Document:

Exhibit 10.1

 

MANUFACTURING SERVICES AGREEMENT

 

This Manufacturing Services
Agreement (this “Agreement”) is made and entered into this 12th day of August 2016 (the “Effective
Date”) by and between Propanc Health Group Corporation, having its office at 555 Riversdale Road, Camberwell, Victoria,
3124, Australia (“COMPANY”) and Q-Biologicals NV, having its office at Technologiepark 4, 9052 Zwijnaarde,
Belgium, RPR Gent 840.165.203 (“Q-BIOLOGICALS”).

 

Q-BIOLOGICALS and COMPANY
being collectively referred to below as the “Parties” and individually as a “Party.”

 

Whereas, Q-BIOLOGICALS
is a contract manufacturing organization with premises at Technologiepark 4, 9052 Ghent Belgium;

 

Whereas, COMPANY is a research
and development organization with premises at level 2, 555 Riversdale Road, Camberwell, Victoria, 3124, Australia.

 

Whereas, COMPANY desires
to engage Q-BIOLOGICALS to provide, and Q-BIOLOGICALS desires to provide to COMPANY, under the terms and conditions set forth herein,
the Services (as defined in Section 1.1) for the Products (as defined in Section 1.1);

 

NOW, THEREFORE, in consideration
of the foregoing, and the mutual covenants contained herein, COMPANY and Q-BIOLOGICALS, intending to be legally bound, hereby agree
as follows:

 

Article
1

OBJECT OF THE AGREEMENT

 

1.1           COMPANY
appoints Q-BIOLOGICALS, who accepts, to perform the cGMP contract manufacturing services described in Annex 1 hereto
(the “Services”) with respect to the enzymes trypsinogen and chymotrypsinogen. When used in this Agreement (or
in the Quality Assurance Agreement, as defined below), “Products” shall mean, as the context may require, (i) purified
trypsinogen and chymotrypsinogen (“Drug Substance”), or (ii) the formulated and/or filled/finished product containing
trypsinogen or chymotrypsinogen (“Drug Product”), or (iii) both the Drug Substance and Drug Product, as further described
in detail in Annex 1.

 

1.2           Q-BIOLOGICALS
shall carry out the Services in good faith and with the standards of care and diligence currently applied in the biopharmaceutical
industry. Q-BIOLOGICALS shall perform the Services in accordance with (i) the cGMP terms and conditions more amply described in
the Quality Assurance Agreement attached in Annex 2 to this Agreement (the “Quality Assurance Agreement”),
(ii) the applicable laws and regulations of the country where the Facility (as defined in Section 1.3) is located, any all other
laws applicable to the performance of the Services and Q-BIOLOGICALS’s obligations under this Agreement or the Quality Assurance
Agreement (collectively, “Laws”); (iii) Q-BIOLOGICALS’s standard operating procedures agreed between the
Parties through the signing of the batch records by Parties’ respective quality persons; and (iv) the Product specifications
set forth in Annex 3 hereto (the “Specifications”). “cGMP” as used herein shall
mean current Good Manufacturing Practices as defined in the EU Directive 2003/94/EC, as implemented (if any) into local law, including
any and all future amendments thereto.

 

     

     

    

 

1.3           Q-BIOLOGICALS
shall perform the Services at its premises at Technologiepark 4, Ghent, Belgium (the “Facility”), except for
that part of the Services which shall be performed by Authorized Subcontractors (as defined in Section 3.3).

 

1.4           Q-BIOLOGICALS
shall use commercially reasonable efforts to perform the Services within the timelines set forth in Annex 1 hereto.
Q-BIOLOGICALS shall inform COMPANY promptly if at any time during the Term (as defined in Section 8.1) Q-BIOLOGICALS is unable
to comply with said timelines. Unless in the case of negligence or willful misconduct of Q-BIOLOGICALS or any of its Personnel,
Q-BIOLGICALS shall not be liable towards COMPANY for not meeting said timelines. As used in this Agreement, “Personnel”
shall mean, with respect to a Party, the agents, employees, contractors or subcontractors engaged or appointed by such Party.

 

1.5           Q-BIOLOGICALS
shall obtain and maintain such approvals, permits and licenses as may be required by any regulatory authority of the jurisdiction
where the Facility is located or any applicable Law, for the Services or the manufacturing at the Facility of the Products for
clinical development.

 

1.6           Q-BIOLOGICALS
shall maintain, during the Term and for a period of five (5) years after the relevant batch release, true, accurate and complete
books, records, reports and accounts in connection with or relative to the Product and the performance of the Services, as set
forth in the Quality Assurance Agreement.

 

1.7           Q-BIOLOGICALS
shall maintain the Facility in good working order and within cGMPs (e.g., qualification, calibration, maintenance, validation),
including critical systems (e.g., utilities, HVAC, clean steam, compressed gasses, etc.).

 

1.8           COMPANY’s
contact person at Q-BIOLOGICALS shall be Martine Vandermarliere (the “Project Manager”). Q-BIOLOGICALS shall notify
COMPANY promptly in writing of a change (if any) in Project Manager. The Parties shall regularly organize face-to-face meetings
and/or calls to discuss the progress of the Services. Each Party will bear its own costs in relation to such meetings and/or calls.

