Offer for Market Analysis & Techno-

Commercial Feasibility Study for Greenfield

Cephalosporine Dry Powder Injectable &
Injectable Facility

JBI Pharma
Noida, India
Offer#: 1057170
March 5, 2024– Version P0

The information in this document is the property of Biopharmax Group.

This document contains confidential proprietary information intended for use only by the named
recipient or its employees or agents in conjunction with Biopharmax Group.
BIPL/BD/F-02/R-03/270521

Registered Office: Biopharmax India Pvt. Ltd., A-401, 4th Floor, Mantri Alpine, S. No. 268, Bandal Estate,
Bavdhan BK, Pune MH – 411021 Ph. No.020 669 333 00. CIN U45201PN2006FTC138676
1. REVISION HISTORY

Version Date Description/Area of Changes

P0 Mar 05, 2024 First Baseline Version

JBI Pharma | Revision History 2

 2. TABLE OF CONTENTS

1. Revision History.................................................................................................... 2

2. Table of Contents ................................................................................................. 3

3. Cover Letter ........................................................................................................... 4

4. About Biopharmax ............................................................................................... 5

5. Project Description ............................................................................................. 10

6. Assumptions........................................................................................................10

7. Scope of Work: Market Assessment & Portfolio Identification ................... 11

8. Timelines .............................................................................................................13

9. Pricing, Terms & Schedule ................................................................................ 13

10. Annexure-I: Region – Key Markets ...................................................................18

JBI Pharma | Table of Contents 3

 3. COVER LETTER
March 5, 2024

To: M/s JBI Pharma

Attn: Mr. Hitesh Katyal

Ref: Offer for Market Analysis & Techno-Commercial Feasibility Study for Greenfield
Cephalosporine Dry Powder Injectable & Injectable Facility

Dear Sir,

We thank you for providing us an opportunity to submit our offer for Feasibility Study for Oral
Dosage (Solid & Liquid) Formulation at Oman.

Based on the details shared with our team, we have understood the project scope and listed
the detailed scope of work and deliverables, in the following chapters of this offer. As per
your requirement, we are glad to submit our offer & given the opportunity, we assure you to
provide our best services, adhering to high quality standards as always.

We are happy to provide and clarify any further information that may be required and look
forward to commencing our cooperation on this project.

Sincerely,
Dropat Singh Chib
Manager- Business Development
Biopharmax India Pvt. Ltd.
Mobile: +91-8655772903

JBI Pharma | Cover Letter 4

4. ABOUT BIOPHARMAX
4.1 Background and experience

4.1.1 Biopharmax Group is active in US, Europe, China, India, and the Middle East.

4.1.2 Past references in similar projects include world leaders like Johnson & Johnson,
Teva, Cipla, Ferring Pharmaceuticals, and others.

4.1.3 Group staff is over 150 expert engineers in the Process, Validation, Mechanical,
Automation and Control, Biological, Chemical, and Industrial fields.

4.1.4 Our office in India is in Pune, with a team of 60+ in-house professionals covering
all disciplines. This office is largely trained and supported by the global offices.

4.1.5 All facilities and plants designed and built by Biopharmax in India and globally are
U.S. FDA and/or EMEA compliant and adhere to the global cGMP standards and
codes.

4.1.6 We will be happy to provide you with the contact information of our clients, to
receive their impressions and recommendations on Biopharmax.

4.1.7 We will be more than glad to invite you to any of our client project sites, to
provide you a real-time demonstration of how our facility design standards
convert into a constructed facility, meeting the international regulatory
standards & pharma customer expectations.

4.2 Expertise, standards, and confidentiality

4.2.1 For over 40 years, Biopharmax has been catering to Teva Pharmaceuticals,
Johnson & Johnson, Bayer Healthcare, Merck Serono, Pluristem, Stem Cells
Medicines, and other world leaders, in facility projects design and construction,
around the globe.

4.2.2 Our accumulated know-how and expertise ensure our quality, reliability, and final
project deliverance compliant with the international regulatory requirements
and codes.

4.2.3 We maintain strict confidentiality for all our clients, ensuring that our
manufacturing technology know-how will be provided to them while keeping in
complete confidence the process technologies of every client.

