instruction:
In this task, you're given a passage that represents a legal contract or clause between multiple parties, followed by a question that needs to be answered. Based on the paragraph, you must write unambiguous answers to the questions and your answer must refer a specific phrase from the paragraph. If multiple answers seem to exist, write the answer that is the most plausible.
question:
EXHIBIT B   MUTUAL TERMINATION AGREEMENT   THIS MUTUAL TERMINATION AGREEMENT (Termination Agreement) is made and entered into this day of , 2009, by and between Beijing SINA Internet Information Service Co. (Beijing SINA) and Shanghai SINA Leju Information Technology Co. Ltd. (SINA Leju).   WITNESSETH:   WHEREAS, Beijing SINA and SINA Leju entered into that certain Domain Name License Agreement dated May 8, 2008 (the Original Agreement); and   WHEREAS, Beijing SINA and SINA Leju desire to mutually terminate the Original Agreement effective as of the date of this Termination Agreement.   NOW, THEREFORE, in consideration of the mutual covenants and conditions contained herein, and other good and valuable consideration, receipt of which is hereby acknowledged by each of the parties hereto, the parties agree as follows:   1. Beijing SINA and SINA Leju agree that, upon the date of execution of this Termination Agreement, the Agreement shall terminate and be of no further force or effect, and, for the avoidance of doubt, no provisions of the Original Agreement survive such termination.   2. This Termination Agreement represents the complete, integrated, and entire agreement between the parties, and may not be modified except in writing signed by the parties.   3. This Termination Agreement shall be governed by the laws of the PRC, without regard to conflicts of law principles.   4. This Termination Agreement may be executed in one or more counterparts, each of which shall be deemed an original but all of which together will constitute one and the same instrument.   5. This Termination Agreement shall be binding upon and inure to the benefit of the parties hereto and their respective successors and assigns.   [SIGNATURES ON NEXT PAGE]   18

Source: LEJU HOLDINGS LTD, DRS (on F-1), 1/21/2014





  IN WITNESS WHEREOF, the undersigned have executed this Termination Agreement as of the date first set forth above.

  Beijing SINA Internet Information Service Co., Ltd.

  By:







  Name:



  Title:

  Shanghai SINA Leju Information Technology Co. Ltd.

  By:







  Name:



  Title:     19

Source: LEJU HOLDINGS LTD, DRS (on F-1), 1/21/2014 
Question: Highlight the parts (if any) of this contract related to Governing Law that should be reviewed by a lawyer. Details: Which state/country's law governs the interpretation of the contract?
answer:
This Termination Agreement shall be governed by the laws of the PRC, without regard to conflicts of law principles.


question:
Exhibit 10.10

CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH [***]. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. MASTER DEVELOPMENT AND MANUFACTURING AGREEMENT

This Master Development and Manufacturing Agreement (including all appendices hereto, this Agreement) is entered into as of February 13, 2018 (the Effective Date) by and between Magenta Therapeutics, Inc., a Delaware corporation having offices at 50 Hampshire Street, 8t h Floor, Cambridge, MA 02139 (Magenta), and Bachem Americas, Inc., a California corporation, having offices at 3132 Kashiwa Street, Torrance, CA 90505 (Bachem). Magenta and Bachem may be referred to individually as a Party or collectively as the Parties.

RECITALS

WHEREAS, Magenta is engaged in the development and research of certain pharmaceutical products and requires assistance in the development and manufacture of active pharmaceutical ingredients for its clinical trials; and

WHEREAS, Bachem is a contract manufacturer that possesses the necessary technical capabilities and operates pharmaceutical process development facilities for both the development and manufacture of pharmaceutical products used in clinical trials, as required by Magenta; and

WHEREAS, Magenta desires Bachem to provide the Services and manufacture the Products specified in Project Plans (as defined below); and

WHEREAS, Bachem is willing to provide the Services, manufacture the Product, and fulfill the Project Plans on the terms and conditions set forth below.

NOW, THEREFORE, in consideration of the mutual promises contained herein, and for other good and valuable consideration, the receipt and adequacy of which each of the Parties does hereby acknowledge, the Parties, intending to be legally bound, agree as follows.

Section 1. DEFINITIONS

As used herein, the following terms shall have the following meanings:

1.1 Affiliate shall mean any corporation or other entity which controls, is controlled by, or is under common control with, a Party to this Agreement. A corporation or other entity shall be regarded as hi control of another corporation or entity if it owns or directly or indirectly controls more than fifty percent (50%) of the voting stock or other ownership interest of the other corporation or entity, or if it 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 fifty percent (50%) or more of the members of the governing body of the corporation or other entity.

1.2 Applicable Laws means all relevant federal, state and local laws, statutes, rules, regulations, and ordinances and industry standards and guidelines as in effect on the Effective Date or adopted thereafter and which are applicable to a Party's activities hereunder in their respective countries, including, without limitation, the applicable regulations and guidelines of the FDA and all applicable GMPs together with amendments thereto.





CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH [***]. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. 1.3 Batch means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

1.4 CMC shall mean (i) manufacturing process development for Product; (ii) all chemistry, manufacturing and control procedures necessary for the manufacturing, testing and quality control release of Product; and (iii) sourcing and testing of all raw materials and components used in the production of any Product.

1.5 [***] means the specific sequence(s) defined in Appendix B.

1.6 Development Specifications shall mean the requirements of all Applicable Laws and the procedures, process parameters, analytical tests and other attributes and written specifications for the Development Work attached hereto as part of a Project Plan.

1.7 Development Work shall mean those development Services that are to be performed by Bachem hereunder and which may include work related to identifying, formulating, developing and demonstrating cost effective, reproducible Product and manufacturing a feasibility Batch.

1.8 DMF means a Drug Master File as described in 21 C.F.R. § 314.420.

1.9 Effective Date has the meaning set forth in the introduction.

1.10 FDA means the United States Food and Drug Administration or any successor entity thereto.

1.11 GMPs shall mean 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, applicable documents developed by the International Conference on Harmonization (ICH) to the extent that they are applicable to Product and the Parties hereunder.

1.12 Governmental Authority means any court, including any political subdivision thereof, court instrumentality, or agency thereof, and any other federal, state, or public authority, domestic or foreign, exercising governmental powers and having jurisdiction over any activity of a Party under this Agreement.

1.13 IND means an investigational new drug application relating to a Product, and includes such applications submitted to the FDA and equivalent applications submitted to a Governmental Authority outside of the U.S.

1.14 Latent Defect means a defect which could have been detected (but was not) by the analytical test methods in operation at the date of shipment to Magenta, attributable to an act or omission of Bachem that causes a Product to fail to conform to the Specifications, which may not be discoverable upon the inspection and testing which Magenta would have been expected to carry out in its ordinary course of business, but is discovered at a later time. 2





CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH [***]. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. 1.15 Product means the product to be developed or manufactured by Bachem pursuant to a Project Plan.

1.16 Project Plant(s) means a mutually agreed to project plan, statement of work, quotation or other ordering document that sets forth a description of the Services to be provided by Bachem, and related timeline(s), costs, and other relevant details, that references, and is expressly governed by this Agreement and is executed by an authorized representative of each Party. Notwithstanding, the Parties acknowledge and agree that the quotations identified in Appendix A attached hereto are Project Plans, and are governed by this Agreement, even though they do not expressly reference this Agreement.

1.17 Services means, with respect to a Project Plan, those services (including Development Work and manufacture of Product) to be provided by Bachem, as described in such Project Plan.

1.18 Specifications means the requirements of all Applicable Laws, the master batch record, current standard operating procedures and the procedures, process parameters, analytical tests and other attributes and written specifications for the Product attached hereto as part of a Project Plan, which the Parties agree are necessary for the manufacture and release of the Product for use in clinical trials. The Parties recognize that specifications for Product for a specific Project Plan are likely to change during the term of this Agreement, and the Parties agree to act in good faith and reasonably to effect such changes as may be required. Copies of such Specifications, as amended, shall be maintained by both Parties, and shall be incorporated into this Agreement and the Quality Agreement (as defined below).

1.19 Third Party means any entity other than Magenta or Bachem.

1.20 U.S. means the United States of America, its territories, commonwealths, and possessions, including the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, and all other places under the jurisdiction thereof.

Section 2. ENGAGEMENT OF BACHEM

Magenta hereby engages Bachem to perform the Services and manufacture the Product in accordance with the applicable Project Plan(s) and in compliance with Applicable Laws and the terms and conditions set forth herein, and Bachem hereby accepts such engagement. Bachem will supply to Magenta all Product ordered by Magenta hereunder as set forth in the Project Plan and related purchase orders.

Section 3. PROJECT PLANS

3.1 Project Plans. All Project Plans entered into after the Effective Date shall be added to Appendix A after execution by the Parties of a written amendment in the form of the Amendment to Appendix A, attached hereto (the Amendment). There shall be no limit to the number of Project Plans that may be added to Appendix A and governed by the terms and conditions of this Agreement. In the event of a conflict between the terms of a Project Plan or any attachments thereto or any purchase order issued in connection therewith and this Agreement, the terms of this Agreement will govern. 3





CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH [***]. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. 3.2 Content of Project Plans. Each Project Plan shall include a description of the Services to be provided, including, if applicable, the Development Work to be completed, the Product to be manufactured, relevant Development Specifications, relevant Specifications, deliverables, a corresponding budget, a schedule for completion of the Project Plan (which may be set forth for the entire Project Plan or stages thereof), a fee and payment schedule, delivery terms, and such other information as the Parties determine is necessary for Bachem to perform the Services and manufacture the Product. Magenta may amend any Project Plan before its completion, subject to prior written approval by Bachem, which approval shall not be unreasonably withheld. If such amendment entails additional expenses that will be incurred by Bachem, the Parties agree to reconsider in good faith the budget and the payment and fee schedule.

3.3 Materials and Equipment. Unless otherwise agreed by the Parties in writing or specified in the applicable Project Plan, Bachem shall supply all materials and standard processing and manufacturing equipment needed to provide the Services and manufacture the Product in accordance with this Agreement and the applicable Project Plan, at its sole cost and expense.

3.4 Change Orders. In the event that Magenta requests or requires Bachem to perform services that are outside the scope of this Agreement, or Magenta desires to amend a Project Plan, such changes must be mutually agreed upon by the Parties in a written change order (a Change Order) prior to the provision of said services or implementation of such amendment by Bachem. Each such Change Order constitutes an amendment to the Agreement and/or the applicable Project Plan, and thereafter the services or amendments set forth therein shall be deemed Services hereunder.

3.5 Project Manager. With respect to each Project Plan, an employee of Bachem shall be appointed as project manager by Bachem (the Project Manager). The Project Manager shall be the primary contact for Magenta and shall timely address all issues and concerns raised by Magenta, as well as provide to Magenta all information requested by Magenta concerning this Agreement or the Services. The Project Manager shall not be replaced without advanced written notice to Magenta. In the event that Bachem becomes aware that the Project Manager plans to leave the employment of Bachem or shall be unable to complete the Services due to dismissal, death or disability, it shall give immediate written notice of the same to Magenta so as not to impact ongoing manufacture or supply. Should Magenta not be satisfied with the services of Project Manager, Magenta may give notice of the same to Bachem and Bachem will assign a suitable replacement who is reasonably acceptable to Magenta within [***] of such notice.

Section 4. COMPENSATION

4.1 Generally. The fees to be paid to Bachem in connection with the Services shall be set forth in reasonable detail in each Project Plan. Bachem represents that it has included all of its costs, fees and expenses, including administrative overhead, in calculating the fee for the Services budget attached hereto as part of the applicable Project Plan, and that Magenta shall not be liable for or be charged for any other costs, fees or expenses of Bachem. No line item in any Project Plan budget shall be exceeded by Bachem without the prior written consent of Magenta. 4





CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH [***]. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. 4.2 Invoicing and Payment. Unless specifically agreed otherwise in writing by the Parties, including as agreed in a Project Plan, (i) all invoices and payments hereunder shall be in U.S. Dollars, (ii) payments will be made payable to Bachem at the address set forth in applicable Project Plan(s), and (iii) all undisputed payments shall be made within [***] of receipt of invoice by Magenta.

