Exhibit 10.7

 

  

 

 

 

 

 

 

 

 

 

DISTRIBUTION AND SUPPLY AGREEMENT

 

by and between

Biocon Limited

 

and

 

Advaxis, Inc.

 

 

 

Note: Portions of this document have been marked “[c.i.]” to indicate that
confidential treatment has been requested for certain redacted confidential
information. The confidential portions have been submitted separately with the
Securities and Exchange Commission.

 

 

 

   

DISTRIBUTION AND SUPPLY AGREEMENT

 

This Distribution and Supply Agreement ("Supply Agreement") is made effective as
of 20th day of January, 2014 ("Effective Date") by and between Biocon Limited, a
company duly incorporated under the laws of India, having a principal place of
business at 20th KM., Hosur Road, Electronics City P.O., Bangalore-560100, India
(herein after referred to as "Biocon") and Advaxis, Inc., a company incorporated
under the laws of New Jersey, having its principal office at 305, College Road
East, Princeton, New Jersey 08540 (hereinafter referred to as "Advaxis").

 

RECITALS

  

A.WHEREAS, Advaxis has developed and owns or has the exclusive rights to the
Products (as defined in Article 1.1.10);

  

B.WHEREAS, Biocon is in the business of promoting and marketing pharmaceutical
products in the Territory (as defined in Article 1.1.17).

 

C.WHEREAS, Biocon is desirous of purchasing the Products from Advaxis for
promoting, marketing and distributing the Product in the Territory and Advaxis
has agreed to supply the Products to Biocon on terms and conditions contained in
this Supply Agreement.

  

NOW, THEREFORE, in consideration of the foregoing and of the mutual covenants
and conditions in this Agreement, Biocon and Advaxis agree as follows:

  

Article 1 Definitions and Interpretation

  

1.1"Affiliate" means, with respect to a particular Party, a person, corporation
or other entity that, directly or indirectly, through one or more
intermediaries, controls, is controlled by, or is under common control with such
Party. For the purposes of this definition, "control" means the direct or
indirect ownership by a Party of at least fifty percent (50%) of the outstanding
voting securities of the controlled entity; provided, that in any country where
the law does not permit foreign equity ownership of at least fifty percent
(50%), then with respect to corporations organized under such country's laws,
"control" shall mean the direct or indirect ownership by a Party of outstanding
voting securities of such corporation at the maximum amount permitted by the law
of such country.

  

1.2"Change of Control" shall mean an event where (i) a Party merges or
consolidates with any other person or entity, (ii) all or substantially all of a
Party's business or assets are transferred in any manner to any other person or
entity or (iii) any other person or entity (or group of persons or entities)
becomes the beneficial owner of at least fifty percent (50%) of the outstanding
voting securities of a Party or otherwise acquires the power, directly or
indirectly, to direct or cause the direction of management and the policies of
that Party; provided, however, that any such transaction in which all parties
were Affiliates of that Party immediately prior to such transaction shall not be
considered to be a Change of Control.

 

 [image_028.jpg]

 

BMR1323002A0624Page 1 of 24

 

 

1.3"Confidential Information" means and includes without limitation any and all
technical and non-technical information relating to the Product, disclosed by
either Party to the other Party in relation to this Agreement, including, but
not limited to, know-how, trade secrets, Data, and other non-public
technical/process/scientific information regarding study, drug, research,
experimental work, clinical development plans, protocols, drug delivery
regiments, and equipments; whether tangible or intangible, and whether stored or
compiled physically, electronically, digitally, graphically, photographically,
or in writing. The Data and all other non-public technical/process/ scientific
information regarding the Product or resulting from the Product or use under
this Agreement, including clinical trials, clinical development plans,
protocols, records, methods, processes, drug delivery regimens, and equipment,
Regulatory Filings, Specifications are the Confidential Information of Advaxis.

  

1.4"Contract Year'' means the period of twelve (12) consecutive calendar months.
The First Contract Year shall commence from the date of Regulatory Approval for
the Product in the Territory and shall end on the immediately following March
31st and the remaining Contract Years shall correspond with the financial year
beginning from April 1 and ending on subsequent March 31st.

  

1.5"Data" shall mean and include data and data rights from clinical development
plans, clinical study reports resulting from clinical trials, protocols,
manufacturing, technical and other information, know-how with respect to the
Product, USA regulatory filings including any IND filings, all CMC technical
information, and copies of Regulatory Filings and Regulatory Approvals

  

1.6"Days" means working days (Monday to Friday), excluding official holidays in
India and the Territory.

  

1.7"Disclosing Party" means the Party disclosing Confidential Information.

  

1.8"Field" means treatment of HPV associated cervical cancer in humans and for
any other indications relating to immunotherapy approved by Regulatory
Authority.

  

1.9"Party" or "Parties" means and refers to Biocon and Advaxis individually, or
collectively, as the context permits.

 

1.10"Product" means ADXS11-001 recombinant listeria monocytogenes LLO-E7
(genetically modified organism) in a glass vial of 1.2ml (1*1010CFU /ml or any
other presentations.

 

 [image_028.jpg]

  

BMR1323002A0624Page 2 of 24

 

 

1.11"Receiving Party" means the Party receiving Confidential Information.

 

1.12"Regulatory Approval" means all necessary approval of the applicable
Regulatory Authority to market the Products in the Territory, including but not
limited to conducting clinical trials, registering, promoting, marketing and
sale of the Product.

 

1.13"Regulatory Authority(ies)" means any federal, national, multinational,
state, provincial or local regulatory agency, department, bureau or other
governmental entity with authority over the marketing and sale of a
pharmaceutical product in India or in the Territory, including the Drug
Controller General of India (DCGI hereafter).

  

1.14"Regulatory Filings" means any and all applications, requests, forms or
filings made to any Regulatory Authority for obtaining Regulatory Approval in
the Territory.

  

1.15"Specifications" means statement of particulars of the Product or any
description regarding the Product provided in Schedule 1 attached hereto

  

1.16"Third Party" means any entity other than Biocon and Advaxis.

  

1.17"Territory" shall mean India, Malaysia, Kenya, Bangladesh, Bhutan, Maldives,
Myanmar, Nepal, Pakistan, Sri Lanka, Bahrain, Jordan, Kuwait, Oman, Saudi
Arabia, Qatar, United Arab Emirates, Algeria, Armenia, Egypt, Eritrea, Iran,
Iraq, Lebanon, Libya, Sudan, Syria, Tunisia and Yemen.

