MANUFACTURING/SUPPLY AGREEMENT
This Agreement made and entered into this 25th day of August, 1992,
by and between GENETIC LABORATORIES WOUND CARE, INC. (hereinafter "GLWC") and
TAPEMARK COMPANY, (hereinafter "TAPEMARK").
WITNESSETH:
WHEREAS, TAPEMARK has the ability to produce certain products or
their components, (hereinafter "PRODUCT"); and WHEREAS, GLWC and
TAPEMARK wish TAPEMARK to manufacture the PRODUCT for GLWC; NOW,
THEREFORE, in consideration of the mutual covenants herein contained,
GLWC and TAPEMARK agree as follows:
Section 1 - Term and Termination of Agreement
1.1 This Agreement shall be in effect from the date on signing through
and concluding August 25, 1999. It shall thereafter be renewable for
successive terms of three years each.
1.2 The Agreement may be terminated in the event TAPEMARK fails to
provide PRODUCT according to specifications, or does not meet agreed
upon completion dates noted on the Production Orders. In such event,
GLWC shall first give TAPEMARK written notice of any default and
allow a period of thirty (30) days for corrective action. If, after
such notice and elapse of time, TAPEMARK is unwilling or unable to
correct the default, GLWC may terminate this Agreement unilaterally,
without further notice.
1.3 This Agreement may also be terminated by either party upon ninety
(90) days notice without any fault on the part of the other party.
Section 2 - Manufacturing
2.1 TAPEMARK shall supply PRODUCT in accordance with specifications
provided by GLWC.
2.2 Any and all changes to the specifications by TAPEMARK need prior
notification and authorization by GLWC.
Section 3 - Pricing and Payments
3.1 All prices shall be completed and mutually agreed to in advance of
any manufacturing commencement by TAPEMARK. 3.2 Terms of payment will
be net thirty (30) days from date of receipt of shipment F.O.B. West
Saint Xxxx, Minnesota.
Section 4 - Equipment
4.1 TAPEMARK agrees to maintain and operate all equipment in compliance
with all applicable federal and state safety regulations.
4.2 TAPEMARK will be responsible for providing its own employees training
in the safe and proper operation of any equipment supplied by GLWC.
Section 5 - Material Usage and Storage
5.1 TAPEMARK shall inspect and approve raw materials on the basis of
criteria provided by GLWC and will not be responsible for
defects in said material.
5.2 TAPEMARK agrees to handle and dispose of all material in accordance
with all applicable federal and state regulations.
Section 6 - Quality
6.1 TAPEMARK agrees to manufacture PRODUCT in accordance with mutually
agreed specifications and CGMP's outlined by the U.S. FDA and DOH.
6.2 GLWC shall have the right to reject PRODUCT that does not meet its
specifications.
6.3 Any rejection of Product shall be in writing and shall specify the
non-compliance.
6.4 TAPEMARK shall allow representatives of GLWC to inspect the
manufacturing site as needed pursuant to GLWC auditing procedures.
GLWC shall provide TAPEMARK with as much advance notification as
possible prior to such inspections. However, it shall have the right
of inspection at any time during normal business hours. In addition,
GLWC shall have the right to inspect the raw material vendors'
manufacturing facilities upon the same conditions. Consummation of
this Agreement shall be subject to a satisfactory preliminary
inspection by GLWC personnel of any manufacturing facility at which
PRODUCT or raw material is to be produced.
6.5 TAPEMARK shall obtain an Establishment Registration Number from FDA,
maintain traceability records on the PRODUCT manufactured, and
cooperate at its expense with GLWC in the event GLWC shall ever
initiate any remedial action for the PRODUCT covered by this
Agreement. TAPEMARK shall notify GLWC promptly in writing in the
event a governmental agency issues an inspection report or other
finding of non-compliance in connection with PRODUCT, its
manufacture, storage of handling and shall provide GLWC with a copy
of any such report or finding, edited for data or information not
related to GLWC or PRODUCT. GLWC shall have the right to participate
with TAPEMARK in the preparation of any response to said finding of
non-compliance. GLWC shall be responsible for creating and printing
all warnings, precautions, and PRODUCT labels required for the
PRODUCT, although TAPEMARK shall assist GLWC in the preparation of
these materials as requested.
6.6 With respect to product liability, each party shall be independently
responsible for its acts and omissions and shall indemnify and hold
the other party harmless for liability caused by its own acts or
omissions.
