CONFIDENTIAL TREATMENT REQUESTED FOR ALL BRACKETED ([]) INFORMATION. THE
CONFIDENTIAL PORTION HAS BEEN SO OMITTED AND FILED SEPARATELY WITH THE
COMMISSION.
DISTRIBUTORSHIP AGREEMENT
THIS AGREEMENT, dated as of the 5th day of August, 1996, by and between
Merck & Co., Inc., a corporation duly organized and existing under the laws of
the state of New Jersey having an address at Xxx Xxxxx Xxxxx, Xxxxxxxxxx
Xxxxxxx, Xxx Xxxxxx 00000 and operating through its Merck AgVet Division,
(hereinafter referred to as "MERCK")
AND
Koffolk, Inc., a business entity duly organized and existing under the laws of
the state of Delaware having an address at Xxx Xxxxxx Xxxxx, Xxxx Xxx, Xxx
Xxxxxx 00000 (hereinafter referred to as "KOFFOLK").
WITNESSETH:
WHEREAS, MERCK is the inventor, developer and supplier of products used
for animal health purposes; and
WHEREAS, KOFFOLK desires to distribute, promote, advertise and sell
certain of such products for animal health purposes in the United States in
accordance with the Food and Drug Administration registration obtained by MERCK;
and
WHEREAS, KOFFOLK shall maintain the necessary sales force and
organization to properly service the territory;
NOW, THEREFORE, in consideration of the premises and of the performance
of the mutual covenants hereinafter set forth, the parties hereto agree as
follows:
1. DEFINITIONS
Each term defined below shall, for the purpose of this Agreement, have
the following meaning and shall include the singular and the plural:
(a) "Product" or "Products" shall mean the finished animal health
products containing amprolium as the active ingredient sold under the Trademark
in such sizes and presentation form as described in Schedule A, for the use in
the treatment of coccidiosis in poultry.
(b) "Territory" shall mean the United States of America, excluding its
territories and possessions.
(c) "Trademark(s)" shall mean the trademarks AMPROL, AMPROL Plus or
other appropriate trademarks designated by Merck AgVet, which are licensed to
KOFFOLK in the Territory by MERCK pursuant to the Trademark License Agreement of
even date.
(d) "Exclusive Distribution Period" shall mean that period of [ ] from
the Effective Date of the Agreement and any applicable renewal periods.
(e)"Affiliate" shall mean with respect to a party to this Agreement (i)
any corporation or business entity, fifty percent (50%) or more of the voting
stock of which is owned directly or indirectly by a party; (ii) any
corporation or business entity which directly or indirectly owns fifty percent
(50%) or more of the voting stock of a party; or (iii) any corporation or
business entity under the direct or indirect control of a corporation or
business entity as described in clause (i) or (ii).
(f)"Promotional Literature" shall mean all Products-related or
disease-related material, or similar material with respect to competitive
Products, written, oral, graphic or other prepared for distribution to or use
with the veterinary or allied professions, sales representatives, the trade,
and/or consumers.
(g) "Calendar Year" shall mean that twelve (12) month period commencing
January 1st and ending December 31st of each year of the Agreement.
(h) "License Agreement" shall mean the Trademark License Agreement of
even date between MERCK and KOFFOLK.
(i) "Marketing Plan" shall mean that document prepared by KOFFOLK on an
annual basis and submitted to MERCK that contains sales forecasts and
promotional efforts of KOFFOLK for sale of the Product for the succeeding
Calendar Year.
(j) "Effective Date" shall mean August 5,1996.
(k) "Like Kind Exchange" shall mean an arrangement whereby MERCK
divests itself of Product via a non-cash exchange for a third party's product(s)
or rights to market and/or distribute a third party's product(s).
(l) "Promotional Efforts" shall mean the expense, not including
salaries and related overhead expenses, associated with the planning,
production, publication and distribution of Product support material, market
support trials, meetings, merchandising allowance funds, and market research
necessary to facilitate the marketing effort.
2. APPOINTMENT OF KOFFOLK
(a) Subject to continuing right to sell its inventory of Product in the
Territory through [ ], MERCK hereby appoints KOFFOLK as an exclusive
distributor in the Territory for the Products.
(b) KOFFOLK shall sell the Products for its own account. All orders by
KOFFOLK's customers shall be promptly filled by KOFFOLK and KOFFOLK shall assume
all credit risks.
3. PURCHASE OF PRODUCTS
(a) MERCK shall sell, and KOFFOLK shall purchase, the Products from
MERCK at the product supply price specified in Schedule B. Product supply prices
are [ ]. All orders shall be subject to acceptance by MERCK or such Affiliate
and all sales shall be subject to the then current Terms and Conditions of Sale.
To the extent there is any inconsistency in the Terms and Conditions of Sale and
this Agreement, this Agreement shall govern.
(b) KOFFOLK shall make payment to MERCK for the Product within ninety
(90) days of the date of the invoice, in the currency stated on the invoice.
(c) KOFFOLK shall provide MERCK with a rolling [ ] forecast of its
expected requirements of Products, updated on a monthly basis, divided into
quarterly quantities of Products by pack size as of the beginning of each
calendar quarter. Purchase orders shall be in writing and submitted by KOFFOLK
to MERCK by January 15 of each Calendar Year and shall specify by product the [
]
2
for that Calendar Year. KOFFOLK shall specify quantities and delivery dates for
Product listed in the annualized purchase order at least three (3) months in
advance of the calendar quarter that KOFFOLK requires Product to be provided by
MERCK. Delivery shall be made as close to such requested dates as possible. The
terms of such purchase order shall be consistent with the provisions of this
Agreement and where inconsistent, this Agreement shall govern.
(d) MERCK shall use reasonable efforts to fill orders that are in
excess of the quantity forecasts provided by KOFFOLK, giving consideration to
the quantity of the Products available at the time, the requirements of other
customers and the capacity of the production facility.
(e) KOFFOLK shall inspect the Products and shall inform MERCK in
writing of any complaints regarding the quantity or quality of the same within
three (3) days of receipt of the Products by KOFFOLK. In the event that a
quality defect is not discoverable by reasonable inspection, such claim for the
quality defect shall be made in writing within three (3) days of discovery. No
quantity of the Products shall be returned to MERCK without MERCK's express
written permission, which permission shall not be unreasonably withheld. Once
permission has been given, Product will be returned to MERCK and, at MERCK's
option, either subsequently replaced within ninety (90) days at no charge to
KOFFOLK or a credit for the amount of defective Product will be provided to
KOFFOLK within thirty (30) days of its return.
4. CERTAIN SPECIFIC RESPONSIBILITIES OF KOFFOLK
(a) KOFFOLK shall prepare and submit to MERCK on an annual basis, a
written marketing plan for the Products which shall include sales forecasts and
promotional efforts for the year. The marketing plan for Calendar Year 1997
shall be provided by December 1,1996. Thereafter, the marketing plan for each
succeeding Calendar Year shall be provided by KOFFOLK to MERCK by September 1st
of the preceding Calendar Year.
