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Adamis Pharmaceuticals Corporation 10-Q [adamis-10q_0204.htm]
 
Exhibit 10.16
 

PRODUCT DEVELOPMENT &
CONTRACT MANUFACTURING AGREEMENT
 

 
 
Adamis Pharmaceuticals Corp., USA
 
 
and
 
 
Beximco Pharmaceuticals Ltd., Bangladesh
 

 
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This agreement is entered into on the 1st day of November, 2010

Between

BEXIMCO PHARMACEUTICALS LTD., a public limited company established according to
the laws of the Peoples’ Republic of Bangladesh with its head office located at
17, Dhanmandi R/A, Road No. 2, Dhaka, Bangladesh (hereinafter referred to as
BEXIMCO, which expression shall unless repugnant to the context shall include
its successors and permitted assigns).

And

ADAMIS Pharmaceuticals Corp., a company registered and established according to
the laws of USA having its office at 2658 Del Mar Heights Rd. Suite 555, Del
Mar, California, 92014, USA (hereinafter referred to as ADAMIS, which expression
shall unless repugnant to the context shall include its successors and permitted
assigns).

witnesseth as follows

whereas,
BEXIMCO is engaged in the manufacturing of pharmaceutical finished dosage forms
and bulk raw materials (APIs) and marketing of those PRODUCTS both at home and
abroad.

whereas,
ADAMIS is willing to authorize BEXIMCO to manufacture certain pharmaceutical
products for the United States of America (USA) hereinafter referred to as the
TERRITORY.

whereas,
BEXIMCO is interested to manufacture certain pharmaceutical products for ADAMIS
in its facilities at Tongi, Gazipur, Bangladesh.

Now therefore, the parties in consideration, premises and covenants hereto agree
as follows:

1.           DEFINITIONS
 
1.1
In this Agreement (including the recitals above) the following terms will have
the meanings set out below:

 
“Certificate of Analysis” is a document, which is signed and dated by a duly
authorised representative of the manufacturer of a Product certifying that that
Product conforms to the Product Specification;
 
“Confidential Information” will mean and include all information which may be
disclosed by one party to the other party either pursuant to this Agreement
including but not limited to information disclosed pursuant to clause 13.1 or
pursuant to any preceding agreement concerning the Products, and any technology,
marketing strategies and business of the disclosing party relating directly or
indirectly to the Products but does not include information which the other
party can show:

 
(a)  
either is or becomes available to the public other than as a result of
disclosure by the other party;

 
 
 
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(b)  
at the time of receipt is already in the possession of the other party or
becomes lawfully available to the other party on a non-confidential basis from a
third party entitled to make that disclosure; or

 
(c)  
is independently developed by the other party without reference to Confidential
Information received hereunder, as evidenced by the other party's own records.

 
"Formulation" is the formulation of the Products;
 
"GMP" is the Code of Good Manufacturing Practice in the Territory, any
requirements of the relevant regulatory authority in the Territory for the
Marketing Authorisation, and the requirements of any GMP licence granted to a
Manufacturer of a Product in the country of manufacture of the Products;
 
“GMP Agreement” is the agreement specified in Annexure 2;
 
"Independent Analyst" is an analyst qualified to analyse the Product and
appointed by agreement between the parties;
 
“Intellectual Property Rights” includes all rights and interests, vested or
arising out of any patent, copyright, design, trade mark, trade secrets,
goodwill or Confidential Information rights whether arising by common law or by
statute or any right to apply for registration under a statute in respect of
those or like rights;
 
"Marketing Authorisation" is the grant of registration approval from the
relevant regulatory authority in the Territory for the importation, storage,
promotion, sale or other distribution of the Products;
 
“Products” mean those Pharmaceutical Products with label, leaflet and carton as
listed in Annexure-1 with indications to the generic name, pharmaceutical form
and strength, and pack sizes. Such list may be amended from time to time on
mutual agreement. The operations to be carried out by BEXIMCO under this
Agreement shall be indicated next to the products.
 
 “Product Specification” is, in relation to a Product, per Annexure 1;
 
 “Quality Control” shall mean that part of GMP dealing with sampling,
specifications, and testing as well as organization, documentation and release
procedures. “Term” means the period of this Agreement described in clause 17.1;
 
“Territory” means the United States of America or USA and any other territory
that may be subsequently agreed upon in writing by the parties, provided that
the terms and conditions herein will apply with the necessary amendments being
made to this Agreement.
 
1.2
In this Agreement, unless the context otherwise requires:

 
 
(a)
Headings and under linings are for convenience only and do not affect the
interpretation of this Agreement;

 
 
(b)
Words importing the singular include the plural and vice versa;

 
 
(c)
Words importing a gender include any gender;

 
 
(d)
A reference to a part, clause, party, annexure, exhibit or schedule is a
reference to a part, clause, party, annexure, exhibit or schedule to, this
Agreement; and

 
 
(e)
A reference to a person includes any individual or individuals, corporation,
partnership or other body, entity or other legal person.

 
 
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2  
OBJECT OF THE AGREEMENT

2.1  
Subject to the terms and conditions of this Agreement, BEXIMCO agrees to support
commercialization of certain Products for ADAMIS and to contract manufacture
these products for ADAMIS, listed in Appendix 1
 

2.2  
The manufacturing of the Products shall be carried out at BEXIMCO’s premises at
Tongi, Gazipur, Bangladesh.

 
3  
PRODUCT DEVELOPMENT

3.1  
For existing formulations of BEXIMCO, ownership will remain with BEXIMCO. For
any newly developed formulation(s) ownership will be determined after mutual
discussion.
 

3.2  
BEXIMCO and ADAMIS will contribute their efforts and cooperate in activities
related to assessment of regulatory issues, product definition and analysis
relating to the Products for the Territory.
 

3.3  
BEXIMCO will contribute its knowledge in development, regulatory, pharmaceutical
/ laboratory science and manufacturing capabilities necessary to commercialize
the Products.
 

3.4  
BEXIMCO will provide for and oversee raw materials and primary packaging
materials (where applicable) sourcing, manufacturing, and provide contract
management for suppliers.
 

