EXHIBIT 10.34
EXECUTION COPY: NOV 18, 2004
MANUFACTURING AND SUPPLY AGREEMENT
DATED 18 NOVEMBER, 2004
INYX USA, LTD
AND
NOVADEL PHARMA, INC.
CONTENTS
SECTION PAGE
1. Definitions..........................................................2
2. Appointment of INyX as supplier.....................................3
3. Production...........................................................4
6. Supply of Product....................................................7
5. Changes to Product Specification.....................................7
6. Supply and storage of Raw Materials and Components...................7
7. Premises, Maintenance, Inspection and insurance......................8
8. Access to premises and technical visits..............................8
9. Regulatory matters...................................................9
10. Product recall.......................................................9
11. Complaints..........................................................10
12. Price and payment...................................................11
13. Intellectual property...............................................11
14. Duration and termination............................................12
15. Stock disposal......................................................13
16. Confidentiality.....................................................13
17. Warranties, Indemnification and Limitiation of Liability............13
18. Limitation of liability.............................................14
19. Force Majeure.......................................................15
20. Notice..............................................................15
21. Further assurance...................................................16
22. Counterparts........................................................16
23. No partnership or agency............................................16
24. Assignment and subcontracting.......................................16
25. Previous agreements.................................................17
26. Amendments..........................................................17
27. Partial invalidity..................................................17
28. Third party rights..................................................17
29. Prevailing conditions...............................................17
30. Waiver..............................................................17
31. Language............................................................18
32. Set off.............................................................18
33. Costs...............................................................18
34. Applicable law competent court......................................18
APPENDICES
Appendix 1....................................................................1
Appendix 2....................................................................2
Appendix 3....................................................................4
Appendix 4....................................................................4
Appendix 5....................................................................5
AN AGREEMENT made this 18 day of November 2004
BETWEEN NovaDel Pharma Inc. having a place of business
at ▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇
AND INyX USA, Ltd having a place of business at San
▇▇▇▇' Road # 604 / Industrial Zone, Cotto Norte,
Manati, PR 00674, Puerto Rico ("INyX")
WHEREAS
(A) NovaDel has the right to market and sell the Product listed in Appendix 1
("the Product") worldwide.
(B) INyX is willing to undertake the manufacture, testing, packaging, packing,
ongoing stability and delivery of the Product for NovaDel in accordance
with the terms and conditions contained in this Agreement.
(C) The parties intend that INyX will undertake the manufacture, packing,
supply and the required stability studies of the Product in accordance
with the terms and conditions contained in a Technical Agreement, which is
incorporated into this Agreement.
(D) In accordance with current US directives and good manufacturing practice,
the Technical Agreement between NovaDel and INyX defines the
responsibilities of the parties with regard to the manufacture of the
Product and the execution of responsibilities by the person responsible
for releasing each batch of the Product for sale.
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NOW IT IS HEREBY AGREED AS FOLLOWS:
1. DEFINITIONS
1.1 In this Agreement:
"AFFECTED OBLIGATION" shall have the meaning specified in section 19;
"BUSINESS DAY" means a day other than a Saturday or Sunday or public
holiday in England and the United States;
"CGMP" means the current Good Manufacturing Practices regulations of the
FDA (as in effect from time to time) currently contained in 21 C.F.R. pts.
210 and 211 and in the Rules Governing Medicinal Products in the European
Union Volume IV .
"COMPONENTS" means the packaging materials as specified in the Technical
Agreement;
"COST OF GOODS" means with respect to that portion of the manufacturing,
processing, testing, packaging and labeling of the Product performed by
INyX, INyX's actual, direct cost of such activities (including the cost of
raw materials and/or Components).
"DEFAULTING PARTY" shall have the meaning specified in section 14.3;
"EFFECTIVE DATE" means the date of this Agreement;
"FDA" means the United States Food and Drug Administration or successor
government agency in the United States.
"FIRST COMMERCIAL SALE" means the first sale of the Product by NovaDel, or
its designee, in an arms' length transaction to an unaffiliated third
party.
"FORCE MAJEURE" means, in relation to either party, any circumstances
beyond the reasonable control of that party (including without limitation
any acts or restraints of governments or public authorities, strikes,
lockouts or other industrial action, war, revolution, riot or civil
commotion);
"INTELLECTUAL PROPERTY RIGHTS" means (a) copyright, patents, supplementary
protection certificates, database rights and rights in trade marks,
designs, know-how and confidential information (whether registered or
unregistered); (b) applications for registration, and the right to apply
for registration, for any of these rights; and (c) all other intellectual
property rights and equivalent or similar forms of protection existing
anywhere in the world;
"NDA" means the new drug application filed by NovaDel with respect to the
Product seeking approval of the Product by the FDA, as the same may be
supplemented and/or amended from time to time.