4.3 Taxes. All prices are stated exclusive of VAT (or equivalent tax) that may or may not become due according to Applicable Law. Each Project Plan shall set forth an estimate of VAT that may become due thereunder and Bachem shall notify Magenta within a reasonable period of time upon becoming aware of a material deviation from such estimate.

4.4 Bachem's Fees for Performance of Services. Bachem's fees for the performance of Services represent the entire cost for the provision of such Services. Magenta shall not be charged for any Service or deliverable that is not performed or delivered, as the case may be, in accordance with this Agreement or the applicable Project Plan(s).

Section 5. BACHEM REPRESENTATIONS, WARRANTIES, AND CERTAIN COVENANTS

5.1 Authority. Bachem represents and warrants mat it has full authority to enter into this Agreement and there is no provision contained in any other agreement to which it is party or arrangement or obligation to which it is bound that prohibits or restricts it from entering into or performing under this Agreement.

5.2 Services. Bachem shall provide the Services in accordance with each Project Plan. Bachem will perform all Services in accordance with this Agreement and the agreed upon Specifications. All Products shall be packaged, labeled and shipped in accordance with this Agreement, the applicable Project Plan and all Applicable Laws. Bachem and its employees and agents have, and will continue to have, the knowledge, experience, facilities, equipment and skill to provide, and will provide, the Services in a professional and timely manner. Services will conform to consistently high standards of workmanship and the specifications applicable to each Project Plan.

5.3 Material/Supplies. In situations where Magenta provides materials or supplies to Bachem in connection with this Agreement and/or a Project Plan(s), Bachem shall use such materials and supplies only in accordance with the applicable Project Plan for which it was received, and Bachem shall not use it for any other purpose. Bachem shall be responsible for all such materials and supplies provided by Magenta while they are in Bachem's control or the control of its agents, and Bachem shall promptly, at Magenta's direction, destroy or return to Magenta all unused quantities of its materials and supplies provided by Magenta. For the avoidance of doubt, Magenta shall retain title to all of its materials and supplies, including any API or intermediates, while it is in Bachem's facility (as of the Effective Date, this facility will [***]. Magenta shall be responsible for all such materials and supplies until delivered to Bachem at its facility. Any such materials or supplies shall be delivered in a timely manner and in accordance with the shipping instructions and specifications to be agreed upon by the Parties. 5





CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH [***]. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. 5.4 Deliverables. Each deliverable (including Product) developed or produced in connection with a Project Plan and this Agreement shall conform to the Specifications. The Development Work, as described in the Project Plan, shall conform to the Development Specifications. Bachem shall warrant compliance with the agreed acceptance criteria together with the results as reported on the Certificate of Analysis in conjunction with the analytical methods at the time of the release of Product. In no event shall Bachem be liable for any defects that could not have been detected by Bachem with the analytical test methods in operation at the date of product release. For reasons of clarity, the Parties acknowledge and agree that it shall remain solely the responsibility and liability of Magenta to determine the suitability of the Product for any intended or specific use of the Product. Bachem makes no expressed or implied guarantees, warranties or undertakings as to the use of the Product for an intended or specific purpose or use.

5.5 Third Party IP. Bachem will not knowingly infringe or misappropriate any third party intellectual property rights in connection with the performance of its obligations hereunder. Materials delivered by Magenta to Bachem will not, to Magenta's knowledge, infringe any third party intellectual property rights.

5.6 No Encumbrance. Bachem hereby (i) acknowledges and agrees that neither it, nor any of its affiliates or subsidiaries, nor any of its or their directors, officers, employees and agents has any interest in Magenta Pre-Existing Intellectual Property or Magenta Developed Intellectual Property (each as defined below) and (ii) covenants that it will not lien or encumber, or otherwise cause, permit or consent to the granting of a lien or encumbrance of Magenta Pre-Existing Intellectual Property or Magenta Developed Intellectual Property.

5.7 Books and Records. Bachem shall maintain true, complete and accurate books, records, test and laboratory data, reports and all other information relating to Services performed and Product manufactured under this Agreement, including all information required to be maintained by Applicable Laws.

5.8 Disclosures. Upon Magenta's reasonable request, Bachem shall also provide all information to Magenta that is specifically related to the Product and Services, including any information which is reasonably required to comply with any disclosure requirements of regulatory authorities.

5.9 Regulatory Inspections. Bachem shall make its facilities and all records relating to the Product, and Services related thereto, available to the FDA or other regulatory authorities, as mutually agreed by the Parties, and shall notify Magenta immediately if the FDA or any other regulatory authority begins or schedules an inspection of Bachem's records, facilities, or manufacturing processes that are solely related to the Product or the Services related thereto. Bachem shall provide Magenta access to any documentation related to or resulting from each such inspection in accordance with the provisions of the Quality Agreement. If a regulatory authority in connection with a preapproval inspection of the Product inspects the Bachem facility used for production of Product, Bachem will notify Magenta in writing within [***] after learning of the inspection unless otherwise specified in the Quality Agreement. If an FDA Form 483 (or an equivalent foreign regulatory authority form) is issued in connection with the Product, Bachem will provide its proposed response to such Form 483 (or equivalent form) to Magenta 6





CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH [***]. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. for Magenta's review and (non-binding) input in accordance with the provisions of the Quality Agreement. Bachem will consider in good faith any comments and suggestions provided by Magenta with respect to such proposed response if received by Bachem in a timely manner. For the avoidance of doubt, nothing in this Agreement shall hinder Bachem from providing its answers to regulatory authorities within the timelines required by such authorities.

5.10 Report of Noncompliance. In the event that an employee or agent of Bachem who is working on a Project Plan fails to comply with Applicable Laws, this Agreement or any applicable agreement as the same relates to the Services, and such failure is discovered by or comes to the attention of Bachem's COO or a supervisor of Bachem with respect to the applicable Project Plan, Bachem will immediately notify Magenta in writing. Appropriate action will be taken by Bachem at the direction of Magenta, after Bachem consults in good faith with Magenta, as to what actions might be undertaken by Bachem in view of the particular facts surrounding such noncompliance.

5.11 Information. Upon request, Bachem shall provide to Magenta access to all information in Bachem's control that relates to the [***], Product and/or the Project Plan within a reasonable period of time. Copies of batch records will be provided on an electronic platform for a period of [***], or another period of time by mutual agreement of the Parties, and with restricted access rights only.

5.12 Debarment. Bachem hereby certifies that it does not and shall not employ, contract with or retain any person directly or indirectly to perform Services under this Agreement or any Project Plan if such person is or has been debarred under 21 U.S.C. 335a (a) or (b) or other equivalent laws, rules, regulations or standards of any other relevant jurisdiction. Upon written request of Magenta, Bachem shall, [***], provide written confirmation that it has complied with the foregoing obligation. Bachem agrees to immediately disclose in writing to Magenta if any employee or agent is debarred, or if any action or investigation is pending or, to the best of Bachem's knowledge, is threatened in relation to the debarment of Bachem or any person performing Services in connection with this Agreement.

5.13 Restrictions on Bachem. Bachem agrees to supply the Product(s) identified in each applicable Project Plan to Magenta pursuant to the terms and conditions of this Agreement and any applicable Project Plans. During the Initial Term and any Renewal Term, Bachem agrees not to sell, supply or otherwise distribute [***] for any clinical or commercial use to any Third Party without Magenta's prior written consent, for so long as Bachem remains Magenta's primary supplier of [***] for the Initial Term and any Renewal Term.

5.14 Changes by Bachem. Bachem shall not make any major changes to the Development Specifications, the Specifications or any manufacturing process with a potential to adversely impact the quality of the Product in connection with a Project Plan without the prior written consent of Magenta. Notwithstanding, Magenta acknowledges and agrees that changes will be required for the development of the Product. Thus, during the development phase of a Product and up to the completion of the full validation of the manufacturing process of a Product, some quality assurance standards may not be fully implemented or applied in the manufacturing, release and supply of such Product. These limited quality assurance standards may relate to (i) the manufacturing and testing procedures in development and/or (ii) formalized 7





CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH [***]. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Product specific procedures that may not be in place and generic procedures that may be applied instead and/or (iii) change control that may be less stringent during development and/or (iv) Product specific validation may not be available. However, Bachem will manufacture the Product according to applicable GMP guidelines as defined in the Quality Agreement.

5.15 DMF/Amendment. Upon Magenta's reasonable request and order, Bachem will compile a DMF for the Product in cooperation and mutual agreement with Magenta. Bachem hereby grants to Magenta, at no additional cost, reference rights to the DMFs, which are necessary to support Magenta's regulatory submissions with respect to the Product. Bachem shall provide reasonable advance written notice to Magenta prior to amending any Bachem DMF that is referenced in a filed IND of Magenta or in a proposed IND filing of Magenta. Bachem will, at Magenta's expense, provide reasonable assistance as necessary so that the FDA (and/or equivalent foreign regulatory authority) can reference the relevant DMF. Bachem shall not permit the FDA or any other regulatory authority to reference its DMF in order to permit a Third Party to develop, manufacture or commercialize [***] or any products that incorporate [***] or compete with [***]. In the event that the Parties agree that Bachem will not file a DMF in connection with a Project Plan, Bachem shall instead fully cooperate with Magenta, and provide a quote (similar to the compiling of a DMF) to provide all information, data, and rights of reference reasonably required by Magenta in connection with its regulatory and governmental filings related to Product.

5.16 Waste Disposal. Bachem shall generate, handle, store, ship and dispose of all wastes associated with its manufacture of Product in accordance with Applicable Laws. Notwithstanding the foregoing sentence, if any specially regulated waste must be removed pursuant to a given Project Plan, such specially regulated waste and the process for its removal shall be expressly set forth in such Project Plan. If the specially regulated waste is solely attributable to Magenta's Product and the Specifications and instructions for production of such Product, then unless the Parties otherwise agree, Magenta shall be responsible for the reasonable costs associated with the removal of such specially regulated waste. Such costs shall be included in the Project Plan or, if not specified therein, included in the price of the Services and Product.

5.17 Audits. Magenta and its agents and designees shall have the right to audit Bachem's facilities, systems, records, procedures, and documentation related to this Agreement. In connection with any such audit, Bachem shall also provide Magenta access to its personnel. Magenta may conduct no more than one (1) technical visit and one (1) quality assurance audit per year, unless there is cause for an additional audit (i.e., a technical issue or quality issue). Such audits may be conducted upon reasonable notice during the term of this Agreement and for [***] thereafter. On-site technical discussions may also be requested and held at mutually agreeable times.

5.18 Person-In-Plant. If reasonably requested by Magenta, at a mutually agreed day and time, Bachem will permit and provide working space for Magenta to staff one person on location at Bachem's premises, limited to no more than [***] days, during preparation for manufacturing and packaging of the Product. Such person shall be given reasonable access to all records, facilities and personnel working on any Services or Project Plans for the purpose or providing advice, coordinating reviews, approvals or any other actions required to ensure compliance with this Agreement to the extent that it does not compromise the confidentiality of other customers. 8





CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH [***]. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. 5.19 Quality Agreement. As reasonably required by Magenta in connection with Product manufacturing activities hereunder, Bachem shall enter into a written quality agreement with Magenta (the Quality Agreement).

Section 6. ADDITIONAL PRODUCT SUPPLY TERMS

6.1 Delivery. Unless otherwise agreed to between the Parties, delivery terms shall be DDP (Incoterms 2010) Magenta's facility located at 50 Hampshire Street, 8t h Floor, Cambridge, MA 02139, or such other destination as Magenta may instruct in writing, at which time risk of loss and responsibility for Product will transfer to Magenta. Bachem shall assume all risk and responsibility for handling, storing, rotating stock, packaging, loading and shipping all Product in accordance with applicable Incoterms. Bachem shall ship the Product in accordance with the applicable Project Plan. Delivery shall occur on the delivery dates set forth in each Project Plan and any related purchase orders or as otherwise agreed to in writing by the Parties.

