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EXHIBIT 10.19
INTERNATIONAL DISTRIBUTOR AGREEMENT
EFFECTIVE DATE: ____________________________
PARTIES: Nastech Pharmaceuticals Inc.,
00 Xxxxxx Xxxxx
Xxxxxxxxx
Xxx Xxxx 00000
XXX
Fax no: 00 0 000 000 0000 ("Company")
Cambridge Selfcare Diagnostics Limited
Xxxxxxxx Xxxxx
Xxx Xxxxxxx Xxxxx
Xxxxxxxxx Xxxx
Xxxxxxxxx-xxxx-Xxxx, XX0 0XX
Xxxxxxx
Fax no: (000) 000 0000 ("Distributor")
RECITALS:
Company and Distributor desire to establish a relationship in which Company will
sell and Distributor will distribute in the Territory the Product manufactured
and/or distributed by Company as specified herein.
AGREEMENT:
In consideration of the mutual covenants contained herein and other good and
valuable consideration, the receipt and sufficiency of which is hereby
acknowledged, the parties agree as follows:-
1 Appointment as Distributor
1.1 Appointment
1.1.1 Subject to the terms and conditions of this Agreement, Company hereby
grants to Distributor the exclusive right to distribute the product
described in Exhibit A attached hereto (the "Product") in the
geographic territory described in Exhibit B attached hereto (the
"Territory").
1.1.2 Company shall have the right to discontinue the Product, to make
improvements to the Product and to materially change the design of
the Product without incurring any liability to Distributor. If
Company proposes to make an improvement to or materially alter the
design of the Product and such improvement or change in design is
likely to result in a need for an alteration in the regulatory
approval for the sale of
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the Product in the Territory Company shall give Distributor at least
twelve (12) months prior written notice of such improvement to or
change in the design of the Product and shall provide Distributor
with copies of all correspondence with the FDA regarding the said
improvement or change in design. Company agrees to give Distributor
not less than six (6) months notice of discontinuance of the Product
or a change in the design or improvement of the Product which is not
likely to require a change in the regulatory approval for the sale of
the Product in the Territory.
1.1.3 If the future improvement or change in design necessitates a new
regulatory approval by a governmental agency in the Territory,
Company and Distributor shall each pay fifty per cent (50%) of the
cost to secure such new regulatory approval.
1.2 Sales Outside Territory
1.2.1 Distributor shall not (i) actively advertise, promote, market or
solicit customers for the Product outside the Territory; (ii)
establish an office outside the Territory through which orders for
the Product are solicited; or (iii) store any Product in a warehouse
or depot located outside the Territory.
1.2.2 If Distributor receives an unsolicited request from a customer
located in the European Community but outside the Territory for
supply of Product to that country, Distributor shall be entitled to
fulfill such a request.
1.2.3 If Distributor receives a request from a customer located outside the
European Community and outside the Territory for supply of the
Product Distributor shall forward such information to Company. If
Company has appointed a distributor for the country where the Product
will be delivered, the lead will be forwarded to such distributor. If
Company has not established a distributor in such country,
Distributor shall be allowed to finalise such sale, subject to the
provisions of sub-section 1.3 below.
1.3 Support Services for Supplementary Sales In the event Distributor
makes a sale to a customer located in the Territory for delivery
outside the Territory or to a customer located outside the Territory
in accordance with the terms and conditions of this Agreement,
Distributor will be required to provide support services to such
customer in relation to such sale. Such support services shall be the
provision of pharmacovigilance and drug information and the provision
of services as a "responsible party" as required by applicable
regulatory approval agencies. Distributor acknowledges that Company
may appoint a distributor in a country where Distributor has made
such supplementary sales and at such time Distributor shall be
required to forward future Product orders to such Company
distributor.
1.4 Exclusiveness The parties agree that the "exclusive" nature of the
foregoing appointment prohibits Company from itself selling the
Product in the Territory and from granting any third party the right
to sell the Product in the Territory. Company shall forward to
Distributor all requests and inquiries regarding sales of the Product
in the Territory.
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1.5 Regulatory Approval
1.5.1 Distributor acknowledges that Meda AB, the Company's distributor in
Sweden, Denmark, Norway, Finland, Iceland, Estonia, Lithuania, Latvia
and Russia, is in the process of applying for marketing approval for
the Product in Sweden under the Mutual Recognition Process (MRP).
Company acknowledges that Meda AB will be responsible for filing the
MRP application for approval of the sale of the Product in the
Territory and that Distributor will have no direct influence over the
timing or conduct of the application. Company shall ensure that Meda
AB makes the MRP application pertaining to the Territory as soon as
possible after the grant of the MRP application in Sweden.
Distributor shall remunerate Meda AB for the services provided by
Meda AB in relation to the MRP application in the manner set forth in
the agreement between Distributor and Meda AB dated the day of
1998. Subject to the foregoing, Distributor agrees to use all
reasonable endeavours to acquire the appropriate regulatory approval
certificates, in Distributor's name or the name of Distributor's
nominated sub-distributor, from the government agencies in the
Territory as are necessary to sell the Product in the Territory. Save
as provided below Distributor shall pay any and all expenses incurred
in securing such regulatory approval. Company shall, at its expense,
give Distributor and Meda AB all reasonable assistance to acquire the
regulatory approval certificates and shall provide to the
Distributor:-
1.5.1.1 a copy of the existing regulatory dossier regarding the Product in
the possession of the Company and/or Meda AB and all other data
pertaining to the MRP application in Sweden for the Product; and
1.5.1.2 a copy of the consolidated file created subsequent to MRP approval in
Sweden; and
1.5.1.3 a copy of all information requested by the governmental regulatory
authorities and such other information as reasonably requested by
Distributor to secure registration of the Product in the Territory.
1.5.2 The parties acknowledge and agree that such regulatory approval
certificates shall be the property of Company and shall remain
Company's property upon termination of this Agreement for whatever
reason. Upon expiration or termination of this Agreement for
whatever reason Distributor agrees to promptly execute and deliver
all documents reasonably requested by Company that may be appropriate
or necessary to change the reference of the authorised distributor of
the Product in the Territory on the regulatory approval to the person
designated by Company.
1.5.3 In the event of termination of this Agreement before the expiration
of a period of two (2) years from the date when price and regulatory
approvals for the Product had been obtained in all countries in the
Territory, Company shall pay to Distributor, within thirty (30) days
of the date of termination, a sum equal to the amount actually and
reasonably expended by the Distributor to third parties in obtaining
said regulatory approvals.
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1.5.4 In the event of termination of this Agreement after the expiration of
a period of two (2) years from the date when price and reimbursement
approvals for the Product had been obtained in all countries in the
Territory but before the expiration of a period of three (3) years
from the date when price and reimbursement approvals for the Product
had been obtained in all countries in the Territory, Company shall
pay to Distributor, within thirty (30) days of the date of
termination, a sum equal to fifty (50) per cent of the amount
actually and reasonably expended by the Distributor to third parties
in obtaining regulatory approvals for the Product in the Territory.