JBI Pharma | About Biopharmax 5

4.3 Turnkey approach – cost effective.

4.3.1 Biopharmax Group is the only consultant/supplier currently active in India, that
provides the full scope of a turnkey project, with all capabilities in-house.

4.3.2 From a very early stage of facility conceptual design through project Detailed
design and construction phases, to complete validation and operation of the
plant, Biopharmax capabilities enable owning responsibilities on total project
cost, timelines, and validation of the plant.

4.3.3 Our approach enables complete project integration considering from a very early
project stage, the validation, process design, and its implementation, software,
and control as well as complying with international standards and codes while
providing procurement, installation, commissioning, site supervision, and project
management services/support.

4.3.4 This results in cost-effective, high-quality facilities, that position the client in a
competitive position, even in the most cost-efficient and competitive market.

4.3.5 After a project is completed, we provide a warranty for its operation as well as
impart training to the manufacturing team.

4.4 Process design and implementation.

4.4.1 Due to the vast accumulated know-how and experience in the generic industry,
Biopharmax has in-house core capabilities in process design, resulting in a
compact linear facility footprint, considering operation optimization and costs
control.

4.4.2 Our in-house team of experts can assist with yield enhancement, cycle time
reduction, optimization of process steps, etc. resulting in reduced CAPEX and
optimized OPEX. Our experience in technology transfer and scale-up from pilot
scale to manufacturing supports the requirements in such projects.

4.5 Automation

4.5.1 In most of the plants designed by us, we strive for a high level of automation, to
ensure:

JBI Pharma | About Biopharmax 6

 • Batch to batch repeatability and reduce rejected batches.

• Improved process control resulting in increased product yield.

• Reducing human intervention, thus enhancing facility safety.

• Multi-product manufacturing/formulation/filling, by utilizing a recipe

program.

• Future expansion supports complete plant integration.

• Process monitoring in compliance with QA and validation requirements.

4.5.2 All these will support an increase in production capacity while reducing
operational costs.

4.6 Procurement capabilities

4.6.1 Project equipment is designed in-house and negotiated by our global

procurement department.

4.6.2 We source from selected Indigenous, European, and U.S. leading vendors, based
on global contracts that are signed on a multi-annual basis at a pre-determined
pricing structure.

4.6.3 Thus, we are capable of controlling project costs, while maintaining the strictest
quality standards.

4.6.4 We also provide continuous training & guidance to local suppliers and
contractors, to comply with international standards, thus ensuring that local
installations are complying with our standards.

4.7 Validation

4.7.1 It is our goal to help our clients ensure their facilities, utilities and equipment
perform as intended. We do that through commissioning and qualification
services, using a risk-based approach to reduce the overall cost and timeline
required to satisfy requirements related to both operations and compliance,
without compromising on the quality of the project.

4.7.2 Biopharmax has multidisciplinary teams with subject matter experts. Our
experienced commissioning and qualification team has the technical skills and

JBI Pharma | About Biopharmax 7

 experience to make projects successful. Our engineers add value to each step of
the process. We have extensive experience in a GMP-regulated environment,
good documentation practices (GDP) and have the support of industry-level
thought leaders for defining and implementing best practices. Our team can
quickly integrate with our client’s project team to complete the project within
their boundaries and expectations.

4.7.3 Biopharmax follows a proven C&Q approach, which intelligently applies risk-
based tools to reduce typical C&Q program time and cost without adding
compliance risk. These proven approaches are based upon our decades of
experience working effectively with General Contractors, Operations, Facilities,
Engineering, and Quality functions.

4.7.4 Biopharmax’s risk-based approach includes User and Functional Requirement

Specifications, Vendor Documentation, Basis of Design (BOD) and Supplier
provided documentation to develop your commissioning and qualification
documents. This approach, coupled with risk analysis, leverages commissioning
activities to reduce project execution time and requires Installation and
Operational Qualification testing moving into Performance Qualification testing
as quickly as possible. Our approach typically includes:

• User requirements based on the process are the key to acceptability.

• Focus on which affects product quality.

• Risk assessments and Process Knowledge used to identify critical elements

(use of FMECA)

• Use of CQA & CPPs as the basis for the qualification.

• Value-added documents based on technical merit.

• Use of supplier documentation.

• Test planning and leveraging (one-time testing)

• Involvement of SME at every stage of C&Q for better technical

understanding.