3.5  
ADAMIS will conduct or oversee clinical research studies, product testing
necessary to obtain market clearance/regulatory approvals for Products, and
additional indications as applicable.
 

3.6  
ADAMIS will ensure all Intellectual Property, regulatory and registration
requirements are satisfactorily addressed for the Territory.
 

3.7  
When a third party involvement is necessary, such involvements will be discussed
mutually, including costs sharing matters and needs to be approved by both
BEXIMCO & ADAMIS.

 
4.
MARKETING AUTHORISATION

4.1
ADAMIS will be responsible for the regulatory dossier development, USFDA
interactions including filings. Beximco will be responsible for site inspections
required by the FDA or other governing body.  Adamis will require support and
data from Beximco to complete the dossier.  Adequate support will be provided by
Beximco at agreed upon rates.

 
4.2
ADAMIS will be responsible for the payment of annual fees and charges payable in
respect of receiving and maintaining the Marketing Authorisations for the
Products and other costs related to any variation of a Marketing Authorisation
for the Products.

 
4.3
BEXIMCO warrants that all information supplied to ADAMIS in relation to the
Products is true to the best of BEXIMCO’s knowledge after all due enquiries and
that it is legally entitled to supply this information to ADAMIS.

 
4.4
BEXIMCO warrants that BEXIMCO will maintain any GMP licence granted to it under
any scheme in the United States of America or Australia or any scheme recognised
by the USFDA and will use reasonable endeavours to promptly provide ADAMIS with
evidence of this when requested by ADAMIS to do so.

 
 
 
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5.
PRICE AND PAYMENT

5.1  
ADAMIS will bear the expense of regulatory filings including any clinical
studies performed for the purpose of obtaining regulatory clearance or approval
for marketing of the Products. This may be decided on a product by product basis
 

5.2  
ADAMIS will bear the expense of all studies and development activities required
for the purpose of obtaining regulatory clearance or approval for marketing of
the Products in the Territory. However, this agreement may change with changes
to individual product agreements.
 

5.3  
In the case of newly formulated drug products i.e., truly novel formulations,
BEXIMCO will bear cost and retain ownership of any patent specific to the drug
unless parties agree to a separate development and cost-sharing agreement
pertaining to such new drug(s).
 

5.4  
ADAMIS and BEXIMCO will agree on a transfer price (CIF) for the Products
supplied on a contract manufacturing basis.  ADAMIS  shall open irrevocable
Letter of Credit at sight in favor of BEXIMCO, payable at 30 days from the date
of the shipment for required Products as per mutually agreed price list and
BEXIMCO would supply to ADAMIS the Products in accordance with the irrevocable
letter of credit opened by ADAMIS.
 

5.5  
Any price change with respect to a Product will be determined by written
agreement between the parties following an annual review of prices.
 

5.6  
ADAMIS will pay for any royalties from the utilization of any third parties
formulation/Intellectual Property or Patents (if necessary).
 

5.7  
Title in respect of the Products shipped under this Agreement shall pass from
BEXIMCO to ADAMIS upon BEXIMCO’s receipt of full payment in respect thereof and
risk in the Products will pass on delivery.

 
6.
SUPPLY

 
6.1  
BEXIMCO will maintain stocks of Products as agreed upon by both parties.

 
6.2  
After the grant of the Marketing Authorisation by USFDA, ADAMIS will provide
BEXIMCO with an initial schedule of its anticipated requirements for the
Products for the remainder of the then current calendar year and thereafter on
an annual basis for each succeeding calendar year by 30 September, provided
however that ADAMIS may provide BEXIMCO with amendments to any such schedule on
a quarterly basis.  Such schedules are estimates only and do not constitute firm
orders. ADAMIS shall have the right to revise the forecast in accordance with
the market situation informing BEXIMCO, 90 days in advance. But any firm order,
for which Beximco has already commenced manufacturing, cannot be cancelled and
will be paid for in full by ADAMIS.

 
6.3  
ADAMIS will place written orders for the Products with BEXIMCO, specifying
quantities (which must be in accordance with the batch sizes for a Product set
mutually by both parties), Product Mix and delivery dates (not being less than
90 days in advance and preferably no less that 120 days in advance) and BEXIMCO
will be deemed to have confirmed these if advice to the contrary, in writing, is
not received by ADAMIS within 10 days. After confirmation by BEXIMCO, ADAMIS
shall not be entitled to cancel such written orders but may reschedule
if  Beximco has not commenced manufacturing of the batch.

 
6.4  
BEXIMCO will use its reasonable endeavours to supply or arrange the supply of
the ordered quantities of Products by the confirmed delivery dates.

 
6.5  
The supply of the Products will be CIF to a single location point in USA as
specified at the time of ordering.

 
 
 
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6.6  
ADAMIS will bear all expenses related to tax, customs clearance, storage,
transportation, maintenance and delivery of PRODUCTS in the Territory.
 

6.7  
In case of any adverse conditions affecting the supply or delivery of any
Products to ADAMIS, BEXIMCO will immediately inform ADAMIS of the same and
ADAMIS shall grant reasonable time for BEXIMCO to supply the Products.

 
6.8  
BEXIMCO will supply a Certificate of Analysis with each delivery of the
Products.

 
7.
MANUFACTURE, TRANSPORT, STORAGE AND DISTRIBUTION OF THE PRODUCTS

 
7.1
BEXIMCO warrants that all quantities of the Products supplied by BEXIMCO to
ADAMIS pursuant to this Agreement will:

 
 
(a)
Conform in all respects to the Product Specification; and

 
 
(b)
Be of merchantable or satisfactory quality; and

 
 
(c)
Upon delivery at Bangladesh port, have a shelf life, which is at least 75% of
the longest registered shelf life for the Products in the Territory.

 
7.3
BEXIMCO and ADAMIS agree to execute the GMP Agreement after the execution of
this Agreement. Said Agreement will be attached hereto as Annexure 2.

 
7.4
BEXIMCO will supply ADAMIS with adequate written directions concerning suitable
conditions for storage and transportation of the Products and ADAMIS represents
it will store and transport the Products materially in accordance with those
directions.