(b) KOFFOLK shall actively promote and distribute and use its best
efforts to expand the sales of the Products in the Territory by all appropriate
means available through the maintenance of its sales organization.
(c) KOFFOLK shall purchase the guaranteed purchases for Calendar Years
1996 and 1997 of the Agreement which are designated in Schedule C (hereafter the
'Guaranteed Amount"). Thereafter, for Calendar Years 1998 through 2000, and any
subsequent renewal periods, such Guaranteed Amounts will be agreed to between
MERCK and KOFFOLK in each Calendar Year by July 31 of the preceding Calendar
Year. If KOFFOLK does not purchase the Guaranteed Amount in any Calendar Year,
KOFFOLK shall be required to eliminate the shortfall as follows:
[
]
[
]
3
(d) If in any two (2) consecutive Calendar Years, KOFFOLK fails to meet
the Guaranteed Amounts, MERCK may terminate this Agreement upon sixty (60) days
notice to KOFFOLK.
(e) KOFFOLK shall keep MERCK informed on a quarterly basis, in writing,
of the Promotional Efforts it will be making in connection with the Products.
Thereafter, KOFFOLK's expenditure for Promotional Efforts for each subsequent
Calendar Year shall be contained in the Marketing Plan as developed by KOFFOLK.
MERCK reserves the right to request, and KOFFOLK shall provide, documentation to
substantiate the amount spent by KOFFOLK on Promotional Efforts in each Calendar
Year of the Agreement.
(f) KOFFOLK shall maintain sufficient stocks of the Products to satisfy
the demand for them in the Territory. Specifically, its inventory shall, at any
given time, not fall below the equivalent of the total estimated sales for each
Product in the upcoming two (2) months. The Products shall be handled and stored
in accordance with instructions provided by MERCK.
(g) KOFFOLK acknowledges that it is aware of the terms of MERCK's
Ethical Business Practices Policy, a copy of which is attached hereto as
Attachment I and made part of this Agreement. KOFFOLK agrees to comply fully
with the requirements of said Policy and agrees to indemnify and hold MERCK
harmless from and against any and all liabilities resulting from the violation
of said policy by KOFFOLK, or any third party that KOFFOLK has instructed to act
on its behalf.
(h) KOFFOLK agrees to develop at its own expense Promotional Literature
to be used in conjunction with the sale of the Products in the Territory. All
Promotional Literature must be consistent with the safety and efficacy data
supplied by MERCK and reviewed and approved by MERCK according to the following
provisions prior to its use:
(i) All Promotional Literature relating to the Products must be
submitted for approval to publish shall be addressed to:
Merck & Co., Inc.
Merck Ag Vet Division
Xx. Xxxxx Xxxxxxxxx
Associate Director, Marketing Communications
U.S. Operations
X.X. Xxx 0000, XXX-000
Xxxxxx, XX 00000-0000
(ii) Within twenty (20) working days of receipt, MERCK will either
approve or reject the submission. No Promotional Literature may be printed,
published or put into use until a signed approval is received from MERCK by
KOFFOLK. Facsimile transmission will be deemed acceptable.
(iii) Approval of each promotional text is valid for one (1) year
unless new Product information or new regulations affecting the Products or text
become available. In the absence of any such changes, approved literature may be
printed, reprinted, used and distributed during this period.
(iv) An approved text may not be changed for publication without the
written authority of MERCK. This applies to all Promotional Literature covered
by this procedure. If even the most minor change of an approved literature piece
is required, the revised text must be submitted for MERCK's approval.
(v) KOFFOLK shall submit, within five (5) days of production, ten
(10) printed specimens of each approved literature piece for after-the-fact
review, accompanied by a confirmation from an authorized
4
representative of KOFFOLK that it is worded exactly as was approved by MERCK.
Specimens and confirmations should be addressed to:
Merck & Co., Inc.
Merck AgVet Division
Xx. Xxxxx Xxxxxxxxx
Associate Director, Marketing Communications
U.S. Operations
X.X. Xxx 0000, XXX-000
Xxxxxx, XX 00000-0000
(vi) Pricing information or bulletins for KOFFOLK's internal use
only that contain no safety, efficacy or other Products-related claims are
excluded from review under this procedure.
(i) KOFFOLK shall provide MERCK with a quarterly report of (i) all
sales of Products by package size and (ii) and inventory status of the Products
which report shall be provided by the twentieth (20th) day of the month
immediately following the close of the quarterly period. Additionally, KOFFOLK
shall keep MERCK advised on a regular basis of general market, economic and
regulatory developments which may affect the promotion and sale of the Products
in the Territory.
(j) KOFFOLK shall not make any claim, either orally or in writing, with
respect to the safety or effectiveness of the Products that is inconsistent with
and/or goes beyond approved claims for the Products, nor shall KOFFOLK recommend
the combination of the Products with any other products, without MERCK's prior
written consent.
(k) KOFFOLK shall do nothing which will jeopardize the goodwill of
MERCK or any of its Affiliates or the reputation of the Products. The
appointment of KOFFOLK as a distributor hereunder shall not create a joint
venture, or principal-agency relationship, or franchise relationship and nothing
hereunder shall be deemed to authorize KOFFOLK to act for, represent, or bind
MERCK or any of its Affiliates, unless specific authority to act on MERCK's
behalf is granted to KOFFOLK in writing.
(l) Both parties agree to comply with all laws and regulations and
other requirements in the Territory governing the performance of their
activities under an agreement such as this.
(m) KOFFOLK shall be responsible for ensuring that its customers obtain
approval of form FDA 1900 with the FDA. In order to ensure that existing
customers of the Products have obtained such approvals, MERCK shall provide
KOFFOLK, within forty-five (45) days of the Effective Date, with copies of all
forms FDA 1900 (or Forms FDA 1800, if applicable) covering the Products which it
has in its possession.
(n) Except as required by law, neither party shall make any public
announcement in connection with the subject matter of this Agreement without the
prior approval of the other party.
5. PROMOTIONAL AND MARKETING EXPENSES
(a) KOFFOLK agrees to pay for all promotional, selling and marketing
costs of Products, including but not limited to customer feed assay costs,
advertising expenses, freight and distribution costs and carrying costs of
accounts receivable.
(b) MERCK agrees to provide customer feed assays to KOFFOLK in 1996 at
an initial price of [ ] and in future Calendar Years at the
prevailing price [ ].
5
6. CONFIDENTIALITY
(a) For the term of this Agreement plus five (5) years thereafter all
information which is received by KOFFOLK or MERCK from the other party during
the term of this Agreement shall be maintained in strict confidence by the
receiving party. All information whether generated by KOFFOLK or MERCK shall be
disclosed only to MERCK or KOFFOLK employees and consultants who have been
instructed to treat such information in strict confidence and on a "need to
know" basis. This information shall be protected from disclosure to third
parties with at least the same degree of care used by such employees when
dealing with their employer's confidential information. Further, such
information shall not be disclosed to any other person, firm, or agency,
governmental or private, or used for purposes other than set forth herein
without the prior written consent of the disclosing party.