6.2 Acceptance and Rejection of Products.

(a) Promptly following receipt of Product, Magenta shall have the right but not the obligation to test such Product to determine compliance with the Specifications. Magenta shall have [***] after receipt of the Product to notify Bachem in writing of any rejection of Product based on a sufficiently documented claim that the Product fails to meet the Specifications. In the event that Magenta does not inform Bachem within the [***] period that the Product does not meet the Specifications, Magenta shall be deemed to have accepted the Product. If there is no dispute between the Parties over a claim that the Product fails to meet the Specifications, Bachem shall (i) replace or (ii) with Magenta's prior written consent, reprocess or rework the rejected Product within an agreed upon time frame, after the notice of such rejection, and in any case as soon as reasonably possible after receiving such notice, provided that Magenta shall, at Bachem's expense, provide to Bachem sufficient quantities of supplies required to be supplied by Magenta under the relevant Project Plan, at no additional cost to Magenta (including transportation costs), and Bachem shall make arrangements with Magenta for the return or disposal of any rejected Product, such return shipping or disposal charges to be paid by Bachem. In the event of a discrepancy between Magenta's and Bachem's test results such that one Party's test results fall within relevant Specifications and the other Party's test results fall outside the relevant Specifications, or there exists a dispute between the Parties over the extent to which such failure is due to acts or omissions of Bachem, the Parties shall cause an independent GMP laboratory or appropriate experts promptly to review records, test data and perform comparative tests and/or analyses on samples of the alleged defective Product. Such independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory's results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rules. 9





CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH [***]. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. (b) If Bachem shall fail to deliver to Magenta the full quantity of the Product as specified in a Project Plan by the delivery date specified therein, for any reason whatsoever other than a breach of this Agreement by Magenta, then at Magenta's election: (i) Bachem shall be relieved of any obligation to deliver the remaining quantity of the Product or (ii) Bachem shall deliver the remaining quantity of the Product as soon as reasonably possible after the date Magenta notifies Bachem of such election. Magenta and Bachem will agree upon the time period to deliver the remaining Product allowed under clause (ii) [***] of the missed delivery date (or, if applicable, the date on which Bachem notifies Magenta that such delivery will be late).

6.3 Latent Defects; Contamination.

(a) As soon as either Party becomes aware of a Latent Defect in any lot of Product, but in no case later than (i) within one (1) week after reaching such awareness or (ii) the end of the indicated retest period for the lot with the Latent Defect, whichever is earlier, it shall immediately notify the other Party. Bachem shall be fully responsible for all Latent Defects. At Magenta's election, the lot or batch with the Latent Defect shall be deemed rejected as of the date of such notice and the provisions of Section 6.2 shall apply.

(b) Bachem shall be fully responsible for any Product and/or Product-related supplies that are adulterated, contaminated, damaged or destroyed while in Bachem's control. Bachem agrees, at the election of Magenta and in addition to any other remedies Magenta may have, to promptly replace such Product and/or Product-related supplies (as the case may be) or refund to Magenta the value of the Product or Product- related supplies.

6.4 Stability, Record Keeping. Bachem shall retain such Product stability samples and keep manufacturing records, and any other records set forth in a Project Plan, for [***] from the expiration or termination of this Agreement. Bachem shall make accessible for review by Magenta during an audit or inspection, or following Product release by Bachem's Quality Assurance Department, either onsite or on an electronic platform with restricted access rights only (as reasonably requested by Magenta), at a mutually agreeable time, all specific Batch and lot records relevant to Bachem's performance hereunder, including written investigations of any deviations and out-of-specification events that may have been generated from manufacturing, packaging, inspection, or testing processes.

6.5 CMC Responsibilities; Regulatory Submissions; Permits. Bachem shall be responsible for obtaining and maintaining, at its sole expense, any facility or other licenses or permits, and any regulatory approvals, necessary for the manufacture of Product, supply of Product, and performance of Services, all in accordance with the terms and conditions of this Agreement, At Magenta's request and expense, Bachem shall also compile the regulatory submissions documentation for the Product (i.e. CMC documentation and DMF) as reasonably requested by Magenta, including permitting the FDA to reference Bachem's DMF, once it is available, in connection with Magenta's IND.

6.6 Recall. In the event of a recall of Product, Magenta shall be responsible for coordinating such recall. Magenta promptly shall notify Bachem if any Product is the subject of a recall and, to the extent required by Bachem, provide Bachem with a copy of all documents relating to such recall. Bachem shall cooperate fully with Magenta in connection with any recall. Magenta shall be responsible for all of the costs and expenses of such recall, except to the extent 10





CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH [***]. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. that Bachem is determined to be responsible for such recall. In such case, Bachem shall be responsible for such costs and expenses. Such determination of responsibility may be made by the governmental agency involved or by mutual agreement by the Parties following examination and review of all records pertinent to the manufacture of the Product subject to such recall. In case of shared responsibility, the costs should be allocated in accordance with each Party's share of responsibility.

Section 7. TERM AND TERMINATION

7.1 Term. This Agreement shall commence on the Effective Date and shall extend for a period of Five (5) years thereafter (Initial Term), unless this Agreement is terminated earlier as provided herein or is extended by mutual written agreement of the Parties. This Agreement may be renewed for additional periods of one (1) year (each such additional period, a Renewal Term) unless either Party provides notice of nonrenewal upon not less than [***] prior written notice to the other Party. Notwithstanding the foregoing, each Project Plan may have separate term and termination provisions, so long as the term of any Project Plan does not extend beyond the Initial Term or a subsequent Renewal Term.

7.2 Termination. This Agreement or any Project Plan may be terminated:

(a) by Magenta for any reason upon [***] written notice to Bachem;

(b) by either Party if the other Party materially breaches a provision of this Agreement or a Project Plan, and fails to cure such breach within [***] following receipt of written notification of such breach from the non-breaching Party;

(c) by either Party, immediately, if the other Party becomes insolvent, is dissolved or liquidated, makes a general assignment for the benefit of its creditors, or files or has filed against it, a petition in bankruptcy that is not dismissed within sixty days after filing, or has a receiver appointed for a substantial part of its assets; and

(d) by a Party or the Parties pursuant to Section 13.

In the event of termination pursuant to Section 7.2(a) or a termination by Bachem pursuant to Section 7.2(b), Bachem shall be compensated for Services rendered up to the date of termination. In the event of any other termination, the Parties shall negotiate in good faith to determine the appropriate amount to be paid by Magenta to Bachem (or refunded to Magenta by Bachem, as the case may be), in light of the circumstances of such termination, in compensation for all Services rendered in accordance with this Agreement. In the event of Bachem's inability to supply the Product or a material breach by Bachem pursuant to Section 7.2(b), Bachem shall provide, without additional charge to Magenta, sufficient information and technology pertaining to its Services to Magenta and/or its technically competent designee, such that Magenta and/or its technically competent designee are enabled to continue Development Work and manufacture of the Product. The termination of any Project Plan may be independent of the termination of this Agreement. 11





CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH [***]. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. 7.3 Regulatory information and Compounds. On or before the effective date of any termination or expiration of this Agreement or upon the written request of Magenta, Bachem shall promptly transfer to Magenta all compounds and other materials and supplies provided to Bachem by or on behalf of Magenta in connection with this Agreement, as well as all works-in-process and raw materials purchased under a Project Plan. Upon the expiration or termination of this Agreement or upon the written request of Magenta, Bachem will also compile CMC documentation as provided for in the applicable Project Plan, which will contain all information necessary for Magenta for regulatory and manufacturing purposes related to the Product. The CMC documentation would also contain the information required for any competent Third Party manufacturing to assume manufacturing of the Product independently, if Magenta desires to transfer the process. Upon the request of and at the expense of Magenta, after termination of this Agreement, Bachem agrees to reasonably assist Magenta in identifying Third-Party manufacturers of the Product. If such termination is due to Bachem's inability to make the Product, or a material breach by Bachem pursuant to Section 7.2(b), Bachem will provide such assistance without charge.

7.4 Project Plans in Progress. In the event of any termination or expiration of this Agreement, Bachem shall, upon the request of Magenta and notwithstanding the effective date of any termination or expiration, complete any Project Plans involving the manufacture of Product that were accepted by Bachem prior to such date, and Magenta shall pay Bachem for any Product produced or services completed, in accordance with the terms of the applicable Project Plans and this Agreement. If this Agreement is terminated by Magenta pursuant to Section 7.2(a) or by Bachem pursuant to Section 7.2(b) or (c), Magenta shall also pay to Bachem amounts for any services that cannot be reasonably stopped at the time of termination; provided, that, Bachem will take all reasonable steps necessary to wind down such work as promptly as practicable.

7.5 Survival. The rights and obligations of each Party which by their nature survive the termination or expiration of this Agreement shall survive the termination or expiration of this Agreement, including Sections 4.2, 5, 6.3-6.6, 7.2-7.5, 8, 9, 10, 11, 12, 14, 15.1, 15.4-15.8, 15.10, 15.11 and 15.12. In addition, Bachem hereby acknowledges that neither expiration nor termination of this Agreement shall affect in any manner Magenta's right to manufacture and sell, or have manufactured and sold, the Product.

Section 8. INTELLECTUAL PROPERTY

8.1 Magenta Pre-Existing Intellectual Property. All intellectual property (including trademarks), including all data, information, know-how, reports and any and all related documentation, which are developed, generated or derived, directly or indirectly by or on behalf of Magenta prior to the Effective Date (Magenta Pre-Existing Intellectual Property) shall remain the sole property of Magenta.

8.2 Bachem Intellectual Property. All intellectual property (including trademarks), including all data, information, reports, manufacturing know- how and any and all related documentation, which are (a) developed, generated or derived, directly or indirectly by or on behalf of Bachem prior to the Effective Date or (b) any manufacturing know-how developed or generated by Bachem that is generally applicable to the field of peptide manufacturing and not specific to the Product or Magenta's Confidential Information (such items under the foregoing clauses (a) and (b), collectively, Bachem Intellectual Property), shall remain the sole property of Bachem. In the event that any Bachem Intellectual Property is incorporated into any 12





CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH [***]. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. deliverable (including Magenta Developed Intellectual Property (including Product)) or is otherwise necessary to fully exploit such deliverable, Bachem hereby grants to Magenta a perpetual, irrevocable, nonexclusive, worldwide, paid up, royalty-free license under such Bachem Intellectual Property (with the full right to sublicense directly or indirectly through multiple tiers) to (i) copy, distribute, display, perform and create derivative works of the Bachem Intellectual Property, in whole or in part; and (ii) to use Bachem Intellectual Property and/or practice the subject matter thereof, in each case solely in connection with manufacturing, marketing, promoting, using, selling, offering for sale, importing or distributing such deliverable (e.g., Product). Without limiting the foregoing, Magenta may use and disclose Bachem Intellectual Property to the extent necessary in connection with the prosecution, maintenance and enforcement of Magenta Developed Intellectual Property.

8.3 Magenta Data. All data, images, information, documents, records in whatever form obtained, developed, recorded or compiled (i) in connection with this Agreement or any Project Plan that relates to the Development Work or the Product, including, but not limited to, its development, manufacture or use, expressly excluding any Bachem Intellectual Property, or (ii) based upon or utilizing Magenta Confidential Information (collectively, Magenta Data) are and shall remain the sole and exclusive property of Magenta, and will be gathered, stored, secured, managed and maintained by Bachem in accordance with Applicable Laws. Bachem agrees to take such further acts as may be requested by Magenta in order to evidence the foregoing. Promptly upon the expiration or termination of this Agreement or any Project Plan, and otherwise upon Magenta's request, Bachem will promptly provide originals or a copy (as applicable) of all Magenta Data to Magenta in a form acceptable to Magenta, and, to the extent that Magenta so requests. Availability of batch records shall be provided as set forth in Section 5.11. At Magenta's request, Bachem will destroy all remaining Magenta Data in Bachem's possession or under Bachem's control, so long as not in contravention of Applicable Laws. Bachem will not utilize Magenta Data for any purpose other than the performance of Services, and will cease use of any Magenta Data after expiration or termination of this Agreement. Notwithstanding anything herein to the contrary, Bachem may retain any Magenta Data in electronically stored archives that cannot be deleted, subject to Bachem's document retention policies and to the terms of confidentiality and non- use set forth in this Agreement.