 
7.5
If the Product is to be supplied unpackaged, BEXIMCO will supply ADAMIS with
adequate written directions concerning the packaging of the Products and ADAMIS
represents it will materially accord with those directions and pack the product
at a USFDA approved facility.

 
7.6
In the event that either of the parties becomes aware of any defect in the
Products or that the Products are unsuitable for the use designated in the
Market Authorisation, it will immediately notify the other party and provide
them with a full disclosure of that defect or unsuitability.

 
7.7  
ADAMIS assumes all risk of loss and indemnifies and holds harmless BEXIMCO and
its employees, agents successors and assigns from and against any and all loss,
liability, damage, fee, cost, expense, suit, claim, demand, judgement and
prosecution directly or indirectly arising from or incidental to or resulting
solely from the storage and distribution and sale of the Products by ADAMIS or
its employees, agents successors and assigns EXCEPT where such liability arises
out of the Formulation, the manufacture of the Products or the storage of the
Products by ADAMIS in accordance with the written directions detailed in  clause
7.4.

 
7.8  
Notwithstanding clause 7.7, where any defect or unsuitability in the Products
arises either partially or wholly as a result of a defect or unsuitability in
raw material supplied to BEXIMCO by a third party, BEXIMCO will use its
reasonable endeavours to have the third party conform to any demands of the
regulatory authority concerning the defect.

 
7.9  
BEXIMCO will not assume any risk of loss, liability, damage, fee, cost, expense,
suit, claim, demand, judgement and prosecution directly or indirectly arising
from or incidental to any defect or unsuitability in the Product arising either
partially or wholly as a result of tampering by any person after delivery to
ADAMIS’s nominated warehouse.

 

 
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8.
MARKETING AND OTHER RELATED DUTIES OF THE PARTIES

8.1  
ADAMIS will plan and execute product launch and ongoing marketing activity,
including introduction into wholesale distribution channels, detailing to
pharmacies and clinicians, and marketing to managed care organizations,
government entities, and other payors.
 

8.2  
 ADAMIS will arrange for co-promotion and/or license to sub-distributors as
desirable in the judgment of ADAMIS management, in consultation with BEXIMCO for
the purpose of expanding the market presence or ability to reach specific
physician specialties.
 

8.3  
ADAMIS will put efforts to evaluate market opportunity for the Products,
including defining candidate medications, defining marketing strategy, including
identifying targeted clinical indications, product naming and branding strategy,
and product pricing, promotion and sales strategy.
 

8.4  
ADAMIS shall make no representation to any person about the Products that is
false or misleading in any material particular.  In no event will the ADAMIS
make any representation beyond those contained in the Product claims or
supporting material supplied by BEXIMCO.
 

8.5  
Each party warrants that it has in place from a reputable insurer product
liability insurance covering the party’s respective products with limits of not
less than $5 million USD in aggregate. Requirements for insurance levels will
increase as products are introduced and approved for marketing and sales in the
US.  Insurance requirements should be reviewed on an annual basis by each
party.  Each party shall promptly deliver a certificate of insurance to the
other party upon the other party’s written request.  Further, a party shall,
during the Term of this Agreement, promptly notify the other party of the
cancellation or lapse of said insurance. If the party fails to rectify the same
within thirty (30) calendar days after notice from the other party, any such
failure shall be deemed a material breach of this Agreement.

 
9.
ADVERSE DRUG EVENTS

 
9.1
The obligations of the parties for when an adverse drug event occurs are set out
in Annexture 3.

 
10.
RECALLS

 
10.1
If a law applicable in the Territory requires that any quantity of the Products
should be recalled by ADAMIS for any reason, ADAMIS will give to BEXIMCO written
notice of its intention to recall that quantity and specify its reasons for the
need to carry out the recall, including by providing copies of documents of a
competent Authority requiring the recall.

 
10.2
If within 7 days of the receipt of the notice the parties are unable to agree
upon the need to carry out the recall, the parties agree to submit a sample of
the Product to an Independent Analyst for a report.  The determination of the
Independent Analyst shall be binding upon the parties.

 
10.3
The cost of the report of the Independent Analyst will be paid by the party
against which the report is unfavourable.

 
10.4
Notwithstanding clauses 10.1 to 10.3, ADAMIS may recall that quantity of
Products at any time and will administer any such recall in the Territory at its
own cost.

 
10.5
Notwithstanding anything to the contrary herein, in the event that the sole
reason for recall of the Products is that the Products do not conform with the
Product Specification due to storage or transport of the Products by ADAMIS or
its affiliates or delegates which is not in accordance with the written
directions given to ADAMIS under clause 8.4, then ADAMIS will be liable for the
cost of the recall and any replacement quantities of Products.

 

 
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11.
WARRANTIES AND LIABILITIES

 
11.1
BEXIMCO warrants that at the time of delivery all Product manufactured and
supplied under this Agreement shall meet the Specification, be manufactured and
supplied in accordance with cGMP and will be free of defects in material and
workmanship.

 
11.2
With regard to the Product, ADAMIS’s sole remedy for breach of the warranty in
clause 11.1 above shall be at ADAMIS’s determination either a full refund or
that BEXIMCO will as soon as is reasonably practicable, and without charge to
ADAMIS, repair or (at BEXIMCO’s option) replace Products which are proven to the
reasonable satisfaction of BEXIMCO to not conform with the Specification. This
obligation will not apply where:

 
 
(a)
The Products have been improperly altered in any way whatsoever, or have been
subject to misuse or unauthorized repair;
 

 
(b)
Any instructions as to storage of the Products have not been complied with in
all respects; or
 

 
(c)
ADAMIS has failed to notify BEXIMCO in writing of any defect or suspected defect
within 30 days of delivery of Products.

 
11.3
BEXIMCO agrees to indemnify ADAMIS from and against all losses, claims, demands,
cost (including any costs incurred from return of defective Products) and other
reasonable legal fees incurred by ADAMIS or arising from any injury to any
person as a result of any breach by BEXIMCO of the warranty in clause 11.1,
provided that ADAMIS (i) promptly gives BEXIMCO written notice of such claim,
(ii) neither negotiates nor makes any settlement of nor makes any admission in
relation to such claim and (iii) provides reasonable assistance (at BEXIMCO’s
cost) to BEXIMCO to defend or settle such claim.

