Terms And Conditons

Effective date: August 2020

 

 

SOVRENITY, INC.
TERMS AND CONDITIONS OF SALE

 

 

1. Definitions

  • “Applicable Laws” means all applicable laws, regulations, rules, and guidance’s, including but not limited to the federal Food, Drug, and Cosmetic Act (“FDCA”), and its implementing regulations, and the United States Health Insurance Portability and Accountability Act of 1996 (“HIPAA”)
  • “Buyer” means the person, firm, or company placing an order with Seller;
  • SARS-CoV-2” means the virus that causes coronavirus disease 2019’
  • “COVID 19” means the disease cause by the virus “SARS CoV-2”
  • “EUA” means emergency use authorization issued by FDA;
  • “FDA” means United States Food and Drug Administration;
  • “Seller” means Sovrenity, Inc., a California corporation
  • “Goods” means the Fingerstick Test, Serum Test and Molecular Test, as applicable;
  • “In writing” or “written” means written on any paper document or electronic communication;
  • “Products” means collectively the Goods and/or Services as applicable;
  • “Serum Test” means serum test for detecting the presence of antibodies to SARS-CoV-2;
  • “Services” means any such services as may be provided by Seller in relation to the supply of the Goods.

2. Offer, Governing Provisions, and Cancellation

All purchases of Products by Buyer shall be subject to and governed by these Terms and Conditions of Sale.  Issuance of this document is not an acceptance of any offer made to purchase goods, but is an offer or counter-offer to sell Products that is expressly conditioned upon Buyer’s assent to these Terms and Conditions of Seller expressly objects to and rejects any additional or different terms contained in any request for proposal, purchase order, acknowledgement or other communication previously or hereafter provided by buyer to Seller.  No such additional or different terms or conditions will be of any force or effect.  The terms contained in or incorporated into this document, together with any documents specifically adopted by reference, will be the entire agreement between Seller and Buyer on the subject of the transaction described herein; there are no conditions to that agreement that are not so contained or incorporated.  THIS OFFER AND THAT AGREEMENT WILL BE GOVERNED BY AND CONSTRUED ACCORDING TO THE LAWS OF THE STATE OF CALIFORNIA WITHOUT REFERENCE TO PRINCIPLES OF CONFLICTS OF LAWS.

No accepted offer may be cancelled or altered by Buyer except upon terms and conditions accepted by Seller in writing, and no changes to this document will be binding unless set forth in writing and manually signed by Seller.  This offer may be revoked by Seller at any time before it is accepted by Buyer, and will automatically expire fifteen (15) calendar days after delivery thereof if buyer has not accepted it before then.  Neither Buyer’s acceptance of this offer nor any conduct by Seller (including but not limited to shipment of goods) will oblige Seller to sell to buyer any quantity of goods in excess of the quantity that Buyer has committed to purchase from Seller at the time of such acceptance or conduct.

3. Delivery, Claims and Force Majeure

Delivery of goods to the carrier will constitute delivery to Buyer, and regardless of shipping terms or freight payment, Buyer will bear all risk of loss or damage in transit.  Seller reserves the right to make delivery in installments, unless otherwise expressly stipulated herein or by referenced document; all such installments to be separately invoiced and paid for when due per invoice, without regard to subsequent deliveries.  Delay in delivery of any installment will not relieve Buyer of its obligations to accept remaining deliveries.

Claims for shortages or other errors in delivery must be made in writing to Seller within ten (10) calendar days after receipt of shipment, and failure to give such notice will constitute unqualified acceptance and a waiver of all such claims for such shortages or delivery errors by Buyer.  Claims for loss of or damage to goods in transit must be made to the carrier, if applicable, and not to Seller.

All delivery dates are approximate.  Seller will not be liable for any losses or damages as a result of any delay or failure to deliver due to any cause beyond Seller’s reasonable control, including but not limited to any act of God, nationwide or global pandemic (including Coronavirus/COVID), act or omission of Buyer, technical problems or technical questions, embargo or other government act, regulation or request, fire, accident, strike, slowdown, war, act of terrorism, riot, delay in transportation, or inability to obtain necessary labor, materials or manufacturing facilities.  In the event of any such delay, the date of delivery will be extended for a period equal to the time lost because of the delay.  Buyer’s exclusive remedy for other delays, and for Seller’s inability to deliver or make available for any reason, will be rescission of its agreement to purchase.

