after the incurrence of such Subordinated Indebtedness, no Default or Event of Default shall have occurred or would be caused by the incurrence of such Subordinated Indebtedness, and (e) other 

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Indebtedness, whether secured or unsecured (so long as no Lien is granted on the Collateral), so long as the aggregate amount of such Indebtedness does not exceed $25,000,000.
7.05    Minimum Liquidity. 
Permit the Liquidity Ratio to be less than 2.0 to 1.0 at any time.  
ARTICLE VIII
 
EVENTS OF DEFAULT AND REMEDIES
8.01    Events of Default.
Any of the following shall constitute an Event of Default:
(a)    Non-Payment.  The Borrower fails to pay (i) when and as required to be paid herein, any amount of principal of any Loan, or (ii) within three (3) Business Days after the same becomes due, any interest on any Term Loan, any fee due hereunder, or any other amount payable hereunder or under any other Loan Document; or
(b)    Specific Covenants.  (i) The Borrower fails to perform or observe any term, covenant or agreement contained in any of Section 2.09(b) (and such failure continues for three (3) Business Days), 2.10(a) (and such failure continues for three (3) Business Days), Article VI, Article VII, or (ii) the Borrower fails to perform or observe any term, covenant or agreement contained in the Security Agreement after giving effect to any notice or grace periods applicable thereto; or
(c)    Other Defaults.  The Borrower fails to perform or observe any other covenant or agreement (not specified in Section 8.01(a) or (b) above) contained in any Loan Document on its part to be performed or observed and such failure continues for thirty (30) days; or
(d)    Representations and Warranties.  Any representation, warranty, certification or statement of fact made in writing or deemed made by the Borrower herein or in any other Loan Document shall be incorrect or misleading in any material respect (or, if any such representation, warranty, certification or statement of fact is by its terms qualified by concepts of materiality, such representation, warranty, certification or statement of fact shall be incorrect or misleading in any respect) when made or deemed made; or
(e)    Cross-Default.  (i) The Borrower or any Subsidiary (A) fails to make any payment when due (whether by scheduled maturity, required prepayment, acceleration, demand, or otherwise) in respect of any Indebtedness or Guarantee (other than Indebtedness hereunder and Indebtedness under Swap Contracts) having an aggregate principal amount (including undrawn committed or available amounts and including amounts owing to all creditors under any combined or syndicated credit arrangement) of more than the Threshold Amount beyond any period of grace provided with respect thereto, or (B) fails to observe or perform any other agreement or condition relating to any such Indebtedness or Guarantee or contained in any instrument or agreement evidencing, securing or relating thereto, or any other event occurs, the effect of which default or other event is to cause, 

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or to permit the holder or holders of such Indebtedness or the beneficiary or beneficiaries of such Guarantee (or a trustee or agent on behalf of such holder or holders or beneficiary or beneficiaries) to cause (in each case after giving effect to any applicable notice or grace period) such Indebtedness to be demanded or to become due or to be repurchased, prepaid, defeased or redeemed (automatically or otherwise), or an offer to repurchase, prepay, defease or redeem such Indebtedness to be made, prior to its stated maturity, or such Guarantee to become payable or cash collateral in respect thereof to be demanded; (ii) there occurs under any Swap Contract an Early Termination Date (as defined in such Swap Contract) resulting from (A) any event of default under such Swap Contract as to which the Borrower or any Subsidiary is the Defaulting Party (as defined in such Swap Contract) or (B) any Termination Event (as so defined) under such Swap Contract as to which the Borrower or any Subsidiary thereof is an Affected Party (as so defined) and, in either event, the Swap Termination Value owed by the Borrower or such Subsidiary as a result thereof is greater than the Threshold Amount; or
(f)    Insolvency Proceedings, Etc.  The Borrower or any Subsidiary institutes or consents to the institution of any proceeding under any Debtor Relief Law, or makes an assignment for the benefit of creditors; or applies for or consents to the appointment of any receiver, trustee, custodian, conservator, liquidator, rehabilitator or similar officer for it or for all or any material part of its property; or any receiver, trustee, custodian, conservator, liquidator, rehabilitator or similar officer is appointed without the application or consent of such Person and the appointment continues undischarged or unstayed for sixty (60) calendar days; or any proceeding under any Debtor Relief Law relating to any such Person or to all or any material part of its property is instituted without the consent of such Person and continues undismissed or unstayed for sixty (60) calendar days, or an order for relief is entered in any such proceeding; or
(g)    Inability to Pay Debts; Attachment.  (i) The Borrower or any Subsidiary becomes unable or admits in writing its inability or fails generally to pay its debts as they become due, or (ii) any writ or warrant of attachment or execution or similar process is issued or levied against all or any material part of the property of any such Person and is not released, vacated or fully bonded within forty-five (45) days after its issue or levy.
(h)    Judgments.  There is entered against the Borrower or any Subsidiary (i) one or more unsatisfied final judgments or orders for the payment of money in an aggregate amount (as to all such judgments and orders) exceeding the Threshold Amount (to the extent not covered by independent third-party insurance as to which the insurer is rated at least “A” by A.M. Best Company, has been notified of the potential claim and does not dispute coverage), or (ii) any one or more non-monetary final judgments that have, or could reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect and, in either case of clauses (i) or (ii) above, (A) enforcement proceedings are commenced by any creditor upon such judgment or order, or (B) there is a period of thirty (30) consecutive days during which a stay of enforcement of such judgment, by reason of a pending appeal or otherwise, is not in effect; or
(i)    ERISA.  (i) An ERISA Event occurs with respect to a Pension Plan or Multiemployer Plan which has resulted or would reasonably be expected to result in liability of the Borrower under Title IV of ERISA to the Pension Plan, Multiemployer Plan or the PBGC in an aggregate amount 