8.4 Magenta's Developed Intellectual Property. Any invention (whether patentable or not), discoveries, improvements, works-of-authorship or other intellectual property made, conceived or reduced to practice by Bachem in connection with its performance under this Agreement or any Project Plan, which expressly excludes Bachem Intellectual Property (Magenta Developed Intellectual Property), shall be exclusively owned by Magenta. For the avoidance of doubt, Magenta Developed Intellectual Property includes Magenta Data. Bachem hereby assigns, and agrees to assign, to Magenta all of its right, title and interest to and in any Magenta Developed Intellectual Property, including all related intellectual property rights. Magenta grants to Bachem a limited, non-exclusive license to use any Magenta Developed Intellectual Property to manufacture and release the Product for Magenta in accordance with the terms and conditions of this Agreement and any applicable Project Plan. 13





CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH [***]. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. 8.5 Disclosure and Assignment. With respect to all Magenta Developed Intellectual Property, Bachem agrees (i) to disclose the same promptly to Magenta; (ii) to execute documents evidencing the rights of Magenta set forth in this Section 8; and (iii) upon the request of Magenta and at the sole expense, discretion and exclusive control of Magenta, to apply, or to assist and cooperate with Magenta in applying for, letters patent or like corresponding legal protection of any of the foregoing in the United States and all foreign countries (and for any extension, continuation, validation, reissue or renewal thereof). For that purpose, Bachem shall, and shall cause its employees and agents to, execute all papers necessary therefor, including assignments to Magenta or its nominee, without consideration, and also agrees without further consideration, but at Magenta's expense, to provide such information as may be required by Magenta and to assist Magenta, or its agents or designees, in the preparation and prosecution of any such patent application, the enforcement of any such resulting patent and the intellectual property protection of any such invention or discovery.

Section 9. CONFIDENTIALITY

9.1 Confidentiality Agreement. The Parties agree that the terms and provisions of this Agreement shall supersede all terms and provisions of that certain Confidentiality Agreement between the Parties dated February 9, 2016 (the Confidentiality Agreement) and, as of the date hereof, the Confidentiality Agreement is hereby terminated and of no further force or effect.

9.2 Confidential Information. As of the Effective Date, the Parties agree to treat all Confidential Information (as described herein) acquired by either of them from the other under this Agreement as being secret and confidential, and each Party agrees that it shall not, at any time, without the express written consent of the other Party, disclose to any third party any Confidential Information. Each Party agrees that it shall use the other Party's Confidential Information solely to conduct the activities contemplated under this Agreement and for no other purpose. Confidential Information of a Party shall only be disclosed to the those employees, agents and Affiliates of the other Party who have a need to know such Confidential Information and only to the extent necessary in order to fulfill the relevant Party's obligations under this Agreement, who have been informed of the confidential nature of such information and who are obligated by written agreement to comply with confidentiality provisions no less restrictive than those set forth in this Agreement. Notwithstanding the foregoing, Magenta may disclose Confidential Information of Bachem relating to a Project Plan(s), Services, or the manufacture of Product to entities with whom Magenta has or may have a marketing and/or development collaboration or partnership and who have a specific need to know such Confidential Information and who are bound by written agreements which contain restrictions regarding disclosure and use of such Confidential Information no less restrictive than those set forth herein. Each Party further agrees to take such reasonable precautions as it normally takes with its own Confidential Information to prevent any unauthorized disclosure or use of such Confidential Information. For the purposes of this Agreement, Confidential Information shall mean all confidential or proprietary materials or information not generally available to the public that is confidential and proprietary to Magenta or Bachem (as the case may be). Magenta's Confidential Information includes, but is not limited to, Magenta Pre-Existing Intellectual Property, Magenta Developed Intellectual Property, confidential information provided to Bachem prior to the date hereof, all information regarding Magenta's materials, processes, know-how, formulations, analytical procedures, clinical procedures, its INDs and any other regulatory filings, other information related to the Product or any other product that may or will be under development by Magenta and any other technical or business information of Magenta (in each case, expressly excluding 14





CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH [***]. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Bachem Intellectual Property). Bachem's Confidential Information includes, but is not limited to, Bachem Intellectual Property, and all information regarding its business, customers, and price lists. As used in this Section 9, the Party in receipt of Confidential Information is the Recipient and the Party disclosing such information is the Disclosing Party.

9.3 Exceptions. The provisions of Section 9.2 shall not apply to any information disclosed hereunder that:

(a) was known to Recipient prior to its date of disclosure by the Disclosing Party as evidenced by Recipient's written records;

(b) is disclosed lawfully to Recipient either before or after the date of the disclosure by the Disclosing Party, without an obligation of confidentiality by a Third Party rightfully in possession of such information;

(c) is published or generally known to the public, either before or after the date of disclosure by the Disclosing Party, through no act or omission on the part of Recipient;

(d) is independently developed by Recipient without reference to or in reliance upon the Confidential Information of the Disclosing Party; and

(e) is required to be disclosed by Recipient to comply with Applicable Laws, to defend or prosecute litigation, or to comply with governmental regulations; provided that Recipient provides prior written notice of such disclosure to the Disclosing Party and cooperates with the Disclosing Party to take reasonable and lawful actions to avoid and/or minimize the degree of such disclosure.

9.4 Return of Confidential Information. Upon request by the Disclosing Party, Recipient shall promptly return to the Disclosing Party the originals and all copies of any Confidential Information then in the Recipient's possession or under the Recipient's control. Notwithstanding the foregoing, the Recipient may retain one (1) copy of such Confidential Information for legal archival purposes, provided that such copy shall be kept confidential after the termination or expiration of this Agreement.

9.5 Handling and Reconstruction of and Access to Confidential Information. Bachem will establish and maintain rigorous safety and facility procedures, data security procedures and other safeguards against the destruction, loss, or alteration of Magenta's Confidential Information in the possession of Bachem. Bachem will be responsible for developing and maintaining procedures for the recovery and reconstruction of lost Confidential Information. Bachem will correct or remedy, at Magenta's request and sole discretion and at no charge to Magenta, any destruction, loss or alteration of any of Magenta's Confidential Information that occurs while such Confidential information is under the control of Bachem. Upon reasonable request by Magenta, Bachem will promptly retrieve any portion of Magenta's Confidential Information reasonably specified by Magenta. Magenta shall have the right to review and retain the entirety of, all computer or other files containing Magenta's Confidential Information. Bachem shall not withhold from Magenta any of Magenta's Confidential Information as a means of resolving a dispute. 15





CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH [***]. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. 9.6 Equitable Relief. In the event of a breach or threatened breach by a Party of any provision of Section 8 or 9 hereof, the other Party shall be authorized and entitled to obtain from any court of competent jurisdiction equitable relief, whether preliminary or permanent, including specific performance, in addition to any other rights or remedies to which such Party may be entitled in law or equity.

9.7 Survival. The obligations of confidentiality set forth in this Agreement shall survive its termination or expiration for a period of [***].

Section 10. INSURANCE

Bachem shall, during the Initial Term and any Renewal Terms, and [***] after the expiration of the last Product is delivered, obtain and maintain, at its own cost and expense and from a qualified insurance company, comprehensive general liability insurance including, but not limited to, contractual liability coverage and standard product liability coverage in an amount commensurate with industry standards. At Magenta's request, Bachem shall provide Magenta with proof of such coverage. Bachem shall provide, and shall cause its Affiliates and sublicensees who perform activities in connection with the manufacture of Product to provide, to Magenta, upon its reasonable request, a statement of coverages, amounts of insurance, and deductibles, and a copy of all policies including clauses within the policies that the insurance company has a duty to defend and indemnify.

Section 11. INDEMNIFICATION

11.1 By Magenta. Magenta agrees to indemnify, defend and hold harmless Bachem, its Affiliates, directors, officers, employees and agents from and against damages finally awarded or finally paid in settlement of any and all losses (including attorneys' fees and expenses), whether arising as a result of third party claims or a claim between the Parties (Losses) arising out of or in connection with (i) the use or sale of the Product (ii) Magenta's labeling or improper handling and storage of Product, or (iii) any gross negligence, willful misconduct or misrepresentation by Magenta or material breach by Magenta of this Agreement, except to the extent that such Losses are attributable to the gross negligence or willful misconduct of or breach of this Agreement by Bachem.

11.2 By Bachem. Bachem shall indemnify, defend and hold harmless Magenta, its Affiliates, directors, officers, employees and agents from and against Losses arising out of or in connection with: (i) any Product that does not meet the Specifications, (ii) Bachem's labeling or improper manufacturing, handling, use or storage of a Product, (iii) any gross negligence, willful misconduct or misrepresentation by Bachem or material breach by Bachem of this Agreement, or (iv) any Latent Defects in a Product, except to the extent that such Losses are attributable to the gross negligence or willful misconduct of or breach of this Agreement by Magenta.

11.3 Limitation of Liability. NEITHER PARTY SHALL BE LIABLE, WHETHER BASED ON CONTRACT LAW, TORTS OR ANY OTHER AREA OF LAW, FOR ANY INDIRECT, INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF OR IN ANY WAY RELATED TO THIS AGREEMENT OR ITS PERFORMANCE AND THE MAXIMUM TOTAL LIABILITY OF EITHER PARTY WHETHER BASED ON 16





CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH [***]. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. CONTRACT LAW, TORTS OR ANY OTHER AREA OF LAW SHALL BE LIMITED TO THE AMOUNT [***]. NOTWITHSTANDING THE FOREGOING, THESE LIMITATIONS SHALL NOT APPLY TO DAMAGES ARISING FROM A PARTY'S (I) INDEMNIFICATION OBLIGATIONS UNDER SECTION 11.1 OR SECTION 11.2 HEREOF, (II) GROSS NEGLIGENCE OR WILFUL MISCONDUCT, (III) BREACH OF ITS OBLIGATIONS UNDER SECTION 9 OR (IV) INFRINGEMENT OR MISAPPROPRIATION OF THE OTHER PARTY'S INTELLECTUAL PROPERTY.

Section 12. PUBLICITY AND PUBLICATIONS

Neither Magenta nor Bachem shall make any news release or other public statement, whether to the press or otherwise, disclosing the existence of this Agreement, the terms thereof or of any amendment thereto, or any Project Plan without the prior written approval of the other Party, except as required by Applicable Laws. To the extent, if any, that a Party concludes in good faith that it is required by Applicable Laws or regulations to file or register this Agreement or a notification thereof with any Governmental Authority, including the U.S. Securities and Exchange Commission, such Party may do so, and the other Party shall cooperate in such filing or notification and shall execute all documents reasonably required in connection therewith. In such situation, the filing Party shall request confidential treatment of sensitive provisions of the Agreement to the extent permitted by Applicable Laws. A Party may disclose this Agreement to a Third Party in connection with or in conjunction with a proposed merger, consolidation, sale of assets that include those related to this Agreement, an assignment of this Agreement or loan financing, raising of capital, or sale of securities; provided, however, that the disclosing Party obtains an agreement for confidential treatment thereof with a limitation on use solely for consideration of the relevant transaction.

Section 13. FORCE MAJEURE

If either Party shall be delayed or hindered in or prevented from the performance of any act required hereunder by reason of strike, lockouts, labor troubles, restrictive governmental or judicial orders or decrees, riots, insurrection, war, terrorist acts, acts of God, inclement weather or other reason or cause reasonably beyond such Party's control (each a Force Majeure), then performance of such act shall be excused for the period of such Force Majeure. The Party affected by the Force Majeure shall provide prompt written notice to the other Party of the commencement and termination of the Force Majeure. Should a Force Majeure continue for more than two (2) months, the Party unaffected by the Force Majeure may terminate this Agreement upon prior written notice to the affected Party. If the Force Majeure equally affects the ability of each Party to perform under this Agreement, then such termination shall only be by mutual written agreement.