1.5.5 In the event of termination of this Agreement after the expiration of
a period of three (3) years from the date when price and
reimbursement approvals for the Product had been obtained in all
countries in the Territory but before the expiration of a period of
four (4) years from the date when price and reimbursement approvals
for the Product had been obtained in all countries in the Territory,
Company shall pay to Distributor, within thirty (30) days of the date
of termination, a sum equal to thirty (30) per cent of the amount
actually and reasonably expended by the Distributor to third parties
in obtaining regulatory approvals for the Product in the Territory.
1.5.6 In the event of termination of this Agreement after the expiration
of a period of four (4) years from the date when price and
reimbursement approvals for the Product had been obtained in all
countries in the Territory but before the expiration of a period of
five (5) years from the date when price and reimbursement approvals
for the Product had been obtained in all countries in the Territory,
Company shall pay to Distributor, within thirty (30) days of the date
of termination, a sum equal to fifteen (15) per cent of the amount
actually and reasonably expended by the Distributor to third parties
in obtaining regulatory approvals for the Product in the Territory.
1.5.7 Save as provided in this sub-clause, if, despite using reasonable
endeavours, the Distributor is unable to obtain regulatory approval
for the sale or distribution of the Product in any country or
countries in the Territory, the Distributor shall be entitled to
relinquish the rights to the Product for that country or those
countries and return those rights to the Company and Company shall
pay to the Distributor a sum equal to the amount actually and
reasonably expended by the Distributor in seeking regulatory
approvals for the sale of the Product in that country. Company shall
not be required to reimburse to Distributor, pursuant to this
sub-clause, the costs of any application for regulatory approval for
the sale of the Product in any country in the Territory other than
the first application for regulatory approval for the sale of the
Product in that country unless Company has given its approval to any
subsequent application being made.
1.6 Sub-distributors/Sub-licensees It is contemplated that Distributor
shall appoint or sublicense third party distributors in each country
Distributor shall notify the Company of the identity of its proposed
sub-distributor for approval by the Company, which approval shall not
be unreasonably withheld. In the event that the Distributor receives
an extraordinary payment from a sub-distributor in consideration of
the appointment of the sub-distributor as sub-distributor in any
country in the Territory (and specifically excluding any royalties or
payments made
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or to be made in the ordinary course of business between the
Distributor and the sub-distributor and any reimbursement received by
the Distributor from any sub-distributor of any expenditure made by
distributor in relation to the section of the Territory in which the
sub-distributor is appointed), the Distributor shall pay to Company
fifty per cent (50%) of such extraordinary payment within 30 days
from the receipt of such payment by the Distributor. In the event
Distributor fails to identify a sub-distributor in a given country in
the Territory within 30 days from the date of pricing and
reimbursement approval for the Product in that country, the Company
shall have the right to remove that country from the Territory
covered by this Agreement. Each sublicense/sub-distribution agreement
shall conform and be subject to the terms and conditions of this
Agreement.
2 Term Unless terminated earlier pursuant to the terms of clause 17,
this Agreement shall commence as of the Effective Date set forth on
the first page hereof and shall continue for a period of ten (10)
years for the Product after the Product has received regulatory
approval for resale in the Territory. This Agreement may be renewed
for a further period of five (5) years after the expiration of its
initial term by the mutual written agreement of the parties.
3 Purchase of Product
3.1 Forecasts/Placement of Orders Six (6) months prior to the Product
receiving pricing and reimbursement approval for sale in all
countries in the Territory, Distributor shall provide to Company a
twelve (12) month rolling forecast of its requirements of the
Product, which forecast will be updated quarterly. Such forecasts
shall be provided in good faith but shall not be legally binding, on
either party, either as a minimum or maximum purchase or sale
requirement and, while in no way limiting the generality of the
foregoing, the amount forecast as required for the period immediately
after the grant of pricing and reimbursement approval in all
countries in the Territory shall be indicative only and dependent on
the grant of said pricing and reimbursement approval proceeding as
scheduled.
3.2 Distributor shall order the Product by delivering a written purchase
order to Company by facsimile or by mail. Company shall inform
Distributor of its acceptance or rejection of any purchase order
within fourteen (14) days after receipt. Company shall not reject any
order submitted by Distributor so long as (1) Distributor submits the
purchase order at least ninety (90) days prior to any requested
delivery date, (2) the purchase order requests supply of a quantity
of the Product within +/- 50% of the quantity forecast as being
required for that period in the immediately preceding rolling
forecast submitted by Distributor. In the first year of this
Agreement after pricing and reimbursement approval has been obtained
in all countries in the Territory the Distributor shall order
quantities of the Product in full lots of 7,000 bottles. In the
second year of this Agreement and in each year thereafter after
pricing and reimbursement approval has been obtained in all countries
in the Territory the Distributor may, at its discretion, order
quantities of the Product in full lots of either 7,000 or 14,000
bottles or multiples thereof. If the
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above provisions are not met in the purchase order, the Company may
accept or reject such purchase order in its sole discretion.
3.3 Terms and Conditions This Agreement sets forth the sole contract
terms between the parties and shall apply to all orders. Company
rejects any terms in any Distributor order forms or other Distributor
documents which are different from or additional to the provisions
hereof and no such terms shall be binding upon Company
notwithstanding Company's acceptance and shipment of Product
specified in Distributor's order form containing such terms.
3.4 Distributor may order Product as and when required at the initial
price set forth in Exhibit C and Company shall supply such Product as
ordered prior to receipt of full marketing authorisation for all
countries in the Territory subject to Distributor complying with
relevant requirements of any relevant regulatory authorities in the
country. Any Product supplied under this clause shall comply with the
FDA approval in all respects save for requirements of packaging and
labelling.
4 Prices
4.1 Save as provided below Company shall sell the Product to Distributor
FOB Company's plant in New York, USA at the prices set forth on
Exhibit C attached hereto. The Distributor shall be responsible for
insurance and freight costs. Risk in any consignment of the Product
shall pass to the Distributor once said consignment is loaded onto
transportation in New York, USA.
4.2 Save as provided below, Company shall have the right to increase such
prices no more than once during each twelve (12) month period during
the term of this Agreement by an amount up to, but not exceeding, (1)
the amount of any increase in manufacturing cost of the Product
experienced by Company, including, without limitation, overhead
allocations or (b) the amount of any increase in the UK
Manufacturer's Prices "All Manufactured Product" Index published by
the Central Statistical Office of the United Kingdom, whichever is
the lesser. Company shall provide Distributor with at least one
hundred and eighty (180) days advance written notice of any such
price increase together with substantiation of the price increase.
4.3 If Distributor experiences direct competition in the Territory and
believes the prices established in this Agreement do not allow
Distributor a sufficient profit margin, Company agrees to discuss
with Distributor the potential for country specific pricing.