 

1.9           COMPANY
shall have the right to use the Products manufactured under this Agreement for development purposes, including for clinical trial
purposes. COMPANY shall not have the right to use the Products manufactured under this Agreement for commercialization relating
to human use, unless explicitly agreed in writing in advance by Q-BIOLOGICALS.

 

1.10         Q-BIOLOGICALS
will use commercially reasonable efforts to cooperate with COMPANY and its successors, licensees or sublicensees with respect to
obtaining all regulatory approvals relating to the Products. Q-BIOLOGICALS will provide COMPANY with such manufacturing information
and quality control documents as set forth in the Quality Assurance Agreement. Notwithstanding anything to the contrary in this
Section, all CMC information that relates solely to the Products will be owned exclusively by, and will be the exclusive proprietary
information of COMPANY.

 

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Article
2

INFORMATION AND MATERIALS

 

2.1           COMPANY
shall provide Q-BIOLOGICALS with the information and assistance described in Annex 1 hereto, and such other information
and assistance as the Parties may agree in writing from time to time.

 

2.2           Within
two (2) weeks from Q-BIOLOGICALS’s request, COMPANY shall provide Q-BIOLOGICALS, free of charge and at COMPANY’s transportation
risk, with the materials described in Annex 1 hereto and in the quantities (if any) stated in that paragraph, which Q-BIOLOGICALS
shall use to perform the Services (hereafter the “Materials”). Q-BIOLOGICALS shall promptly notify COMPANY in
writing of obvious defects in the Materials delivered by COMPANY or on behalf of COMPANY hereunder discovered by Q-BIOLOGICALS
upon receipt of the Materials. As soon as practicable after receipt of said notice COMPANY shall provide Q-BIOLOGICALS with replacement
Materials at its own cost and Q-BIOLOGICALS shall promptly return said defective Materials to COMPANY at COMPANY’s expense
or, at Company’s election, destroy them.

 

2.3           Q-BIOLOGICALS
shall not use the information and Materials referred to in Articles 2.1 and 2.2 hereof received from COMPANY for any purpose other
than performing the Services hereunder. Said information and Materials shall at all times remain the property of COMPANY.

 

2.4           Q-BIOLOGICALS
shall not be liable for any loss or damage to COMPANY Materials while in storage at the Facility, except if such loss or damage
is caused by the willful misconduct or gross negligence of Q-BIOLOGICALS or its Personnel.

 

2.5           Q-BIOLOGICALS
shall not be liable for any Defective Product (as defined in Section 5.3) or for any Product not complying with the manufacturing
standards set forth in Article 1.2 to the extent such Defect or non-compliance results solely from defective COMPANY Materials.

 

2.6           COMPANY
acknowledges that on the Effective Date there are no lawsuits, actions, administrative proceedings against COMPANY for infringing
third party patent and/or intellectual property rights. COMPANY further acknowledges that on the Effective Date it is not aware
of any third party patent rights that would be infringed by COMPANY, or Q-BIOLOGICALS relating to the information or Materials
provided by COMPANY, or by Q-BIOLOGICALS performing the Service in accordance with this Agreement.

 

Article
3

ASSIGNMENT - SUBCONTRACTING

 

3.1           Q-BIOLOGICALS
shall not transfer, assign or subcontract this Agreement or any of its rights and obligations under this Agreement, in whole or
in part, without the prior written agreement of COMPANY, which shall not be unreasonably withheld; provided, however, in
the event of a contemplated transfer or assignment of this Agreement or of any of Q-BIOLOGICALS’ rights and obligations under
this Agreement to an acquirer of all or part of the business to which this Agreement relates,
COMPANY shall only be entitled to refuse its agreement if the aforementioned transfer or assignment manifestly conflicts with the
legitimate interests of COMPANY or otherwise will have a material negative impact on the quality of the Product.

 

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3.2           Contrary
to the provisions of Article 3.1 hereof but subject to the provisions of Section 3.3, it is agreed that Q-BIOLOGICALS may sub-contract
certain Services to the subcontractors approved by COMPANY listed in Annex 4 hereto.

 

3.3           Any
subcontractor to which Q-BIOLOGICALS subcontracts any Services pursuant to Section 3.1 (with the consent of COMPANY) or pursuant
to Section 3.2 is referred to as an “Authorized Subcontractor.” Where required under cGMP Q-BIOLOGICALS shall
audit the Authorized Subcontractor and Q-BIOLOGICALS will impose on each Authorized Subcontractor obligations no less strict than
the ones binding upon Q-BIOLOGICALS under this Agreement, and Q-BIOLOGICALS will remain liable to COMPANY for any breach by such
Authorized Subcontractor, as if such breach had been committed by Q-BIOLOGICALS.

