Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions, marked by * and [ ], have been
separately filed with the Commission.
Ex. 10.78 CONTRACT MANUFACTURING AGREEMENT
This Agreement is entered into as of this 21st day of November 1995, by
and between Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road,
Ridgefield, Connecticut 06877 (hereinafter referred to as "BOEHRINGER"), and
Interneuron Pharmaceuticals, Inc., One Ledgemont Center, 99 Hayden Avenue,
Lexington, Massachusetts 02173 (hereinafter referred to
as "INTERNEURON").
WHEREAS, BOEHRINGER is a contract manufacturer of pharmaceutical
products; and
WHEREAS, INTERNEURON desires that BOEHRINGER manufacturer and supply to
INTERNEURON the Product, as hereinafter defined , and
WHEREAS, BOEHRINGER is willing to manufacture and supply the PRODUCT as
hereinafter defined, to INTERNEURON in accordance with the provisions hereof.
NOW THEREFORE, in consideration of the premises and the undertakings of
the parties hereinafter set forth, the parties agree as follows:
1. DEFINITIONS
1.1 "PRODUCT" shall mean the capsule dosage form of the pharmaceutical
product containing 15 mg. of dexfenfluramine HCl, packaged for sale in bottles
of either 60, 100, 500 or 1,000 capsules each, or in blister cards containing 10
capsules with 10 cards per package, or packaged for distribution as samples in a
form to be agreed upon by the parties, which meets the SPECIFICATIONS.
1.2 "SPECIFICATIONS" shall mean any and all specifications for the
manufacture, testing, labeling and packaging of the PRODUCT, as provided by
INTERNEURON to BOEHRINGER, attached as Exhibit A and as modified from time to
time. All SPECIFICATIONS and any changes agreed to by the parties from time to
time shall be in writing, dated and signed by the parties.
1.3 "NDA" shall mean the New Drug Application for the PRODUCT submitted
to the FDA and as subsequently approved by the FDA as the same may be
supplemented or amended from time to time.
1.4 "FDA" shall mean the U.S. Food and Drug Administration.
1.5 "DEA" shall mean the U.S. Drug Enforcement Administration.
1.6 "ACTIVE INGREDIENT" shall mean the active ingredient
dexfenfluramine HCl, provided to BOEHRINGER free of charge, for use in the
manufacture of the PRODUCT.
1.7 "BATCH(ES)" shall mean approximately 840,000 capsules of the
PRODUCT,
1
presently containing approximately 12.6 kg of the ACTIVE INGREDIENT in the
manufacture of each such BATCH. INTERNEURON shall use its best efforts to have
the size of the BATCH increased to 3,360,000 capsules, containing approximately
50.4 kg of the ACTIVE INGREDIENT of the PRODUCT by the FDA, or such other size
as INTERNEURON and BOEHRINGER shall mutually agree. When the batch size is
increased it is expected that the BOEHRINGER cost structure would reflect the
resulting economies of scale.
1.8 "LAUNCH" shall mean the date of first commercial shipment of the
PRODUCT by INTERNEURON or its distributor to third parties other than its
affiliates or distributors after approval of the NDA.
1.9 "GOVERNMENTAL AGENCY" shall mean any federal or state government
authority that has jurisdiction over the manufacture, marketing, use and
distribution of the Product and includes, but is not limited to, the Food and
Drug Administration (FDA), Federal Trade Commission (FTC), Environmental
Protection Agency (EPA) and Drug Enforcement Agency (DEA).
1.10 "COST" shall include material, labor consumed and all applied
production overhead as defined in Schedule B.
1.11 "FDA's cGMP's" shall mean current good manufacturing practices
required by the FDA for the production of the PRODUCT as set forth under 21 CFR
210 and 211.
2. QUANTITY
2.1 Subject to the terms and conditions hereinafter set forth,
BOEHRINGER shall manufacture and sell to INTERNEURON and INTERNEURON shall
purchase from BOEHRINGER, such orders for the PRODUCT as shall be placed from
time to time by INTERNEURON on its own behalf and on behalf of its distributor
for sale in the United States during the Initial Term (as hereinafter defined in
Paragraph 3.1 hereof) of the Agreement. Subject to the terms and conditions
contained herein, BOEHRINGER shall convert the ACTIVE INGREDIENT, supplied to
BOEHRINGER, into PRODUCT and shall package, label and otherwise prepare for the
market the PRODUCT, all in accordance with the SPECIFICATIONS.
3. TERM OF AGREEMENT
3.1 The term of this Agreement shall extend from the date first set
forth above and shall continue through the Initial Term, which is defined as the
period following the date of final written approval of INTERNEURON's NDA from
the FDA of the PRODUCT through December 31, 1998.
2
3.2 INTERNEURON may terminate its obligations under this Agreement upon
written notice, at any time before approval or up to ninety (90) days after
approval of the PRODUCT's NDA, if INTERNEURON decides for commercial reasons
that neither it nor its distributor will market or promote the PRODUCT in the
United States. In such event, INTERNEURON shall pay to BOEHRINGER the sum Four
Hundred Fifty Thousand ($450,000) dollars and reimburse BOEHRINGER as provided
in Paragraphs 3.8, 4.18 and 12.4. INTERNEURON's obligation to purchase minimum
quantities of PRODUCT, during the Initial Term, pursuant to Paragraph 3.5, would
cease upon termination under the operation of this Paragraph.
3.3 This Agreement may be terminated by written notice by either
INTERNEURON or BOEHRINGER in the event that the other is in breach of this
Agreement or has defaulted in any material manner and shall have failed to
remedy such breach or default within sixty (60) days after notice thereof from
the other party.
3.4 In the event INTERNEURON fails to secure approval from the FDA to
market the PRODUCT by November 23, 1997, BOEHRINGER may upon written notice
terminate this Agreement unless INTERNEURON agrees to pay to BOEHRINGER $62,500
for each three (3) month period (or a part thereof) commencing November 23, 1997
until the NDA receives FDA approval or the NDA is withdrawn. Payments to
BOEHRINGER pursuant to this paragraph shall be made within thirty (30) days of
the end of each three (3) month period. If FDA approval once received, is later
withdrawn or suspended for a period of six (6) months, BOEHRINGER or INTERNEURON
may at its option and upon written notice terminate this Agreement. If after
LAUNCH, the DEA changes the PRODUCT to a Schedule I or II drug, either
BOEHRINGER or INTERNEURON may at its option and upon written notice terminate
this Agreement.