4.4 Save as provided in clause 4.7, in the event that either:-
4.4.1 the average price, over all countries in the Territory, at which the
Distributor or the sub-distributor sells the Product to third parties
other than sub-distributors (hereinafter "the Average Price") decreases
each year for three consecutive years; or
4.4.2 the Average Price decreases in any one year of the agreement by more than
ten
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percent (10%)
the price at which the Product is sold by the Company to the Distributor shall
be amended to (i) thirty two per cent (32%) of the Average Price if four
hundred and eighty thousand units (480,000) of the Product or more have
been ordered by the Distributor from the Company; or (ii) thirty six per
cent (36%) of the Average Price if less than four hundred and eighty
thousand units (480,000) but one hundred and twenty thousand (120,000) or
more units of the Product have been ordered by the Distributor from the
Company; or (iii) forty per cent (40%) of the Average Price if less than
one hundred and twenty thousand (120,000) units of the Product have been
ordered by the Distributor from the Company (said percentages hereinafter
referred to as "the Applicable Percentage"). During any year of the
Agreement Company shall sell the Product to the Distributor at the
Applicable Percentage of the Average Price from the previous year. At the
end of each year of the Agreement Distributor shall provide to Company a
report setting forth the Average Price for that year and the information
used in the calculation of such. If it transpires the Average Price for
the year is higher than the Average Price for the previous year Company
shall render to Distributor an invoice for the Applicable Percentage of
the difference between the Average Price for the year and the Average
Price for the previous year. Distributor shall pay such invoice within
thirty (30) days of receipt of such. If it transpires that the Average
Price for the year is lower than the Average Price for the previous year
Distributor shall render to Company an invoice for the Applicable
Percentage of the difference between the Average Price for the year and
the Average Price for the previous year. Company shall pay such invoice
within thirty (30) days of receipt of such
4.5 Distributor shall use reasonable endeavours to maximise the
Average Price.
4.6 Should Distributor determine that, in its opinion, it is economically
undesirable for it to continue to distribute the Product in a
particular country in the Territory it may, by written notice to the
Company relinquish the rights to the Product for that country or
those countries and return those rights to the Company without
incurring or being subject to any liability to the Company. In such
circumstances the Distributor will provide to Company a final
accounting for the country in the Territory so relinquished including
inventory units on hand for that country and an estimate as to the
likely on the Average Price and the Applicable Percentage for the
year.
4.7 In the event that thirty-two percent (32%) of the Average Price for
the Product in a country in the Territory is less than the equivalent
of thirteen US Dollars (US$13.00) per unit, Company may provide to
Distributor sixty (60) days' notice of its intention to withdraw the
rights of the Distributor to distribute the Product in that country.
At any time before expiry of that notice Distributor may, by written
notice, advise Company that either:-
4.7.1 it will hand back to Company the rights to distribute the Product in
that country in the Territory; or
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4.7.2 Distributor will pay to Company the difference between thirty-two
percent (32%) of the Average Price for the Product in that country
and the equivalent of thirteen US Dollars ($13.00) per unit for each
unit of the Products sold in that country in the Territory.
5 Payment
5.1 Payment Unless otherwise determined by the Company the Distributor
shall open a confirmed irrevocable documentary letter of credit in
favor of the Company for the amount of each shipment inclusive of all
costs. All amounts owing by Distributor to Company for the Product
shall be paid within ninety (90) days of the date of shipment of the
Product. Distributor shall make all payments to Company for the
Product in US dollars by transfer to such bank account as Company may
from time to time designate in writing.
5.2 Late Payment Fee/Collection Costs Any amounts not paid by Distributor
when due will be subject to a late payment fee computed daily at a
rate equal to one and one half percent (1.5%) per month or at the
highest rate permitted under applicable usury law, whichever is the
lower. In addition, Distributor shall be liable to Company for all
costs incurred by Company in its collection of any amounts owing by
Distributor which are not paid when due, including reasonable
attorneys' fees, regardless of whether actual suit is brought.
5.3 Change in Payment Terms If Distributor fails to make any payment at
the time required pursuant to the terms of this Agreement, Company
shall have the right to withhold shipment of Product until all late
payment has been made or to revoke or alter the above credit terms by
delivery of written notice to Distributor.
6 Delivery, Shipment and Inspection
6.1 Certificate of Analysis and Shipping Company shall include batch
documentation and a certificate of analysis with each batch of
Product shipped and shall ensure that any cartons in which the
Product is transported bear on the outside the batch number and the
expiry date of the Product.
6.2 Delivery Dates Company shall make deliveries of the Product on the
dates set forth in the Distributor's orders.
6.3 QC/QA Release. Distributor shall request that its third party Quality
Assurance contractor provide a similar service for Meda AB at
Nastech's request.
7 Quota
7.1 Save as provided below Distributor agrees to order, accept delivery
of and make payment in full for the number of units of the Product
during the period(s) set forth on Exhibit D attached hereto (the
"Quota"). The number of units set forth in the Quota for the first
three (3) years of this Agreement following the grant of pricing and
reimbursement approval for the sale of the Product in all EU
countries in the
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Territory shall be indications of likely sales only and there shall
be no liability or penalty under this contract for failure to order,
take delivery of and make payment in full for those units. In the
third year of the Agreement following the grant of pricing and
reimbursement approval for the sale of the Product in all EU
countries in the Territory the parties shall agree a binding quota
for the remaining years of this Agreement and the provisions of
clauses 7.2 and 17.3 shall apply in respect of the quotas for those
years of the Agreement.
7.2 Save as provided in clause 7.1 above, if Distributor fails to meet
the Quota for any specified period in any specified portion of the
Territory and fails to cure such breach as provided under Section
17.3 herein, Company shall have the right to delete such portion of
the Territory from Exhibit B of this Agreement or to terminate this
Agreement in the manner provided in Section 17.3 herein SAVE THAT if
the Distributor has achieved the overall Quota for the whole of the
Territory in the relevant specified period such rights to delete
some of the rights given or terminate this Agreement in accordance
with this clause shall not arise.
7.3 The parties agree to review and renegotiate the Quota in good faith,
if appropriate, for any Product based upon any discontinuance,
improvement or change in design of the Product, any changes in the
market which the Distributor feels should be considered with regard
to the Quota and the handing back to the company of the rights to
distribute the Product in any country in the Territory.
8 Laws Regulating Exports and Imports
8.1 Import Licences Distributor shall be responsible for securing and
paying for all import licences required for shipment of the Product
into the Territory. Company agrees to provide such reasonable
information as requested by Distributor to facilitate obtaining the
import licences.
8.2 Export Licences Company shall be responsible for securing and paying
for all export licenses required for shipment of the Product from the
United States to the Territory. Distributor agrees to provide such
reasonable information as requested by Company to facilitate
obtaining the required export licences, including information
regarding the intended country of resale. Company reserves the right,
on provision of reasonable notice to Distributor, to cancel orders
for, or to stop in transit, any Product for which Company reasonably
believes is about to be exported in violation of any applicable US
law or regulation. If such action is necessary due to the inaccuracy
of the information provided by Distributor or any breach of this
Agreement by Distributor, Company shall hold any Product stopped in
transit for Distributor's expenses and shall resell or otherwise
dispose of the same in a lawful manner in accordance with
Distributor's instructions.
