GENESIS MEDICAL PLASTICS LTD. CO. SUPPLY AGREEMENT WITH MEDICAL DEVICE MANUFACTURER

This Agreement is entered into, by and between the Medical Device Manufacturer located at and Genesis Medical Plastics Ltd. Co. located at 14863 Grant Road, Cypress, Texas, 77429.

GMP and Converter agree as follows:

1. Order: Orders for services and the sale of products (collectively “Products”) to be provided by Genesis Medical Plastics Ltd Co. (“GMP”) to its customers (each an “MDM”) are subject to acceptance by GMP and will be governed by the following terms and conditions and any additional terms agreed in writing by an authorized representative of GMP (collectively the “Agreement”).

2. Delivery and Payment: As long as raw materials are available and GMP is able to supply, GMP shall deliver Products to MDM, F.O.B. GMP Cypress, Texas. MDM shall pay to GMP in USD for Products plus actual shipping costs. Payment to be made within terms agreed in the Order. All Product sales shall be made within the United States of America, title and risk of loss shall pass to MDM as soon as the Products depart GMP Cypress, Texas facility. MDM shall pay all applicable customs, excise, import and other duties related to the MDM’s shipment of Products outside the United States of America.

3. Use: The application area is and the devices are generally described as . This agreement applies to devices of this type with this MDM only. A new agreement is required for all new applications.

4. Non-Compete: The parties are encouraged to communicate openly to shorten timelines, improve outcomes and reduce costs. We recognize that sensitive MDM commercial information may be shared between parties. No information obtained from MDM will be used by GMP to compete with MDM in the aplication(s) they serve nor equip others to do the same. Keeping in mind that as a materials supplier, GMP, MDM’s and Converters may compete in markets and applications, but will do so without influence, information or favor from GMP.

5. Safety/Efficacy: It shall be the MDM’s sole and ultimate responsibility to determine the safety and efficacy of use of the Products, including Biomaterials, for their specific application. It is the MDM’s exclusive responsibility to satisfy itself that the use to which the Product is to be put will not infringe the rights (including, without limitation, the intellectual property rights) of any third party. GMP does not, and has not, designed, specified or sold any implantable device.

6. Samples and Test Products - Limited Use: Products, including Biomaterials, supplied to MDM for evaluation and testing are for the sole limited purpose of the development and testing of MDM’s medical device/product. Unless supplied and sold for implant use, HUMAN IMPLANTATION OF THESE MATERIALS IS FORBIDDEN. MDM shall not sell or otherwise transfer any test or limited use product to any third party without written and acknowledged statement regarding NOT FOR IMPLANT USE.

7. Warranties: GMP warrants to MDM that the Products, including Biomaterials, shall conform to GMP’s published specifications as of the Order date or the specifications agreed to in writing by GMP and MDM.

In the event GMP is to provide Products to MDM based upon MDM’s specific request that GMP assist in the development, manufacture, testing or use of Products that are intended to satisfy a unique need identified by MDM and are not “standard” Products of GMP, MDM hereby recognizes and agrees that the specialty Products being provided do not necessarily have or contain the same or similar characteristics as GMP’s “standard” Products. In developing, manufacturing, testing and putting to use any specialty Products, GMP will be relying upon information and specifications provided by MDM relating to the unique needs of MDM. As such, GMP shall have no responsibility for the design, manufacture or engineering of any such specialty Products, even though GMP may have participated in the development and manufacture of the specialty Products, or for any MDM-furnished materials, information and specifications.

If any of the Products, excluding “Developments” (defined as mutual collaboration for potential future products not currently commercially available) to conform to the specifications, and MDM notifies GMP in writing of such failure within sixty (60) days, then MDM’s exclusive remedy and GMP’s sole liability under this warranty shall be, and is limited to, the repayment of any applicable purchase price paid to GMP for such Products or at the option of the MDM, the provision of replacement Products in like quantity as soon as reasonably practical after receipt of written notice of such failure. Developments are for the sole account of the MDM.

EXCEPT FOR THE FOREGOING LIMITED WARRANTIES, GMP MAKES NO WARRANTY, INCLUDING, WITHOUT LIMITATION, NO IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR OF PATENT NON-INFRINGEMENT, WHICH ARE EXPRESSLY DISCLAIMED, WHETHER EXPRESS OR IMPLIED, IN FACT OR BY LAW, GMP SHALL HAVE NO FURTHER OBLIGATION OR LIABILITY WITH RESPECT TO THE PRODUCTS. GMP WARRANTY OBLIGATIONS ARE NON-TRANSFERABLE AND GMP DISCLAIMS ANY WARRANTY TO ANY THIRD PARTY. GMP SHALL NOT BE LIABLE FOR ANY GENERAL, DIRECT, INDIRECT, CONSEQUENTIAL, PUNITIVE, OR INCIDENTAL DAMAGES RELATING TO THE PRODUCTS OR SERVICES PROVIDED UNDER THIS AGREEMENT.