 

1.18"Net Sales" means with respect to any period, the total amount invoiced for
all sales of the Product made by Biocon less the following deductions: (i)
normal and customary trade and quantity discounts actually given; (ii) freight
costs and, insurance charges on shipment at distributor location by Biocon to
customers and other transportation expenses inside the Territory; (iii)
governmental sales, value-added or excise taxes, tariffs and duties, and other
taxes directly related to the sale of Product; all to the extent that such items
are included in the gross invoice price whether or not specified on the invoice
(but not including taxes assessed against the income derived from such sale);
(iv) allowances, credits, chargebacks and refunds granted on account of
rejection, return or price reduction of the Product, if actually allowed to and
taken by the customer; and (v) customary rebates, refunds by Biocon to customers
for recalled Product (as more particularly set forth below) and price
reductions/adjustments, if actually allowed to and taken by the customer (vi)
provisions for expiries, as customarily made and provided for by Biocon.

  

1.19"Quality Agreement" shall mean the agreement between Biocon and Advaxis
which defines the responsibilities of each Party with respect to the practices
to be followed to ensure the Product's quality compliance with the Regulatory
Approval and as may be amended from time to time by written agreement between
the Parties. The agreed Quality Agreement between the Parties is attached
herewith as Schedule 3.

 

 [image_028.jpg]

 

BMR1323002A0624Page 3 of 24

 

 

Article 2 License, Regulatory Filing and Approval

 

2.1Advaxis hereby grants Biocon an exclusive license with the right to
sublicense, during the term of this Agreement; to i) use the contents and copies
of Data to enable Biocon to submit Regulatory Filings for the Product in the
Territory and ii) import, promote, market, distribute and sell the Product in
the Territory. Biocon may not use the Product for any other use other than as
explicitly stated herein. Biocon may not make derivatives of the Product.

 

2.2Subject to Article 2.1 Biocon shall use commercially reasonable efforts to
obtain the marketing authorization for marketing, sale and distribution of the
Product in the Territory, at its sole cost and in the name of Biocon. Advaxis
shall provide necessary support to assist Biocon in submitting regulatory
applications and obtaining Regulatory Approvals. Biocon shall own and hold all
Regulatory Approvals for the Product in the Territory. Upon termination of this
Agreement, Biocon shall cooperate in any and all procedures (including, but not
limited to, the completion of any documentation) required to transfer such
registrations to Advaxis or its designee at the sole cost of Advaxis.

 

2.3Advaxis owns exclusively all right, title and interest in respect of the
Product and the Data.

  

2.4Biocon will be the sole owner of all right, title, and interest in respect of
Regulatory Approvals of the Product in the Territory during the term of this
Agreement. Biocon shall own all brand names and trademarks for the Product in
the Territory, unless otherwise agreed between the Parties.

 

2.5Advaxis shall inform Biocon in case the Product receives approval from any
Regulatory Authority for any future indications and provide the related data and
documents to Biocon, which may be used by Biocon for regulatory filings with the
relevant Regulatory Authorities. Biocon shall provide Advaxis with copies within
10 Days of all documents, filings, records, responses and transcripts of
communications with regulatory agencies in the Territory, and all Regulatory
Filings.

 

2.6Biocon shall, at its cost and expense, obtain and maintain in effect such
licenses, permits, approvals or consents as may be required for the performance
of its obligations and undertakings hereunder.

 

Article 3 Clinical Trial

  

3.1(i) Clinical trials for the current indication (Cervical Cancer): Advaxis
shall be responsible for conducting all clinical trials with the Product, at its
sole cost for obtaining all Regulatory Approvals in the Territory

  

[image_028.jpg] 

 

BMR1323002A0624Page 4 of 24

 

  

(ii) Clinical trial for the current indication (Cervical cancer) in India:
Subject to 3.1 (i) above, Biocon will use commercially reasonably efforts to
obtain the Regulatory Approvals for the Product in India by submitting a data
package to be provided by Advaxis, which shall include the CMC data, Regulatory
Approvals in the EU and USA and all other data that may be required by the
Regulatory Authorities to be provided by Advaxis. In the event Phase II or Phase
III clinical trials are required by the Regulatory Authorities for obtaining
marketing approvals or after obtaining marketing approval for the Product in
India, Advaxis shall conduct such clinical trials at its sole cost, as may be
required by the Regulatory Authorities in India. Such clinical trials must begin
within six (6) months of obtaining feedback from the Regulatory Authorities in
India. Should Advaxis not have sufficient resources to commence conducting such
clinical trials within the said agreed time of six (6) months, Advaxis may opt
out from conducting such clinical trials, with a prior written notice of at
least thirty (30) days to Biocon, in which case, Biocon may at its sole option
conduct such clinical trials and subject to 3.1(i) Advaxis agrees to reimburse
all amounts spent by Biocon on such clinical trials through interim billing
raised as the same may be invoiced by Biocon from time to time. All data,
results, intellectual property rights, information, documents, methods,
regulatory filings and reports generated during the clinical trial conducted by
Biocon shall be the sole and exclusive property of Advaxis, however subject to
the condition that Advaxis refunds all monies spent by Biocon as mentioned
herein above. Without prejudice to any other right or remedy that Biocon may
have under this Agreement or at law or in equity, Biocon reserves the right to
terminate this Supply Agreement in case Advaxis fails to reimburse Biocon for
such clinical trial expenditures invoiced by Biocon from time to time within
(60) days of receipt of any such invoice. If neither Party elects to conduct
such additional clinical trials within six (6) months of obtaining feedback from
the Regulatory Authorities in India then the Parties expressly agree to discuss
the future strategy based on good faith discussions including the termination of
this Supply Agreement on mutual agreement without any liability on the part of
any Party to the other Party.

 

(iii) Clinical trials for all future indications: Biocon may at its option
choose to participate in clinical trials for the Product for any future
indication upon such terms and conditions as may be mutually agreed between the
Parties and such terms shall be incorporated in this Supply Agreement by an
amendment.

  

3.2Subject to Section 3.1, it shall be the responsibility of Advaxis to carry
out at its expense all clinical trials and prepare such data and documentation
as may be required by applicable Regulatory Authority(ies) to obtain at its
expense the Regulatory Approval for the Product in the Territory. In case the
approval of any Regulatory Authority in the Territory is conditional and is
subject to submission of post marketing studies, then Biocon shall be
responsible or conducting such post marketing studies and preparing the relevant
documentations as may be required by the applicable Regulatory Authority, at its
expense.