(b) With respect to tangible materials provided by MERCK to KOFFOLK
under this Agreement, including samples of Products, KOFFOLK agrees to (i) not
provide such materials to third parties, (ii) not conduct demonstration trials
or protocols for the promotional use of the product except with the prior
written permission of MERCK, and (iii) return unused portions of such materials
to MERCK.
(c) In the event KOFFOLK desires to disclose to MERCK any information
considered confidential and proprietary to KOFFOLK ("KOFFOLK Confidential
Information") during the course of this Agreement, KOFFOLK shall first provide
MERCK with notice of KOFFOLK's intent to disclose KOFFOLK Confidential
Information, then for the term of this Agreement plus three (3) years
thereafter, MERCK shall keep KOFFOLK Confidential Information confidential by
not disclosing to any third party, and shall not use for any purpose other than
pursuant to this Agreement.
(d) The foregoing obligations shall not apply when and to the extent
such information:(I)is or becomes a part of the public domain without the breach
of this Agreement;(ii)is already known to the receiving party prior to its
disclosure or development hereunder(iii)can be shown to have been independently
developed by or on behalf of MERCK without reference or access to KOFFOLK
Confidential Information as evidenced by MERCK's written records; or(iv)is
disclosed to the receiving party by an independent third party not under an
obligation of confidence to the disclosing party with respect thereto.
(e) This Agreement shall not supersede any existing Confidentiality
Agreement between MERCK and KOFFOLK and/or its Affiliates with respect to any
information already or hereafter disclosed between the parties, and shall be
deemed additive to those confidentiality obligations that may have already been
assumed.
7. PRODUCT REGISTRATION
Registrations for the Products with the Food and Drug Administration
shall be maintained by MERCK. All fees and other expenses in connection with the
registration of the Products shall be for the account of MERCK. Product
registrations shall be in the name of MERCK or a designated Affiliate under the
separate Trademarks as owned by MERCK as set forth in Paragraph 8 and listed in
Schedule A. All product registrations so obtained shall be and remain the
property of MERCK or such Affiliate. Any registrations required pursuant to
state law to allow for distribution of the Products by KOFFOLK in each state in
the Territory, including distribution licenses, shall be applied for, maintained
by, be the property of, and for the account of KOFFOLK only.
8. PACKAGING AND LABELING
KOFFOLK will promote and market the Products under labeling and
package design approved by MERCK. All packages will bear the name and logo of
MERCK, and shall identify that the Products are manufactured by MERCK.
9. TRADEMARKS
6
(a) [ ], KOFFOLK
shall have the exclusive right to use the Trademarks in the Territory pursuant
to the terms of this Agreement and the Trademark License Agreement of even date
annexed as Attachment 2.
(b) Except as provided by this Agreement and/or the Trademark License
Agreement, nothing in this Agreement shall be construed as granting to KOFFOLK
any right, title, interest, or license under or to any intellectual property of
MERCK relating to the Product.
10. REGULATORY MATTERS
(a) The Product covered by this Agreement is registered with the Center
for Veterinary Medicine of the Food and Drug Administration (FDA).
(b) (i) KOFFOLK agrees that it shall undertake in accordance with
applicable FDA regulations, and any other applicable laws or regulations, the
submitting of periodic drug experience reports to MERCK.
(ii) KOFFOLK further agrees to report to MERCK in writing all
adverse experience and adverse physical occurrence information of which it
becomes aware associated with the Products relating to hazards,
contraindications, side effects, injuries, toxicity, sensitivity reactions,
Product defects and mix-ups, whether or not the adverse experience or physical
occurrence is determined to be causally related to the Products. This reporting
obligation shall be in full compliance with the MERCK Policy and Procedure No.
4, "Reporting Adverse Experiences and Adverse Physical Occurrences for Animal
Health Products," a copy of which is attached as Attachment 3 and incorporated
herein by reference. KOFFOLK shall submit a copy of such report to MERCK within
five (5) working days after learning of the adverse experience or physical
occurrence using the required RA 1932 Form, a blank copy of which is attached as
Attachment 4.
(iii) When complete information is not available within the five-day
period, KOFFOLK shall submit any available information within the five-day
period, and also submit a supplement as soon as further details become
available. MERCK shall be authorized to submit such adverse experience or
physical occurrence information to government authorities as it considers
appropriate. KOFFOLK agrees to permit MERCK to audit KOFFOLK's files for adverse
drug experience or physical occurrence on a routine basis as determined
necessary by MERCK. If MERCK becomes aware of adverse experiences or physical
occurrences which in its opinion may require a change in label content, MERCK
shall provide KOFFOLK with all information relating to such adverse experiences
or physical occurrences.
(iv) KOFFOLK agrees to provide a signed statement identifying the
category of its operation (i.e., wholesaler, retailer) and stating that it will
distribute the Products only under labeling provided for in the new animal drug
application for Product and approved by MERCK; that any other labeling or
advertising for the drug will prescribe, recommend and/or suggest its use only
under the conditions stated in the labeling provided for in the application; and
that it is regularly and lawfully engaged in the distribution of Product.
(v) KOFFOLK will advise MERCK immediately concerning any FDA
inspections, notices, or enforcement action with respect to the Product.
11. FORCE MAJEURE
Neither of the parties hereto shall be liable or be in breach of any
provision hereof for any failure or delay on its part to perform any obligation
(other than the obligation to make payments when due) under any provision of
this Agreement because of force majeure, including, but not limited to, war,
riot, fire, explosion, flood, sabotage, accident or breakdown of machinery;
unavailability of fuel, labor, containers, or transportation facilities;
accidents of navigation or breakdown or damage of vessels, or other conveyances
for air, land or sea; other impediments or
7
hindrances to transportation; strike or other labor disturbances; government
restraints or any other cause beyond the control of the party thus failing to
perform or whose performance is thus delayed.
12. TERM AND TERMINATION
(a) This Agreement shall have an Effective Date as defined herein, and
unless sooner terminated as provided herein, shall remain in full force and
effect for a period of five (5) years from the Effective Date subject to the
terms and conditions set forth herein. Thereafter the Agreement shall be renewed
for successive one (1) year periods upon mutual agreement of the parties
expressed in writing at least ninety (90) days prior to expiration of this
Agreement and each successive renewal term.
(b) Should either MERCK or KOFFOLK cease to do business or be
adjudicated as bankrupt or make an assignment for the benefit of creditors or
become involved in any insolvency proceeding or receivership proceeding, this
Agreement shall terminate immediately.
(c) This Agreement may also be terminated by MERCK on one hundred and
eighty (180) days prior written notice to KOFFOLK in the event that maintenance
of the Product registration or manufacture of the Product becomes infeasible as
reasonably determined by MERCK or MERCK divests Product via a Like Kind Exchange
arrangement with a third party.
(d) Either party may terminate the Agreement in case of material breach
by the other party, such termination to be effected by sixty (60) days prior
written notice which specifically identifies the breach and provides the
opportunity for the breach to be cured within that sixty (60) day period. By way
of example without limitation, failure by KOFFOLK to follow and comply with
Paragraph 4(h) (promotional material) and Paragraph 10 (regulatory matters)
shall be considered a material breach.