8. Definitions, Liabilities, Releases and Indemnification:

  1. In this Agreement (i) “GMP Indemnitees” means GMP, its parent, subsidiary and affiliated or related companies; resin suppliers; and the owners, members, officers, directors, employees, consultants, insurers and agents of all of the foregoing; (ii) “CLAIMS” means all claims, demands, causes of action, liabilities, damages, judgments, fines, penalties, awards, losses, costs, expenses (including, without limitation, attorneys' fees and costs of litigation or arbitration) of any kind arising out of, or related to, the Products of GMP or any other performance under this Agreement; (iii) “CONSEQUENTIAL DAMAGES” means any indirect, special, punitive, exemplary or consequential damages or losses (whether foreseeable or not at the date of this Agreement) under applicable law and damages for lost production, lost revenue, lost product, lost profit, lost business, lost business opportunities, regardless of whether the same would be considered indirect, special, punitive, exemplary or consequential damages or losses.
  2. MDM SHALL RELEASE, INDEMNIFY, DEFEND AND HOLD GMP INDEMNITEES HARMLESS FROM AND AGAINST ANY AND ALL CLAIMS ARISING OUT OF OR RELATED TO (I) PERSONAL OR BODILY INJURY, ILLNESS, SICKNESS, DISEASE OR DEATH OF ANY PERSON; (II) LOSS, DAMAGE, RECALL OR DESTRUCTION OF ANY PROPERTY WHICH ATTACH OR INCORPORATE ANY OF THE PRODUCTS PROVIDED BY GMP; (III) ANY VIOLATION OR ALLEGED VIOLATION OF STATUTES, ORDINANCES, LAWS, ORDERS, RULES AND REGULATIONS (INCLUDING, WITHOUT LIMITATION, ANY CLAIMS UNDER FEDERAL, STATE OR FOREIGN LAWS, FDA REGULATIONS FOR MEDICAL DEVICES OR OTHER APPLICABLE STATUTES OR REGULATIONS); AND (IV) ANY CLAIMS FOR CONSEQUENTIAL DAMAGES ASSERTED BY OR IN FAVOR OF MDM AND ANY PERSON, PURCHASER OR USER OF MDM’S PRODUCTS.
  3. THE EXCLUSIONS OF LIABILITY, RELEASES AND INDEMNITIES SET FORTH IN THIS AGREEMENT SHALL APPLY TO ANY CLAIM WITHOUT REGARD TO THE CAUSES THEREOF, INCLUDING BUT NOT LIMITED TO PRE-EXISTING CONDITIONS, WHETHER SUCH CONDITIONS BE PATENT OR LATENT, IMPERFECTION OF MATERIAL, DEFECT OR FAILURE OF PRODUCTS OR MDM’S EQUIPMENT, BREACH OF REPRESENTATION OR WARRANTY (EXPRESS OR IMPLIED), STRICT LIABILITY, TORT, BREACH OF CONTRACT, BREACH OF DUTY (STATUTORY OR OTHERWISE), BREACH OF ANY SAFETY REQUIREMENT OR REGULATION, OR THE NEGLIGENCE, GROSS NEGLIGENCE, WILLFUL MISCONDUCT, OR OTHER LEGAL FAULT OR RESPONSIBILITY OF ANY PERSON, PARTY, OR ENTITY (INCLUDING THE INDEMNIFIED OR RELEASED PARTY), WHETHER SUCH FORM OF NEGLIGENCE BE SOLE, JOINT OR CONCURRENT, ACTIVE OR PASSIVE. REDRESS UNDER THE INDEMNITY PROVISIONS SET FORTH IN THIS AGREEMENT SHALL BE THE EXCLUSIVE REMEDIES AVAILABLE TO THE PARTIES FOR THE CLAIMS COVERED BY SUCH PROVISIONS.
  4. MDM shall furnish to GMP certificates of insurance evidencing insurance in an amount not less than $2,000,000 for the benefit of GMP to support MDM’s indemnity obligations hereunder. To the extent of MDM's release and indemnity obligations hereunder, MDM agrees that all such insurance policies shall (I) include Genesis Medical Plastics, its parent, subsidiary and affiliated or related companies, its subcontractors and resin suppliers, and its and their respective officers,directors, employees, consultants and agents as additional insured; (II) be primary to the GMP's insurance; and (III) be endorsed to waive subrogation against Genesis Medical Plastics, its parent, subsidiary and affiliated or related companies, its subcontractors and resin suppliers, and its and their respective officers, directors, employees, consultants and agents.