"PRICE" means the price specified in Appendix 2;
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"PRODUCT" means the Product listed in Appendix 1, which may be amended by
prior written agreement of the parties from time to time;
"PRODUCT SPECIFICATION" means the specification for a Product contained in
the relevant Regulatory Approval and such additional amended specification
as may be agreed by the parties in writing;
"PURCHASE ORDER" shall have the meaning specified in section 3.2;
"RAW MATERIALS" means the substances required to be incorporated into the
Product and specified in the Technical Agreement;
"REGULATORY APPROVAL" means the final approval to market the Products in
any country of the Territory, including without limitation, pricing and
reimbursement approval and any other approval which is required to market
the Products in the normal course of business;
"REGULATORY AUTHORITY" means any governmental or regulatory bodies,
agencies, departments or entities (whether national or supra-national)
which regulate, direct or control commercial and other related activities
in the Territory;
"TECHNICAL AGREEMENT" means the agreement between NovaDel and INyX, which
is attached as Appendix 3 and which is incorporated into this Agreement;
"TERRITORY" means the countries specified in Appendix 4;
"VAT" means: (a) any tax imposed in compliance with the Sixth Directive of
the Council of the European Communities (77/388/EEC); and (b) any other
tax of a similar fiscal nature, whether imposed in a member state of the
European Union in substitution for or in addition to such tax, or imposed
elsewhere; and
1.2 In this Agreement, a reference to a month is to a calendar month.
1.3 Headings in this Agreement are for ease of reference only and shall not
affect its construction or interpretation.
1.4 The appendices to this Agreement form part of it.
2. APPOINTMENT OF INYX AS SUPPLIER
2.1 During the term of this Agreement and subject to Section 14.1, INyX agrees
to manufacture, pack and supply the Product from Raw Materials and
Components obtained from NovaDel's nominated or agreed supplier, in
accordance with the Technical Agreement.
2.2 INyX agrees to perform all stability studies as may be required for
ongoing marketing and sale of the Product and shall conduct such stability
studies in compliance with FDA requirements as further defined in the
Technical Agreement
2.3 INyX undertakes to NovaDel that INyX shall not directly or indirectly
sell, supply, manufacture or distribute the Product to any person or
company in the Territory or outside the Territory other than NovaDel or
its designee.
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3. PRODUCTION
3.1 Forecasts.
(a) NovaDel, or its designee, shall provide INyX with written quarterly
forecasts of the quantities of the Product that it expects to order
for each rolling 12-month period. Such forecasts are estimates and
purchases of Product shall be affected pursuant to Purchase Orders
submitted to INyX by NovaDel or its designees, provided however, the
Product requirements for the first 3 months of each forecast are
regarded as firm requirements and Purchase Orders will be placed
accordingly by NovaDel or its designee.
(b) NovaDel, or its designee, shall deliver the first such quarterly
forecast no later than 60 days after the Effective Date, and shall
deliver the updated and extended forecasts not less than 5 Business
Days before the end of each quarter thereafter.
3.2 Purchase Orders.
(a) Subject to the other provisions of this Agreement, NovaDel, or its
designee, shall from time to time, but not before January 1, 2005,
place orders for the Product (a Purchase Order) and identify the
requested delivery dates for each such order.
(b) The delivery dates specified in any such Purchase Orders shall not
be less than (60) days from the dates of such Purchase Orders.
(c) Each Purchase Order placed pursuant to this Section 3.2 shall
constitute a firm obligation to purchase the ordered quantities of
the Product, subject to the following provisions
(i) A Purchase Orders may be modified or cancelled by NovaDel, or
its designee, upon written notice to INyX; provided, however,
that if any modification or cancellation of an order shall
occur less than 60 days prior to the delivery date, NovaDel
shall pay INyX within 30 days after invoice therefore any
out-of-pocket costs incurred by INyX as a direct result of
such modification or cancellation by NovaDel and which would
not otherwise be recovered by INyX hereunder.
(ii) INyX shall provide a Purchase Order confirmation to NovaDel
within three Business Days of receipt of a Purchaser Order
that complies with the provisions of clause 3.2.
(iii) INyX shall have the right to refuse any Purchase Orders which
do not comply with the provisions of section 3.2.
(iv) The terms, conditions and limitations of this Agreement shall
be controlling over any conflicting terms and conditions
contained in any Purchase Order or other documentation used by
NovaDel in ordering the Product or by INyX in accepting or
confirming Purchase Orders, and any term or condition of such
Purchase Order, acceptance or other document that shall
conflict with, or be in addition to, the terms, conditions and
limitations of this Agreement is hereby expressly rejected.
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3.3 Packaging.
(a) INyX shall ensure that the Product is packaged with labels, Product
inserts and other labelling as reasonably approved by NovaDel and
specified in the Technical Agreement. NovaDel, or its designee, may,
in its sole discretion, but subject to the requirements of
applicable laws and regulations in the relevant Territory, make
changes to labels, Product inserts and other labelling for the
Product.
(b) NovaDel shall reimburse INyX for the actual costs incurred by INyX
of any labels, Product inserts, other labelling or any other primary
component rendered obsolete due to a change precipitated by NovaDel
in its sole discretion; provided, that:
(i) INyX shall provide reasonable documentation of such cost;
(ii) the cost of such components shall not be included in the
Price; and
(iii) INyX shall maintain no more than 180 days inventory of such
labels, Product inserts and other labelling at all times.
3.4 Delivery.
INyX shall use commercially reasonable efforts to ensure that the Product
ordered by NovaDel, or its designee, in accordance with this Agreement is
shipped to the facility designated by NovaDel, or its designee, in
accordance with the delivery dates specified in NovaDel's, or its
designee's, Purchase Orders, and INyX shall notify NovaDel, or its
designee, promptly of any significant anticipated delay.
3.5 Quality Control, Assurances and Release Documentation.
(a) INyX shall perform all in-process quality control tests and quality
assurance reviews on the Product as specified in the Technical
Agreement and shall certify in writing that each batch of the
Product delivered to NovaDel, or its designee, was manufactured in
strict conformity with the Product Manufacturing Requirements as
specified in the Technical Agreement and that the Product contained
in such shipment complies with the provisions set out in the
Technical Agreement and the other terms of this Agreement.