4. Buyer’s Obligations

Buyer shall obtain and maintain all licenses, permits and other governmental approvals necessary to permit the purchase and use of and payment for Goods and Services by Buyer and shall otherwise comply with Applicable Laws.  Without limiting the generality of the foregoing, Buyer: (i) shall store the Goods in accordance with Applicable Laws and any instructions for use provided with the Goods; (ii) shall make the Goods available and ship the specimens in accordance with all Applicable Laws and in accordance with  any reasonable specific packaging and labeling requirements as reasonably requested by the Manufacturer or Seller; (iii) shall dispose of any unused or expired Goods in accordance with all Applicable Laws and reasonable instructions from the Manufacturer or Seller; (iv) shall not adulterate or misbrand Goods, or engage in any activity that could or does render Goods adulterated or misbranded; and (v) shall maintain all necessary records for compliance with the terms of this Agreement and all Applicable Laws.

Buyer shall also comply with all Federal, state, and local laws and regulations regarding Coronavirus Disease testing, the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance, and any medical device distribution requirements pursuant to state or local laws and regulations commonly referred to as “Regulatory Laws”.  With respect to any part of the territory covered by a Regulatory Law, Buyer shall ensure its compliance with Regulatory Law obligations. Buyer will also comply with all federal, state and local laws and regulations applicable to health care professionals, including professional licensure rules and standards. 

All Goods must be ordered in compliance with any applicable Emergency Use Authorization (EUA) of the US Food and Drug Administration and the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”).  Unless explicitly agreed to in writing, Seller takes no responsibility for FDA or CLIA compliance.  Should Buyer wish to contract with Buyer healthcare services for the purposes of such compliance (the “Services”), a statement of work will be appended to these Terms and Conditions of Sale.

5. Warranties

Seller shall assign to Buyer the same limited warranties of the manufacturer or suppliers of the Goods sold by Manufacturer to Seller as in effect on the date of delivery of such Goods to the extent permitted by such warranties and applicable law.  All claims under such limited warranties must be made by Buyer directly to the and not to Seller. The warranties Seller assigns to Buyer are as follows:

Negative results do not rule out infection, particularly in persons who have been in recent contact with COVID-19 or those infected with COVID-19.  Results from antibody tests should not be used as the sole basis to diagnose or exclude infection, or to inform infection status.  Positive antibody results may be due to past or present infection with non-COVID-19 coronavirus strains.

THE ABOVE WARRANTIES ARE EXCLUSIVE AND IN LIEU OF ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED.  LABORATORY AND SELLER MAKE NO OTHER WARRANTIES OR GUARANTEES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR ANY WARRANTY AGAINST INFRINGEMENT OF A THIRD PARTY’S INTELLECTUAL PROPERTY.  SELLER AND MANUFACTURER EXPRESSLY DISCLAIM AND EXCLUDE ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE, AND ANY WARRANTIES ARISING FROM COURSE OF DEALING OR USAGE OF TRADE AND ALL OTHER WARRANTIES.

Any description of the Goods, whether in writing or made orally by Seller or its agents, specifications, samples, models, bulletins, drawings, diagrams, engineering sheets or similar materials used in connection with Buyer’s order are for the sole purpose of identifying the Goods and shall not be construed as an express warranty.  Any suggestions by Seller or Seller's agents regarding use, application or suitability of the Goods shall not be construed as an express warranty.

6. Emergency Use Authorization

Buyer expressly acknowledges that an Emergency Use Authorization is not a 510(k) clearance to market and sell in perpetuity.  Buyer further acknowledges that pursuant to 21 U.S.C. 360bbb-3(b)(1) the FDA may revise or revoke an EUA if the circumstances justifying issuance no longer exist, the criteria for its issuance are no longer met, or other circumstances make a revision or revocation appropriate to protect public health or safety.  Buyer agrees that, should such a revision or revocation be issued, Buyer will discontinue further resales of the goods (as and if so required by the revision or revocation), and understands that Buyer will in such event have no right to cancel or revoke its agreement to purchase the goods, or to receive any refund of the purchase price of goods purchased hereunder.

