Exhibit 10.33
Execution Copy: Nov 18, 2004
MANUFACTURING AND SUPPLY AGREEMENT
DATED 18TH 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 18th day of November 2004
BETWEEN NovaDel Pharma Inc. having a place of business at 00
Xxxxxxxxxxxx Xxxx, Xxxxxxxxxx, Xxx Xxxxxx 00000 Xxxxxx Xxxxxx
AND INyX USA, Ltd having a place of business at San Xxxx' 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.
1
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.
2
"Price" means the price specified in Appendix 2;
"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
3
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.
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.
4
(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.
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
5
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.
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.
6
(c) Parties will appoint a key account manager with specific
responsibility for this relationship, names and contact
details as per Appendix 5
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.
7
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.
8
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.
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.
9
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 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
10
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.
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]
11
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.
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
12
(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 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:
13
(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.
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.
14
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 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 (pound)5,000,000 any one event
------------------------------------------------------------------------
2. Products Liability (pound)5,000,000 any one event and in all in
any one insurance year
------------------------------------------------------------------------
3. Errors and Omissions (pound)5,000,000 any one event and in all in
Extension any one insurance year
------------------------------------------------------------------------
a) Injury/Damage (pound)5,000,000 any one event and in all in
any one insurance year
------------------------------------------------------------------------
b) Financial Loss (pound)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.
15
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.
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: x0 000 000 0000 FAX: x0 000 000 0000
Attn. VP Sales and Marketing Attn VP Business Development
INyX USA Ltd. NovaDel Pharma Inc
XXXxx 000 00 Xxxxxxxxxxxx Xxxx
Xxx Xxxx' Xxxx # 000 Xxxxxxxxxx
Xxx Xxxxxx
Industrial Zone
00000
Xxxxx Xxxxx
Xxxxxx Xxxxxx
Xxxxxx
XX 00000
Puerto Rico
----------------------------------------- ----------------------------
or, to such other address and fax numbers as may be notified to the
parties from time to time.
16
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.
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.
17
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.
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) Xxx 0000.
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
18
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.
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/ Xxxxx Xxxxx Signed: /s/ Xxxxxx Xxxxxx
------------------- -------------------
Name : Xxxxx Xxxxx Name : Xxxxxx Xxxxxx
Status :Vice President, New Status : Vice President,
Business and Product Global Sales and
Development Marketing
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; bottle containing
as a propellant. NovaDelwill initiate 240 doses.
process to increase Additional sizes
batch size to 50,00 may be added in the
units for commercial future.
production.
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
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
Appendix 3
Technical Agreement
[to be agreed on completion of Process Validation batches]
Xxxxxxxx 0
XXXXXXXXXXX
Xxx Xxxxxxxxx consists of the following countries:
The territory is Worldwide with the exception of the following countries:
- Poland
- Byelorussia
- The former Russian Republics of Xxxxxxx, Xxxxxx, Xxxxxxxxx xxx Xxxxxxx
- Xxx Xxxxxx Xxxx Xxxxxxxx
Appendix 5
Contact Persons - details
INyX:
Key account manager: Xxxxxxxxx Xxxxxxxxxx, phone x00 0000 000 000
VP Sales & Marketing: Xxx Xxxxxx, phone x00 0000 000 000
VP Quality: Xxxx Xxxxxxxxx: phone x00 0000 000 000
NovaDel:
Key account manager [to be advised]
NovaDel Designee:
Key account manager [to be advised]
