Abarceo Pharma

Proposal for Discovery services

(Chemistry FTEs)

Document: Version 4
Date: 27 April 2022
FTE Proposal for Discovery Chemistry services

Presented to:
William Dalby Brown
Head of Medicinal Chemistry and Screening
Medeon Science Park
Per Albin Hanssons väg 41
205 12 Malmö, Sweden
william.brown@abarceo.com

Presented by:
Pujitha Reddy Kamineni
Aurigene Pharmaceutical Services Limited (APSL)
pujithar@aurigeneservices.com

© Aurigene Pharmaceutical Services Limited.

Company Profile

• Global provider of pharmaceutical development and manufacturing services, led

by entrepreneurial team with international experience

• Fully integrated technology platforms from discovery to commercial phase

• Independent business affiliated to Dr Reddy’s Laboratories, with strong financial

support and access to world-class facilities

• Focus on accelerating pharmaceutical development and market access for

innovative products, enhancing value for patients

• Strong track record of developing and launching pharmaceutical products in

multiple regions

• Combined offering for drug substance and drug product supplies from lab to
commercial scale, providing significant supply chain and economic efficiencies

• High-level of Compliance, Quality and Integrity, and commitment to sustainable

and long-term partnerships

© Aurigene Pharmaceutical Services Limited.

Business Model and Value Proposition

Lifecycle Management
Drug discovery Clinical supplies Commercial Launch
- Support market
•FTE-based •Process development •Cost effective supply of expansions and demand
collaborations •Supply of drug drug substance (NCE) with flexible capacity
•Flexible fee for service substance (NCE) and drug product
- Cost optimization to
model •Supply of drug product •Regulatory track record ensure competitive
•Fully integrated (complex solid dose, and filing support product supply
services sterile injectables..) •Supply assurance
- QA/EHS/Regulatory
•Expertise in peptides •CMC / regulatory compliance

Aurigene provides a flexible and comprehensive range of services and capabilities for each phase
of the drug lifecycle, in order to address any requirement and challenges of our business partners

• Integrated services and resources enable a seamless and accelerated development from discovery to
commercial launch
• Chemical capabilities for supply from gram scale (including libraries generation) to multi-ton supplies
of active ingredients and complex intermediates
• Core areas of competence in challenging chemistry (peptides, carbohydrates, chiral molecules,
steroids…)
• Drug product capabilities cover multiple dosage forms, from formulation development to commercial
production in GMP facilities (FDA-inspected)

© Aurigene Pharmaceutical Services Limited.

Global Network

Mirfield (UK)
GMP chemical manufacturing
• Prostaglandins
• m-PEG derivatives (activated)
Network of strategic business partners
(regional)
• Development
• Contract manufacturing services
• Qualified as subcontractors for special
technologies and/or capabilities

Shreveport, La. Hyderabad (India)

(US) Drug discovery services
Drug product Research
manufacturing
• oral dosage forms, Process and analytical
• Non-sterile semi- development
solids and liquids
GMP manufacturing
• Carbohydrates
• Highly-potent drugs
Cuernavaca (Mexico) • NCEs and intermediates
GMP chemical manufacturing Bangalore (India)
• Steroids Drug discovery services Drug product development
• M-PEG alcohol • Peptides platform and manufacturing

Process development
Vizag (India)
GMP chemical manufacturing
• Oncology / Cytotoxic drugs
• Peptides
© Aurigene Pharmaceutical Services Limited. • Carbohydrates

Drug product manufacturing

• Oral dosage forms
• Sterile injectables
• Semi solids
© Aurigene Pharmaceutical Services Limited.
Overview of Contract Services - Discovery

Discovery team • Bangalore campus (100,000 sq. ft) and

SMEs led by chemistry/biology coordinator Hyderabad facilities (110,000 sq. ft)
• ~375 scientists across multiple
Medicinal chemistry ADME/PK
Biochemistry Pharmacology disciplines
Analytical chemistry Pharmaceutical development
Cell and molecular biology Safety/toxicology • Expertise in peptidic drugs
Protein sciences Process development

