Document:

Exhibit 10.15

 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO ACELL, INC. IF PUBLICLY DISCLOSED.

 

Supply Agreement for Porcine Urinary Bladders

 

This agreement (the “Agreement”) is between Clemens Food Group, LLC., a Delaware limited liability company with a principal place of business at 2700 Clemens Road, P.O. Box 902, Hatfield, PA 19440-0902  (“Supplier”), and ACell, Inc., with offices at 6640 Eli Whitney Drive, Columbia, MD 21046, (“ACell”), effective as of November 1, 2016 (the “Effective Date”).

 

1.                                      Definitions:  For purposes of this Agreement the terms set forth in this Section 1, whether capitalized or not, shall have the following meanings:

 

1.1. “ACell Compliant pig(s)” means pigs harvested in accordance with ACell specification [*] that meet the requirements of ACell specification [*] and the QTA (defined in Section 1.4 below).

 

1.2. “Bladder” means the urinary bladder of an ACell Compliant pig

 

1.3. “Disease” means an unusual or significant event that affects the health of the pigs and could render their Bladders (defined below) ineligible for medical use or may require special treatment or vaccination to control.

 

1.4. “QTA” means the [*] Supplier Quality Technical Agreement [*]

 

2.                                      Agreement to Sell:  Supplier hereby agrees to sell to ACell and ACell agrees to purchase from Supplier Bladders from ACell Compliant pigs at the price listed on Attachment A to this Agreement, which is incorporated by reference.

 

3.                                      Supplier Obligations:

 

3.1                   Supply shall fulfill all of the obligations set forth in the QTA.  If there are any direct conflicts between the terms of this Agreement and the QTA, this Agreement shall prevail for any supply and business concerns and the QTA shall prevail for all quality-related concerns.

 

3.2                   Supplier has and will maintain at all times while this Agreement is in force, and for a period of 7 years after this Agreement expires or is terminated, a product liability insurance policy providing at least [*] Dollars [*] coverage per occurrence and [*] Dollars [*] aggregate coverage per policy year.  This policy shall identify ACell as a named insured and shall provide, by endorsement or otherwise, coverage to ACell for any claim, relating to ACell specification [*] compliance and the safety of Bladders provided by Supplier under this Agreement for use in ACell products to the extent such claim is related to Supplier’s conduct.  Supplier shall furnish ACell with acceptable certificates evidencing such insurance coverage within thirty (30) days of the execution of this Agreement.  Supplier shall provide ACell with written notice at least thirty (30) days prior to the cancellation, non-renewal or material change in such insurance.  Notwithstanding any other term of this Agreement, if Supplier does not obtain replacement insurance providing comparable coverage within such thirty (30) day period, ACell shall have the right to terminate this Agreement effective at the end of such thirty (30) day period without notice of any additional waiting periods.

 

3.3                   Supplier guarantees that no article sold to ACell pursuant to this Agreement is adulterated or misbranded within the meaning of the Federal Food, Drug and Cosmetic Act, or is an article which may not under the provisions of Sec. 404 or 505 of that Act be introduced into interstate

 

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commerce.  Supplier guarantees that no article sold to ACell pursuant to this Agreement is produced in violation of any provisions of the Fair Labor Standard Act.

 

3.4                   Supplier agrees to comply with the applicable provisions of any Federal or State law and all executive orders, rules and regulations issued thereunder, whether now or hereafter in force; and any provisions, representations or agreements required thereby to be included in any purchase order under this Agreement are hereby incorporated by reference, including but not limited to, Executive Order 11246, as amended, Chapter 60 of Title 41 of the Code of Federal Regulations prohibiting discrimination against any employee or applicant for employment because of race, color, religion, sex, or national origin; Section 60-741, as amended, Chapter 60 of Title 41 of the Code of Federal Regulations prohibiting discrimination against any employee or applicant for employment because of physical or mental handicap; and Section 60-250.4 of Chapter 60 of 41 Code of Federal regulations, as amended, providing for the employment of disabled veterans and veterans of the Vietnam era.

 

3.5                   Supplier further guarantees full compliance with all applicable provisions of any other Federal and all state and municipal laws.

 

3.6                   Supplier agrees that [*].

 

4.                                      ACell’s Representations and Warranties:

 

4.1                   On a monthly basis, ACell will provide Supplier a rolling forecast [*]

 

4.2                   ACell will assume all liability, save those representations made by Supplier in this Agreement or its attachments, for all ACell products made with Bladders.

 

4.3                   Non Interference:  Except to the extent reasonably necessary to enforce ACell’s rights under this Agreement, ACell agrees not to interfere in any way with Supplier’s ability to market and/or sell pigs or porcine products, including but not limited to porcine bladders, to other purchasers.