 

3.3Each Party shall inform the other Party immediately in case any serious
adverse events ("SAEs") or adverse events (''AEs") pertaining to the use of the
Product is reported during any stage of the clinical trial for the Product or
thereafter and shall reasonably cooperate and exchange information regarding
such events. Without prejudice to any other rights or remedy that Biocon may
have under this Agreement or at law or in equity, Biocon reserves the right to
terminate this Supply Agreement upon written notice to Advaxis with immediate
effect in case any SAE or AE is reported with regard to the Product.

  

[image_028.jpg] 

 

BMR1323002A0624Page 5 of 24

 

 

3.4Advaxis shall provide Biocon with Data and Biocon shall treat the copies and
contents of the Data as Advaxis's Confidential Information and shall keep said
copies and the contents thereof in confidence and shall not disclose the same to
any Third Parties without prior written approval from Advaxis. However, Biocon
and its marketing partners and sublicensees are permitted to use the copies and
contents of Data for the purposes of obtaining Regulatory Approvals and
marketing the Product in the Territory in accordance with and subject to the
provisions of this Supply Agreement.

  

3.5Advaxis shall supply such quantity of the Product as may be requested by
Biocon from time to time and the relevant Data and information, at no cost to
Biocon to enable Biocon to obtain Regulatory Approvals for the Product in the
Territory.

  

Article 4 Launch

  

Biocon shall commence the commercial distribution of the Product in the
Territory (the "Launch") promptly after Biocon obtains Regulatory Approvals for
the Product in the Territory and no later than nine (9) months from receiving
approval in -in the respective country, provided Advaxis has submitted to Biocon
all information and Data with regard to the Product necessary for Biocon to
obtain the necessary Regulatory Approvals. Biocon shall commercialize the
Product under its Advaxis's brand name, unless otherwise agreed by the Parties
in writing, in which case all names and brands shall be assigned to Advaxis upon
termination of this Supply Agreement for any reason.

  

Article 5 Supply of Product and Forecast

  

5.1During the Term of this Agreement and subject to other terms and conditions
of this Agreement, Advaxis shall supply on an exclusive basis to Biocon the
Product ordered by Biocon in accordance with this Agreement for sale in the
Territory. Biocon will exclusively purchase all its requirements of the Product
from Advaxis, solely for the purpose of marketing and selling the Product in the
Territory, on the terms and conditions contained in this Agreement. Advaxis
shall supply the Product manufactured in accordance with the Specifications.

 

5.2

At least three (3) months prior to the Launch of the Product and thereafter at
least thirty (30) days prior to the commencement of each calendar quarter during
the term of this Agreement, Biocon shall submit to Advaxis a good faith rolling
forecast of the quantities of the Product that Biocon will purchase from Advaxis
for the twelve (12) month period commencing on the first day of each calendar
quarter. Of the twelve month (12) forecast, the first three (3) months' forecast
shall be a binding forecast and Biocon shall be obliged to issue firm purchase
orders for the binding portion of the forecast and the forecast for the
remaining nine (9) months shall be a non-binding forecast.

   

[image_028.jpg] 

 

BMR1323002A0624Page 6 of 24

 

 

Article 6 Orders

  

6.1The Parties hereby agree that Biocon shall periodically submit purchase
orders to Advaxis for supply of the Product which shall set forth the specific
quantities within the binding ranges specified in Article 5.2 above, expected
delivery date and shipping instructions. Such purchase orders shall be submitted
to Advaxis by facsimile or in any other written or electronic form, at least
three (3) months prior to the expected delivery date specified therein.

 

6.2Advaxis shall, within twenty (20) days of receipt of a purchase order, convey
its acceptance or rejection in writing of such purchase order to Biocon.
Purchase orders once accepted by Advaxis cannot be amended unless agreed to in
writing by the Parties. Upon acceptance by Advaxis, each purchase order will
constitute a binding obligation on the Parties. In the event of any ambiguity,
contradiction or discrepancy between the purchase orders, invoice or other
documents of the Parties and this Agreement, this Agreement shall prevail and
will be binding on the Parties.

  

6.3Advaxis shall supply the Product within the delivery date as per the purchase
order issued by Biocon. However, should Advaxis for any reason be unable to
supply the Products in terms of the purchase order, Advaxis shall inform Biocon
for any delay in delivery at least four (4) weeks in advance of expected
delivery date.

 

6.4Advaxis shall ensure that the Product supplied by Advaxis will have a minimum
remaining shelf-life of ninety percent (90%) of the label claim of the Product
at the date of delivery.

  

6.5

In order to promote efficient and effective supply chain planning, the
appropriate personnel representing the Parties may, in good faith, confer on a
regular basis during the term of the Agreement to consider and implement such
measures as they consider appropriate to manage the demand and supply aspects of
the Product under this Agreement, review performance and provide
recommendations. However, no amendment to this Supply Agreement shall be binding
on either Party unless made in accordance with Article 17.17 below.

  

[image_028.jpg] 

 

BMR1323002A0624Page 7 of 24

 

 

Article 7 Delivery of Product

  

7.1Except for the case otherwise agreed upon between the Parties, the delivery
of Product under this Agreement shall be on CIF (INCOTERMS 2010), Biocon
facility Bangalore, India. The Product shall be delivered along with the
respective invoice in Advaxis's standard packing as referred in the
Specification as per Schedule I. Title and Risk of loss shall pass from Advaxis
to Biocon upon delivery CIF (INCOTERMS 2010), Biocon facility Bangalore, India.

 

7.2Advaxis shall be responsible for obtaining any export licenses necessary for
shipment of the Product out of its facility and Biocon shall be responsible for
obtaining any import licenses necessary for importing the Product into the
Territory. The Product shall be labelled by Advaxis in accordance with mutually
pre-agreed Biocon's requirements. The initial labelling for the Product will be
described in the Specifications or as may be modified or revised by mutual
agreement of the Parties from time to time. If the labelling for the Product is
required to be changed under the laws, rules, administrative order or guidelines
of any applicable country in the Territory, Advaxis shall, upon request by
Biocon, carry out such changes, at Advaxis sole cost.