4.7.5 Besides our C&Q approach, the other factor influencing our success rate is our
strategic planning.

JBI Pharma | About Biopharmax 8

4.8 Vendor Inspection Services & PMC Services

4.8.1 Biopharmax proposes to offer vendor inspection services at periodic intervals or

major milestones during the production of Major Equipment.

4.8.2 This is to verify and keep a check on the quality of work in accordance with
approved specifications / drawings.

4.8.3 We will suggest corrective measures if required to meet expected quality and
help to expedite work in case of delays.

4.9 Document Management System

4.9.1 Besides our Engineering approach, the other factors influencing our success rate
are our strategic planning. We have the basic infrastructure required to handle
projects of any size.

4.9.2 Our electronic document management system provides an excellent platform for
managing documents, we have a huge pool of back-office staff supporting the
massive documentation required for such projects.

4.9.3 Biopharmax has exclusive software KOTEV based on web nest system platform
for Document Management, Server of which is located in house in our office.

4.9.4 It provided a Central repository and secure environment and immediate web-
based access to documents to authorized statement. If required, we can provide
secured access to our clients.

JBI Pharma | About Biopharmax 9

5. PROJECT DESCRIPTION
5.1 JBI Pharma (Hereinafter referred as ‘Client’) desires to retain Biopharmax as
Consultant who can assist them to set up a Greenfield Project for Sterile Injectable
Facility in India, primarily focusing on Cephalosporin Dry Powder Injectables &
General Injectable Products. Biopharmax will conduct market research and execute
the Techno-Commercial Feasibility Study. The study will be conducted for MENA
regions (including GCC Markets) - Key Markets (Annexure-I) only.

5.2 Biopharmax has the essential expertise to offer the scope of services which can help
the client to understand the opportunity through the analytical Approach and
services offered by Biopharmax.

5.3 The Feasibility Study Services specified in this document will be executed at
Biopharmax India, Pune office.

5.3.1 Project Name: Techno-Commercial Feasibility Study for Sterile Injectables

(Cephalosporin & General Category of Drugs)

5.3.2 Project Site Address: India.

6. ASSUMPTIONS
6.1 Owner’s Obligations
a. In order to enable Biopharmax to provide the services, Biopharmax has assumed that
CLIENT will fulfil the following obligations in such a way as to be compatible with
the agreed completion schedule.
b. Client will provide the following details in English Language.
• Project capital investment details- costs related to land, Plant construction cost
& Technology to be provided by Client.
• Machinery, & Utility shall be provided by Biopharmax.
• A Land lease payment schedule to be provided by Client.
• Capital structure – Debt to Equity to be provided by Client.

JBI Pharma | Project Description 10

 c. Biopharmax will execute the project, using Proprietary/ secondary date points only.
• Biopharmax Partners will use import/export data or sales data from public
domain wherever available.
7. SCOPE OF WORK: MARKET ASSESSMENT & PORTFOLIO IDENTIFICATION
7.1 Capacity estimation and Sales forecast
• Biopharmax will estimate plant capacity considering current exports to the
intended region. Based on publicly available information or paid sources limited
to EXIM database. Biopharmax will draw up the sales forecast based on market
potential.

7.2 Required Cost Calculation (Investment, Operating, Factor, and Input costs)
• Investment costs

➢ Based on the data provided by CLIENT, team will calculate the cost related
to Pre-operating expenses.
➢ Working capital – Addition to capital investment, certain costs which
includes material, utility costs which company will be made in initial years
before the operation will commence.
• Operating costs

This includes the day-to-day cost of production, outlay of funds for inputs,
services used in production, total costs include fixed, and variable costs.
➢ Fixed cost: One that does not change during production period -
examples: Fixed salaries, land taxes, principal and interest on loans,
insurance premiums, non-operational energy expenses, legal,
environmental cost etc.
➢ Variable cost: One that does change – raw material, operating energy,
water, etc.
➢ Other costs: Manpower; recurring cost related to engineering/ repair &
maintenance (plant, ETP, equipment, validation, and software); Selling
and Marketing costs, In-process quality control costs, other overheads,
etc.
• Factor and Input costs – duties and import controls for basic raw material,
solvent, packaging materials, etc.