7. Force Majeure Neither

Seller nor Manufacturer will be liable or responsible to Buyer, nor be deemed to have breached these Terms and Conditions of Sale, for any failure or delay in performing any term hereof when and to the extent such failure or delay is caused by or results from acts or circumstances beyond their reasonable control including, without limitation, acts of God, flood, fire, earthquake, explosion, governmental actions, war, terrorist threats or acts, riot, or other civil unrest, national emergency, revolution, insurrection, epidemic, pandemic, quarantine, stay home order, lock-outs, strikes or other labor disputes (whether or not relating to either party’s workforce), or restraints or delays affecting carriers or inability or delay in obtaining supplies of adequate or suitable materials.

8. Consequential Damages and Other Liability

Seller’s liability with respect to the Goods and Services sold hereunder will be limited to the remedy and indemnity provided in Section 6 (Warranties) of these Terms and Conditions of Sale and, with respect to any other breaches of its contract with Buyer, will be limited to the contract price of the affected Services.  SELLER WILL NOT BE SUBJECT TO ANY OTHER OBLIGATIONS OR LIABILITIES, WHETHER ARISING OUT OF BREACH OF CONTRACT, WARRANTY, TORT (INCLUDING NEGLIGENCE AND STRICT LIABILITY), OR UNDER OTHER THEORIES OF LAW OR EQUITY, WITH RESPECT TO GOODS SOLD BY SELLER, OR ANY UNDERTAKINGS, ACTS OR OMISSIONS RELATING THERETO.  Without limiting the generality of the foregoing, Seller specifically disclaims any liability for property damages, penalties, special or punitive damages, damages for lost profits or revenues, down-time, lost good will, cost of capital, cost of substitute goods, or for any other types of economic loss, or for claims of Buyer’s customers or any third party for any such damages, costs or losses.  SELLER WILL NOT BE LIABLE FOR, AND DISCLAIMS, ALL CONSEQUENTIAL, INCIDENTAL, INDIRECT AND CONTINGENT DAMAGES WHATSOEVER.

9. Recall

Buyer shall promptly notify Seller and Manufacturer of any complaint or adverse claim about any Goods or its use of which Buyer becomes aware. If any government agency requires the recall of any Goods or packaging or Seller or Manufacturer reasonably determines that any Goods or packaging should be recalled, then Seller and Buyer shall coordinate the immediate cessation of sale and distribution and the recall or withdrawal, as determined by Seller and/or Manufacturer to be necessary, of all such Goods or packaging. If determined by Seller and/or Manufacturer to be necessary or advisable, Buyer and Seller shall cooperate to recall or reacquire the applicable goods or packaging from any purchaser thereof.  In no event shall Buyer be entitled to recover lost profits or other consequential damages as a result of any recall of the goods.  If the problem at issue was caused by Buyer, then Buyer shall pay the costs and expenses associated with any such recall, and Buyer shall indemnify Seller for its reasonable costs and expenses associated with such recall.

10. Buyer’s Indemnity 

BUYER WILL INDEMNIFY AND HOLD HARMLESS SELLER, MANUFACTURER, AND EACH OF THEIR DIRECTORS, OFFICERS, EMPLOYEES, AND AGENTS FROM AND AGAINST ANY AND ALL CLAIMS, LOSSES, LIABILITIES, DAMAGES, COSTS, AND EXPENSES (INCLUDING BUT NOT LIMITED TO ATTORNEYS FEES AND OTHER COSTS OF DEFENSE) THAT SELLER AND/OR MANUFACTURER MAY INCUR THAT ARISES OUT OF ANY CLAIMS MADE BY THIRD PARTIES RELATING TO THE GOODS OR USE OF THE TEST RESULTS (COLLECTIVELY, “CLAIMS”), EXCEPT TO THE EXTENT SUCH CLAIMS ARE CASUED BY THE GROSS NEGLIGENCE OR INTENTIONAL MISCONDUCT OF LABORATORY AND/OR SELLER. 

Seller shall be entitled to participate in the defense of any such third-party claim and to employ counsel at its expense to assist in such defense.  Buyer shall not settle a Claim in any manner that admits fault on behalf of the Seller or imposes injunctive relief on the Seller without Seller’s prior written consent, which consent will not be unreasonably withheld or delayed.

