1.1

“Acceptance Procedure” shall mean the review of the Batch Related Documents and test(s) of the Product, if necessary, to verify that the Product delivered meets the Specifications and complies with Regulatory Authority requirements, conducted by Client after SBL’s release of the Product, to determine whether to accept the same, in accordance with the applicable QAG as modified from time to time by written agreement between the Parties.

1.2

“Affected Party” is defined in Section 17.3.

1.3

“Affiliate” shall mean any corporation, company, partnership or other entity which directly or indirectly, controls, is controlled by or is under common control with either Party hereto. A corporation or other entity shall be regarded as controlling another corporation or other entity if it owns or directly or indirectly controls more than fifty percent (50 %) of the voting stock or other ownership interest of the corporation or other entity, or if possesses, directly or indirectly, the power to direct or cause the direction of the management and policies of the corporation or other entity or the power to elect or appoint more than fifty percent (50 %) of the members of the governing body of the corporation or other entity.

1.4

“Applicable Laws” shall mean any and all applicable laws of any jurisdiction which are applicable to any of the Parties in carrying out activities described in this MSA or any PSAs that may be in effect from time to time, and shall include all statutes, enactments, acts of legislature, laws, ordinances, rules, regulations, notifications, guidelines, directions, directives and orders of any Regulatory Authority, statutory authority, stock exchange, securities regulatory agency, tribunal, board, or court or any central or state government or local authority or other governmental entity in such jurisdictions.

1.5

“Background IP” shall mean Intellectual Property which has been owned and/or controlled by a Party prior to the Effective Date or outside, or not relating to, the performance of the MSA and any pertinent PSA.

1.6

“Batch” shall mean Product Manufactured by SBL from a single run of the applicable Manufacturing Process.

1.7

“Batch Record” is defined in the applicable QAG.

1.8

“Batch Related Documents” means Manufacturing Documentation in support of the SBL’s release of a Product.

1.9

“Binding Year” shall be defined in the applicable PSA.

1.10

“Business Day” shall mean a day on which commercial banks are open for business in both the Republic of Korea and New York, New York.

1.11

“Cell Line” shall mean the aliquot of cells supplied to SBL by Client to perform the Services and their progeny.

1.12

“Certificate of Analysis” is defined in the applicable QAG.

1.13

“Certificate of Compliance” is defined in the applicable QAG.

1.14

“Change” is defined in Section 6.1.

1.15

“Client” is defined in the preamble.

1.16

“Client Materials” shall mean Client reagents and other materials supplied by Client or its third party supplier to be used in the Service hereunder, as each is further defined in the PSA and/or applicable QAG. In the case of a Drug Product PSA, Client Materials shall also include Drug Substance and/or other active pharmaceutical ingredients, which may or may not be Manufactured by SBL.

1.17

“Client Technology” shall mean know-how, technology, research and other information of Client including and relating to the Manufacturing Process, analytical methods, quality control analysis, specifications, transportation and storage requirements provided by Client to SBL in connection with this MSA and applicable PSA.

1.18

“Clinical Product” shall mean a Drug Substance or Drug Product which is Manufactured by SBL pursuant to a PSA and which is to be used by Client in a research study or studies that investigate the safety of human use or prospectively assign human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.

1.19

“Commercial Product” shall mean a Drug Substance or Drug Product which is Manufactured by SBL which is intended for commercial sale and use by humans and for importation or exportation into countries or regions designated in each PSA.

1.20

“Commercially Reasonable Efforts” shall mean with respect to an activity to be carried out by a Party, the carrying out of such activity in a diligent manner, which, in the case of SBL, requires using the efforts of sufficient numbers of personnel appropriately qualified by experience and training, in the application of such resources as would be reasonably applied by a qualified manufacturer of biologics for human use adhering to recognized standards in the manufacture and testing of such products, or, in the case of Client, using such efforts as would be typically be used in the biopharmaceutical industry by companies of comparable resources and expertise. “Commercially Reasonable Efforts” requires prompt assignment of responsibility for such task or activity to specific qualified employee(s) and allocation of resources designed to advance progress with respect to such task or activity but does not require the taking of actions which would require either Party to violate Applicable Laws or break any existing contractual commitments with third parties which were entered into prior to the Effective Date, the performance of which at such time was not reasonably foreseeable to be in conflict, or otherwise inconsistent, with such Party’s obligations under the MSA or any PSA.

1.21

“Common Raw Materials” is defined in Section 5.3.1.

1.22

“Confidential Information” is defined in Section 10.1.

1.23

“Control” (including, with correlative meanings, “Controlled”) means possession, directly or indirectly, of power to direct or cause the direction of management or policies (whether through ownership of securities or other ownership interest, by contract or otherwise) of that person or entity and/or the ownership of more than 50% of the voting shares of that person or entity.

1.24

“Core Team” is defined in Section 3.3.

1.25

“current Good Manufacturing Practices” or “cGMP” shall mean current good manufacturing practices and regulations applicable to the Manufacture of Product that are promulgated by any Regulatory Authority, including as promulgated under and in accordance with (i) the U.S. Federal Food, Drug and Cosmetic Act, Title 21 of the U.S. Code of Federal Regulations, Parts 210, 211, 600, 601 and 610, (ii) relevant EU legislation, including European Directive 2003/94/EC or national implementations of that Directive, (iii) relevant guidelines, including the EU Guidelines for Good Manufacturing Practices for Medicinal Products (Eudralex Vol. 4 and Annexes thereto), (iv) International Conference on Harmonisation Good Manufacturing Practice Guide for Active Pharmaceuticals Ingredients and (v) and any analogous set of regulations, guidelines or standards as defined, from time to time, by any relevant Regulatory Authority having jurisdiction over the development, manufacture or commercialization of the Product, as applicable, in each case as in effect as of the date such manufacturing for the Product are or were conducted.

1.26

“Damages” means any damages, costs, expenses, fines, penalties (including reasonable attorneys’ fees and costs), losses and liabilities.

1.27

“Disclosing Party” is defined in Section 10.1.

1.28

“Drug Product” means a finished or intermediate dosage form that contains a Drug Substance, generally, but not necessarily, in association with one or more other ingredients.

1.29

“Drug Substance” means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

1.30

“Effective Date” is defined in the preamble.

1.31

“EMA” shall mean the European Medicines Agency, or any successor agency.

1.32

“Engineering Batch” shall mean a Batch that is intended to demonstrate the transfer of the Manufacturing Process to the Facility. After Manufacture, Client shall have the right to make whatever further use of non-cGMP Engineering Batches as it shall determine, provided that Client pays for such Batches according to this MSA, such use is not for human use and does not violate any Applicable Laws. SBL makes no warranty that Engineering Batches will meet cGMP or the Specifications. If SBL determines that an Engineering Batch does meet cGMP and the Specifications, it will release such Engineering Batch as a cGMP Batch, and thereafter Client shall be entitled to use such Engineering Batch for human use.

1.33

“Facility” shall mean one or more of the manufacturing facilities of SBL where the Services shall be performed, located at 300, Songdo bio-daero, Yeonsu-gu, Incheon, 21987, Republic of Korea.

1.34

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

1.35

“Firm Period” shall be defined in the applicable PSA.

1.36

“Force Majeure Event” is defined in Section 17.3.

1.37

“Implementation Plan and Budget” is defined in Section 6.2(b).

1.38

“Indemnified Party” is defined in Section 13.3.

1.39

“Indemnifying Party” is defined in Section 13.3.