 

Article
4

CONSIDERATION

 

4.1           In
consideration of the performance of the Services and of the associated tasks defined herein, COMPANY shall pay Q-BIOLOGICALS the
fixed price (exclusive of VAT) set out in Annex 1 hereto. Q-BIOLOGICALS will provide COMPANY with invoices at the
intervals specified in said Annex 1.

 

4.2           COMPANY
shall reimburse Q-BIOLOGICALS for the raw materials and supplies in the quantities as defined in the batch records, as well as
for the other costs set out in Annex 1 hereto. Reimbursement of costs shall be subject of separate invoices, which
shall be accompanied by supporting documents and which shall be sent to COMPANY on a regular basis during the Term.

 

4.3           COMPANY
shall pay the invoices in Euro within thirty (30) days from receipt by COMPANY of a written invoice from Q-BIOLOGICALS, specifying
the amount payable and the bank account number to which the payment should be made. The invoice shall be sent to COMPANY at the
address and the to the attention of the person referred to in Article 12 or to any other address or person that may be communicated
by COMPANY to Q-BIOLOGICALS. Any invoice due which remains unpaid by COMPANY after the due date shall bear an interest on a daily
basis at a rate equivalent to Libor one (1) month plus two percent (2%).

 

Article
5

STORAGE AND DELIVERY

 

5.1           Q-BIOLOGICALS
shall store and warehouse all Materials received and Products manufactured pursuant to this Agreement in the Facility in a secure
and clean area and compliant with Q-BIOLOGICALS’s Standard Operating Procedures. All Materials and Products shall be clearly
marked in such a way as to identify that they are owned by COMPANY and for use only for or by COMPANY.

 

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5.2           Q-BIOLOGICALS
shall deliver the Products manufactured under this Agreement to COMPANY ex-works (lncoterms 2010) at Q-BIOLOGICALS’s Facility
in accordance with COMPANY’s directions (packaging, temperature, etc.). Said delivery shall either take place promptly upon
positive review by COMPANY of the manufacturing batch records provided by Q-BIOLOGICALS to COMPANY or upon request of COMPANY after
storage of the Products at Q-BIOLOGICALS. Q-BIOLOGICALS shall store the Products at Q-BIOLOGICALS’s Facility in qualified
storage freezers, free of charge for a maximum period of six (6) weeks after receipt of the completed manufacturing batch records
by COMPANY. After this six (6) weeks period, Q-BIOLOGICALS will store the Products at a storage price of five hundred Euro (500
€) per month for a maximum period of six (6) months.

 

The costs related to the
storage shall be paid by COMPANY thirty (30) days from the date of the invoice for such costs. After said six (6) month period,
Q-BIOLOGICALS will ship the Products to COMPANY or designated site at COMPANY’s expense. Risk and title to the Products shall
pass to COMPANY upon delivery of the Products.

 

5.3           (a)
COMPANY shall notify Q-BIOLOGICALS in writing (and provide supporting documentation and samples of the delivery concerned to Q-BIOLOGICALS)
if it considers that any Products delivered hereunder is subject to a Defect (a “Defective Product”), in which
case the Parties shall immediately use good faith efforts to agree whether or not such Products are Defective Products. As used
in this Agreement, “Defect” means the failure of any Product to conform in any material respect to (i) the Specifications
or (ii) any other requirement (including manufacturing requirements) for such Product specified in this Agreement (including, without
limitation, Section 1.2) or the Quality Assurance Agreement.

 

Any such notification by
COMPANY to Q-BIOLOGICALS shall be done, in case of visible Defect(s) (i.e. Defect(s) that could reasonably be detected upon proper
visual inspection), within thirty (30) days from the date of receipt of the relevant shipment or, in case of hidden Defect(s) (i.e.
defect(s) that could not be reasonably detected upon proper visual inspection), within thirty (30) days from the date of detection
of the hidden Defect(s). Failure by COMPANY to notify Q-BIOLOGICALS in writing within said timelines will constitute acceptance
of the Products by COMPANY and Q-BIOLOGICALS shall be released from any liability towards COMPANY in relation to such Products

 

Q-BIOLOGICALS shall be
entitled at all reasonable times to inspect and/or analyze the Product delivery in question.

 

Q-BIOLOGICALS shall only
be responsible for Defects that existed on or prior to delivery to COMPANY. Q-BIOLOGICALS shall in no way be responsible for Defects
caused after the delivery thereof (such as, non-compliance that is caused by the incorrect handling, storage and/or shipment of
the Products after the delivery). Q-BIOLOGICALS shall not be responsible for any Defect in the Products to the extent such Defect
(i) results from any non-compliance of or defect in the COMPANY Materials, consumables, raw materials and/or components delivered
by COMPANY to Q-BIOLOGICALS, except to the extent Q-BIOLOGICALS was aware of such defect or non-compliance and failed to advise
COMPANY in accordance with this Agreement.

 

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(b)          In
the event that the Parties cannot agree as to whether any Product is a Defective Product, the Parties shall appoint an independent
laboratory agreed upon between the Parties, who shall be instructed to determine within sixty (60) days from its appointment whether
such Products are Defective Products and what the cause of such Defect is. The independent laboratory’s decision shall be
regarded as final settlement of the dispute and its decision shall be binding upon the Parties. The costs of such laboratory shall
be borne by the Party against which the decision is rendered.