(e) MERCK may terminate this Agreement upon thirty (30) days written
notice upon a change in management or in the event that a majority of the stock,
assets or control of KOFFOLK is acquired by any other party(s) which MERCK
determines, in its sole judgment, is prejudicial to its interests. In the event
of such-change in management or control, notwithstanding the provisions of
Paragraph 13, MERCK shall have the right in its sole discretion to purchase back
any and all remaining inventory of Products at KOFFOLK's full purchase price.
(f) Upon termination of this Agreement in accordance with its terms,
KOFFOLK shall make no claim or request compensation of any kind because of such
termination. KOFFOLK agrees to waive any statutory amount which may be allowable
or imposed for such termination such as liquidated damages or other such
statutory payments, if any.
(g) Termination shall not extinguish obligations and liabilities of the
parties accrued prior to termination or non-renewal.
13. TRANSITION PERIOD
At the conclusion of the Exclusive Distribution Period, or in the event
of earlier termination under Paragraph 12 with the exception of Paragraph 12
(e), KOFFOLK shall have the right to sell any remaining MERCK product bearing
the Product label in its inventory for a period not to exceed three (3) months
from the conclusion of the Exclusive Distribution Period or the date of
termination. KOFFOLK shall notify MERCK in writing of its existing inventory of
Products at the beginning of that three (3) month period. KOFFOLK shall exercise
its best efforts to sell existing inventory of Products during this three (3)
month period. KOFFOLK further agrees to take all reasonable steps necessary to
minimize the amount of product inventory bearing the Product label remaining on
the first day immediately following conclusion of the Exclusive Distribution
Period. The parties' respective rights and obligations under the Agreement shall
remain in full force and effect during the Transition Period.
8
14. RECALL
(a) In the event MERCK shall be required or shall voluntarily decide to
recall any Product distributed by KOFFOLK pursuant to this Agreement, then
KOFFOLK shall fully cooperate with MERCK in connection with the recall. If such
recall is initiated because of the negligence or failure of MERCK to comply with
the terms of this Agreement, then MERCK will credit KOFFOLK for the price it
invoiced KOFFOLK for all Product returned and, in addition, MERCK will reimburse
KOFFOLK for all reasonable recall expenses in connection therewith. If such
recall is initiated because of the negligence or failure of KOFFOLK to comply
with the terms of this Agreement, then KOFFOLK will reimburse MERCK for all
reasonable recall expenses in connection therewith.
(b) KOFFOLK agrees to abide by all decisions of MERCK to recall Product
and both parties shall fully cooperate with each other in the event of any
recall of Product under this Agreement.
15. JURISDICTION/CHOICE OF LAW
This Agreement shall be governed by, interpreted and construed, and all
claims and disputes, whether in tort, contract or otherwise be resolved in
accordance with the substantive laws of the State of New York, United States of
America, without reference to any rules of conflict of laws or renvois. In the
event of any controversy or claim arising out of or relating to this Agreement,
performance hereunder, termination hereof, or relationship created hereby, each
party irrevocably submits to the exclusive jurisdiction of the courts of the
Supreme Court of the State of New York and the U.S. District Court for the
Southern District of New York for the purposes of any suit, action or other
proceeding arising out of this Agreement or transactions contemplated hereby.
Each party irrevocably and unconditionally waives any objection to the laying of
venue in the courts of New York as stated above and that any such action was
brought in an inconvenient forum. Notwithstanding the foregoing, in the event of
a threatened disclosure in violation of this Agreement, MERCK shall have the
right to seek injunctive relief from any competent court in the jurisdiction
where the disclosure is threatened to prevent such disclosure pending resolution
of the merits of the dispute.
16. PRODUCT WARRANTIES AND INDEMNIFICATION
(a) MERCK warrants that the Products shall meet the ingredient
specifications contained on the label and conform to MERCK's specifications for
the Products when it leaves MERCK's control. MERCK makes no other warranties,
either express or implied, including warranties of merchantability or of fitness
for a particular use.
(b) MERCK shall defend and indemnify KOFFOLK against all expenses,
claims, demands, liabilities or money judgments, including recall, incurred by
KOFFOLK arising from the negligence or fault of MERCK or from MERCK's failure to
comply with the terms of this Agreement, except to the extent that said
expenses, claims, demands, liability or money judgments are caused by the
negligence or fault on the part of KOFFOLK or KOFFOLK's failure to comply with
the terms of this Agreement.
(c) KOFFOLK shall defend and indemnify MERCK against all expenses,
claims, demands, liabilities or money judgments, including recall, incurred by
MERCK arising from the negligence or fault of KOFFOLK or from KOFFOLK's failure
to comply with the terms of this Agreement, except to the extent that said
expenses, claims, demands, liability or money judgments are caused by the
negligence or fault on the part of MERCK or MERCK's failure to comply with the
terms of this Agreement.
17. ENTIRE AGREEMENT
This Agreement and Trademark License Agreement of even date comprises
the entire Agreement between the parties and merges all prior agreements between
them relative to the Products hereunder. This Agreement may not be amended
except in writing, signed by both parties referencing this Agreement.
9
18. NOTICES
All notices hereunder required to be in writing shall be sufficient if
sent by certified mail, return receipt requested, postage prepaid, addressed as
follows:
If to MERCK: Merck & Co., Inc.
X.X. Xxx 0000
Xxxxxx, XX 00000-0000
Attention: President
Merck AgVet Division
If to KOFFOLK: Koffolk, Inc.
Xxx Xxxxxx Xxxxx
Xxxx Xxx, Xxx Xxxxxx 00000
Attn: President
19. SEVERABILITY
In the event that any one or more of the provisions contained in this
Agreement shall for any reason be held invalid, illegal or unenforceable in any
respect, such invalidity, illegality or unenforceability shall not affect any
other provisions contained in this Agreement. If any one or more of the
provisions contained in this Agreement shall for any reason be held to be
excessively broad as to time, duration, geographical scope, activity or subject,
it shall be construed by limiting and reducing it so as to be enforceable to the
extent compatible with applicable law.
20. TITLES
The titles to each paragraph of this Agreement are for reference only
and shall not be used to interpret said paragraph. All interpretations of the
meaning of each paragraph to this Agreement shall rely solely upon the wording
of the Agreement and shall not incorporate the paragraph titles for its
interpretation.
21. AMENDMENT
Except as otherwise expressly stated herein, this Agreement cannot be
amended or modified except by a written instrument which shall state that it is
an amendment or modification of this Agreement and which shall be signed and
dated by the parties hereto.
22. WAIVER
Failure by MERCK or KOFFOLK at any time to enforce any of the terms or
conditions of this Agreement shall not be deemed a continuing waiver as to such
terms or conditions, and shall not affect the right of MERCK or KOFFOLK to later
avail itself of such remedies as it may have for any subsequent breach of such
terms or conditions under the provisions of this Agreement in equity or at law.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed by their duly authorized officers or representatives as of the day and
year first above written.
