The following Standard Terms and Conditions (the "Terms") apply to all purchases of
products made available for sale ("Products") by Organogenesis Inc., having a business
address at 85 Dan Road, Canton, Massachusetts 02021 ("Manufacturer") to its customers
(each referred to in these Terms, individually, as "Customer") and the facilities
Customer owns, manages, or controls (referred to in these Terms as "Facility" or
"Facilities"). Except as superseded by a separate, written agreement in effect between
Customer and Manufacturer that is signed by an officer or duly authorized representative
of Manufacturer, or as provided in Section 2B herein, these Terms will apply to all
purchases of Products by Customer. Manufacturer may, in its sole discretion, revise
or update these Terms at any time, with or without notice, effective upon posting of
the modified Terms on its website at
www.organogenesis.com.
- ORDERS, SHIPPING, AND RESTRICTIONS.
- Manufacturer shall ship orders to destination(s) in the United States designated
by Customer. Customer shall designate the date upon which Customer intends to apply
Product (the "Application Date"). Manufacturer shall ship all orders standard
freight within a minimum of two (2) business days of the Application Date provided
that the order was placed sufficiently in advance of the Application Date and order
quantities are reasonable and available at the time of order.
- Title to Products and risk of loss of Products shall pass to Customer upon
delivery by Manufacturer to the destination designated by Customer.
- All order shortages, overages, or other discrepancies must be reported to
Manufacturer within one (1) day of receipt.
- Any and all Products ordered are to be used solely for application to patients
of Customer in the United States. Distribution, redistribution, transshipment,
freight forwarding, and exportation of Products is prohibited. Products ordered
from Manufacturer shall not be used in clinical trials, comparative testing or
for reverse engineering without prior written consent from Manufacturer.
Violation of these restrictions shall provide Manufacturer a basis for immediate
termination of any agreement with Manufacturer.
- PRICES & PAYMENT.
- The initial prices payable by Customer for Products shall be at the applicable
contracted price, or, in the absence of any applicable contract, at the price
currently offered by Manufacturer. Manufacturer shall give Customer at least
forty-five (45) days' prior notice of any price change. Manufacturer may change
the specific Products available from Manufacturer (either by adding or removing
Products from its product list) after giving Customer written notice of any
such change. Customer shall be responsible for any and all taxes however designated
payable in connection with Customer's purchase of Products (except for any taxes
based on Manufacturer's income).
- To the extent that any group purchasing organization ("GPO") demands any
administrative fees from Manufacturer relating to the purchases made by Customer
pursuant to these Terms, Customer shall be solely responsible to pay such fees.
In the event Manufacturer enters into an agreement with a GPO for the sale of
any Products, and Customer (i) is a member of such GPO, (ii) has elected to
purchase the Products under the pricing and terms set forth on such agreement
between Manufacturer and the applicable GPO, and (iii) Manufacturer has been
notified of such election consistent with the terms of the applicable GPO agreement,
these Terms shall be suspended during the term of such GPO agreement for the sale
of only those Products (i.e., specific product/item numbers) set forth on the
applicable GPO agreement. During the period of suspension, with respect to the
sale of such Products set forth on the applicable GPO agreement, the terms of
such GPO agreement will supersede these Terms. If the Manufacturer has been
notified, consistent with the terms of the applicable GPO agreement, that Customer
is no longer a member of such GPO, or if such GPO agreement terminates for any
reason, Customer agrees that these Terms will resume effectiveness.
- TERMS OF PAYMENT.
- Payment shall be due on or before the forty-fifth (45th) day from the date of
Manufacturer's invoice.
- Manufacturer may levy a late payment charge of 1.5% per month (or the maximum
amount permitted by law, if lower) to any amount for which payment is not received
by the due date.
- Manufacturer reserves the right to suspend deliveries to Customer at any time
without notice if any overdue amounts remain outstanding. Customer shall have
thirty (30) days following receipt of any invoice to contest any alleged errors
in such invoice. Claims made following such period shall be deemed waived by
Customer.
- RESPONSIBILITY FOR PAYMENT.
- Customer is solely responsible for payment to Manufacturer of the entire purchase
price for all Products ordered, irrespective of whether or when Customer may receive
reimbursement for Products from Medicare, Medicaid, and/or any other third-party
payors.