 
11.4  
BEXIMCO does not exclude its liability (if any) to ADAMIS:
 

 
(a)
For personal injury or death resulting from BEXIMCO’s negligence;
 

 
(b)
For any matter for which it would be illegal for BEXIMCO to exclude or to
attempt to exclude its liability; or
 

 
(c)
For fraud.

11.5  
Except as expressly provided otherwise in clause 11.2, BEXIMCO will be under no
liability to ADAMIS whatsoever (whether in contract, tort (including
negligence), breach of statutory duty, restitution or otherwise) for any of the
following losses or damage (whether such losses or damage were foreseen,
foreseeable, known or otherwise):  loss of revenue, loss of actual or
anticipated profits (including for loss of profits on contracts), loss of the
use of money, loss of anticipated savings, loss of business, loss of
opportunity, loss of goodwill, loss of reputation, loss of, damage to or
corruption of data, or any indirect or consequential loss or damage howsoever
caused.

11.7  
The aggregate liability of BEXIMCO to ADAMIS with respect to all claims arising
out of this Agreement with the exception of any claims made pursuant to clause
11.3 (or the subject matter hereof) during any period of 12 months either (a)
during the period of this Agreement, and/or (b) after the termination or
expiration of this Agreement, shall be limited to damages not exceeding the
purchase price paid by ADAMIS for Products in 12 months preceding the date of
any claim.

 
 
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11.8  
Except as set out in clause 11.1, BEXIMCO hereby excludes to the fullest extent
permissible by law, all conditions, warranties and stipulations, express (other
than those set out in this Agreement) or implied, statutory, customary or
otherwise which, but for such exclusion, would or might subsist in favour of
ADAMIS.

 
12.
INSPECTION OF THE PLANT

 
12.1
Up to two employees of ADAMIS or its authorised representatives will have the
right, upon giving reasonable notice to BEXIMCO, to visit BEXIMCO's
manufacturing plant in respect of Products specified in Annexure 1.  Unless for
cause, ADAMIS may visit BEXIMCO’s manufacturing plant once a year for a maximum
of two days each during normal business hours. During any such visit, ADAMIS
will have the right to:

 
 
(a)
Inspect the manufacturing facilities;

 
 
(b)
Inspect quality control procedures; and

 
 
(c)
Inspect records and reports pertinent to the manufacture, quality control or
transport of those of the Products manufactured by BEXIMCO.

 
  12.2 
BEXIMCO will permit the inspection by any relevant regulatory authority of the
Territory, which is required, as part of the Marketing Authorisation, including
the inspection of:

 
 
(a)
The manufacturing facilities;

 
 
(b)
Quality control procedures; and

 
 
(c)
Records and reports pertinent to the manufacture, quality control or transport
of those of the Products manufactured by BEXIMCO

 
12.3
BEXIMCO warrants that for the duration of the Agreement, its manufacturing
facilities for the Products comply with the regulatory requirements for the
Marketing Authority of the Territory and GMP.

 
12.4
If in the manufacture of any of the Products BEXIMCO uses raw material supplied
from a third party or sources Products from a third party, BEXIMCO will use all
reasonable commercial endeavours to procure the agreement of that third party to
permit the inspection by any relevant regulatory authority of the Territory,
which is required as part of the Marketing Authorisation, including the
inspection of the third party’s:

 
 
(a)
Manufacturing facilities;

 
 
(b)
Quality control procedures; and

 
 
(c)
Records and reports pertinent to the manufacture, quality control or transport
of the   Products

 
13.
TRADE MARKS

 
13.1
If providing Product in packaged form, BEXIMCO will apply a trademark nominated
by ADAMIS to such Product according to the directions and specifications
provided by ADAMIS from time to time.

 
13.2
Other than as set out in this clause 12, BEXIMCO makes no warranty or
representation in relation to the Intellectual Property Rights contained in the
Products and any prior statements or representations are hereby revoked.

 
 
 
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13.3
ADAMIS shall be solely responsible for its trade marks applied to Products or
packaging of Products according to clauses 12.5 and ADAMIS indemnifies and shall
keep indemnified BEXIMCO from and against any and all claims, liabilities, costs
(on an indemnity basis) expenses, damages by any third party making any
allegation concerning such trade marks.

 
14.
CONFIDENTIALITY

 
14.1
Each of the parties will not, unless specifically authorised by the other party
or by this Agreement:

 
 
(a)
Disclose any Confidential Information of the other party to a third party;

 
 
(b)
Make use of any Confidential Information of the other party for any purpose
other than for the purposes set forth in this Agreement; or

 
 
(c)
Make, or allow anyone else to make, copies of any Confidential Information of
the other party unless for the purposes set forth in this Agreement.

 
14.2
Each of the parties will:

 
 
(a)
Use its best endeavours to prevent unauthorised disclosure of the Confidential
Information of the other party, by its employees; and

 
 
(b)
Restrict the disclosure of the Confidential Information of the other party to
only those of its employees or employees of its affiliates or delegates who
require the Confidential Information for the purposes of fulfilling that party’s
obligations under this Agreement and to the relevant regulatory authority in the
Territory.

 
14.3
Subject to clause 13.4, all Confidential Information, whether in permanent or
magnetic/computer disk form or any other form will be returned to the party who
disclosed the Confidential Information within 30 days of being requested to do
so. However ADAMIS shall have no obligation pursuant to clause 13.3 if the
return of Confidential Information would result in ADAMIS’s inability to
exercise any of its valid rights pursuant to this Agreement including but not
limited to the sale of Products.

 
14.4
Each party may:

 
 
(a)
Provide one copy of the Confidential Information to its legal advisers, to be
held by them solely for the purpose of determining the scope of that party’s
obligations under this clause; and

 
 
(b)
Retain one copy of such of the Confidential Information that is required: in
order to maintain its obligation of confidence described herein; or by the
relevant authorities in the Territory, to be retained by that party.

 
15.
ACCOUNTS

  
15.1
ADAMIS and BEXIMCO will keep proper books of account and records (including
stock records) clearly recording all matters and transactions relating to the
Products, and stocks of the Products, held from time to time.