KOFFOLK, INC.
By: /s/ X.X. Xxxxxxxx
-----------------
Name: X. X. Xxxxxxxx
Title: Pres.
10
MERCK & CO, INC.
By: /s/ Xxxx X. Xxxxxxx
-------------------
Name: Xxxx X. Xxxxxxx
Title: President
11
SCHEDULE A
CONFIDENTIAL TREATMENT REQUESTED FOR ALL BRACKETED ([]) INFORMATION. THE
CONFIDENTIAL PORTION HAS BEEN SO OMITTED AND FILED SEPARATELY WITH THE
COMMISSION.
[ ]
[ ]
[ ]
[ ]
[ ]
SCHEDULE B
MINIMUM SUPPLY PRICES
CONFIDENTIAL TREATMENT REQUESTED FOR ALL BRACKETED ([ ]) INFORMATION. THE
CONFIDENTIAL PORTION HAS BEEN SO OMITTED AND FILED SEPARATELY WITH THE
COMMISSION.
[ ]
[ ]
[ ]
[ ]
[ ]
SCHEDULE C
GUARANTEED PURCHASES
CONFIDENTIAL TREATMENT REQUESTED FOR ALL BRACKETED ([]) INFORMATION. THE
CONFIDENTIAL PORTION HAS BEEN SO OMITTED AND FILED SEPARATELY WITH THE
COMMISSION.
[ ]
ATTACHMENT 1
ETHICAL BUSINESS PRACTICES
KOFFOLK agrees to comply with Merck & Co., Inc.'s Ethical Business Practices
policy which reflects the highest standard of corporate and individual behavior.
KOFFOLK shall adhere to business practices which are in accordance with the
letter and spirit of applicable laws and ethical principles. KOFFOLK agrees that
all transactions in connection with MERCK's business will be accurately
reflected in its books and records, and that no funds or other assets shall be
paid directly or indirectly to government officials or persons acting on their
behalf for the purpose of influencing government decisions or actions with
respect to MERCK's business. Violation of this policy on the part of KOFFOLK,
its employees, or representatives, shall result in the immediate termination of
this Agreement.
ATTACHMENT 2
TRADEMARK LICENSE AGREEMENT
AGREEMENT, effective as of August 5, 1996 by and between MERCK & CO.,
INC., a corporation organized and existing under the laws of the State of New
Jersey, U.S.A., with an office at Whitehouse Station, New Jersey, U.S.A.
(hereinafter "Licensor"), and KOFFOLK, INC. (including its affiliates and
subsidiaries), a business entity duly organized and existing under the laws of
Delaware (hereinafter "Licensee").
WHEREAS, Licensor is the owner in the United States of America and its
territories (hereinafter the "Territory") of the right, title and interest in
and to the trademarks, AMPROL(R) (amprolium) and AMPROL(R) Plus and the
applications for registration and registrations thereof (hereinafter
"Trademarks'); and
WHEREAS, Licensee desires the right and license to use the Trademarks,
in the Territory on and in association with the sale of certain pharmaceutical
preparations containing amprolium as an active ingredient used in the treatment
of poulty (hereinafter "Products") pursuant to the Distributorship Agreement
dated August 5, 1996 between Merck AgVet, a division of Merck & Co., Inc. and
KOFFOLK, USA (hereinafter "Distributorship Agreement");
NOW, THEREFORE, for good and valuable consideration, the receipt and
sufficiency of which is hereby acknowledged, the parties herein agree as
follows:
1. Licensor hereby grants to Licensee, for the term of the Distributorship
Agreement, and Licensee accepts, an exclusive, royalty-free,
non-sublicensable, non-assignable license to use the Trademarks in the
Territory solely in connection with the packaging, promotion, and sale
of the Products.
2. Licensee shall use the Trademarks only for the Products supplied by
Licensor. From time to time, upon request of Licensor, Licensee shall
submit samples of any of the Products to Licensor or its duly appointed
agent to insure compliance with Licensor's storage and handling
specifications. Licensor, or its duly appointed agent, shall have the
right to inspect the premises of Licensee, and Licensee shall permit
such inspection, at any reasonable time, to confirm that Licensee is
adhering to Licensor's standards and specifications used in the
repackaging, storage and sale of the Products, pursuant to the
Distributorship Agreement under which Licensee is licensed herein to
use the Trademarks. Licensee shall not sell or otherwise dispose of,
any of the Products under the Trademarks that fail to comply with the
standards and specifications of Licensor as determined by Licensor. Any
economic loss resulting from the failure of Product to conform to
Licensor's quality control standards and requirements, caused by an
action or failure to act by Licensee pursuant to the terms of the
Distributorship Agreement, shall be borne by Licensee.
3. Licensee shall use the Trademarks only in such form and manner as shall
be approved in writing from time to time by Licensor. Licensee
undertakes to comply with all laws pertaining to the Trademarks in
force at any time in the Territory including, but not limited to,
compliance with marking requirements. Use of the Trademarks by Licensee
on labels and packaging or on other printed material shall be presented
as AMPROL and AMPROL(R)Plus accompanied by an appropriate statement
that such trademarks are "Licensed Trademarks", or such other
appropriate legend as Licensor shall direct. The Trademarks shall
always be given distinctive typographical treatment when used by
Licensee. Copies of all labels, packaging and other printed material on
which the Trademarks is used shall be submitted to Licensor for
approval prior to use in accordance with the terms of the
Distributorship Agreement. Licensee shall not use the Trademarks in any
manner whatsoever which may jeopardize the significance,
distinctiveness or validity thereof.
4. The Trademarks shall at all times remain the exclusive property of
Licensor and all use of the Trademarks hereunder shall inure to the
benefit of Licensor. Nothing in this Agreement shall be construed as
granting or transferring to Licensee any right, title or interest in
and to the Trademarks either by operation of law or otherwise except
the right to use the same during the term of this Agreement, as
provided in this Agreement and in the Distributorship Agreement.
5. Licensee agrees that it shall not use the Trademarks in combination
with any other trademark or trade name of its own or any third party or
as a component of its business name or to characterize its business in
any other way; and that it will use the Trademarks only on, or in
connection with, the Products, and will not use or permit use of the
Trademarks in connection with goods other than the Products; and that
the Trademarks and the goodwill associated therewith, are and shall
continue to be the exclusive property of Licensor.
6. Licensor agrees to maintain the trademark registrations for the
Trademarks. However, if the Trademarks are not in use in a particular
jurisdiction of the Territory, Licensor may allow the registration to
expire. Licensee agrees to cooperate with Licensor in providing
information, specimens, and documentation that may be useful or
required in order to effect trademark registrations, or for maintenance
and renewal of trademark registrations for the Trademarks.
7. Licensee shall, at all times, execute any documents reasonably required
by Licensor to record Licensee as a registered user or licensee of the
Trademarks. Licensee agrees to cooperate as requested by Licensor in
arranging for such recordings and/or entries, or in maintaining,
varying or canceling such recordings and/or entries in the event of
amendment to, or termination of, this Agreement for any reason.