3.5 INTERNEURON shall be required to purchase a minimum of five (5)
BATCHES of PRODUCT during each twelve (12) month period or part thereof of the
Initial Term, except that Product produced for INTERNEURON prior to LAUNCH shall
be credited towards satisfying INTERNEURON's minimum purchase obligation during
the first twelve (12) month period of the Initial Term. In the event INTERNEURON
fails to purchase the minimum quantities set forth in this Paragraph 3.5,
INTERNEURON shall pay to BOEHRINGER a sum equal to the difference between the
price of such minimum quantities pursuant to Paragraph 7.1 based on a blended
price computed by deriving the weighted average of the prices of the packaged
sizes ordered by INTERNEURON in the last three (3) month order period and in the
event no orders were placed, then based
on the price of bottles of 60. Payment to be made within thirty (30) days of
receipt of BOEHRINGER's invoice. INTERNEURON's obligation to purchase the
foregoing minimum quantities shall be suspended in the event that INTERNEURON's
inability to purchase such quantities is attributable solely to the fault of
BOEHRINGER.
3.6 If either INTERNEURON or BOEHRINGER shall commence as debtor to any
proceedings under any bankruptcy, insolvency, reorganization, readjustment of
debt, dissolution or liquidation law or statute of the Federal Government or any
State Government or any
3
subdivision of either now or hereafter in effect; or if any such proceedings
shall be commenced against either party, or any trustee or receiver in respect
of either party shall be appointed in any such proceedings, and any such party
shall by any act or failure to act indicate approval of, or consent to or
acquiescence in such proceedings or in the appointment of any such trustee or
receiver; or if any such proceedings brought against either party shall be
approved by any court or shall remain undismissed for thirty (30) days; or if
any warrant of attachment shall be issued against all, or substantially all, of
the assets of either party and shall not be released within thirty (30) days
after its levy, then, in any such case, such other party not involved in such
proceedings, other than as a creditor, shall have the option to terminate this
Agreement by written notice and upon the giving of such notice this Agreement
shall immediately terminate.
3.7 If upon approval of INTERNEURON's NDA or during the Initial Term of
this Agreement, the PRODUCT, which is represented to be a Schedule IV drug, is
required by the FDA to be identified under 21 CFR 1308.13 as a Schedule III
drug, then the parties shall meet to determine the changes to be required in the
manufacturing facilities to enable BOEHRINGER to manufacture and/or store the
PRODUCT. The additional COSTS, if any, associated with a change in Schedule
shall be identified by BOEHRINGER. BOEHRINGER may upon written notice terminate
this Agreement unless INTERNEURON agrees to pay to BOEHRINGER the additional
COSTS required to enable BOEHRINGER to manufacture and/or store such Schedule
III drug. Notwithstanding anything to the contrary, BOEHRINGER shall not be
required or obligated to alter its facilities to manufacture or store Schedule I
or II drugs in the event that the PRODUCT is required to be listed as a Schedule
I or II drug.
3.8 Upon the expiry, termination or cancellation of this Agreement by
either party, for any reason other than BOEHRINGER's breach, INTERNEURON shall
purchase from BOEHRINGER all remaining PRODUCT which was ordered by INTERNEURON
at the price then in effect or in the case of work-in-process at BOEHRINGER's
COST. Ingredients (other than the ACTIVE INGREDIENT) and any packaging and/or
labeling components which are used to manufacture the PRODUCT shall be purchased
by INTERNEURON at BOEHRINGER's COST. The foregoing, as well as any ACTIVE
INGREDIENT, shall be shipped to INTERNEURON, or its designee F.O.B. BOEHRINGER's
warehouse in Danbury, Connecticut. INTERNEURON shall also be responsible for
reimbursing BOEHRINGER for any actual out-of-pocket costs incurred by BOEHRINGER
as the result of binding purchase commitments it has made with respect to the
PRODUCT, but which BOEHRINGER cannot terminate prior to the termination or
cancellation of the Agreement. Notwithstanding the foregoing, BOEHRINGER shall
purchase from INTERNEURON such quantities of packaging components and /or
ingredients that it can use itself at its Danbury, Connecticut manufacturing
facility.
4. PERFORMANCE
4
4.1 INTERNEURON shall supply BOEHRINGER with copies of the chemical,
manufacturing control and approved labeling sections of the NDA and any
amendments thereto, which shall be identified as SPECIFICATIONS and attached as
Exhibit A. INTERNEURON shall cooperate fully with BOEHRINGER in providing
technical assistance and associated services to enable BOEHRINGER to produce the
PRODUCT, labeling components and packaging components in conformity with the
SPECIFICATIONS. BOEHRINGER will manufacture PRODUCT in accordance with FDA
cGMP's. Any process deviations, associated with manufacturing , packaging,
labeling or testing the PRODUCT will be reported by BOEHRINGER to INTERNEURON.
4.2 Except for the ACTIVE INGREDIENT, and finished camera ready art for
all labeling, which will be provided by or on behalf of INTERNEURON, BOEHRINGER
shall supply all other ingredients and all packaging and labeling components as
set forth in the SPECIFICATIONS. INTERNEURON shall also advise BOEHRINGER of the
identity of the PRODUCT's distributor so that the labeling components are
properly prepared.
4.3 The ACTIVE INGREDIENT required by BOEHRINGER for the manufacture of
PRODUCT will be supplied by or on behalf of INTERNEURON at no charge, in lot
size quantities as determined by the manufacturer of the ACTIVE INGREDIENT.
4.4 With respect to the ACTIVE INGREDIENT, INTERNEURON shall provide to
BOEHRINGER a copy of any Supplement to the NDA, as submitted to the FDA and the
changes thereto. In the event BOEHRINGER considers such change(s) may affect its
manufacture of the PRODUCT, BOEHRINGER may run such additional validation
testing as both BOEHRINGER and INTERNEURON deem necessary, the COST of such
additional testing shall be billed to and paid for by INTERNEURON.
4.5 INTERNEURON, or the ACTIVE INGREDIENT supplier shall test or cause
to be tested the ACTIVE INGREDIENT prior to delivery to BOEHRINGER. A written
certificate of analysis shall be sent to BOEHRINGER by INTERNEURON with the
shipment.
4.6 Upon receipt of the ACTIVE INGREDIENT in bulk form, BOEHRINGER
shall inspect such ACTIVE INGREDIENT and assay samples thereof in accordance
with the same monograph procedures provided by and used by INTERNEURON or the
ACTIVE INGREDIENT supplier, attached as Exhibit C and as modified from time to
time. BOEHRINGER shall notify INTERNEURON within twenty-eight (28) business days
of receipt of any shipment of ACTIVE INGREDIENT which does not meet monograph
specifications and shall cooperate with INTERNEURON or the ACTIVE INGREDIENT
supplier in verifying the non-conformity of such ACTIVE INGREDIENT.
4.7 Any questions raised by BOEHRINGER with respect to the ACTIVE
INGREDIENT or the certificate of analysis shall be directed to INTERNEURON, who
shall use its best efforts to quickly answer such questions and/or investigate
the cause of any non-conformity. BOEHRINGER's COSTS for testing any
non-conforming ACTIVE INGREDIENT and for returning it to INTERNEURON or the
supplier of the ACTIVE INGREDIENT, shall be paid by INTERNEURON. Except as
otherwise set forth herein, upon
5
delivery to the carrier, BOEHRINGER shall have no liability with respect to the
non-conforming ACTIVE INGREDIENT.