 

7.3The Product shall be delivered in Advaxis's standard packing as per article
7.1 above. Advaxis shall charge Biocon additional charges in addition to supply
price in the event Biocon requires delivery of the Product in special packaging,
unless such special packaging is the regulatory requirement in the Territory.
The Product shall be labelled by Advaxis in accordance with Biocon's
requirements and the labelling specification will be set forth in the
Specification. Both Parties agree that there shall be no modifications or
revisions to the labelling requirement without mutual written consent.

 

Article 8 Inspection, Acceptance or Rejection of Product Shipments

 

8.1

Biocon shall within thirty (30) Days of delivery of the Product conduct an
inspection of the Product to confirm if the Product delivered confirms to the
Specifications and send a written notice ("Rejection Notice") to Advaxis should
it determine that the Product does not conform to the Specifications, along with
a copy of its analysis report. If Advaxis accepts the Rejection Notice, Advaxis
shall at Biocon's option i) replace the nonconforming Product without any
charges to Biocon within thirty (30) Days from the date of acceptance of
Rejection Notice by Biocon or ii) reduce the invoicing amount to Biocon or
return the amount paid by Biocon for the non-conforming Product, and shall
reimburse Biocon for any reasonable expenses actually incurred by Biocon for
freight and for disposal of the non conforming Products.

 

[image_028.jpg] 

 

BMR1323002A0624Page 8 of 24

 

 

8.2In the event Advaxis does not accept the Rejection Notice, Biocon shall
submit a sample retained from the relevant batch of the Product under dispute to
Advaxis to enable Advaxis to ascertain Biocon's claim in Rejection Notice. Upon
receipt of such samples, Advaxis shall inspect samples and if Advaxis accepts
the Rejection Notice, Advaxis shall at Biocon's option i) replace the
non-conforming Product without any charges to Biocon within fifteen (15) Days of
acceptance of the Rejection Notice, or ii) reduce the invoicing amount to Biocon
or return the amount paid by Biocon for the non-conforming Product, and shall
reimburse Biocon for any reasonable expenses actually incurred by Biocon for
freight and disposal of the non-conforming Products. In the event Advaxis does
not accept the Rejection Notice, Biocon shall submit the sample received from
Advaxis to an independent competent laboratory or institution selected by the
Parties, whose determination as to whether the Product conforms to the
Specifications shall be final and binding on the Parties. The expenses incurred
in connection with such Third Party determination shall be borne by the Party
against whom the findings are made. If the said laboratory finds the Product
does not conform to the Specifications, Advaxis shall at Biocon's option i)
replace the same without any charges to Biocon within thirty (30) Days from the
date such Third Party determination is received by Advaxis or ii) reduce the
invoicing amount to Biocon or deduct the amount for the non-conforming Product
in the subsequent invoice sent to Biocon, and shall reimburse Biocon for any
reasonable expenses actually incurred by Biocon for freight and disposal of the
non-conforming Products.

  

Article 9 Quality and Product Recall

  

9.1Biocon agrees to provide to its customers in the Territory initial customer
support relating to the Product in accordance with the Quality Agreement. Biocon
shall forward any customer complaints concerning the quality of the Product to
Advaxis. Advaxis shall promptly respond to Biocon with respect to all inquiries
from customers and Biocon, including complaints forwarded to Advaxis by Biocon.
Advaxis shall conduct analysis of the Product that is the subject of any
customer complaint at Advaxis's cost and provide Biocon with the analysis report
upon request of Biocon.

 

[image_028.jpg] 

 

BMR1323002A0624Page 9 of 24

 

 

9.2Within the Shelf-life period of the Product, if the Products are found to be
defective and further such defect or non-conformance could not be ascertained by
Biocon under Article 8.1 above, Biocon shall notify Advaxis within fifteen (15)
Days of discovery of such defects. If such defects or non-conformance are solely
and directly due to manufacturing defect of the Product or otherwise
attributable solely to Advaxis, as determined using the procedures set forth in
Article 8.2, Advaxis shall, at Biocon's option, i) replace at Advaxis's own cost
and expense such defective Products or ii) return the amount paid by Biocon for
the defective Product.

 

9.3In the event any Regulatory Authority in the Territory issues a request,
directive or order that the Product be recalled, or a court of competent
jurisdiction orders such a recall, Advaxis shall take all appropriate corrective
actions, and Biocon shall cooperate with and assist Advaxis in any governmental
investigations relating to the recall.

  

9.4In the event of Product recalls as provided in Article 9.3 above or in any
other case of Product recall by Advaxis or Biocon, Advaxis shall, unless such
recall is the result of gross negligence attributable solely to Biocon, in which
case Biocon will bear all costs and expenses associated with such a recall; be
responsible for i) replacement of the Products to be supplied to the market in
exchange of said recall, and ii) the expenses of the recall. Advaxis shall
complete the recall of the Product from the Territory within a reasonable time
through consultation with Biocon and applicable Regulatory Authority. Biocon
agrees to provide reasonable assistance to Advaxis in relation thereto. For this
purpose, Biocon agrees to maintain a list of all customers who have purchased
the Products in the Territory, the Products purchased, and the dates of such
purchases. For purposes of this Agreement, the expenses of the recall shall
include, but not be limited to, the expenses of notification, the expenses for
administrating the recall, the expenses for reimbursement of expenses incurred
by distributors for recall, and destruction or return of the recalled Product
(inclusive of freight expenses).

 

Article 10 Price and Payments

  

10.1

Supply Price: The supply price per unit of the Product ("Price") on CIF
(Incoterms 2010) Biocon facility, Bangalore, India for first Contract Year shall
be [c.i.] ([c.i.]). Thereafter, sixty (60) days prior to the beginning of each
Contract Year, the Parties shall agree on the supply price of the Product for
the subsequent Contract Year which shall not be greater than [c.i.] ([c.i.]) of
the average (per unit) Net Sales of the Product during the preceding Contract
Year but in no event shall be less than [c.i.] ([c.i.]). The Parties expressly
agree that in case of any improvement in the Product or change or modification
in the presentation of the Product, Advaxis shall offer such improved Product or
Product in a changed presentation at a competitive price, which shall in no
event be more than [c.i.] ([c.i.]) above the average (per unit) supply price of
the Product in the preceding three (3) Contract Years, and the same shall be
mutually agreed between the Parties based on good faith discussions. Supply
price of the Product includes all taxes, levies freight, insurance and other
shipping charges, each of which shall be borne exclusively by Advaxis. Biocon
shall pay the supply price for the Product supplied by Advaxis in the United
States Dollars (USD) and in accordance with the terms of this Agreement. Biocon
shall be responsible to the relevant authorities for payment of any import
duties applicable on the import of the Product in the Territory.