Medicinal chemistry and Bioassay development Drug metabolism/ Toxicology and

pharmaceutical Pharmacokinetics pharmacology
development • Target-selective assays (DMPK) evaluations
for multiple classes:
• Versatile technology Absorbance, • ADME studies • GLP/non-GLP studies
toolbox allowing even luminescence, • Optimization of PK • In-vitro and in-vivo tox
challenging chemistries fluorescence, profile studies: mutagenicity,
(photoredox catalysis, fluorescence resonance • Assessment of physico- models for CV/CNS
microwave reactions…) energy transfer FRET)… chemical and druggable risks, acute toxicity…
• Focused libraries • Cell-based assays to properties – • Impurity qualification
• Route scouting and measure compound permeability, solubility, • In-vivo pharmacology
optimization. Multi-gram effects bioavailability, stability models customized for
synthesis • Biomarkers identification • CYP-inhibition multiple therapeutic
• CMC activities and testing method • Chemical and metabolic areas
• Analytical development development for stability studies
• Formulation development (pre)clinical studies

Aurigene provides a fully integrated drug discovery platform and a flexible approach
for business partners: modular fee for service or collaborative program development

© Aurigene Pharmaceutical Services Limited.

Project Management and Operations

• Agile and entrepreneurial culture focused on service

and delivery

• Compliance with international quality and regulatory

standards

• Strict firewalls and procedures established to protect

partner data

• Expert teams in IP and patent screening to guarantee

freedom to operate with synthetic routes and
processes developed by Aurigene

• EHS metrics established to drive performance and

sustainability, with particular emphasis on employee
protection

• Digital platforms enabling regular exchange of

information with partners

• Integration of QbD and PAT in project management

• Continuous learning from evolving industry trends,

audits, CAPAs, partner recommendations

© Aurigene Pharmaceutical Services Limited.

 Commercial Proposal

Abarceo Pharma – Discovery Services

8
© Aurigene Pharmaceutical Services Limited.
 CONFIDENTIAL
Proposal Assumptions
Abarceo Pharma (Abarceo) has expressed potential interest in a collaboration (Chemistry FTE program and ADME/PK) with
Aurigene to support drug discovery activities.

Aurigene has expertise and a strong track record in drug discovery services, and confirmed interest to perform such activities for
Abarceo.

This proposal is intended to define the terms to be mutually agreed to initiate this collaboration.
Infrastructure Description – Discovery Facility

Aurigene shall provide full access to state-of-the-art laboratories, consumables and instrumentation as needed.
• Aurigene has 50 chemistry labs in the current infrastructure.
• The modular set-up of our chemistry labs includes the following instrumentation per lab (for information purpose)
o 5-10 fume-hoods with supply of chilled water, nitrogen, air and vacuum
o Stirring equipment and 2-4 rotary evaporators
o 1 oven and 3 high vacuum pumps
o Grids to fit flash columns in each fume hood
o Dedicated MPLC purification machine
• Aurigene DMPK facility has over 10,000 sq.ft. lab space with the following facilities and instrumentation
o in-vitro ADME & Tissue culture labs
o Bioanalytical labs (GLP & Non-GLP)
o Animal facility for in-vivo studies and Cell culture lab
o 10 LC-MS/MS: Sciex API (6500 Qtrap, 6500, 5500 Qtrap, 5500, 4000), Xevo TQS
o HPLCs/UFLCs (Waters, Dionex, Agilent & Shimadzu) with UV, PDA and fluorescence detector

Aurigene shall provide sufficient other personnel as necessary to perform all administrative and other non-scientific activities to support the
Services. This includes a Program Manager assigned for coordination and reporting.
Aurigene provides full access to an existing chemicals inventory (~45,000 chemicals) managed with a barcode identification system.

© Aurigene Pharmaceutical Services Limited.

 CONFIDENTIAL
Commercial Proposal

Description of Services Price/FTE/Per Annum Total Price Conditions

4 chemistry FTEs 63,000 USD plus

63,0000 USD plus
Trial period – 3 months Project Specific
chemicals
(16th May July to 15th August 2022) chemicals
4 FTEs 63,000 USD plus Extension of the collaboration to
189,000 USD plus
Extended collaboration period – 9 months Project Specific be confirmed with 30-day notice
chemicals
(16th September 2022 to 15th May 2023) chemicals before end of the trial period

• Abarceo and Aurigene may modify the number of FTEs involved in the collaboration by mutual agreement with a 30 day notice.