4.8 Failure of BOEHRINGER to give written notice to INTERNEURON within
twenty-eight (28) business days of receipt that any shipment of ACTIVE
INGREDIENT does not meet SPECIFICATIONS shall constitute the presumption that
such ACTIVE INGREDIENT does meet SPECIFICATIONS. Notwithstanding any other
provision of this Agreement, BOEHRINGER shall not be liable for losses of ACTIVE
INGREDIENT or PRODUCT caused by the failure of ACTIVE INGREDIENT to meet
SPECIFICATIONS if such failure could not have been detected by BOEHRINGER at the
time of delivery or if the ACTIVE INGREDIENT was produced following a route of
synthesis different than the route of synthesis described in the PRODUCT's NDA.
4.9 BOEHRINGER agrees that it will use the ACTIVE INGREDIENT only for
the purpose of manufacturing PRODUCT for INTERNEURON. INTERNEURON or its
designee shall at all times have sole title to all ACTIVE INGREDIENT and to
finished camera ready art for labeling supplied by INTERNEURON or its designee
to BOEHRINGER hereunder. All ACTIVE INGREDIENT, and any other materials supplied
by INTERNEURON or its designee and PRODUCT manufactured hereunder shall be
clearly identified as the property of INTERNEURON. Upon the termination or
expiry of this Agreement, the ACTIVE INGREDIENT and other materials supplied by
INTERNEURON or its designee remaining in the possession of BOEHRINGER which have
not been manufactured and packaged as PRODUCT shall be returned to INTERNEURON
or its designee pursuant to Paragraph 3.8.
4.10 INTERNEURON shall arrange and pay for transportation and transit
insurance for the shipment of the ACTIVE INGREDIENT to BOEHRINGER's facility in
Connecticut and its return to INTERNEURON or its designee, if necessary.
INTERNEURON will cooperate with BOEHRINGER so that each shipment of the ACTIVE
INGREDIENT shall arrive at BOEHRINGER's facility not more than one hundred
eighty (180) days, but at least ninety (90) days prior to its planned use (based
upon INTERNEURON's forecast) by BOEHRINGER.
4.11 The parties agree, that except as otherwise provided in Paragraphs
4.8, 4.13, 14.2 and this Paragraph, BOEHRINGER shall not be liable to
INTERNEURON for any loss, damage, or destruction of the ACTIVE INGREDIENT.
During the term of this Agreement, BOEHRINGER shall maintain insurance against
the risk of damage to or loss of ACTIVE INGREDIENT and other materials supplied
by INTERNEURON or its designee hereunder and PRODUCT manufactured by BOEHRINGER.
BOEHRINGER's insurance policy shall include INTERNEURON as an additional
insured. BOEHRINGER shall furnish INTERNEURON, at its request, with
certification of insurance showing the above coverage, signed by an authorized
agent of the insurance company.
6
The information below marked by * and [ ] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been separately filed with
the Commission.
4.12 BOEHRINGER shall keep appropriate and complete records to monitor
inventory levels and utilization of the ACTIVE INGREDIENT, and materials
provided by INTERNEURON or its designee, and the PRODUCT. Copies of such reports
shall be forwarded to INTERNEURON within twenty (20) days of the end of each
calendar quarter or more frequently as requested by INTERNEURON, but in no event
more than once per month. INTERNEURON or its designee shall be given access to
BOEHRINGER's facilities to visually inspect the ACTIVE INGREDIENT and any
inventories of materials it provides to BOEHRINGER as set forth in Paragraph
13.1.
4.13 In manufacturing PRODUCT and in conducting quality control tests
some losses of ACTIVE INGREDIENT are considered inevitable and expected. Losses
of ACTIVE INGREDIENT in excess of five (5%) percent of the amount of ACTIVE
INGREDIENT used annually during the manufacture of the PRODUCT or in conducting
quality control tests is considered to be excessive. BOEHRINGER shall take all
reasonable steps to minimize ACTIVE INGREDIENT losses. BOEHRINGER shall provide
to INTERNEURON an inventory reconciliation report for each lot of ACTIVE
INGREDIENT. Such report shall be forwarded to INTERNEURON within thirty (30)
days after each lot of ACTIVE INGREDIENT is completely utilized. BOEHRINGER
shall reimburse INTERNEURON, or issue a credit to INTERNEURON, offsetable within
sixty (60) days of the end of a calendar year for any loss of the ACTIVE
INGREDIENT in the actual manufacturing/testing process, which is in excess of
five (5%) percent of the amount of ACTIVE INGREDIENT required to manufacture the
number of BATCHES of PRODUCT delivered to INTERNEURON or its designee during
such calendar year. For the purposes of this paragraph, the ACTIVE INGREDIENT
shall be valued at the lowest cost available to INTERNEURON, (presently
[******]/kg.) .
4.14 BOEHRINGER agrees that, during the term of this Agreement and for
three (3) years following termination, it will not manufacture the PRODUCT for,
nor sell the PRODUCT to, any person other than INTERNEURON, (provided
INTERNEURON or its designee, is still actively marketing or promoting the
PRODUCT). BOEHRINGER recognizes that the confidentiality obligations as set
forth in Paragraph 10 survives the expiry or termination of this Agreement.
4.15 BOEHRINGER shall test and release the PRODUCT prior to shipment to
INTERNEURON or its designee. The number and location of shipping point(s), shall
be agreed upon by the parties, but in no event shall the number of shipping
points exceed eight (8). BOEHRINGER shall be under no obligation to ship PRODUCT
to any shipping points in quantities that do not constitute full pallet load(s)
of each package size.
4.16 INTERNEURON or its designee may test or cause to be tested the
PRODUCT after receipt. If, within forty-six (46) calendar days after receipt of
the PRODUCT by INTERNEURON or its designee, INTERNEURON notifies BOEHRINGER in
writing that the PRODUCT does not meet SPECIFICATIONS, BOEHRINGER shall with
reasonable promptness replace all such non-conforming PRODUCT, with PRODUCT
meeting SPECIFICATIONS at no cost to INTERNEURON. BOEHRINGER shall bear freight,
tax, insurance and any actual out-of-pocket cost incurred by INTERNEURON in
transporting such replacement PRODUCT to one of INTERNEURON's eight (8)
designated shipping points.
7
The parties acknowledge that BOEHRINGER shall not be responsible for any loss,
costs or claims associated with such non-conforming PRODUCT, if INTERNEURON or
its designee have shipped PRODUCT to their customers either prior to
ascertaining the results of any pre- release testing performed by INTERNEURON
and/or its designee or if INTERNEURON or its designee has negligently performed
such test. Notwithstanding the foregoing, it is understood and agreed by the
parties that INTERNEURON or its designee shall have no obligation to test each
batch of the PRODUCT provided to it by BOEHRINGER. Notification by INTERNEURON
to BOEHRINGER of non-conforming PRODUCT shall indicate the SPECIFICATION claimed
to be unmet and the test procedure used in making this conclusion.