  

[image_028.jpg] 

 

BMR1323002A0624Page 10 of 24

 

  

10.2Milestone Payments. In the event Phase II or Phase III clinical trials are
required by the Regulatory Authorities for obtaining marketing approvals or
after obtaining marketing approval for the Product in India, and Advaxis
conducts such clinical trials at its sole cost, in the manner as may be required
by the Regulatory Authorities in India, then in the Contract Year following such
initiation of the said clinical trial by Advaxis, Biocon shall make a one time,
non-refundable milestone payment to Advaxis as per the Schedule 2.

  

10.3Payment Terms and Taxes. Biocon shall make the payments under this Agreement
to Advaxis in U.S. Dollars. All payments shall be made by Biocon to Advaxis
within sixty (60) days of receipt of Advaxis' invoice. Such payment shall be
made by wire transfer to the bank account specified by Advaxis. All Payments
from Biocon under this Agreement shall be subject to withholding taxes as may be
applicable.

  

10.4Currency Conversion: Where applicable, Net Sales shall be converted from INR
to USD at the average exchange rate of conversion in the last Contract Year. For
the purposes of this Agreement, exchange rates shall be those obtained from the
Reserve Bank of India.

  

Article 11 Representation and Warranties

  

11.1Product Warranty. Advaxis represents and warrants to Biocon that the Product
delivered to Biocon hereunder shall 1) conform to the Specifications during its
shelf life; 2) will be manufactured in accordance with the requirements of the
applicable laws; 3) comply with the GMP regulations applicable to the
manufacture of the Product in the Territory; 4) during its shelf life, be free
from defects in workmanship, material or design.

  

11.2

Advaxis represents and warrants that neither Advaxis nor any of its
manufacturing facilities, Affiliates, agents, sub-contractors, suppliers,
professional advisors, their individual employees that are retained by Advaxis
with respect to performance under this Supply Agreement are (i) currently
debarred or disqualified by the relevant authorities, or (ii) involved in any
investigation or proceedings that could lead to debarment, or (iii) a party to
any debarment or disqualification proceedings. During the term of this Supply
Agreement, Advaxis will notify Biocon within three (3) Days if any such
disqualification proceedings commence. Advaxis will not use the services of any
debarred individual or entity in performing its obligations under this Supply
Agreement.

  

[image_028.jpg] 

 

BMR1323002A0624Page 11 of 24

 

 

11.3Advaxis represents and warrants that the Product does not infringe any Third
Party intellectual property rights or misappropriate any trade secret.

 

11.4Biocon represents, warrants and covenants that it shall use the Product for
marketing and distribution in the Territory in accordance with the terms of this
Agreement and all applicable laws and it shall not make any representations,
warranties or guarantees to end users or its customers that are inconsistent
with the Product information provided to it by Advaxis.

 

11.5Each Party further represents, warrants and covenants that they it shall
represent the Product accurately and fairly and shall refrain from misleading or
unethical business practices

  

11.6Each Party represents and warrants to the other as follows;

 

11.6.1it is a corporation duly organized, validly existing and in good standing
under the laws of its jurisdiction of formation and operations;

  

11.6.2it has, and will have on all relevant dates, all requisite legal and
corporate power to execute and deliver this Supply Agreement, and to carry out
and perform its obligations under the terms of this Supply Agreement;

  

11.6.3the execution and delivery of this Supply Agreement and the performance of
the transactions contemplated hereby have been duly authorized by all
appropriate corporate action; and

 

11.6.4the performance by it of any of the terms and conditions of this Supply
Agreement on its part does not and will not constitute a breach or violation of
any other agreement or understanding, written or oral, to which it is a party.

 

11.7EXCEPT FOR THE EXPRESS REPRESENTATIONS AND WARRANTIES SET FORTH IN THIS
SUPPLY AGREEMENT, NEITHER PARTY MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED
(INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A
PARTICULAR PURPOSE).

 

[image_028.jpg] 

 

BMR1323002A0624Page 12 of 24

 

   

Article 12 Indemnification

  

12.1Indemnification by Advaxis. Advaxis shall indemnify, defend and hold
harmless Biocon and its officers, directors and employees, from any judgments,
losses, damages, liabilities, suits, costs and expenses (including reasonable
attorney fees)("Losses") arising from any Third Party claims in connection with
or relating to i) any breach by Advaxis of any representation, warranty,
covenant or obligation of Advaxis contained in this Supply Agreement or ii) any
gross negligence or willful misconduct of Advaxis in the performance of its
obligations under this Supply Agreement or iii) any act or omission of
negligence, recklessness, fraud or willful misconduct of Advaxis, its
Affiliates, and their respective officers, directors, employees and agents or
iv) any and all product liability claims, v) actual or alleged infringement of
any third party intellectual property rights or trade secrets by Advaxis or its
Affiliates. Notwithstanding anything herein to the contrary, Advaxis shall have
no obligation to indemnify pursuant to Article 12.1 if such Losses result from
or are solely attributable to: (i) mishandling, modifying, combination with
third party materials or tampering of the Products by Biocon; (ii) negligence or
failure to comply with instructions regarding use of the Products and storage
thereof by Biocon (iii) any misrepresentation or breach of any representation,
warranty, covenant or agreement made by Biocon under this Supply Agreement; or
(iv) any act or omission of negligence, recklessness, fraud or willful
misconduct of Biocon, its Affiliates, and their respective officers, directors,
employees and agents.

 

12.2Indemnification by Biocon. Subject to the indemnification obligation of
Advaxis as per Clause 12.1 Biocon shall indemnify, defend and hold harmless
Advaxis and its officers, directors and employees, from any Losses arising from
any Third Party claims in connection with or relating to i) use or
commercialization of any Product in the Territory, ii) any breach by Biocon of
any representation, warranty, covenant or obligation of Biocon contained in this
Supply Agreement or iii) any gross negligence or willful of Biocon in the
performance of its obligations under this Supply Agreement.. However Biocon
shall not be liable to indemnify and hold harmless Advaxis for any Losses that
arise or are in any way related to the warranties or representations given by
Advaxis, instructions for use or labelling instructions provided by Advaxis in
the product literature/brochure or otherwise.