9 Distributor's Responsibilities
9.1 Product Promotion Distributor shall use its commercially reasonable
efforts to promote and increase the distribution and sale of the
Product in the Territory and
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further agrees to promotional and launch budget set forth in Exhibit
F. Distributor and Distributor's employees, agents and
representatives will follow Company's reasonable recommendations
regarding the demonstration and use of the Product for promotional
purposes and subject to compliance with those requests being within
the agreed promotional and launch budget set forth in Exhibit F. All
expenses associated with the promotion and launch of the Product by
Distributor in the Territory and performance of the Distributor's
other obligations hereunder shall be borne solely by Distributor.
9.2 Noncompetition During the term of this Agreement, Distributor shall
not, directly or indirectly, sell, solicit the sale of or purchase
for resale any product that competes with the Product. Distributor
agrees to secure from each of Distributor's agents and
sub-distributors written noncompetition agreements in substantially
the form of this Section 9.2 and to deliver such written agreement to
Company before such agent or sub-distributor undertakes to perform
any of Distributor's obligations hereunder.
9.3 Written Reports and Records For the first six (6) months of this
Agreement Distributor agrees to supply to Company monthly written
sales reports, delivered on the tenth (10th) day of each calendar
month, which report the number of units and sales in U.S. $ of each
Product in each month sold by Distributor in each country in the
Territory. Thereafter, Distributor agrees to supply to Company
quarterly written sales reports, delivered within thirty (30) days
after the end of each calendar quarter , which report the number of
units and sales in U.S.$ of each Product in each month of the quarter
sold by Distributor in each country the Territory.
9.4 Compliance With Laws Distributor shall obtain all licences, permits
or certificates which are required under applicable law to conduct
its business and to resell the Product in the Territory and shall
comply with all laws applicable to its business. Distributor agrees
to not make any payment or gift directly or indirectly to any
employee, officer or representative of any government under
circumstances where such payment would constitute a bribe, kickback
or illegal payment under, or otherwise be in violation of, the
Foreign Corrupt Practices Act of the United States or any applicable
foreign laws. Distributor shall be responsible for ensuring
compliance with all applicable laws, rules and regulations regarding
post approval reports, licenses and registrations within the
Territory. Distributor shall provide to Company within thirty (30)
days of submission, copies of all reports.
9.5 Recall Distributor shall maintain complete and accurate records of
all Product sold by Distributor. If Company, any governmental agency
or other proper authority issues a product recall of any of the
Product, Distributor agrees to fully cooperate with Company (i) in
promptly contacting any purchasers which Company desires to be
contacted during the course of any such recall (ii) in promptly
communicating to such purchasers such information or instructions as
Company may desire be transmitted to such purchasers (iii) in
obtaining the removal of all such recalled Product from Distributor's
inventory and the inventory of its customers and (iv) in disposing of
such recalled Product as Company so directs. Company agrees to
reimburse Distributor for all direct out-of-pocket costs and expenses
actually
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incurred by Distributor as a result of securing the removal of and
disposing of such recalled Product as requested by Company including
but not limited to reimbursement to the Distributor of the cost of
the Product recalled. All costs associated with product recall, which
resulted from the action or in-action of the Distributor, shall be
the sole responsibility of the Distributor.
9.6 No Copying or Reproducing of Product Distributor agrees not to
modify, copy or otherwise reproduce the Product for whatever reason
without the prior written consent of Company.
10 Product Labelling and Promotional Materials
10.1 Product Labels
10.1.1 Distributor shall ensure that the Product is sold and advertised in
the form and with the labelling or marking required by the law of the
Territory.
10.2 Promotional Materials If Distributor desires to create promotional
materials, Distributor shall pay all expenses relating to the
creation of such new promotional materials SAVE THAT Company shall,
at Company's expense, provide to Distributor transparencies or discs
containing existing artwork for the US packaging, package inserts and
promotional materials. Distributor shall also be responsible for
ensuring that such promotional material complies with all applicable
laws, rules and regulations. Any new or translated promotional
materials shall be submitted to Company for its written approval
before their use or dissemination; however, such approval shall not
relieve Distributor of its responsibility for ensuring that such
promotional materials comply with all applicable laws, rules and
regulations in the Territory.
10.3 Company Representation Company represents and warrants to Distributor
that, to the best of its knowledge, the sale of the Product shall not
infringe any third party patent rights in the Territory and the use
of the Company's trademarks on the Product packaging, shall not
infringe on any third party's trademark rights in the Territory.
11 Product Warranty
11.1 Limited Warranty Company warrants to Distributor that, during the
shelf life of the Product, (a) the Product will conform with the
specifications developed by Company and approved by the product
regulatory authorities in the Territory, which specifications will be
attached to this Agreement as Exhibit E at the time the regulatory
approval is granted, (the "Specifications"), (b) the Product has been
manufactured in accordance with accepted manufacturing practices
approved by the regulatory authorities in the Territory with regard
to the manufacture of the Product, and (c) the Product has been
manufactured in accordance with applicable health, safety and
environmental rules, regulations and laws in effect in the United
States as of the date of manufacture.
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11.2 Notification of Defect
11.2.1 Distributor shall inspect and/or test the Product as soon as
practicable following delivery of such. If Distributor wishes to
reject any delivery, or part of delivery, of Product, it must notify
Company within 30 days of receipt of the Product and such
notification must be in writing and include a detailed indication of
the reasons for rejection. In the event of a latent defect coming to
the attention of the Distributor after the 30 day period, the notice
of defect shall be provided within 30 days of discovery of the
defect. Company shall notify Distributor within 30 days of receipt
of such notification of rejection whether it accepts Distributor's
claim. If Company accepts that the Product is defective it shall
reimburse Distributor for the reasonable shipping costs incurred by
Distributor in the return of the defective Product
11.2.2 If Company does not accept any claim by the Distributor that the
Product does not comply with Specification and Distributor still
insists the claim is correct, an independent laboratory, mutually
agreed upon by the parties or failing agreement the Medicines Control
Agency laboratory in Edinburgh, shall be requested to analyse an
appropriate amount of the Product from the batch or batches in
dispute. The samples shall be supplied by Distributor from the
batches in question and by Company from any samples that it has
retained.
11.2.3 Following receipt of the report from the independent laboratory, the
parties will discuss the findings. If Company accepts that the
Product does not conform to the Specification and that it is
responsible for such failure to comply with the Specification,
Company shall manufacture and deliver to Distributor a sufficient
quantity of the Product to replace the defective batch or batches and
pay for the return or destruction of the defective Product. If
Distributor accepts that the relevant batches of Product were
manufactured in accordance with the Specifications or that any defect
did not arise due to Company's negligence or default, Company shall
have no liability or obligation to Distributor in respect of such
batches. If the parties can not agree whether replacement Product
should be provided, either may commence arbitration proceedings in
accordance with clause 19.