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in excess of the Threshold Amount, or (ii) the Borrower or any ERISA Affiliate fails to pay when due, after the expiration of any applicable grace period, any installment payment with respect to its withdrawal liability under Section 4201 of ERISA under a Multiemployer Plan in an aggregate amount in excess of the Threshold Amount; or
(j)    Invalidity of Loan Documents.  Any provision of any Loan Document, at any time after its execution and delivery and for any reason other than as expressly permitted hereunder or thereunder or satisfaction in full of all Obligations arising under the Loan Documents, ceases to be in full force and effect; or the Borrower or any other Person contests in any manner the validity or enforceability of any provision of any Loan Document; or the Borrower denies that it has any or further liability or obligation under any provision of any Loan Document, or purports to revoke, terminate or rescind any provision of any Loan Document; or
(k)    Collateral Documents.  (i) Any Collateral Document after delivery thereof pursuant to the terms of the Loan Documents shall for any reason cease to create a valid and perfected first priority Lien on the Collateral purported to be covered thereby, or the Borrower shall assert the invalidity of such Liens, or (ii) any Collateral shall be subject to a Lien in favor of any Person (other than (x) the Lien of the Lender securing the Secured Obligations and (y) Permitted Liens); or
(l)    Change of Control.  There occurs any Change of Control.
If a Default shall have occurred under the Loan Documents, then such Default will continue to exist until it either is cured (to the extent specifically permitted) in accordance with the Loan Documents or is otherwise expressly waived by Lender as determined in accordance with Section 9.01; and once an Event of Default occurs under the Loan Documents, then such Event of Default will continue to exist until it is expressly waived by the Lender, as required hereunder in Section 9.01.
8.02    Remedies upon Event of Default.
If any Event of Default occurs and is continuing, the Lender may take any or all of the following actions:
(a)    declare the Term Commitment (if any) to be terminated, whereupon such commitments and obligation shall be terminated;
(b)    declare the unpaid principal amount of all outstanding Term Loans, all interest accrued and unpaid thereon, and all other amounts owing or payable hereunder or under any other Loan Document to be immediately due and payable, without presentment, demand, protest or other notice of any kind, all of which are hereby expressly waived by the Borrower;
(c)    apply Cash Collateral to the Secured Obligations; and
(d)    exercise all other rights and remedies available to it under the Loan Documents or applicable Law or equity;

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provided, however, that upon the occurrence of an Event of Default under Section 8.01(f), the obligation of the Lender to make Term Loans shall automatically terminate, the unpaid principal amount of all outstanding Term Loans and all interest and other amounts as aforesaid shall automatically become due and payable, in each case without further act of the Lender.
8.03    Application of Funds.
After the exercise of remedies provided for in Section 8.02 (or after the Term Loans have automatically become immediately due and payable), all Collateral or any other amounts received on account of the Secured Obligations shall be applied to the Secured Obligations in the manner and in such order (including, to be retained as cash collateral for such Secured Obligations) as determined by the Lender in its sole discretion.  
ARTICLE IX
 
MISCELLANEOUS
9.01    Amendments, Etc.
No amendment or waiver of any provision of this Agreement or any other Loan Document, and no consent to any departure by the Borrower therefrom, shall be effective unless in writing signed by the Lender and the Borrower, and each such waiver or consent shall be effective only in the specific instance and for the specific purpose for which given.
9.02    Notices; Effectiveness; Electronic Communications.
(a)    Notices Generally.  Except in the case of notices and other communications expressly permitted to be given by telephone (and except as provided in subsection (b) below), all notices and other communications provided for herein or in any other Loan Document shall be in writing and shall be delivered by hand or overnight courier service, mailed by certified or registered mail or sent by fax transmission or e-mail transmission as follows, and all notices and other communications expressly permitted hereunder to be given by telephone shall be made to the applicable telephone number, to the address, fax number, e-mail address or telephone number specified for the Borrower or the Lender on Schedule 1.01(a).
Notices and other communications sent by hand or overnight courier service, or mailed by certified or registered mail, shall be deemed to have been given when received; notices and other communications sent by fax transmission shall be deemed to have been given when sent (except that, if not given during normal business hours for the recipient, shall be deemed to have been given at the opening of business on the next Business Day for the recipient).  Notices and other communications delivered through electronic communications to the extent provided in subsection (b) below shall be effective as provided in such subsection (b).
(b)    Electronic Communications.  Notices and other communications to the Lender hereunder may be delivered or furnished by electronic communication (including e-mail, FpML messaging and Internet or intranet websites) pursuant to procedures approved by the Lender.  The 