• KPIs and Productivity metrics (Appendix 3) shall be mutually agreed upon during the kick-off of the collaboration.

• Deliverables are defined in Appendix 2.

Other costs

Chiral separation costs Included in FTE Price, up to final product output of 25 mg scale.

Standard chemicals and reagents,

Included in FTE Price (Reference list is in Appendix 1).
Inhouse chemical inventory.
Specific reagents and chemicals NOT included - To be charged based on actuals

Project-specific columns NOT included -To be charged based on actuals

Shipping costs As defined in commercial terms and conditions

© Aurigene Pharmaceutical Services Limited.

 CONFIDENTIAL
Commercial Terms and Conditions
• Prices defined in the table under commercial proposal shall be considered firm and binding.

• Typical scale of synthesis is considered up to a standard of 25 mg of final compound and potentially some of the
key intermediates up to 1-5 gram quantity at purity of >95%. Abarceo and Aurigene shall discuss separately any
requirement for larger lab quantities (> 25 mg) of a specific compound to be synthesized, which may lead to a
fee-for-service arrangement or any other mutual agreement within the scope of services.

• Aurigene has a Chemical inventory system that has an inventory of about 45,000 chemicals. This inventory
system is managed with bar code for all 45,000 chemicals. This inventory system can be accessed as part the
FTE program.

• Aurigene shall provide upon request any documentation to support the invoicing of any additional costs (based
on actuals) to Aberceo, as defined above.

• Aberceo shall provide Aurigene the SOP ‘Instructions for use of laboratory notebooks’ and Aurigene shall
guarantee that all involved personnel observe and respect the guidelines of the SOP.

• Aberceo shall inform 2-3 weeks in advance about specific requirements to enable sufficient time to plan
resources and activities, and timely procurement of reagents, chemicals, and consumables, as necessary.

• Proposal assumes one shipment per week to Aberceo. Additional Shipments (if any) will be billed at actuals. Any
low temperature shipment is not included and would be charged additionally to Aberceo based on actuals.

• Sample shipments shall be managed by certified express carriers, in accordance with DAP Incoterms 2010.
Aurigene shall provide all necessary documentation for the shipment.

© Aurigene Pharmaceutical Services Limited.

 CONFIDENTIAL
Commercial Terms and Conditions
• Working hours: 5 days a week – 8 hrs a day. Each employee is entitled to declared holidays and leaves as per
the labor laws.

• Aurigene will allocate experienced chemists who can resolve chemistry challenges themselves (average
experience 6-8 years of industrial experience) and who have experience handling Biotech needs by being
flexible.

• Aurigene will allocate a senior project leader (PhD) with industrial experience who will be responsible for the
project delivery and real time communication as expected by Aberceo.

• Aurigene will aim to achieve a higher productivity and deliver the project goals as expected by Aberceo. In case
if needed Aurigene will make appropriate changes within the team to keep the productivity high.

• Payment terms: Invoicing is on a monthly basis (on the 5th day of the month) based on number of FTEs and
actual costs to be charged, as defined above. Payment is due 30 days after the date of invoice.

• Intellectual Property: All intellectual property generated during the collaboration will be exclusively transferred
to Abarceo, which will have sole ownership of such IP rights.

• Termination: Aberceo may terminate the Project with a written notice period of Sixty (60) days. Aberceo will
have an option to increase/ decrease the number of FTEs as desired, with at least a 30 days written notice to
Aurigene.

• Proposal is considered valid for 1 month.

© Aurigene Pharmaceutical Services Limited.

 CONFIDENTIAL
Commercial Terms and Conditions
• Working hours: 5 days a week – 8 hrs a day. Each employee is entitled to declared holidays and leaves as per
the labor laws.

• Aurigene will allocate experienced chemists who can resolve chemistry challenges themselves (average
experience 6-8 years of industrial experience) and who have experience handling Biotech needs by being
flexible.

• Aurigene will allocate a senior project leader (PhD) with industrial experience who will be responsible for the
project delivery and real time communication as expected by Aberceo.

• Aurigene will aim to achieve a higher productivity and deliver the project goals as expected by Aberceo. In case
if needed Aurigene will make appropriate changes within the team to keep the productivity high.

