GENERAL TERMS & CONDITIONS

1. Plymouth Medical LLC will be known as «the Company» in these «Terms & Conditions of Sale».

2. These Terms and Conditions of Sale shall govern all dealings between the Company and purchaser («Purchaser») for the acquisition of equipment, products, hardware, software, data, marketing and/or other intangible materials. The equipment and licensed materials are referred to here as «Products» from the Company and shall be incorporated into all agreements made between the Company and Purchaser, including agreements set out in the Company’s Product Schedules, Quotes and/or Order Forms, whether made in writing or in any other tangible or electronic form. These conditions shall apply in place of and prevail over any terms and conditions contained or referred to in writing by the Company. Without limiting the generality of the foregoing, the Company will not be bound by any standard or printed terms produced by the Purchaser, unless otherwise agreed in writing.

3. Purchaser agrees that ALL SALES ARE FINAL. Full payment is required prior to shipment. There is no provision for a refund for any goods returned or any refusal of delivery or cancellation of the Purchase Order, including events of default clause (13). In the extreme event that a return is approved by the Company then this will incur a thirty percent penalty fee or loss of profit. Refunds will be granted as a credit. Goods remain the property of the Company until all monies owed are paid in full.

4. Delivery is expected within the Company’s and/or manufacturer’s advised current delivery schedule. This is not to be taken as a guaranteed delivery date. The Company shall not be liable for any monetary loss or damages of any kind arising from late delivery or installation of the Goods to the Purchaser.

5. Deliveries of Products shall be to a site specified by Purchaser to the Company. Absent written instructions to the contrary, the Company will select the carrier on behalf of Purchaser but such carrier shall not in any circumstances be construed as an agent of the Company. All shipping charges and insurance costs shall be paid by the Purchaser. If the Company, at its option, elects to pay any such charges on behalf of Purchaser then such charges shall be included in the price shown on the relevant invoice and shall be paid to the Company by Purchaser. Unless otherwise specified in the Purchaser’s purchase order the Company shall be authorized to make deliveries in partial shipments and to submit invoices in respect of each such partial shipment. Estimated time of delivery is three to five days from receipt of Purchasers official purchase order. The Company reserves the right to substitute refurbished medical equipment Products provided the product carries the same warranty as original equipment. When a product is to be delivered to Purchaser over an electronic network including the internet, delivery shall be deemed to have occurred upon transmission of the copy to Purchaser electronically.

6. Risk of loss or damage for Products and/or equipment shall pass to Purchaser upon delivery to Purchaser. Any product damage incurred during transfer must be reported within 7 days of receipt to the Company for replacement. The Company will make reasonable efforts to deliver Products on dates agreed to in the Company’s product schedules and order forms, but will not be liable for any loss or damage whether directly or indirectly from delays in delivery. Risk of loss or damage to Products delivered over an electronic network shall pass to Purchaser upon the transmission of copy to Purchaser electronically.

7. Purchaser acknowledges that nothing herein shall transfer to Purchaser any intellectual or industrial property right (including copyright, trade secret, trademark or patent) for any Products.

8. This agreement shall not be amended except in writing agreed to by both parties and referring specifically to this agreement.

9. Purchaser shall indemnify, defend and hold the Company harmless from and against any and all damages, expenses, liabilities and losses of any kind whatsoever (including, without limitation, attorney’s fees).

10. In no event shall the Company be liable to Purchaser hereunder or in respect of any Products ordered or delivered to Purchaser, whether in contract, not including negligence or otherwise for a loss of profits or loss of use or for any incidental, consequential, special or indirect damages howsoever caused whether or not the Company has been advised of the possibility of such loss or damage.

11. The parties agree to use their best efforts to resolve disputes by negotiation. In the event that a dispute occurs that cannot be re-solved by negotiation between parties, the parties agree to use the services of a mediator to attempt to resolve their differences. This clause does not preclude the parties from taking all necessary legal steps or from taking steps to have their dispute resolved by any other appropriate dispute resolution process, including arbitration or the appropriate Court process.

12. The waiver by a party of a breach of any provision of this agreement shall not operate as nor be construed as a waiver of any subsequent breach thereof.

13. An event of default shall occur upon the happening of any of the following events (i) any non-payment, when due, of any portion of the price or any other sum due to the Company hereunder; (ii) the failure by Purchaser to perform, keep or observe any of the covenants, agreements or other terms of this agreement, or the terms of any other agreement with the Company; (iii) Purchaser becomes insolvent or unable to pay its debts as they mature or become due, or any proceeding is instituted by or against Purchaser alleging that Purchaser is bankrupt, insolvent or unable to pay its debts as they become due; or (iv) the dissolution of Purchaser or the transfer by Purchaser of substantially all of its assets.

14. The effective date of this agreement is the date of execution and continues for a term of two (2) years. This agreement may be terminated as follows (i) by the mutual agreement of the parties, (ii) by either party, with cause, upon sixty (60) days prior written notice to the other party.

15. Purchaser promises to pay for all purchases within the terms agreed. In the event any third parties are employed to collect any outstanding monies owed by the Purchaser, the Purchaser agrees to pay reasonable collection costs, including attorney fees, whether or not litigation has commenced, and all costs of litigation incurred.

16. Purchaser agrees that the Company is the sole source vendor and provider for all EmCyte biologics products and services which Purchaser may require (applicable to EmCyte product purchases only). Purchaser agrees that it will not purchase or receive any point-of-care biologics products or services from other vendors of EmCyte Corporation (or the manufacturer) at any time.