Non-conforming PRODUCT shall, upon mutual agreement by BOEHRINGER and
INTERNEURON and at BOEHRINGER's sole expense, either (i) be returned to
BOEHRINGER within a reasonable period of time and relabelled or reworked as
permitted in the NDA or if permitted by the FDA or (ii) destroyed. A credit
shall be issued by BOEHRINGER within thirty (30) days of agreement that the
PRODUCT is non-conforming or such determination of non- conformance is made by
an independent testing laboratory. Such credit shall include the cost of any
ACTIVE INGREDIENT provided to BOEHRINGER by INTERNEURON or its designee which
was destroyed or otherwise lost in connection with such non-conforming PRODUCT.
INTERNEURON's or its designee's failure to notify BOEHRINGER of a failure to
meet SPECIFICATIONS within forty-six (46) calendar days after INTERNEURON's
receipt of PRODUCT shall constitute irrevocable acceptance of such PRODUCT by
INTERNEURON.
If the analysis or assay of a sample of the PRODUCT performed by
either party differs from the other party's analysis or assay of its sample from
the same shipment or BATCH, the parties shall conduct a joint investigation to
determine whether the PRODUCT met SPECIFICATIONS and the cause of the PRODUCT
not meeting SPECIFICATIONS.
4.17 Either of the parties hereunder shall have the right to request
changes to the SPECIFICATIONS. Recommendations to change any SPECIFICATIONS
shall be in writing. No change in the SPECIFICATIONS shall be implemented by
BOEHRINGER, whether requested by INTERNEURON or requested or required by any
Governmental Agency, until the parties have agreed in writing to such change and
the implementation date of such change. The COSTS associated with any changes to
the SPECIFICATIONS requested by INTERNEURON shall be paid by INTERNEURON and any
savings shall be credited to INTERNEURON.
4.18 Inventories of PRODUCT, ingredients (other than ACTIVE
INGREDIENT), packaging and labeling components, and in-process work which cannot
be used by BOEHRINGER as the result of a change in the SPECIFICATIONS or as the
result of the termination or expiration of this Agreement shall be identified by
BOEHRINGER and purchased by INTERNEURON from BOEHRINGER at BOEHRINGER's direct,
out-of-pocket cost. BOEHRINGER agrees to maintain inventories at levels
consistent with its customary business policy.
8
4.19 BOEHRINGER shall promptly notify INTERNEURON of any problems or
unusual production situations which have the potential to adversely affect
production of the PRODUCT, or its timely delivery to INTERNEURON or its
distributor. INTERNEURON shall promptly notify BOEHRINGER of any problems which
have the potential to affect INTERNEURON's obligation to deliver ACTIVE
INGREDIENT to BOEHRINGER.
4.20 In the event BOEHRINGER shall be unable to manufacture or have
manufactured and deliver PRODUCT in sufficient quantities to satisfy
INTERNEURON's forecasted requirements, (due to any cause, except an act or
omission of INTERNEURON or its designee), and such inability shall continue or
is projected to persist for a period in excess of ninety (90) days, INTERNEURON
may manufacture the PRODUCT, or have the PRODUCT manufactured by a third party,
during the continuation of such period of inability to manufacture. BOEHRINGER
shall inform INTERNEURON of the expected duration of its inability to
manufacture PRODUCT and shall keep INTERNEURON informed on a timely basis of
developments during any such period of time. The parties shall cooperate to
expedite the scheduling of the resumption of manufacture of PRODUCT by
BOEHRINGER when any such inability has been alleviated.
4.21 INTERNEURON shall have the right to qualify a second source of
supply at any time during the term of this Agreement. The PRODUCT produced by
such second source during the process of validating the second source, and/or
thereafter during the term of this Agreement, may be sold by INTERNEURON itself
or through its distributor in the United States without being considered a
breach of this Agreement, provided, however, that (a) INTERNEURON may obtain
from such second source an amount of PRODUCT equal to a maximum of ten percent
(10%) of any amount of the PRODUCT produced by BOEHRINGER for so long as
BOEHRINGER's annual production amount of the PRODUCT supplied to INTERNEURON in
such calendar year is less than 113 million capsules of PRODUCT; and (b) if
BOEHRINGER's annual production amount of PRODUCT supplied to INTERNEURON is
greater than 113 million capsules of PRODUCT, INTERNEURON shall have the right
to obtain all or any part of its requirements of the PRODUCT in excess of 113
million capsules of PRODUCT from such second source.
4.22 BOEHRINGER shall initiate and maintain a product stability program
according to the stated commitment described in INTERNEURON's NDA. Any results
not meeting the SPECIFICATIONS will be reported to INTERNEURON within
twenty-four (24) hours.
5. ADVERSE DRUG AND PRODUCT COMPLAINT REPORTS
5.1 INTERNEURON or its designee shall be responsible for reporting to
the FDA, if required, any adverse drug experiences associated with the PRODUCT
and for modifying the PRODUCT's labeling if necessary. On a quarterly basis, for
the first contract year and annually thereafter, BOEHRINGER shall be provided
with a copy of all adverse drug reports that have been submitted to the FDA by
INTERNEURON.
9
5.2 If BOEHRINGER receives any reports of adverse drug experience
associated with the PRODUCT, or other complaints about the PRODUCT, BOEHRINGER
shall provide INTERNEURON with a copy of such report(s) within three (3)
business days of the receipt of same, except that reports of serious injury or
death shall be reported by BOEHRINGER within two (2) business days, with a
written report to follow promptly thereafter. INTERNEURON or its designee shall
be responsible for investigating such reports, for reporting them to the FDA, or
other Governmental Agency, if necessary, and for corresponding with the
complainant. BOEHRINGER shall cooperate fully with INTERNEURON or its
distributor to help INTERNEURON investigate adverse events or product complaints
involving the manufacture of the PRODUCT, whether initially reported to
BOEHRINGER or INTERNEURON, but BOEHRINGER shall not be required to perform any
test or analysis that would not customarily be performed by BOEHRINGER had
BOEHRINGER been the NDA holder. The COST of any testing undertaken by BOEHRINGER
at INTERNEURON's request shall be borne by INTERNEURON.
6. ORDER PROCEDURE
6.1 INTERNEURON agrees to purchase the PRODUCT in production BATCH
quantities or multiples thereof.
6.2 PRODUCT shall be ordered on INTERNEURON or its designees' standard
purchase order forms (the "Purchase Order").