 
16.
REPRESENTATION AND WARRANTS OF THE AGREEMENT

 
16.1
The parties hereto agree and acknowledge each with the other that, each of the
parties hereto has entered into this Agreement in reliance on the
representations and warranties of the other party in the following terms, and
each party hereby accordingly warrants and represents that:

 
 
 
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16.2
It is duly incorporated with limited liability and validly existing under the
laws of the country in which it is incorporated and has the power to own its own
assets and to conduct the business which it conducts;

 
16.3  
It has power under its constitution to enter into this Agreement in connection
therewith and to exercise its rights and perform its obligations there under;
 

16.4  
That all corporate or other actions required to authorize the execution and
performance by it of its obligations under this Agreement has been duly taken,
including the obtaining of all consents or approvals of, or exemptions by, any
state, governmental or public bodies and authorities whether required in
Bangladesh or otherwise;
 

16.5  
The signing and delivery of this Agreement and the performance of any of the
transactions contemplated hereunder will not contravene or constitute a default
under any provision contained in any agreement, instrument, law, judgment,
order, license, permit or consent by which it is bound or affected;  and
 

16.6  
All acts, conditions and things required by the laws of Bangladesh to be carried
out, fulfilled and performed in order to ensure that its obligations under the
Agreement are legal, valid and enforceable and to make the Agreement admissible
in evidence in Bangladesh have been carried out, fulfilled and performed in
strict compliance with the laws of Bangladesh.

17.
EXECUTION OF THE AGREEMENT

17.1
This agreement shall come into force immediately upon signature by the parties
concerned. This Agreement shall be for a term of 5 (Five) years and will be
renewed automatically for 5 (Five) years unless either party notifies the other
of its intention not to renew the same.

18.
TERMINATION OF THE AGREEMENT

18.1  
This agreement may be terminated by either of the parties by providing 3 (three)
months’ prior written notice.
 

18.2  
On the occurrence of an Event of Default as defined hereunder, the
non-defaulting party shall serve a notice of default on the defaulter requesting
it to cure the breach within 15  (fifteen) days from the date of the notice,
failing which the non-defaulter shall be entitled forthwith to terminate this
Agreement.
 

18.3  
If the Event of Default is cured, the notification letter becomes null and void.
If the Event of Default is not curable, then the non-defaulting party shall be
entitled to terminate this Agreement upon serving 7 (seven) days’ notice.
 

18.4  
An Event of Default shall occur on following:
 

(a)  
A breach of any terms of this Agreement;
 

(b)  
A breach in payment obligation under this Agreement;
 

(c)  
Any representation or warranty under this Agreement proving to be incorrect and
such representation or warranty having an adverse effect on the party’s ability
to perform its obligation therein;
 

(d)  
Ceases to function as a going concern or conduct its operations in the normal
course of business;
 

(e)  
Is declared bankrupt, insolvent or is subject to an order of the court for
attachment of its asset, including and not limited to suspension of operation of
business/bank accounts;
 

(f)  
Is subject to winding up proceeding whether voluntary or involuntary or an order
of the court has been made for appointment of liquidator or receiver to manage
the assets/affairs of such party; or
 

 
 
 
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18.5
Upon termination of this agreement for any reason whatsoever the parties shall:
 

 
 
(a)
Settle all outstanding dues up to the date of termination of this Agreement
between the parties hereto within 30(thirty) days of the termination.

 
 
(b)
ADAMIS shall return to BEXIMCO all documents and any other materials related to
PRODUCTS or to this Agreement as may have been supplied by BEXIMCO within 30
(thirty) days, except for those documents which they are required to retain
according to the law of the country

 
 
BEXIMCO shall return to ADAMIS all documents and any other materials related to
PRODUCTS or to this Agreement as may have been supplied by ADAMIS within 30
(thirty) days, except for those documents which they are required to retain
according to the law of the country

 
 
(c)
Both parties shall not be discharged from their responsibilities from any
pending orders until such orders have been completed and paid for
notwithstanding the termination of this Agreement.

 
19.  
FORCE MAJEURE

19.1  
Failure on the part of either party to perform any of its obligations set forth
in this Agreement will not give either Party to this Agreement any claim against
the other Party or be deemed to be a breach of the Agreement to the extent that
such failure arises from Force Majeure. If through Force Majeure, the
fulfillment of either Party of any obligation set forth in this Agreement will
be delayed, the period of such delay will not be counted on in computing periods
prescribed by this Agreement. Any Party failing to perform its obligations under
this Agreement because of Force Majeure shall give notice in writing to the
other Party of such force majeure as soon as possible after the occurrence.
 

19.2  
Force majeure shall include any war, civil commotion,  floods, earthquake, fire,
strike, governmental action, lockout, accident, epidemic or any other event of
any nature or kind whatsoever beyond the control of the Parties that directly or
indirectly hinders or prevents the Parties from commencing or proceeding with
consummation of the transactions contemplated hereby. Any Party hereto who fails
because of force majeure to perform its obligations hereunder will upon the
cessation of force majeure, take all reasonable steps within its power to resume
with the least possible delay compliance with its obligations. If the conditions
of force majeure shall continue for a period exceeding 6 months, then the
Parties shall meet to decide upon the future performance of the Agreement.

 
 
Page 12 of 23

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20.  
NOTICES

 
20.1
Any notice given under this Agreement must be in writing and will be deemed duly
given or made if given to a party personally or sent by registered post or
facsimile to the address or facsimile number shown below.

 
 
ADAMIS Pharmaceuticals Corp,

 
Attn: CEO

 
2658 Del Mar Heights Road, Suite 555

 
Del Mar, California 92014, USA

 
 
Other Party:
BEXIMCO PHARMACEUTICALS LTD.

 
Attn: Managing Director

 
17 Dhanmandi R/A, Road No. 2

 
Dhaka 1205, Bangladesh

 
Phone: +880 2 8619 151 (5 lines)

 
Fax: +880 2 8613 888

 
20.2
Either party may change its address or facsimile number for the purpose of this
Agreement by giving notice of the change to the other party.