• Payment terms: Invoicing is on a monthly basis (on the 5th day of the month) based on number of FTEs and
actual costs to be charged, as defined above. Payment is due 30 days after the date of invoice.

• Intellectual Property: All intellectual property generated during the collaboration will be exclusively transferred
to Abarceo, which will have sole ownership of such IP rights.

• Termination: Aberceo may terminate the Project with a written notice period of Sixty (60) days. Aberceo will
have an option to increase/ decrease the number of FTEs as desired, with at least a 30 days written notice to
Aurigene.

• Proposal is considered valid for 1 month.

© Aurigene Pharmaceutical Services Limited.

 CONFIDENTIAL
Commercial Terms and Conditions – Based on Trade
Sanctions.

• In the event that trade sanctions decided by any international multilateral organisation as for example but not
exhaustive the United Nations, the European Union or similar organisation or by any state or states poses a risk
for a negative effect on the subject of this agreement or otherwise on Abarceo’s business, Abarceo shall be
entitled to terminate the agreement immediately. Abarceo shall not be liable for any damages or other
compensation to [the counterpart] in the event of such termination.
• Upon such termination [the counterpart] shall immediately refrain from commencing any new work for Abarceo
and wrap up any ongoing work by finish purifying what can be purified, write up any remaining experimental
work and ship any physical material which is stored by [the counterpart] no later than five days after termination.
• Abarceo’s liability for payment of any agreed compensation for work ordered or not yet finalized shall cease in
the event of such termination. This notwithstanding Abarceo shall compensate [the counterpart] for reasonable
costs for winding down ongoing work according to above, and for all costs outstanding or incurred since the last
billing according to the agreed contractual terms.
• In any circumstance, Aurigene shall provide the corresponding invoice within three working days after the
notification of termination by Abarceo, and Abarceo shall ensure the corresponding payment is made before the
application of effects of trade sanctions.

© Aurigene Pharmaceutical Services Limited.

Appendix 1 – List of Standard Lab Chemicals CONFIDENTIAL
GENERAL ORGANICS Specification CAS
GENERAL INORGANICS Specification CAS
Acetic acid glacial, 99.8% 64-19-7
Aluminium oxide 90, 70-230 mesh
Alumina, Neutral Acetone ≥99% 67-64-1
ASTM
Acetonitrile (LC/MS) LC-MS grade, ≥99.9% 75-05-8
Ammonia solution, 25% 28.0-30.0% as NH3 Acetonitrile 99%
Ammonium chloride ≥99.5% 12125-02-9 Chloroform ≥99% 67-66-3
ammonium hydroxide 1336-21-6 cyclohexane 110-82-7
Anti-bumping granules 1,2-dichloroethane ≥99.0%
Calcium chloride technical grade, −4-+30 mesh Dichloromethane Anhydrous, ≥99.5%
Celite 545 Dichloromethane ≥99.5%, 75-09-2
Activated Charcoal decolorizing agent Diethyl ether, AR ≥99.0%
Citric acid ≥99% 77-92-9 99 Diethyl ether anhydrous, ≥99.7%, 60-29-7
Cuprous chloride 97% Diisopropyl ether
Drierite, 8 mesh, no indicator without indicator, 8 mesh N',N-dimethylacetamide 127-19-5
hydrobromic acid 10035-10-6 N,N-Dimethylformamide anhydrous, 99.8% 68-12-2
Hydrochloric acid (sg 1.18) 37% 7647-01-0 N,N-Dimethylformamide ≥99.8%
lithium hydroxide ≥98% 1310-66-3 Dimethylsulfoxide ≥99.9% 67-68-5
Magnesium sulfate anhydrous, reagent grade, ≥97% 7487-88-9 Dimethylsulfoxide Anhydrous, ≥99.9%
1,4-dioxane ≥99.0%
molecular sieves
Ethanol anhydrous, ≥99.5% (200 proof) 64-17-5
Ninhydrin spray
Ethanol reagent grade, denatured
Nitric acid 70%
Ethyl acetate ≥99.5%, 141-78-6
Phosphomolybdic acid 95%
n-Heptane 99% 142-82-5
phosphoric acid 7664-38-2 hexanes 110-54-3
Phosphorus pentoxide ≥98.0%, powder 96-37-7
potassium acetate 127-08-2 96-14-0
potassium bicarbonate 298-14-6 107-83-5
Potassium carbonate 99% 584-08-7 99 isopropyl acetate 108-21-4
Potassium fluoride ≥99.0% Methanol Anhydrous, ≥99.8%
Methanol ≥99.5%, 67-56-1
Potassium hydroxide ≥90%, flakes 1310-58-3
Methanol (for LCMS) LC-MS grade, 99.9%
potassium phosphate tribasic 7778-53-2
Methyl tert-butyl ether 1634-04-4
potassium phosphate dibasic 04/11/7758 2-propanol ≥99% 67-63-5
potassium phosphate monobasic 7778-77-0 Tetrahydrofuran ≥99.9%, inhibitor-free, anhydrous
Sand −50-70 mesh particle size 14808-60-7 Tetrahydrofuran ≥99.0%, Inhibitor-free
Sieves, 3 angstrom pellets, 1.6 mm Toluene ≥99.5% 108-88-3
Sieves, 4 angstrom powder powder, activated, 5 μm Anisole 99%
Sieves, 4 angstrom pellets, 1.6 mm 1,2-dimethoxyethane anhydrous, 99.7%
Silica gel with moisture indicator Triethylamine ≥99% 121-44-8
(blue gel), dessicant ~1-3mm pyridine ≥99% 110-86-1
Silicone oil, high temp. (230 C) Silicone oil, high temp. (230 C)
sodium acetate 127-09-3
Sodium bicarbonate ≥99.5%, crystalline 144-55-8
Sodium carbonate ≥99.0% 497-19-8
Sodium chloride (AnalaR) ≥98%, 80 mesh particle size 7647-14-5
Sodium hydride, 60% in oil 60 % dispersion in mineral oil
Sodium hydroxide 97%, beads 1310-73-2
Sodium sulfate ≥99.0%, anhydrous, granular 7757-82-6
sodium sulfite 7757-83-7
Sodium thiosulphate.5H2O Pentahydrate, 99.5%
Sodium iodide ≥99%
solka floc
© Aurigenestandard glassware
Pharmaceutical Services Limited.
Sulfuric acid 95-98% 7664-93-9
Appendix 2 – Program Deliverables CONFIDENTIAL