8. In the event that Licensee learns of any infringement or threatened
infringement of the Trademarks, or any passing-off, Licensee shall
immediately notify Licensor or its authorized representative in writing
giving particulars thereof and Licensee shall provide necessary
information and assistance to Licensor or its authorized
representatives in the event that Licensor decides that proceedings
should be commenced or defended. The commencement, strategies,
termination and settlement of any action relating to the validity
and/or infringement of the Trademarks shall be decided. by Licensor.
Any such proceedings shall be at the expense of Licensor, and any
recoveries shall be to the benefit of Licensor. Nothing herein,
however, shall be deemed to require Licensor to enforce the Trademarks
against others.
9. Licensee shall promptly notify Licensor of any claims arising out of
the use of the Trademarks, and Licensor will provide for the defense
thereof with counsel of its own selection and will pay all costs and
expenses incurred in so defending against such claims, provided such
use of the Trademarks by Licensee was in accordance with the terms of
this Agreement and the Distributorship Agreement. Licensee shall also
have the right to participate in the defense of any such claim with
attorneys of its own selection, at its own expense, however, the extent
to which any such claim shall be prosecuted, defended or settled, will
be solely within the discretion of Licensor. Licensor hereby
indemnifies and shall hold harmless Licensee from and against the cost
and expenses of any claims, demands, causes of action, judgments,
damages or liabilities, arising out of the use by Licensee of the
Trademarks in accordance with the terms of this Agreement, provided
that written notice of such claim, demand or cause of action is
promptly given to Licensor and Licensee cooperates fully with Licensor
in the defense of such claim, demand or cause of action.
10. Licensee agrees to indemnify and hold Licensor harmless from and
against any and all claims and agrees to reimburse Licensor for any and
all losses, damages, costs, fees, expenses, liabilities and obligations
of any kind (including reasonable attorney's fees and other reasonable
legal costs and expenses) that Licensor may at any time suffer or
incur, or become subject to as a result of or arising from the
unauthorized use of the Trademarks by Licensee. Licensee shall have the
right to defend any such action or proceeding with
2
attorneys of its own selection, and Licensor shall have the right to be
represented by attorneys of its selection.
11. This Agreement shall be effective as of the date first written above
and shall continue in force for as long as the Distributorship
Agreement remains in effect, and shall terminate upon termination of
the Distributorship Agreement.
12. This Agreement shall terminate immediately and automatically in the
event that Licensee makes any assignment for the benefit of creditors
or shall file for, or have filed against it, a petition for bankruptcy;
or if Licensee is dissolved or loses its charter by forfeit or
otherwise or if a trustee or receiver is appointed for Licensee or for
any of its property in any proceeding, or if any court takes
jurisdiction of the property of Licensee by foreclosure or otherwise.
13. In the event that Licensee defaults or breaches any of the provisions
of this Agreement, Licensor shall have the right to terminate this
Agreement upon thirty(30) days written notice to Licensee, provided,
however, that if Licensee, within the said thirty (30) day period,
cures the default or breach to the satisfaction of Licensor, the
Agreement shall continue in full force and effect.
14. Upon termination of this Agreement for whatever reason, Licensee shall
promptly discontinue any further use of the Trademarks, and shall not
use any trademark which, in the reasonable opinion of Licensor, is
confusingly similar to the Trademarks, except that after termination of
this Agreement, Licensee may for a period of twelve (12) months
immediately following termination, sell existing stocks of the Products
bearing the Trademarks without removing the Trademarks provided that
such Products comply with the standards and specifications of Licensor,
in force at the time of termination.
15. The failure of a party to require the performance of any term of this
Agreement or the waiver by a party of any breach of this Agreement
shall not prevent a subsequent enforcement of such term nor be deemed a
waiver of any subsequent breach.
16. Should Licensee be or become aware of any applicable laws or
regulations which are inconsistent with the provisions of this
Agreement, Licensee shall promptly notify Licensor of such
inconsistency.
17. The remedies provided for in this Agreement are not exclusive of other
remedies available to the parties.
18. This Agreement may be assigned by Licensor to an affiliate without
approval, otherwise it may be assigned by either party only with the
written approval of the other party.
19. This Agreement shall be binding upon and inure to the benefit of any
successors in interest of each party.
20. All notices provided for herein shall be deemed sufficient if in
writing and delivered or sent by pre-paid registered or certified mail,
facsimile, cablegram or telex to the party hereto at its address
specified in Paragraph 18 of the Distributorship Agreement or to such
other business address as may have been furnished in writing by the
intended recipient to the sender. The date of mailing, faxing, cabling
or telexing shall be deemed to be the date on which such notice or
request has been given.
21. This Agreement, and its construction, interpretation, performance and
breach shall be governed according to the laws of the State of New
Jersey.
22. This Agreement and the Distributorship Agreement constitute the entire
agreement and understanding between the parties and supersedes all
previous agreements between them concerning the matters covered
3
herein, whether written, oral or implied. This Agreement may only be
changed or modified by written agreement signed by both parties.
4
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed by their duly authorized representatives.
KOFFOLK, INC.
By: /s/ X.X. Xxxxxxxx
-----------------
Name: X. X. Xxxxxxxx
Title: Pres.
MERCK & CO, INC.
By: /s/ Xxxx X. Xxxxxxx
-------------------
Name: Xxxx X. Xxxxxxx
Title: President
5
MERCK AGVET DIVISION POLICY AND PROCEDURE
REPORTING ADVERSE EXPERIENCES AND ADVERSE PHYSICAL OCCURRENCES FOR ANIMAL
HEALTH PRODUCTS
Date: 03/01/94
Supersedes: 10/30/92
I. Objective
To describe the procedure for reporting adverse experiences and adverse physical
occurrences for Merck animal health products, both marketed and investigational,
and to emphasize to all Merck & Co., Inc. personnel their specific
responsibilities in implementing this Procedure when required. This document
deals exclusively with animal health products. For agricultural chemical
products see Merck Ag Vet Division Policy and Procedure No. 5, and for human
pharmaceuticals see MRL Medical Affairs Procedures and Policies Manual,
Procedure No. 13.
II. Policy
This Procedure sets forth the manner in which Merck & Co., Inc. identifies,
collects and reports information about adverse experiences and adverse physical
occurrences related to animal health products so that the Company may comply
with applicable United States federal, state and local laws and regulations. The
reporting of information as required by this Procedure is in line with the
relevant legal requirements of the United States Food and Drug Administration
and other regulatory authorities. Failure to report adverse expenences and
adverse physical occurrences, as set forth below, may result in regulatory
action against the Company and may subject individual violators to disciplinary
action up to and including dismissal.
The reporting requirements set forth in this document are to be incorporated
with those required by other Merck procedures and other national or local
governmental authorities.
III. Definitions
A. Adverse Experience
An adverse experience is any unfavorable and unintended change in the structure,
function or chemistry of an animal or human being and includes any injury,
side-effect, toxicity or sensitivity reaciton that may be associated with the
use of a Merck animal health product, whether or not the experience is
considered to be causally related ot the Merck product. For a marketed product,
this would also include any failure of the marketed Merck product to exhibit its
expected pharmacological activity in the animal.