Section 14. NOTICES

All notices or other communications that are required or permitted by this Agreement shall be in writing and shall be delivered personally, sent by fax (and promptly confirmed by overnight courier), sent by nationally recognized overnight courier, or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows: 17





CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH [***]. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. If to Magenta: Magenta Therapeutics, Inc. Attn: [***] 50 Hampshire Street 8t h Floor Cambridge, MA 02139 [***]

If to Bachem: Bachem Americas, Inc. Attn: [***] 3132 Kashiwa Street, Torrance, CA 90505 [***]

All notices delivered pursuant to this Section 14 shall be considered delivered upon receipt by the intended recipient.

Section 15. MISCELLANEOUS

15.1 Further Actions. The Parties shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments, and to do and cause to be done such further acts that may be necessary to carry out the provisions and purposes of this Agreement, notwithstanding any expiration or termination of this Agreement.

15.2 Amendments; Assignment. This Agreement, including any Project Plans or other attachments, may not be altered, amended or modified except by a written document signed by both Parties. Bachem will not assign this Agreement without the prior written consent of Magenta, and any purported assignment in contravention of this Section 15.2 shall be null and void; provided, however, that either Party may assign this Agreement in connection with (i) the sale, transfer or other disposition of its assets related to this Agreement, (ii) a change in control of such Party, or (iii) the sale or transfer of substantially all of such Party's outstanding stock.

15.3 Subcontracting. Bachem shall not assign, subcontract or delegate any of its rights or obligations under this Agreement without the express prior written authorization of Magenta, provided however, that Bachem may subcontract its rights and obligations hereunder to those subcontractors identified and agreed to by the Parties in the Quality Agreement. Bachem shall cause any such authorized subcontractor to be subject by contract to the same restrictions, exceptions, obligations, reports, termination provisions and other provisions contained in this Agreement and any applicable Project Plan(s). Bachem shall remain primarily obligated for all acts and omissions of any of its subcontractors as if Bachem had performed the subcontracted obligations itself, and shall guarantee the performance of the same.

15.4 Successors; Assigns. This Agreement shall be binding upon and inure to the benefit of the Parties hereto and each of their respective successors and permitted assigns.

15.5 Severability. All agreements and covenants contained herein are severable, and in the event any of them shall be held to be invalid by any competent court, this Agreement shall be interpreted as if such invalid agreements or covenants were not contained herein.

15.6 Entire Agreement. This Agreement, including the attached Project Plans, constitutes the entire agreement between the Parties related to the subject matter hereof, and supersedes all prior communications, representations, or agreements, either verbal or written, between the Parties. Each Party confirms that it is not relying on any representations or warranties of the other Party except as specifically set forth herein. 18





CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH [***]. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. 15.7 Independent Contractor. This Agreement shall not be deemed to create any partnership, joint venture, or agency relationship between the Parties. Each Party shall act hereunder as an independent contractor, and its agents and employees shall have no right or authority under this Agreement to assume or create any obligation on behalf of, or in the name of, the other Party. All persons employed by a Party shall be employees of such Party and not of the other Party, and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such Party.

15.8 Waiver. The waiver by either Party of any right hereunder shall not be deemed a waiver of that same right in the future or a waiver of any other right hereunder.

15.9 Counterparts. This Agreement may be executed by original or facsimile signature in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute the same instrument.

15.10 Headings. The headings used in this Agreement are for convenience only and are not a part of this Agreement.

15.11 Governing Law. This Agreement will be construed and interpreted and its performance governed by the laws of the State of New York, without giving effect to its conflict of laws principles. The parties submit to the exclusive jurisdiction of the state and federal courts in New York for any suit, action or proceeding relating to this Agreement.

15.12 Dispute Resolution. The parties shall attempt in good faith to resolve any dispute arising out of or relating to this Agreement promptly by negotiations between executives who have authority to settle the controversy. Any party may give the other party written notice of any dispute not resolved in the normal course of business. Within [***] after delivery of said notice, executives of both parties shall meet at a mutually acceptable time and place in the State of New York or as otherwise agreed and thereafter as often as they reasonably deem necessary to exchange relevant information and to resolve the dispute. Once the executive of either party determines that additional meetings are not likely to resolve the dispute, each of the parties shall be entitled to terminate such meetings and the dispute shall be submitted to binding arbitration. The binding arbitration shall be in accordance with the rules and procedures for commercial arbitration of the American Arbitration Association. Unless the parties to such dispute agree otherwise in writing, any such arbitration shall be conducted in New York pursuant to New York law, without any consideration of conflict of law issues, and the results of such arbitration shall be final and binding on the parties and enforceable in any court of competent jurisdiction. Notwithstanding the foregoing, the parties acknowledge and agree that each of them shall have the right to seek immediate injunctive and other equitable relief through the courts in the event of any material breach by the other party of any provision of this Agreement that would cause the non-breaching party irreparable injury for which there would be no adequate remedy at law. Any such legal proceeding will be brought in the applicable state or federal court of the State of New York, and the parties hereby consent to this exclusive jurisdiction for this purpose.

* * * * * 19





CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH [***]. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. IN WITNESS WHEREOF, each of the Parties hereto has caused this Master Development and Manufacturing Agreement to be executed by its duly authorized representative as of the Effective Date. Magenta Therapeutics, Inc.

By:/s/ Christina Isacson Name: Christina Isacson Title: CBO

Bachem Americas, Inc.

By:/s/ Brian Gregs Name: Brian Gregs Title: COO

Acknowledged by Bachem AG

By:/s/ Beat Sax Name: Beat Sax Title: Site Manager

By:/s/ Boris Corpateaux Name: Boris Corpateaux Title: VP BD & Sales 20





CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH [***]. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. APPENDIX A

List of Existing Project Plans [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] 21





CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH [***]. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. [Form of Amendment to Appendix A]

AMENDMENT TO APPENDIX A

This Amendment to Appendix A is dated as of [ ], 20[_], and made pursuant to Section 3.1 of the Master Development and Manufacturing Agreement (the Master Agreement), dated [ ] [ ], 20[ ], between Magenta Therapeutics, Inc. and Bachem Americas, Inc. In consideration of the mutual promises contained in the Master Agreement and for other good and valuable consideration, the receipt and adequacy of which each of the Parties does hereby acknowledge, the Parties hereby agree to amend Appendix A by adding the attached new Project Plan entitled [ ], which is designated as Project Plan A-[ ]. This Project Plan is effective as of [ ], 20[ ] and shall terminate on [ ], 20[ ], unless earlier terminated as permitted in the Master Agreement.

Project Plan A-[ ] shall hereby be deemed incorporated into the Master Agreement referenced above. Magenta Therapeutics, Inc.

By: Name: Title:

Bachem Americas, Inc.

By: Name: Title: 22





CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH [***]. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. APPENDIX B

[***] [***] [***] Date Added [***] [***] Effective Date [***] [***] Effective Date [***] [***] Effective Date 
Question: Highlight the parts (if any) of this contract related to Insurance that should be reviewed by a lawyer. Details: Is there a requirement for insurance that must be maintained by one party for the benefit of the counterparty?
answer:
Bachem shall provide, and shall cause its Affiliates and sublicensees who perform activities in connection with the manufacture of Product to provide, to Magenta, upon its reasonable request, a statement of coverages, amounts of insurance, and deductibles, and a copy of all policies including clauses within the policies that the insurance company has a duty to defend and indemnify.


question:
Exhibit 10.1 MANUFACTURING, DESIGN AND MARKETING AGREEMENT This MANUFACTURING, DESIGN AND MARKETING AGREEMENT (this Agreement) is entered into by and between Zounds Hearing, Inc., a Delaware corporation (Subcontractor) and InnerScope Hearing Technologies, Inc., a Nevada corporation, (the Manufacturer) Manufacturer dated effective October 3, 2018 (the Effective Date). Subcontractor and Manufacturer may also be referred to herein individually as Party or collectively as the Parties. RECITALS WHEREAS, Subcontractor currently is the registered manufacturer of hearing aids and related components and accessories (the Zounds Products) that are sold under the Subcontractor's brand names through various marketing and distribution channels. WHEREAS the Parties desire to enter an agreement whereby the Subcontractor as the Manufacturer's subcontractor will provide design, technology, manufacturing and supply chain services to the Manufacturer to enable the Manufacturer to manufacture comparable hearing aids and related components and accessories to be sold under Manufacturer's exclusive brand names (the Manufacturer's Products) through the Manufacturer's various marketing and distribution channels. WHEREAS, the Parties also desire to enter into a lease agreement of Subcontractor's current Chandler, Arizona facility that provides the Manufacturer an FDA medical device facility for the Manufacturer's Products. WHEREAS, the Parties also desire to enter into an agreement that provides for the joint marketing and sale of each other's products. NOW, THEREFORE, in consideration of the promises and covenants contained herein, the Parties hereby agree as follows: 1. Term. Subject to earlier termination as provided in this Agreement, the initial term of this Agreement shall be for a period beginning on the Effective Date and ending ten (10) years thereafter unless this Agreement is terminated earlier as provided herein. This Agreement will renew automatically thereafter for successive one-year terms unless and until one Party gives notification of termination with at least sixty (60) days written notice. All orders placed under this Agreement must be placed prior to the expiration or termination of this Agreement.

2. Technology Access Fee. Manufacturer will pay Subcontractor One Million and No/100 USD ($1,000,000) (the Technology Access Fee). The Technology Access Fee will be paid in two equal installments of $500,000 each. The first installment will be due thirty (30) days following the Effective Date and the second installment will be due sixty (60) days following the Effective Date.

3. Orders for Manufacturer's Products to be Manufactured by Subcontractor

3.1 Purchase Orders: Excess Inventory. Manufacturer shall provide to Subcontractor a purchase order setting forth the proposed quantity of Manufacturer's Products to be purchased by Manufacturer and delivery dates, which purchase order will be subject to written acceptance by Subcontractor. All purchase orders are non-cancellable, and the Manufacturer shall pay for the purchaser orders as follows: (i) for purchase orders for less than or equal to a total of five hundred (500) units in any given calendar month, payment of fifty percent (50%) of Product Cost (as defined below) shall be made in full at the time the order is placed and the remaining balance paid in full before the Manufacturer's Products are shipped; and (ii) for purchase orders for more than five hundred (500) units in any given calendar month, payment of one hundred percent (100%) of Product Cost shall be made in full at the time the order is placed. Manufacturer's purchase orders accepted by Subcontractor and any forecast provided to Subcontractor by Manufacturer will constitute authorization for Subcontractor to procure product components to manufacture the Manufacturer's Products covered by such purchase orders based on their lead times. Subcontractor will advise Manufacturer of the lead time of components contained within their order and any forecast and Manufacturer will pay for the components prior to the Subcontractor placing orders for the components.

3.2 Contract Formation: Acceptance and Entire Agreement. Each time Manufacturer submits an order for Manufacturer's Products and Subcontractor accepts the order or ships the ordered Manufacturer's Products to Manufacturer, a new contract is formed consisting of this Agreement, the quantities and delivery dates specified in the order and the prices then offered by Subcontractor. ACCEPTANCE OF MANUFACTURER'S ORDER IS EXPRESSLY LIMITED TO THE TERMS AND CONDITIONS OF THIS AGREEMENT, NOTWITHSTANDING ANY ORAL OR WRITTEN STATEMENT MADE BY MANUFACTURER, AND DOES NOT IN ANY WAY WHATSOEVER CONSTITUTE ACCEPTANCE OF MANUFACTURER'S TERMS AND CONDITIONS EXCEPT AS SET FORTH IN THE TERMS OF THIS AGREEMENT. NO TERMS AND CONDITIONS CONTAINED IN ANY PURCHASE ORDER FORM, WHETHER PROVIDED BY MANUFACTURER OR SUBCONTRACTOR, WILL BECOME A PART OF THE CONTRACT AND THIS CONTRACT WILL GOVERN ALL PURCHASES. Manufacturer's acceptance of or payment for Manufacturer's Products that Manufacturer has not ordered creates a contract comprised of this Agreement, the quantities of Manufacturer's Products accepted or paid for, and the prices then offered by Subcontractor. This Agreement shall constitute the entire agreement with respect to any contract formed and shall not be altered, amended, supplemented or canceled without the express written agreement of both Manufacturer and Subcontractor.