9. Governing Law and Arbitration: THIS AGREEMENT SHALL BE GOVERNED BY AND INTERPRETED IN ACCORDANCE WITH THE SUBSTANTIVE LAWS OF TEXAS, EXCLUDING CONFLICTS OF LAW AND CHOICE OF LAW PRINCIPLES. ANY DISPUTE, CONTROVERSY OR CLAIM (“DISPUTE”) ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT OR THE FURNISHING OF PRODUCTS HEREUNDER SHALL BE RESOLVED BY FINAL AND BINDING ARBITRATION CONDUCTED IN ACCORDANCE WITH THE COMMERCIAL RULES OF ARBITRATION OF THE AMERICAN ARBITRATION ASSOCIATION (THE “RULES”). The Tribunal shall consist of three arbitrators, with each party appointing one arbitrator, and the two arbitrators appointing the third arbitrator who shall act as Chair (the “Tribunal”). The seat of arbitration shall be Houston, Texas and proceedings shall be in English. No award shall be made for consequential, punitive, or extra-contractual damages. Judgment upon the Tribunal’s award may be enforced by any court of competent jurisdiction. All statutes of limitation that would otherwise be applicable shall apply to the arbitration proceeding. The right of nondisclosure for confidential or privileged information, including the attorney-client and work product privileges, shall be available in the arbitration. The parties shall treat all matters relating to the arbitration as confidential and not disclose them to third parties. The Tribunal shall provide a reasoned written award.

10. Regulatory Approvals: MDM is responsible for any government or regulatory approvals for the manufacture, sale or use of any Products which may have medical or biomaterial applications. Unless otherwise agreed in writing, all Orders for Products are for raw materials or component parts for use by MDM in the manufacture or assembly of finished products for sale or marketing by the MDM. GMP has no responsibility to secure government or regulatory approval for MDM’s products or services.

11. General: Each party shall maintain all data and information obtained from the other party in strict confidence. It is expressly understood that GMP is an independent contractor, and that neither GMP nor its principals, partners, employees, or subcontractors are servants, agents, or employees of MDM. Failure of MDM or GMP to enforce any of the terms and conditions of this Agreement shall not prevent a subsequent enforcement of such terms and conditions or be deemed a waiver. Should any provision of this Agreement be unenforceable, then the validity of the remaining provisions, and portions thereof, shall not be affected by such unenforceability and this Agreement shall be construed as if such provisions were not included. This Agreement contains all representations of the parties and supersedes all prior oral or written agreements or representations. MDM acknowledges that it has not relied on any representations other than those contained in this Agreement. This Agreement shall not be varied, supplemented, qualified, or interpreted by any prior course of dealing between the parties or by any usage of trade and may only be amended by an agreement executed in writing by both parties. In the event that any conflict exists between the provisions of this Agreement and any other terms and conditions in MDM’s purchase orders, work orders, invoices, statements, or documents used by MDM, the provisions of this Agreement shall govern.

IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by a duly authorized officer, and the Agreement shall take effect on the date the last party executes this Agreement.

Genesis Medical Plastics Ltd. Co. Company:
By: ___________________________________ By:
Name: ________________________________ Name:
Title: _________________________________ Title:
Date: October 2, 2023 Date: October 2, 2023

ISO 13485:2016
14863 GRANT ROAD | CYPRESS, TX 77429 | 281.255.6848 | GENESISMEDICALPLASTICS.COM

Leave this empty:

Signature arrow sign here


Signature Certificate
Document name: GMP and Converter agreement
lock iconUnique Document ID: 3d236f24b1fb5de07ee0db626b6bc1b044597528
Timestamp Audit
June 1, 2023 10:28 am CDTGMP and Converter agreement Uploaded by Cameron Yonts - cameron@genesismedicalplastics.com IP 69.221.250.105
Audit trial Qr code
This audit trail report provides a detailed record of the online activity and events recorded for this document.
https://www.genesismedicalplastics.com/
Audit Trail Serial# c9fbcca78806d0e016b44197a286de44