Reports of an adverse experience may originate from a variety of sources such
as: Merck or extramural research personnel, veterinarians, animal health
professionals, agricultural workers, pet and livestock owners, distributors,
sales personnel, marketing staffs, etc.
Three important classes of adverse experiences have special reporting
requirements. These are:
1) Serious Adverse Experience
A Serious adverse experience is (1) one resulting in severe funtional
debility or death of one or more animals, (2) one that is life-threatening to
man, or (3) one involving a large number of animals.
2) Unexpected Adverse Experience
6
This includes any experience not described in the labeling of the
product or not reported in the New Animal Drug Application (NADA) trials prior
to Food and Drug Administration or international approval. It also includes
those experiences that show a significant increase in incidence or severity over
what appears on the labeling of marketed drugs or in NADA trials or that are a
failure of a marketed product to achieve the claimed activity.
This includes all experiences in species of animals or classes of
livestock not listed on the labeling; i.e., reactions in animals, including man,
following extra-label or accidental usage in a species for which the product is
not approved or marketed.
3) Human Reaction To Animal Drugs
Human reactions, including those resulting from exposure due to
handling, mixing, administering or for any other reason, are adverse experiences
and must be promptly reported.
4) Nonserious and Expected Adverse Experience
Any adverse experience not falling within the definitions of III A.l, 2
or 3 will be considered nonserious and expected.
B. Adverse Physical Occurrence
An adverse physical occurrence is any of the following developments
related to a Merck animal health product:
1) a mix-up of the product or its labeling with another article;
2) any bacteriological or significant physical change or
deterioration in the product; or
3) any failure of a distributed product to meet the
specifications established for it in the NADA (See IV A.1)
C. Product Defect Complaint
Physical and/or chemical problems associated with animal heath products
manufactured and/or marketed both in and outside the United States not falling
within the above definitions for adverse experiences" or "adverse physical
occurrences" are considered "product defect complaints." Product defect
complaints are covered under a separate procedure administered by MMD.
IV. Reporting Procedures
A. Adverse Experiences and Adverse Physical Occurrences Associated with
the Use of Marketed Products
Any employee or Merck who learns of a serious, unexpected or human
adverse experience or adverse physical occurrence (as defined in III A & B)
associated with a marketed product must report it to his/her immediate
supervisor, who will in turn ensure that the report is pased without delay to
the Merck AgVet Technical Services representative with responsibility for that
market, the Animal Health & Agriculture Research & Development (AHAD) Director
or the Merck AgVet Country Director, as appropriate. It is the responsibility of
those individuals who receive such information to act as follows:
7
1) in the case of human reactions to animal drugs in particular,
but also serious and unexpected adverse experiences in animals
and adverse physical occurrences (III.A.1 and 2 and III.B), to
advise Regulatory Affairs in Woodbridge (WBC-130) immediately
by the fastest route possible (e.g., telephone, telex,
facsimile, etc.) of any initial information available,
followed within five working days, with a written report, as
required in IV A.2 (See Addendum I).
The requirement for the expeditious reporting of human adverse
experiences to AHAD Regulatory Affairs is in addition to the
MRL Medical Affairs Procedures and Policies Manual, Procedure
No. 13 requirement that any human adverse experience
temporally associated with exposure to an AgVet product be-
reported to Worldwide Product Safety and Epidemiology (WPS&E)
within two working days. Worldwide Product Safety &
Epidemiology has the responsibility for submitting reports of
human adverse experiences associated with AgVet products to
the Food and Dnzg Adminstration's Center for Drug Evaluation
and Research.
2) to prepare and submit to Animal Health & Agricultural Research
& Development (AHAD) Regulatory Affairs, in Woodbridge, on
Form RA1932 within five working days a detailed written report
of any adverse experiences or adverse physical occurrences.
Where full details are not available when the RA1932 is filed,
a follow-up RA1932 (specifically identifying that it is a
follow-up) providing all details, must be filed within one
calendar month. Upon receipt of such reports, AHAD Regulatory
Affairs will advise Merck AgVet Technical Services, Merck
AgVet Legal Counsel and the Merck Ag Vet Quality Complaint
Manager and will provide them with a copy of the related
written report (Form RA1932). AHAD Regulatory Affairs will
ensure that WPS&E has also received an initial report on any
human adverse experience and will ensure that the Vice
President, AHAD and the Executive Directors of Regulatory
Affairs, ASR and Technical Services or their designated
representatives receive expeditious notification of human
adverse experience incidents associated with exposure to
animal health products. If the adverse experience or adverse
physical occurrence is from a study conducted under an INAD
exemption, a narrative summary should be used instead of Form
RA1932.
3) to record all nonserious and expected adverse experiences (Ill
A.4) when received on Form RA1932 and submit the forms once
each quarter to AHAD Regulatory Affairs in Woodbridge (WBC-1
30) (See Addendum I). These need not be reported by telephone,
telex or facsimile to Woodbridge; and
4) to, in addition, report adverse experiences and adverse
physical occurrences, as may be required, to local regulatory
authorities in compliance with local regulatory requirements.
B. Adverse Experiences Associated with Investigational Studies
Merck field investigators and outside investigators, such as
veterinarians, university collaborators, etc. must be instructed verbally and by
protocol to notify their Merck monitor immediately or any adverse experience or
adverse physical occurrence involving either marketed or non-marketed products.
The supervisor, superior or monitor will in turn ensure that the report
is passed without delay to the Animal Science Research AHAD Area Director.
Regulatory Affairs, AHAD, is responsible for reporting adverse
experiences and adverse physical occurrences to the Food and Drug
Administration.
8
V. Reporting By Non-Merck Entities
All distributorship agreements, license agreements, patent and know-how
licenses, etc. must include provisions for reporting of adverse experiences and
adverse physical occurrences in accordance with Company procedures.
Accordingly, all parties should be alerted during negotiations that
Merck considers that to be a vital aspect of any agreement.
Attachments:
Addendum I: Communicating Adverse Experiences/Adverse Physical Occurrences to
Regulatory Affairs in Woodbridge
Addendum II: Guidelines for Handling the Complainant and the Investigation
Reporting Form RA1932
Addendum III: Form RA 1932
9
ADDENDUM I
COMMUNICATING ADVERSE EXPERIENCES/ADVERSE PHYSICAL
OCCURRENCES
TO REGULATORY AFFAIRS IN WOODBRIDGE
I. All communications should be directed to:
Xxxxxxxx X. Xxxx
Manager, Regulatory Coordination & Planning
Regulatory Affairs
Animal Science Research
Merck & Co., Inc.