(b) All deliveries of Product by INyX shall be accompanied by
appropriate documentation - as specified in the Technical Agreement
- required under applicable law to import the Product into, and for
NovaDel, or its designee, to offer the Product for sale in, the
relevant Territory, including any quality assurance or quality
control audit results and/or certifications that approval for the
Product has been audited to ensure that any Product supplied
hereunder has been manufactured in conformity with cGMP and other
applicable regulations in the relevant Territory.
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3.6 Acceptance and Rejection.
(a) NovaDel, or its designee, shall give written notice to INyX of any
claims that the Product manufactured by INyX does not comply with
the requirements as set out in the Technical Agreement promptly upon
its becoming aware of such non-compliance.
(b) In the event that NovaDel, or its designee, shall fail to notify
INyX of any such claim within 45 Business Days of NovaDel's, or its
designee's, receipt thereof at its facility, such Products shall be
deemed accepted by NovaDel; provided, however, that, other than with
respect to defects or other non-compliance plainly observable from a
visual inspection, any such acceptance or deemed acceptance shall
not adversely affect or otherwise shorten any applicable Product
warranty period.
(c) Any notice by NovaDel, or its designee, pursuant to this Section 3.6
that any Products do not comply with the terms and conditions hereof
shall be accompanied by a true and correct copy of the results of
any tests conducted by NovaDel, or its designee thereon, although no
such tests are required with respect to defects or other
non-compliance plainly observable from a visual inspection.
(d) The parties shall cooperate in good faith to resolve any disputes
arising therefrom and, in the event that the parties shall be unable
to resolve such dispute within 30 calendar days from the date of
NovaDel's, or its designee's, notice pursuant to this Section 3.6,
the parties shall submit such dispute to a mutually satisfactory
independent laboratory. The determination by such laboratory shall
be final and binding on the parties and the costs therefor shall be
borne by the non-prevailing party.
(e) NovaDel, or its designee, shall not dispose of any Product claimed
by it not to comply with the terms and conditions of this Article 3
until resolution of any dispute with respect thereto.
(f) INyX shall promptly replace any Product that does not comply with
the terms and conditions hereof, at INyX's sole cost and expense, by
delivery thereof to NovaDel, or its designee.
(g) NovaDel shall pay INyX within ten Business Days for any Products
delivered by INyX and found to be in compliance with the terms and
conditions of this Article 3 after a challenge under this Section
3.6
3.7 Sales and Operations Planning / Communication
(a) The parties agree to establish and maintain regular meetings between
the parties and /or their designees to discuss MARKETING-, DEMAND-,
MANUFACTURING- and CAPACITY planning.
(b) Meetings will be held on a monthly basis until further notice.
(c) Parties will appoint a key account manager with specific
responsibility for this relationship, names and contact details as
per Appendix 5
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4. SUPPLY OF PRODUCT
4.1 INyX shall use commercially reasonable efforts to supply the Product
requested in each Purchase Order by the requested delivery date.
4.2 Each Product supplied by INyX to NovaDel shall be:
(a) in such form as is required under the Technical Agreement;
(b) delivered in accordance with the provisions of Appendix 2 to such
addresses as NovaDel, or its designee, shall designate; and
(c) conform to the Product Specification and all applicable laws,
including cGMP.
4.2 Insufficiency of Supply.
(a) Subject to NovaDel's, or its designee's, delivery of a forecast and
Purchase Order pursuant to Sections 3.1 and 3.2, respectively, in
the event that INyX shall fail or shall be unable to supply
NovaDel's, or its designee's, reasonable requirements for the
Product hereunder for a period exceeding 90 cumulative days in any
given 365 day period, then NovaDel may, in its discretion, elect to
terminate this Agreement and NovaDel shall give INyX not less than
90 days notice of its intention to do so.
(b) INyX shall - at NovaDel's cost - upon the reasonable request of
NovaDel, cooperate with, assist and provide NovaDel (or its
Affiliate or third-party manufacturer, as applicable) with all and
any documentation and technology necessary or desirable to
manufacture, test, package the Product as herein contemplated.
4.3 INyX shall be deemed to have fulfilled its contractual obligations in
respect of each Purchase Order provided that the quantity actually
delivered is not more or less than [10 percent.] of the quantity specified
in the relevant Purchase Order. NovaDel shall pay for the actual quantity
delivered.
5. CHANGES TO PRODUCT SPECIFICATION
5.1 If:
(a) changes to the Product Specification are required by law or by any
Regulatory Authority; or
(b) NovaDel reasonably requests changes to the Product Specification,
INyX shall promptly implement any such change at NovaDel's sole cost.
Otherwise, changes shall only be made to the Product Specification by
agreement between the parties which will be reflected in the Technical
Agreement attached hereto.
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6. SUPPLY AND STORAGE OF RAW MATERIALS AND COMPONENTS
6.1 Within 30 Business Days of the Effective Date, INyX will provide NovaDel
with the names and addresses of all suppliers INyX proposes to buy Raw
Materials and Components from.
6.2 All Raw Materials purchased by INyX shall at all times remain the property
of INyX.
6.3 INyX shall be solely responsible for ordering the necessary quantities of
Raw Materials and Components.