- Customer shall be solely responsible for obtaining reimbursements, if any, from
third-party payors, including, without limitation, Medicare, Medicaid, and/or any
other third-party payors, for amounts Customer pays Manufacturer for Products,
and for obtaining all information and documentation necessary to bill and collect
from such third-party payors in the manner prescribed by such third-party payors.
- Customer shall be solely responsible for obtaining any pre-certification and/or
other authorization required by Medicare, Medicaid, and/or third-party payors.
- Manufacturer shall have no obligation to compensate Customer for any failure by
Customer, for any reason, to collect amounts otherwise payable to Customer on
account
of services rendered by Customer in connection with Products.
- ATTORNEYS' FEES AND COSTS OF COLLECTION. Customer shall reimburse Manufacturer
on demand for any and all costs, including, without limitation, court costs, attorneys'
fees, fees of collection agents, and related costs and expenses incurred in collecting
and attempting to collect any amounts due from Customer hereunder.
- LIMITED WARRANTY, RETURNS, RECALL AND FIELD CORRECTIONS.
- Limited Warranty. Manufacturer hereby warrants to Customer, for the lesser
of the shelf life of the specific Product and the period of twelve (12) months after
the delivery of the specific Product, that the Product shall (i) comply with and
perform in accordance with Manufacturer's written specifications for the Product
and (ii) be produced, labeled, and packaged in compliance with all applicable United
States laws and regulations in effect at the date of delivery of the Product to
Customer. Customer's exclusive remedy and Manufacturer's sole liability under this
warranty shall be to replace any non-complying Product or, at Manufacturer's option,
to refund the purchase price paid therefor. The above warranties do not apply to any
Product which has (a) been subjected to abuse, misuse, accident, or mishandling,
(b) been modified or altered by anyone other than Manufacturer, (c) been used for
or subjected to applications, environments, or stress or conditions other than as
intended and recommended by Manufacturer, (d) been improperly stored, transported,
installed, or used, (e) been used for any use not approved by the Food and Drug
Administration and not specified on the Product's label or otherwise permitted under
applicable law, or (f) had its serial number or other identification markings
altered
or removed. THE WARRANTIES SET FORTH IN THIS SECTION 6(A) ARE THE ONLY WARRANTIES
GIVEN BY MANUFACTURER WITH RESPECT TO THE PRODUCTS AND ARE GIVEN IN LIEU OF ANY AND
ALL OTHER WARRANTIES, WHETHER EXPRESS, IMPLIED, STATUTORY, OR ARISING BY CUSTOM,
TRADE USAGE, OR COURSE OF DEALING OR OTHERWISE, INCLUDING WITHOUT LIMITATION ANY
IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, AND
MANUFACTURER HEREBY DISCLAIMS ANY AND ALL OTHER WARRANTIES TO THE MAXIMUM EXTENT
PERMITTED BY APPLICABLE LAW.
- Product Returns. Manufacturer's Return Product and Order Cancellation
Policy ("Return Policy") is set forth below and shall govern all Product orders.
Manufacturer may change the Return Policy at any time by updating the terms thereto.
- Products Recall and Field Corrections. In the event of a general recall
or a limited recall, whether directed by the Food and Drug Administration or
undertaken voluntarily by Manufacturer, Manufacturer shall, at Customer's
discretion,
either replace the applicable Product or refund all amounts paid by Customer for the
applicable Product. Customer shall return the applicable recalled
Product to Manufacturer, and Manufacturer shall bear all return shipping costs.
- REJECTION.
- Manufacturer may reject all or any part of any purchase order for any reason.
- Rejection of a purchase order shall not relieve Customer of any duty, claim, or
liability that accrued before the date of termination.
- Any provision of these Terms that, by its terms, is intended to continue beyond
the Customer's use of the Product or any other date certain shall continue in
effect thereafter.
- CONFIDENTIAL INFORMATION. Customer agrees (a) to hold in strict confidence
all information given to it by Manufacturer, unless such information is publicly
available or otherwise available to Customer without restriction or breach of any
confidentiality agreement or is independently developed by Customer, and (b) that
it will not, without Manufacturer's prior approval, disclose such information or
use it for any purpose other than as contemplated by these Terms. The obligations
set forth herein shall not apply with respect to any information which is disclosed
pursuant to the requirement of a governmental agency or any law requiring disclosure
thereof, provided that Customer has provided prior written notice of any such
disclosure to Manufacturer and has given Manufacturer the opportunity to contest
or minimize such disclosure.