17. Warranty is supplied with the manufacturer’s original warranty. Warranty terms and conditions are provided in the manufacturer’s documentation where applicable.

18. Purchaser shall not assign or transfer or purport to assign or transfer this agreement. This agreement may be assigned by the Company. This agreement shall be binding upon all insure to the benefit of the parties and their respective successors and assigns.

19. Purchaser agrees to allow the Company at the Company’s discretion access to premises to collect any equipment covered in this contract where payments have fallen in arrears. Further should this access not be granted and/or all payments have not been rectified within a further 7 days from the date of notice to recover the goods, the Purchaser further agrees to a default judgment in the court governing this contract along with being liable for costs associated with the recovery action and Court proceedings.

PAC SERVICE DISCLAIMER

The ABX Micros devices are quantitative multi-parameter, automated hematology analyzers for in vitro diagnostic use in clinical laboratories to identify and enumerate the following parameters: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, LYM#, LYM%, MON#, MON%, GRA#, GRA% in K2-EDTA & K3-EDTA anticoagulated venous whole blood samples from adult patients and pediatric patients ≥ 1 month of age. These medical devices are FDA cleared to provide platelet counts up to a range of 2m-4m platelets per microliter. The ABX Micros ES 60 and Micros 60 results from BMC samples have not yet been validated by the manufacturer and no claim is given as to the accuracy, precision or linearity of this device. No reimbursement is available when using this service for research purposes. Patient results may vary and baseline whole blood results will not be shared to providers and patients. Plymouth Medical reserves the right to refrain from testing on samples that have not been properly sampled, tagged, packaged or shipped per instructions and is not liable for any delivery service failures. The collection and analysis of blood and PRP samples is not intended as a diagnostic tool. The data and cellular characteristics of samples are intended for information purposes only. Plymouth Medical is not offering a diagnosis, treatment suggestions or any other medical advice. The reports are to be used at the discretion of the ordering physician. Plymouth Medical reserves the right to use the data collected in marketing, promotional activities and for future product development purposes.

ETHICAL GUIDELINES FOR ORTHOBIOLOGICS

Orthobiologic modalities are defined as living cells or other substances or materials that can affect the healing of bone, cartilage, tendon, ligament, muscle, or nerve. Typical orthobiologic therapies currently include stem cells, macrophages, leukocytes, pericytes, RBCs, cytokines, growth factors, platelet rich or poor plasma, serum, extracellular matrix, fat grafts, and other tissues. The guidelines expressed in this document are not meant to be all-inclusive and are best viewed as a collaborative living document with the flexibility for modification and refinement as the growing specialty of orthobiologics matures.

1. Clinicians should practice within the scope of practice of their training and specialty. Providers commonly trained to see neuromusculoskeletal injury such as Physiatrists, Orthopedic Surgeons, Interventional Pain Physicians, Family Practice with a Sports Fellowship, or other disciplines where significant structured academic orthopedic training has been pursued should only treat patients with neuromusculoskeletal injuries. For example, Orthopedic Surgeons or Physiatrists treating patients with multiple sclerosis or pulmonary fibrosis or dementia with an IV infusion of a biologically active substance would be outside their specialty training. Similarly, an Anesthesiologist or Internist evaluating and treating a patient with a chronic orthopedic condition such as degenerative joint disease of the knee, or a tendinopathy or ligament injury would be outside their traditional training. Since there is no Specialty Board for Orthobiologics in the US, clinicians without formal musculoskeletal training in residency or fellowship programs who are interested in practicing in this field are encouraged to seek training through post-graduate educational opportunities.

2. The decision to add orthobiologic modalities into a treatment plan for a patient typically requires a medical history, physical exam, image ordering and interpretation, and medication evaluation. These skills usually constitute the practice of medicine and as such fall under the scope of practice of a licensed physician or independent health care provider such as a Nurse Practitioner. Non-physician or non-independent providers who require physician oversight should only use orthobiologic modalities to the extent that it falls within their scope of practice and State Board guidelines. If a mid-level provider is required to have physician oversight as defined by theirState Licensing Medical Board, that requirement should be followed for orthobiologic procedures.

3. Any clinician using orthobiologic modalities should comply with all applicable state and federal laws, regulations, and guidance documents.

4. Informed consent for orthobiologic procedures should include discussion of published human outcomes relevant to the specific procedure to be performed. Clinicians may also discuss outcomes solely based on their personal experience. For example, placing a claim on a web-site that “80%” of patients get improvement is unethical unless it’s substantiated by at least case series data.However, discussing a clinician’s personal experience with the patient that about 80% of patients get improvement is consistent with appropriate ethical behavior.

5. If research is posted in a publicly accessible location, it should be research that represents the procedure under consideration. For example, if a provider is using stromal vascular fraction from adipose tissue, posting research that used culture expanded mesenchymal stem cells would be inappropriate.

6. Marketing and advertising claims made about the biological content or activity of a product should be substantiated and publicly available. If the claim of an orthobiologic product does not have reasonable, publicly available data, then advertising may constitute consumer fraud.

7. When using investigational procedures, substances, or devices clinicians are encouraged to collect registry data and to make such information publicly available thru publication or other means when appropriate.

8. All new orthobiologic interventions should have appropriate labor animal models using the specific live cell or product showing evidence of beneficial effect before use in humans. Safety and efficacy of new orthobiologic modalities should be established in small pilot trials, after documented evaluation from an independentInstitutional Review Board (IRB).

Access full document [Last rev. 6.15.2017].