1.40

“Intellectual Property” is shall mean (a) patents, patent rights, provisional patent applications, patent applications, designs, registered designs, registered design applications, industrial designs, industrial design applications and industrial design registrations, including any and all divisions, continuations, continuations-in-part, extensions, restorations, substitutions, renewals, registrations, revalidations, reexaminations, reissues or additions, including supplementary certificates of protection, of or to any of the foregoing items; (b) copyrights, copyright registrations, copyright applications, original works of authorship fixed in any tangible medium of expression, including literary works (including all forms and types of computer software, including all source code, object code, firmware, development tools, files, records and data, and all documentation related to any of the foregoing), pictorial and graphic works; (c) trade secrets, technology, developments, discoveries and improvements, know-how, proprietary rights, formulae, confidential and proprietary information, technical information, techniques, inventions, designs, drawings, procedures, processes, models, formulations, manuals and systems, whether or not patentable or copyrightable, including all biological, chemical, biochemical, toxicological, pharmacological and metabolic material and information and data relating thereto and formulation, clinical, analytical and stability information and data which have actual or potential commercial value and are not available in the public domain; (d) trademarks, trademark registrations, trademark applications, service marks, service mark registrations, service mark applications, business marks, brand names, trade names, trade dress, names, logos and slogans, Internet domain names, and all goodwill associated therewith; and (e) all other intellectual property or proprietary rights, in each case whether or not subject to statutory registration or protection.

1.41

“Joint Steering Committee” or “JSC” is defined in Section 3.2.1.

1.42

“Manufacturing” or to “Manufacture” shall mean the manufacturing of the Product, and any services relating to such manufacturing, including, but not limited to, testing, quality control, documentations, archiving, handling, storage and packaging, release and delivery of the Product, to be performed by SBL at the Facility under the MSA and any applicable PSA.

1.43

“Manufacturing Documentation” shall mean data acquired and generated, documents and records describing or otherwise related to the Manufacturing Process including, without limitation: documents and records consisting of or containing process descriptions, requirements and specifications; Client Materials and Specifications; analytical methods, process trend and variability data; validations protocols and reports; process development reports; Batch Records; Batch Related Documents, and SOPs, including, without limitation, SOP’s for the Raw Materials handling, the Manufacturing operations, equipment operation, in-process, final Product and stability quality control testing, quality assurance, validation, storage and shipping.

1.44

“Manufacturing Process” shall mean the mutually agreed production process and analytical methods for the Manufacturing of the Product pursuant to the applicable PSA, as summarily described in the applicable QAG and as described in the Manufacturing Documentation, as such process may be changed from time to time in accordance with the MSA.

1.45

“Manufacturing Process Transfer” means the Commercially Reasonable Efforts of the parties undertaken pursuant to the Manufacturing Process Transfer Plan to transfer the Manufacturing Process (together with copies of relevant books and records) in SBL’s possession or under its control, to Client as set forth in greater detail in the Manufacturing Process Transfer Plan. SBL shall only be obligated to use its Commercially Reasonable Efforts in the implementation of the Manufacturing Transfer Plan, and in no case shall SBL personnel be required to visit the site of Client or any third party manufacturer. For the avoidance of doubt, the foregoing prohibition shall not be construed as a basis for SBL refusing to assist in the transfer of analytical methods to an independent laboratory, including a visit by SBL personnel to such site to assist in method transfer, if, and only as, reasonably necessary, and at Client’s cost and expense. For the avoidance of doubt, Manufacturing Process Transfer shall include, without limitation, the transfer of data, information, or samples of validated or SBL manufactured or partially manufactured Products or other indicia measured at various points during Manufacture, to the extent SBL possesses such data, information, or samples. SBL shall not be obligated to deliver the proprietary process information contained in any drug master file with respect to which SBL has granted Client a right of reference. SBL shall provide Manufacturing Process Transfer services with a capacity of one (1) full time employee equivalent (“FTE”) month for each of upstream, downstream and analytics, for a total maximum of three (3) FTE months. SBL will have no obligation to provide Manufacturing Process Transfer services more than twelve (12) months after termination of the MSA or applicable PSA. For clarity, SBL's assistance shall be time-based, and SBL shall in no way guarantee or ensure that after Manufacturing Process Transfer services is complete, Client or its third-party manufacturer will be able to manufacture the Product.

1.46

“Manufacturing Process Transfer Plan” means that plan addressing orderly Manufacturing Process Transfer, to be prepared in writing and reasonably agreed to by the parties within the forty (40) Business Day period following notice from Client to SBL of its intention to commence Manufacturing Process Transfer.

1.47

“Non-Affected Party” is defined in Section 17.3.

1.48

“Non-Conforming Product” shall mean an entire Batch of Product, any portion of which fails to conform to the Specifications, cGMP (if applicable), and any other mutually agreed upon written express requirements for SBL to follow under the applicable PSA and the applicable QAG.

1.49

“Party” and “Parties” is defined in the preamble.

1.50

“Pilot Batch” means a Batch of Product designated as a pilot Batch which shall not comply with cGMP and is not required to meet the Specifications.

1.51

“Pre-Approval Inspection” means an on-site inspection of the Facility by the Regulatory Authority prior to granting the Regulatory Approval for a Commercial Product as required by various Regulatory Authorities to ensure that the Manufacturing Process and the Facility meet the appropriate requirements and comply with cGMP.

1.52

“Process Validation Batch” shall mean a Batch of Commercial Product produced from a process validation run conducted by SBL hereunder to (i) demonstrate and document the consistency and reproducibility of the Manufacturing Process at the Facility, and (ii) support the Regulatory Approval of both the Product Manufactured and the Manufacturing Process at the Facility each as defined in the Project Plan.

1.53

“Product” shall mean Clinical Product or Commercial Product to be Manufactured by SBL pursuant to this MSA and any applicable PSA.

1.54

“Product Purchase Commitment” is defined in Section 5.7.

1.55

“Product specific agreement” or “PSA” is defined in Section 2.1.

1.56

“Project Management Team Leader” is defined in Section 3.3.2.

1.57

“Project Plan” shall mean a formal, approved document used to guide both project execution and project control. The primary uses of the Project Plan are to document planning assumptions and decisions, facilitate communication among project stakeholders, and document approved scope, cost, and schedule baselines. The Project Plan will contain the description and overall objectives of the Services for Manufacturing a Product and shall include, among other things: (a) JSC and Core Team membership rosters, (b) change request procedures, (c) details, intentions, and deliverables for Technology Transfer, (d) project schedule, (e) detailed procurement plan, as needed, and (f) project budgets and invoicing plans.

1.58

“PSA Effective Date” shall mean the effective date of any PSA governed by this MSA.

1.59

“Purchase Order” is defined in Section 5.6.

1.60

“Quality Agreement” or “QAG” shall mean that certain quality agreement between the Parties that governs their respective responsibilities related to quality systems and quality requirements for the Product(s) Manufactured hereunder, including quality control, testing and release of such Product(s) at the Facility. Clinical Products and Commercial Products shall have separate forms of QAGs.

1.61

“Quarter” means each period of three (3) consecutive calendar months beginning on January 1, April 1, July 1, or October 1.

1.62

“Raw Materials” shall mean those materials that are used in the Manufacturing Process, including, but not limited to, chemicals, reagents, filters, excipients, disposable consumables, and secondary packaging materials. Raw Materials exclude the Client Materials.

1.63

“Receiving Party” is defined in Section 10.1.

1.64

“Reference Standards” shall mean materials for standards prepared by Client and/or SBL in accordance with the applicable QAG.