X.X. Xxx 0000
XX00-000
Xxxxxx, XX 00000-0000
Telephone Number: (908) 594--4624
Panafax Number: (908) 594--4395
2. If a full report is not or will not be available within the five-day
reporting time due to delays in the investigation and/or reporting of the
necropsy, pathology, bacteriology results, etc., the responsible investigator
should relay as much information as is available; i.e., according to Form
RA1932, to Woodbridge as soon as possible. Upon receipt of this information in
Woodbridge, a preliminary Adverse Reaction/Adverse Physical Occurrences Report
will be prepared and sent to the FDA as required.
Note that a facsimile of the Form RA1932 can be transmitted to
Woodbridge by Rapifax and Panafax and is usually received within a twenty-four
hour period.
3. When the additional information concerning a specific adverse reaction
is received from the responsible field investigator, a follow-up request will be
prepared and sent to the FDA. This will complete the file.
4. All written correspondence should indicate clearly that the
investigator is actually reporting an adverse experience of adverse physical
occurrence.
10
ADDENDUM II
GUIDELINES FOR HANDLING THE COMPLAINANT AND TEE INVESTIGATION
The following guidelines are provided for Merck personnel responsible
for dealing with persons who have made a complaint and for investigating the
complaint itself:
1. Admit no liability under any circumstances. Do not become involved in
conversations dealing with lawsuits or litigation or Merck liability with
respect to claims.
2. If dictated by the circumstances, apparent seriousness of the case, or
need to obtain detailed information, visit the complainant personally. Take the
distributor or salesperson with your where appropriate.
3. In dealing with the complainant, show that you take the complaint
seriously. With simple common sense and courtesy:
a. Listen; do not argue.
b. Ask questions openly and simply; record the details.
4. Observe the complainant, his or her operation, the people, animals,
crops and equipment etc. concerned; note for inclusion in your report any
details you think have a bearing on the facts and/or the validity of the
complaint.
5. Take photographs of the subject matter of the complaint, if
appropriate.
6. Obtain a number of samples appropriate for testing commensurate with
the nature of the complaint. In the case of product sizes not larger than one
liter/one kilo, approximately four to twelve specimens will normally be
adequate. For larger sizes, or when in doubt, consult with superiors.
7. When appropriate, attempt to retain and preserve for testing specimens
of the animals or crops concerned.
8. Advise the complainant that you must report the complaint to
head-quarters for further action and that you will contact him/her as soon as
possible. Make no promises! Do not propose any solution except under specific
instructions from headquarters.
9. No claims should be settled without prior headquarters and, where
appropriate, legal approval and execution of a proper release.
11
ADDENDUM III
FORM RA 1932
ADVERSE REACTION, LACK OF EFFECTIVENESS, PRODUCT DEFECT REPORT
1. REPORT SOURCE AND ADDRESS (MFR. DISTR.)
2.
3. TYPE OF REPORT
INITIAL
FOLLOW UP TO REPORT OF (GIVE DATE)
4. NAME, ADDRESS AND PHONE NO. OF ATTENDING VETERINARIAN (IN CONFIDENCE)
5. NAME OR CASE IDENTIFICATION OF OWNER (IN CONFIDENCE)
6. TRADE NAME AND GENERIC NAME OF ACTIVE INGREDIENT(S) (INCLUDE DOSAGE
FORM AND STRENGTH - EX. TAB, 500 MG.)
7. NAME OF MANUFACTURER
8. LOT NUMBER
9. DOSAGE REGIMEN AND XXXXX (XX. 000 XX., X, 00 X, X.X.)
00. DATES OF ADMINISTRATION
11. ILLNESS/REASON FOR USE OF THIS DRUG
12. DRUG WAS ADMINISTERED BY
VETERINARIAN, STAFF
OWNER, OTHER
13. NUMBER OF ANIMALS IN THIS INCIDENT
TREATED WITH DRUG
REACTED
DIED
14. REACTING ANIMALS
SPECIES
BREED
AGE
WEIGHT
SEX
FEMALE
MALE
PREGANT
NEUTERED
15. CONCOMITANT MEDICAL PROBLEMS
16. OVERALL STATE OF HEALTH AT TIME OF REACTION
GOOD
FAIR
POOR
CRITICAL
17. DID ANY NEW ILLNESS DEVELOP OR DID INITIAL DIAGNOSIS CHANGE AFTER
SUSPECT DRUG STARTED NO YES (EXPLAIN)
18. CONCOMITANT DRUGS ADMINISTERED
NAME OF DRUG
ROUTE
DOSAGE REGIMEN
DATE(S) OF XXXXXXXXXXXXXX
00
00. DESCRIBE SUSPECTED ADVERSE REACTION: INCLUDE ALL SIGNS, RESULTS OF
PERTINENT LAB TESTS, NECROPSY RESULTS, POSSIBLE CONTRIBUTING FACTORS,
ETC. ALSO INCLUDE IN THIS ECTION PRODUCT INEFFECTIVENESS AND PRODUCT
DEFECTS SUCH AS CRACKED TABLETS, CLOUDY SOLUTION, ETC.
20. ATTENDING VETERINARIAN'S LEVEL OF SUSPICION THAT DRUG CAUSED REACTION
HIGH
MEDIUM
LOW
NO ATTENDING VET.
21. LENGTH OF TIME BETWEEN LAST ADMINISTRATION OF SUSPECT DRUG AND ONSET OF
REACTION
22. DATE OF ONSET (MO., DAY, YR.)
23. DURATION OF REACTION (HRS., DAYS, ETC.)
24. WAS THE ADVERSE REACTION TREATED?
NO
YES (DESCRIBE TREATMENT)
25. OUTCOME OF REACTION OT DATE
DIED
REMAINS UNDER TREATMENT
ALIVE WITH SEQUELAE
RECOVERED
UNKNOWN
26. WHEN REACTION APPEARED, TREATMENT WITH SUSPECT DRUG:
HAD ALREADY BEEN COMPLETED
DISCONTINUED DUE TO THE REACTION
DISCONTINUED, REPLACED WITH ANOTHER DRUG
DISCONTINUED, REINTRODUCED LATER
CONTINUED AT ALTERED DOSAGE
OTHER (EXPLAIN)
AND THE REACTION
CONTINUED
STOPPED
RECURRED
OTHER (EXPLAIN)
27. HAD ANIMAL(S) BEEN PREVIOUSLY EXPOSED TO THIS DRUG?
NO
YES
UNKNOWN
28. DID ANIMALS PREVIOUSLY REACT TO THIS DRUG:
NO
YES
UNKNOWN
29. HAD ANIMALS PREVIOUSLY REACTED TO OTHER DRUGS?
NO
YES (IF YES, GIVE DRUG(S) AND REACTION IF KNOWN)
UNKNOWN
30. HAS THE ATTENDING VETERINARIAN SEEN SIMILAR REACTIONS TO THIS DRUG IN
ANY OTHER ANIMALS?
NO
YES (IF YES, SUMMARIZE)
13
31. NAME AND TITLE OF INDIVIDUAL RESPONSIBLE FOR ACCURACY OF REPORTED
INFORMATION (TYPE OR PRINT)
32. SIGNATURE OF INDIVIDUAL RESPONSIBLE FOR ACCURACY OF REPORTED
INFORMATION
14