6.4 INyX shall do all acts and things lawfully possible that NovaDel may
reasonably request to protect the Raw Materials, Components and the
Product against any persons having claims against INyX.
7. PREMISES, MAINTENANCE, INSPECTION AND INSURANCE
7.1 INyX shall be responsible for providing and maintaining all facilities
including but not limited to suitable premises and all necessary labour,
plant, machinery, equipment and services as approved in writing by NovaDel
for the manufacture and quality control of the Product and for the storage
of Raw Materials, Components and Product.
7.2 INyX shall have the right to transfer manufacture of the Product to other
facilities within the INyX Group of companies, subject to
(a) Agreement in writing by NovaDel, such agreement not to be
unreasonably withheld or delayed
(b) having the necessary Regulatory Approvals in place
(c) such transfer having no adverse effect on Price and other relevant
supply conditions as defined in this Agreement for the Product
7.3 INyX shall maintain and operate the manufacturing facility or facilities
designated in the NDA and implement such quality control procedures so as
to meet the requirements of FDA regulations and so as to be able to timely
perform its obligations hereunder.
7.4 INyX shall promptly provide NovaDel, and its designee, with a copy of any
FDA Form 483 ("Notice of Observations") received at the conclusion of an
inspection relating to the Product and all follow-up correspondence from
the FDA, if any.
7.5 Such premises, Raw Materials, Components and Product, plant, machinery and
equipment therein shall be insured at INyX's cost for their full
reinstatement value against fire, storm, accident, flood, theft and such
other risks as shall be agreed between the parties hereto from time to
time.
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8. ACCESS TO PREMISES AND TECHNICAL VISITS
8.1 INyX shall allow any Regulatory Authority to enter the premises to conduct
an inspection at any time.
8.2 INyX shall permit quality assurance representatives of NovaDel, and/or its
designee, to inspect such manufacturing facility or facilities at all
times upon reasonable notice, during normal business hours and on a
confidential basis.
9. REGULATORY MATTERS
9.1 INyX shall be responsible, at INyX's expense, for filing for and
maintaining:
(a) all necessary export or import licences in respect of Raw Materials
or Components used in the production of the Product; and
(b) its manufacturing licence applicable to the manufacture of the
Product.
9.2 Except as provided in section 9.1, NovaDel shall be responsible for filing
and maintaining all necessary Regulatory Approvals.
9.3 INyX shall be responsible for all stability studies, including post
marketing stability studies as may be required for ongoing marketing and
sale of the Product and shall conduct such stability studies at NovaDel's
cost in compliance with the NDA and FDA requirements and as further
specified in the Technical Agreement.
9.4 INyX shall be responsible for conducting an annual product review at
NovaDel's cost, as further specified in the Technical Agreement and for
providing a report thereof to NovaDel and/or its designee.
9.5 INyX shall:
(a) provide NovaDel at NovaDel's cost, with all necessary support and
assistance for the maintenance, variation or renewal of any of the
Regulatory Approvals;
(b) keep NovaDel fully and promptly informed of all relevant changes
that relate to the manufacture of the Product or Product
Specification and make no changes unless and until NovaDel has
confirmed that approval has been granted for the change by any
relevant Regulatory Authority or that a Regulatory Authority
approval is unnecessary; and
(c) use reasonable commercial efforts to secure the assistance of any
third party supplier of Raw Materials or Components in meeting any
request made by a Regulatory Authority.
10. PRODUCT RECALL
10.1 In the event that either NovaDel, or its designee, or INyX determines that
a recall of the Product is necessary for any reason, NovaDel or INyX, as
applicable, shall so notify the other in writing. If NovaDel determines to
recall the Product, NovaDel, or its designee, shall give notice of such
recall to each customer to
9
which it has sold any applicable Product, along with the instructions, if
any, prepared by NovaDel, or its designee, and/or INyX relating to the
recall. The decision to initiate such actions as described above shall
remain solely with NovaDel or its designee.
10.2 Except as set forth in Section 10.2(c), in the event of any recall or
seizure of any Product and only if INyX is culpable for the recall due to
error or negligence on INyX part, INyX shall, at the written election of
NovaDel, either:
(a) promptly replace the amount of Product recalled or seized; and/or
(b) give credit to NovaDel against outstanding receivables due from
NovaDel in an amount equal to the amount paid by NovaDel for the
Product so recalled or seized or otherwise owing by NovaDel
hereunder; plus promptly reimburse (or, at the election of NovaDel,
credit) NovaDel for the aggregate transportation costs, if any,
taxes, freight insurance, handling and reasonable and verifiable
out-of-pocket costs incurred by NovaDel in respect of such recalled
or seized Product; provided, however, that the foregoing shall not
apply if and to the extent that such recall or seizure arises out of
any improper act or omission of NovaDel, or its designee. Any costs
incurred by INyX in complying with its obligations pursuant to this
Section 10.2(b) shall not be, directly or indirectly, passed on to
NovaDel in the calculation of the Price or otherwise.
(c) In the event and to the extent that any recall or seizure of any
Product arises out of any improper act or omission by NovaDel, or
its designee, NovaDel shall be responsible for such recalled or
seized Product and shall promptly reimburse INyX in cash for any
reasonable and verifiable out-of-pocket expenses incurred by INyX in
connection therewith.