 

(c)          If,
at the time of delivery, any Products are Defective Products, Q-BIOLOGICALS will deliver replacement Products, or multiple replacement
deliveries until said Defect is resolved, of the Products to COMPANY as soon as practicable at Q-BIOLOGICALS’s own cost,
contingent upon receipt from COMPANY of the COMPANY Materials, at COMPANY’s costs (except in the event the Defect results
from Q-BIOLOGICALS’s gross negligence, in which case Q-BIOLOGICALS will bear the costs of the COMPANY Materials required
for such replacement), in such quantities needed for the replacement of the Products. COMPANY shall promptly return to Q-BIOLOGICALS
such Defective Products at Q-BIOLOGICALS’s expense.

 

Except for Q-BIOLOGICALS’s
indemnification obligations pursuant to Article 9.2.1, any replacement of Products to which Q-BIOLOGICALS is obligated in accordance
with the above, shall constitute Q-BIOLOGICALS’s sole and exclusive liability in relation to such Defective Products. Except
for Q-BIOLOGICALS’s indemnification obligations pursuant to Article 9.2.1, the liability of Q-BIOLOGICALS to COMPANY in connection
with any Defective Product shall not exceed the cost of replacement thereof (such replacement costs including shipping expenses
of the Defective Products referred to above [and excluding any and all costs related to COMPANY Materials]), except for liability
arising from gross negligence or willful misconduct of Q-BIOLOGICALS or its Personnel.

 

(d)          If
any Defect is due to a change in the Products after delivery, Q-BIOLOGICALS will deliver a replacement delivery of the Products
to COMPANY as soon as practicable at COMPANY’s cost and COMPANY shall, at its discretion either keep or promptly return such
Defective Products to Q-BIOLOGICALS at COMPANY’s expense.

 

(e)          If
any Defect is due to a hidden defect in the COMPANY Materials, consumables, components and raw materials provided by COMPANY, Q-BIOLOGICALS
will deliver a replacement delivery of the Defective Products to COMPANY as soon as practicable at COMPANY’s cost and COMPANY
shall at its discretion either keep or promptly return such Defective Products to Q-BIOLOGICALS at COMPANY’s expense. COMPANY
will be entitled to keep the retain samples of said Defective Products.

 

Article
6

CONFIDENTIALITY

 

6.1          From
time to time during the Term, either Party (as the “Disclosing Party”)
may disclose or make available to the other Party (as the “Receiving Party”)
information about its business affairs, products (including the Products) and services, confidential information and materials
comprising or relating to intellectual property rights, trade secrets, third-party confidential information and other sensitive
or proprietary information. Such information, as well as the terms of this Agreement, whether orally or in written, electronic
or other form or media, and whether or not marked, designated or otherwise identified as “confidential” constitutes
“Confidential Information” hereunder. Confidential Information does
not include information that, at the time of disclosure and as established by documentary evidence:

 

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(a)          was
known by or in the possession of the Receiving Party or its Personnel prior to being disclosed by or on behalf of the Disclosing
Party;

 

(b)          is
or comes into the public domain other than as a result of, directly or indirectly, the Receiving Party’s breach of this Article
6;

 

(c)          is
or becomes available to the Receiving Party on a non-confidential basis from a third-party source, provided that such third party
is not and was not prohibited from disclosing such Confidential Information;

 

(d)          was
or is independently developed by the Receiving Party without reference to or use of, in whole or in part, any of the Disclosing
Party's Confidential Information; or

 

(e)          is
required to be disclosed by law, court order of a competent jurisdiction or regulation, provided the Receiving Party, to the extent
permitted by law or regulation, consults with the Disclosing Party regarding the contents of such disclosure prior thereto so that
the Disclosing Party may have a reasonable opportunity to take appropriate actions (if any) to preserve its rights in the Confidential
Information and to restrict to the maximum extent legally possible the portion of Confidential Information to be disclosed.

 

6.2          During
and after the Term, the Receiving Party shall (a) protect and safeguard the confidentiality of the Disclosing Party’s Confidential
Information with at least the same degree of care as the Receiving Party would protect its own Confidential Information, but in
no event with less than a commercially reasonable degree of care; (b) not use the Disclosing Party’s Confidential Information,
or permit it to be accessed or used, for any purpose other than to exercise its rights or perform its obligations under this Agreement;
and (c) not disclose any such Confidential Information to any Person, except to the Receiving Party’s Personnel who need
to know the Confidential Information to assist the Receiving Party, or act on its behalf, to exercise its rights or perform its
obligations under this Agreement. The Receiving Party shall be responsible for any breach of this Article 6 caused by any
of its Personnel.

 

6.3          Upon
termination of this Agreement, each Party shall destroy all of the other Party’s Confidential Information which it has in
its possession or under its control and provide written proof thereof upon request or, if so requested by the other Party, return
the other Party’s Confidential Information.