 
20.3
A notice will be deemed to be received by a party in the following
circumstances:

 
 
(a)
The elapse of 24 hours from the dispatch of the notice by facsimile
transmission, where the transmission report confirms that the notice has been
dispatched without a transmission error to the correct facsimile number;

 
 
(b)
The elapse of 3 business days from the dispatch of the notice by mail to a
destination within the same jurisdiction; and

 
 
(c)
The elapse of 7 business days from the dispatch of the notice by mail to a
destination outside the jurisdiction.

 
21.
ARBITRATION

21.1
All disputes arising out of the interpretation or the implementation of this
Agreement shall be referred to a panel of arbitrators of London, UK.  Each party
shall appoint one arbitrator and the third arbitrator shall be appointed by the
first two. The arbitration shall be conducted in accordance with the `Rules of
Arbitration and Reconciliation’ of the International Chamber of Commerce.

22.
OTHERS

 

22.1  
Any amendment to this Agreement shall not be valid unless duly executed by the
authorized persons of both the parties.
 

22.2  
This Agreement is subject to decisions of both parties’ policies, interest and
the government regulations.
 

 
 
 
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22.3  
All notices between the parties hereto shall be made in writing. The notice
period shall be deemed to start from the date of receiving the same by the
either of the parties concerned. The notices to the parties shall be sent to
their registered official addresses.
 

22.4  
This Agreement has been extended in two originals written in English, one of
these has been retained by BEXIMCO and the other by ADAMIS.

In witness whereof the parties hereto have signed this Agreement on the day,
month and year mentioned herein before.

Adamis Pharmaceuticals Corp.
 
Beximco Pharmaceuticals Ltd.
         
Signature:
/s/ Dennis Carlo
 
Signature:
/s/ Nazmul Hassan
Name:
Dennis J. Carlo, PhD
 
Name:
Nazmul Hassan, MD
Title:
CEO Adamis Pharmaceuticals Corp
 
Title:
 

In witness of:
 
In witness of:
            1.   1.

 
 
 
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 Annexure-I
 
Product List (Draft)
 
Sl. No.
 
Product Description
Strength
Pack Size
Operations to be completed by BEXIMCO
  1  
Salbutamol Inhalation
Aerosol with HFA propellant
100 mcg/ actuation
200 doses
Complete product under ADAMIS’s brand/generic name
  2  
Beclometasone Nasal Spray with HFA propellant
Aerosol with HFA propellant
   
Complete product under ADAMIS’s generic name
  3  
Beclomethasone Inhalation
Aerosol with HFA propellant
50 mcg/ actuation
200 doses
Complete product under ADAMIS’s generic name
  4  
Beclomethasone Inhalation
Aerosol with HFA propellant
100 mcg/ actuation
200 doses
Complete product under ADAMIS’s generic name

 

 
 
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Annexure 2
GMP AGREEMENT
 
SPECIFICATION OF GMP RESPONSIBILITES FOR PRODUCT SUPPLY TO USA

This agreement is valid for 60 months and will take effect as of1st day of
November in the year of 2010

It is the responsibility of both parties to review this agreement prior its
expiry.

Signed on behalf of Manufacturer
 
Signed on behalf of Sponsor
                 
Beximco Pharmaceuticals Ltd
 
Adamis Pharmaceuticals Corp.
     
Name:  Nazmul Hassan
 
Name:  Dennis Carlo
     
Position:  Managing Director
 
Position:  CEO
     
Date:
 
Date:

GMP AGREEMENT

1.  
In order to comply with the current USFDA Code of GMP for medicines the
following GMP agreement is entered into between.

 
1.1  
Contract Giver: ADAMIS Pharmaceuticals Corp,2658 Del Mar Heights Road,
Suite 555 Del Mar, California 92014, USA ,(hereunder called ADAMIS or “Sponsor”)

 
AND
 
1.2  
Contract Acceptor: Beximco Pharmaceuticals Ltd with its registered office at:
17 Dhanmandi R/A, Road No. 2, Dhaka-1205, Bangladesh and pharmaceutical
manufacturing facility located at:
126, Kathaldia, Auchpara, Tongi 1711, Gazipur, Bangladesh (hereunder called
“Beximco”)

 
2.  
Beximco Agrees to manufacture / package the products listed in the ‘Annexure 1’
as requested by the receipt of a purchase order following the signing & / or a
current GMP agreement with Sponsor.

 
 
 
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GMP AGREEMENT
ASSIGNED RESPONSIBILITIES

    Activity
Responsibility
 
Beximco
Sponsor (ADAMIS)
1
 
Sponsors / or appointed quality representative will be given access to Beximco
premises for the purpose of GMP audits as agreed by
Ö
 
2
  Starting Materials    
2.1
  Specified by
Ö
Ö
2.2
  Supplied by (refer to quotation)
Ö
 
2.3
  Approved by
Ö
           
3
  Packaging Materials    
3.1
  Specified by
Ö
Ö
3.2
  Supplied by
Ö
 
3.3
  Approved by
Ö
Ö
         
4
  Labels    
4.1
  Specified by
Ö
Ö
4.2
  Supplied by
Ö
 
4.3
  Approved by  
Ö
4.4
  Verified by
Ö
           
5
  Printed Materials    
5.1
  Specified by
Ö
Ö
5.2
   Supplied by
Ö
 
5.3
  Approved by  
Ö
         
6
  Master / Listing Formula    
6.1
  Product registration with USFDA supplied by  
Ö
6.2
  Processing instructions supplied by
Ö
Ö
6.3
  Product Specifications supplied by
Ö
Ö
6.4
  Manufacturing process change – communication with USFDA  
Ö
         
7
  Master packaging B.O.M.    
7.1
  Supplied by
Ö
 
7.2
  Processing instructions supplied by
Ö
 
7.3
  Specifications
Ö
Ö
         
8
  Beximco Master Document / Product Specifications    
8.1
  Prepared by
Ö
 
8.2
  Approved by
Ö
Ö
         
9
  Bulk Release
Ö
           

 
 
 
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10
 
Release for supply
   
10.1
 
Release to USA
The person responsible for quality control and release for final packaging or
supply of Products shall, to the extent determined by this agreement, be the
Head of Quality or the person deputised to act on his/her behalf.
The final release document to include a statement that the specific product is
released as per USFDA GMP and product registration.
Ö
           