6.3 The only function of the Purchase Order is to set forth the
quantities of PRODUCT desired by package size and the desired delivery dates for
the quantity of PRODUCT ordered and destination of the PRODUCT. Within five (5)
business days, BOEHRINGER will either acknowledge receipt of INTERNEURON's
Purchase Order on BOEHRINGER's standard acknowledgment form, or contact
INTERNEURON about BOEHRINGER's ability to supply quantities of PRODUCT in excess
of the forecast, and /or alternative ship dates which shall be agreed to in
writing using the purchase order form and acknowledgment form. Except as
otherwise set forth above, the only function of BOEHRINGER's acknowledgment form
is to acknowledge receipt of INTERNEURON's Purchase Order. All other terms and
conditions of either the Purchase Orders or the acknowledgment forms are void
and of no effect, and the terms and conditions of this Agreement shall control.
6.4 A twelve (12) month rolling forecast of purchases of the PRODUCT,
including desired delivery dates, shall be submitted to BOEHRINGER every month
during the term of this Agreement. Except for the initial order, the first three
(3) months of each forecast shall be a firm order by INTERNEURON, against which
BOEHRINGER is authorized to institute production and INTERNEURON is authorized
to give shipping orders. Together with the issuance of INTERNEURON's next
forecast, INTERNEURON
10
shall forward to BOEHRINGER a new purchase order for the new month of the firm
order requirement. INTERNEURON will exercise reasonable efforts to level load
its production requirements in recognition of BOEHRINGER's finite capacity and
the lead times necessary for production. Except for the quantities of PRODUCT
ordered for the LAUNCH, BOEHRINGER will exercise reasonable efforts to ship the
quantities ordered, including up to twenty-five (25%) percent in excess of the
forecast, within ninety (90) days of receipt of INTERNEURON's Purchase Orders,
and within one hundred eighty (180) days for orders for those amounts which are
in excess of twenty-five (25%) percent of the forecast. Notwithstanding the
foregoing and considering BOEHRINGER's required ninety (90) day lead time for
production, INTERNEURON shall not submit orders for PRODUCT which shall require
production by BOEHRINGER after December 31, 1998.
6.5 The parties acknowledge that as of the date of this Agreement,
BOEHRINGER's encapsulation capacity working one(1) shift per day is at 2.4M
capsules per week. It is agreed by the parties that BOEHRINGER's production of
the PRODUCT is not limited to one shift per day. Notwithstanding the foregoing,
BOEHRINGER shall be under no obligation to fill orders in excess of 226 million
capsules per year.
6.6 Except for Product manufactured for LAUNCH, PRODUCT manufactured by
BOEHRINGER shall not be held in bulk or packaged and labeled form for greater
than six (6) months prior to shipment to INTERNEURON or its designee.
7. PAYMENTS
7.1 BOEHRINGER agrees to sell and INTERNEURON agrees to purchase the
PRODUCT manufactured by BOEHRINGER at the prices set forth in Exhibit C attached
hereto and made a part hereof, F.O.B. Danbury, Connecticut. PRODUCT produced
pursuant to INTERNEURON's Purchase Order(s) which is manufactured on an
accelerated basis (delivery requested by INTERNEURON or its designee and
delivered in less than one hundred twenty (120) days after receipt of components
which are to be provided by INTERNEURON), will be priced to reflect a 10%
premium on delivery price for such effort. All PRODUCT shall be invoiced at the
time BOEHRINGER releases the PRODUCT. Payment terms are net 30 days. All
payments to BOEHRINGER shall be by wire transfer to BOEHRINGER's account No.
68403, The Northern Trust Company, Chicago, Illinois, ABA # 071000152.
7.2 The parties agree that the purchase prices set forth in Exhibit D
shall remain in effect through December 31, 1995 and the prices set forth in
Exhibit D shall remain in effect through December 31, 1996. Thereafter,
BOEHRINGER shall notify INTERNEURON by November 30 of each year during the term
of the Agreement and the prices for the subsequent year shall be increased or
decreased annually on all orders for delivery after January 1 to reflect any
increase or decrease in COSTS incurred by BOEHRINGER in purchasing the
ingredients of the PRODUCT, and/or the packaging and/or labeling components and
labor and/or overhead for the next calendar year but in no event shall any
annual price increase exceed seven (7%) percent, except if there is a change in
the SPECIFICATIONS as set forth in Paragraph 4.17. The elements that constitute
overhead are set forth in Exhibit B which if changed pursuant to a change in
BOEHRINGER's policy, shall be applied to all parties for whom BOEHRINGER is
11
providing third party manufacturing services. In addition to any price increase
as set forth above, in the event that annual production quantities are in excess
of 113 million capsules in any twelve(12) month period, the cost of PRODUCT in
excess of 113 million during the remainder of such twelve (12) month period
shall be increased by two (2%) percent ; provided, however, that BOEHRINGER
offset any such price increases by amounts saved by BOEHRINGER due to economics
of scale resulting from such increased production quantities.
7.3 During the Term of this Agreement, INTERNEURON shall have the right
to have a certified public accounting firm to which BOEHRINGER has no reasonable
objection, examine the relevant books and records of BOEHRINGER, and shall
certify to INTERNEURON that BOEHRINGER's calculation of costs of production of
the PRODUCT was made in accordance with generally accepted accounting
principles. The cost of such review is to be paid for by INTERNEURON, unless the
certified public accounting firm cannot make the foregoing certification, in
which case the cost of the audit shall be paid by BOEHRINGER.
8. LABELS, LABELING
8.1 INTERNEURON shall specify the trade name, tradedress, trademark and
the name of the distributor which will appear on the label, and package inserts
identifying the PRODUCT. INTERNEURON or its designee will supply BOEHRINGER with
finished camera art for all labeling. INTERNEURON will also specify the exact
wording which is to appear on all labels and package inserts. No labels or
labeling shall be used by BOEHRINGER which have not first been approved by
INTERNEURON.
8.2 BOEHRINGER shall have responsibility for ordering and purchasing
all inactive ingredients, packaging components and labeling components pursuant
to the NDA and SPECIFICATIONS.
9. TRADEMARKS
9.1 The trademark(s) selected by INTERNEURON for use with the PRODUCT
shall be those which have been duly licensed to INTERNEURON or its designee and
to which INTERNEURON has the right to permit BOEHRINGER to use for purposes of
performing this Agreement. BOEHRINGER shall not pay any of the expenses incurred
in either securing registration for and maintaining any trademark to be used by
INTERNEURON.
9.2 BOEHRINGER recognizes and agrees that it will have no right in or
to the said trademark(s), except as otherwise provided in this Agreement.
10. CONFIDENTIALITY
12
10.1 Each party undertakes to keep secret and confidential and not to
disclose to any third party, except as it is necessary in carrying out the
purposes of this Agreement, during the term of this Agreement and for a period
of five (5) years thereafter, any information, data or know-how disclosed to it
by the other party or otherwise pursuant to this agreement.