 

4.4                   Indemnity:  ACell shall indemnify and hold harmless Supplier from any liability to a third party which may arise from this Agreement, except for claims based on or related to Supplier’s breach of its obligations under this Agreement.  ACell has and will maintain at all times while this Agreement is in force, and for a period of [*] after this Agreement expires or is terminated, general liability insurance policy providing at least [*] Dollars [*] coverage per occurrence and [*] Dollars [*] aggregate coverage per policy year.  This policy shall identify Supplier as a named insured and shall provide, by endorsement or otherwise, coverage to Supplier for any and all claims, demands, liabilities, damages, losses, costs and expenses, relating to Supplier.  ACell shall furnish to Supplier with acceptable certificates evidencing such insurance coverage within thirty (30) days of the execution of this Agreement.  ACell shall provide Supplier with written notice at least thirty (30) days prior to the cancellation, non-renewal or material change in such insurance.  Notwithstanding any other term of this Agreement, if ACell does not obtain replacement insurance providing comparable coverage within such thirty (30) day period, Supplier shall have the right to terminate this Agreement effective at the end of such thirty (30) day period without notice of any additional waiting periods.

 

5.              [*]

 

6.              Invoice Payment:   Bladders shall be delivered to ACell at the slaughter plant (identified on Attachment B hereto) where the ACell Compliant pigs are processed.  ACell will use best efforts to email the completed inspection report relating to that shipment of Bladders within [*] after ACell takes delivery of the Bladders, and will add the number of  accepted Bladders to a purchase order.  Supplier shall use that purchase order to prepare an invoice to ACell for such delivery, which invoice

 

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may be transmitted to ACell, at Supplier’s discretion, by email or U.S. mail.  Payment shall be due from ACell [*] after receipt of invoice.  Payment of all invoices shall be made by check or other form for payment agreed upon by the parties.

 

7.              Shipping:  Supplier will pay all costs of transporting and shipping ACell Compliant pigs to the slaughter plant identified on Attachment B.  ACell will take delivery of Bladders at the slaughter plant unless otherwise mutually agreed.

 

8.              Assignment:  Except for an assignment by either party to an entity under common control with, controlled by or which controls that party or to an entity that merges with or purchases that party or substantially all of that party’s assets, ACell and/or Supplier shall not have the right to assign this Agreement without the other party’s prior written consent, which shall not be unreasonably withheld.

 

9.              Obligation to Purchase:  ACell shall not be required to accept or purchase any pig bladders that are defective, Diseased, damaged or otherwise unsuitable for processing by ACell.

 

10.       Force Majeure:  A party shall be excused for delays in performance or failure of performance hereunder to the extent arising from causes beyond such party’s control, including without limitation, changes in regulations, strikes, wars, fire, flood, disease, earthquake, or other Acts of God (“Force Majeure Event”).  Force Majeure Event also includes changes in laws or regulations that prevent ACell from purchasing or Supplier from selling Bladders that were harvested in accordance with ACell specification [*] (Bladder Harvesting, Processing, Packaging and Shipping) or ACell specification [*] (Bladder Specifications) or satisfy the requirements of the QTA.  If a party is delayed or prevented from fulfilling any of its obligation due to a Force Majeure Event, that party shall notify the other party promptly of such Force Majeure Event (in no event more than two (2) business days after the party becomes aware of the delay or inability to perform) and shall make diligent efforts to perform at its earliest opportunity.  During any such period of non-performance by one party, the other party shall be permitted to suspend its performance hereunder.

 

11.       Duration of Contract and Termination:

 

11.1.         This Agreement shall commence on the Effective Date and shall continue for a period of three (3) years, unless earlier terminated in accordance with this Section 11.

 

11.2.         Either party may terminate this Agreement following prior written notice to the other party of its intent to terminate as set forth below.

 

11.2.1.           ACell may terminate this Agreement by providing ninety (90) days written notice to Supplier.  In such an event, upon the expiration of ninety (90) days after the date of the notice Supplier shall have no further obligation to provide Bladders to ACell, and ACell shall have no further obligation to purchase Bladders from Supplier.

 

11.2.2.           Supplier may terminate this Agreement by providing one (1) year written notice to ACell.  In that event, Supplier shall continue to provide Bladders to ACell for a period of one (1) year after the date of such notice and upon the expiration of one (1) year after the date of the notice Supplier shall have no further obligation to provide Bladders to ACell, and ACell shall have no further obligation to purchase Bladders from Supplier.