1.65

“Regulatory Approval” shall mean all approvals, licenses, registrations or authorizations thereof of any national, regional, state or local regulatory agency, department, bureau or other governmental entity in any jurisdiction where the Product is marketed or intended to be marketed, necessary for the manufacture and sale of the Product, which manufacturing includes the Manufacturing of the Products at the Facility.

1.66

“Regulatory Authority” shall mean any national (e.g., the FDA), supra-national (e.g., the EMA), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, in any jurisdiction responsible for granting the Regulatory Approval.

1.67

“SBL Assignable Error” means: [*].

1.68

“Service” or “Services” is defined in Section 2.1.

1.69

“Service Fee” is defined in Section 9.1.

1.70

“Specialized Raw Materials” is defined in Section 5.3.1.

1.71

“Specification(s)” shall mean the observable and measurable characteristics of the Products, Client Materials, or Raw Materials, as the case maybe, and the criteria for their storage, handling, packaging and shipping, which details are provided in documentation as reviewed and approved in writing by the Parties.

1.72

“Standard Operating Procedure(s)” or “SOP(s)” shall mean the standard operating procedures established by and mutually agreed upon by both Parties regarding the Manufacturing Process.

1.73

“Technology Transfer” shall mean the activities by the Parties necessary to Manufacture the Product for Client at the Facility or otherwise conduct the Services, as further described in the applicable PSA and/or Project Plan which may include: (i) transfer of the Client Technology and Client Material from Client to SBL; (ii) implementation of the Manufacturing Process at the Facility, including establishing a small scale Manufacturing Process model at SBL; (iii) all Manufacturing Process fit activities, including required small- and large-scale process development and validation work as allocated between the Parties to SBL and process engineering required to modify / equip, qualify and validate the Facility for the Manufacturing of the Commercial Product; (iv) stability testing, if applicable, for the Product required for licensure; (v) comparability testing to the appropriate reference product, and (vi) regulatory support for all Regulatory Approvals, each as further described in the Project Plan.

1.74

“Term” is defined in Section 15.1.

1.75

“Warehouse” shall mean SBL’s warehouse for storage of the Product located at 300, Songdo bio-daero, Yeonsu-gu, Incheon, 21987, Republic of Korea.

2.1

Product specific agreements. Pursuant to one or more product specific agreements entered into and mutually agreed from time to time by duly authorized representatives of the Parties (“Product specific agreements” or “PSAs”), SBL will perform manufacturing services for Client as specified in such PSAs and applicable Project Plan and in accordance with the terms and conditions of this MSA (“Services”). Each PSA shall refer to this MSA and contain as applicable (i) a high level scope of work of the Services to be performed under such PSA which describes key activities, (ii) the Product for which Samsung will perform such Services for Client, (iii) a description of the Cell Line; (iv) fees to be paid to SBL by Client for the Services with a general timing plan for invoicing and a more detailed plan to be in the Project Plan, (v) if the Services pertain to the manufacture of the Product, the number of batches of Product to be manufactured by SBL and delivered to Client and the Specifications, (vi) any other deliverables, (vii) the Samsung facility where the Services are to be performed, and (viii) the Regulatory Approvals to be obtained by the Parties. Services shall be governed by the terms and conditions of this MSA, the applicable PSA, and any applicable Quality Agreement. In the event of a conflict between a Quality Agreement and either any provision of this MSA or any PSA, the MSA or PSA shall control except with respect to Product quality terms, in which case, the Quality Agreement will control. In the event of a conflict between any provision of this MSA and the PSA, this MSA shall control, except as otherwise explicitly specified in the PSA.

2.2

Project Plan. Concurrently with the execution of a PSA or within a reasonable time after the PSA effective date, the Parties shall agree upon a Project Plan which will specify in detail scope and schedule of the Services, including Technology Transfer and Manufacture. The Project Plan shall also set forth the JSC members (if applicable), Core Team members, and Project Management Team Leader for the Services as well as the frequency and duration of meetings. The Project Plan may be updated as needed by the mutual agreement of the Client and SBL and is governed by and incorporated into the applicable PSA by reference. If there is a conflict between the Project Plan and the applicable PSA, the PSA shall control. If any of the assumptions shared in writing by the Parties and on which the Parties have relied in defining the scope of the activities required to effect the Technology Transfer and/or other Services including but not limited to Manufacture, and the associated timeframes, fees, expenditures and costs proves to be invalid, or if for any reason other than a Party’s negligence in planning, it becomes apparent that additional activities are required as part of or in connection with the Technology Transfer and/or other Services including but not limited to Manufacture, the Parties shall (acting reasonably and in good faith) discuss and seek to agree appropriate revisions to the Technology Transfer activities, and associated timelines and pricing.

2.3

Quality Agreement (QAG). The Parties shall agree upon and finalize a Quality Agreement in good faith within a reasonable period time after each PSA Effective Date which shall cover such PSA. No Manufacturing of Products for human use shall be conducted without an agreed upon, applicable QAG.

3.1

General. Each Party will be responsible for its internal decision making process and for reasonably informing the other Party of decisions affecting the Service in a regular and timely manner. Without limiting the foregoing, the Parties shall establish the joint committees or teams set forth herein to advise the Parties on certain matters including, without limitation, Facility modification, Technology Transfer, and optimization of the Manufacturing operation relating to the Product.

3.2

Joint Steering Committee.

3.3

Core Team.

3.4

Meetings

3.5

Decisions. All decisions of JSC, the Core Team and any other joint committee or team formed under the MSA or any applicable PSA, except as expressly set forth herein, shall be made by the unanimous agreement of its members or their designated representatives, with a Party’s members of designated representatives having, in the aggregate, one (1) vote (with the casting of fractional votes being impermissible), and shall be reflected in written meeting minutes which summarily address topics discussed, delegation of work, schedules and decision of such committee or team. SBL shall prepare written minutes of the JSC and Core Team within fifteen (15) Business Days of the meeting to which they relate, which shall be subject to approval by the authorized representatives of the Parties; provided, however, no joint committee or team herein may amend or waive any provision of the MSA or applicable PSA, including without limitation, the financial terms set forth in Section 9. The MSA or any PSA may be amended, and provision of the MSA or any PSA may be waived, pursuant to Section 17.9 only.

3.6

Disputes.

4.1

Services. During the Term, in accordance with and subject to the terms and conditions set forth in this MSA, applicable PSA, and the applicable QAG, SBL shall provide the Services to Client relating to the Product(s). SBL shall at all times make Commercially Reasonable Efforts to complete the Services in accordance with the timelines set forth in the applicable PSA. Except as otherwise expressly set forth in the MSA, applicable PSA, or the applicable QAG or as otherwise mutually agreed in writing by the Parties, SBL shall be responsible at its own cost and discretion for operating and maintaining the Facility.

4.2

Compliance with Applicable Law. Subject to the provisions of Section 6 below, SBL shall maintain the Facility in accordance with cGMP and in such condition as will allow SBL to Manufacture the Products in accordance with the terms of the MSA and the applicable QAG. SBL shall perform the Services under the MSA in conformance with cGMP, if applicable, any requirements of the Regulatory Authorities that shall be mutually agreed upon by the Parties, and all Applicable Laws.

4.3

Project Personnel. SBL shall adequately staff the Facility with personnel necessary (including consultants and contractors), who have sufficient technical expertise by virtue of training and experience to perform its obligations under the MSA and any applicable PSA. Notwithstanding anything to the contrary and in addition to the JSC and Core Team meetings described in Section 3 above, Client and SBL may arrange for core project personnel to have regular meetings, which shall be by audio or video teleconference. The Project Plan shall specify the frequency and duration of such meetings; provided that the associated costs for meetings requested solely by Client in excess of the number set forth in the Project Plan shall be passed through to Client by SBL, unless such meeting is for the purpose of addressing a deficiency in Manufacturing caused by SBL Assignable Error or assessing remediation thereof.