3.3 Product Prices. Pricing shall be the actual cost of the manufacturing of each Manufacturer's Product plus the proportional allocation of the costs of Subcontractor's manufacturing, engineering, and supply chain overhead, as mutually agreed by the Parties (the Product Cost). Title of the product will transfer to the Manufacturer at the shipping dock of the manufacturing facility. Manufacturer will be responsible for shipping costs. Manufacturer shall pay any taxes incurred in the manufacture of Manufacturer's Products, including any taxes incurred as a result of purchasing components or maintaining inventory. In addition to the Royalties paid under this Agreement to the Subcontractor, Manufacturer shall pay any other third-party royalties for technology that are required to manufacture the Manufacturer's Products for their intended purpose. As of the date of this Agreement neither Party is aware of any third-party royalties for technology that Manufacturer would be liable to pay. Subcontractor will provide Manufacturer with documentation substantiating any Product Cost variance upon request.

3.4 Cost Reductions. Potential Product Cost reductions as a result of materials pricing will be reviewed and implemented periodically as mutually agreed and passed on to the Manufacturer. Product Cost reductions resulting from engineering changes or other changes, initiated by Manufacturer, that would impact either Product Costs or process changes at Subcontractor will be implemented at an agreed upon time. Manufacturer will be responsible for their proportionate share of any Product Cost reduction that is a result of engineering investment by the Subcontractor. If the Manufacturer does not pay its proportionate share, the Manufacturer will pay the Product Cost as if the cost reduction had not been made (i.e., the Product Cost prior to the cost reduction as if the cost reduction were not made). The Subcontractor will list the new Product Cost and a line item for engineering investment that accounts for the difference.

3.5 Royalties. In addition to paying the Product Costs of Manufacturer's Products, Manufacturer shall also pay to Subcontractor the following royalty payments (each a Royalty and collectively the Royalties) for each of Manufacturer's Product purchased under this Agreement. Royalties shall be paid 50% at time of shipping and the remaining balance of 50% due in 15-days after the Manufacturer's Products have shipped from the manufacturing facility. a) Non-Rechargeable Products. For Manufacturer's Products that are non-rechargeable, Manufacturer shall pay Subcontractor a Royalty equal to the higher of (i) eighty percent (80.0%) of the Product Cost; and (ii) $80 per unit. b) Rechargeable Products. For Manufacturer's Products that are rechargeable, Manufacturer shall pay Subcontractor a Royalty equal to the higher of (i) one hundred percent (100.0%) of the Product Cost; and (ii) $100 per unit. 3.6 Zounds' Products and Manufacturers Products Built to Manufacturer's Specifications. Subject to Section 7 below, Subcontractor agrees to manufacture Manufacturer's Products (i) that are identical to Zounds' Products allowing Manufacturer to utilize Subcontractor's existing product designs and features and/ or (ii) to specifications provided by Manufacturer from time to time with approval of such changes by Subcontractor. Any advice given by Subcontractor to Manufacturer before or after delivery of Products built to Manufacturer's specifications is based solely upon the information available to Subcontractor, and the use of such advice by Manufacturer is solely and entirely at Manufacturer's own risk. Manufacturer represents and warrants that it has independently determined the fitness, need, usefulness, and applicability of the Manufacturer's Products built to Manufacturer's specifications it has ordered and does not rely on any representation of Subcontractor in that regard.

3.7 Engineering Services and Design Changes. Manufacturer may elect to utilize Subcontractor's design engineering resources (the Engineering and Design Services) to further customize Manufacturer's Products. The cost of Engineering and Design Services to be paid by Manufacturer will be agreed to in a written document setting forth the scope, timing and other terms of such Engineering and Design Services executed by the Parties prior to any services being provided by Subcontractor. Subject to the written agreement of the parties with respect to any resulting change in price, delivery schedule and other terms, Subcontractor will accept design changes (i.e., Engineering Change Orders or ECO's) according to Manufacturer's instructions.

3.8 Tooling, Setup and Non-Recurring Engineering (NRE) Charges. Subcontractor agrees to provide Manufacturer with a quote for any one-time tooling, setup or NRE charges payable by Manufacturer as a result of a change in design requested by Manufacturer, change in minimum quantity requirements by Manufacturer as originally quoted by Subcontractor, or an addition to the Manufacturer's Products purchased under this Agreement requested by Manufacturer. If Manufacturer elects to proceed with the design change, minimum quantity requirements change or addition as specified in Subcontractor's quote, Manufacturer will provide Subcontractor with written acceptance of Subcontractor's quoted terms.

3.9 Inventory Reports. Subcontractor agrees to report its inventory position to Manufacturer on a monthly basis, including the following information: quantity of raw material, work in process and any open orders that cannot be cancelled to the supplier lead time. The report will specifically identify any material on hand or on order where the quantity exceeds the agreed three (3) month forward looking forecast plus safety stock as agreed upon by Subcontractor and Manufacturer. The Subcontractor and Manufacturer will review inventory levels and safety stocks quarterly.

4. Delivery and Shipping. The agreed upon delivery dates are based on the Subcontractor's projected lead time, current inventory, commitments and Subcontractor's advice. Manufacturer agrees and acknowledges that all shipment dates are firm delivery dates. All shipments shall be F.O.B. the manufacturing facility unless otherwise mutually agreed upon in writing. The method and route of shipment shall be at Subcontractor's discretion, unless Manufacturer supplies instructions in writing at least five days prior to shipment. In addition to the purchase price, Manufacturer shall pay any and all transportation charges (including insurance). The risk of loss of and title to the Manufacturer's Products pass to Manufacturer upon the receipt of the Manufacturer's Products by the carrier. Subcontractor is not responsible for any installation of Manufacturer's Products sold





hereunder or delays caused by Manufacturer-specified suppliers.

5. Leased Space Agreement. Manufacturer will lease from Subcontractor a well-defined space for Manufacturer's Products within the Subcontractor's current FDA registered manufacturer's facility. Subcontractor is solely responsible for maintaining all aspects of such leased space including but not limited to; (i) segregation of Manufacturer's Products with all Manufacturer's Products clearly segregated and marked; and (ii) meeting all necessary requirements deemed appropriate by the FDA and any regulatory authorities for a medical device manufacturer's facility. Subcontractor will be also solely responsible for remaining in good standings at all times with all regulatory authorities including but not limited to the standards set forth by the FDA for medical device manufacturing facilities. The Manufacturer may list the address of the Subcontractor's current FDA registered manufacturer's facility as the Manufacturer's own FDA approved manufacturer's facility for the Manufacturer's Products. The terms of such lease agreement will be mutually agreed to by the Parties in a separate document.

6. Payment Terms. Upon Subcontractor's approval and acceptance of a production forecast provided by Manufacturer, Manufacturer's payment for Manufacturer's Products will be due when forecasted materials or components must be ordered by the Subcontractor as set forth in Section 3 above. A schedule of the forecast payables will be provided by the Subcontractor to the Manufacturer based on the approved forecast. Components and products will only be procured and/or manufactured once payment has been received. All payments will be made by electronic wire transfer and all of the appropriate forms will need to be signed so that this can happen efficiently. Alternately, payments can be made to Subcontractor's address as shown Subcontractor's invoice. No offsets are allowed to be taken by either Party. Manufacturer represents that all sales to Manufacturer under this Agreement are sales for use in production or resale; therefore no sales, use, excise or other taxes are due as a result of such sales and Manufacturer will be responsible for payment of any such taxes. A copy of the Manufacturer's resale certificate will be provided by Manufacturer within 15-days of the Effective Date.

7. Limited Warranty; Nonconforming Products. Since Manufacturer is paying the actual manufacturing cost of the product, Supplier has not reserved for any warranty related costs. The Manufacturer acknowledges that it is solely responsible for any warranty costs associated with Manufacturer's Products. Should any nonconformities be detected during or after the manufacturing process, Subcontractor will assist Manufacturer in resolving any quality issues with the suppliers. Subcontractor will provide support to Manufacturer to train Manufacturer's employees to repair the non-conforming products as appropriate. Upon Manufacturer's request, Subcontractor will provide repair services for a fee equal to the actual cost of these services. In the event Manufacturer in good faith believes that Manufacturer's Products are nonconforming under the specifications agreed to among the Parties (the Standards), Manufacturer shall give written notice to Subcontractor specifying in detail the nonconformity within thirty (30) days of Manufacturer's receipt of such Manufacturer's Products. Upon Manufacturer's request, Subcontractor will facilitate such Manufacturer's Products being repaired or replaced, Manufacturer must return the Manufacturer's Products to Subcontractor, transportation charges prepaid by Manufacturer, within fifteen (15) days of the end of such thirty (30) date notice period. Notwithstanding anything else in this Agreement, Subcontractor makes no representations or warranties whatsoever with respect to: (i) any materials, components or subassemblies; (ii) defects resulting from the Specifications or the design of the Manufacturer's Products; (iii) Manufacturer's Product that has been abused, damaged, altered or misused by any person or entity after title passes to Manufacturer; (iv) first articles, prototypes, pre-production units, test units or other similar Manufacturer's Products; or (v) defects resulting from tooling, designs or instructions produced or supplied by Manufacturer. Manufacturer shall be liable for costs or expenses incurred by Subcontractor related to the foregoing exclusions to Subcontractor's express limited warranty. If Subcontractor determines that the Manufacturer's Products are nonconforming under the Standards, Subcontractor, shall work with their vendors to rework the Manufacturer's Products or otherwise replace the Manufacturer's Products. Manufacturer shall be liable for the cost of rework or replacement and all associated costs therewith including, without limitation, transportation charges and inspection fees. If requested by the Manufacturer, Subcontractor will provide a cause of failure, a failure analysis provided in Subcontractor's standard format and correction action.





MANUFACTURER ACKNOWLEDGES THAT SUBCONTRACTOR IS NOT THE MANUFACTURER OF MOST, IF NOT ALL, OF THE COMPONENTS OF THE MANUFACTURER'S PRODUCTS OR ANY THIRD PARTY MANUFACTURER'S AGENT. SUBCONTRACTOR MAKES NO REPRESENTATIONS OR WARRANTIES IN CONNECTION WITH THE PRODUCTS OR COMPONENTS THEREOF WHICH SUBCONTRACTOR DID NOT MANUFACTURE. FURTHER, SUBCONTRACTOR SPECIFICALLY DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, IN FACT OR BY OPERATION OF LAW OR OTHERWISE, CONTAINED IN OR DERIVED FROM THIS AGREEMENT, ANY ORDER, OR IN ANY OTHER MATERIALS, BROCHURES, PRESENTATIONS, SAMPLES, MODELS OR OTHER DOCUMENTATION OR COMMUNICATIONS WHETHER ORAL OR WRITTEN, INCLUDING, WITHOUT LIMITATION, IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, CONFORMANCE WITH THIRD PARTY MANUFACTURER'S SPECIFICATIONS OR OTHERWISE, WHICH WOULD EXTEND BEYOND THE WARRANTIES EXPRESSLY CONTAINED HEREIN. SUBCONTRACTOR AUTHORIZES MANUFACTURER TO ASSERT AT MANUFACTURER'S EXPENSE FOR SUBCONTRACTOR'S ACCOUNT, ALL OF SUBCONTRACTOR'S RIGHTS UNDER ANY APPLICABLE THIRD PARTY MANUFACTURER'S WARRANTY, AND SUBCONTRACTOR AGREES TO COOPERATE WITH MANUFACTURER IN ASSERTING SUCH RIGHTS; PROVIDED, HOWEVER, THAT MANUFACTURER WILL DEFEND, INDEMNIFY AND HOLD SUBCONTRACTOR HARMLESS FROM AND AGAINST ANY LOSS, LIABILITY OR EXPENSE, INCLUDING REASONABLE ATTORNEY'S FEES, RESULTING FROM OR ARISING IN CONNECTION WITH ANY ACTION BY MANUFACTURER RELATING TO THE ABOVE AUTHORIZATION. THIS SECTION 7 SETS FORTH SUBCONTRACTOR'S SOLE AND EXCLUSIVE LIABILITY, AND MANUFACTURER'S SOLE AND EXCLUSIVE REMEDY, AS TO ANY FAILURE OF THE MANUFACTURER'S PRODUCTS TO MEET THE WARRANTY STANDARDS. 8. Orders; Termination.