- INDEMNIFICATION. Customer shall defend, indemnify and hold Manufacturer
harmless against all liabilities to third parties whatsoever (and expenses connected
therewith, including reasonable attorneys' fees) not caused by the negligence or
other wrongful conduct of Manufacturer, arising as a result of (a) Customer's use
of Manufacturer's Product otherwise than as directed by Manufacturer and (b) any
actual or asserted violation(s) of federal, state or local law or regulation by
Customer in connection with Customer's use of Product.
- FORCE MAJEURE. Manufacturer shall not be liable for any loss, damage,
delay or failure to perform in whole or in part resulting from causes beyond
Manufacturer's reasonable control, including, but not limited to, fires, strikes,
insurrections, riots, embargoes, or requirements of any governmental authority.
- INDEPENDENT RELATIONSHIP. Nothing in these Terms shall constitute or be
construed as the creation of a partnership or joint venture between Customer and
Manufacturer. Customer shall not represent Customer or Customer's organization as
having any relationship to Manufacturer other than that of an independent purchaser
of Product for the limited purposes described in these Terms.
- TRADENAMES AND TRADEMARKS. Solely to the extent reasonably necessary to
enable Customer to inform patients regarding the availability and nature of the
Product, Manufacturer grants to Customer a non-exclusive, non-transferable,
royalty-free right to use the various trade names, trademarks, service marks
and other word and design marks that Manufacturer associates with the Product.
Customer acknowledges that Manufacturer is the exclusive owner or authorized
user of the above-mentioned intellectual property and agrees that Manufacturer
has the right to control the use or display thereof by Customer. The license
granted hereunder is a limited license and may be terminated at any time by
Manufacturer.
- LIMITATION OF LIABILITY.
- MANUFACTURER SHALL NOT BE LIABLE FOR ANY INDIRECT, SPECIAL, INCIDENTAL,
PUNITIVE, OR CONSEQUENTIAL DAMAGES OF ANY KIND, REGARDLESS OF THE FORM OF
ACTION, WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT PRODUCT
LIABILITY, OR OTHERWISE, EVEN IF MANUFACTURER HAS BEEN ADVISED OF THE
POSSIBILITY OF SUCH DAMAGES. THE AGGREGATE LIABILITY OF MANUFACTURER FOR
ANY CLAIM, LOSS, DAMAGE, OR EXPENSE FROM ANY CAUSE WHATSOEVER RELATING TO
OR ARISING UNDER THESE TERMS SHALL IN NO EVENT EXCEED THE AMOUNT PAID BY
CUSTOMER FOR THE QUANTITY OF THE PARTICULAR PRODUCT DIRECTLY GIVING RISE
TO THE LIABILITY WHICH WAS SHIPPED TO CUSTOMER BY MANUFACTURER DURING THE
TWELVE (12) MONTHS PRECEDING THE CLAIM.
- NO ACTION OR PROCEEDING AGAINST MANUFACTURER MAY BE COMMENCED MORE THAN
TWELVE (12) MONTHS AFTER THE SPECIFIC PRODUCT GIVING RISE TO THE CLAIM WAS
INITIALLY SHIPPED BY MANUFACTURER.
- LAWS. These Terms have been entered into in the Commonwealth of
Massachusetts and all questions regarding construction of the Terms and the
rights and liabilities of the parties shall be governed by the laws of the
Commonwealth of Massachusetts without reference to its choice of law rules.
Each party agrees that all disputes arising in connection with these Terms
shall be heard in Boston, Massachusetts, and each party irrevocably submits
to the exclusive jurisdiction of, and venue in, the state and federal courts
located in Suffolk County, Massachusetts and agrees that service in any such
disputes may be made in accordance with the notice provisions of these Terms.
- NOTICES. Any notice required or permitted by these Terms shall be
in writing and delivered as follows with notice deemed given as indicated:
(a) by personal delivery when delivered personally, (b) by reputable overnight
courier upon written or electronic verification of receipt, (c) by telecopy or
facsimile transmission when confirmed by telecopier or facsimile transmission,
or (d) by certified or registered mail, return receipt requested, upon
verification of receipt. All notices must be sent to the addresses first
described above or, for notices to Customer, to the address that the
Manufacturer has on file applicable to Customer for delivery of Product.