JBI Pharma | Scope of Work: Market Assessment & Portfolio Identification 11

7.3 Manpower estimation
Biopharmax will provide an estimation of manpower along with its minimum
qualifications.

7.4 Financials Statements:

Team will provide Projected Income Statement, Projected Balance Sheet, and
Projected Cash-flow Statement for the project. All statements will be projected for
the next 8 years. This will contain-
• The Income Statement notes estimated sales, earnings on investments, salaries
and wages, payroll expenses, rent and utilities. This is important for planning,
including the company budget.
• The Balance Sheet lists specific account balances on a business' assets, liabilities,
and equity for a specified future time. A forecasting balance sheet is a useful tool
for business planning in general, and it particularly assists in arranging and
bringing in additional financing.
• The Cash-flow statement provides information about a company's gross receipts
and gross payments for a specified period. Will show the cash generated from
Operation and new investment activities and financial activities for the projected
period. Actual cash in hand generated from the project can be found here.

7.5 Feasibility analysis

The team will submit realistic estimates and reasonableness of the cost of the project
after considering all project’s relevant factors into account. The feasibility study
would include – Net Present Value (NPV), IRR, and Pay-Back period calculations.

7.6 Project report

The team will summarize the study outputs in the project report. The report will be
provided in PDF or PowerPoint format.

JBI Pharma | Scope of Work: Market Assessment & Portfolio Identification 12

 8. TIMELINES
8.1 The Techno-commercial Feasibility Study are expected to be completed in 8 to 9 weeks’
time from receipt of a confirmed letter of execution of the assignment along with receipt
of the Advance payment.
9. PRICING, TERMS & SCHEDULE
9.1 Techno-commercial Feasibility Study & Detailed Project Report

S/N DESCRIPTION TOTAL PRICE (₹)

1. Techno-Commercial Feasibility Study ₹ 18,50,000

9.2 Payment Terms

9.2.1 Payments will be made in US Dollars.

9.2.2 Payments shall be performed by wire transfer to an account designated by

Biopharmax.

9.2.3 Our offer is firm for a period of 30 days from the offer date.

9.2.4 The above offer is applicable for all disciplines taken together.

9.2.5 Payment shall be made within 5 working days from the date of Invoice receipt.

9.2.6 All taxes, duties & levies (prevailing & applicable in future) and bank charges as
applicable shall be borne by the Client.

9.3 Payment Schedule

9.3.1 50% of the amount shall be paid as non-refundable advance on signing of the
contract.

9.3.2 40% of the amount shall be paid against submission of the Initial draft report.

9.3.3 10% amount shall be paid on Final Submission of the Report.

9.4 Additional terms

JBI Pharma | Timelines 13

9.4.1 One set of hard copies of drawings will be submitted with a soft copy in A-CAD &
PDF.

9.4.2 The actual order and implementation of deliverables are subject to change, as
lessons are learned and agreed upon by both parties.

9.4.3 Biopharmax reserves the right to change the project pricing if circumstances arise
which require us to spend considerably more time than originally anticipated,
either because of change in the scope of our work or because of the difficulties
encountered in carrying out the work, we will discuss and agree on the fee
implications thereof as soon as possible in advance.

9.4.4 Documents shall be reviewed with comments in the 3 working days timeframe.
Documents/ Drawings /Deliverables will be assumed approved after 5 working
days if no comments are received from M/s Client.

9.4.5 Biopharmax Reserves the right to use Client/End User Logo, Project Details for its
Marketing, Advertising, Promotions as the reference of work done by
Biopharmax.

9.4.6 Clause for delay in Project completion.

a) In case of delays caused in total project timeline by 25% due to factors

attributable to the acts on the part of client, consultant reserves the right to
charge an extra premium of 20% of remaining project value. At the same
time if such delays occur from the consultants on account any issues related
to its performance or contractual obligation except in case of
events/incidences attracting provisions of ‘Force Majeure’ client can
demand the same quantum of compensation or as agreed mutually on case-
to-case basis in amicable manner.