(d) For purposes of this Section 10.2, "recall" means
(i) any action by NovaDel, its designee or INyX to recover title
to or possession of any Product sold or shipped (including,
but not limited to, market withdrawal) and/or
(ii) any decision by NovaDel, or its designee, not to sell or ship
Product to third parties that would have been subject to
recall if it had been sold or shipped, in each case taken in
the good faith belief that such action was appropriate under
the circumstances. For purposes of this Section 10.2,
"seizure" means any action by any government, authority or
agency to detain or destroy any Product.
(e) INyX and NovaDel shall keep the other fully informed in writing of
any notification or other information, whether received directly or
indirectly, that might affect the marketability, safety or
effectiveness of any Product, or that might result in liability
issues or otherwise necessitate action on the part of either party,
or that might result in recall or seizure of any Product.
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11. COMPLAINTS
Complaints received by NovaDel relating to the manufacturing or packaging of the
Product shall be sent to INyX who will acknowledge receipt of the complaint
within five Business Days. A formal written report on the complaint, with
corrective actions where applicable, shall be prepared and sent to NovaDel
sufficiently in advance of the time period required under FDA regulations. In
the event, that the investigation exceeds this period INyX shall issue an
interim report pending the final report.
11.1 Records & Reports--Pursuant to 21CFR ss.310.305, if INyX receives a
potential reportable event for follow-up or investigation, such
investigation and report will be submitted to NovaDel within two days
prior to the 15-day "alert reports" due to FDA. INyX will further
cooperate with any 15-day follow-up reports by assisting and investigating
any new information relating to the report.
12. PRICE AND PAYMENT
12.1 NovaDel shall pay to INyX the Price.
12.2 If:
(a) The price which INyX must pay for the Raw Materials or Components
used to produce a Product increases by a percentage in excess of 5
percent as compared with the price at the Effective Date;
(b) Additional regulatory obligations are imposed on INyX by law or a
Regulatory Authority; or
(c) any other price increase is required or agreed in accordance with
clause 5,
INyX may increase the Price by such amount as is necessary to recover the
additional costs of supplying the Product. In any event prices are to be
reviewed annually on the anniversary of the Effective Date hereof.
12.3 Payment for all Products supplied to NovaDel shall be made in Pound
Sterling by the 20th day of the month following the date of invoice;
provided however, that no payment shall be required thereon during the
pendency of any dispute pursuant to clause 3.6. NovaDel shall make payment
into the account identified below
[TO BE ADVISED]
12.4 INyX may charge interest on sums not paid to INyX on the date on which
payment should have been made pursuant to the applicable provisions of
this Agreement over the period from date payment was due until the date of
actual payment (both before and after judgement) at the rate of four per
cent. per annum above the base rate of Barclays Bank PLC. This is without
prejudice to INyX's other rights or remedies.
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13. INTELLECTUAL PROPERTY
13.1 In this section 13, NovaDel Intellectual Property Rights means any and all
Intellectual Property Rights which are owned by NovaDel or licensed to
NovaDel by a third party and which but for the licence in section 13.2
would be infringed by INyX manufacturing, packaging or supplying any of
the Product to NovaDel.
13.2 During the term of this Agreement, NovaDel grants to INyX a non-exclusive
royalty-free licence under NovaDel Intellectual Property Rights for the
sole purpose of manufacturing, packaging or supplying NovaDel, or its
designee, with Product.
13.3 NovaDel shall indemnify INyX against any and all claims, losses or
expenses (including legal fees) suffered or incurred by INyX as a result
of any claim by any third party that the manufacture, packaging or supply
of any of the Products infringe or are alleged to infringe the
Intellectual Property Rights owned by or licensed to that third party.
14. DURATION AND TERMINATION
14.1 This Agreement shall commence on the Effective Date and shall continue for
a period of ten years. For the first five years of this Agreement, INyX
will be the exclusive provider of Product to NovaDel in the Territory. For
the second five years of this Agreement, INyX will manufacture/supply
Product to NovaDel on a non-exclusive basis. Thereafter this Agreement
shall be renewed automatically, on a non-exclusive basis, for further
periods of two years unless either party indicates its intention not to
renew this Agreement and notice of the intention not to renew this
Agreement is given to the other party at least 12 months prior to the
expiry of the relevant period.
14.2 If either party to this Agreement commits any material breach of this
Agreement and fails to remedy or to commence to remedy and diligently
persue such remedy in good faith the breach within 30 Business Days of
notice from the other party (if capable of remedy) or offer adequate
compensation therefor, the other party may terminate this Agreement
immediately by notice to the party in breach.
14.3 This Agreement may be terminated by a party immediately by written notice
to the other party (the "Defaulting Party") if the Defaulting Party:
(a) is unable to pay its debts or is liable to be wound up by a court of
competent jurisdiction; or
(b) enters into a composition or arrangement with its creditors or a
moratorium is declared in respect of any of its indebtedness or any
creditor action; or
(c) takes any action to appoint, to request the appointment of, or
suffers the appointment of, a receiver, administrative receiver,
administrator, trustee or similar officer over all or a material
part of its assets or undertaking; or
(d) has a winding-up or administration petition presented in relation to
it or has documents filed with a court for an administration in
relation to it provided that, in the case of a winding-up petition,
if the Defaulting Party is contesting the winding-up petition in
good faith and with due diligence it
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shall not be a Defaulting Party until a period of five Business Days
has expired since the presentation of the winding-up petition
without it having been either discharged or struck out; or
(e) is affected in any way in any jurisdiction other than England and
Wales by anything equivalent to any of the things referred to in
clauses 14 (a) to 14 (d) above.