 

11.2.3.           In addition to Sections 11.2.1. and 11.2.2. above, if ACell must change ACell specification [*] ACell specification [*], or the requirements set forth in the QTA to this Agreement, in order to ensure that the Bladders provided by Supplier remain eligible for medical use and the parties cannot resolve the issue in accordance with Section 3.4 above, upon 90 days prior written notice to Supplier, ACell may terminate

 

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this Agreement in its entirety and shall have no further obligation to purchase Bladders from Supplier.

 

11.2.4.           This Section 11.2 should not be interpreted to limit any other legal or equitable remedies to which the non-breaching party may be entitled in the event of a termination for cause.

 

12.       Limitation of Liability:  Supplier’s liability to ACell for product liability claims shall be limited to the amounts of insurance coverage specified in Section 3.5 above.  TO THE EXTENT ALLOWABLE BY LAW, IN NO EVENT SHALL ANY PARTY HEREUNDER BE LIABLE TO ANY OTHER PARTY HEREUNDER FOR SPECIAL, INCIDENTAL, CONSEQUENTIAL OR INDIRECT DAMAGES ARISING FROM OR IN RELATION TO THIS AGREEMENT (WHETHER IN CONTRACT, TORT, NEGLIGENCE, STRICT LIABILITY, BY STATUTE OR OTHERWISE).  THIS LIMITATION SHALL APPLY EVEN IF SUCH PARTY HAS BEEN ADVISED OR IS AWARE OF THE POSSIBILITY OF SUCH DAMAGES.

 

13.       Notification:  In case of any infectious disease or other unusual occurrence noted or recognized during the raising of the pigs destined for ACell use, Supplier must notify ACell as soon as possible (but in no event later than five (5) business days after such infectious disease or other unusual occurrence is noted or recognized by Supplier).

 

14.       Governing Law; Forum:  This Agreement is governed by the laws of the State of Delaware, exclusive of its choice of law rules.

 

15.       Entire Agreement; Waiver, Modifications and Amendments:  This Agreement (along with applicable Attachments) is the entire agreement between the parties with respect to its subject matter, and there are no other terms  or conditions, expressed or implied, written or oral, with respect to that subject matter.  This Agreement supersedes all prior oral or written representations, agreements, promises, or other communications concerning or relating to the subject matter of this Agreement.  This Agreement may not be amended or modified except by a written agreement signed by an officer of each party.  No term, condition or provision of any purchase order, invoice or other form is effective as a modification of this Agreement.

 

16.       Non-Exclusivity:  The parties acknowledge and agree that the relationship between ACell and Supplier described herein shall be non-exclusive and that either party may enter into a similar arrangement with any other party during the term of this Agreement and/or after the termination hereof.

 

17.       Legal Proceedings:  If Supplier is requested or authorized by ACell or required by government regulation, subpoena, or other legal process to produce documents or Supplier’s personnel as witnesses with respect to ACell’s processing of the Bladders, ACell will, so long as Supplier is not a party to the proceeding in which the information is sought, reimburse Supplier for Supplier’s reasonable professional time and expenses, including reasonable outside counsel fees.  To the extent any professional time and expenses exceed [*] Supplier and ACell shall work together to determine a mutually agreeable amount for such time and expenses and reduce any such amount to writing.  For purposes of this Agreement, professional time shall be calculated by multiplying the number of hours worked by a Supplier employee by that employee’s pro-rated hourly rate (derived from that employee’s base salary).  Supplier shall submit to ACell itemized invoices for any professional time and expenses for which Supplier seeks reimbursement under this Section 17.

 

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Accepted and Agreed:

 

	
CLEMENS   FOOD GROUP, LLC
    	
 
    	
ACELL, INC.
    
	
 
    	
 
    	
 
    
	
By:
    	
[*]
    	
 
    	
By:
    	
/s/ Miles Grody
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Print Name:
    	
[*]
    	
 
    	
Print Name:
    	
Miles Grody
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Title:
    	
Sr. Vice President
    	
 
    	
Title:
    	
SVP/General Counsel
    

 

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Attachment A

to Supply Agreement for Porcine Urinary Bladders between Clemons Food Group, LLC and ACell, Inc.

 

Pricing Schedule and Slaughter Plant Location

 

The price for Bladders to be paid by ACell to Supplier is [*] per acceptable Bladder.  The term “acceptable Bladder” shall mean a Bladder that is not defective, Diseased, damaged, a rejectable Bladder (as set forth in ACell specification [*], or otherwise unsuitable for processing by ACell.  The price is all inclusive and includes, without limitation, taxes and all applicable Supplier costs.

 

Supplier’s slaughter plant is located at:

 

Clemens Food Group, LLC

2700 Clemens Road

Hatfield, PA  19440

 

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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO ACELL, INC. IF PUBLICLY DISCLOSED.