 

Article
7

INTELLECTUAL PROPERTY

 

7.1          Rights
to Background Technology.

 

Any and all technology,
including but not limited to protocols, methods, procedures, know-how and software, but excluding the Products, COMPANY Material
and COMPANY Technology which are owned by COMPANY, together with any improvements thereof made by Q-Biologicals in the conduct
of the Services (hereafter “Q-BIOLOGICALS Technology”) and any and all biological material and related information,
related to the expression, purification, production and analysis of proteins which will be used by Q-BIOLOGICALS in executing the
Services, including any parts or sub-units, descendants, progeny, mutants, mutations or any other derivatives thereof (hereafter
“Q-BIOLOGICALS Materials”) shall exclusively be owned by Q-BIOLOGICALS, who shall have the right to protect
any such Q-BIOLOGICALS Technology and/or Q-BIOLOGICALS Material through intellectual property rights.

 

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Nothing in this Agreement
grants to COMPANY any rights to Q-BIOLOGICALS Technology, Q-BIOLOGICALS Material or Q-BIOLOGICALS Confidential Information, nor
does this Agreement grant COMPANY licenses to any patent or patent application comprising Q-BIOLOGICALS Technology, Q-BIOLOGICALS
Material or Q-BIOLOGICALS Confidential Information except as provided for in this Agreement.

 

Any and all biological
material and related information, active and raw materials, reagents, intermediates, processing aids, ingredients, components,
equipment, documentation and other materials delivered or made available by COMPANY to Q-BIOLOGICALS, including any parts or sub-units,
descendants, progeny, mutants, mutations or any other derivatives thereof; together with any improvements thereof made by Q-BIOLOGICALS
in the conduct of the Services (hereafter “COMPANY Materials”) and any and all technology and information relating
to the Product, owned or licensed by COMPANY that may be disclosed by COMPANY or its Affiliates to Q-BIOLOGICALS prior to or during
performance by Q-BIOLOGICALS of the development activities hereunder (“COMPANY Technology”) shall exclusively
be owned by COMPANY, who has the right to protect any such COMPANY Technology and/or COMPANY Material through intellectual property
rights.

 

Nothing in this Agreement
grants to Q-BIOLOGICALS any rights to the Products, COMPANY Technology, COMPANY Material or COMPANY Confidential Information, nor
does this Agreement grant Q-BIOLOGICALS licenses to any patent or patent application comprising COMPANY Technology, COMPANY Material
or COMPANY Confidential Information except as provided for in this Agreement.

 

7.2          Disclosure
of Improvements.

 

Q-BIOLOGICALS shall promptly
upon completion of the Services, disclose in the reporting of the activities all new or improved process, technique, method, formula,
invention or know-how concerning the Product (hereafter “Product Improvements”) and all new or improved generic
process, strain, expression cassette, plasmid, technique, method, formula, invention or know-how other than Product Improvements.
(hereafter “Technological Improvements”) conceived by Q-BIOLOGICALS or of which it has become aware during the
performance of the activities under the Services.

 

7.3          Property
of Product Improvements.

 

Product Improvements made
either solely by Q-BIOLOGICALS or together with COMPANY during the performance of this Agreement shall be the exclusive property
of COMPANY and COMPANY shall be free to seek patent protection as it deems appropriate and to use the same without restriction
throughout the world including the right to grant sub-licenses. Q-BIOLOGICALS shall ensure the transfer of rights as necessary
free of charge.

 

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All intellectual property
rights in Product Improvements made solely by COMPANY during the performance of this Agreement shall remain the property of COMPANY
and shall only be used by Q-BIOLOGICALS for the sole purpose of performing Services under this Agreement and in accordance with
the terms hereof.

 

7.4          Property
of Technological Improvements.

 

All intellectual property
rights in Technological Improvements made either solely by Q-BIOLOGICALS or together with COMPANY in the performance of this Agreement
shall be the exclusive property of Q-BIOLOGICALS and Q-BIOLOGICALS shall be free to seek patent protection it deems appropriate
and, to use the same without restriction throughout the world, including the right to grant licenses thereto. COMPANY shall ensure
the transfer of rights as necessary free of charge.

 

7.5          COMPANY
herewith grants Q-BIOLOGICALS the right to use the COMPANY Materials, COMPANY Technology and Product Improvements solely for the
performance of the Services during the terms of this Agreement.

 

Article
8

TERM AND TERMINATION

 

8.1          The
Agreement shall remain in effect for a term (the “Term”) commencing as of the Effective Date and, unless terminated
earlier in accordance with the provisions of this Agreement, continuing for three years (or such extended date as may be agreed
in writing by the Parties from time to time).

 

8.2          COMPANY
shall have the right to terminate this Agreement at any time for any reason with six (6) weeks prior written notice to Q-BIOLOGICALS.
This right of termination shall be without prejudice to any obligation COMPANY shall have accrued and shall owe to Q-BIOLOGICALS
prior thereto and it being understood between the Parties that the 40% pre-payment (as set out in Annex 1) paid by COMPANY to Q-BIOLOGICALS
after signing this Manufacturing Services Agreement is non-refundable in the case of a termination pursuant to this Section 8.2
(but not in the case of a termination by COMPANY pursuant to Section 8.3.