14.4 Termination of this Agreement shall not release either party hereto from
any liability or right of action which at the time of termination has
already accrued to either party hereto or which may thereafter accrue in
respect of any act or omission prior to such termination. Such rights
shall include but not be limited to the recovery of any monies due
hereafter.
15. STOCK DISPOSAL
15.1 On termination of this Agreement INyX shall, within reasonable time,
deliver all quantities of finished Product with an actual remaining shelf
life exceeding 12 months to NovaDel or its nominees. Unless otherwise
agreed, all stocks held by INyX of the Product which are not in good and
usable condition shall be destroyed by and at the cost of INyX in the
presence of NovaDel authorised representative.
16. CONFIDENTIALITY
16.1 During the term of this Agreement and for [five] (5) years thereafter,
neither party shall use, reveal nor disclose to third parties any
confidential information (including without limitation the Product
Specification) received from the other party or otherwise developed by
either party in the performance of activities in furtherance of this
Agreement without first obtaining the written consent of the disclosing
party, except as may be otherwise provided herein, or as may be required
for purposes of investigating, manufacturing or marketing Product or for
securing essential or desirable authorisations, privileges or rights from
governmental agencies, or is required to be disclosed to a governmental
agency or is necessary to file or prosecute patent applications concerning
the Product or to carry out any litigation concerning the Product.
16.2 This confidentiality obligation shall not comply to such information
which:
(a) has become a matter of public knowledge, unless through default of
the other party under this Agreement or
(b) is already in the possession of the receiving party unless through
default of the other party under this Agreement, or
(c) is disclosed to the receiving party by a third party having the
right to do so, or
(d) is subsequently and independently developed by employees of the
receiving party or affiliate thereof who had no knowledge of the
confidential information disclosed.
13
16.3 The parties shall take reasonable measures to assure that no unauthorised
use or disclosure is made by others to whom access to such information is
granted.
17. WARRANTIES AND INDEMNIFICATION.
17.1 Certain Representations, Warranties and Covenants of INyX.
(a) INyX hereby represents and warrants to NovaDel that:
(i) INyX has the requisite power and authority to enter into this
Agreement and perform its obligations hereunder;
(ii) the terms of this Agreement do not conflict with or breach any
agreement to which INyX or any affiliate is a party or by
which INyX or any affiliate is otherwise bound or violate any
applicable law.
(b) INyX hereby warrants and covenants to NovaDel that all Product
supplied by it to NovaDel, and its designee, pursuant to this
Agreement shall be manufactured, tested, packaged, labelled, stored
and handled in accordance with the Technical Agreement and that, at
the time of the delivery of such Product to NovaDel, or its
designee, such Product:
(i) will meet the Product Specification and will not be
adulterated or misbranded.
17.2 Certain Representations, Warranties and Covenants of NovaDel.
NovaDel hereby represents and warrants to INyX that
(a) NovaDel has the requisite corporate power and authority to enter
into this Agreement and perform it obligations hereunder; and
(b) the terms of this Agreement do not conflict with or breach any
agreement to which NovaDel is a party or by which NovaDel is
otherwise bound or violate any applicable law.
18. LIMITATION OF LIABILITY
18.1 INyX does not exclude or limit its liability for fraud, death or personal
injury caused by its negligence or that of its employees, agents or
subcontractors.
18.2 Subject to section 18.1, the total liability of INyX to NovaDel under or
in relation to this Agreement, whether arising from negligence, breach of
contract, negligent misrepresentation or otherwise shall not exceed the
limits of available insurance set out in section 18.5 to the extent such
insurance responds to the relevant claim.
18.3 Subject to section 18.1, INyX shall not be liable to NovaDel for any loss
of profits, loss of business, revenue, goodwill or anticipated savings, or
for any indirect or
14
consequential loss or damage suffered by NovaDel in connection with the
Products or this Agreement.
18.4 NovaDel shall indemnify (on an after tax basis) INyX, and keep INyX
indemnified, on demand, against each loss, liability or cost (including
reasonable lawyers fees and expenses) which is incurred by INyX to the
extent such loss, liability or cost arises out of any claim against INyX
in relation to any Product sold by NovaDel, or its designee, from the
Effective Date provided that such claim is not due to the failure of any
Product to conform to the applicable Product Specification due to the
negligence of INyX.
18.5 INyX Indemnity limits are
----------------------------------------------------------------------------------------------------------
SECTION LIMIT OF INDEMNITY
Inclusive of deductible
----------------------------------------------------------------------------------------------------------
1. Public Liability GBP 5,000,000 any one event
-----------------------------------------------------------------------------------------------------------
2. Products Liability GBP 5,000,000 any one event and in all in any one insurance year
-----------------------------------------------------------------------------------------------------------
3. Errors and Omissions GBP 5,000,000 any one event and in all in any one insurance year
Extension
-----------------------------------------------------------------------------------------------------------
a) Injury/Damage GBP 5,000,000 any one event and in all in any one insurance year
-----------------------------------------------------------------------------------------------------------
b) Financial Loss GBP 1,000,000 any one event and in all in any one insurance year
-----------------------------------------------------------------------------------------------------------
18.6 Notwithstanding any provision herein neither party shall be liable for any
indirect or consequential damages including without limitation any loss of
profit, loss of business, loss of capital and loss of plant, whether such
liability arises in tort, negligence, contract or otherwise.