11
 
Expiry Date
       
Responsibility of
Ö
           
12
 
Product Stability
       
Responsibility of
Ö
           
13
 
Customer’s Complaints
   
13.1
 
Initial investigation including safety & efficacy
Ö
Ö
13.2
 
Follow up investigation relating to
       
Manufacturing
Ö
     
Packaging
Ö
     
Control Testing
Ö
           
14
 
Responses to Complaint
   
14.1
 
Initial to contract giver
Ö
 
14.2
 
Final reply to customer
 
Ö
         
15
 
Retention Samples
   
15.1
 
Starting Materials
Ö
 
15.2
 
Finished Pack
Ö
           
16
 
Records
   
16.1
 
Batch documentations maintained by
Ö
           
17
 
Potential hazards to Premises, Plant / or Personnel
   
17.1
 
(specify if known)
Ö
           
18
 
Product Deviations Prepared
Ö
     
Approved / Rejection
 
Ö

 
 
 
Page 18 of 23

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19
 
Beximco and Sponsor agree that all information and documentation not in the
public domain nor previously known to either party, passing between Beximco and
Sponsor will be kept strictly confidential and is not to be divulged to any
other party except to:
1. Beximco employees in order to carry out manufacturing & / or packaging
processes & / or
2. government authorities for any mandatory requirements & / or
3. It should not pass to a third party any of the work entrusted to it by
Sponsor without the latter having evaluated & consented to
Ö
Ö

 
 
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Annexure 3
 
REPORTING OF ADVERSE DRUG EVENTS FOR THE PRODUCT
 

 
 
1.           Adverse drug experience. Any adverse event associated with the use
of a drug in humans, whether or not considered drug related, including the
following: An adverse event occurring in the course of the use of a drug product
in professional practice; an adverse event occurring from drug overdose whether
accidental or intentional; an adverse event occurring from drug abuse; an
adverse event occurring from drug withdrawal; and any failure of expected
pharmacological action.
 
Disability: A substantial disruption of a person's ability to conduct normal
life functions.
 
Life-threatening adverse drug experience: Any adverse drug experience that
places the patient, in the view of the initial reporter, at immediate risk of
death from the adverse drug experience as it occurred i.e. , it does not include
an adverse drug experience that, had it occurred in a more severe form, might
have caused death.
 
Serious adverse drug experience: Any adverse drug experience occurring at any
dose that results in any of the following outcomes: Death, a life-threatening
adverse drug experience, inpatient hospitalization or prolongation of existing
hospitalization, a persistent or significant disability/incapacity, or a
congenital anomaly/birth defect. Important medical events that may not result in
death, be life-threatening, or require hospitalization may be considered a
serious adverse drug experience when, based upon appropriate medical judgment,
they may jeopardize the patient or subject and may require medical or surgical
intervention to prevent one of the outcomes listed in this definition. Examples
of such medical events include allergic bronchospasm requiring intensive
treatment in an emergency room or at home, blood dyscrasias or convulsions that
do not result in inpatient hospitalization, or the development of drug
dependency or drug abuse.
 
Unexpected adverse drug experience: Any adverse drug experience that is not
listed in the current labeling for the drug product.  This includes events that
may be symptomatically and path physiologically related to an event listed in
the labeling, but differ from the event because of greater severity or
specificity. For example, under this definition, hepatic necrosis would be
unexpected (by virtue of greater severity) if the labeling only referred to
elevated hepatic enzymes or hepatitis. Similarly, cerebral thromboembolism and
cerebral vasculitis would be unexpected (by virtue of greater specificity) if
the labeling only listed cerebral vascular accidents. "Unexpected," as used in
this definition, refers to an adverse drug experience that has not been
previously observed (i.e. , included in the labeling) rather than from the
perspective of such experience not being anticipated from the pharmacological
properties of the pharmaceutical product.
 
(b)  Review of adverse drug experiences. Each applicant having an approved
application under 314.50 or, in the case of a 505(b)(2) application, an
effective approved application, shall promptly review all adverse drug
experience information obtained or otherwise received by the applicant from any
source, foreign or domestic, including information derived from commercial
marketing experience, post marketing clinical investigations, post marketing
epidemiological/surveillance studies, reports in the scientific literature, and
unpublished scientific papers. Applicants are not required to resubmit to FDA
adverse drug experience reports forwarded to the applicant by FDA; however,
applicants must submit all follow-up information on such reports to FDA. Any
person subject to the reporting requirements under paragraph (c) of this section
shall also develop written procedures for the surveillance, receipt, evaluation,
and reporting of post marketing adverse drug experiences to FDA.
 
 
 
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(c)  Reporting requirements.:The applicant shall report to FDA adverse drug
experience information, as described in this section. The applicant shall submit
two copies of each report described in this section to the Central Document
Room, 5901-B Ammendale Rd., Beltsville, MD 20705-1266. FDA may waive the
requirement for the second copy in appropriate instances.
 
(1)(i)  Post marketing 15-day "Alert reports". The applicant shall report each
adverse drug experience that is both serious and unexpected, whether foreign or
domestic, as soon as possible but in no case later than 15 calendar days of
initial receipt of the information by the applicant.
 
(ii)  Post marketing 15-day "Alert reports"--follow-up. The applicant shall
promptly investigate all adverse drug experiences that are the subject of these
post marketing 15-day Alert reports and shall submit follow-up reports within 15
calendar days of receipt of new information or as requested by FDA. If
additional information is not obtainable, records should be maintained of the
unsuccessful steps taken to seek additional information. Post marketing 15-day
Alert reports and follow-ups to them shall be submitted under separate cover.
 
(iii)  Submission of reports: The requirements of paragraphs (c)(1)(i) and
(c)(1)(ii) of this section, concerning the submission of post marketing 15-day
Alert reports, shall also apply to any person other than the applicant
(non-applicant) whose name appears on the label of an approved drug product as a
manufacturer, packer, or distributor. To avoid unnecessary duplication in the
submission to FDA of reports required by paragraphs (c)(1)(i) and (c)(1)(ii) of
this section, obligations of a non-applicant may be met by submission of all
reports of serious adverse drug experiences to the applicant. If a non-applicant
elects to submit adverse drug experience reports to the applicant rather than to
FDA, the non-applicant shall submit each report to the applicant within 5
calendar days of receipt of the report by the non-applicant, and the applicant
shall then comply with the requirements of this section. Under this
circumstance, the non-applicant shall maintain a record of this action which
shall include:
 
(A)  A copy of each adverse drug experience report;
 
(B)  The date the report was received by the non-applicant;
 
(C)  The date the report was submitted to the applicant; and
 
(D)  The name and address of the applicant.
 