10.2 The confidential obligations of this article shall not apply to:
a. information, data and know-how which at the time of
disclosure is in the public domain or publicly known
or available;
b. information, data and know-how which, after
disclosure, becomes part of the public domain or
publicly known or available by publication or
otherwise, except by breach of this Agreement by the
receiving party.
c. information, data and know-how which the receiving
party can establish was in its possession at the time
of disclosure by the other party, or was received in
good faith from a source other than the other party.
d. information, data or know-how which the receiver derives
independently of such disclosure; or
e. information, data, or know-how which must be
disclosed as the result of judicial or administrative
process or other requirements of law. The party being
compelled to disclose, shall provide the other with
as much notice as it reasonably can under the
circumstances, so that the party not being compelled
may, at its option, seek an appropriate order.
11. WARRANTIES
11.1 BOEHRINGER represents and warrants to INTERNEURON as follows:
a. The PRODUCT at the time of delivery to carrier for
shipment shall conform to the PRODUCT SPECIFICATIONS and
be manufactured, tested and stored in accordance with the
SPECIFICATIONS and with FDA's cGMP's DEA regulations, if
applicable, and other applicable federal, state and local
laws and regulations. Any failure of the PRODUCT to meet
the foregoing which is due to a defect in the
SPECIFICATIONS, technical material or other supplies
(including the ACTIVE INGREDIENT and camera ready art)
provided by INTERNEURON to BOEHRINGER shall be excluded
from BOEHRINGER's representations and warranties
hereunder.
b. BOEHRINGER has the right to enter into this Agreement
and to undertake the obligations set forth herein.
13
c. AT THE TIME OF DELIVERY TO THE CARRIER, THE PRODUCT
SHALL NOT AS THE RESULT OF ITS UNDERTAKINGS OR ITS
FAILURE TO PERFORM ITS UNDERTAKINGS AS SET FORTH IN
THIS AGREEMENT (I) BE ADULTERATED OR MISBRANDED
WITHIN THE MEANING OF SECTION 404 OR 505 OF THE
FEDERAL FOOD, DRUG AND COSMETIC ACT, ("THE ACT") AS
AMENDED, AND THE REGULATIONS ISSUED THEREUNDER OR
WITHIN THE MEANING OF ANY APPLICABLE STATE OR
LOCAL LAW, THE ADULTERATION AND MISBRANDING
PROVISIONS OF WHICH ARE SIMILAR TO THE FEDERAL ACT,
OR (ii) BE PROHIBITED FROM BEING INTRODUCED INTO
INTERSTATE COMMERCE. EXCEPT AS SET FORTH IN
PARAGRAPH 11.1, BOEHRINGER MAKES NO OTHER
WARRANTIES OF ANY KIND WHATEVER, EXPRESS OR
IMPLIED, INCLUDING THE WARRANTY OF MERCHANTABILITY
AND FITNESS FOR A PARTICULAR PURPOSE, WHICH
WARRANTIES ARE HEREBY DISCLAIMED BY BOEHRINGER
AND EXCLUDED FROM THIS AGREEMENT.
11.2 INTERNEURON represents and warrants to BOEHRINGER as
follows:
a. SPECIFICATIONS, label copy, information and materials
supplied to BOEHRINGER shall be true, accurate and
complete and if applicable, be in compliance with the
PRODUCT's NDA and applicable FDA and DEA regulations
and other applicable federal, state and local laws
and regulations.
b. INTERNEURON will use its best efforts to maintain the
PRODUCT's NDA and to provide ACTIVE INGREDIENT
produced following the validated route of synthesis
filed in compliance with cGMP regulations and the
PRODUCT's NDA and to identify any changes to the
validated manufacturing process, specifications, raw
materials, sources of raw materials or the analytical
method for the manufacture and testing of the ACTIVE
INGREDIENT.
12. INDEMNITY
12.1 INTERNEURON shall defend, indemnify, protect, save and hold
harmless BOEHRINGER and each of its directors, and officers, from all claims,
demands, suits, or proceedings for damages, costs (including reasonable
attorney's fees), expenses and losses which arise (1) from any claim or charge
by a third party for trademark or patent infringement arising out of or in
connection with the promotion, marketing, distribution or sale of the
14
PRODUCT or of the use and manufacture of the PRODUCT in conformity with the NDA
or (2) as the result of any breach of this Agreement by INTERNEURON or (3) out
of any claim for product liability arising from the use of the PRODUCT;
provided, however, that BOEHRINGER will not be indemnified under this Paragraph
for any claims arising in whole or in part as the result of the manufacture and
packaging of the PRODUCT which fails to conform to the SPECIFICATIONS or is in
violation of any of the warranties set forth in Article 11 or (4) from any claim
or charge by INTERNEURON's distributor or designees, or as the result of any act
of a INTERNEURON distributor or designee resulting from their undertakings or
INTERNEURON's under this Agreement.
12.2 BOEHRINGER will defend, indemnify, protect, save and hold harmless
INTERNEURON and each of its directors, and officers from all claims, demands,
suits or proceeding for damages and costs (including reasonable attorney's fees)
expenses and losses which arise as the result of BOEHRINGER's failure to provide
the PRODUCT in conformity with the SPECIFICATIONS, or breach of this Agreement,
or as the result of a violation of its warranties as set forth in Article 11.
12.3 Except as otherwise provided in Paragraph 4.16, BOEHRINGER shall
reimburse INTERNEURON for its expense in the event of a recall, stop sale or
governmental action or directive, resulting solely from a breach of this
Agreement by BOEHRINGER, to the extent of providing a quantity of conforming
PRODUCT to INTERNEURON sufficient to replace that quantity of PRODUCT that was
recalled or the subject of such stop sale, governmental action or directive
without charge to INTERNEURON and with all transportation charges prepaid as
well as for necessary and proven out of pocket expenses incurred in connection
with such recall of any PRODUCT.
12.4 In the event of any claim under Paragraph 12.1, 12.2 or 12.3
hereof, the party claiming the right to indemnity (the "Claimant") shall
promptly notify the indemnifying party (the "Indemnitor") in writing of such
claim. The notice shall describe such claim in reasonable detail.
a. Indemnitor shall have twenty (20) days after receipt of such notice
to decide whether it will undertake, conduct and control, through
counsel of its own choosing and at its own expense, the settlement or
defense of the tendered claim; provided, however, that Claimant shall
have the right to consent to such counsel, which consent shall not be
unreasonably withheld. Notwithstanding anything in this Agreement,
Claimant shall have the right to employ its own counsel at its own
expense if Claimant deems such action necessary or advisable to fully
protect its interests.
b. Indemnitor shall not settle or compromise any action, or consent to
the entry of any judgment in any tendered claim, without the written
consent of Claimant, which shall not be unreasonably withheld.
Indemnitor's obligation to defend and indemnify Claimant shall survive
any settlement, compromise or judgment that does not include as an
unconditional term thereof the delivery by the underlying claimant or
plaintiff to Claimant of a duly executed written release of Claimant
from all liability in respect to such action, which release shall be
reasonably satisfactory in form and substance to Claimant's counsel.