Section 7 - Confidential Information
7.1 TAPEMARK shall not grant access to any current or potential customers
to the immediate area and equipment where GLWC products are being
manufactured without prior approval of GLWC. The manufacturing
area(s) will be partitioned off to limit access when other customers
or customer representatives are present in the manufacturing
facility.
7.2 All information designated as confidential and exchanged between GLWC
and TAPEMARK while this Agreement is in effect shall be treated as
confidential and neither party shall, for a period of three (3) years
after termination of this Agreement or any renewal thereof (or such
longer period as may be specified in writing) exchange or disclose
such information to any third party without the prior written
approval of GLWC.
Section 8 - Responsibilities of GLWC - It shall be the responsibility of GLWC
hereunder to:
8.1 Issue purchase orders for all PRODUCT to be manufactured at TAPEMARK.
8.2 If GLWC changes the production schedule and interrupts an order in
process, GLWC will advise TAPEMARK either to: A. Transfer the balance
to another order.
B. Hold interrupted order open until further notification.
Section 9 - Notice
9.1 Any notices in correspondence given hereunder shall be in writing
directed to the addresses specified below and effective upon receipt
when delivered by hand or posted as first class Certified Mail,
Return Receipt Requested.
9.1.1 If intended for TAPEMARK;
TAPEMARK Company
000 Xxxx Xxxxx Xxxxxx
Xxxx Xx. Xxxx, XX 00000
Attention: President
9.1.2 If intended for GLWC:
Genetic Laboratories Wound Care, Inc.
0000 Xxxxxx Xxxx
Xx. Xxxx, XX 00000
Attention: President
Section 10 - Production Planning and Scheduling
10.1 GLWC shall provide TAPEMARK with a rolling six (6) month estimate of
product requirements for production planning and material purchases.
GLWC orders will be issued to TAPEMARK to cover a minimum two (2)
months time frame. Requirements established for month one (1) will be
considered fixed. GLWC shall have the ability to make revisions to
Production Orders issued for month two (2).
10.2 GLWC shall review production requirements with TAPEMARK at regular
monthly intervals.
Section 11 - General
11.1 The relationship between GLWC and TAPEMARK is intended to be that of
buyer and seller. TAPEMARK and its employees, agents, and
representatives shall under no circumstances be considered agents,
partners, joint venturers, or representatives of GLWC. TAPEMARK shall
not act or attempt to act, or represent itself, directly or be
implication, as agent, joint venturer, or representative of GLWC or
in any manner assume or attempt to assume or create any obligation or
liability of any kind, nature, or sort expressed or implied on behalf
of or in the name of GLWC.
11.2 This Agreement and the exhibits attached hereto contain the entire
understanding of the parties, It shall superseded any other oral or
written agreements and shall be binding upon and inure to the benefit
of the respective parties, their successors and permitted assigns.
11.3 This agreement shall not be modified in any way without written
consent of both parties, and neither party shall have the right to
assign this Agreement, in whole or in part, without the prior written
consent of the other, which consent shall not be unreasonably
withheld provided, however, that GLWC may assign this Agreement to a
purchaser or successor of GLWC entire business related to this
subject matter.
11.4 This Agreement shall be construed in accordance with laws of the
State of Minnesota.
11.5 The obligations of either party to perform under this Agreement shall
be excused if such failure to perform or any delay is caused by
matters such as acts of god, strikes, civil commotion, riots, wars,
revolution, acts of government, or any other cause whether similar or
dissimilar to those enumerated which is reasonably beyond the control
of the party obligated to perform. Upon the occurrence of such event,
the duties and obligations of the parties shall be suspended for the
duration of the event preventing proper performance under this
Agreement; provided, however, that if such suspension shall continue
in excess of ninety (90) days, the parties shall attempt to arrive at
a mutually acceptable compromise within the spirit and intent of this
Agreement.
11.6 If any provision of this Agreement is held to be void or illegal, the
rest of the Agreement shall be deemed binding upon the parties
hereto.
IN WITNESS WHEREOF, the parties hereto have by their duly authorized
officers, executed this Agreement as of the day and year first
written above.
GENETIC LABORATORIES WOUND TAPEMARK COMPANY
CARE, INC.
By _____________________________ By _____________________________
H. Xxxxx Xxxxxxxx Xxxxxx X. Xxxx, Xx.
Title: President Title: President
Dated: August 25, 1992 Date: August 25, 1992
---------------------------- --------------------