 

First Amendment

to the

Supply Agreement for Porcine Urinary Bladders between

Clemens Food Group, LLC. and ACell, Inc.

 

This Amendment, effective November 1, 2019 (the “First Amendment Effective Date”), amends the Supply Agreement for Porcine Urinary Bladders, effective November 1, 2016 (“Agreement”) between Clemens Food Group, LLC (“Supplier”) and  ACell, Inc. (“ACell”).  Capitalized terms used in this Amendment shall have the same meaning as in the Agreement unless otherwise expressly indicated in this Amendment.

 

Background

 

The purpose of this Amendment is to extend the term of the Agreement.

 

Terms and Conditions

 

1.  The Parties agree that the term of the Agreement shall be extended for three (3) years.  The new termination date for the Agreement is October 31, 2022, unless earlier terminated in accordance with Section 11 of the Agreement.

 

2.  This Amendment and the Agreement constitute the entire agreement between the parties with respect to its subject matter, and there are no other agreements written or oral, expressed or implied.  If there is any conflict between the terms of the Agreement and the terms of this Amendment, the terms of this Amendment will prevail.  Except as modified in this Amendment, the Agreement remains in full force and effect in accordance with its terms.

 

Accepted and agreed:

 

	
ACell, Inc.
    	
 
    	
Clemens   Food Group, LLC
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
/s/ Christopher Branch
    	
 
    	
[*]
    
	
Signature
    	
 
    	
Signature
    
	
 
    	
 
    	
 
    
	
Christopher Branch | General Counsel
    	
 
    	
[*]
    
	
Printed Name/Title
    	
 
    	
Printed Name/Title
    
	
 
    	
 
    	
 
    
	
10/11/19
    	
 
    	
10/11/19
    
	
Date
    	
 
    	
Date
    

 

1Exhibit 10.16

 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO ACELL, INC. IF PUBLICLY DISCLOSED.

 

PROCESSING AGREEMENT

 

THIS AGREEMENT (“Agreement”) is between Synergy Health AST, LLC., including its affiliates,  (“STERIS”), with headquarters at 5960 Heisley Road, Mentor, Ohio 44060, and ACell, Inc. (“Customer”), having a principal place of business at 6640 Eli Whitney Drive, Columbia, Maryland 21046.

 

WHEREAS, Customer seeks to have certain medical devices (“Product” or “Products”), processed with radiation and STERIS is in the business of operating various radiation processing facilities (the “Facilities”); and

 

WHEREAS, the Food and Drug Administration (“FDA”) has recognized that it is a common industry practice to manufacture and/or assemble, package and fully label a device as sterile at one establishment and then ship such device in interstate commerce to another establishment or to a contract sterilizer for processing; and

 

WHEREAS, the FDA will institute no regulatory action against the device as misbranded or adulterated during such shipment when the device is labeled sterile, provided the requirements of 21 C.F.R. § 801.150 are met.

 

NOW THEREFORE, in consideration of the agreements hereinafter set forth, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereby agree as follows:

 

1.             INTENT OF THE PARTIES.  It is the intention of the parties hereto to adhere to all of the requirements of the FDA, including 21 C.F.R.  § 801.150.

 

2.             PRODUCT HANDLING.

 

(a)           Both Customer and STERIS acknowledge that Products transported from Customer to STERIS pursuant to this Agreement are non-sterile and are being shipped for further processing.

 

(b)           All Products shipped by Customer to STERIS shall be conspicuously marked “Non-Sterile — Shipped for Further Processing” or the equivalent and shall not be identified as sterile until the Products are established as sterile after treatment by methods specified by the Customer. The provisions of this paragraph shall apply during all times when the Product is introduced into or moving in intrastate or interstate commerce, during processing, and when held in quarantine.

 

(c)           Each shipment of the Product for processing will be accompanied by documents (packing list and/or bill of lading) stating the number of cartons or other designated units in the shipment listed by manufacturer’s lot and code number and the non-sterile nature of the Product. Upon receipt and prior to processing, STERIS will record on its receiving documents the number of cartons or other designated units by manufacturer’s lot and code number received from Customer. STERIS will notify Customer of all count discrepancies and the parties shall ensure that

 

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all such discrepancies are reconciled before processing.

 

(d)           STERIS will segregate unprocessed Products from processed Products, to prevent accidental mixing of Products. STERIS will also segregate Customer’s Products from all other products stored at the STERIS Facility.

 

(e)           After completion of processing and until released by the Customer, the Product will be conspicuously marked by STERIS in the following way: each pallet, carton or other designated unit will show that the Product is “Processed” or the equivalent. Labels with such markings will be provided by STERIS.

 

(f)     After radiation processing, STERIS will return all cartons or other designated units to the Customer’s address or to a controlled destination point selected by the Customer.