15
c. In the event Indemnitor does not notify Claimant in writing within
twenty (20) days after receipt of notice of the tendered claim that it
elects to undertake its defense, Claimant shall have the right to
contest, settle or compromise such claim, but shall not thereby waive
any right to indemnity from Indemnitor for such claim. Notwithstanding
the foregoing, Indemnitor shall have the right to assume the defense of
such claim with counsel reasonably satisfactory to Claimant at any time
prior to settlement, compromise or final determination.
d. Claimant and Indemnitor shall cooperate fully in the defense of any
claim for which indemnity is sought pursuant to this Agreement
including providing each other with reasonable access to their
employees during regular business hours (including as witnesses) and
other reasonably necessary information. Claimant to be reimbursed for
any out-of-pocket expense resulting from such cooperation.
12.5 Effective throughout the term of this Agreement and thereafter,
for a period of not less than six (6) years, the parties shall each carry and
maintain in full force and effect insurance, or maintain adequate self-insurance
reserves, insuring themselves for Commercial General Liability, including
Product Liability. In any such insurance policy from an insurance company, each
party shall include the other as an additional insured thereon, said insurance
policies shall be obtained from an insurance company having a Best's rating of
B+, Class IV or higher. Commercial General Liability insurance or adequate
reserves providing coverage for liability of not less than $25,000,000 Combined
Single Limit, Bodily Injury and Property Damages shall be secured as of the date
of the first commercial shipment of PRODUCT. Each party shall furnish the other
with certificates of said Commercial General Liability and Product Liability
insurance policy naming the other as an additional insured thereon, which shall
provide to each party that thirty (30) days prior written notice of cancellation
or material changes in said insurance policies shall be given to such other
party. The indemnification obligations herein shall apply on a first dollar
basis without limitation or reduction due to any deductible or self-insured
retention which either party may have under their respective insurance coverage.
12.6 INTERNEURON shall reimburse BOEHRINGER for any provable damages
incurred by BOEHRINGER resulting from a recall, stop sale or governmental action
or direction resulting from a breach of this Agreement by INTERNEURON or its
designee or early termination, by INTERNEURON including termination pursuant to
Paragraph 3.2 or as the result of the removal of the PRODUCT from the market, or
the cessation of sale of the PRODUCT prior to the expiry date of this Agreement
resulting from a breach of the Agreement by INTERNEURON.
13. PRODUCTION FACILITY INSPECTION
16
13.1 Appropriate representatives of INTERNEURON or its designee
(provided they have executed a confidentiality agreement) shall have the right,
as provided in Paragraph 4.12, to inspect those sections of BOEHRINGER's
manufacturing, laboratory, packaging and warehousing facilities used in the
manufacture, packaging, labeling storage, testing, shipping or receiving of the
PRODUCT or its components, and its manufacturing and production batch records,
upon forty-eight (48) hours notice and during regular business hours, provided
the PRODUCT or its components are actually in the foregoing areas at the time of
inspection.
13.2 With respect to PRODUCT supplied by it, BOEHRINGER shall be
responsible for all process and equipment validation required by the FDA and
shall take all steps necessary to pass government inspection by the FDA, DEA or
other GOVERNMENTAL AGENCY. BOEHRINGER shall also assist INTERNEURON in preparing
and updating any required regulatory submission and all other documents required
by the FDA for approval of the PRODUCT, including providing INTERNEURON with a
right of reference to any Drug Master File for the facility provided such
request is made on reasonable notice; BOEHRINGER has the capacity to provide
such assistance and BOEHRINGER is reasonably compensated for such assistance.
BOEHRINGER will make no amendment to such Drug Master File without notification
to INTERNEURON. BOEHRINGER shall maintain all appropriate original regulatory
documents retention samples and records relating to its responsibilities with
respect to the manufacturing of the PRODUCT according to cGMP's. Copies of the
PRODUCT's manufacturing and packaging batch records and certificates of analysis
will be provided to INTERNEURON and or its designee upon request.
13.3 In the event that BOEHRINGER's facilities are the subject of an
inspection by any duly authorized agency of the federal, state, local or any
foreign government and the inspection is specific for the PRODUCT, BOEHRINGER
shall thereafter notify INTERNEURON of such inspection within one (1) business
day and shall promptly thereafter provide to INTERNEURON a written summary of
findings as directly relates to the manufacture of the PRODUCT and corrective
action(s) taken or planned by BOEHRINGER. Any Form 483 comments related to the
PRODUCT shall be provided to INTERNEURON. Any response to such 483 comments
shall be provided to INTERNEURON.
13.4 In the event that INTERNEURON's facilities or the facilities of the
manufacturer of the ACTIVE INGREDIENT, are the subject of an inspection by any
duly authorized agency of the federal, state, local or any foreign government
and the inspection is specific for the ACTIVE INGREDIENT, INTERNEURON shall
notify BOEHRINGER of such inspection within one day from INTERNEURON's notice.
INTERNEURON shall thereafter use its best efforts to provide BOEHRINGER with any
information about such inspection which may effect the ACTIVE INGREDIENT or
BOEHRINGER's manufacture of the Product.
14. SAFETY; ACCIDENTS DURING TRANSPORTATION
14.1 INTERNEURON shall furnish or cause to be furnished BOEHRINGER
with
17
material safety data sheets for ACTIVE INGREDIENT supplied by INTERNEURON or the
ACTIVE INGREDIENT supplier hereunder.
14.2 In the event of an accidental release of ACTIVE INGREDIENT or
PRODUCT, as between BOEHRINGER and INTERNEURON, responsibility for cleaning up
any spilled ACTIVE INGREDIENT or PRODUCT, disposing of same in accordance with
applicable laws and regulations and notifying appropriate authorities shall be
allocated as follows:
a. INTERNEURON shall have such responsibility with
respect to the ACTIVE INGREDIENT from the time it
leaves INTERNEURON or its designee's facility until
it arrives at BOEHRINGER's facilities in Danbury,
Connecticut.
b. INTERNEURON shall have such responsibility with
respect to PRODUCT from the time it is loaded aboard
transportation equipment or otherwise delivered at
the FOB Point for PRODUCT specified in Paragraph 7.1.
c. BOEHRINGER shall have such responsibility with
respect to the ACTIVE INGREDIENT, from the time it
arrives at the FOB Point for ACTIVE INGREDIENT
specified in Article 3.8; with respect to PRODUCT,
until such time as it is loaded aboard
transportation.
d. BOEHRINGER and INTERNEURON shall each advise each
other of any accidental spill or discharge of ACTIVE
INGREDIENT or PRODUCT in transit promptly after
learning of such spill or discharge.