9.4.7 Force Majeure

• Any delay in or failure of performance except as specified in this
document by either party shall be excused if and to the extent that same
has been caused by an event, incident or occurrence constituting Force
Majeure under the terms of Section 3 below.
• Each party shall not be entitled to avail itself of the provisions of Section
1 hereof and said provisions shall not apply to any event, occurrence or
incident constituting Force Majeure and affecting its performance unless
such party shall notify the other party in writing of the occurrence of such
event no later than five (5) working days from its occurrence, setting forth

JBI Pharma | Pricing, Terms & Schedule 14

 the estimated effect thereof on the performance of its obligations and
undertakings hereunder
• For the purpose hereof, "Force Majeure" shall mean any one or more of
the following events, occurrences and incidents directly creating any such
delay in or failure of performance:

• Floods, hurricanes and earthquakes and other natural disasters and

occurrences.

• General riots and strikes (not solely within a party's premises) and civil
disturbances.

• War, blockades, sabotage, war-like and terror actions, and general

mobilization of reserves.

• Epidemics and widespread diseases.

• Notwithstanding the above, it is agreed that no reason whatsoever,

including without limitation, any event, incident, or occurrence
constituting Force Majeure in terms of this Agreement shall serve as an
excuse for non-conformity of the Work to the provisions (except for
timetables) of this Agreement.

9.4.8 Indemnification.

a) In no event shall the Consultant be liable for any indirect, punitive,

incidental, special consequential damages whatsoever arising out of or
connected with the use or misuse of its services. The Consultant assumes no
responsibility for any special, incidental, indirect, or consequential damages
of any kind, or any damages whatsoever (including without limitation, those
resulting from its work product or from:

• User or the Client reliance on the materials or documents produced.

• Costs of replacement writings, training, or documents

• Loss of use, data, or profits

• Delays or business interruptions

• Any theory of liability arising out of or in connection with the use or

performance of the Consultant’s work whether or not the Consultant has
been advised of the possibility of such damages.

JBI Pharma | Pricing, Terms & Schedule 15

9.4.9 Liability

a) Except with respect to the parties’ indemnification obligations, neither

party shall be liable to the other for any special, indirect, incidental,
punitive, or consequential damages arising from or related to this
agreement, including bodily injury, death, loss of revenue, or profits or
other benefits, and claims by any third party, even if the parties have been
advised of the possibility of such damages. The foregoing limitation applies
to all causes of action in the aggregate, including without limitation breach
of contract, breach of warranty, negligence, strict liability, and other torts.

9.5 Change Management:

9.5.1 For major changes in the works after approval on drawings/ documents,
additional man-hour spent to redo the work shall be quoted separately.

9.5.2 Change control will be issued after two numbers of revisions &changes in Client
inputs.

9.5.3 In case of addition in deliverables and scope, Change Control will be issued.

9.5.4 Any revision or change of scope in the Project will be undertaken only after
written confirmation of the change order from the Client.

9.6 Service Extension / Termination

9.6.1 In case the Design services are to be discontinued due to unforeseen site
situations, Client shall give 15 days prior intimation to Biopharmax. Client shall
pay the full amount of completed work plus 20% PO value or Balance amount
whichever is lesser.

9.6.2 If there is a need for extension/amendment of Design services, the PO shall be

amended before the expiration of the PO period.

9.7 Jurisdiction & Dispute Resolution

9.7.1 All disputes and differences of any kind whatsoever arising out of this agreement
shall be referred to the Arbitrator.

9.7.2 The aggrieved party, the owner, or the consultant shall give notice in writing to
the other party. Such written notice shall specify the matters which are in dispute

JBI Pharma | Pricing, Terms & Schedule 16

 and such dispute or difference, of which such written notice has been given, will
be referred to the Arbitrator.

9.7.3 The Arbitrator will be a fellow of the Institution of Engineers (India). Both the
parties will discuss this beforehand and decide and identify a person to work as
the Arbitrator, whose decision will have to be accepted by both parties.

9.7.4 The Arbitrator will work as per the Indian Arbitration Act 1996 and any statutory
modifications and amendments thereof.

9.7.5 The venue of Arbitration shall be Pune, India.

9.7.6 The award of the Arbitrator shall be conclusive, final, and binding on both parties.

JBI Pharma | Pricing, Terms & Schedule 17

10. ANNEXURE-I: REGION – KEY MARKETS
10.1 Oman

10.2 Bahrain

10.3 Egypt

10.4 Saudi Arabia

10.5 Kuwait

10.6 Qatar

10.7 UAE

JBI Pharma | Annexure-I: Region – Key Markets 18