 

 

12.3

Notification of Claim. Each Party will promptly notify the other Party if it
becomes aware of a claim (actual or potential) by any Third Party for which
indemnification may be sought by that Party and will give such information with
respect thereto as the other Party shall reasonably request. If any proceeding
(including any governmental investigation) is instituted involving any Party for
which such Party may seek an indemnity under Article 12.1 or 12.2 (the
"Indemnified Party"), the Indemnified Party shall not make any admission or
statement concerning such Third Party claim but shall promptly notify the other
Party (the "Indemnifying Party") orally and in writing and the Indemnifying
Party and the Indemnified Party shall discuss how to respond to such claims. The
Indemnifying Party shall not be obligated to indemnify the Indemnified Party to
the extent any admission or statement made by the Indemnified Party or the
failure by such Indemnified Party to notify the Indemnifying Party materially
prejudices the defense of such claim.

  

[image_028.jpg] 

 

BMR1323002A0624Page 13 of 24

 

 

12.4Defense of Claim. If the Indemnifying Party elects to defend or, if local
procedural rules or laws do not permit the same, elects to control the defense
of a Third Party claim, it shall be entitled to do so provided it gives notice
to the Indemnified Party of its intention to do so within 45 days after the
receipt of written notice from the Indemnified Party of the potentially
indemnifiable claim. The Indemnifying Party shall retain counsel reasonably
acceptable to the Indemnified Party (such acceptance not to be unreasonably
withheld, refused, conditioned or delayed) to represent the Indemnified Party
and shall pay the fees and expenses of such counsel related to such proceeding.
In any such proceeding, the Indemnified Party shall have the right to retain its
own counsel, but the fees and expenses of such counsel shall be at the expense
of the Indemnified Party. The Indemnified Party shall not settle any claim for
which it is seeking indemnification without the prior written consent of the
Indemnifying Party, which consent shall not be unreasonably withheld, refused,
conditioned or delayed. The Indemnified Party shall, if requested by the
Indemnifying Party, cooperate in all reasonable respects in the defense of such
claims that are being managed or controlled by the Indemnifying Party at the
sole cost of the Indemnifying Party. The Indemnifying Party shall not, without
the written consent of the Indemnified Party effect any settlement of any
pending or threatened proceeding in which the Indemnified Party is, or based on
the same set of facts could have been, a party and indemnity could have been
sought hereunder by the Indemnified Party, unless such settlement includes an
unconditional release of the Indemnified Party from all liability on claims that
are the subject matter of such proceeding.

  

Article 13 Limitation of Liability

  

13.1NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED IN THIS AGREEMENT, EXCEPT
WITH RESPECT TO INDEMNIFICATION OBLIGATIONS AS SET FORTH IN THIS SUPPLY
AGREEMENT, IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER FOR ANY
INCIDENTAL, CONSEQUENTIAL, SPECIAL, PUNITIVE, INDIRECT DAMAGES, LOSS OF PROFIT,
LOSS OF REVENUE, LOSS OF USE EVEN IF INFORMED OF POSSIBILITIES OF SUCH DAMAGES
OR LOSSES.

  

Article 14 Pharmacovigilance

 

14.1To the extent of any development or commercialization of the same Products
inside and outside the Territory, the Parties shall enter into a worldwide
safety information exchange and reporting agreement to coordinate such matters
between the Parties.

 

[image_028.jpg] 

 

BMR1323002A0624Page 14 of 24

 

  

Article 15 Confidentiality

  

15.1Permitted Use of Confidential Information. The Receiving Party shall not use
any Confidential Information, directly or indirectly, for its own benefit,
except for the explicit purpose of effectuating this Agreement. No other use of
Confidential Information is permitted except as set forth in this Article 15.

 

15.2Non-Disclosure of Confidential Information. The Receiving Party agrees to
protect and maintain the confidentiality of all Confidential Information
obtained pursuant to this Agreement. Notwithstanding the foregoing, the
Receiving Party may disclose Confidential Information of the Disclosing Party to
the Receiving Party's directors, officers, employees, Affiliates, consultants,
subcontractors, sublicensees or agents to the extent reasonably necessary to
carry out its obligations under this Supply Agreement, provided that such
directors, officers, employees, Affiliates, consultants, subcontractors,
sublicensees or agents have been advised of the confidential nature of such
information and have agreed to maintain such information as confidential to the
same extent required by this Article 15. The Receiving Party shall not
duplicate, disclose, or discuss any Confidential Information to or with any
Third Parties, in whole or in part, without the prior written consent of the
Disclosing Party.

 

15.3Exceptions to Confidential Information. Notwithstanding anything to the
contrary set forth herein, the Receiving Party shall not be obligated to
maintain the confidentiality of any information provided to it under this
Agreement which:

 

15.3.1was at the time of disclosure or subsequently became, through no act,
fault or omission of the Receiving Party, available to the general public
through publication or otherwise;

 

15.3.2was subsequent to the disclosure, lawfully and independently received in
good faith by the Receiving Party from a Third Party who was under no duty of
confidentiality with respect to such disclosure;

 

15.3.3was at the time of disclosure already known to the Receiving Party, as
shown by written records in the possession of or available to the Receiving
Party, provided that it was not directly or indirectly derived from the
Disclosing Party or its Confidential Information.

 

15.3.4information which the Receiving Party can establish by competent evidence
was subsequently and independently developed by employees of or on behalf of the
Receiving Party without use or access, direct or indirect, of Confidential
Information protected by this Agreement.

  

15.4Opportunity to Oppose Disclosure. If a Receiving Party is required by a
government body, regulatory authority, court of law or administrative order to
disclose Confidential Information, then prior to any disclosure, the Receiving
Party agrees to immediately notify the Disclosing Party and to cooperate with
the efforts of Disclosing Party to contest the disclosure, seek an appropriate
protective order or other remedy or waive the Receiving Party's compliance with
the provisions of this Agreement.

  

[image_028.jpg] 

 

BMR1323002A0624Page 15 of 24

 

  

15.5Confidentiality Term. The confidentiality obligations shall survive this
Agreement and continue until expiry or sooner termination of this Agreement or
such other period as may be permitted as per the applicable laws, whichever is
longer.