11.2.4 The costs of the independent laboratory appointed pursuant to clause
11.2.2 above shall be paid by the Company unless it is found that the
Distributor was at fault in which case the said costs shall be paid
by the Distributor.
11.3 Limitation of Warranty The Warranty set forth in sub-paragraph 11.1
above shall not apply to any Product which has been abused, altered,
modified (other than labelling or packaging), used in a manner not
originally intended, or stored or maintained in a manner contrary to
Company's written instructions.
11.4 DISCLAIMER OF WARRANTIES EXCEPT AS EXPRESSLY PROVIDED IN THIS SECTION
11 AND IN SECTION 10.3, COMPANY HEREBY DISCLAIMS, AND DISTRIBUTOR
HEREBY EXPRESSLY WAIVES ANY AND ALL WARRANTIES, EXPRESS OR IMPLIED,
WITH RESPECT TO THE PRODUCT
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13
SOLD HEREUNDER, INCLUDING, BUT NOT LIMITED TO, IMPLIED CONDITIONS OF
REASONABLE FITNESS FOR A PARTICULAR PURPOSE, MERCHANTABILITY,
NON-INFRINGEMENT, WARRANTIES ARISING FROM COURSE OF DEALING OR USAGE
OF TRADE OR ANY OTHER MATTER. NO AGENT, EMPLOYEE OR REPRESENTATIVE OF
COMPANY HAS ANY AUTHORITY TO BIND COMPANY TO ANY AFFIRMATION,
REPRESENTATION OR WARRANTY EXCEPT AS STATED IN THIS AGREEMENT.
12 Distributor's Indemnification Distributor shall indemnify and hold
Company harmless from any and all loss, damage or expense (including
reasonable attorney's fees) which Company may incur or suffer as a
result of any third party claim arising from (a) breach of warranty
given or purportedly given by Distributor, its employees, agents or
sub-distributors regarding the Product save where Distributor has
merely repeated a warranty provided to it by the Company herein or a
representation made by the Company with regard to the Product; or (b)
improper storage, handling or other act or omission by Distributor,
its employees, agents or sub-distributors; or (c) any trademark or
copyright infringement based on the use of any information contained
on the Product packaging provided by Distributor or on the use of any
promotional materials prepared by Distributor for use in selling the
Product (except to the extent of Company's indemnification obligation
in Section 13.1 below). Company shall notify Distributor of any third
party claim made against it within ten (10) days of knowledge of same
if Company intends to seek indemnity with respect to such claim under
this paragraph. Distributor shall have the right to undertake,
conduct and control the case, shall have the right to be represented
by counsel of its own choosing, but at its own expense. So long as
Distributor is contesting any such claim in good faith, Company shall
not pay or settle such claim.
13 Company Indemnification Company shall indemnify and hold Distributor
harmless from any and all loss, damage or expense (including
reasonable attorneys' fees)) which Distributor may suffer or incur as
a result of (a) any third party claim resulting from the Company's
breach of its representation in Section 10.3; and (b) any third party
claim arising out of (i) the failure of the Product to conform with
the Specifications, (ii) failure of the Product to have been
manufactured in accordance with accepted good manufacturing
processes, (iii) failure of the Product to have been manufactured in
accordance with applicable health, safety and environmental rules,
regulations and laws in effect in the United States at the date of
manufacture, (iv) proper use of the Product itself as approved by the
governing regulatory agency, or (v) the Product itself save where the
circumstances are such that an indemnity in favour of the Company
arises under clause 12; or (vi) any other manufacturing defect in the
Product. Distributor shall notify Company of any third party claim
made against it within ten (10) days of knowledge of same if
Distributor intends to seek indemnity with respect to such claim
under this paragraph. Company shall have the right to undertake,
conduct and control the case and shall have the right to be
represented by counsel of its own choosing, but at its own expense.
So long as
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Company is contesting any such claim in good faith, Distributor shall
not pay or settle such claim.
14 Independent Contractor Distributor is not an agent, employee, joint
venturer, partner, franchisee or legal representative of Company for
any purposes whatsoever. Distributor does not have any right or
authority to bind Company in any manner whatsoever. Distributor shall
be exclusively responsible for the manner in which it performs its
duties under this Agreement. Distributor shall be solely responsible
to its own employees for any compensation due to them and for
compliance with all applicable laws imposed by any governmental
authority regarding Distributor's employees.
15 Confidential Information
15.1 Definition The parties acknowledge that each party may acquire
knowledge of certain trade secrets and confidential information of
the other party during the term of this Agreement. The term
"Confidential Information" means any information or compilation of
information, not generally known, which is proprietary to a party
hereunder (the "Disclosing Party") and relates to the Product or a
party's other products or product research, including, without
limitation, information relating to manufacturing techniques,
marketing strategies, research data, product development, financial
information, customer lists, customer information and any other
information about the Disclosing Party's business which is normally
considered confidential or is indicated by Disclosing Party to be
confidential or proprietary. Confidential Information shall not
include any information (i) which is or becomes publicly available
through no fault of the party receiving it (the "Receiving Party"),
(ii) which is disclosed to the Receiving Party by a third party not
under an obligation of confidence; (iii) which is already known by
the Receiving Party at the time of disclosure to the Receiving Party
by the Disclosing Party existing prior to such disclosure; or (iv)
which is independently developed by the Receiving Party through
persons who have not had access to or knowledge of the Confidential
Information of the Disclosing Party, as evidenced by written
documentation of the Receiving Party.
15.2 Non-disclosure During the term of this Agreement and at all times
thereafter the Receiving Party shall hold in strictest of confidence
and never disclose, transfer, convey or make accessible to any person
any Confidential Information, whether oral or written. The Receiving
Party agrees not to use the Confidential Information for its own
personal benefit (except as permitted under this Agreement) or the
benefit of anyone other than the Disclosing Party. The Receiving
Party agrees to take reasonable precautions to prevent Distributor's
employees and others from disclosing or appropriating for their own
use any Confidential Information of the Disclosing Party. Distributor
agrees to secure from each of Distributor's agents and
sub-distributors insofar as is legally permissible written
confidentiality agreements in substantially the form of this Section
15 and to deliver such written agreement to
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Company before such agent or sub-distributor undertakes to perform
any of Distributor's obligations hereunder.