- NO THIRD-PARTY BENEFICIARIES. Except as set forth herein, no provision
of these Terms shall give any rights, remedies, or other benefits to any person
or entity other than Manufacturer and Customer.
- FACILITIES LIST. Customer represents and warrants that it has the
corporate or limited liability company power and authority on behalf of its
Facilities and shall be responsible for payment of the purchases of Products
by those Facilities. Customer shall update its authorized Facilities by
giving written notice to Manufacturer.
- TRANSMISSION OF UNWARRANTED INFORMATION. These Terms do not constitute
a Business Associates Agreement ("BAA"). In the context of utilizing these Terms,
Customer is responsible for not transmitting any information to Manufacturer,
its employees, officers, directors, managers, vendors, consultants, and/or
contractors (collectively "Manufacturer's Employee(s)") via any communication
medium (including but not limited to in-person communications, emails, faxes,
and/or phone-calls) that contains/may contain information that may be
reasonably considered: (a) privileged and/or confidential; (b) patient information
and/or protected health information as defined under relevant/applicable law;
and/or (c) subject to protection under relevant law, including the Health
Insurance Portability and Accountability Act of 1996, as amended and/or The
Health Information Technology for Economic and Clinical Health Act (HITECH Act).
Such information shall collectively be known as "Unwarranted Information." In
the event that, while utilizing these Terms, Customer transmits unwarranted
information via any medium to Manufacturer and/or Manufacturer's Employee(s),
Customer must immediately contact Manufacturer's Healthcare Compliance Department
(compliance@organo.com) and provide: (1) the name, address and contact information
of the person(s) who are responsible for maintaining privacy and/or compliance on
behalf of Customer; (2) the date and time the transmission occurred; (3) the medium
by which the transmission was sent; and/or (4) any other information that could
possibly assist Manufacturer in identifying the communication. Should Unwarranted
Information be transmitted by Customer to Manufacturer, Customer agrees to assist
Manufacturer with any necessary steps to remediate any further breaches and to
keep Manufacturer notified of steps Customer reasonably takes to notify
potentially affected patients.
- OBSERVATIONS OF NON-COMPLIANCE. Customer agrees to notify Manufacturer
in the event that Customer reasonably observes instances where Manufacturer's
Employee(s) may not be in compliance with relevant law, regulation, and/or
policy. Notice must include details of the observation and a Customer
point-of-contact who may be able to reasonably assist Manufacturer with its
investigation of the observation. Customer shall send notice of any such
observations to Manufacturer's Healthcare Compliance Department via either
of the email addresses or phone numbers below:
- ENTIRE AGREEMENT. These Terms together with the Return Policy set forth the
entire agreement between Manufacturer and Customer concerning the subject matter hereof,
and supersede all prior and contemporaneous written and oral negotiations and agreements
between them concerning the subject matter hereof. Except as herein provided, any
modification of these Terms must be in writing and signed by both parties. Any different,
conflicting, and additional terms in any purchase order, invoice, confirmation, or
other writing or communication from Customer (except for administrative details
about each quantity of Products ordered) are superseded by these Terms and shall
be of no force or effect. Notwithstanding the foregoing, in the event Customer and
Manufacturer have previously executed a written contract governing the sale of the
Products, the parties agree that the terms and conditions of such written contract
shall control in all respects so long as such contract remains in effect.
- NO IMPLIED WAIVERS. The failure of Manufacturer at any time to require the
performance by the Customer of any provision of these Terms shall not affect in any
way the right to require such performance at any later time nor shall the waiver by
Manufacturer of a breach of any provision hereof be taken or held to be a waiver of
such provision. All rights and remedies of Manufacturer are cumulative and concurrent,
and the exercise of one right or remedy shall not be deemed a waiver or release of
any other right or remedy.
- ASSIGNMENT. The rights or obligations hereunder cannot be assigned without
the prior written consent of both parties. Subject to the foregoing, these Terms
shall be binding on and inure to the benefit of each party's successors and assigns.
- SEVERABILITY. If any provision of these Terms is determined to be invalid
or unenforceable by a court of law, the provision shall be deemed automatically
adjusted to conform to the requirements for validity in a manner to best effect
the parties' intent (or deleted if it cannot be so adjusted), and the validity
and enforceability of the remainder of these Terms shall not be affected.
Return Product and Order Cancellation Policy
Our Commitment to Our Customer: We want you to be 100% satisfied with your purchase.