19. FORCE MAJEURE
19.1 If any Force Majeure occurs in relation to either party which affects or
may affect the performance of any of its obligations under this Agreement
(other than a payment obligation) ("Affected Obligation"), it shall notify
the other party forthwith as to the nature and extent of the circumstances
in question.
19.2 Subject to section 19.1, neither party shall be deemed to be in breach of
this Agreement, or shall be otherwise liable to the other party, by reason
only of any delay in performance, or the non-performance of any of its
Affected Obligations hereunder, to the extent that the delay or
non-performance is due to any Force Majeure of which it has duly notified
the other party, and the time for performance of the Affected Obligations
shall be extended accordingly.
19.3 If the performance by either party of any of its obligations under this
Agreement is prevented or delayed by Force Majeure for a continuous period
in excess of five Business Days, the parties shall enter into bona fide
discussions with a view to alleviating its effects, or to agreeing upon
such alternative arrangements as may be fair and reasonable in the
circumstances.
15
19.4 If the performance by either party of any of its Affected Obligations
under this Agreement is prevented or delayed by Force Majeure for 60
Business Days or more, consecutively or cumulatively, in any one year,
then the other party shall in its discretion have the right to terminate
this Agreement forthwith upon written notice to the other party.
20. NOTICE
20.1 Any notice to be given under this Agreement shall be in writing and shall
be sent by fax or by registered mail to:
---------------------------- ----------------------------
FAX: ▇▇ ▇▇▇ ▇▇▇ ▇▇▇▇ FAX: ▇▇ ▇▇▇ ▇▇▇ ▇▇▇▇
Attn. VP Sales and Marketing Attn VP Business Development
INyX USA Ltd. NovaDel Pharma Inc
▇▇▇▇▇ ▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇
San ▇▇▇▇' Road # 604 Flemington
Industrial Zone ▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇ ▇▇▇▇▇
Puerto Rico
---------------------------- ----------------------------
or, to such other address and fax numbers as may be notified to the
parties from time to time.
20.2 Any notice sent by mail shall be deemed delivered within five Business
Days after despatch and any notice sent by fax shall be deemed to have
been delivered upon confirmation of receipt.
21. FURTHER ASSURANCE
Each party shall (and shall use its reasonable commercial efforts to procure
that any necessary third parties shall) execute such documents, and do all acts
and things as may be reasonably required after the execution of this Agreement
to provide to the other party the full benefit of the terms of this Agreement.
16
22. COUNTERPARTS
This Agreement may be signed in any number of counterparts, and this has the
same effect as if the signatures on the counterparts were on a single copy of
this Agreement.
23. NO PARTNERSHIP OR AGENCY
Nothing in this Agreement shall be deemed to constitute a partnership between
the parties, or constitute one party the agent of the other party for any
purpose.
24. ASSIGNMENT AND SUBCONTRACTING
24.1 Neither party may assign, sublicense, create any form of security over or
otherwise dispose of any of its rights under this Agreement without the
prior written consent of the other party, which shall not be unreasonably
withheld or delayed.
24.2 NovaDel agrees that INyX may appoint subcontractors to perform any or all
of INyX's obligations under this Agreement provided that INyX shall remain
liable to NovaDel for any and all acts or omissions of such subcontractor
as if such acts or omissions were those of INyX.
25. PREVIOUS AGREEMENTS
25.1 Each of the parties acknowledges and agrees that in entering into this
Agreement it has not relied on any representation, warranty or other
statement except as expressly identified in this Agreement or any document
referred to in this Agreement.
25.2 This Agreement identifies all of the Agreements and understandings between
the parties with respect to the subject matter of this Agreement and
supersedes and terminates all prior Agreements and understandings between
the parties with respect to the subject matter of this Agreement but
without prejudice to any accrued rights and obligations under such prior
Agreements.
25.3 Nothing in this section 25 shall operate to exclude any liability which
any party would otherwise have to the other party or any right which
either of them may have to rescind this Agreement in respect of any
statement made fraudulently by the other prior to the execution of this
Agreement or any rights which each party may have against the other party
in respect of fraudulent concealment by the other party.
26. AMENDMENTS
No amendments to this Agreement shall be effective or binding on any party
unless such amendments are in writing and signed by both parties.
17
27. PARTIAL INVALIDITY
If any provision of this Agreement is found to be in violation of any applicable
law, such provision shall be self-deleting and shall not affect the validity of
the remaining provisions as contained herein. The parties agree to negotiate in
good faith in order to replace such invalid provision by such provision which
comes closest to the content and purpose of this Agreement.
28. THIRD PARTY RIGHTS
A person who is not a party to this Agreement may not enforce any of its terms
under the Contracts (Rights of Third Parties) ▇▇▇ ▇▇▇▇.
29. PREVAILING CONDITIONS
In the event of any condition within this Agreement being incompatible with a
condition within the Technical Agreement, the content of this Agreement shall
prevail.
30. WAIVER
No waiver of any right under this Agreement shall be deemed effective unless
contained in a written document signed by the party charged with such waiver,
and no waiver of any breach or failure to perform shall be deemed to be a waiver
of any future breach or failure to perform or any other right arising under this
Agreement.
31. LANGUAGE
Any notice or other communication given under or in connection with this
Agreement shall be in English. All other documents provided under or in
connection with this Agreement shall be in English or, if not in English,
accompanied by a certified English translation and, in this case, the English
translation shall prevail unless the document is a statutory or other official
document.