• The format of reports shall be mutually agreed by the Program Managers upon kick-off and aligned with the requirements of Abarceo,
based on applicable SOPs.

• Weekly reporting shall be established to ensure seamless and transparent information to Abarceo, and monitoring of the progress.

• Weekly virtual meetings will be organized between Abarceo and Aurigene program teams (involving program manager and scientific
team members) to resolve issues, discuss any update, and define objectives and directions.

• Data transfer and storage shall be managed through Dotmatics/SharePoint - To be confirmed by Abarceo.

• All data, reports, information exchanged between Abarceo and Aurigene, shall be considered as strictly confidential, and managed
according to the applicable agreed confidentiality terms and obligations.

Deliverables Description Frequency Conditions

Description of experimental
Report To be agreed ACS format
procedures

Analytical reports Report To be agreed PDF format

Notebook pages Scanned documents To be agreed Scan copies (PDF)

Consolidated reports Report Monthly Available on 5th day after end of each month

Performance metrics (KPIs) Table / Report Monthly Format and metrics to be defined (Appendix 3)

Virtual meetings TCs, calls, … Weekly -

© Aurigene Pharmaceutical Services Limited.

Appendix 3 – KPIs and Productivity metrics CONFIDENTIAL
• Abarceo and Aurigene shall define relevant KPIs and metrics to monitor performance.

• The below table is an example of a standard for monthly performance indicators, which may be customized by mutual agreement.

JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC AVG
Total FTE’s
>1 g
Shipped 100 mg – 1g
Compounds
10 mg -100 mg

1-10 mg

Total No. of Compounds Shipped

Total Amount of Compounds

Shipped (gm)
Avg. amount of Compounds Shipped
(gm)

Compounds shipped/FTE

Avg. Synthesis Time in Days

Total No. of Steps completed

Avg. No. of Steps/FTE

Total No. of Reactions Performed

Avg. No. of Reactions/FTE

Reactions/Step
Accident
FTE Retention

© Aurigene Pharmaceutical Services Limited.

 Thank you for your interest

© Aurigene Pharmaceutical Services Limited.

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