16 Trademarks
16.1 Use and Registration of Trademarks Company hereby authorises
Distributor to use Company's trademarks and trade names for the
Product (the "Trademarks") (including but not limited to the right to
authorise sub-distributors to use the trade xxxx) solely in
connection with advertising, promoting or selling the Product in the
Territory during the term of this Agreement. Distributor shall
provide written notice of the countries in the Territory within which
it requires the Company to make any applications for registration of
the Trademarks and Company shall be responsible, at its expense, for
filing and maintaining all trademark registrations and/or equivalent
protections. Distributor agrees to provide Company, at Company's
expense, with all reasonable assistance requested by Company in the
registration of the Trademarks in the Territory. Distributor shall be
responsible for filing, at Company's expense, any registered user
application that may be required in the Territory relating to
Distributor's use of the Trademarks. Distributor may not use any of
the Trademarks in its corporate or business name, or in any other
manner which Company deems adverse to its interests. However,
Distributor may indicate that it is an authorised distributor of the
Product on Company approved letterhead, business cards or other
advertising
16.2 Unauthorised use of Trademarks Distributor agrees to notify Company
of any unauthorised use of the Trademarks by others as it comes to
Distributor's attention. If Company elects not to bring any
infringement, unfair competition or similar action based on such
unauthorised use or infringement in the Territory, Distributor shall
have the option of doing so at its own expense. If Distributor
exercises this option, it may join Company as a party only if
Distributor indemnifies Company against any damages or expenses
resulting therefrom. In any litigation against third parties relating
to the Trademarks, unless otherwise agreed, any proceeds or recovery
obtained in any such action shall be apportioned between the parties
according to how expenses of the litigation were borne.
17 Termination
17.1 Termination For Failure to Secure Regulatory Approval Subject to
clause 1.5, if Distributor is unable to secure regulatory approval
for the Product within two years of approval in Sweden, either party
may terminate this Agreement by delivery of written notice to the
other party; provided, however, if the terminating party is Company,
Distributor shall have a period of sixty (60) days from the delivery
of the notice to secure such regulatory approval or provide written
evidence to Company that such approval is imminent.
17.2 Termination for Breach Except as expressly provided in subsection
17.3 below, either party may terminate this Agreement effective upon
delivery of written notice to the other party, if the other party
breaches or otherwise fails to be in conformance
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with any term or condition of this Agreement; provided however, if
such breach or non-performance is capable of remedy this Agreement
shall not terminate if such breach or non-performance is remedied
within sixty (60) days after delivery of the written notice of
termination, which notice shall specify the breach or failure.
17.3 Failure to Meet Quota or comply with Requirements set forth in
Exhibit F
17.3.1 Failure of Distributor to meet the Quota set forth in Exhibit D, or
failure of Distributor to execute the marketing plan set forth in
Exhibit F, or as later agreed between the parties in writing, shall,
save as provided below, be considered a material breach of this
Agreement. Within sixty (60) days of the end of each year of this
Agreement, the Company shall provide to Distributor a report setting
forth the amount of the Product ordered from the Company and the
Quota for that year. The Distributor shall within sixty (60) days of
the end of each year of this Agreement, provide to the Company a
report setting forth the marketing activities undertaken during such
year and the U.S. Dollar amount expended on marketing and promotional
activities for such period.
17.3.2 In the event that Distributor has failed to purchase the amount of
Product specified during any Quota period, Distributor may, at its
option:-
17.3.2.1 pay to Company the dollar amount equal to the order price for the
difference between Quota quantity and the actual quantity of Product
purchased by Distributor in the Quota period for such period (the
"Quota shortfall") within sixty (60) days of receipt from the Company
of the report to be provided pursuant to clause 17.3.1. If
Distributor has indicated that it wishes to exercise its option to
cure a failure to order the Quota for a year pursuant to this Clause
17.3.2.1 and Company has not received payment of the Quota shortfall
within such sixty (60) day period, Company shall have the right to
terminate this Agreement, or to delete from Exhibit B that portion of
the Territory to which the Quota applied, effective immediately upon
delivery of written notice to Distributor without further opportunity
for cure; and/or
17.3.2.2 make up the Quota shortfall in the following year of the Agreement by
ordering in that following year of the Agreement a quantity of the
Product equal to the sum of the Quota shortfall and the Quota for
that following year.
17.3.3 The Company shall have the right to conduct an audit through an
independent firm of certified public accountants to audit (not more
than once per year) the Distributor's marketing expenses related to
the Product, the Average Price and the Applicable Percentage. In the
event that the Distributor has failed to expend the sums committed to
the marketing budget as set forth in Exhibit F the Company shall have
the right to terminate this Agreement.
17.4 Insolvency Either party may terminate this Agreement effective
immediately upon delivery of written notice to the other party, if
the other party (i) becomes unable to pay its debts as they mature,
(ii) admits in writing its inability to pay its debts as they mature
(iii) makes a general assignment for the benefit of creditors, (iv)
files a
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voluntary petition for bankruptcy, (v) has an involuntary petition of
bankruptcy filed against it, or (vi) applies for the appointment of a
trustee or receiver for any substantial portion of its property or
business or permits the appointment of any such trustee or receiver
who is not discharged within a period of thirty days after such
appointment.
18 Effect of Termination
18.1 Trademarks/Confidential Information Upon expiration or termination of
this Agreement for whatever reason, Distributor shall cease using
Company Trademarks or any name or description that relates or
pertains to the name Company or its products (except to the extent
provided in subsection 18.3 below), and shall return or destroy all
Confidential Information and destroy all sales literature, pamphlets,
and any information of any kind that relates or pertains to Company
or its products. Distributor shall take such steps as are necessary,
and Company agrees to co-operate as necessary, to procure the
cancellation of any registered user agreement entered into to allow
for Distributor to use the Trademarks in the Territory. Any filing
fees necessary to procure such cancellation shall be paid by the
Company.
18.2 Product Inventory Company shall have the option to repurchase from
Distributor all of the current Product in Distributor's inventory as
of the effective date of expiration or termination of this Agreement
for whatever reason, at a price equal to the original purchase price
for the Product paid by Distributor to Company plus the cost of
packaging and labelling the Product. Company may exercise its option
by delivery of written notice to Distributor within thirty (30) days
after the effective date of expiration or termination of this
Agreement. Distributor shall ship all such inventory of Product to
Company, at Company's expense, within ten (10) days after receipt of
Company's exercise of its option. Company shall pay the amount owing
to Distributor for such inventory within thirty (30) days after
receipt of the inventory. If Company elects not to purchase
Distributor's inventory of Product, Distributor shall have the right
to sell such inventory in the Territory for a period of six (6)
months following the effective date of termination or expiration of
this Agreement and shall have a limited right to continue to use
Company's Trademarks to effectuate such sales in accordance with the
provisions of Section 16.1 herein.
18.3 Payments Owing Termination of this Agreement shall not relieve or
release either party from any liability which either party may have
to the other party arising out of this Agreement, including any
obligation to make any payments which may be owing to the other party
under the terms of this Agreement as of the effective date of
expiration or termination. However, if either party terminates this
Agreement in accordance with the terms hereof, such party shall not
be liable to the terminated party for any claim for lost future
revenues of the other party.
18.4 Acceptance of Orders Acceptance of orders from Distributor by Company
after termination of this Agreement shall not constitute a renewal of
this Agreement or a waiver of the right to Company to treat this
Agreement as terminated.