4.4

Subcontract. SBL may subcontract any portion of the Services without approval from Client; provided, however, that SBL will not subcontract or otherwise engage subcontractors or other third party agents to manufacture, conduct quality control testing, or perform Services directly related to manufacturing or quality control testing without the prior written approval of Client, which shall not be unreasonably withheld, conditioned, or delayed. Notwithstanding any subcontracting, SBL shall be primarily obligated to Client for any subcontracted services as if it were providing the Services itself, and shall be jointly and severally liable to Client for the performance of any such Service. The preceding sentence is not meant to nor shall it be construed as altering or eliminating any mutually agreed upon limitations of

4.5

Development and Manufacturing Site. Except as is provided in Section 4.4 or otherwise agreed by Client, all Services shall be performed by SBL at the Facility.

4.6

Access to the Facility.

4.7

Manufacturing Documentation. SBL shall maintain in the English language, complete, true and accurate Manufacturing Documentation, and shall keep them in strict confidence and shall not use them for purposes other than providing or performing the Service or other obligations hereunder. SBL shall maintain all such Manufacturing Documentation for at least that period specified in the applicable QAG or such longer period as may be required by Applicable Law. Upon written request of Client and at mutually agreeable times, Client shall have the right to review Manufacturing Documentation, including the Batch Records, at the Facility as further defined in the applicable QAG; provided, however, SBL shall not delay any such request of Client for more than fifteen (15) Business Days. Client may also request scanned or printed copies of such Manufacturing Documentation, but shall be responsible for reasonable costs associated therewith. SBL shall record and maintain such records, data, documentation

5.1

Technology Transfer Requirements. The Parties shall make their personnel available at the Facility to enable the transfer and implementation in accordance with the Project Plan. Client shall transfer to and grant SBL the limited license set forth below in Section 11.2 in respect of the Reference Standards, Client Technology, Client Materials, and Cell Line In the event that Client agrees to utilize SBL’s [*] portal for Technology Transfer, Client agrees that (a) in the event of any relevant change that affects a Client user’s authorization to use such portal, Client shall promptly notify SBL so that SBL may disable their usernames and remove / change passwords in order to secure the SBL Portal and (b) Client shall ensure that all of Client’s users have up-to-date antivirus software installed on the computer devices used to access such portal.

5.2

Facility Modification and Equipment. Except as otherwise specifically provided herein to the contrary, and upon mutual agreement of the Parties, Client and SBL will agree on what equipment in the Facility is necessary to perform the Services, and if it is necessary or Client deems it necessary to procure additional equipment beyond that which is in the Facility as of the applicable PSA Effective Date, the Core Team shall determine equitable allocation of costs including, as applicable, procurement, validation, installation, maintenance, commissioning, and decommissioning/validation (which determination shall be escalated to the JSC if in dispute). Thereafter, if any additional equipment is necessary at the request of Client, such costs shall be dealt with by the Change provisions of this MSA. SBL shall modify the Facility and engineer, procure, install, commission, test, qualify, troubleshoot and validate necessary equipment and instruments in order to accommodate Manufacture of the Product at the Facility, as further described in the Project Plan and applicable QAG. Except as provided in this Section 5.2 or any applicable PSA, the Facility, Warehouse and all the equipment shall be maintained, tested, validated, calibrated and qualified for their intended uses by SBL at SBL’s expense. For the avoidance of doubt, it shall be the responsibility of SBL to effect such changes at the Facility including, but not limited to changes in equipment, as are required by changes in laws, rules or regulations related to the manufacture, handling, storage, packaging and disposal of biologics generally, compliance therewith being necessary in order for SBL to hold itself out as a qualified manufacturer of biologics for

5.3

Raw Materials.

5.4

Client Materials.

5.5

Forecasts. For each Commercial Product, the Parties shall determine a mutually agreeable mechanism for forecasting of each Product, which shall be detailed in writing and attached to each relevant PSA. For Clinical Product, the Parties shall agree upon the number and schedule of Batches to be Manufactured by SBL in the applicable PSA.

5.6

Purchase Orders. For each Clinical Product or Commercial Product, Client shall notify SBL in a binding form and procedure to be agreed upon in the applicable PSA requesting a specific amount of Product to be Manufactured (a “Purchase Order”).

5.7

Product Purchase Commitment. As further set forth in a PSA, during the Term the Parties may agree that Client will purchase a minimum quantity of batches of a certain Product in a given year (a “Product Purchase Commitment”).

5.8

Batch Failure during Manufacture

5.9

Storage, Packaging and Delivery.

(a)

Release by SBL and Acceptance by Client.

(i)

SBL shall perform all testing in accordance with the Specifications of the Product and release the Product in accordance with the terms of the applicable QAG. Upon such release SBL shall deliver to Client a copy of the Manufacturing Documentation in support of the SBL’s release of the Product for each Batch (“Batch Related Documents”), including a Certificate of Analysis and Certificate of Compliance, in accordance with the applicable QAG;

(ii)

Acceptance of Product. Client will complete the Acceptance Procedure and determine the acceptability of such Product in accordance with the applicable QAG and notify SBL of the result within the latter of [*] of SBL’s release of Product or Client’s receipt of the Batch Related Documents. Upon Client’s acceptance, SBL will have no liability for such Product once entrusted to the carrier (the Parties shall use good-faith efforts to minimize the time-period between Client’s acceptance and SBL’s delivery to the carrier), except as set forth in Section 5.9.2(a)(iv) regarding Latent Defects. If Client does not reject such Product within the [*] period, the Product will be deemed to have been accepted by Client and SBL will have no liability for such Product once entrusted to the carrier (the Parties shall use good-faith efforts to minimize the time-period between Client’s acceptance and SBL’s delivery to the carrier), except (A) as set forth in Section 5.9.2(a)(iv) regarding Latent Defects or (B) due to a breach of SBL’s obligations with regard to (I) handling or storage or (II) the Specifications insofar as they relate to packaging and shipping.

(iii)

Non-Conforming. If, during the Acceptance Procedure, any Product is determined by Client or SBL as Non-Conforming Product, at the option of Client, SBL shall take Commercially Reasonable Efforts to promptly Manufacture replacement Product (except to the extent prohibited by cGMP or applicable QAG) and deliver to Client the quantity of the Product equivalent to the quantity of Non-Conforming Product on a date to be mutually agreed by the Parties and such replacement Batch shall be invoiced and paid for as if it were the original Non-Conforming Product. If SBL does not confirm the non-conformity, the Parties shall refer to an independent and mutually agreed-on laboratory or firm with international repute to test the disputed Product. The costs of the independent

(iv)

Latent Defect. At any time after completion of review of the Batch Related Documents, if Client finds any hidden defects of the Product which could not have been reasonably discovered through the review of the Batch Related Documents (“Latent Defect”), Client shall promptly give notice of such claim in writing to SBL. In such case, if Client proves the Latent Defect is solely due to SBL Assignable Error, the above Section 5.9.2(a)(iii) and Section 13.1 shall apply. If no written claim for Latent Defect of the Product is received by SBL within [*] discovery of the Latent Defect, the Product shall be deemed as irrevocably accepted. Notwithstanding anything to the contrary; such claim for Latent Defect must be made within a time period to be set forth in the applicable PSA, but in no event after the expiration date of the Product. For the avoidance of doubt, a Latent Defect is a defect in existence at the time of completion of the Acceptance Procedure.