 

(g)           Except as otherwise agreed by STERIS and Customer, Products will be shipped in the same manner as received.

 

3.             PROCESSING.

 

(a)           All Product processing will occur in accordance with a set of processing specifications (“Procedures”).  Customer will develop Procedures, which shall be in writing and shall clearly state minimum and maximum dose limitations, instructions regarding product counts, and handling, shipping, receiving, and special processing requirements. STERIS may accept or reject the Procedures, but no processing will occur until STERIS and Customer agree in writing to the applicable Procedures.  STERIS’s approval of the Procedures is limited to confirmation of its ability to process to the specifications and is not an approval or determination of the efficacy of the dose which is solely the responsibility of Customer.

 

(b)           Customer shall provide and STERIS shall process Products in volumes summarized in Appendix A, “Processing Volumes,” which is hereby incorporated into this Agreement.   If, at any time, STERIS determines that the demand for certain processing exceeds the supply, then STERIS shall allocate the supply in a manner which STERIS shall determine in its reasonable discretion.  Notwithstanding anything in this Agreement, STERIS shall process all Products within five (5) business days after receipt.

 

(c)           Customer shall bear sole responsibility for determining the compatibility of Products and packages with the radiation process and for determining the radiation dosage(s). The Customer shall ship Product to STERIS in cases that are the same dimensions, weight, and internal packing configuration as qualified by STERIS. The Customer shall notify STERIS of any changes to the Product, its materials, packaging or configuration. STERIS will not be responsible for non-sterile or damaged Product because of changes made to Products. All tests related to the processing of the Products are the responsibility of Customer.

 

(d)           After STERIS receives all required Products and documentation, STERIS will complete processing within such time frame as agreed by the parties.

 

(e)           STERIS will inform the Customer, in writing, of any changes or modifications to the processing equipment which may impact routine processing or validation. STERIS will notify the Customer of deviations from the Procedures and the Customer will direct STERIS as to the

 

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disposition or reprocessing of those affected Products.

 

(f)            All tests related to assessing the final sterility assurance of the Products are solely the responsibility of the Customer. Release of the sterilized Product to the market is the sole responsibility of the Customer. Customer shall develop appropriate procedures for approving the sterilized Products for release into the stream of commerce. Such procedures shall be designed to prevent the release of any Product for commercial distribution until Customer’s designated representative shall properly approve the Product’s release. Customer bears ultimate and full responsibility for Products released into commercial distribution, including labeling of Products as sterile.

 

(g)           Except for Products sent to STERIS for test purposes (which shall be clearly labeled “FOR TESTING PURPOSES ONLY”), the Customer warrants to STERIS that Products sent for services can be processed without violating any government regulations.

 

4.             TITLE TO PRODUCTS.  Customer shall retain title to the Products at all times.

 

5.             AUDITS.  STERIS will allow the Customer access to the Facilities, upon reasonable notice and subject to STERIS’s restrictions of confidentiality, during normal business hours, for the purpose of conducting QSR/ISO/EN audits related to the processing of the Products.    STERIS will also make training records available to Customer during such audits, provided Customer requests such records reasonably in advance of the audit. STERIS will conduct periodic internal audits according to STERIS’s QSM/QA Manual. STERIS will retain confirmation that it performed these internal audits, and Customer may review the confirmation upon reasonable prior notice. Customer shall keep confidential all information revealed to it during its audit of STERIS.  The parties agree that notified bodies of the Customer are permitted to perform unannounced audits when necessary.

 

6.             TERM AND TERMINATION.  The initial term of this Agreement shall be for a period of three (3) years from the date of execution by both parties (the “Initial Term”). Either party shall have the right to terminate this Agreement at any time upon sixty (60) days written notice if the other party is materially in default with respect to any of its obligations hereunder, and such default is not cured within sixty (60) days of notice to the defaulting party.

 

7.             RIGHT OF FIRST REFUSAL.  If, at any time during the term of this AgreementCustomer receives an offer from a third party for the provision of processing or other sterilization services which are: (a) not covered by this Agreement; or (b) to begin subsequent to the termination of this Agreement, then Customer shall notify STERIS, in writing, of the offer’s material terms, conditions and associated charges. If within fifteen (15) days of receiving written notice, STERIS makes an offer to Customer upon more favorable terms and conditions, with charges less than those offered by the third party, then Customer shall contract with STERIS for the provision of such services.

 

8.             REQUIREMENTS.   Customer agrees that STERIS will perform, pursuant to this Agreement, one hundred percent (100%) of Customer’s radiation sterilization processing requirements as set forth in Appendix A during the term of the Agreement. Customer will use its best efforts to ensure that such processing will be requested of STERIS at a uniform monthly rate.