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Lender and the Borrower may each, in its discretion, agree to accept notices and other communications to it hereunder by electronic communications pursuant to procedures approved by it, provided that approval of such procedures may be limited to particular notices or communications.
Unless the Lender otherwise prescribes, (i) notices and other communications sent to an e-mail address shall be deemed received upon the sender’s receipt of an acknowledgement from the intended recipient (such as by the “return receipt requested” function, as available, return e-mail or other written acknowledgement), and (ii) notices and other communications posted to an Internet or intranet website shall be deemed received by the intended recipient upon the sender’s receipt  of an acknowledgement by the intended recipient (such as by the “return receipt requested” function, as available, return email address or other written acknowledgement) indicating that such notice or communication is available and identifying the website address therefor; provided that, for both clauses (i) and (ii), if such notice, email or other communication is not sent during the normal business hours of the recipient, such notice, email or communication shall be deemed to have been sent at the opening of business on the next Business Day for the recipient.
(c)    Change of Address, Etc.  The Borrower and the Lender may change its address, fax number or telephone number or e-mail address for notices and other communications hereunder by notice to the other parties hereto.
(d)    Reliance by Lender.  The Lender shall be entitled to rely and act upon any notices (including, without limitation, telephonic or electronic notices, Loan Notices and Notice of Loan Prepayment) purportedly given by or on behalf of the Borrower even if (i) such notices were not made in a manner specified herein, were incomplete or were not preceded or followed by any other form of notice specified herein, or (ii) the terms thereof, as understood by the recipient, varied from any confirmation thereof.  The Borrower shall indemnify the Lender and the Related Parties of each of them from all losses, costs, expenses and liabilities resulting from the reliance by such Person on each notice purportedly given by or on behalf of the Borrower, except in the case of the Lender’s bad faith, gross negligence or willful misconduct as determined by a court of competent jurisdiction a final and nonappealable judgment in the Borrower’s favor with respect to such claim.  All telephonic notices to and other telephonic communications with the Lender may be recorded by the Lender, and each of the parties hereto hereby consents to such recording.
9.03    No Waiver; Cumulative Remedies; Enforcement.
No failure by the Lender to exercise, and no delay by any such Person in exercising, any right, remedy, power or privilege hereunder or under any other Loan Document shall operate as a waiver thereof; nor shall any single or partial exercise of any right, remedy, power or privilege hereunder or under any other Loan Document preclude any other or further exercise thereof or the exercise of any other right, remedy, power or privilege.  The rights, remedies, powers and privileges herein provided, and provided under each other Loan Document, are cumulative and not exclusive of any rights, remedies, powers and privileges provided by law.