(b)

Delivery. Shipping conditions, title transfer to Client and risk of loss for the Product Manufactured hereunder shall be [*]. The Parties further agree as follows:

(i)

At the time of SBL’s release of the Product and prior to each pick-up by Client or Client’s designated carrier, SBL shall propose to Client a delivery schedule of the Product, in order for the Parties to agree on it in advance for each pick-up. SBL shall schedule Delivery with the carrier selected and paid for by Client;

(ii)

SBL shall not deliver the Product until it has been instructed to by Client in accordance with the applicable QAG. Client shall confirm specific delivery instructions with SBL prior to SBL release. Upon SBL’s release of Product, SBL shall store the Manufactured Product as described in Section 5.9.2(c) and Client shall compensate SBL for storage costs for the Manufactured Product stored with SBL for more than sixty (60) calendar days following release, as set forth in the applicable PSA;

(iii)

SBL shall provide Client with invoice, packing lists, supporting export documents as specified by Client by separate delivery and shipment documentation instructions, together with each shipment of the Product (or such other deliverables); and

(iv)

In cooperation with Client and subject to the delivery schedule agreed by the Parties, SBL shall adhere to the first-expire-first-out (FEFO) principle in shipping all released Product.

(c)

Storage, Packaging and Shipping Container.

(i)

Pursuant to the terms of this MSA and any applicable PSA, SBL shall store the Products Manufactured hereunder.

(ii)

SBL shall store, package, label and prepare shipment according to the Specifications for the Product Manufactured hereunder, the applicable QAG and the SOPs, and using storage and/or shipping containers determined in the applicable PSA.

(iii)

If Client does not direct SBL to prepare Manufactured Product to be picked up by Client or Client’s designated carrier with a pick-up date within [*] of Client’s receipt of the Batch Related Documents, SBL shall store the Product at the Warehouse and Client shall pay storage fees to SBL as set forth in Section 9.1 for the period of storage at the Warehouse in excess of [*] from release until the actual delivery date, in accordance with the applicable PSA.

(iv)

SBL shall store and handle all Manufactured Product in accordance with applicable storage and handling Specifications, including all times when SBL and Client agree that SBL shall store Manufactured Product per Section 5.9.2(c)(iii), but shall have no obligation regarding risk of loss and damage of Manufactured Product in its possession unless such loss or damage resulted from SBL’s negligence or willful misconduct.

5.10

Supply Interruptions. On a PSA by PSA basis, the Parties will discuss appropriate steps to alleviate any expected or actual shortfall in Manufactured Product. The Parties may agree on a PSA by PSA basis, in what events, if any, such a supply failure could constitute a material breach of this MSA or a PSA.

6.1

Approval for Change.  SBL shall not make any change to the Manufacturing Process, the Services,  or the Specifications (a “Change”), without the prior written consent of Client in accordance with the applicable QAG.

6.2

Changes Required by cGMP, Regulatory Authorities or Requested by Client. Except as otherwise expressly set forth to the contrary in the applicable QAG, in the event that cGMP, a Regulatory Authority, Applicable Law, or any other regulatory or legal authority requires, or Client requests, a Change, SBL shall accommodate such requirements or requests, subject to the following:

(a)

Client shall promptly notify SBL in writing of the required and/or requested Change(s), and provide information necessary for SBL to evaluate the effect of such Change(s); provided, however, in the event SBL first learns of a required Change it shall notify Client thereof in writing, and SBL shall promptly advise Client as to any (i) additional equipment required, modifications to the Facility or equipment, and/or additional equipment and the Facility qualification and validation requirements; (ii) Manufacturing Process development, transfer, scale-up, testing, qualification, or validation requirements; (iii) regulatory requirements pursuant to such Changes; (iv) changes to the Manufacturing scheduling and/or Product delivery schedule; and (v) other impacts on the Facility or SBL’s ability to manufacture products (including the Products) in the Facility, if any, which may result from such Change(s). The notification and formal approval procedure of such Changes shall be in accordance with the applicable QAG (i.e., change control procedures) (if applicable). The Parties shall meet in a timely manner to identify and discuss such Changes as appropriate;

(b)

Prior to implementation of any such Change(s), SBL, subject to Section 5.2, shall provide Client with an estimated plan and budget of the reasonable and necessary costs that would be incurred by SBL as a result of the implementation of any such Change(s), including, but not limited to for (i) process and analytical development; (ii) equipment and/or the Facility modifications, qualification, validation, maintenance, and decommissioning/disposal; (iii) process and analytical validation; (iv) document revisions or changes, the Facility, equipment, and system modifications or changes; (v) additional stability testing; and (vi) preparing submissions to Regulatory Authorities (collectively, the “Implementation Plan and Budget”). Following review and approval by Client of such Implementation Plan and Budget, subject to the Core Team’s approval and agreement followed by the Parties’ written agreement pursuant to Section

(c)

During any such implementation, SBL shall provide Client with regular updates on the progress of implementation. Subject to any timeframe imposed by Applicable Law, SBL shall exercise Commercially Reasonable Efforts to implement the Change according to

(d)

Upon the approval of the Implementation Plan and Budget for Change(s), both Parties shall negotiate in good faith to determine the allocation of the costs incurred by SBL for the implementation of any such Change(s) between the Parties, in accordance with the following principles:

7.1

Regulatory Approvals. SBL shall provide reasonable assistance and cooperation in order for Client to obtain and maintain the Regulatory Approvals. The direct costs and fees associated with such assistance and cooperation, to the extent not detailed in the MSA or PSA shall be borne by Client, or as otherwise mutually agreed between the Parties. As specified in the applicable PSA, the Parties shall agree on which Regulatory Approvals are to be obtained.

7.2

Regulatory Approvals for the Facility. SBL shall obtain and continuously maintain all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity (other than the Regulatory Approvals, which will be obtained or maintained by Client) that are required to Manufacture and ship the Product at the Facility and perform the Services including, but not limited to, cGMP Manufacture.

7.3

Regulatory Inspections. SBL shall facilitate on-site inspections of the Facility conducted by Regulatory Authorities. SBL shall notify Client according to the applicable QAG provisions of any contacts or inquiries by the Regulatory Authorities, including inspections, Pre-Approval Inspections, sample requests, and written correspondence and its result, related to the Manufacture of Product by SBL at the Facility, as further defined in the applicable QAG. Any direct expenses or costs incurred by SBL for

7.4

Regulatory Support. During the Term, SBL will assist Client with all regulatory matters relating to Services and Manufacture and review the Common Technical Document pertaining to the Products, as it relates to Chemistry, Manufacturing and Controls, and make such corrections as are necessary to accurately reflect the Products, in each case at Client’s request and reasonable expense; provided, however, SBL shall review and correct such documents as they relate to SBL activities at no charge to Client (updates will be made with respect to regulatory filings for which Client has engaged SBL and paid the associated flat rate fees for support). In addition, SBL will maintain at SBL’s expense, the relevant Drug Master File, including any updates thereto, and shall provide a letter authorizing Client to reference SBL’s Drug Master Files on file with the FDA and other Regulatory Authorities in connection with the pursuit of Regulatory Approval for the Products.

8.1

Quality Agreement. Both Parties shall adhere to the provisions of the applicable  QAG and the  Parties agree that all elements of quality assurance, quality control and the like shall be governed by the terms and conditions of the applicable QAG. In the event of a conflict between the MSA and the applicable QAG, the MSA shall prevail over those of the applicable QAG with the exception of Product quality-related matters, cGMP and related regulatory requirements in which case, the terms of the applicable QAG shall prevail.