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19 General Provisions
19.1 Force Majeure Neither party shall be liable to the other party for
any delay or failure of delivery or other performance caused in whole
or in party by any contingency beyond such party's reasonable
control, including, without limitation, fire, flood, acts of god,
acts of any government or any agency or subdivision thereof or
shortage or inability to secure labour, fuel, energy, raw materials,
supplies or machinery at reasonable prices from regular sources.
Should the event of force majeure continue for a period of six (6)
months, either party may terminate this Agreement on the provision of
written notice.
19.2 Limitation of Remedy Except as expressly set forth in Section 9.5
regarding recalled Product and Section 13 regarding indemnification
for certain third party claims, Company shall have no liability to
Distributor for indirect, special, incidental, or consequential
damages of any description, whether arising out of warranty or other
contract, negligence or other tort, or otherwise. Distributor shall
have no liability to Company for indirect, special, incidental or
consequential damages of any description whether arising out of
warranty or other contract, negligence or other tort or otherwise.
19.3 Entire Agreement This Agreement, together with Schedule 1 and
Exhibits X, X, X, X, X, X, X and H attached hereto, contains the
entire agreement of the parties concerning the subject matter hereto,
and supersedes all prior communications, understandings, and
agreements between the parties with respect thereof.
19.4 Modification and Waiver No purported amendment, modification or
waiver or any provision hereof shall be binding unless set forth in a
writing in the English language signed by both parties (in the case
of amendments and modifications) or by the party to be charged
thereby (in the case of waivers). Any waiver shall be limited to the
circumstance or event specifically referenced in the written waiver
document and shall not be deemed a waiver of any other term of this
Agreement or of the same circumstance or event upon any recurrence
thereof. Only officers of either party holding the same title as
those who have signed this Agreement shall have the right to execute
any amendment, modification or waiver document on behalf of the
relevant party.
19.5 Notices All notices and other communications required or permitted to
be given hereunder shall be in writing in the English language and
shall be deemed to have been duly given (i) when received if
delivered by hand; (ii) the next business day if delivered by
facsimile (sender's copy of the facsimile must show a confirmation of
receipt from receiver's facsimile machine); (ii) three (3) business
days after placement with a reputable international overnight
carrier; or (iv) ten (10) business days after deposit, if placed in
the mail for delivery by airmail, postage pre-paid, and addressed to
the appropriate party using the address set forth on page one of this
Agreement. If either party should change its address and/or facsimile
number, such party shall give written notice of the other party of
the new address and/or facsimile
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number in the manner set forth above, but any such notice shall not
be effective until actually received by the addressee.
19.6 Nonassignment Distributor shall not establish sub-distributors,
assign, transfer or sell all or any part of its rights or obligations
hereunder, by operation of law or otherwise, without the prior
written consent of Company which consent shall not be unreasonably
withheld. This Agreement shall be binding upon and inure to the
benefit of any successor or assignee of Company and of any permitted
successors and assigns of the Distributor as provided above.
19.7 Severability Should any part of this agreement, for any reason, be
declared invalid, such decision shall not affect the validity of any
remaining portions, and such remaining portion shall remain in full
force and effect as if this Agreement had been executed with the
invalid portion eliminated.
19.8 Injunctive Relief In addition to any other relief afforded by law,
each party shall have the right to enforce covenants contained in
this Agreement by specific performance and preliminary, temporary and
permanent injunctive relief against the other party or any other
person concerned thereby. Damages, specific performance and
injunctive relief shall be considered proper modes of relief and are
not to be considered alternative remedies.
19.9 Governing Law Any dispute, controversy or claim arising out of or in
connection with this Agreement shall be determined and settled by
arbitration in New York, New York, pursuant to the Rules of
Arbitration then in effect of the American Arbitration Association.
Any reward rendered shall be final and conclusive upon the parties
and a judgement thereon may be entered in a court having competent
jurisdiction. Any arbitration hereunder shall be (i) submitted to an
arbitration tribunal comprised of three (3) independent members
knowledgeable in the pharmaceutical industry, one of whom shall be
selected by the Distributor, one of whom shall be selected by the
Company, and one of whom shall be selected by the other two
arbitrators; (ii) allow for the parties to request discovery pursuant
to the rules then in effect under the Federal Rules of Civil
Procedure for a period not to exceed 90 days; and (iii) require the
award to be accompanied by findings of fact and a statement of
reasons for the decision. Each party shall bear its own costs and
expenses, including attorney's fees incurred in any dispute which is
determined and/or settled by arbitration pursuant to this Section.
Except where clearly prevented by the area in dispute, both parties
agree to continue performing their respective obligations under this
Agreement while the dispute is being resolved. Arbitration shall not
prevent any party from seeking injunctive relief where such remedy is
an appropriate form of remedy under the circumstances.
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The parties hereto have caused this Agreement to be executed in the manner
appropriate to each to be effective as of the date entered on the first page
hereof.
CAMBRIDGE SELFCARE DIAGNOSTICS LIMITED
("Distributor")
By .......................................................
Its .......................................................
NASTECH PHARMACEUTICALS INC.
("Company")
By Xx Xxxxxxx X. Xxxxx
Its President and Chief Executive Officer
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List of Exhibits
Schedule 1 = Adverse Events Procedure
A = Product
B = Territory
C = Prices
D = Quota (by quarter) and Time Period to Secure Regulatory Approval
E = Specifications
F = Marketing Plans
G = Patents
H = Trade Marks
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SCHEDULE 1
ADVERSE EVENTS PROCEDURE
A. For the purposes of this Schedule "Adverse Event" ("AE") shall have
the meaning ascribed to such term under applicable law, but in any
event shall include any reaction, side-effect or other undesirable
events (such as injuries, toxicity or sensitivity reaction, or any
other unexpected incident and the severity thereof) that is
associated with the use of the Product in humans, whether or not the
event is considered drug related, including, but not limited to, the
following: an AE occurring in the course of the use of the Product
in professional practice, including use in clinical studies; drug
overdose, whether accidental or intentional; an AE occurring from
drug abuse; an AE occurring from drug withdrawal; any significant
failure of expected pharmacological or biological actions and any AE
associated with the clinical use, study, investigation, testing and
marketing of the Product. In addition, when an AE is herein
referred to as "serious" it shall have the meaning ascribed to such
term under applicable law but in any event shall include any
occurring at any dosage that is fatal, life threatening, disabling,
incapacitating, results in or prolongs hospitalisation, necessitates
medical or surgical intervention to prevent permanent impairment or
damage, a congenital anomaly or in the opinion of a medical reviewer
is of major clinical significance.