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9.04    Expenses; Indemnity; Damage Waiver.
(a)    Costs and Expenses.  The Borrower shall pay (i) all reasonable and documented out-of-pocket expenses incurred by the Lender and its Affiliates (including the reasonable and documented fees, charges and disbursements of counsel for the Lender), in connection with the preparation, negotiation, execution, delivery and administration of this Agreement and the other Loan Documents or any amendments, modifications or waivers of the provisions hereof or thereof (whether or not the transactions contemplated hereby or thereby shall be consummated), and (ii) all reasonable and documented out-of-pocket expenses incurred by the Lender (including the reasonable and documented fees, charges and disbursements of counsel for the Lender (limited to one counsel for the Lender and, if reasonably necessary, a single local counsel for the Lender in each relevant jurisdiction and, solely in the case of a conflict of interest, one additional counsel in each relevant jurisdiction to the Lender)), in connection with the enforcement or protection of its rights (A) in connection with this Agreement and the other Loan Documents, including its rights under this Section, or (B) in connection with Term Loans made hereunder, including all such reasonable and documented out-of-pocket expenses incurred during any workout, restructuring or negotiations in respect of such Term Loans.
(b)    Indemnification by the Borrower.  The Borrower shall indemnify the Lender and each Related Party (each such Person being called an “Indemnitee”) against, and hold each Indemnitee harmless from, any and all losses, claims, damages, liabilities and related reasonably documented and out-of-pocket expenses (including the reasonable fees, charges and disbursements of any counsel for any Indemnitee (limited to one counsel for all Indemnitees taken as a whole and, if reasonably necessary, a single local counsel for all Indemnitees taken as a whole in each relevant jurisdiction and, solely in the case of a conflict of interest, one additional counsel in each relevant jurisdiction to the affected Indemnitees similarly situated taken as a whole)), incurred by any Indemnitee or asserted against any Indemnitee by any Person (including the Borrower) arising out of, in connection with, or as a result of (i) the execution or delivery of this Agreement, any other Loan Document or any agreement or instrument contemplated hereby or thereby, the performance by the parties hereto of their respective obligations hereunder or thereunder or the consummation of the transactions contemplated hereby or thereby, or the administration of this Agreement and the other Loan Documents (including in respect of any matters addressed in Section 3.01), (ii) any Term Loan or the use of the proceeds therefrom, (iii) any actual or alleged presence or release of Hazardous Materials on or from any property owned or operated by the Borrower or any of its Subsidiaries, or any Environmental Liability related in any way to the Borrower or any of its Subsidiaries, or (iv) any actual or prospective claim, litigation, investigation or proceeding relating to any of the foregoing, whether based on contract, tort or any other theory, whether brought by a third party or by the Borrower or any of the Borrower’s directors, shareholders or creditors, and regardless of whether any Indemnitee is a party thereto, IN ALL CASES, WHETHER OR NOT CAUSED BY OR ARISING, IN WHOLE OR IN PART, OUT OF THE COMPARATIVE, CONTRIBUTORY OR SOLE NEGLIGENCE OF THE INDEMNITEE; provided that such indemnity shall not, as to any Indemnitee, be available to the extent that such losses, claims, damages, liabilities or related expenses are determined by a court of competent jurisdiction by final and nonappealable judgment to have resulted from (A) the bad faith, gross negligence or willful misconduct of such Indemnitee, (B) a material breach of the obligations of such Indemnitee under 

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the Loan Documents, or (C) any dispute solely among Indemnitees (other than (x) any claims against Wells Fargo in its capacity as, or in the fulfillment of its role, as Lender and (y) any claims arising out of any act or omission on the part of the Borrower or any of its Affiliates).  This Section 9.04(b) shall not apply with respect to taxes, other than taxes that represent losses, damages, etc. arising from any non-tax claim.
(c)    Waiver of Consequential Damages, Etc.  To the fullest extent permitted by applicable Law, no party hereto shall assert, and each party hereto hereby waives, and acknowledges that no other Person shall have (through such Person), any claim against any Indemnitee or any other party hereto, on any theory of liability, for special, indirect, consequential or punitive damages (as opposed to direct or actual damages) arising out of, in connection with, or as a result of, this Agreement, any other Loan Document or any agreement or instrument contemplated hereby, the transactions contemplated hereby or thereby, any Term Loan or the use of the proceeds thereof.  No Indemnitee referred to in subsection (b) above shall be liable for any damages arising from the use by unintended recipients of any information or other materials distributed to such unintended recipients by such Indemnitee through telecommunications, electronic or other information transmission systems in connection with this Agreement or the other Loan Documents or the transactions contemplated hereby or thereby.
(d)    Payments.  All amounts due under this Section shall be payable not later than ten (10) Business Days after written demand therefor.
(e)    Survival.  The agreements in this Section and the indemnity provisions of Section 9.02(d) shall survive the termination of the Term Commitment and the repayment, satisfaction or discharge of all the other Secured Obligations.
9.05    Payments Set Aside.
To the extent that any payment by or on behalf of the Borrower is made to the Lender, or the Lender exercises its right of setoff, and such payment or the proceeds of such setoff or any part thereof is subsequently invalidated, declared to be fraudulent or preferential, set aside or required (including pursuant to any settlement entered into by the Lender in its discretion) to be repaid to a trustee, receiver or any other party, in connection with any proceeding under any Debtor Relief Law or otherwise, then to the extent of such recovery, the obligation or part thereof originally intended to be satisfied shall be revived and continued in full force and effect as if such payment had not been made or such setoff had not occurred.
9.06    Successors and Assigns.
(a)    This Agreement is binding on the Borrower’s and the Lender’s successors and assignees.  The Borrower agrees that it may not assign this Agreement without the Lender’s prior consent.  Subject to the terms and conditions hereof, the Lender may sell participations in or assign this loan, and may exchange information about the Borrower (including, without limitation, any information regarding any hazardous substances) with actual or potential participants or assignees.   The consent of the Borrower (such consent not to be unreasonably withheld or delayed) shall be required with respect to any assignment by the Lender of the Term Loans to an assignee unless (1) 