 

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9.             REMOVAL AND STORAGE; SHIPPING.

 

(a)           STERIS shall provide, at no extra charge to Customer, sufficient storage space for all processed Product for not more than three (3) calendar days from completion of processing. Thereafter, STERIS shall have the option of removing Customer’s Product via common carrier or other means to an alternate facility designated by Customer, or of charging Customer for storage for each day in excess of the aforementioned three (3) days.

 

(b)           The Customer shall pay all shipping costs. STERIS will not be responsible for any shipping damage or delay.

 

10.          CHARGES AND TERMS OF PAYMENT.

 

(a)           The charges for the processing of Customer’s Products pursuant to the Procedures are set forth in Appendix B, “Processing Charges.” Customer shall have full and sole responsibility for all charges. Invoices will be rendered upon shipments made against a blanket order issued to STERIS by the Customer. Taxes, if applicable, are not included in the prices and shall be paid by the Customer.

 

(b)           Payments shall be due thirty (30) calendar days from the date of invoice. All payments shall be made in United States dollars. Any amount not paid when due shall bear interest at one and one-half percent (1- l/2%) per month (18% per annum) or the highest lawful rate, if less, from the date due until paid.

 

11.          NOTICES. All communications related to the terms of this Agreement or communication seeking approval for changes in any procedures covered thereby shall be in writing and shall be personally delivered or sent by registered or certified mail, postage prepaid, to the address indicated below, or to such other address as to the addressee shall have designated by notice given to the other party hereto, and shall be effective when received.

 

If to STERIS:

 

	
[*]
    	
cc:
    	
Kenneth   E. Kohler
    
	
[*]
    	
 
    	
Vice   President and General Manager
    
	
[*]
    	
 
    	
STERIS   Applied Sterilization Technologies
    
	
[*]
    	
 
    	
5960   Heisley Road
    
	
 
    	
 
    	
Mentor,   Ohio 44060
    
	
 
    	
 
    	
 
    
	
If to Customer:
    	
 
    	
 
    
	
Chris   Kinniry
    	
cc:
    	
ACell, Inc.
    
	
ACell, Inc.
    	
 
    	
Attn:   General Counsel
    
	
6640   Eli Whitney Drive
    	
 
    	
6640   Eli Whitney Drive
    
	
Columbia,   Maryland 21046
    	
 
    	
Columbia,   Maryland 21046
    

 

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12.          CONFIDENTIALITY; OWNERSHIP OF INTELLECTUAL PROPERTY.

 

(a)          The parties acknowledge and agree that in connection with the services provided under this Agreement valuable technical or marketing information of a confidential nature may be exchanged by the parties; that such information will be retained by the receiving party in confidence; that the transmittal of such information by a disclosing party is upon the condition that the information is to be used solely for the purpose of effectuating the Agreement; and that the receiving party shall not, either during the term of the Agreement or after its termination, use, publish, or disclose any technical or marketing information supplied by the disclosing party.  This restriction on disclosure and use shall not apply to any information which the receiving party can show by written evidence was known to it through proper means at the time of receipt thereof from the disclosing party, or which may subsequently be obtained from sources other than the disclosing party who are not bound by a confidentiality agreement with Customer or STERIS.

 

(b)           The parties acknowledge and stipulate that the covenants and agreements contained herein are of a special nature and that any breach, violation, or evasion by it of the restrictions of disclosure and use contained in this Agreement (i) may result in damages to the disclosing party in amounts difficult to ascertain; and (ii) may give rise to irreparable injury to the disclosing party. Accordingly, the parties agree that the disclosing party has a right to sue and is entitled to seek equitable relief, including, without limitation, injunctive relief and specific performance, in addition to any other legal remedies that may be available. In the event of any breach, violation, or evasion of the restriction on disclosure and use contained in this Agreement, the disclosing party shall be entitled to recover reasonable legal fees and all costs and expenses associated with the enforcement of any provision hereof or of the Agreement.

 

(c)           STERIS shall retain all trademark, copyright, trade secret, and patent rights which it may have with respect to the processing. Customer shall retain all trademark, copyright, trade secret, and patent rights it may have with respect to the Products.  Neither party shall use the trademark or tradename of the other party or its parents or affiliates in its company name or for otherwise conducting business with its customers.