 

8.3          Each
Party shall have the right to terminate this Agreement forthwith by written notice to the other Party if the other Party commits
a material breach of this Agreement, provided the terminating Party gave the other Party notice of the breach which has not been
cured within a period of thirty (30) days after receipt of the notice.

 

8.4         Upon
any termination or expiration of this Agreement:

 

8.4.1           The
following Articles of this Agreement shall continue in force: 6, 7, 8.4, and 9 to 12.

 

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8.4.2           Q-BIOLOGICALS
shall deliver promptly to COMPANY (and/or, at COMPANY’s request, store at Q-BIOLOGICALS’s premises for up to six (6)
weeks) and COMPANY shall compensate Q-BIOLOGICALS for (a) all work-in-progress commenced by Q-BIOLOGICALS up to such point in time
(including for the avoidance of doubt all documentation, batch records); (b) all finished Products manufactured by Q-BIOLOGICALS,
and (c) all consumables, raw materials and components (i) received by Q-BIOLOGICALS for the purposes of this Agreement prior to
termination or (ii) ordered by Q-BIOLOGICALS for the purposes of this Agreement prior to its delivery or receipt of notice of termination
but not received until after termination, if such order is not cancellable.

 

Article
9

REPRESENTATION AND WARRANTIES, LIABILITY,

INDEMNIFICATION AND INSURANCE

 

9.1         Representations
and Warranties.

 

9.1.1           Except
for the representations and warranties explicitly granted by Q-BIOLOGICALS or COMPANY in this Agreement, Q-BIOLOGICALS AND COMPANY
MAKE NO OTHER WARRANTIES OR REPRESENTATION OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY
OR FITNESS FOR ANY PARTICULAR PURPOSE, OR ANY OTHER MATTER WITH RESPECT TO THE PRODUCT.

 

9.1.2           Each
Party hereby represents and warrants to the other Party as follows:

 

(a)          Organization.
It is a duly organized and validly existing corporation, as applicable, in good standing under the laws of its jurisdiction.

 

(b)          Authorization.
It has full power and authority to enter into this Agreement and to perform its obligations hereunder. It has taken all action
required by any applicable law, its organizational documents or otherwise to authorize the execution and delivery of this Agreement.
This Agreement constitutes a valid and binding agreement of the representing Party, and the execution, delivery and performance
of this Agreement by the representing Party are within the representing Party’s corporate or institutional power, as applicable,
and have been duly authorized by all necessary corporate or institutional action, as applicable.

 

9.1.3           Q-BIOLOGICALS
represents and warrants to COMPANY that on the Effective Date there are no lawsuits, actions, administrative proceedings against
Q-BIOLOGICALS for infringing third party patent and/or intellectual property rights.

 

9.2         Liability
and Indemnification.

 

9.2.1           Subject
to the limitations and exclusions of liability set forth in this Agreement, Q-BIOLOGICALS shall indemnify, defend and hold COMPANY,
and their affiliates and their respective officers, directors, employees and agents (each, an “COMPANY Indemnified Party”)
harmless from and against any and all claims, demands or lawsuits instituted by a third party against a COMPANY Indemnified Party
to the extent arising out of (1) a material breach of this Agreement caused by, or the negligence or willful misconduct of, Q-BIOLOGICALS
or its Personnel (including Authorized Subcontractors); (2) the material breach by Q-BIOLOGICALS of its representations, warranties
or covenants contained in this Agreement; or (3) Q–BIOLOGICAL’s background intellectual property (including, without
limitation, Q-BIOLOGICAL Materials and Q-BIOLOGICAL Technology) used for the performance of the Services infringing any third party
intellectual property rights; in each case save for any event for which COMPANY is obligated to indemnify Q-BIOLOGICALS under this
Agreement.

 

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9.2.2           Subject
to the limitations and exclusions of liability set forth in this Agreement, COMPANY shall indemnify, defend and hold Q-BIOLOGICALS
and its affiliates and its respective officers, directors, employees and agents (each, a “Q-BIOLOGICALS Indemnified Party”)
harmless from and against any and all claims, demands or lawsuits instituted by a third party against a Q-BIOLOGICALS Indemnified
Party to the extent arising out of (1) a material breach of this Agreement caused by, or the negligence or willful misconduct
of, COMPANY or its Personnel; (2) the material breach by COMPANY of its representations, warranties or covenants contained in this
Agreement; (3) COMPANY’s use (including, but not limited to, in clinical trials) of the Product(s) that are subject of the
Services; or (4) the use of COMPANY’s Background Intellectual Property, including but not limited to COMPANY Materials, by
Q-BIOLOGICALS infringing any third party intellectual property rights; in each case save for any event for which Q-BIOLOGICALS
is obligated to indemnify COMPANY under this Agreement.