If a return is necessary, please follow our return policy below.
RETURN GOODS POLICY: Organogenesis will issue a credit to Customer for unused
product
returned in accordance with the following policy guidelines. Organogenesis will provide
a credit or replacement product to Customer for unused product associated with specific
situations out of the Customer's control, including:
- Product complaints (e.g., product quality, appearance, package integrity, pH out-of-range,
etc.).
- Product shipping issues such as damaged, lost, or misdirected shipments that do not arrive
in time for customer use.
Organogenesis will not be responsible for product received and unused as a result
of:
- Product deteriorating because of characteristics beyond Organogenesis' control (e.g.,
improper storage of product, heat, cold, smoke, fire, etc.).
- Unused product being discarded due to improper storage at Customer.
- Customer not open or staffed for delivery when product is delivered.
APLIGRAF® RETURNS:
- Customer must contact Customer Service concerning unused product within seven (7)
business days after the expiration date on the product unit label.
DERMAGRAFT®,
AFFINITY®,
and NUCEL® RETURNS:
- For Dermagraft® product stored in a freezer, Customer must contact Customer
Service concerning unused product within seven (7) business days after the
expiration date on the product unit.
- For Affinity® product stored in a refrigerator, Customer must contact
Customer
Service concerning unused product within seven (7) business days after the
expiration date on the product unit.
- For NuCel® products stored in a freezer, Customer must contact Customer
Service concerning unused product within six (6) months from the original
delivery date of the product unit.
- For Dermagraft®, Affinity®, or NuCel® product
stored in the shipper box,
Customer must communicate to Customer Service of unused product within seven
(7) business days of expiration date on shipper box.
Please note: The Dermagraft® Shipper box is recyclable and
is to be returned separately from product using the mailing label
attached to the inside box flap.
PURAPLY®, PURAPLY®
ANTIMICROBIAL,
NUSHIELD®, OSTEOCONDUCTION MATRIX PLUS™, AND
FIBEROS™ RETURNS:
- Customer must contact Customer Service concerning unused product within six
(6) months from the original delivery date of the product unit.
PURAFORCE™ RETURNS:
- Customer must contact Customer Service concerning unused product within
thirty (30) days from the original delivery date of the product unit.
RETURN GOODS PROCESS: To return product, the Customer is
to contact Customer Service to obtain a Return Material Authorization (RMA) and a
shipping return label within the time periods set forth above or, for products not
listed above, thirty (30) days of the original delivery date. Customer must return
product to Organogenesis within twenty (20) business days of RMA being issued with
the following:
- Product unit(s) must be un-opened.
- Copy of RMA must be included in package with unit(s) being returned.
- The RMA label will indicate what location the return should be sent to for processing.
- RMA number must appear on outside of the return package.
Customer account will be credited when the Organogenesis
Receiving/Distribution Department verifies units and RMA match.
Please note: If any unit is returned without a RMA or if a unit in a returned box
doesn't match the RMA issued, that returned unit will be considered unauthorized. No
credit
will be issued, and product will be appropriately destroyed.
FOR PRODUCT MANUFACTURING COMPLAINTS:
- Contact our technical support team at our Customer Service so they
may obtain the necessary information and authorize and provide instructions
to you for the product's return or local destruction.
- When a product return is requested, your Organogenesis Tissue
Regeneration Specialist or our Technical Support Team will provide
special return goods packaging kit for your use.
- You will have the option of a replacement product or a credit.
FOR DELIVERY ISSUES: Contact our Customer Service
for delivery issues Monday-Friday, from 8:00 AM to 8:00 PM EST. If product delivery
cannot be successfully facilitated, staff will be ready to assist in arranging a
replacement shipment or a credit.
ORDER CANCELLATION POLICY: Your order confirmation
number is required to cancel an order.
- Apligraf®, PuraPly®, PuraPly®
Antimicrobial or PuraForce™ orders may
be cancelled up to 10:00 AM Eastern Time on the date the unit is
scheduled to ship.
- Dermagraft® orders may be cancelled up to
10:00 AM Pacific Time on the date the unit is scheduled to ship.
- Affinity®, NuShield®, NuCel®,
Osteoconduction Matrix Plus™, and FiberOS™ orders may be cancelled
up to 10:00 AM Central Time on the date the unit is scheduled to ship.