  

15.6Expiration of Agreement and Return of Confidential Information. Upon
expiration or termination of the Agreement, the Receiving Party shall:

 

15.6.1immediately discontinue all use of Confidential Information;

 

 

15.6.2return all Confidential Information to the Disclosing Party within thirty
(30) Days;

 

 

15.6.3immediately erase or destroy all Confidential Information contained in
computer memory or other data storage apparatus, except where such destruction
would otherwise violate applicable law;

 

15.6.4warrant in writing to the Disclosing Party that it has taken all actions
described in the foregoing Articles 15.6.1 through 15.6.3, and provide such
document to the Disclosing Party within five (5) Days following the Disclosing
Party's demand pursuant to this Article 15.6. Upon the expiration or termination
of this Agreement, the Receiving Party shall return or destroy all Confidential
Information within the possession of its directors, officers, employees, agents
or consultants and, upon written demand from Disclosing Party, warrant such
return or destruction of Confidential Information in writing which shall be
delivered to the Disclosing Party within five (5) Days following the Disclosing
Party's demand pursuant to this Article 15.6.

 

15.7Authority to Disclose Confidential Information. Each Party warrants and
represents that it has the right to disclose its Confidential Information for
purposes of this Agreement.

 

15.8Injunctive Relief to Enforce Performance. The Parties acknowledge that it is
impossible to measure fully, in money, the injury that may be caused in the
event of a breach or threatened breach of any of the confidentiality provisions
of this Agreement. Each Party shall be entitled to injunctive relief to enforce
the confidentiality provisions of Article 15 of the Agreement, without prejudice
to any other remedy that such Party may have at law or in equity. The
obligations set forth in this Article 15.9 shall survive any expiration or
termination of the Agreement.

   

[image_028.jpg] 

 

BMR1323002A0624Page 16 of 24

 

  

Article 16 Term and Termination

 

16.1This Agreement shall come into force on the Effective Date and shall be
valid till later of twenty (20) years or last to expire patent or patent
application unless terminated earlier in terms of this Agreement.

 

16.2Without prejudice to any rights or remedies available to each Party under
this Supply Agreement, under law or equity, either Party shall be entitled to
terminate this Agreement by giving a prior written notice of thirty (30) days to
the other Party identifying the breach and requiring it to be cured, if the
other Party commits any breach of this Agreement and fails to remedy the breach
within thirty (30) days after receipt of such notice.

 

16.3Either Party shall be entitled to terminate this Agreement by giving a prior
written notice of thirty (30) days if the other Party ceases to do business,
unable to pay its debts as they fall due, becomes or is deemed insolvent, has a
receiver, liquidator, manager, administrator, administrative receiver or similar
officer appointed in respect of the whole or any part of its assets or business
(or is the subject of a filing ,with any court for the appointment of any such
officer), makes any composition or arrangement with its creditors, takes or
suffers any similar action in consequence of debt or an order or resolution is
made for its dissolution or liquidation (other than for the purpose of solvent
amalgamation or re construction), or any equivalent or similar action or
proceeding is taken or suffered in any jurisdiction;

  

16.4Effect of Termination

  

16.4.1Upon expiration or sooner termination of this Supply Agreement for any
reason whatsoever, all licenses and rights granted to Biocon by Advaxis under
this Supply Agreement stands revoked from the effective date of expiration or
sooner termination.

  

16.4.2In the event of expiry or sooner termination of this Supply Agreement,
except for termination by Advaxis under Articles 16.2 or 16.3 at Advaxis's
option, Biocon may sell the remaining stock in the Territory, subject to
compliance with all applicable laws, within nine (9) months after expiry or
termination of the Supply Agreement or return it to Advaxis provided it has a
minimum of 25% of its original shelf life and is in its original packaging.

  

16.5Termination or expiration of this Agreement shall not affect in any way
rights and obligations of the Parties accrued up to the effective date of
termination or expiry as the case may be.

 

16.6Upon expiry or sooner termination of this Agreement, all provisions
including Article 15 (Confidentiality), Article 12 (Indemnity) and Article 17.7
(Governing Law) that should survive by nature shall survive expiry or
termination of this Supply Agreement.

 

[image_028.jpg] 

 

BMR1323002A0624Page 17 of 24

 

   

Article 17 MISCELLANEOUS

 

17.1Right of First Refusal: Advaxis may develop new products during the Term
that Advaxis will seek to license in the Territory. In such event, prior to
offering a license to a Third Party, Advaxis shall promptly notify Biocon of any
such new product, together with a summary of relevant information to obtain such
license from Advaxis on commercially reasonable terms. Upon Biocon's receipt of
such notice, the Parties shall promptly commence good faith negotiations for a
period of forty five (45) days in an effort to reach mutually acceptable terms
for such rights and license. During such forty five-day period, the new product
may not be offered to any Third Party. If the Parties are unable to reach a
definitive agreement during such period, Advaxis may offer the new product to a
Third Party on terms no less favorable than the terms offered to Biocon.

 

17.2Change of Control. If either Party undergoes a Change of Control, it shall
immediately notify the other Party. Such other Party may terminate this Supply
Agreement with written notice of thirty (30) days to the Party undergoing the
Change of Control or other mutually agreed notice period from the date of
conclusion of the discussion for Change of Control. In case the other Party does
not terminate this Supply Agreement, the new entity taking over the management
and control of the Party undergoing the Change of Control (i.e. the acquiring
entity) shall be responsible for fulfillment of all the terms and conditions of
this Agreement as if it is the Party to the Agreement. This will be a condition
precedent for continuation of the Agreement in the event of all Changes in
Control.

 

17.3Assignability. This Agreement shall not be assigned in whole or in part by
any of the Parties to any Third Parties without the prior consent of the other
Party; provided, however, that either Party hereto shall be entitled to assign
all or any part of its rights and obligations herein to its Affiliate(s) by
prior written intimation of at least seven (7) Days to the other Party.

 

17.4Notice. All notices under this Supply Agreement shall be sent by registered
or certified mail, postage prepaid, or by overnight courier service. Notices may
be sent by facsimile or e-mail, if confirmed by also sending as described above;

 

If to Biocon; If to Advaxis     Biocon Ltd Advaxis, Inc., 20th K.M. Hosur Road
305, College Road East, Electronics City, Bangalore -560 100 Princeton, New
Jersey India 08540     Attention: President -Marketing Attention: CEO Copy to:
Head - Group Legal Copy to: COO   Facsimile: 91 80 2852 3423 Facsimile:
609-452-9818

  

[image_028.jpg] 

 

BMR1323002A0624Page 18 of 24

 

 

17.5No Waiver. Failure, delay, or any partial exercise by either Party of any
right, power, or privilege available to such Party hereunder shall not operate
as a waiver or preclude further exercise by such Party of any other right, power
or privilege.