 

9.2.3           If
and to the extent the injury or liability is caused by the negligence of both Q-BIOLOGICALS and the COMPANY, the apportionment
of said damages shall be shared between Q-BIOLOGICALS and COMPANY based upon the comparative degree of each other’s negligence,
and each Party shall be responsible for its own defense and costs including but not limited to the cost of defense, attorneys’
fees and witnesses’ fees and expenses incident thereto.

 

9.2.4           Notwithstanding
any other provision in this Agreement and except for Q-BIOLOGICALS’s indemnification obligation set forth in Article 9.2.1,
Q-BIOLOGICALS’s maximum liability under or in relation to this Agreement towards COMPANY and its affiliates shall be limited
to the aggregate amount of payments received by Q-BIOLOGICALS from COMPANY pursuant to Article 4 hereof during the period of twelve
(12) month preceding the event giving rise to the claim. For the avoidance of any doubt, multiple replacement deliveries to resolve
the same non-compliance matter shall be counted as one replacement delivery. This limitation of liability shall not apply for claims
arising from Q-BIOLOGICALS’s willful misconduct or gross negligence. Parties agree that product liability in respect of the
Products shall remain at all times with COMPANY and Q-BIOLOGICALS shall have no liability towards COMPANY in relation to and shall
have no obligation to indemnify or hold COMPANY harmless for any product liability arising for Products manufactured by Q-BIOLOGICALS
under this Agreement, except to the extent caused by the gross negligence or willful misconduct of Q-BIOLOGICALS or its Personnel.

 

9.2.5           Except
to the extent included in third party claims referred to under Articles 9.2.1 and 9.2.2, neither Party nor its affiliates, employees,
agents, officers, and directors will be liable to the other Party for any incidental, special, consequential or punitive damages
or amounts for loss of income, profits or savings arising out of or relating to its performance or failure to perform under this
Agreement, regardless of the basis on which a Party is entitled to claim damages, whether in contract or tort.

 

    11 

     

    

 

9.2.6           Nothing
in this Agreement shall limit either Party’s liability for (1) fraud or intentional misconduct, (2) any claim relating to
a breach of confidentiality; and (3) any other liability which cannot lawfully be limited or excluded.

 

9.3         Insurance.

 

9.3.1           Both
Parties shall throughout the Term maintain at their own cost insurance to cover their respective liabilities hereunder. Each Party
shall upon request of the other Party provide such Party with such documentary evidence of said insurance as the other Party may
reasonably require, including evidence that the last premium due has been duly paid. 

 

Article
10

INDEPENDENT CONTRACTOR

 

Q-BIOLOGICALS shall act
at all times as an independent contractor hereunder. Nothing in this Agreement shall be construed as to give Q-BIOLOGICALS the
power of authority to act for, bind or commit COMPANY.

 

Article
11

APPLICABLE LAW, JURISDICTION

 

This Agreement shall be
construed and interpreted in accordance with the laws of Belgium. Any dispute concerning the validity, the interpretation or the
performance of this Agreement which cannot be settled amicably, shall be submitted to the competent courts of Brussels (Belgium).

 

Article
12

MISCELLANEOUS

 

12.1         Schedules.
The Annexes attached to this Agreement form an integral part of this Agreement. In the event of a contradiction between the provisions
of this Agreement and those of its Annexes, the provisions of this Agreement shall prevail.

 

12.2         Waiver.
No waiver of any rights shall be effective unless consented to in writing by the Party to be charged and the waiver of any breach
of default shall not constitute a waiver of any other right hereunder or any subsequent breach or default.

 

12.3         Compliance
with Laws. In exercising their rights under this Agreement, the Parties shall fully comply in all material aspects with the
requirements of any and all applicable laws, regulations, rules and orders of any governmental body having jurisdiction over the
exercise of rights under this Agreement. Each Party shall be responsible, at its own expense, for making any required registrations
or filings with respect to this Agreement and obtaining any necessary governmental approvals with respect hereto.

 

    12 

     

    

 

12.4         Entire
Agreement; Amendment. This Agreement and the Quality Assurance Agreement constitute the entire Agreement between the Parties
with respect to the subject matter hereof and supersede and cancel all previous discussions, agreements, commitments and writings
in respect, provided, however, that the Confidentiality Agreement dated December 15, 2015 by and between COMPANY and Q-BIOLOGICALS
remains in full force and effect. No amendment or addition to this Agreement shall be effective unless reduced to writing and executed
by the authorized representatives of the Parties.

 

12.5         Force
Majeure. Neither Party shall be held in breach of its obligations hereunder to the extent only that due performance or observance
of such obligation is prevented or delayed by reason of war and other hostilities, civil commotion, accident, strikes, lock-outs,
trade disputes, acts or restraints of government imposition or restrictions of imports or exports or any other cause not within
the control of the Party concerned. The Party concerned shall forthwith notify the other Party of the nature and effect of such
event and both Parties shall, where the same is practicable, use every reasonable endeavour to minimize such effect and to comply
with the respective obligation herein contained as nearly as may be in their original form.