32. SET OFF
All payments made by the parties under this Agreement shall be gross, free of
right of counterclaim or set off and without deduction or withholding of any
kind other than any deductions or withholding required by law.
18
33. COSTS
Except as specifically provided in this Agreement, each party shall pay its
costs and expenses incurred by it in connection with the entering into and
completion of this Agreement.
34. APPLICABLE LAW COMPETENT COURT
This Agreement shall be governed by English law and the parties submit
themselves to the exclusive jurisdiction of the English courts.
19
AS WITNESS the hand of the duly authorised representatives of the parties
hereto the day and year first before written.
SIGNED AGREED and ACCEPTED
For and on behalf of For and on behalf of
NOVADEL PHARMA, INC. INYX USA LTD
-------------------- ------------
Signed: /s/ ▇▇▇▇▇ ▇▇▇▇▇ Signed: /s/ ▇▇▇▇▇▇ ▇▇▇▇▇▇
--------------- -----------------
Name : ▇▇▇▇▇ ▇▇▇▇▇ Name : ▇▇▇▇▇▇ ▇▇▇▇▇▇
----------- -------------
Status : VP New Business Status : VP Sales & Marketing
and Product Development --------------------
-----------------------
Date : November 18, 2004 Date : November 18, 2004
----------------- -----------------
20
APPENDIX 1
THE PRODUCT(S)
PRODUCT TRADEMARK MINIMUM BATCH SIZE Further details
------- --------- ------------------ ---------------
Nitroglycerin Lingual TBD 12,500 for process Initial size: 15ml.
Spray containing butane validation batches; NovaDel bottle containing 240
as a propellant. will initiate process to doses. Additional sizes
increase batch size to may be added in the
50,000 units for commercial future.
production.
1
APPENDIX 2
DELIVERY AND PRICE
Price: GBP ____________ per 1000 bottle
[ TO BE ADVISED ON COMPLETION OF PROCESS VALIDATION]
DELIVERY TERMS
1. Delivery:
a. Product to be delivered Ex Works (Incoterms 2000)
2. Means of transport:
a. Product to be delivered by truck / sea / air
3. Transport requirements:
a. Product shall always be transported in rigid box trailers under
temperature control
b. The temperature shall be between +2 - +25 degrees Celsius, unless
NovaDel provides INyX with written instructions otherwise
c. Product shall be shipped in accordance to relevant shipping
regulations
4. Carrier:
a. Product shall be packed on EUR pallet (1200 x 800 mm)
b. Maximum height for the loading incl the pallet is 1150 mm
c. The loading shall be fixed with a sheet on the top and shrink
wrapped or stretch banded
d. No overhang outside the EUR pallets external dimensions
e. The goods shall be marked on both shorter sides
f. Part box / sample box should be clearly marked
g. Only one product and batch on each pallet
h. The pallet shall be dry, clean and undamaged
5. Marking:
a. The carrier shall be marked with a label on both sides of the load
b. The following information shall be stated on the label:
i. INyX name
ii. NovaDel and / or Designee article number
iii. NovaDel and / or designee purchasing reference
iv. Lot no
v. Quantity (sales unit)
vi. Pallet / package no. referring to the packing list / delivery
note
vii. Market country
2
c. Each shipper (carton) shall be marked with its content
i. NovaDel and /or designee article no.
ii. Lot no.
iii. Expiry date
iv. Name of product
v. No of units / shippers
vi. Market country
6. Delivery address
a. According to NovaDel and / or designee purchase order
7. Exchange of Documents
a. Documents shall be sent to NovaDel and / or designee
i. Purchase Order confirmation
ii. Delivery plan / confirmation
iii. Shipping advice
1. the shipping note advice shall be sent by fax to NovaDel
and / or Designee at the latest the same day as the
Product is shipped from INyX.
2. The advice shall contain the same information regarding
the actual shipment as the delivery note
iv. Delivery note / packing list
1. the delivery list / packing list shall always be
included in the delivery and clearly marked.
2. The following information shall be stated on the note /
list:
a. NovaDel and / or designee Purchase Order reference
b. NovaDel and / or designee article no
c. Lot no
d. Manufacturing year / month
e. Expiry date
f. Each pallet no and no of units per pallet
g. Total number of units (sales units)
v. With product
1. delivery note / packing list
2. forwarding documents
3. certificate of Analysis
vi. By separate mail;
1. Invoice
3
APPENDIX 3
TECHNICAL AGREEMENT
[TO BE AGREED ON COMPLETION OF PROCESS VALIDATION BATCHES]
4
APPENDIX 4
TERRITORIES
The Territory consists of the following countries:
The territory is Worldwide with the exception of the following countries:
- Poland
- Byelorussia
- The former Russian Republics of ▇▇▇▇▇▇▇, ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇
- ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇
5
APPENDIX 5
CONTACT PERSONS - DETAILS
INYX:
Key account manager: ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇, phone ▇▇▇ ▇▇▇▇ ▇▇▇ ▇▇▇
VP Sales & Marketing: ▇▇▇ ▇▇▇▇▇▇, phone ▇▇▇ ▇▇▇▇ ▇▇▇ ▇▇▇
VP Quality: ▇▇▇▇ ▇▇▇▇▇▇▇▇▇: phone ▇▇▇ ▇▇▇▇ ▇▇▇ ▇▇▇
NOVADEL:
Key account manager [TO BE ADVISED]
NOVADEL DESIGNEE:
Key account manager [TO BE ADVISED]
6