B. The Company shall:-
(i) maintain a data base of AEs arising from the Product reported anywhere in
the world; and
(ii) notify the Distributor of all serious AEs within 3 days of receipt of
notice of such and all other AEs of which it receives notice within 10
days of receipt of notice of such;
(iii) provide to Distributor quarterly and annual summaries of AEs (as CIOMS I
forms/ CIOMS II line listings) within two months of the end of the quarter
or year and in addition provide, with the annual report, an estimate of
the number of people treated during the relevant 12 month period;
(iv) provide to Distributor cumulative summary reports of AEs on reasonable
demand (as CIOMS I forms/CIOMS II line listings) to cover the period from
the commencement of marketing of the Product;
(v) notify the Distributor of any change in the safety profile or clinical
particulars or other such information regarding the Product and make
recommendations for changes in the Product labelling when appropriate; and
(vi) prepare worldwide periodic safety update reports as required by the
regulators under the terms of the marketing authorisations.
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C. Distributor shall:-
(i) forward to the Company information reported in the Territory and relating
to AEs or other data regarding the safety of the Product; and
(ii) inform the Company of any serious AEs occurring in the Territory within 3
days of receipt of information regarding such serious AE;
(iii) notify the Company of any non-serious AEs occurring in the Territory
within 10 days of receipt of information regarding such non-serious AE;
(iv) submit relevant reports to the regulatory authorities in the Territory
(which may be on the Company's behalf if Distributor is not the holder of
the regulatory approval regarding any AEs occurring in the Territory; and
(v) submit relevant reports to the regulatory authorities in the Territory
(which may be on the Company's behalf if Distributor is not the holder of
the regulatory approval) regarding any AEs concerning the Product
occurring outside the Territory which are being forwarded to Distributor
by the Company.
D. All information regarding all AEs, which is to be exchanged between the
parties, shall be in the English language.
E. All reasonable efforts should be made to ensure the following information
is provided in AE reports:
General
Local Identification number
Date of receipt
Source - health professional name, address and telephone number. If the report
is from a consumer, or a health professional who is not a physician, the name of
the attending physician.
Patient details
Identification (initials)
Date of birth or age if date of birth is not known or indication of age group
(Elderly, adult or child etc) if neither date of birth nor age are known.
Gender
Race
Hospital number if applicable
Relevant medical history
Relevant diagnostic tests
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Adverse event
Description of event
Onset date (or time since onset if not known)
Time since onset if less than 24 hours
Outcome
Relationship to suspect product, in the opinion of the reporting physician
Treatment given, if any
Information on dechallenge/rechallenge (if applicable)
Suspect product
Name of Product
Date treatment started; date treatment stopped (or duration of treatment if
dates not known)
Dose
Reason for use
Route of administration
Batch number
Concomitant medication (or any medication given in previous month)
Name
Date treatment started; date treatment stopped (or duration of treatment and
temporal relationship to AE if dates not known)
Dose
Reason for use
Route of administration
F. In no instance should an initial report for any AE be delayed while
awaiting further information. The report of any AE should permit
identification of a discernible subject, suspect product, AE and source
report. If additional information is expected, this should be stated on
the initial report. A follow up report should be made as soon as the
additional information is available.
G. Each party will exercise due diligence and exert all reasonable efforts to
collect AE information from its affiliates in other related parties
worldwide.
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Exhibit A
The Product shall mean a pharmaceutical preparation in intranasal form
containing cyanocobalamin as the active therapeutic ingredient as well as any
future developments thereof complying with the Specification. Any product
supplied prior to the grant of full marketing authorisation should comply with
the FDA approved specification save in respect of packaging and labelling
requirements.
The Product shall be supplied to Distributor in trade units of 5ml bottles,
equivalent to 8 doses, unlabeled on both the inner and outer package, including
nasal pump. The Company will not supply any patient information or package
insert, both of which shall be provided by the Distributor. Company shall
provide to Distributor, free of charge, transparencies of existing US artwork
for packaging and package inserts.
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Exhibit B
The "Territory" shall include the United Kingdom, Eire, France, Greece, Germany,
Spain, Italy, Portugal, the Netherlands, Belgium, Austria, the Czech Republic,
Slovakia, Slovenia, Hungary, Poland, Australia and New Zealand.
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Exhibit C
The initial price (in U.S. Dollars) per unit of Product shall be as follows:
For the first 119,999 Units the price to Distributor shall be $19.00;
For Units beginning with Unit 120,000 through Unit 479,999 the price to
Distributor shall be $17.00;
For Units beginning with Unit 480,000 and thereafter the price to
Distributor shall be $15.00;
The pricing calculations set forth above shall be cumulative from
inception. ie. beginning with the first purchase by the Distributor.
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Exhibit D
The Distributor's reasonable estimate of the number of units for that it will
sell by the end of the first year following grant of pricing and reimbursement
approvals in all EU countries in the Territory and in the second and third years
of this Agreement following grant of pricing and reimbursement approvals in all
EU countries in the Territory is as follows:
Year No. 1 42,000 Units
Year No. 2 140,000 Units
Year No. 3 480,000 Units
If Distributor elects to withdraw an application for regulatory or pricing and
reimbursement approval for the Product in the last EU country in the Territory
for which regulatory or pricing and reimbursement approval for the Product is
required, pricing and reimbursement approval for the Product in all EU countries
in the Territory shall be deemed to have occurred on the date the said
application was withdrawn.
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Exhibit E
The Specifications for the Product shall be as follows that which conforms with
the regulatory approvals granted in each country in the Territory copies of
which shall be inserted into this agreement once such approval has been granted.
Prior to such approvals being granted the Product will comply with the
specification set forth in the FDA approval save in respect of labelling and
regulatory requirements.
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Exhibit F
The Distributor shall consult with the Company on the development and
particulars of its marketing plan. The Distributor shall commit to the following
promotional and launch budget for the Product in the Territory in each year of
this Agreement after the grant of pricing and reimbursement approval for the
Product in all EU countries in the Territory as follows:
Year No. 1 $US 1,595,200
Year No. 2 $US 2,970,560
Year No. 3 $US 5,226,240
Expenditure on the following items shall be considered expenditure made in
accordance with the promotional and launch budget:-
regulatory submissions
consultancy fees associated with preparation of regulatory submissions
the person hours of the sales and marketing persons involved in the sale
and marketing of the Product
promotion and marketing of the Product
packaging and distribution costs
legal costs associated with the appointment of sub-distributors, regulatory
matters and the promotion and launch of the Product
If Distributor elects to withdraw an application for regulatory or pricing and
reimbursement approval for the Product in the last EU country in the Territory
for which regulatory or pricing and reimbursement approval for the Product is
required, pricing and reimbursement approval for the Product in all EU countries
in the Territory shall be deemed to have occurred on the date the said
application was withdrawn.
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Exhibit G
---------
Patents
-------
Country Expiration
------- ----------
Australia April 0000
Xxxxxxx April 0000
Xxxxxx April 0000
Xxxxxxx April 2006
Great Britain April 2006
Hungary April 2006
Ireland April 0000
Xxxxx April 0000
Xxxxxxxxxxx April 0000
Xxxxx April 2006
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Exhibit H
TRADE MARKS
NASCOBAL
32