(iv)  Report identification:. Each report submitted under this paragraph shall
bear prominent identification as to its contents i.e. , "15-day Alert report,"
or "15-day Alert report follow-up."
 
(2)  Periodic adverse drug experience report: (i) The applicant shall report
each adverse drug experience not reported under paragraph (c)(1)(i) of this
section at quarterly intervals, for 3 years from the date of approval of the
application, and then at annual intervals. The applicant shall submit each
quarterly report within 30 days of the close of the quarter (the first quarter
beginning on the date of approval of the application) and each annual report
within 60 days of the anniversary date of approval of the application. Upon
written notice, FDA may extend or reestablish the requirement that an applicant
submit quarterly reports, or require that the applicant submit reports under
this section at different times than those stated. For example, the agency may
reestablish a quarterly reporting requirement following the approval of a major
supplement. Follow-up information to adverse drug experiences submitted in a
periodic report may be submitted in the next periodic report.
 
(ii)   Each periodic report is required to contain: (a ) a narrative summary and
analysis of the information in the report and an analysis of the 15-day Alert
reports submitted during the reporting interval (all 15-day Alert reports being
appropriately referenced by the applicant's patient identification number,
adverse reaction term(s), and date of submission to FDA); (b ) a FDA Form 3500A
(Adverse Reaction Report) for each adverse drug experience not reported under
paragraph (c)(1)(i) of this section (with an index consisting of a line listing
of the applicant's patient identification number and adverse reaction term(s));
and (c ) a history of actions taken since the last report because of adverse
drug experiences (for example, labeling changes or studies initiated).
 
 
 
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(iii)  Periodic reporting, except for information regarding 15-day Alert
reports, does not apply to adverse drug experience information obtained from
post marketing studies (whether or not conducted under an investigational new
drug application), from reports in the scientific literature, and from foreign
marketing experience.
 
(d)  Scientific literature: (1) A 15-day Alert report based on information from
the scientific literature is required to be accompanied by a copy of the
published article. The 15-day reporting requirements in paragraph (c)(1)(i) of
this section (i.e. , serious, unexpected adverse drug experiences) apply only to
reports found in scientific and medical journals either as case reports or as
the result of a formal clinical trial.
 
(2)  As with all reports submitted under paragraph (c)(1)(i) of this section,
reports based on the scientific literature shall be submitted on FDA Form 3500A
or comparable format as prescribed by paragraph (f) of this section. In cases
where the applicant believes that preparing the FDA Form 3500A constitutes an
undue hardship, the applicant may arrange with the Office of Surveillance and
Epidemiology for an acceptable alternative reporting format.
 
(e)  Post marketing studies: (1) An applicant is not required to submit a 15-day
Alert report under paragraph (c) of this section for an adverse drug experience
obtained from a post marketing study (whether or not conducted under an
investigational new drug application) unless the applicant concludes that there
is a reasonable possibility that the drug caused the adverse experience.
 
(2)  The applicant shall separate and clearly mark reports of adverse drug
experiences that occur during a post marketing study as being distinct from
those experiences that are being reported spontaneously to the applicant.
 
(f)  Reporting FDA Form 3500A: (1) Except as provided in paragraph (f)(3) of
this section, the applicant shall complete FDA Form 3500A for each report of an
adverse drug experience (foreign events may be submitted either on an FDA Form
3500A or, if preferred, on a CIOMS I form).
 
(2)  Each completed FDA Form 3500A should refer only to an individual patient or
a single attached publication.
 
(3)  Instead of using FDA Form 3500A, an applicant may use a computer-generated
FDA Form 3500A or other alternative format (e.g., a computer-generated tape or
tabular listing) provided that:
 
(i)  The content of the alternative format is equivalent in all elements of
information to those specified in FDA Form 3500A; and
 
(ii)  The format is agreed to in advance by the Office of Surveillance and
Epidemiology.
 
(4)  FDA Form 3500A and instructions for completing the form are available on
the Internet athttp://www.fda.gov/medwatch/index.html .
 
 
 
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(g) Multiple report:An applicant should not include in reports under this
section any adverse drug experiences that occurred in clinical trials if they
were previously submitted as part of the approved application. If a report
applies to a drug for which an applicant holds more than one approved
application, the applicant should submit the report to the application that was
first approved. If a report refers to more than one drug marketed by an
applicant, the applicant should submit the report to the application for the
drug listed first in the report.
 
(h) Patient privacy: An applicant should not include in reports under this
section the names and addresses of individual patients; instead, the applicant
should assign a unique code number to each report, preferably not more than
eight characters in length. The applicant should include the name of the
reporter from whom the information was received. Names of patients, health care
professionals, hospitals, and geographical identifiers in adverse drug
experience reports are not releasable to the public under FDA's public
information regulations in part 20.
 
(i)  Recordkeeping: The applicant shall maintain for a period of 10 years
records of all adverse drug experiences known to the applicant, including raw
data and any correspondence relating to adverse drug experiences.
 
(j)  Withdrawal of approval. If an applicant fails to establish and maintain
records and make reports required under this section, FDA may withdraw approval
of the application and, thus, prohibit continued marketing of the drug product
that is the subject of the application.
 
(k)  Disclaimer: A report or information submitted by an applicant under this
section (and any release by FDA of that report or information) does not
necessarily reflect a conclusion by the applicant or FDA that the report or
information constitutes an admission that the drug caused or contributed to an
adverse effect. An applicant need not admit, and may deny, that the report or
information submitted under this section constitutes an admission that the drug
caused or contributed to an adverse effect. For purposes of this provision, the
term "applicant" also includes any person reporting under paragraph (c)(1)(iii)
of this section.

 
 
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