8.2

Responsibility for Recalled Product. For a Commercial Product, either Party shall notify the other Party as soon as practicably possible if any Commercial Product is the subject of a threatened or actual recall by a Regulatory Authority, (a “Recall”) which may be attributable to any Service or Manufacture by or on behalf of SBL hereunder. Client shall be responsible for conducting all Recalls and shall make all decisions regarding, and in all events shall have sole authority for, conducting any recalls, market withdrawals or corrections with respect to the Product and SBL shall at all times exercise Commercially Reasonable Efforts to provide its assistance and cooperation to Client in conducting such Recalls to the extent the Recall arises out of SBL’s Manufacture of Product. Details regarding the roles and responsibilities of the Parties in regard to Recalls are set forth in the applicable QAG. If such Recall results solely from SBL Assignable Error, SBL shall be responsible for direct and documented out-of- pocket costs associated with such Recall subject to the limitation of liability sections of the PSA applicable to such Recalled Product and, subject to written instructions of Client to the contrary, will use

8.3

Records & Audit.

9.1

Consideration. In consideration for SBL’s performing the Service and other obligations undertaken  by SBL pursuant to a PSA, Client shall pay SBL amounts as set forth in the applicable PSA (the “Service Fee”); (ii) a handling surcharge of a certain percentage or certain amount to be set forth in the applicable PSA of the costs of Raw Materials paid by SBL (including but not limited to taxes and customs duties/fees); (iii) a handling surcharge of a certain percentage or certain amount to be set forth in the applicable PSA related to the Client Materials (which shall be based on the actual costs of such materials as supported by reasonable documentary evidence as opposed to the market value thereof); and (iv) storage fees as set forth in the relevant PSA.

9.2

Invoices.

9.3

Payment.

10.1

Confidential Information.   “Confidential Information” shall mean any data, know-how and other information, whether technical or non-technical disclosed by one Party (hereinafter the “Disclosing Party”) or otherwise became known to the other Party (hereinafter the “Receiving Party”) hereunder relating to the subject matter of the MSA, regardless of form or manner of disclosure, i.e., whether disclosed in writing, in electronic file or format or in other tangible manner, or orally, visually or in other intangible manner. If a Party intends to disclose such information in writing, in electronic file or format or in other tangible manner, such Party will make reasonable efforts to indicate it is confidential; and if

(a)

was at the time of disclosure by the Disclosing Party hereunder publicly known or available;

(b)

after disclosure by the Disclosing Party hereunder, became publicly known or available by publication or otherwise, other than by an authorized act or omission by the Receiving Party;

(c)

was in the possession of the Receiving Party without confidentiality restriction at the time of the disclosure by the Disclosing Party hereunder;

(d)

was lawfully received from any third party having the lawful right to make such disclosure, without obligation of confidentiality; or

(e)

was independently developed by the Receiving Party’s directors, officers or employees without reference to the Confidential Information, as demonstrated by records created contemporaneously with such development.

10.2

Confidentiality. The Receiving Party recognizes the proprietary and confidential nature of the Disclosing Party’s Confidential Information and agrees that no right, title, ownership, license, or interest of any character in the Disclosing Party’s Confidential Information other than as specifically granted herein, is conveyed or transferred to the Receiving Party. Both Parties further agree to maintain the Disclosing Party’s Confidential Information in confidence and not to disclose or divulge the Disclosing Party’s Confidential Information, in whole or in part, to any third party, and not use the Disclosing Party’s Confidential Information for any purpose other than pursuing the MSA. Each Party shall guard such Confidential Information using the same degree of care as it normally uses to guard its own confidential or proprietary information of like importance, but in any event no less than reasonable care. The Receiving Party shall limit disclosure of the Disclosing Party’s Confidential Information to its and those of its Affiliates’ directors, officers, employees, consultants and agents (“Representatives”) who have a need to know the Disclosing Party’s Confidential Information for performance of the Service and implementation of the MSA, provided that, the Receiving Party shall undertake procedures to ensure that each of its Representatives to whom the Disclosing Party’s Confidential Information is disclosed

10.3

Authorized Disclosures. Disclosure is permitted in the event that (a) the Disclosing Party’s Confidential Information is reasonably required to obtain or maintain any Regulatory Approvals for the Products in any or all jurisdictions or (b) the Disclosing Party needs to disclose such Confidential Information to comply with Applicable Law; provided that such Receiving Party shall exercise its Commercially Reasonable Efforts to limit disclosure of the Disclosing Party’s Confidential Information to that which is necessary for compliance and to otherwise maintain the confidentiality of the Confidential Information.

10.4

Survival of confidential obligations. The confidential obligations of the Receiving Party shall survive for a period of five (5) years from the expiration or termination of this MSA.

10.5

Return of the Confidential Information. All written, printed or other tangible Confidential Information of the Disclosing Party disclosed under the MSA, and all copies thereof shall be returned to the Disclosing Party (or destroyed at the Disclosing Party’s request) by the Receiving Party within thirty (30) business days from the written request by the Disclosing Party. All Confidential Information disclosed electronically shall be completely deleted and destroyed by the Receiving Party within thirty (30) business days from the written request by the Disclosing Party. Notwithstanding the foregoing, (i) digital backup files automatically generated by the Receiving Party’s customary electronic data processing system may be retained and properly stored as confidential files for the sole purpose of backup and will be deleted in accordance with the Receiving Party’s retention policy, and (ii) a single copy of the Confidential Information may be retained in the secured files of the Receiving Party for the sole purpose of determining the scope of obligations incurred by it under the MSA provided that the Receiving Party shall keep such Confidential Information in confidence and will use the Confidential Information solely to comply with the terms of the MSA as well as the applicable law, rule and regulation.

11.1

Reference Standard, Client Technology, Client Materials, Cell Line, and Product. SBL hereby understands and agrees that all rights to, titles of and interests in the Reference Standards, Client Technology, Client Materials, Cell Line, Product, the Manufacturing Process and any work in process or semi processed goods thereof belong to Client, unless otherwise provided herein.

11.2

Background Intellectual Property.  It is acknowledged that each Party possesses Background IP. Any Intellectual Property relating to the Reference Standards, Client Technology, Client Materials and Cell Line owned and/or controlled by Client as of the date of provision of such Reference Standards, Client Technology, Client Materials and Cell Line by Client to SBL pursuant to Section 5.1, shall be deemed to be included in the Background IP of Client. Client hereby grants SBL a royalty-free, non- transferable, revocable and non-sublicensable and fully-paid-up right and license to use such Intellectual

11.3

Inventions. Any Intellectual Property arising out of or resulting from the Service under the MSA, including but not limited to those contained in the Manufacturing Documentation, shall be hereinafter collectively called an “Invention”.

12.1

The Parties General Warranties.   Each Party warrants and represents that: (i) it has the corporate power and authority to enter into this MSA and has taken all necessary action on its part required to authorize the execution, delivery and performance of this Agreement; (ii) it is aware of no legal, contractual or other restriction, limitation or condition that might adversely affect its ability to enter into this MSA and perform its obligations hereunder; (iii) it is duly organized, validly existing and in good standing under the laws of the jurisdiction in which it is incorporated; (iv) this MSA (a) has been duly executed and delivered by a duly authorized representative of it, and (b) is the legal, valid and binding obligation of it, enforceable against it in accordance with its terms, except as enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium or other similar laws now or hereafter in effect relating to or affecting creditors’ rights generally; and (v) the execution, delivery and performance of this Agreement by it does not and will not (a) violate any Applicable Laws applicable to it, or (b) violate or conflict with any provision of its Articles of Incorporation or By-laws or other organizational documents.