8.1 Orders: All orders whether for Manufacturer's Products or components or inventory to be used in the manufacture of Manufacturer's Products are non-cancellable. 8.2 Termination. Either Party may terminate this Agreement and either may terminate a purchase order, effective upon written notice in any of the following events: (a) the other Party materially breaches this Agreement and such breach remains uncured for thirty (30) days following written notice of breach to the breaching Party; (b) the other Party (i) voluntarily suspends transaction of business; (ii) becomes insolvent or unable to pay any indebtedness as it matures; (iii) commences a voluntary case in bankruptcy or a voluntary petition seeking reorganization or to effect a plan or other arrangement with creditors; (iv) makes an assignment for the benefit of creditors; (v) applies for or consents to the appointment of a receiver or trustee for it or for any substantial portion of its property; (vi) makes an assignment to an agent authorized to liquidate any substantial part of its assets; (vii) has an involuntary case commenced against it with any court or other authority seeking liquidations, reorganization or a creditor's arrangement; (viii) by an order of any court or other authority, has appointed any receiver of trustee for it or for any substantial portion of its property; or (ix) has a writ or warranty of attachment or any petition seeking liquidation, reorganization or a creditor's arrangement or such order appointing a receiver or trustee is not vacated or stayed, or such writ, warranty of attachment or similar process is not vacated, released or bonded off within thirty (30) days after its entry or levy. 8.3 Party Liability Upon Termination a) Manufacturer Termination Without Cause. If the Manufacturer terminates this Agreement or cancels any purchase order without cause pursuant to Section 8.2, Subcontractor will stop all shipments and retain all inventory. Subcontractor may, at its sole discretion, assist Manufacturer in the liquidation of any inventory that is generic that does not utilize any of Subcontractor's technology. Manufacturer shall be liable for cancellation charges including the Product Costs and the costs as provided in Section 3.8. b) Manufacturer Termination With Cause. If the Manufacturer terminates this Agreement or cancels any purchase order for cause pursuant to Section 8.2 Manufacturer shall not be liable for any termination or cancellation charges but Subcontractor may, at Subcontractor's sole discretion, purchase all or part of any remaining inventory. c) Subcontractor Termination for Cause. If the Subcontractor terminates this Agreement or any purchase order for cause pursuant to Section 8.2, Manufacturer shall be liable for cancellation charges including the Product Costs and the costs as provided in Section 3.8. Subcontractor may at its sole discretion make commercially reasonable efforts to mitigate these costs by attempting to return products or components thereof to suppliers. 9. Joint Marketing. Subcontractor and Manufacturer have agreed to assist each other with marketing in other channels. When the Subcontractor helps the Manufacturer there will be a marketing fee associated with that assistance. When the Manufacturer helps the Subcontractor there will likewise be a marketing fee associated with that assistance. The Subcontractor and Manufacturer will mutually agree on the marketing fee before any assistance is provided. In some cases the marketing fee will be a percentage of the margin received by the other Party. The terms of such joint marketing agreement will be mutually agreed to by the Parties in a separate document. 10. Limitation of Liability. No Other Liability. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER FOR ANY COVER DAMAGES (INCLUDING INTERNAL COVER DAMAGES WHICH THE PARTIES AGREE MAY NOT BE CONSIDERED DIRECT DAMAGES), OR ANY INCIDENTAL, CONSEQUENTIAL, SPECIAL OR PUNITIVE DAMAGES OF ANY KIND OR NATURE ARISING OUT OF THIS AGREEMENT OR THE SALE OF MANUFACTURER'S PRODUCTS, WHETHER SUCH LIABILITY IS ASSERTED ON THE BASIS OF CONTRACT, TORT (INCLUDING THE POSSIBILITY OF NEGLIGENCE OR STRICT LIABILITY), OR OTHERWISE, EVEN IF THE PARTY HAS BEEN WARNED OF THE POSSIBILITY OF ANY SUCH LOSS OR DAMAGE, AND EVEN IF ANY OF THE LIMITED REMEDIES IN THIS AGREEMENT





FAIL OF THEIR ESSENTIAL PURPOSE. NEITHER PARTY SHALL BE LIABLE FOR ANY DAMAGES ARISING FROM DELAY IN MANUFACTURE, SHIPMENT OR DELIVERY OF ANY MANUFACTURER'S PRODUCTS, IF SUCH DELAYS ARE DUE TO FORCE MAJEURE, AS DEFINED IN SECTION 15.2. 11. Confidentiality; Public Announcements; Non-Use; Intellectual Property Rights. 11.1 Confidentiality. Parties acknowledge that during the term of this Agreement, either Party may disclose to the other Party from time to time certain business, product pricing, financial, marketing, technical and other proprietary and sensitive information of each party. Both Parties shall use commercially reasonable efforts to keep confidential (a) the existence and terms of this Agreement and all information concerning the unit number and fees for Manufacturer's Products and inventory, and (b) any and all information concerning customers, suppliers, trade secrets, methods, processes or procedures and any other confidential, financial and business information of the other Party that is marked Confidential or the like or, if delivered verbally, confirmed in writing to be Confidential within thirty (30) days of the initial disclosure (Confidential Information) with the same standard of care as it uses for its own Confidential Information. Neither Party shall disclose Confidential Information to any third Party without the prior written consent of the other party, except that both parties agree that the other party may disclose Confidential Information to its auditors and contractors under an obligation of confidentiality, to governmental authorities having jurisdiction over such Party or as otherwise required by applicable law, provided however, in the event the Manufacturer or Subcontractor is ordered to provide Confidential Information by a lawful judicial or government order, the party who is subject to such order shall promptly inform the Party whose information is to be disclosed and shall permit the Party to defend against such order of disclosure and shall assist in such defense to the extent permitted by law. In no other circumstances may the Manufacturer or Subcontractor disclose information without the consultation and prior written consent of the non-disclosing Party. Confidential Information of either Party hereto shall not include information which (i) is in the public domain, (ii) is previously known or independently developed by the receiving Party, (iii) is acquired by the receiving Party from any third party having a right to disclose such information or (iv) the receiving party is obligated to produce under a court or governmental order; provided, the disclosing Party complies with the notice requirements of the previous paragraph with respect the information subject to such court or governmental order. The Parties acknowledge that a breach by either Party of this Section 11 will give rise to irreparable injury to the other, inadequately compensable in damages. Accordingly, the Parties hereby consent to allow the other Party to seek injunctive relief against the breach or threatened breach of the undertakings of the Parties contained in this Section 11. The Parties further agree that such an order so enjoining a Party may be issued pending final determination thereof, without the requirement to post bond. 11.2 Public Announcements. Each Party reserves the right to publish press releases and public announcements (collectively, the Publications) pertaining to this Agreement; provided, however, no Publications will contain any Confidential Information of a Party without such Party's prior written consent. The publishing Party shall indemnify and hold the non-publishing Party its, officers, agents, shareholders, and employees harmless against any and all claims, demands, damages, liabilities and costs which directly or indirectly result from, or arise in connection with, any negligent act or omission of the disclosing Party, its agents, or employees, pertaining to such disclosing Party's Publications under this Agreement. 11.3 Non-Use. Each Party to this Agreement acknowledges and agrees that at any time during the Term of this Agreement and at all times following the termination of this Agreement, neither Party may use any Confidential Information, Inventions and Intellectual Property (as these terms are defined in Section 11.3 below) of the other Party for any purpose other than in conjunction with its obligations under this Agreement. The Parties further agree that neither Party may analyze, or reverse engineer any samples, software or hardware provided by the other Party to determine composition, method of manufacture, or construction. 11.4 Intellectual Property Rights. Except as otherwise expressly provided in this Section 11,4, all inventions, discoveries, and trade secrets whether or not patentable, that are made by Subcontractor or Manufacturer, either alone or with others, in the course of its performance of its obligations under this Agreement (collectively, Inventions) will become the exclusive property of Subcontractor. In the event this Agreement terminates for any reason or no reason, all licenses of Subcontractor's patents, trademarks, software, trade secrets or other intellectual property (collectively the Intellectual Property) of Subcontractor, granted expressly or otherwise to Manufacturer under the terms of this Agreement or any other Agreement between Subcontractor and Manufacturer shall immediately terminate and Manufacturer must immediately cease use of all of Subcontractor's Intellectual Property. 12. Manufacturer's Indemnity. Manufacturer shall indemnify, defend and hold Subcontractor and its affiliates (Subcontractor Indemnities) harmless from and against any and all loss, liability or expense, including reasonable attorneys' fees, resulting from or arising in connection with any claim or suit by any third party against the Subcontractor Indemnities (i) alleging infringement or dilution of any copyright, trademark, trade name, trade secret, patent or other third party proprietary rights, relating to the design, manufacture, sale, normal use or normal disposition of any Manufacturer's Products built to the specification of Manufacturer, (ii) alleging any failure of any Manufacturer's Product (or any Manufacturer's Product components contained therein) sold by Subcontractor hereunder to comply with any safety standards or any environmental regulations, or (iii) alleging loss, damages, bodily injury, sickness, disease, or death, or injury to property which is caused by (1) the negligence or intentional acts of Manufacturer, its agents, employees or subcontractors, or (2) a defect in Manufacturer Specifications or Manufacturer specified materials, components or design of the Manufacturer's Products or caused by Manufacturer specified suppliers; provided however, that Subcontractor shall have the right, at its option, to participate in the defense of any such claim or suit,





without relieving Manufacturer of any obligations hereunder. 13. Ownership of Tooling and Testing Equipment. All tooling and testing equipment used in connection with this Agreement shall be owned by Subcontractor.

14. Regulatory Compliance and Record Keeping.

14.1 Approvals. Manufacturer shall be registered as the manufacturer of Manufacturer's Products and shall obtain such approvals from the United States Food and Drug Administration (the FDA) and other regulatory bodies, public or private as may be required to manufacture and sell the products in the United States or internationally. Both Manufacturer and Subcontractor shall be responsible for complying with all federal, state and local laws, rules, regulations, guidelines and the like in the United States and in other countries as they may pertain to the Manufacturer's Products and to the obligations on the Parties to perform under this Agreement, including, without limitation, requirements in the United States with respect to registration of establishment, listing of medical devices, reporting of deaths, serious injuries and certain malfunctions under 21 CFR Medical Device Regulations and the potential therefore, tracking of medical devices, recalls, safety alerts and process controls. In no event shall either Party assume any risk arising out of the other Party's failure to comply with such laws, rules, regulations, guidelines and the like, and each Party shall cooperate with the other in all respects to facilitate and promote strict compliance with the provisions of this Section 14.