 

17.6Descriptive Headings. All section headings, titles, and subtitles in this
Agreement are for convenience of reference only, and are to be ignored in any
construction of this Agreement's provisions. This Agreement has been prepared on
the basis of mutual understanding of the Parties and shall not be strictly
construed against either Party as the drafter.

 

17.7Governing Law and Dispute Resolution. This Agreement shall be governed by
and interpreted in accordance with the laws of United Kingdom, without reference
to its conflict of law provisions. The Parties agree that they shall in good
faith work towards implementation of this Agreement and any dispute and
difference arising out of or in relation to this Agreement shall be first
attempted to be resolved amicably by mutual negotiations, failing which such
dispute shall be referred to and finally resolved by arbitration in London in
accordance with the Rules of International Chamber of Commerce ("ICC Rules") for
the time being in force, which rules are deemed to be incorporated by reference
in this clause. The venue of arbitration shall be London. The Tribunal shall
consist of three arbitrator(s). The arbitration shall be conducted in English
language. The arbitral award shall be final, conclusive and binding on the
Parties and shall be enforceable in any court of competent jurisdiction.

 

17.8Non-Compete: During the period of this Agreement, neither Party shall on its
own or with any Third Party, directly or indirectly, market, promote, sell or
distribute in the Territory any HPV mediated immunotherapy product in the Field
that competes with the Product.

 

17.9Force Majeure. If either Party is delayed in performing an obligation under
this Agreement by strike, lockout, or other labor troubles of a Third Party; by
restrictive governmental or judicial order or by riots, insurrection, war,
inclement weather, or Acts of God; performance is excused for the period of such
delay. The Party affected by such Force Majeure event shall promptly notify the
other in writing of the delaying event. If such delay continues for more than
ninety (90) days, the Party not claiming Force Majeure may terminate the Supply
Agreement.

 

17.10Compliance with Law. Each Party hereby covenants and agrees to comply in
all material respects with all laws and regulations applicable to its activities
in connection with this Supply Agreement and commercialization of the Products,
including any applicable import and export laws and regulations.

 

17.11Insurance. Each Party will maintain insurance policies in an amount
adequate to cover its obligation hereunder. Upon request, each Party shall
provide the other Party with copies of all such insurance policies.

 

[image_028.jpg] 

 

BMR1323002A0624Page 19 of 24

 

 

17.12Relationship. The relationship hereby established between the Parties is
solely that of the independent contractors. This Supply Agreement shall not
create any agency, partnership, or joint venture relationship.

  

17.13No Third Party Beneficiary. This Agreement shall be for the sole benefit of
the Parties to this Supply Agreement and is not intended, nor shall be construed
to give any person, other than the Parties hereto any legal or equitable right,
remedy or claim.

  

17.14Severability. If any provision of this Agreement is held illegal,
unenforceable, or otherwise invalid, such holding shall not affect the other
provisions or applications of this Agreement which can be given effect.

  

17.15Complete Understanding. This Supply Agreement together with the Schedules
attached hereto constitutes the complete understanding between the Parties and
merges and supersedes all prior discussions, agreements and understandings of
every nature between the Parties. No alterations or modifications of any
provisions of this Agreement shall be valid unless made in writing and signed by
both of the Parties.

 

17.16Counterparts. This Agreement may be executed in counterparts, each of which
shall be considered an original and all of which shall constitute one and the
same document for all purposes.

 

17.17Communication. Advaxis and Biocon shall communicate with each other on a
periodic basis (at least once in six months) on the status and development of
its activities under this Agreement.

 

17.18Amendment. No amendment, modification, supplement, and novation of this
Agreement or its Annexure and no waiver of any of the terms or conditions hereof
shall be valid or binding unless made in writing and duly executed by the
Parties.

 

 

 

(Signature Page Follows)

 

 

[image_022.jpg] 

  

BMR1323002A0624Page 20 of 24

 

 

IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed
by affixing their signatures below

 

Biocon Limited   Advaxis Inc.                        [image_035.jpg]       1
 /s/ Shukrit Chimote     Name: Shukrit Chimote   Name:  Daniel J. O’Connor  
Title: Vice President – Marketing   Title: President & CEO                      
    EO2  /s/ Murali Krishnan K.N.       Name: Murali Krishnan K. N.       Title:
President - Group Finance      

 

 

 [image_024.jpg]

  

BMR1323002A0624Page 21 of 24

 

 

 

 

 

 

SCHEDULE 1

 

SPECIFICATION OF THE PRODUCT

 

Substance: [c.i.]

 

Product: [c.i.]

 

Characteristics of micro-organism:

[c.i.]

 

 

 

Package Specification

Packed on dry ice

Product: UN 3373

Cat. B

 

Packing Method: Glass vials are packed in a cardboard box which is inserted in a
biosafety bag

Dry Ice

Thermo-resistant box

Cardboard surrounding box

 

 [image_026.jpg]

 

 

BMR1323002A0624Page 22 of 24

 

 

 

 

SCHEDULE 2

 

MILESTONE PAYMENT

 

 

Total Net Sales in the Contract Year following the initiation of clinical trials
in India  by Advaxis (in USD) Milestone Payment (in USD)

[c.i.]

[c.i.]

[c.i.]

[c.i.]

[c.i.]

[c.i.]

   

 

Biocon will calculate sales for the applicable Contract Year before the end of
the immediate quarter following the said Contract Year and inform Advaxis'
entitlement as per the table above. Upon receipt of communication from Biocon,
Advaxis shall submit invoice to Biocon. Biocon will make the one time non
refundable milestone payment within 60 days of receipt of invoice from Advaxis,
subject to withholding tax as may be applicable.

 

 [image_028.jpg]

 

 

BMR1323002A0624Page 23 of 24

 

 

 SCHEDULE 2

 

QUALITY AGREEMENT

 

 

 

 

(SEPARATELY ATTACHED)

 

 

 

 

 

 [image_028.jpg]

 

 

BMR1323002A0624Page 24 of 24