15. SAFETY AND ENVIRONMENTAL
15.1 In performing services hereunder, BOEHRINGER shall:
a. not utilize INTERNEURON's SPECIFICATIONS and other technical
information to manufacture and/or package PRODUCT until a safe
procedure of operation has been established and mutually
agreed upon;
b. permit INTERNEURON or its designated representative to inspect
BOEHRINGER's facilities as provided in Paragraph 13.1 where
PRODUCT is manufactured, packaged, labeled, tested or stored
to evaluate BOEHRINGER's work practices; review BOEHRINGER's
compliance with applicable safety, health, and environmental
regulations and good manufacturing practices and procedures;
and evaluate BOEHRINGER's capability for responding
effectively to any spills or releases of hazardous materials
utilized or produced by
18
BOEHRINGER in the manufacture or PRODUCT; INTERNEURON will
provide a copy of any such evaluations to BOEHRINGER;
c. except as otherwise provided for herein, report to
INTERNEURON, as soon as possible, all environmental accidents
related to the manufacture and/or packaging of the PRODUCT
which:
(1) result in personal injuries requiring more
than first aid treatment or
(2) result in illness and/or loss of consciousness; or
(3) result in property damage; or
(4) result in environmental damage; or
(5) any other accident which potentially could result in
serious consequences.
d. prior to commencement of manufacture and/or packaging
of PRODUCT using INTERNEURON's SPECIFICATIONS and other
technical information, and at least once during each
contract year, BOEHRINGER will permit INTERNEURON or its
designated representative to review BOEHRINGER's licenses
and permits relating to the facilities and operations
utilized by BOEHRINGER in the manufacture and/or
packaging of PRODUCT. Such review shall be conducted
during ordinary business hours, on mutually agreeable
dates; and
e. identify to INTERNEURON all haulers and disposal sites
utilized for disposal of waste material generated by
BOEHRINGER in connection with the manufacture and/or
packaging of PRODUCT and BOEHRINGER will permit, or cause
those with whom BOEHRINGER contracts for the disposal of
waste to permit, INTERNEURON or its designated
representative to visit all disposal sites for hazardous
waste as defined in 40 CFR 261, generated in connection
with the manufacture and/or packaging of PRODUCT.
16. GENERAL TERMS
16.1 This Agreement shall be governed and construed in
accordance with the laws of the State of Connecticut and any and all disputes
arising under or concerning this Agreement shall be before the Courts of the
State of Connecticut.
16.2 Any notice, required or permitted to be given under this
Agreement, shall be deemed sufficient if: sent prepaid through a nationally
recognized overnight courier service such as Federal Express, to the other party
to the address shown below or to such other address as either party may
designate pursuant to these provisions. Any notice sent pursuant to this
paragraph shall be deemed received one (1) business day after it is sent.
19
If to BOEHRINGER:
President
Boehringer Ingelheim
Pharmaceuticals, Inc.
900 Ridgebury Road
Ridgefield, CT 06877
Copy to Corporate Counsel
If to INTERNEURON:
President
Interneuron Pharmaceuticals, Inc.
99 Hayden Avenue
Lexington, MA 02173
Copy to Corporate Counsel
16.3 No liability shall result from delay in performance in
whole or in part if performance has been made impracticable by compliance in
good faith with any applicable or domestic governmental regulations or order
whether or not it later proves to be invalid, or by the occurrence of a
contingency the non- occurrence of which was a basic assumption on which this
Agreement was made, including, but not limited to, acts of God, fire, flood,
accident, riot, war, sabotage, strike, labor trouble or shortage, embargo. If
any such circumstances affect only a part of BOEHRINGER's capacity to perform,
BOEHRINGER shall have the right to allocate production and deliveries among all
of its customers and its own requirements based on their previous purchases over
the immediately proceeding twenty four (24) month period prior to such fire,
flood, etc. Quantities affected by this paragraph may, at the option of either
party, be eliminated from the Agreement without liability, but the Agreement
shall remain otherwise unaffected.
16.4 The failure of either INTERNEURON or BOEHRINGER to insist
on the strict performance of any provision or to take advantage of any right
hereunder shall not be construed as a waiver or any subsequent performance of
such provision or right.
16.5 The headings and captions contained herein are for
reference only and shall not constitute a substantive part of this Agreement.
16.6 The parties are and will remain at all times independent
contractors, and no agency, partnership, joint venture or employment
relationship exists between them.
16.7 This Agreement may not be assigned by any of the parties
without the prior written consent of the others (which consent shall not be
unreasonably withheld) except to an affiliate (meaning any business entity
controlled by, controlling or under common control with INTERNEURON or
BOEHRINGER. "Control" shall mean direct or indirect beneficial ownership of
forty percent (40%) or more of the voting stock or a forty percent (40%) or
greater interest in the income thereof) or in the case of sale or transfer of
all or substantially all of its assets or business by way of acquisition,
consolidation or merger.
16.8 If any provisions of this Agreement are held invalid or
unenforceable, by a Court or body of competent jurisdiction unless the
invalidity or unenforceability substantially frustrates the underlying intent
and sense of the remainder of the Agreement, such invalidity and
unenforceability shall not affect the validity or enforceability of any other
provisions of the Agreement except those where the invalidated or unenforceable
provisions comprise an integral part of, or are otherwise clearly inseparable
from, the intent and sense of the Agreement. In the event any provision is held
invalid or unenforceable, the parties will attempt to agree upon a valid and
enforceable provision which shall be a reasonable substitute for such invalid or
20
unenforceable provision in light of the intent of this Agreement and upon so
agreeing, shall incorporate such substitute provision in this Agreement.
16.9 This document contains the entire agreement between the
parties pertaining to its subject matters and shall not be altered or modified,
except in a writing signed by the party to be bound by such alteration or
modification.
IN WITNESS WHEREOF, the parties hereto have caused this
Agreement to be executed by their duly authorized representatives as of the date
and year first written above.
BOEHRINGER INGELHEIM INTERNEURON PHARMACEUTICALS, INC.
PHARMACEUTICALS, INC.
BY: /s/ R.L. Charles BY: /s/ Dr. Glenn Cooper
--------------------- -------------------------
DATE: November 20, 1995 DATE: November 21, 1995
21
The information below marked by * and [ ] (representing 381 pages) has been
omitted pursuant to a request for confidential treatment. The omitted portion
has been separately filed with the Commission.
EXHIBIT A
PRODUCT SPECIFICATIONS
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The information below marked by * and [ ] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been separately filed with
the Commission.
EXHIBIT B
ELEMENTS OF PRODUCTION OVERHEAD
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The information below marked by * and [ ] (representing 39 pages) has been
omitted pursuant to a request for confidential treatment. The omitted portion
has been separately filed with the Commission.
EXHIBIT C
ACTIVE INGREDIENT SPECIFICATIONS
AND METHODS
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The information below marked by * and [ ] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been separately filed with
the Commission.
SCHEDULE D
BIPI
DEXENFLURAMINE 15 MG
1996 DELIVERY PRICES
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