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an Event of Default has occurred and is continuing at the time of such assignment or (2) such assignment is to another lender (party hereto by assignment (an “Assignee Lender”)), an Affiliate of an Assignee Lender or an Approved Fund; provided that the Borrower shall be deemed to have consented to any such assignment unless it shall object thereto by written notice to the Lender within five (5) Business Days after having received notice thereof.  If a participation is sold or the loan is assigned, the purchaser will have the right of set-off against the Borrower.  Notwithstanding anything herein to the contrary, no such assignment or participation shall be made to a natural person.  No participant shall be entitled to receive any greater payment under Sections 3.01 or 3.04, with respect to any participation, than the Lender from whom it acquired the applicable participation would have been entitled to receive, unless the sale of the participation to such participant is made with the Borrower’s prior written consent.
(b)    Lender, acting solely for this purpose as an agent of the Borrower, shall maintain at one of its offices a register for the recordation of the names and addresses of the Lenders, and the commitments of, and principal amounts (and stated interest) of the Term Loans owing to, each Lender pursuant to the terms hereof from time to time (the “Register”).  The entries in the Register shall be conclusive absent manifest error, and the Borrower and the Lenders shall treat each Person whose name is recorded in the Register pursuant to the terms hereof as a Lender hereunder for all purposes of this Agreement.  The Register shall be available for inspection by the Borrower and any Lender, at any reasonable time and from time to time upon reasonable prior notice. 
(c)    Each Lender that sells a participation shall, acting solely for this purpose as an agent of the Borrower, maintain a register on which it enters the name and address of each participant and the principal amounts (and stated interest) of each participant’s interest in the Loans or other obligations under the Loan Documents (the “Participant Register”); provided that no Lender shall have any obligation to disclose all or any portion of the Participant Register (including the identity of any participant or any information relating to a participant's interest in any commitments, loans, letters of credit or its other obligations under any Loan Document) to any Person except to the extent that such disclosure is necessary to establish that such commitment, loan, letter of credit or other obligation is in registered form under Section 5f.103-1(c) of the United States Treasury Regulations.  The entries in the Participant Register shall be conclusive absent manifest error, and such Lender shall treat each Person whose name is recorded in the Participant Register as the owner of such participation for all purposes of this Agreement notwithstanding any notice to the contrary.
9.07    Treatment of Certain Information; Confidentiality.
(a)    Treatment of Certain Information.  The Lender agrees to maintain the confidentiality of the Information (as defined below), except that Information may be disclosed (i) to its Affiliates and to its Related Parties (it being agreed that the Persons to whom such disclosure is made will be informed of the confidential nature of such Information and instructed to keep such Information confidential in accordance with the terms hereof), (ii) to the extent required or requested by any regulatory authority purporting to have jurisdiction over such Person or its Related Parties (including any self-regulatory authority, such as the National Association of Insurance Commissioners), (iii) to the extent required by applicable Laws or regulations or by any subpoena or similar legal process (in which case the Lender agrees, to the extent reasonably practicable, to inform the Borrower 

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promptly thereof prior to such disclosure to the extent not prohibited by Law), (iv) to any other party hereto, (v) in connection with the exercise of any remedies hereunder or under any other Loan Document or any action or proceeding relating to this Agreement or any other Loan Document or the enforcement of rights hereunder or thereunder, (vi) subject to an agreement containing provisions substantially the same as those of this Section, to (A) any assignee of or participant in, or any prospective assignee of or participant in, any of its rights and obligations under this Agreement or (B) any actual or prospective party (or its Related Parties) to any swap, derivative or other transaction under which payments are to be made by reference to the Borrower and its obligations, this Agreement or payments hereunder, (vii) on a confidential basis to any rating agency in connection with rating the Borrower or its Subsidiaries or the credit facility provided hereunder, (viii) with the consent of the Borrower or to the extent such Information (1) becomes publicly available other than as a result of a breach of this Section by Lender or any of its Affiliates or Related Parties or (2) becomes available to the Lender or any of its Affiliates on a nonconfidential basis from a source other than the Borrower or any Subsidiary.  For purposes of this Section, “Information” means all information received from the Borrower or any Subsidiary relating to the Borrower or any Subsidiary or any of their respective businesses, other than any such information that is available to the Lender on a nonconfidential basis prior to disclosure by the Borrower or any Subsidiary, provided that, in the case of information received from the Borrower or any Subsidiary after the date hereof, such information is clearly identified at the time of delivery as confidential.  Any Person required to maintain the confidentiality of Information as provided in this Section shall be considered to have complied with its obligation to do so if such Person has exercised the same degree of care to maintain the confidentiality of such Information as such Person would accord to its own confidential information.  In addition, the Lender may disclose the existence of this Agreement and information about this Agreement to market data collectors, similar service providers to the lending industry and service providers the Lender in connection with the administration of this Agreement, the other Loan Documents and the Term Commitment.
(b)    Press Releases.  The Borrower and its Affiliates agree that they will not in the future issue any press releases or other public disclosure (except public filings with the SEC) using the name of the Lender or its Affiliates or referring to this Agreement or any of the Loan Documents without the prior written consent of the Lender, unless (and only to the extent that) the Borrower or such Affiliate is required to do so under law and then, in any event the Borrower or such Affiliate will consult with such Person before issuing such press release or other public disclosure except in the case of any public filings with the SEC.
(c)    Customary Advertising Material.  The Borrower consents to the publication by the Lender of customary advertising material relating to the transactions contemplated hereby using the name, product photographs, logo or trademark of the Borrower.
9.08    Right of Setoff.
If an Event of Default shall have occurred and be continuing, the Lender and each of its Affiliates is hereby authorized at any time and from time to time, to the fullest extent permitted by applicable Law, to set off and apply any and all deposits (general or special, time or demand, provisional or final, in whatever currency) at any time held and other obligations (in whatever 