11. Taxes and Other Charges

Any manufacturer’s tax, occupation tax, use tax, sales tax, excise tax, value added tax, duty, custom, inspection or testing fee, or any other tax, fee, interest or charge of any nature whatsoever imposed by any governmental authority on or measured by the transaction between Seller and Buyer will be paid by Buyer in addition to the prices quoted or invoiced unless Buyer furnishes Seller with exemption certificates acceptable to taxing authorities.  In the event Seller is required to pay any such taxes or other charges, Buyer will reimburse Seller therefor on demand.

12. Changes

Seller may at any time make such changes in the Products as Seller deems appropriate, without notice to Buyer.  Seller may furnish suitable substitutes for any materials or services unobtainable because of priorities or regulations established by governmental authority, or nonavailability of materials from suppliers.

13. Technical Information

Any inventions, technical information, processes, trade secrets, know-how, designs, formulations, certificates of analysis, specifications, plans, drawings, blueprints, samples, catalogs, service manuals, data sheets, sales, service and technical bulletins, customer lists, sales and marketing programs, price lists, cost data, sales aids, and all other publications and information provided by Seller to Buyer will remain the property of Seller, and will be treated as confidential information.  No use or disclosure of such confidential information, sketches, models or samples, or any design or production techniques revealed thereby, will be made without the express, prior written consent of Seller.

14. Payment Terms

Payment in full will due upon receipt of each Purchase Order.  No Test Kits will be released until Seller has received full payment for all tests ordered as indicated in the Purchase Order.  No returns or refunds will be granted for unused Test Kits.

15. Assignment

 Buyer shall not assign any of its rights or delegate any of its obligations under this Terms and Conditions of Sale without the prior written consent of Seller. Any purported assignment or delegation in violation of this Section is null and void. No assignment or delegation relieves Buyer of any of its obligations under this Terms and Conditions of Sale.

16. Severability

If any term or provision of this Terms and Conditions of Sale is invalid, illegal, or unenforceable in any jurisdiction, such invalidity, illegality, or unenforceability shall not affect any other term or provision of this Terms and Conditions of Sale or invalidate or render unenforceable such term or provision in any other jurisdiction.

17.  Independent Contractors

It is expressly agreed that the relationship between Buyer and Seller created by this Terms and Conditions of Sale shall be one of independent contractors, and neither party shall have the power or authority to bind or obligate the other party except as expressly set forth in this Terms and Conditions of Sale.

18. Waiver

The parties understand and agree that no failure or delay in exercising any right under this Terms and Conditions of Sale shall operate as a waiver.  To be effective under this Terms and Conditions of Sale, a waiver shall be in writing and signed by the party against whom the waiver is sought to be enforced.

19. Arbitration

Any dispute or claim in law of equity between the Parties arising out of these Terms and Conditions of Sale will be decided by neutral, binding arbitration before one arbitrator.  The arbitration will take place in California.  The arbitration will be conducted in accordance with the commercial arbitration rules of the American Arbitration association and in accordance with the law of the State of California.  The arbitrator will not award punitive or consequential damages nor any other element of damages specifically excluded within these Terms and Conditions of Sale, will not ignore or vary these Terms and Conditions of Sale, will follow applicable principles of law as if n a court of law, and will issue a reasoned opinion.  Judgment upon the award rendered by the arbitrator may be entered in any court having jurisdiction thereof.  All arbitration fees will be paid equally by the parties.  The non-prevailing party will be responsible for and pay the reasonable attorney’s fees of the prevailing party.  Any such arbitration award will be final and binding upon all parties.

20. Waiver of Jury Trial

EACH PARTY KNOWINGLY, VOLUNTARILY, AND INTENTIONALLY WAIVES ITS RIGHT TO A TRIAL BY JURY IN ANY PROCEEDING ARISING OUT OF OR RELATING TO THESE Terms and Conditions of Sale.

21. Survival

The obligations of the parties under this Terms and Conditions of Sale and Purchase Order which by their nature would continue beyond the termination, cancellation or expiration of these Terms and Conditions, including by way of illustration and not limitation, those in Section 4, shall survive termination, cancellation or expiration of this Terms and Conditions of Sale and
the applicable Purchase Order.

 

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