14.2 Regulatory Inspection and Revision of Specifications. Following inspections by applicable regulatory authorities, including, without limitation, the FDA, Subcontractor shall do such actions or cause such actions to be done that are necessary, advisable or appropriate so that Subcontractor remains in good standing with any such regulatory authorities. Prior to undertaking any action pursuant to this section, Subcontractor shall notify Manufacturer of the inspection and disclose to Manufacturer the regulatory authorities' findings and related results of such inspection (the Findings) pertaining to the business with Manufacturer. Subcontractor shall also provide full disclosure to Manufacturer with respect to any action undertaken or proposed to be undertaken pursuant to this Section prior to acting. Subcontractor shall keep correct and complete records and books covering the manufacture of the Manufacturer's Products and other documents relating to this Agreement. Each of the Parties will immediately notify the other of any complaints, adverse events, deaths or serious injuries relating to Manufacturer's Products that are manufactured by Subcontractor. All complaints, adverse events, deaths or serious injuries pertaining to Manufacturer's Products will be reported to Subcontractor's Quality Assurance departments in accordance with the requirements established in Subcontractor's and Manufacturer's Complaints Handling and Reporting procedures. All complaint related Manufacturer's Products returned to Manufacturer will be forwarded to Subcontractor for complaint handling and failure investigation. Subcontractor agrees to provide Manufacturer, at Manufacturer's expense and reasonable request and during ordinary business hours, access to, and copies of, such records, books and all other documents and materials in the possession and under the control of Subcontractor relating to or pertaining to the subject matter of this Agreement; including, but not limited to, the following:

a) Subcontractor will provide Manufacturer a schedule of all audits of Subcontractors for materials used in the manufacture of Manufacturer's Products upon request. The schedule will be provided in accordance with the requirements established in Subcontractor's Auditing procedure. Reports on all material Subcontractors for the Manufacturer's Products will be made available to Manufacturer upon request.

b) Upon reasonable notice, Manufacturer may review at any time routine reports relating to all nonconforming materials identified by Subcontractor during the manufacture or inspection of the Manufacturer's Products.

Subcontractor shall maintain quality systems in compliance with ISO 9001 (the 2000 or current version) and the Quality System Requirements of the FDA. 14.3 Change Notification. Subcontractor will notify Manufacturer and obtain approval prior to implementing changes that may require amendments to the Device Master Record, manufacturing process changes or material changes relating to the manufacture and distribution of Manufacturer's Products. Manufacturer will notify Subcontractor of all changes to the Device Master Record, manufacturing process changes or material changes relating to the manufacture of Manufacturer's Products manufactured by Subcontractor. Manufacturer will provide appropriate documentation to Subcontractor to effect any changes to the Device Master Record, manufacturing process or changes in materials. 15. General Provisions.

15.1 Notice. Notice shall be deemed effective and delivered three days after mailing if sent certified mail, return receipt requested, or when received if sent by electronic mail (e-mail), telecopy, prepaid courier, express mail or personal delivery to the intended recipient thereof at the address shown on the first page hereof with confirmation of delivery, or to such other address as either Party may specify in a written notice to the other Party pursuant hereto.





15.2 Force Majeure. Except as otherwise provided herein, neither Party shall be liable to the other for its failure to perform any of its obligations hereunder during any period in which performance is delayed by circumstances beyond its reasonable control, including, without limitation, an act of God, war, civil disturbance, court order, labor dispute, third party nonperformance, acts of third parties, or failures, fluctuations or non-availability of materials, components, electrical power, heat, light, air conditioning, computing or information systems or telecommunications (force majeure), provided that the Party experiencing such delay promptly notifies the other Party of the delay and the cause thereof. The happening of any contingency beyond Subcontractor's reasonable control, including delays caused by Manufacturer or suppliers, shall not constitute cause for cancellation of Manufacturer's order, but shall extend Subcontractor's time to ship goods for a period equal to the duration of such contingency.

15.3 Relationship of Parties. Subcontractor, in providing Manufacturer's Products hereunder, is acting as an independent contractor and does not undertake by this Agreement or otherwise to perform any obligation of Manufacturer, or to assume liability for Manufacturer's business or operations. Subcontractor has the sole right and obligation to supervise, manage, contract, direct, procure, perform, or cause to be performed, all work to be performed by Subcontractor hereunder.

15.4 Right of Subcontractor to Sell Products to Others. Manufacturer understands and agrees that Subcontractor may itself use, manufacture or sell similar products as provided to Manufacturer hereunder to third parties and affiliates, some of whom may be competitors of Manufacturer, so long as: (a) Subcontractor does not use or disclose any Confidential Information of Manufacturer, (b) Subcontractor and third party do not infringe any of Manufacturer's patents or other intellectual property rights.

15.5 No Third Party Beneficiaries. The Parties agree that this Agreement is for the benefit of the Parties hereto only and is not intended to confer any legal rights or benefits on any third party, and that there are no third party beneficiaries to this Agreement or any part or specific provision of this Agreement.

15.6 Attorneys' Fees. The prevailing Party in any legal proceedings brought by or against the other Party to enforce any provision of this Agreement shall be entitled to recover against the non-prevailing Party the reasonable attorneys' fees, court costs and other expenses incurred by the prevailing Party. 15.7 Assignment; Change of Control. Neither Party may assign or transfer this Agreement by operation of law or otherwise. Any assignment made by either Party in contravention of this Section 15.7 shall be null and void for all purposes. In the event of a Change of Control (as defined below) this Agreement shall immediately terminate. A Change of Control shall occur with respect to the Manufacturer, unless Subcontractor shall have expressly consented to such Change of Control in writing. A Change of Control shall mean any event or circumstance as a result of which (i) any Person or group (as such terms are defined in Sections 13(d) and 14(d) of The Securities Exchange Act of 1934 (the Exchange Act), as in effect on the date hereof), other than the Subcontractor, is or becomes the beneficial owner (as defined in Rules 13(d)-3 and 13(d)-5 under the Exchange Act), directly or indirectly, of 50% or more on a fully diluted basis of the then outstanding voting equity interest of the Company, (ii) the board of directors of the Manufacturer shall cease to consist of a majority of the Manufacturer's board of directors on the date hereof (or directors appointed by a majority of the board of directors in effect immediately prior to such appointment) or (iii) the Manufacturer or any of its affiliates merges or consolidates with, or sells all or substantially all of its assets to, any other person or entity; 15.8 Amendment. This Agreement may be amended only by written amendment duly signed by authorized representatives of both Parties.

15.9 Non-Solicitation of Employees. During the term hereof and for a period of five (5) years thereafter, each Party agrees not to, either directly or indirectly, for itself or on behalf of any other person, firm, partnership, corporation or other entity hire, solicit, contract for, attempt to solicit, or cause to be solicited, the employment or services of any current or previous employee of the other Party (unless a period of sixty months has elapsed from the last date that such employee was employed by such party) without the prior written consent of such other Party. Each Party agrees that in the event it violates the provisions of this Section 15.9, it will pay to the other Party as liquidated damages, and not as a penalty, an amount equal to one hundred times (100 X) of any such employee's then-current base annual salary. 15.10 Severability; Validity. If any provision of this Agreement is held invalid or unenforceable under applicable law, the parties agree to renegotiate such provision(s) in good faith, in order to maintain or achieve the economic position enjoyed by each Party as close as possible to that under the provision(s) rendered unenforceable. In the event that the Parties cannot reach a mutually agreeable and enforceable replacement for such provision(s), then (i) such provisions shall be excluded from this Agreement, (ii) the balance of the Agreement shall be interpreted as if such provision(s) were so excluded, (iii) the balance of the Agreement shall be enforceable in accordance with its terms, and (iv) the parties will revise the Agreement to effect the intent of such excluded provisions. 15.11 Waiver. Any waiver of any kind by a Party of a breach of this Agreement must be in writing, shall be effective only to the extent set forth in such writing and shall not operate or be construed as a waiver of any subsequent breach. Any delay or omission in exercising any right, power or remedy pursuant to a breach or default by a Party shall not impair any right, power or remedy which either Party may have with respect to a future breach or default.

15.12 Dispute Resolution. 15.12.1 Obligation to Negotiate. Any dispute arising out of or relating to this Agreement shall be resolved exclusively in accordance with the procedures specified in this Section 15.12. The Parties shall attempt in good faith to resolve any





dispute arising out of or relating to this Agreement by negotiation between a committee composed of four (4) members (two (2) from each Party) mutually agreed upon from the Subcontractor and Manufacturer boards of directors. Any Party may give the other Party written notice of any dispute not resolved in the normal course of business. Such notice shall include (a) a statement of that Party's position and a summary of arguments supporting that position, and (b) the name and title of the executive who will be representing that Party and of any other person who will accompany the executive in the negotiations. Within fifteen (15) days after delivery of the notice, the receiving Party shall respond with (a) a statement of that Party's position and a summary of arguments supporting that position, and (b) the name and title of the executive who will represent that Party and of any other person who will accompany the executive in the negotiations. Within thirty (30) days after delivery of the initial notice, the executives of both Parties shall meet at a mutually acceptable time and place and thereafter as often as they reasonably deem necessary to attempt to resolve the dispute. All reasonable requests for information made by one Party to the other will be honored. All negotiations pursuant to this clause are confidential and shall be treated as compromise and settlement negotiations for purposes of applicable rules of evidence. 15.12.2 Mediation. If the dispute has not been resolved by the negotiation process specified in Section 15.12.1 within forty-five (45) days following the initial notice, the Parties may endeavor to settle the dispute by mediation under the then current CPR Mediation Procedure published by the CPR Institute for Dispute Resolution (NYC). Unless otherwise agreed, the Parties will select a mediator from the CPR Panels of Distinguished Neutrals. 15.12.3 Choice of Law; Venue. If any dispute has not been resolved by a non-binding procedure as provided herein, within one-hundred twenty (120) days of the initiation of such procedure the complaining Party may seek such legal or equitable relief as may be appropriate in the federal or state courts located in Maricopa County, Arizona. The Parties agree that this Agreement shall be governed by and construed in accordance with the laws of the State of Arizona without regard to conflicts of law provisions thereof or any other applicable law and that exclusive venue shall be in the federal or state courts located in Maricopa County, Arizona. Nothing stated herein is intended to limit either Party's right to seek emergency, temporary or permanent injunctive relief and both Parties expressly agree that either Party will be entitled to such relief to prevent actual or threatened violation of the confidentiality provisions in Section 11 herein. If there is a dispute or legal action regarding this agreement, the prevailing Party shall be entitled to reasonable attorney's fees and costs. 15.13 Binding Effect; Recitals. This Agreement shall be binding on and inure to the benefit of the Parties and their respective successors and assigns. The recitals to this Agreement are incorporated into and shall constitute a part of this Agreement.

15.14 Survival. The rights, limitations, obligations and duties under Sections 7, 10, 11, 12, 14 and 15 shall survive the expiration or termination of this Agreement. 15.15 Entire Agreement. This Agreement and the attachments attached hereto contain the entire agreement of the Parties with respect to the subject matter of this Agreement, and supersede all prior negotiations, agreements and understandings with respect thereto. Signature Page to Follow





IN WITNESS WHEREFORE, the Parties have caused this Agreement to be executed by their duly authorized representatives as set forth below: ZOUNDS HEARING, INC. Date: ________________________ By:______________________________ Name: Samuel L. Thomasson Title: President & Chief Executive Officer Address: 6825 W. Galveston Street, Suite 9 Chandler, AZ 85226 Fax: _____________________________ Email: ____________________________ INNERSCOPE HEARING TECHNOLOGIES, INC. Date: ________________________ By:________________________________ Name: Matthew Moore Title: CEO Address: 2151 Professional Drive 2nd Floor Roseville, CA. 95616 Fax: (916) 218-4101 Email: matthew@innd.com 
Question: Highlight the parts (if any) of this contract related to Warranty Duration that should be reviewed by a lawyer. Details: What is the duration of any  warranty against defects or errors in technology, products, or services  provided under the contract?
answer:

Upon Manufacturer's request, Subcontractor will facilitate such Manufacturer's Products being repaired or replaced, Manufacturer must return the Manufacturer's Products to Subcontractor, transportation charges prepaid by Manufacturer, within fifteen (15) days of the end of such thirty (30) date notice period.