12.2

Client’s Warranties. Client represents, warrants and covenants to SBL that as of the Effective Date of the MSA and during the Term: (a) Client will comply with all Applicable Laws, and that it will keep SBL informed of any information known to Client which would affect SBL’s provision of the Service hereunder and (c) to the best of its knowledge, SBL’s use of the Client Materials, Manufacturing Process, and Client Technology for the purpose of the Service and to the extent as set forth in the MSA will not infringe any third party’s Intellectual Property rights.

12.3

SBL’s Warranties. SBL represents, warrants and covenants that:

12.4

No Other Warranties. THE REPRESENTATIONS AND WARRANTIES CONTAINED IN THIS SECTION ARE EXPRESSLY IN LIEU OF AND EXCLUDE, AND THE PARTIES HEREBY EXPRESSLY DISCLAIM AND NEGATE, TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAWS, ALL OTHER REPRESENTATIONS AND WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED (ARISING BY OPERATION OF LAW OR OTHERWISE), INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, EVEN IF THAT PURPOSE IS KNOWN.

13.1

Indemnification by SBL. SBL shall indemnify and hold harmless Client, its Affiliates, and their respective officers, directors, employees or agents from and against any Damages arising or resulting from any third party (which shall exclude Client Affiliates) claims to the extent such Damages are relating to, arising out of, in connection with, or resulting from claims, demands, or actions based upon

13.2

Indemnification by Client. Client shall indemnify and hold harmless SBL, its Affiliates, and their respective officers, directors, employees or agents from and against any Damages arising or resulting from any third party (which shall exclude SBL Affiliates) claims to the extent such Damages are relating to, arising out of, in connection with, or resulting from claims, demands or actions based upon (i) gross negligence or willful misconduct, (ii) any claim that SBL’s use of the Client Materials, Manufacturing Process, and Client Technology for the purpose of the Services and solely to the extent as set forth in the MSA infringes any third party’s Intellectual Property rights, (iii) breach of the MSA or any PSA, or (iv) violation of Applicable Law, in each case except to the extent that such Damages are caused by the causes as set forth in Section 13.1 for which SBL is obliged to indemnify and in the case of clauses (i), (iii), and (iv) of or by Client or its officers, directors, employees, or agents.

13.3

Indemnification Procedure.    The foregoing indemnification by SBL or Client shall be conditioned, if and to the extent Damages are based on or related to a third party claim, upon a Party who intends to claim indemnification under Sections 13.1 and 13.2 (the “Indemnified Party”) (i) providing written notice to the other Party (“Indemnifying Party”) within twenty (20) calendar days after the Indemnified

14.1

Disclaimer of Consequential Damages. EXCEPT FOR DAMAGES BASED ON OR RELATED TO A THIRD PARTY CLAIM ARISING UNDER SECTIONS 13.1 AND 13.2, OR BASED ON GROSS NEGLIGENCE OR WILLFUL MISCONDUCT, NEITHER PARTY WILL BE LIABLE UNDER THIS AGREEMENT FOR ANY SPECIAL, PUNITIVE, CONSEQUENTIAL, INCIDENTAL OR OTHER INDIRECT DAMAGES OF ANY TYPE OR NATURE, WHETHER BASED IN CONTRACT, TORT, STRICT LIABILITY, NEGLIGENCE OR OTHERWISE, INCLUDING LOSS OF PROFITS OR REVENUES.

14.2

Limitation of Liability. Specific caps on Damages shall be set forth in the applicable PSA.

15.1

Term. This MSA will become effective as of the Effective Date and will be in effect for as long as a PSA is in effect (the “Term”). Each PSA will have its own initial term as stated therein. Each PSA for clinical supply shall automatically renew for successive terms of one (1) year each or upon execution of a PSA for commercial supply, whichever is earlier, and each PSA for commercial supply, including supply of stocking inventories in advance of Regulatory Approval, shall automatically renew for successive terms of three (3) years each, unless a Party gives written notice to the other Party of its intention to not renew a PSA for clinical supply ninety (90) days prior to the end of the then current PSA term, or a Party gives written notice to the other Party of its intention to not renew a PSA for commercial supply thirty-six (36) months prior to the end of the then current PSA term.

15.3

Effect of Expiration or Termination.

(a)

Fully Manufactured Product.

(i)

If Client terminates a PSA pursuant to Section 15.2.1, 15.2.2, 15.2.3, 15.2.4 or 15.2.5, upon Client’s election, SBL shall (i) deliver already fully Manufactured Product to Client in accordance with the terms and conditions of the MSA and applicable PSA or (ii) destroy such Product. If Client elected (i) above, Client shall pay the [*] and any related costs or fees for the Service relating to such Product in accordance with the terms and conditions of the MSA and applicable PSA, and if Client elected (ii) above, SBL shall [*], except in the case of Section 15.2.4 or Section 15.2.5 for which destruction Client shall pay the cost.

(ii)

If SBL terminates a PSA pursuant to Section 15.2.1, 15.2.2, 15.2.3, or 15.2.5, upon SBL’s election, SBL may (i) deliver the fully Manufactured Product to Client in accordance with the terms and conditions of the MSA and applicable PSA (including the current Firm Period period or Binding Year in the PSA) or (ii) destroy such Product. If SBL elected (i) above, Client shall pay the [*] and any related costs or fees for the Service relating to such Product in accordance with the terms and conditions of the MSA and applicable PSA, and if SBL elected (ii) above, Client shall bear the costs and expenses for [*]; provided, however, such costs and expenses to be borne by Client shall in no event exceed the Service Fee for the Service relating to such Product.

(iii)

If a PSA is naturally expired pursuant to Section 15.1, the provisions of (ii) above shall apply

(b)

Client Materials being used for the Service (Product in Process).

(i)

If Client terminates a PSA pursuant to Section 15.2.1, 15.2.2, 15.2.3, 15.2.4, or 15.2.5, upon Client’s election, SBL shall (i) continue to use the Client Materials being used for the Manufacturing hereunder (the Product in process) and deliver the fully Manufactured Product to Client in accordance with the terms and conditions of the MSA and applicable PSA, or (ii) deliver to Client or destroy such Product in process. If Client elected (i) above, Client shall pay the [*] and any related costs or fees for the Service relating to the fully Manufactured Product in accordance with the terms and conditions of the MSA and applicable PSA, and if Client elected (ii) above, SBL shall [*].

(ii)

If SBL terminates a PSA pursuant to Section 15.2.1, 15.2.2, 15.2.3, or 15.2.5, upon SBL’s election, SBL may (i) continue to use the Client Materials being used

(iii)

If a PSA is naturally expired pursuant to Section 15.1, the provisions of (ii) above shall apply.

(c)

Client Materials, Cell Line, and Reference Standards. Upon expiration or termination of a PSA, upon Client’s election, SBL shall deliver to Client and/or destroy all remaining Client Materials (subject to Sections 15.3.2(a) and 15.3.2(b)), all remaining Cell Line vials, Reference Standards and other materials required for Manufacturing.

(i)

If Client terminates the PSA pursuant to Section 15.2.1, 15.2.2 or 15.2.3, SBL shall [*];

(ii)

If SBL terminates the PSA pursuant to Section 15.2.1, 15.2.2, 15.2.3, or 15.2.5, or Client terminates the PSA pursuant to Section 15.2.4 or 15.2.5, [*];

(iii)

If a PSA is naturally expired pursuant to Section 15.1, the provisions of (ii) above shall reply.