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currency) at any time owing by the Lender or any such Affiliate to or for the credit or the account of the Borrower against any and all of the obligations of the Borrower now or hereafter existing under this Agreement or any other Loan Document to the Lender or its Affiliates, irrespective of whether or not the Lender or Affiliate shall have made any demand under this Agreement or any other Loan Document and although such obligations of the Borrower may be unmatured, secured or unsecured, or are owed to a branch, office or Affiliate of the Lender different from the branch, office or Affiliate holding such deposit or obligated on such indebtedness.  The rights of the Lender and its Affiliates under this Section are in addition to other rights and remedies (including other rights of setoff) that the Lender or its Affiliates may have.  The Lender agrees to notify the Borrower promptly after any such setoff and application, provided that the failure to give such notice shall not affect the validity of such setoff and application.  Notwithstanding the provisions of this Section 9.08, if at any time the Lender or any of its Affiliates maintains one or more deposit accounts for the Borrower into which Medicare and/or Medicaid receivables are deposited, such Person shall waive the right of setoff set forth herein.
9.09    Interest Rate Limitation.
Notwithstanding anything to the contrary contained in any Loan Document, the interest paid or agreed to be paid under the Loan Documents shall not exceed the maximum rate of non-usurious interest permitted by applicable Law (the “Maximum Rate”).  If the Lender shall receive interest in an amount that exceeds the Maximum Rate, the excess interest shall be applied to the principal of the Loans or, if it exceeds such unpaid principal, refunded to the Borrower.  In determining whether the interest contracted for, charged, or received by the Lender exceeds the Maximum Rate, such Person may, to the extent permitted by applicable Law, (a) characterize any payment that is not principal as an expense, fee, or premium rather than interest, (b) exclude voluntary prepayments and the effects thereof, and (c) amortize, prorate, allocate, and spread in equal or unequal parts the total amount of interest throughout the contemplated term of the Obligations hereunder.
9.10    Counterparts; Integration; Effectiveness.
This Agreement and each of the other Loan Documents may be executed in counterparts (and by different parties hereto in different counterparts), each of which shall constitute an original, but all of which when taken together shall constitute a single contract.  This Agreement, the other Loan Documents, and any separate letter agreements with respect to fees payable to the Lender, constitute the entire contract among the parties relating to the subject matter hereof and supersede any and all previous agreements and understandings, oral or written, relating to the subject matter hereof.  Except as provided in Section 4.01, this Agreement shall become effective when it shall have been executed by the Lender and when the Lender shall have received counterparts hereof that, when taken together, bear the signatures of each of the other parties hereto.  Delivery of an executed counterpart of a signature page of this Agreement or any other Loan Document, or any certificate delivered thereunder, by fax transmission or e-mail transmission (e.g. “pdf” or “tif”) shall be effective as delivery of a manually executed counterpart of this Agreement or such other Loan Document or certificate.  Without limiting the foregoing, to the extent a manually executed counterpart is not specifically required to be delivered under the terms of any Loan Document, upon 

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the request of any party, such fax transmission or e-mail transmission shall be promptly followed by such manually executed counterpart.
9.11    Survival of Representations and Warranties.
All representations and warranties made hereunder and in any other Loan Document or other document delivered pursuant hereto or thereto or in connection herewith or therewith shall survive the execution and delivery hereof and thereof.  Such representations and warranties have been or will be relied upon by the Lender, regardless of any investigation made by the Lender or on its behalf and notwithstanding that the Lender may have had notice or knowledge of any Default at the time of any Term Borrowing, and shall continue in full force until the Facility Termination Date.
9.12    Severability.
If any provision of this Agreement or the other Loan Documents is held to be illegal, invalid or unenforceable, (a) the legality, validity and enforceability of the remaining provisions of this Agreement and the other Loan Documents shall not be affected or impaired thereby and (b) the parties shall endeavor in good faith negotiations to replace the illegal, invalid or unenforceable provisions with valid provisions the economic effect of which comes as close as possible to that of the illegal, invalid or unenforceable provisions.  The invalidity of a provision in a particular jurisdiction shall not invalidate or render unenforceable such provision in any other jurisdiction.
9.13    Governing Law; Jurisdiction; Etc.
(a)    GOVERNING LAW.  THIS AGREEMENT AND THE OTHER LOAN DOCUMENTS (EXCEPT, AS TO ANY OTHER LOAN DOCUMENT, AS EXPRESSLY SET FORTH THEREIN) AND ANY CLAIMS, CONTROVERSY, DISPUTE OR CAUSE OF ACTION (WHETHER IN CONTRACT OR TORT OR OTHERWISE) BASED UPON, ARISING OUT OF OR RELATING TO THIS AGREEMENT OR ANY OTHER LOAN DOCUMENT (EXCEPT, AS TO ANY OTHER LOAN DOCUMENT, AS EXPRESSLY SET FORTH THEREIN) AND THE TRANSACTIONS CONTEMPLATED HEREBY AND THEREBY SHALL BE GOVERNED BY, AND CONSTRUED IN ACCORDANCE WITH, THE LAW OF THE STATE OF NEW YORK.
(b)    SUBMISSION TO JURISDICTION.  THE BORROWER IRREVOCABLY AND UNCONDITIONALLY AGREES THAT IT WILL NOT COMMENCE ANY ACTION, LITIGATION OR PROCEEDING OF ANY KIND OR DESCRIPTION, WHETHER IN LAW OR EQUITY, WHETHER IN CONTRACT OR IN TORT OR OTHERWISE, AGAINST THE LENDER OR ANY RELATED PARTY IN ANY WAY RELATING TO THIS AGREEMENT OR ANY OTHER LOAN DOCUMENT OR THE TRANSACTIONS RELATING HERETO OR THERETO, IN ANY FORUM OTHER THAN THE COURTS OF THE STATE OF NEW YORK SITTING IN NEW YORK COUNTY AND OF THE UNITED STATES DISTRICT COURT OF THE SOUTHERN DISTRICT OF NEW YORK, AND ANY APPELLATE COURT FROM ANY THEREOF, AND EACH OF THE PARTIES HERETO IRREVOCABLY AND UNCONDITIONALLY SUBMITS TO THE JURISDICTION OF SUCH COURTS  AND AGREES THAT ALL CLAIMS IN RESPECT OF ANY SUCH ACTION, LITIGATION OR PROCEEDING MAY BE HEARD AND DETERMINED IN SUCH NEW YORK STATE COURT OR, TO THE 

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FULLEST EXTENT PERMITTED BY APPLICABLE LAW, IN SUCH FEDERAL COURT.  EACH OF THE PARTIES HERETO AGREES THAT A FINAL JUDGMENT IN ANY SUCH ACTION, LITIGATION OR PROCEEDING SHALL BE CONCLUSIVE AND MAY BE ENFORCED IN OTHER JURISDICTIONS BY SUIT ON THE JUDGMENT OR IN ANY OTHER MANNER PROVIDED BY LAW.  NOTHING IN THIS AGREEMENT OR IN ANY OTHER LOAN DOCUMENT SHALL AFFECT ANY RIGHT THAT THE LENDER MAY OTHERWISE HAVE TO BRING ANY ACTION OR PROCEEDING RELATING TO THIS AGREEMENT OR ANY OTHER LOAN DOCUMENT AGAINST THE BORROWER OR ITS PROPERTIES IN THE COURTS OF ANY JURISDICTION.
(c)    WAIVER OF VENUE.  EACH PARTY HERETO IRREVOCABLY AND UNCONDITIONALLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY OBJECTION THAT IT MAY NOW OR HEREAFTER HAVE TO THE LAYING OF VENUE OF ANY ACTION OR PROCEEDING ARISING OUT OF OR RELATING TO THIS AGREEMENT OR ANY OTHER LOAN DOCUMENT IN ANY COURT REFERRED TO IN PARAGRAPH (B) OF THIS SECTION.  EACH PARTY HERETO IRREVOCABLY AND UNCONDITIONALLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, THE DEFENSE OF AN INCONVENIENT FORUM TO THE MAINTENANCE OF SUCH ACTION OR PROCEEDING IN ANY SUCH COURT.
(d)    SERVICE OF PROCESS.  EACH PARTY HERETO IRREVOCABLY CONSENTS TO SERVICE OF PROCESS IN THE MANNER PROVIDED FOR NOTICES IN SECTION 9.02.  NOTHING IN THIS AGREEMENT WILL AFFECT THE RIGHT OF ANY PARTY HERETO TO SERVE PROCESS IN ANY OTHER MANNER PERMITTED BY APPLICABLE LAW.
9.14    Waiver of Jury Trial.
EACH PARTY HERETO HEREBY IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN ANY LEGAL PROCEEDING DIRECTLY OR INDIRECTLY ARISING OUT OF OR RELATING TO THIS AGREEMENT OR ANY OTHER LOAN DOCUMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY OR THEREBY (WHETHER BASED ON CONTRACT, TORT OR ANY OTHER THEORY).  EACH PARTY HERETO (a) CERTIFIES THAT NO REPRESENTATIVE, AGENT OR ATTORNEY OF ANY OTHER PERSON HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PERSON WOULD NOT, IN THE EVENT OF LITIGATION, SEEK TO ENFORCE THE FOREGOING WAIVER AND (b) ACKNOWLEDGES THAT IT AND THE OTHER PARTIES HERETO HAVE BEEN INDUCED TO ENTER INTO THIS AGREEMENT AND THE OTHER LOAN DOCUMENTS BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION.
9.15    No Advisory or Fiduciary Responsibility.
In connection with all aspects of each transaction contemplated hereby (including in connection with any amendment, waiver or other modification hereof or of any other Loan Document), the Borrower acknowledges and agrees, and acknowledges its Affiliates’ understanding, 

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that:  (a) (i) the services regarding this Agreement provided by the Lender and any Affiliate thereof are arm’s-length commercial transactions between the Borrower and its Affiliates, on the one hand, and the Lender and its Affiliates, on the other hand, (ii) the Borrower has consulted its own legal, accounting, regulatory and tax advisors to the extent it has deemed appropriate, and (iii) the Borrower is capable of evaluating, and understands and accepts, the terms, risks and conditions of the transactions contemplated hereby and by the other Loan Documents; (b) (i) the Lender and its Affiliates each is and has been acting solely as a principal and, except as expressly agreed in writing by the relevant parties, has not been, is not, and will not be acting as an advisor, agent or fiduciary, for Borrower, or any of its Affiliates, or any other Person and (ii) neither the Lender nor any of its Affiliates has any obligation to the Borrower or any of its Affiliates with respect to the transactions contemplated hereby except those obligations expressly set forth herein and in the other Loan Documents; and (c) the Lender and its Affiliates may be engaged in a broad range of transactions that involve interests that differ from those of the Borrower and its Affiliates, and neither the Lender nor any of its Affiliates has any obligation to disclose any of such interests to the Borrower or any of its Affiliates.  To the fullest extent permitted by law, the Borrower hereby waives and releases any claims that it may have against the Lender or any of its Affiliates with respect to any breach or alleged breach of agency or fiduciary duty in connection with any aspect of any transactions contemplated hereby.
9.16    Electronic Execution.
The words “delivery,” “execute,” “execution,” “signed,” “signature,” and words of like import in any Loan Document or any other document executed in connection herewith shall be deemed to include electronic signatures, the electronic matching of assignment terms and contract formations on electronic platforms approved by the Lender, or the keeping of records in electronic form, each of which shall be of the same legal effect, validity or enforceability as a manually executed signature, physical delivery thereof or the use of a paper-based recordkeeping system, as the case may be, to the extent and as provided for in any applicable Law, including the Federal Electronic Signatures in Global and National Commerce Act, the New York State Electronic Signatures and Records Act, or any other similar state laws based on the Uniform Electronic Transactions Act; provided that notwithstanding anything contained herein to the contrary, the Lender is under no obligation to agree to accept electronic signatures in any form or in any format unless expressly agreed to by the Lender pursuant to procedures approved by it; provided further without limiting the foregoing, upon the request of the Lender, any electronic signature shall be promptly followed by such manually executed counterpart.
9.17    USA PATRIOT Act Notice.
The Lender hereby notifies the Borrower that pursuant to the requirements of the USA PATRIOT Act (Title III of Pub. L. 107-56 (signed into law October 26, 2001)) (the “Act”), it is required to obtain, verify and record information that identifies the Borrower, which information includes the name and address of the Borrower and other information that will allow the Lender to identify the Borrower in accordance with the Act.  The Borrower agrees to, promptly following a request by the Lender, provide all such other documentation and information that the Lender requests 

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in order to comply with its ongoing obligations under applicable “know your customer” and anti-money laundering rules and regulations, including the Act.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]

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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly executed as of the date first above written.

SPARK THERAPEUTICS, INC., Borrower
                                                  	
		
	By:
	/s/ Stephen W. Webster

	Name:
	Stephen W. Webster

	Title:
	Chief Financial Officer

WELLS FARGO BANK, NATIONAL ASSOCIATION, as Lender
                                                   	
		
	By:
	/s/ Monique Dubisky

	Name:
	Monique Dubisky

	Title:
	Director

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