 

13.          WARRANTY; LIMITATION OF LIABILITY.

 

(a)           STERIS warrants only that Products shall be processed in accordance with Customer specifications, as accepted by STERIS. STERIS’s obligation under this warranty shall be limited to the reprocessing of Products not processed in accordance with such specifications. EXCEPT AS SET FORTH ABOVE, STERIS MAKES NO REPRESENTATION OR WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

 

(b)           STERIS SHALL NOT BE RESPONSIBLE FOR LOSS OF USE, LOSS OF INCOME OR PROFITS, COST OR RENTAL OF A SIMILAR PRODUCT, OR ANY OTHER CONSEQUENTIAL OR INCIDENTAL DAMAGES OF ANY KIND WHATSOEVER, WHETHER DUE TO BREACH OF CONTRACT OR WARRANTY OR TORT, INCLUDING NEGLIGENCE OF STERIS OR STRICT LIABILITY, OR ANY OTHER CAUSE. In the event STERIS fails to process any Products as agreed, or any Products are damaged or destroyed due to the fault of STERIS, STERIS’s liability shall be limited to the lesser of the manufacturing cost of

 

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the Products, or ten (10) times the processing charge. However, if the Products can only be processed one (1) time, Customer must designate this in writing prior to processing and STERIS’s liability regardless of cause or circumstance related to such Products shall be limited to the original processing cost only.

 

14.          INDEMNITY.       Customer agrees to defend, indemnify, and hold harmless STERIS from any and all third party claims, liability, damages or expenses due to personal injury or property damage, arising from Customer’s negligence or breach of contract, except to the extent caused by STERIS’s negligence or breach of contract.  Subject to the Limitations of Liability set forth above, STERIS agrees to defend, indemnify, and hold harmless Customer from any and all third party claims, liability, damages or expenses due to personal injury or property damage arising from STERIS’s negligence or breach of contract, except to the extent caused by Customer’s negligence or breach of contract.

 

15.          MISCELLANEOUS.

 

(a)           If any provision of this Agreement shall be held invalid by a court of competent jurisdiction, such invalidity shall not affect any other provision which can be given effect without the invalid provision.

 

(b)           The delay or failure of either party to require performance by the other party, or the waiver of a breach of any provision of this Agreement by either party, will not affect such party’s right to subsequently require performance of any provision of this Agreement.

 

(c)           The headings are inserted in the Agreement only as a matter of convenience and for reference and are not intended to define, limit, or describe the scope of the Agreement nor the intent of any of its provisions.

 

(d)           The Agreement represents the complete agreement, understanding and obligation between the parties concerning its subject matter and supersedes all previous negotiations, representations, commitments and agreements, whether written, oral or implied, relating to its subject matter. No change, amendment or modification of this Agreement shall be effective unless made in writing and signed by both parties.  Any terms in Customer’s purchase order or any other document of order or acceptance which are different from or additional to this Agreement shall be of no force and effect.  No course of dealing, or custom or usage, which is contrary to this Agreement shall serve to modify the terms of this Agreement.

 

(e)          Neither party shall be liable for either its failure to perform or its delays in performance hereunder arising out of or resulting from causes beyond its control. Such causes includes but are not restricted to acts of God, acts of Government or the public enemy, fires, floods, epidemics, power disruptions, equipment failure, quarantine restrictions, strikes, freight embargoes, unusually severe weather or default of suppliers due to any such causes.

 

6

 

(f)            The relationship between the parties is that of vendor and independent contractor. Neither the Customer nor any of its officers, directors, agents, or employees shall be considered as an agent or employee of STERIS. In performing obligations and accepting benefits under this Agreement, Customer acts on its own account and has no authority or power to bind or to create any express or implied obligation on STERIS’s behalf.

 

(g)           Neither party shall assign this Agreement, or any of the rights or privileges contained in this Agreement, to any third party without the written consent of the other party which shall not be unreasonably withheld. STERIS may assign its rights and duties hereunder to an affiliate of STERIS.

 

(h)           The Agreement and the relationship between the parties shall be governed by and interpreted in accordance with the laws of the State of Ohio.

 

IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their duly authorized representatives.

 

	
Synergy Health AST, LLC.
    	
 
    	
ACell, Inc.
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/   Kenneth E. Kohler
    	
 
    	
By:
    	
/s/   Christopher Branch
    
	
 
    	
(Signature)
    	
 
    	
 
    	
(Signature)
    
	
 
    	
Kenneth   E. Kohler
    	
 
    	
 
    	
Christopher   Branch
    
	
 
    	
(Print Name)
    	
 
    	
 
    	
(Print Name)
    
	
Title:
    	
VP   and General Manager, STERIS
    	
 
    	
Title:
    	
General   Counsel
    
	
 
    	
Applied   Sterilization Technologies
    	
 
    	
 
    	
 
    
	
Date:
    	
October 19,   2018
    	
 
    	
Date:
    	
Sept.   28, 2018
    

 

7

 

APPENDIX A

PROCESSING VOLUMES

 

E-Beam Processing:

 

[*]

[*]

[*]

[*]

 

CUSTOMER REQUIREMENTS

 

[*]

 

E-Beam Processing:

 

[*]

 

	
Company Name
    	
 
    	
Product Description
    	
 
    	
Cases 
   Per 
   Shipment
    	
 
    	
Total Yearly 
   Carriers for all 
   products
    	
 
    	
Total Carriers 
   Per month
    
	
ACell
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    

 

	
[*]
    	
 
    	
Product   Description
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    
	
[*]
    	
 
    	
Micromatrix
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    
	
[*]
    	
 
    	
Cytal   Wound Matrix
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    
	
[*]
    	
 
    	
Surgical   Matrix
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    
	
[*]
    	
 
    	
Surgical   Matrix Thick
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    
	
[*]
    	
 
    	
Gentrix   Surgical Matrix
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    

 

8

 

APPENDIX B

PROCESSING CHARGES

 

Description: E-Beam Processing

 

[*]

 

Product may be added through the Customer Specifications. Such additions will not require execution of a new contract but will be considered an addendum to this contract. Customer and STERIS will mutually agree upon pricing for new products.

 

On the first anniversary date of this Agreement, and on each anniversary date thereafter, [*].

 

[*].

 

9

 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO ACELL, INC. IF PUBLICLY DISCLOSED.

 

FIRST AMENDMENT TO
 PROCESSING AGREEMENT

 

THIS FIRST AMENDMENT TO PROCESSING AGREEMENT (“Amendment”) is made on October 23, 2019, between Synergy Health AST, LLC., including its affiliates, (“STERIS”), with headquarters at 5960 Heisley Road, Mentor, Ohio 44060, and ACell, Inc. (“Customer”), having a principal place of business at 6640 Eli Whitney Drive, Columbia, Maryland 21046.

 

WHEREAS, STERIS and Customer executed a Processing Agreement on or about October 18, 2018 (the “Agreement”) pursuant to which STERIS performs processing services for Customer; and

 

WHEREAS, the parties desire to [*].

 

NOW THEREFORE, in consideration of the agreements hereinafter set forth, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereby agree as follows:

 

l.              Appendix A of the Agreement is hereby replaced in its entirety with the Appendix A attached to this Amendment.

 

2.             Appendix B of the Agreement is hereby replaced in its entirety with the Appendix B attached to this Amendment.

 

3.             All other terms and conditions of the Agreement not specifically amended hereby shall remain in full force and effect.

 

IN WITNESS WHEREOF, the parties have caused this First Amendment to Processing Agreement to be executed by their duly authorized representatives.

 

	
Synergy Health AST, LLC
    	
 
    	
ACell, Inc.
    
	
By:
    	
/s/ Kenneth Kohler
    	
 
    	
By:
    	
/s/ Christopher F. Branch
    
	
 
    	
 
    	
 
    
	
Kenneth Kohler
    	
 
    	
Christopher F. Branch
    
	
(Print Name)
    	
 
    	
(Print Name)
    
	
 
    	
 
    	
 
    
	
Title:
    	
VP & GM
    	
 
    	
Title:
    	
General Counsel
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Date:
    	
10/23/2019
    	
 
    	
Date:
    	
10/18/2019
    
							

 

1

 

APPENDIX A

PROCESSING VOLUMES

 

E-Beam Processing:

 

[*]

 

CUSTOMER REQUIREMENTS

 

Customer’s Volume Requirements:

 

E-Beam Processing:

 

An estimated volume of units annually to process at E-beam facility with additional volumes processed on a commercially reasonable basis.

 

	
Company Name
    	
 
    	
Product Description
    	
 
    	
Cases Per
   Shipment
    	
 
    	
Total Yearly
   Carriers for all
   products
    	
 
    	
Total Carriers
   per month
    
	
ACell
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    

 

	
[*]
    	
 
    	
Product Description
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    
	
[*]
    	
 
    	
Micromatrix
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    
	
[*]
    	
 
    	
CytalWound Matrix
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    
	
[*]
    	
 
    	
Surgical Matrix
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    
	
[*]
    	
 
    	
Surgical Matrix Thick
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    
	
[*]
    	
 
    	
Gentrix Surgical Matrix
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    	
 
    	
[*]
    

 

2

 

APPENDIX B

PROCESSING CHARGES

 

Description:  E-Beam Processing

 

[*]

 

3

 

[*]

 

On the first anniversary date of this Agreement, and on each anniversary date thereafter, [*]

 

Product may be added through the Customer Specifications. Such additions will not require execution of a new contract but will be considered an addendum to this contract. Customer and STERIS will mutually agree upon pricing for new products.

 

[*]

 

4

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