(d)

Raw Materials.

(i)

If Client terminates a PSA pursuant to Section 15.2.1, 15.2.2 or 15.2.3 and if Client so elects, SBL shall deliver the remaining Raw Materials to Client for Client’s payment of SBL’s cost to procure such Raw Materials, or dispose of them at Client’s election. SBL shall [*].

(ii)

If SBL terminates a PSA pursuant to Section 15.2.1, 15.2.2, 15.2.3 or 15.2.5, or Client terminates a PSA pursuant to Section 15.2.4 or 15.4.5, SBL may deliver the remaining Raw Materials to Client or dispose of them at SBL’s election. If so delivered, Client shall pay [*] to SBL and bear the costs and expenses for the [*] by SBL.

(iii)

If a PSA is naturally expired pursuant to Section 15.1, the provisions of (ii) above shall apply.

(e)

Outstanding Obligations Regarding Purchase of Product.

(i)

If Client terminates a PSA pursuant to Section 15.2.1 or 15.2.2 Client shall be released from any outstanding binding obligations to purchase Product as of the date of notice of termination including but not limited to pursuant to a Firm Period, binding forecast, purchase order, minimum purchase commitment, or otherwise; provided, however, that Client shall purchase Product Manufactured prior to such date of notice, pursuant to the terms of this MSA and PSA.

(ii)

If SBL terminates a PSA pursuant to Section 15.2.1 or 15.2.2, outstanding binding obligations to purchase Product as of the date of notice of termination shall survive termination of such PSA, including but not limited to pursuant to a Firm Period, binding forecast, purchase order, minimum purchase commitment, or otherwise.

(iii)

For all other cases of termination of a PSA, subsection (ii) shall apply.

(f)

Survival. Any termination or expiration of this MSA shall not affect any outstanding obligations due hereunder prior to such termination or expiration, nor shall it prejudice any other remedies that the parties may have under this MSA. For greater certainty, except as otherwise expressly provided, termination or expiration of this MSA, irrespective of the cause, shall not affect any rights or obligations which, from the context thereof, are intended to survive termination or expiration of this MSA, including but not limited to Sections 1, 8, 9, 10, 11, 12, 13, 14, 15, 16 and 17.2.

16.1

Informal Discussions. Except as otherwise provided herein, in the event of any controversy or claim arising out of or relating to this MSA, or the rights or obligations of the Parties hereunder, the Parties shall first try to settle their differences amicably between themselves through the Core Team and then the JSC. Thereafter, either Party may initiate informal dispute resolution on the executive level by sending written notice of the dispute to the other Party, and within thirty (30) days after such notice appropriate executives of the Parties shall meet for attempted resolution by good faith negotiations. If such representatives are unable to resolve such disputed matter within such thirty (30) day period, either Party may refer the matter by written notice to the Chief Executive Officer of the other Party, or his/her

17.1

Notices. Any notice required or permitted under the MSA shall be in writing with duly authorized signature and made to the following addresses or facsimile numbers:

17.2

Governing Law. This MSA shall be construed and interpreted in accordance with the laws of State of New York, United States and all rights and remedies shall be governed by such laws without regard to principles of conflicts of law. The United Nations Convention on Contracts for the International Sale of Goods shall not apply to the transactions contemplated by the MSA.

17.3

Effect of Force Majeure Event. Neither Party (the “Affected Party”) shall be liable to the other Party (the “Non-Affected Party”) for failure or delay to perform its obligation under the MSA or any applicable PSA when such failure or delay is due to riots, storms, fires, explosions, floods, earthquakes, war, embargoes, blockades, insurrections, terrorism, an act of God or any other cause similar thereto which is beyond the control of the Affected Party including those affected upstream suppliers (“Force Majeure Event”).

17.4

Assignment. Neither Party shall assign, in whole or in part, the MSA without the prior written consent of the other Party, such approval not to be unreasonably withheld, conditioned or delayed. Notwithstanding the above, Client may, without such consent, assign the MSA to (i) its Affiliate or (ii) any purchaser of Client’s rights relating to the Product or all or substantially all of the assets of Client, or of all of its capital stock, or to any successor corporation or entity resulting from any merger or consolidation of such Party with or into such corporation or entity. Notwithstanding the above, SBL may, without such consent, assign the MSA to (i) its Affiliate or (ii) any purchaser of substantially all of the assets of SBL, or of all of its capital stock, or to any successor corporation or entity resulting from any merger or consolidation of such Party with or into such corporation or entity.

17.5

No Grant of License. Nothing in the MSA shall affect, or grant any right to, patents, know-how or other intellectual property owned by either Party prior to the commencement of the MSA unless otherwise expressly provided in the MSA.

17.6

No Right to Use Names. Except as expressly provided herein, no right, expressed or implied, is granted by the MSA to use in any manner the name of either of the Parties or any other trade name, symbol, logo or trademark of the other Party in connection with the performance of the MSA, without the prior written consent of the other Party.

17.7

Independent Contractors. The Parties hereto are independent contractors and nothing contained in the MSA shall be deemed or construed to create a partnership, joint venture, employment, franchise, agency or fiduciary relationship between the Parties.

17.8

Integration. This MSA constitutes the entire agreement between the Parties relating to the subject matter of the MSA and supersedes all previous oral and written communications between the Parties with respect to the subject matter of the MSA.

17.9

Amendment; Waiver. Except as otherwise expressly provided herein, no alteration of or modification to the MSA shall be effective unless made in writing and executed by an authorized representative of both Parties. No course of dealing or failing of either Party to strictly enforce any term, right or condition of the MSA in any instance shall be construed as a general waiver or relinquishment of such term, right or condition. The observance of any provision of the MSA may be waived (either generally or any given instance and either retroactively or prospectively) only with the written consent of the Party granting such waiver.

17.10

Severability. The Parties do not intend to violate any Applicable Law. However, if any sentence, paragraph, clause or combination of the MSA is in violation of any law or is found to be otherwise unenforceable, such sentence, paragraph, clause or combination of the same shall be deleted and the remainder of the MSA shall remain binding, provided that such deletion does not alter the basic purpose and structure of the MSA.

17.11

Construction. The Parties mutually acknowledge that they have participated in the negotiation and preparation of the MSA. Ambiguities, if any, in the MSA shall not be construed against any Party,

17.12

Interpretation. The captions and headings to the MSA are for convenience only, and are to be of no force or effect in construing or interpreting any of the provisions of the MSA. Unless context otherwise clearly requires, whenever used in the MSA: (a) the words “include” or “including” shall be construed as incorporating, also, “but not limited to” or “without limitation”; (b) the words “hereof,” “herein,” “hereby” and derivative or similar words refer to the MSA; (c) the word “law” or “laws” shall mean any applicable, legally binding statute, ordinance, resolution, regulation, code, guideline, rule, order, decree, judgment, injunction, mandate or other legally binding requirement of a governmental authority (including a court, tribunal, agency, legislative body or other instrumentality of any (i) government or country or territory, (ii) any state, province, county, city or other political subdivision thereof, or (iii) any supranational body); and (d) all references to the word “will” are interchangeable with the word “shall” and shall be understood to be imperative or mandatory in nature. All references to days, months, quarters or years are references to calendar days, calendar months, calendar quarters, or calendar years. Whenever any matter hereunder requires consent or approval, such consent or approval shall not be unreasonably withheld or delayed.

17.13

Counterparts. This MSA may be executed in two or more counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument.