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Clinical Trial and Commercial Services for Pharmaceutical Companies, Biotechs and CROs

Myonex, LLC Standard Terms And Conditions

Last updated January 15, 2026

For Ordering Documents dated prior to January 15, 2026, click here: https://www.myonex.com/legal/myonex-llc-standard-terms-and-conditions-010323/

MYONEX, LLC

STANDARD TERMS AND CONDITIONS

These Standard Terms and Conditions (the “Agreement” or “Myonex Terms”) shall govern any Ordering Document (as defined below) between Myonex, LLC or the Affiliate of Myonex, LLC specified on the applicable Ordering Document (“Myonex”) and the customer specified on the applicable Ordering Document (“Customer”) in which reference to this Agreement is incorporated unless otherwise specified in such Ordering Document or agreed upon in writing by the Parties.  Customer and Myonex are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.  The Parties hereto agree as follows:

  1. Definitions. Unless this Agreement expressly provides to the contrary, the following terms have the respective meanings set forth below:
    1. “Affiliate” means, with respect to a Party, any person or entity which controls, is controlled by or is under common control with such Party. As used in this Section, “control” means (a) direct or indirect ownership of at least fifty percent (50%) of the equity interests of an entity or (b) the direct or indirect power to manage, direct or cause the direction of the management and policies of the entity or the power to elect at least fifty percent (50%) of the directors or equivalent members of the governing body of such entity.
    2. “Applicable Laws” means all applicable ordinances, rules, regulations, laws, guidelines, guidance, requirements and court orders of any federal, state, municipal, or other governmental entity or division, as amended from time to time.
    3. “Customer-Supplied Materials” shall mean any drug products (including investigational medicinal products), ancillary supplies, medical equipment, or other materials provided to Myonex by Customer (or by a third party on behalf of Customer) in connection with Myonex’s performance of packaging, labeling, storage, distribution, and/or other related services.
    4. “Finished Materials” shall mean the Customer-Supplied Materials packaged, labeled, and/or otherwise prepared by Myonex in accordance with the specifications set forth in the applicable Ordering Document.
    5. “Intellectual Property Rights” means without limitation, any rights to inventions, copyrights, patents, trademarks, business names and domain names, goodwill, design rights, trade secrets, rights to use and protect Confidential Information and all other intellectual property rights whether registered or unregistered, which subsist now or in the future in any part of the world.
    6. “Ordering Document” means any (a) mutually executed Work Order and/or (b) a Quotation, together with its corresponding Purchase Order and Order Confirmation.
    7. “Product” means any marketed pharmaceutical products, placebo, non-drug supplies, equipment and/or laboratory or medical equipment to be sold (or in the case of laboratory and medical equipment, potentially leased) by Myonex to Customer for use in Customer’s clinical trial(s), which Products shall be set forth in each applicable Ordering Document.
    8. “Quality Agreement” means an agreement between the Parties governing technical and quality obligations with respect to Current Good Manufacturing Practice activities.
    9. “Services” means any services to be provided by Myonex, as identified in each applicable Ordering Document, to Customer.  Services may include, but are not limited to, logistics, storage, distribution, packaging, labeling, compounding, and/or the preparation of patient kits.
    10. “Work Order” means a written work order, statement of work, or other similar agreement between the Parties, signed by authorized representatives of Customer and Myonex, for the provision of Products and/or Services under this Agreement.
  2. Engagement of Myonex.
    1. Process
      1. Use of Quotations and Purchase Orders. From time to time, Customer may request that Myonex prepare a written quotation or proposal for the supply of Products or Services (a “Quotation”).  Such Quotation shall specify, as applicable: the name, strength, quantity, estimated lead time(s), expiry, lot details, unit price, total price, insurance charges, shipping charges, storage charges, and/or any other ancillary charges, with respect to the Product(s) requested, and/or a description of the applicable Services.  Customer may accept such Quotation by issuing a purchase order referencing such Quotation (a “Purchase Order”).  A Purchase Order shall become binding upon Customer at the time of issuance and shall be deemed accepted by Myonex (or the relevant Myonex Affiliate) when accepted in writing (via email or otherwise) (an “Order Confirmation”) or upon the delivery by Myonex of such Products or Services, whichever occurs first.  In the event of a conflict or inconsistency between the terms of the Purchase Order and the terms of the Quotation (or the terms of this Agreement), the terms of the Quotation (or the terms of this Agreement, as applicable) shall control, unless the Order Confirmation expressly acknowledges and accepts such conflicting or inconsistent terms.  Any additional terms contained in a Purchase Order (for example, Customer’s standard terms of purchase) are expressly rejected and shall be null and void. 
      2. Use of Work Orders. The Parties may choose to utilize a Work Order in which each such Product and/or Service is identified, which shall become binding upon the Parties when the Work Order is signed by both Parties. Each Work Order will set forth the particular Products and/or Services to be provided, together with any applicable specifications, instructions, deliverables, timelines, types and quantities of Products to be provided, compensation, payment terms, delivery destination(s), and such other details and special arrangements as are agreed to by the Parties with respect to such Products and/or Services.   
      3. Leased Medical Equipment. In the event that the Ordering Document provides for the medical equipment to be leased rather than sold (“Leased Equipment”), the terms and conditions set forth in Appendix A attached hereto shall apply in addition to, and not in lieu of, all other terms of this Agreement relating to Products.  In the event of any conflict between the terms of Appendix A and the terms of this Agreement, the terms of Appendix A shall prevail with respect to any such Leased Equipment.
    2. Conflict Between Documents. If there is any conflict, discrepancy, or inconsistency between the terms of this Agreement and any Ordering Document, the terms of the applicable Ordering Document will control for such Ordering Document only.  Otherwise, the terms of this Agreement may not be modified or supplemented by any subsequent documents or communications between the Parties except for amendments jointly executed by the Parties.
    3. Changes. Myonex reserves the right to amend the specifications of any Products or Services from time to time if required in order to comply with Applicable Laws. Customer may, at any time and from time to time, by written notice to Myonex (email is acceptable), request changes to the terms of an Ordering Document, including without limitation changes in specifications, method of packing or shipment, quantity ordered, destinations, delivery schedules, or scope or duration of Services.  Any mutually agreed changes shall be effective only through the Parties’ execution of a change order or issuance of an updated Quotation, Purchase Order, and Order Confirmation (as described above in 2.1(a)).
  3. Audit. No more than once annually during the term of the applicable Ordering Document, upon request by Customer provided with reasonable prior written notice, and at a date mutually agreed between Myonex and Customer, Myonex shall allow Customer or Customer’s authorized representatives with reasonable access to inspect and examine any Myonex facilities and records (including applicable Myonex standard operating procedures) which directly relate to the Products and/or Services provided hereunder, to ensure the Products and/or Services are being provided in accordance with the terms of this Agreement, any applicable Quality Agreement, and Applicable Laws.  Such audits shall be conducted at Customer’s expense, shall not utilize more than two (2) auditors, and shall not exceed two (2) business days in length.  Customer shall make reasonable efforts to provide an audit agenda at least ten (10) business days in advance of such audit, but in no event less than five (5) business days in advance of such audit.  Such audit agenda shall detail the subject matter(s) to be audited and the records of Myonex which are requested to be examined.  In the event Customer engages a third party representative to conduct such audit, the third party shall be obligated to execute an appropriate confidentiality agreement with Myonex.  In addition, Myonex may refuse an audit by a third party in the event that Myonex has a reasonable, good faith basis to object, including that the third party is a competitor of Myonex or other conflict of interest exists between the third party and Myonex.  Nothing in the foregoing shall require Myonex to disclose or otherwise make available to Customer (or its designated third-party auditor) any legally privileged, proprietary, or sensitive internal (including financial) information of Myonex, nor any other information not directly related to any obligations of Myonex under this Agreement.  Myonex reserves the right to charge Customer additional fees for any other audits (including certification audits) requested by Customer which are outside the scope of this paragraph.
  4. Delivery, Acceptance, and Title to Products.
    1. Shipping; Delivery; Insurance. Myonex will ensure that delivery of Products is made to Customer or Customer’s designee, (a) to the destination designated by Customer in the applicable Ordering Document, and (b) in accordance with the specifications, provisions and instructions agreed to in an Ordering Document or as otherwise agreed to by the Parties in writing, or as modified pursuant to Section 2.4 (Changes).  Myonex will bear all costs of packaging except as set forth in the applicable Ordering Document.  Customer will be responsible for paying to Myonex all costs of transportation and insurance in delivering the Products as specified in the applicable Ordering Document.  In the event that Customer fails to pay Myonex for such insurance costs as set forth in the applicable Ordering Document, or in the event that Customer elects to arrange and pay insurance directly rather than to utilize Myonex and include the costs of same in the Ordering Document, Myonex shall have no responsibility for any risk to Product that relate to transportation or storage of, or insurance on, such Products, and Customer assumes all risk with respect to transportation or storage of such Products.   In any event, Customer is responsible for arranging insurance for the Products with effect from the point of delivery of the Products.  A bill of lading will be furnished to Customer with respect to each shipment.  Shipping dates, where stated, are approximate and not guaranteed.  If applicable, shipments of Products will be delivered in accordance with the Incoterms (2020) specified in the applicable Ordering Document.  
    2. Acceptance of Products.  Customer (or its designated recipient) shall inspect all Products delivered or distributed by Myonex and notify Myonex in writing of any damage, defects, or nonconformity with specifications within fourteen (14) days of receipt.  With respect to any defects in the Products which may not or would not have been obvious at delivery by visual inspection of such Products made with reasonable care, Customer shall notify Myonex without undue delay throughout their shelf life but in no event later than one year after delivery, provided that Customer can demonstrate it stored the allegedly defective Products as per the manufacturer’s instruction at all times.  Customer shall be deemed to unconditionally accept all Products purchased or distributed hereunder and waive every claim from any cause, including without limitation claims under the limited warranties contained herein, unless Customer provides notice of such claim in accordance with this Section.  In the event of any disagreement regarding nonconformity with specifications of Products, the Parties will be guided by the Product manufacturer’s label and other supporting information provided by the manufacturer.  Myonex shall have the opportunity to procure conforming replacement Products within a mutually agreed period of time (but in no event less than thirty (30) days) following receipt of written notice from Customer.  Myonex’s failure to procure conforming replacement Products within such mutually agreed period of time shall entitle Customer to cancel its order for such damaged, defective, or nonconforming Products without further liability to Myonex. Customer shall in good faith consider any request by Myonex for a reasonable extension of time if Myonex provides good reason for same, such as, by way of example only, time periods necessary to clear imports.
    3. Title to Products. Title to Products will not pass to Customer until Myonex has received payment in full for the Products.
  5. Customer-Supplied Materials and Finished Materials.
    1. Customer shall be responsible at its expense for securing any necessary export, import, or other licenses, clearances, permits, authorizations, or certifications required by applicable regulatory authorities in respect of any Customer-Supplied Materials.  Any third party supplier of Customer-Supplied Materials shall be duly qualified by Customer.  Myonex shall use Customer-Supplied Materials solely for performing Services.  Prior to delivery of any Customer-Supplied Materials, Customer shall provide to Myonex a copy of all associated material safety data sheets, safe handling instructions, health and environmental information, and any governmental certification or authorization that may be required under Applicable Laws relating thereto and thereafter shall provide promptly any update(s) to such documents, instructions, or information.
    2. Unless otherwise expressly agreed in an Ordering Document, Myonex shall have no obligation to test Customer-Supplied Materials to confirm that they meet certain product specifications or otherwise, but, in the event that Myonex detects or suspects a nonconformity with respect to such Customer-Supplied Materials (“Nonconforming Materials”), Myonex shall give Customer prompt notice (email is acceptable) of such nonconformity.  Myonex shall follow Customer’s reasonable written instructions in respect of return or disposal of Nonconforming Materials, at Customer’s cost and risk.  If Customer does not reply to Myonex’s notice (email is acceptable) of nonconformity within ten (10) days, Myonex shall be entitled to return the Nonconforming Materials to Customer at Customer’s cost.  Customer shall, promptly and at Customer’s own expense, deliver to Myonex replacement Customer-Supplied Materials. Customer shall always retain title to Customer-Supplied Materials and shall bear the risk of loss thereof.
    3. Customer represents and warrants that (a) it is the owner of all Customer-Supplied Materials (or that Customer has the right to provide such Customer-Supplied Materials to Myonex for purposes of performing the Services), (b) all Customer-Supplied Materials shall have been produced and provided to Myonex in accordance with Applicable Laws, and (c) all Customer-Supplied Materials shall comply with all applicable specifications, and shall not be adulterated, misbranded, or mislabeled within the meaning of Applicable Laws.
    4. Myonex shall not be liable for (including any delay or failure to perform the Services as a result of) (a) any defective or non-conforming Customer-Supplied Materials (including the packaging provided therewith), (b) late receipt (or no receipt) of the required Customer-Supplied Materials, (c) any defect occurring either from any design flaw or instructions attributed to Customer, (d) any defects or damages caused by natural wear and tear, (e) any error in communications by Customer (or Customer’s agent(s)) regarding the Customer-Supplied Materials including any failure to provide necessary information or documents (including authorizations or certifications) required to be provided by Customer (or its agent(s)) to Myonex for the performance of Services, or (f) any defects or damages caused by any modification to the Customer-Supplied Materials not attributable to Myonex.  Except as otherwise expressly stipulated by Myonex, any time frames indicated with respect to the Services are given for indicative purposes only.
    5. Customer (or its designated recipient) shall visually inspect the Finished Materials and notify Myonex in writing of any damage, defects, or nonconformity with the agreed upon specifications therefor within ten (10) days of receipt.  With respect to any defects in the Finished Materials which may not or would not have been obvious at delivery by visual inspection of such Finished Materials made with reasonable care, Customer shall notify Myonex within five (5) days following discovery, throughout their shelf life but in no event later than one year after delivery, provided that Customer can demonstrate it stored the allegedly nonconforming Finished Materials in accordance with the applicable specifications therefor at all times.  Customer shall be deemed to unconditionally accept all Finished Materials distributed hereunder unless Customer provides notice of such nonconformity in accordance with this paragraph.
    6. In the event that it is necessary for Myonex to store Customer-Supplied Materials and/or packaging (including labeling) materials in excess of the period specified in any applicable Ordering Document due to a delay caused by Customer (e.g., cancellation or postponement of an order, failure to provide technical elements or information essential to the completion of the Services, etc.), Myonex may charge additional storage fees to Customer and/or may destroy or return such Customer-Supplied Materials and/or packaging materials to Customer, at Myonex’s option, and at Customer’s expense.
    7. In the event that Customer terminates any Ordering Document or Services, Customer must indicate to Myonex if any unused stocks of remaining Customer-Supplied Materials and/or packaging (including labelling) materials shall be: (i) returned to Customer or (ii) destroyed by Myonex, in each case at Customer’s sole cost and expense.  If Customer does not notify Myonex of its election to return or destroy the Customer-Supplied Materials and/or packaging (including labeling) materials within ten (10) days following the date of the notice of termination, Myonex shall be entitled to destroy or return the Customer-Supplied Materials to Customer, at Myonex’s option and at Customer’s expense.
  6. Price and Payments.
    1. Price. The prices of Products will be set forth in the applicable Ordering Document.  Myonex shall be entitled to change Product prices at any time before shipment of Product to reflect any increase in the cost of the Products that is due to any factor beyond Myonex’s control (including, without limitation, foreign exchange fluctuations, increases in taxes and duties, increases in labor or materials, manufacturer or wholesaler price increases, and increases in other supply chain costs).  Myonex will (i) promptly notify Customer upon becoming aware of an applicable price increase, and (ii) provide reasonable documentation of the reason for any such price increase upon Customer’s request.  In the event of a Product price increase above the price set forth in the original Ordering Document, Customer shall be entitled to cancel its order for such Products without liability (a) at any time prior to Myonex purchasing the Products from its supplier(s), or (b) thereafter, in accordance with Section 11 below.  Unless otherwise specified in an Ordering Document, prices for Services are valid for a period of twelve (12) months following the effective date of the applicable Ordering Document and thereafter are subject to increase annually upon written notice by Myonex.
    2. Invoice and Payment.
      1. Myonex will invoice Customer according to the payment schedule in the applicable Ordering Document.  If the Ordering Document does not specify a payment schedule, Myonex will invoice Customer for Product purchases upon delivery and for Services on a monthly basis in arrears.  Unless otherwise specified in the applicable Ordering Document, Customer shall pay all invoices within thirty (30) days after the date of the invoice.
      2. Customer will make all payments pursuant to this Agreement, without setoff, by ACH or wire transfer to a bank account designated in writing by Myonex.  All payments under this Agreement will be made in United States Dollars unless otherwise specified in the Ordering Document.
    3. Taxes.  Customer is responsible for any and all taxes (except for taxes based on Myonex’s income) and similar charges related to the supply of Products and/or the provision of Services by Myonex (including without limitation, sales taxes, VAT or any equivalent tax chargeable elsewhere, tariffs, broker fees, and/or other fees assessed in connection with the international import or export of Products pursuant to this Agreement) (collectively, “Additional Charges”).  Additional Charges will be added to each invoice, as applicable.
  7. Confidentiality and Privacy.
    1. Confidential Information. During the course of performing this Agreement, the Parties may be given or observe certain trade secrets, technical know-how, pricing information, vendor information, supplier information, business strategies, and other confidential information of the other Party or its Affiliates (“Confidential Information”). The Parties agree: (a) to hold all Confidential Information of the other Party in confidence, using the same degree of care that they would use in safeguarding their own Confidential Information, but in no event less than a reasonable degree of care; (b) not to disclose Confidential Information of the other Party to others except as expressly provided herein; and (c) not to use Confidential Information of the other Party for any purpose other than to fulfill their obligations or exercise their rights under this Agreement. The Parties agree to limit dissemination of and access to Confidential Information to its (or its Affiliates’) employees, consultants, contractors, subcontractors, suppliers, vendors, and/or agents who have a need to know Confidential Information for the above-described purpose, have been made aware that such Confidential Information is subject to the confidentiality obligations set forth in this Agreement, and have entered into a written agreement with the receiving Party containing confidentiality obligations no less stringent than those contained in this Agreement.
    2. Exceptions to Confidential Information. Notwithstanding the foregoing, Confidential Information shall not include information which: (a) is or hereafter becomes generally available to the public other than by reason of any breach hereof; (b) was already known by the receiving Party prior to the date of disclosure; (c) is disclosed to receiving Party by a third party who has the right to disclose such information without any obligations of confidentiality; (d) is developed by or on behalf of receiving Party independently, without reliance on Confidential Information received hereunder, as demonstrated by written records.  Further, a Party may disclose Confidential Information of the other Party as may be required in order to comply with Applicable Laws (including any order of a court or administrative or regulatory body or other compulsory legal process), provided that the receiving Party (i) promptly notifies (to the extent legally permitted) the disclosing Party of the obligation to disclose in order to allow the disclosing Party (at its sole expense) to seek a protective order or other similar order to protect its Confidential Information; (ii) reasonably cooperates with the disclosing Party’s efforts to obtain a protective order or other remedy against disclosure; (iii) only discloses the minimum amount of Confidential Information that is necessary to comply with the required disclosure; (iv) uses reasonable efforts to ensure that any Confidential Information so disclosed is afforded confidential treatment by the recipient(s); and (v) such information otherwise remains treated by the Parties as Confidential Information for all other purposes.
    3. Restricted Period. These restrictions upon disclosure and use of Confidential Information shall continue during the Term and shall extend beyond the Term for a period of five (5) years, unless otherwise agreed by the Parties in writing.
    4. Obligations upon Termination. Upon the written request of the disclosing Party, the receiving Party will destroy the disclosing Party’s Confidential Information that the receiving Party has in its possession or control, except that the receiving Party may retain a copy of such Confidential Information for archival purposes.  Further, any electronic back-up files that may have been created by the receiving Party by automatic or routine archiving or back-up procedures and that may contain Confidential Information of the disclosing Party need not be destroyed.  Any Confidential Information of the other Party retained shall continue to be governed by the terms of this Section.
    5. Privacy (Generally). The Myonex Data Processing Terms appearing at https://www.myonex.com/legal/myonex-data-processing-terms/ shall govern Myonex’s processing of Personal Data (as defined therein) on behalf of Customer and shall apply only in respect of such Personal Data. When performing the Services, Customer acknowledges and confirms that (i) Myonex will process such Personal Data on behalf of Customer, (ii) Customer shall have and retain sole effective control over such Personal Data, (iii) the provision of such Personal Data shall not be a disclosure (as such term is used under applicable privacy or data protection laws), and (iv) the sharing of Personal Data by Customer (or on its behalf) with Myonex shall not be in contravention of Applicable Laws.
    6. Privacy (United States). To perform certain Services, depending on the nature of the Services, Myonex and its subcontractors may need to receive and process certain patient-identifiable information, such as each patient’s name, date of birth, address, and other information necessary for prescription processing for such Services. Customer is responsible for obtaining all necessary consents, including authorizations required by the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), and its implementing regulations, from patients participating in Customer’s clinical trial(s) that allow Myonex and its subcontractors to receive and process personally identifiable information (“PII”) in relation to the Services.  Myonex shall ensure that PII is only processed in accordance with the consents and the project plan described in the applicable Work Order(s) and is only used as necessary for Myonex’s obligations as part of the Services.  The Parties further acknowledge and agree that the Services are being provided in support of clinical research and not patient treatment, and that the Parties’ use and disclosure of PII for the Services, has been authorized by the subjects of the information who are participants in clinical research, and such information is also defined as Identifiable Private Information for purposes of the federal policy for the protection of human subjects under 45 C.F.R. Part 46. Accordingly, the Parties agree that (1) Myonex is receiving PII pursuant to study subjects’ authorizations under HIPAA, and (2) such PII is exempt from applicability to the California Consumer Privacy Act, including all regulations enacted in connection therewith, as the same may be amended, supplemented, or replaced from time-to-time. The Parties further agree to protect the privacy and security of all information received, maintained, or transmitted by a party in connection with the Services and will use such information solely for purposes of providing the Services.
  8. Representations and Warranties; Exclusive Remedies.
    1. Myonex Representations.  Myonex represents and warrants to Customer that all Products delivered hereunder will conform in all material respects to the specifications set forth in the applicable Ordering Document and will be free of liens and encumbrances.  Myonex represents and warrants that all Services provided hereunder will conform in all material respects with (i) the terms and specifications set forth in the applicable Ordering Document, (ii) Myonex’s standard operating procedures, and (iii) standards of reasonable care in Myonex’s industry.  Myonex further represents and warrants that it has not been debarred, nor is it subject to a pending debarment, and that it will not use in any capacity in connection with the Products or Services any person who is debarred pursuant to section 306 of the United States Federal Food, Drug and Cosmetic Act (21 U.S.C. §321 et seq., as amended from time to time), or who is the subject of a conviction described in such section. Myonex agrees to notify Customer in writing within a commercially reasonable period of time, but in no event later than five (5) days after discovery, if Myonex or any person directly involved in providing the Services on behalf of Myonex is debarred.
    2. Disclaimer of Warranties. MYONEX DISCLAIMS AND NEGATES ANY OTHER WARRANTIES, EITHER EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. NO ORAL OR WRITTEN INFORMATION OR ADVICE GIVEN BY MYONEX OR ITS EMPLOYEES SHALL CREATE A WARRANTY OR MAKE ANY MODIFICATION OR ADDITION TO THIS WARRANTY.
    3. Exclusive Remedies. CUSTOMER’S SOLE AND EXCLUSIVE REMEDY RELATING TO THE LATE DELIVERY, UNAVAILABILITY, AND/OR CONDITION OF PRODUCT(S) SHALL BE, AT MYONEX’S SOLE DISCRETION: (A) REPLACEMENT OF ANY NON-CONFORMING PRODUCTS; OR (B) REFUND OF THE PURCHASE PRICE FOR SUCH NON-CONFORMING PRODUCTS AS PROVIDED IN SECTION 4.2 (ACCEPTANCE OF PRODUCTS) ABOVE. CUSTOMER’S SOLE AND EXCLUSIVE REMEDY RELATING TO THE QUALITY OF SERVICES SHALL BE, AT MYONEX’S SOLE DISCRETION: (A) RE-PERFORMANCE OF THE NON-CONFORMING SERVICES, IF PRACTICABLE; OR (B) REFUND OF THE COMPENSATION PAID FOR THE NON-CONFORMING SERVICES.
  9. Indemnification.
    1. Indemnification by Myonex.  Myonex will indemnify, defend and hold harmless Customer, its Affiliates and their respective officers, directors, employees and agents (each a “Customer Indemnitee”) from and against any and all losses, costs, damages, liabilities or expenses, including reasonable attorneys’ fees and other costs of defense on an indemnity basis (collectively, “Losses”) incurred in connection with any and all actions, suits, claims or demands that may be brought or instituted against any Customer Indemnitee by any third party, to the extent that such Losses are finally determined to have been caused by (a) any material breach by Myonex of its representations, warranties or covenants under this Agreement, or (b) the gross negligence or the willful misconduct of Myonex, its Affiliates, and/or their respective officers, directors, employees and agents in performing obligations under this Agreement.
    2. Indemnification by Customer. Customer will indemnify, defend and hold harmless MYONEX, its Affiliates and their respective officers, directors, employees and agents (each a “Myonex Indemnitee”) from and against any and all Losses incurred in connection with any and all actions, suits, claims or demands that may be brought or instituted against any Myonex Indemnitee by any third party, to the extent that such Losses are finally determined to have been caused by (a) any material breach by Customer of its representations, warranties or covenants under this Agreement, (b) any harm, damage, personal injury, illness, or death suffered as a result of any Customer-Supplied Materials or otherwise as a result of any clinical trial or study supported by Customer (except where due to the negligence or willful misconduct of Myonex); or (c) the gross negligence or the willful misconduct of Customer, its Affiliates, and/or their respective officers, directors, employees and agents.
    3. Procedures. The indemnified Party agrees to notify the indemnifying Party in writing, as soon as is reasonably practicable, but in no event later than thirty (30) days, of receipt of any claims made for which indemnification might be due hereunder (each, a “Claim”), provided that any delay in giving such notice shall not relieve the indemnifying Party of its obligations hereunder except to the extent it is prejudiced by such delay.  The indemnifying Party shall have the right, but not the obligation, to assume control of the defense of each such Claim. If the indemnifying party: (a) does not notify the indemnified Party in writing of its intent to assume control of the defense of the Claim within ten (10) business days after receiving notice of the Claim, or (b) notifies the indemnified Party that it declines to assume the defense of the Claim, then the indemnified Party shall have the right to defend and/or settle the Claim with counsel of its choosing, at the indemnifying Party’s expense, and the indemnifying Party shall remain responsible for all Losses resulting from such Claim, including the costs of defense and any settlement or judgment.  The indemnified Party shall provide such information and assistance as the indemnifying Party may reasonably request, at the indemnifying Party’s expense. Notwithstanding the foregoing, the indemnified Party shall nevertheless be entitled to retain separate counsel at its own cost to participate in the defense of any Claim.
    4. Settlement. An indemnified Party will not be responsible or bound by any settlement of any claim or suit made without its prior written consent; provided, however, that the indemnified Party will not unreasonably withhold or delay such consent. If a settlement contains an absolute waiver of liability for an indemnified Party and does not require an indemnified Party to admit liability or make any financial or material non-monetary contribution to the settlement, and the indemnifying Party has acted in compliance with the requirements of Section 9.3 above, then such indemnified Party’s consent will be deemed given.
  10. Limitations of Liability.
    1. IN NO EVENT SHALL MYONEX BE LIABLE TO CUSTOMER, ITS AFFILIATES, AND/OR ANY THIRD PARTY FOR ANY AND ALL SPECIAL, INDIRECT, CONSEQUENTIAL, PUNITIVE, OR INCIDENTAL DAMAGES, INCLUDING, BUT NOT LIMITED TO, LOST REVENUES AND/OR LOST PROFITS, EVEN IF MYONEX IS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES OR CLAIMS.
    2. EACH PARTY’S TOTAL AGGREGATE LIABILITY TO THE OTHER PARTY UNDER THIS AGREEMENT (INCLUDING ANY ORDERING DOCUMENTS AND QUALITY AGREEMENT(S)), WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), BREACH OF STATUTORY DUTY, RESTITUTION, AND/OR OTHERWISE HOWSOEVER ARISING UNDER ANY LEGAL THEORY WHATSOEVER SHALL IN ALL CIRCUMSTANCES BE LIMITED TO AND SHALL NOT EXCEED: (A) FOR NON-PAYMENT OF ANY AMOUNTS DUE UNDER THIS AGREEMENT, THE AMOUNT OF THE DEBT DUE (PLUS ANY INTEREST DUE THEREON FOR LATE PAYMENT PLUS ALL COSTS (INCLUDING REASONABLE LEGAL COSTS) INCURRED IN RECOVERING SUCH SUMS); (B) FOR ANY OTHER TYPE OF LIABILITY, A TOTAL SUM EQUAL TO THE TOTAL AMOUNT OF FEES PAID BY CUSTOMER TO MYONEX (EXCLUDING AMOUNTS PAID FOR PRODUCTS) FOR THE APPLICABLE SERVICES UNDER THE APPLICABLE ORDERING DOCUMENT GIVING RISE TO SUCH LIABILITY OVER THE IMMEDIATELY PRECEDING TWELVE (12) MONTHS, NOT TO EXCEED TWO MILLION DOLLARS ($2,000,000.00).
  11. Term and Termination.
    1. Term. This Agreement will take effect as of the effective date specified on the applicable Ordering Document and, unless earlier terminated pursuant to this Section, will expire upon the completion of Services by Myonex and payment by Customer (the “Term”).
    2. Termination for Convenience. Either Party will have the right to terminate any Ordering Document for convenience upon sixty (60) days prior written notice to the other Party.
    3. Termination for Cause. Either Party will have the right to terminate any Ordering Document immediately upon written notice to the other Party following the occurrence of any of the following:
      1. The other Party files a petition in bankruptcy, or applies for or consents to the appointment of a receiver or trustee, or makes an assignment for the benefit of creditors, or becomes subject to involuntary proceedings under any bankruptcy or insolvency law (which proceedings remain undismissed for sixty (60) days); or
      2. The other Party fails to cure a material breach of this Agreement and/or any Ordering Document within thirty (30) days after receiving written notice from the other Party of such breach.
    4. Monies Due for Cancellation of Products. In the event of any termination of a pending order for Products by Customer, Customer shall pay the purchase price set forth in the applicable Ordering Document for any Products that have been ordered by Myonex from its supplier(s) as of the time of cancellation, provided that Myonex shall (a) use all commercially reasonable efforts to return or re-sell any such Products for a period of three (3) months from the time of cancellation and (b) refund to Customer any amount(s) paid by Customer (less any third-party fees and other out of pocket costs incurred by Myonex relating to the return or resale of any such Products) that Myonex is able to recoup by returning or re-selling such Products within three (3) months from the time of cancellation.
    5. Monies Due for Cancellation of Services. In the event of any termination of a pending order for Services by Customer, Customer shall pay the sum of (a) the price specified in the applicable Ordering Document for any Services provided prior to the effective date of termination, (b) any costs incurred by Myonex in reliance on the applicable Ordering Document, which cannot be avoided through reasonable efforts, and (c) reasonable compensation (to be mutually agreed by the Parties) for Myonex’s efforts to wind up and/or transition any Services pending at the time of termination.
    6. Suspension.  Without limiting its other rights or remedies, Myonex may suspend provision of the Products and/or Services under the Agreement if Customer becomes subject to any of the events listed in Section 11.3, or Myonex reasonably believes that Customer is about to become subject to any of them, or if Customer fails to pay any amount due under the Agreement or any Ordering Document on the due date.
    7. Survival of Terms. Notwithstanding anything to the contrary that may be contained herein, in the event of a termination or expiration of this Agreement, any sections of this Agreement which by their terms or nature are intended to survive, including Sections 1 (Definitions), 2.3 (Conflict Between Documents), 6 (Price and Payments), 7 (Confidentiality), 8 (Representations and Warranties; Exclusive Remedies), 9 (Indemnification) (for a period of 5 years), 10 (Limitations of Liability), 11.4 (Monies Due for Cancellation of Products), 11.5 (Monies Due for Cancellation of Services), 11.7 (Survival of Terms), 12 (Intellectual Property) and 14 (Miscellaneous), will survive.
  12. Term and Termination.
    1. Myonex Intellectual Property. Myonex and its licensors shall retain all Intellectual Property Rights in all documents, materials, information, and items which are owned by Myonex (or licensed from a third party) and which are utilized by Myonex in the performance of the Services, whether or not the same are provided to the Customer in connection with the performance of the Services, together with any improvements or modifications made thereto and any know-how, methods, processes, or technologies developed by Myonex in the course of performing such Services without reliance on the Confidential Information of Customer (“Myonex Materials”) and no right or license is granted to Customer in respect of Myonex Materials.  Any suggestions or feedback provided by Customer in respect of the Services shall become the sole and exclusive property of Myonex.
    2. Customer Intellectual Property. Customer and its licensors shall retain all Intellectual Property Rights in all Customer-Supplied Materials and any other documents, materials, information, and items which are owned by the Customer (or licensed from a third party) and which are provided to Myonex in connection with the performance of the Services (“Customer Materials”) and no right or license is granted to Myonex in respect of the Customer Materials.
  13. Force Majeure. If a Party (an “Affected Party”) is prevented or delayed in or from performing any of its obligations under this Agreement (including any applicable Ordering Document) by any event beyond its reasonable control, including, without limitation, strikes, lock-outs or other industrial disputes, failure or interruption of energy sources or transport network or utility service, a default or failure in performance by manufacturers, suppliers and/or subcontractors, general shortages of raw materials or drugs, any law or any action taken by a government or public authority, acts of God, war, terrorism, epidemics, pandemics, breakdown of plant or machinery, nuclear, chemical or biological contamination, or fires, floods, earthquakes, or similar events, natural disasters or extreme adverse weather conditions (“Force Majeure Event”), the Affected Party shall not be in breach of this Agreement (including the applicable Ordering Document) or otherwise liable for any such failure or delay in the performance of such obligations, the time for performance of such obligations shall be extended accordingly (provided that such relief shall not extend to the payment of invoices duly raised under this Agreement).  In the event the Force Majeure Event prevents or delays the Affected Party’s performance of its obligations for a continuous period of more than three (3) months, the Party not affected by the Force Majeure Event may terminate the applicable Ordering Document upon written notice to the Affected Party.
  14. Miscellaneous.
    1. Independent Contractor. Myonex is an independent contractor, and this Agreement does not create an employer-employee, partner, joint venture, or agency relationship between Customer and Myonex. Myonex will not in any way represent itself to be a partner or joint venturer of or with Customer.
    2. Solicitation of Personnel. If Customer (or any of its Affiliates), during (i) the Term or (ii) the twelve (12) month period following the expiration of the Term, without the prior written consent of Myonex, solicits or entices away from Myonex or employs or attempts to employ any person who is engaged as an employee, consultant or subcontractor of Myonex, or has been engaged as an employee, consultant, or subcontractor of Myonex any time during the preceding six-month period (a “Restricted Person”), Customer shall pay to Myonex a sum equal to forty percent (40%) of one year’s base salary and target bonus that was payable by Myonex to the Restricted Person plus the recruitment costs incurred by Myonex in replacing such Restricted Person. The provisions of this Section shall not apply to (i) the hiring of any otherwise Restricted Person responding to an unsolicited advertisement for work or (ii) the targeted recruitment of a Restricted Person based on general and objective criteria applicable to all candidates and not targeted by the hiring Party by virtue of the Restricted Person’s association with the Services.
    3. Publicity.  Neither Party will issue any announcements or press releases mentioning the other Party and will not disclose to others the fact that Customer has purchased or plans to purchase Products or Services from Myonex, or the terms and conditions of such purchase, without the other Party’s prior written consent, except as is necessary to fulfill its obligations hereunder, or as required by Applicable Law.  Notwithstanding the foregoing, Myonex may include Customer’s name and logo in its published list of customers in marketing materials, including on its website.
    4. Notices. Except where otherwise expressly stated in this Agreement, all notices required to be given to a Party under this Agreement must be written and sent to the address identified below for Myonex, and the address identified on the applicable Ordering Document for Customer, or to such other address as a Party may specify for such purpose in a subsequent notice. All such notices must be given (a) by prepaid certified or registered mail, with confirmation of delivery, or (b) by prepaid recognized express delivery service (e.g. FedEx, UPS, DHL). Notices will be effective upon receipt.
      If to Myonex, to:
      Myonex, LLC
      100 Progress Drive
      Horsham, PA 19044
      Attention: General Counsel
      With a copy via email to [email protected]      		  
    5. Assignment. This Agreement may not be assigned by the Parties, by operation of law or otherwise, without the prior written consent of the other Party, which shall not be unreasonably withheld, except that either Party shall have the right to assign this Agreement (including by operation of law) to an Affiliate or to the surviving party of any merger, acquisition, or reorganization to which it is a party, or to the purchaser of all or substantially all of the assigning Party’s assets. Any permitted assignee will assume the rights and obligations of the assignor under this Agreement.
    6. Entire Agreement. This Agreement, including any attached Appendices and any applicable Ordering Document(s), each of which are incorporated herein, constitute the entire agreement between the Parties with respect to the specific subject matter hereof. If the Parties have entered into or later enter into a Quality Agreement, technical and quality obligations only would be governed by the Quality Agreement. There are no written or oral understandings, promises, agreements, statements, or representations between the Parties directly or indirectly related to this Agreement that are not set forth herein.
    7. No Oral Modification. This Agreement and the applicable Ordering Document may be changed only by a writing signed by authorized representatives of both Parties, which refers to this Agreement or the relevant Ordering Document.
    8. Severability; Reformation. Each provision in this Agreement is independent and severable from the others, and no provision will be rendered unenforceable as a result of any other provision(s) being held to be invalid or unenforceable in whole or in part, except that the invalidity or unenforceability of Customer’s payment obligation shall relieve Myonex of its obligation to supply Products and/or Services to Customer. If any provision of this Agreement is invalid, unenforceable or too broad, that provision will be appropriately limited and/or reformed in accordance with the intent of the original provision to the extent necessary to render the provision fully valid and enforceable under Applicable Law.
    9. Compliance with Applicable Laws. Myonex and Customer will comply with all Applicable Laws that govern the performance of their respective obligations under this Agreement.
    10. Governing Law; Jurisdiction; Venue. This Agreement will be construed and interpreted, and its performance governed by the laws of the State of Delaware, U.S.A., without regard to any choice of law principle that would dictate the application of the law of another jurisdiction. The application of the 1980 United Nations Convention on Contracts for the International Sale of Goods is expressly excluded from this Agreement.   Any dispute, suit, action or proceeding between Customer and Myonex arising out of or relating to this Agreement, or to enforce any judgment entered by any court in respect of this Agreement, will be brought in the state or federal courts located in Wilmington, Delaware. The Parties hereby submit to the jurisdiction of such courts for the purpose of any such dispute, suit, action or proceeding and irrevocably waive, to the fullest extent permitted by law, any objection which they may now or hereafter have to the laying of venue for any suit, action or proceeding arising out of or relating to this Agreement, or to enforce any judgment entered by any court in respect hereof, brought in Wilmington, Delaware.
    11. Waiver. The waiver by either Party hereto of (i) any right under this Agreement, (ii) a Party’s failure to perform, or (iii) a breach by the other Party, will not be deemed a waiver of any other right under this Agreement or of any other breach or failure by such other Party, whether of a similar nature or otherwise.
    12. Headings and Interpretation. This Agreement contains headings only for convenience, and the headings do not constitute or form a part of this Agreement and should not be used in the construction of this Agreement.  A person includes both a natural person, and a corporate or unincorporated entity (whether or not having separate legal personality).  A reference to a statute or statutory provision is a reference to such statute or provision as amended or re-enacted. A reference to a statute or statutory provision includes any subordinate legislation made under that statute or statutory provision, as amended or re-enacted.  Words in the singular include the plural and vice versa.
    13. No Benefit to Third Parties. The representations, warranties, covenants and agreements set forth in this Agreement are for the sole benefit of the Parties hereto and their successors and permitted assigns, and they will not be construed as conferring any rights on any other persons.
    14. Counterparts. Any Ordering Document and any amendments may be executed in counterparts, each of which shall be deemed an original, and which taken together shall constitute one and the same instrument. Each Party may execute any Ordering Documents and any amendments thereto by scanned electronic signature or certified electronic signature which shall be as effective as an original signature, or may provide any Purchase Order and/or Order Confirmation, as applicable, by email or other electronic means.

APPENDIX A

LEASED EQUIPMENT ADDITIONAL TERMS

  1. Covenants. Customer agrees that at all times during the term of any lease, Customer shall comply, and shall cause each of its employees, agents, representatives, clinical sites and customers, as applicable using any Leased Equipment through Customer (each a “User”) to comply, with the following covenants:
    1. Customer’s Compliance. Customer shall comply, and shall cause each User to comply, with all contractual obligations and applicable laws, rules and regulations related to the Leased Equipment.
    2. Liens. Customer shall not, and shall not permit any User to, incur any liens on the Leased Equipment, and shall keep all Leased Equipment free and clear of all Liens.
    3. Location. Customer shall not, and shall not permit any User to, move any Leased Equipment from its location of designated delivery or use, as specified in the Ordering Document (“Location”) without Myonex’s prior written consent.  In the event consent is given by Myonex, Customer shall remain responsible for all costs relating to the transportation, calibration, and installation of such Leased Equipment, together with the full replacement cost of replacing such Leased Equipment if damaged.
    4. Third Party Use. Customer shall not allow any third party other than a User to use the Leased Equipment.
    5. Maintenance and Repairs in General. Customer shall, or shall cause User to, perform routine maintenance on Leased Equipment and keep Leased Equipment in the same condition as when delivered, ordinary wear and tear excepted. Customer shall immediately notify Myonex of any loss, damage, malfunctions of, or deficiencies in, the Leased Equipment.
    6. Early Termination.  In the event of any early termination by Customer of any lease term for Leased Equipment, Customer shall remain responsible and liable to pay to Myonex the balance of fees due for the remainder of the applicable lease term, as specified in the Ordering Document.
  2. Risk of Loss.  During the lease term, Customer shall bear all risk of loss, damage, destruction, theft, and condemnation to or of such Leased Equipment from any cause whatsoever.
  3. Removal of Equipment.  Promptly following the expiration of the lease term for any Leased Equipment, Customer (or Customer’s designated representative), shall inspect, decontaminate (and provide documentation of such decontamination process), pack, and remove such Leased Equipment from the Location and return such Leased Equipment to Myonex in accordance with Myonex’s instructions and all applicable laws. Myonex shall provide reasonable assistance to Customer to facilitate any such removal and return of Leased Equipment. Myonex shall have no obligation to remove the Leased Equipment from the Location, absent the Parties having agreed in writing to the same.
  4. Tax benefits.  Myonex is entitled to all deductions, credits, and other tax benefits that are provided in the Internal Revenue Code or applicable state and/or local laws to an owner of property.  Customer shall not take or omit to take any action that results in the disqualification of any Leased Equipment for, or recapture of, all or any portion of such tax benefits.