 

12.6         Assignment.
Q-BIOLOGICALS may not assign this Agreement or any part of its rights or obligations under this Agreement without the prior written
consent of COMPANY. COMPANY may assign this Agreement as part of a sale or change of control, regardless of whether such a sale
or change of control occurs through an asset sale, stock sale, merger or other combination, or any other transfer of (a) COMPANY’s
entire business; or (b) that part of COMPANY’s business that exercises all rights granted under this Agreement. Upon a permitted
assignment of this Agreement, COMPANY shall be released of liability under this Agreement and the term “COMPANY”
in this Agreement will mean the assignee.

 

12.7         Severability.
In the event one or more of the provisions of this Agreement should for any reason be held by any court or authority having jurisdiction
over this Agreement or any of the Parties hereto be invalid, illegal or unenforceable, such provision(s) shall be validly reformed
to as nearly approximate the intent of the Parties as possible and if unreformable, the Parties shall meet to discuss what steps
should be taken to remedy the situation; elsewhere, this Agreement shall not be affected.

 

12.8         Notices.
Except as otherwise explicitly provided in this Agreement, all notices, requests, reports and other communications provided in
this Agreement shall be in writing and shall be deemed to have been made or given: (a) when delivered, if delivered by hand; (b)
when confirmation of transmission received, if sent by facsimile or the like; (c) two (2) days following deposit with an overnight
courier; or (d) on the date three (3) business days following deposit, as certified or registered mail, with the postal service
of the country of the Party providing notice:

 

	To COMPANY:
	
        Propanc Health Group Corporation

        Attn: James Nathanielsz

        555 Riversdale Road

        Camberwell, Victoria, 3124

        Australia

 

    13 

     

    

 

	To Q-BIOLOGICALS:
	 
	
        Dr. Annie Van Broekhoven

        CEO

        Q-Biologicals NV

        Technologiepark 4

        9052 Zwijnaarde

        Belgium

        Tel. +32 475 96 60 70

 

The above addresses may
be altered by notice given in accordance with this section.

 

12.9       Headings.
The headings of the various provisions of this Agreement are used solely for the convenience of the Parties, do not form a part
of this Agreement and are not intended to affect the interpretation or meaning of this Agreement or to define, limit, extend or
describe its scope or intent.

 

Remainder of page left
intentionally blank

 

    14 

     

    

 

IN WITNESS WHEREOF,
the Parties have caused this Agreement to be executed in duplicate by their duly authorized representatives; each Party receiving
one original.

 

	Q-BIOLOGICALS	 
	 	 
	/s/ Annie Van Broekhoven	 
	Signature	 
	 	 
	By:	
        CreaBioSupport BVBA

        represented by Annie Van Broekhoven
	 
	 
	Title:	CEO	 
	Date:	22/08/2016	 

 

	Q-BIOLOGICALS	 
	 	 
	 	 
	Signature	 

 

	By:	
        Karine Clauwaert

        On behalf of Yves Gonnissen
	 
	 
	Title:	Director Business Development Q-Biologicals	 
	Date:	22/08/2016	 

 

	Propanc Health Group Corporation	 
	 	 
	/s/ James Nathanielsz	 
	Signature	 

 

	By:	James Nathanielsz	 
	Title:	CEO	 
	Date:	August 12th, 2016	 

 

    15Exhibit 10.2

 

QUALITY ASSURANCE AGREEMENT

 

This Quality Assurance
Agreement (“QA Agreement”) is made and entered into this 12th day of August 2016 (the “Effective
Date”) by and between Propanc Health Group Corporation, having its office at 555 Riversdale Road, Camberwell, Victoria, 3124,
Australia (“COMPANY”) and Q-Biologicals NV, having its office at Technologiepark 4, 9052 Zwijnaarde, Belgium,
RPR Gent 840.165.203 (“Q-BIOLOGICALS”). Q-BIOLOGICALS and COMPANY being collectively referred to below as the
“Parties” and individually as a “Party.”

 

Whereas, COMPANY and Q-BIOLOGICALS
have entered into a Manufacturing Services Agreement (the “Manufacturing Services Agreement”) on August 12th,
2016 for the manufacturing of the Products (as defined in the Manufacturing Services Agreement).

 

Whereas, by means of this
QA Agreement, the Parties intend to define the respective responsibilities of Q-BIOLOGICALS and COMPANY at the quality level for
manufacturing and testing of the Products.

 

1.            Purpose
of the Quality Assurance Agreement 

 

1.1           All
capitalized terms in this QA Agreement shall have the same meaning as in the Manufacturing Services Agreement, unless otherwise
explicitly stated herein.

 

1.2           The
purpose of this QA Agreement is to establish the respective obligations and responsibilities of Q-BIOLOGICALS and COMPANY relating
to the manufacturing and testing of Products under the Manufacturing Services Agreement.

 

1.3           cGMPs
or current Good Manufacturing Practices shall mean the applicable standards relating to manufacturing practices for intermediates,
bulk products or finished pharmaceutical products. For the purposes of this Agreement, cGMPs refers to Eudralex The Rules Governing
Medicinal Products in the European Community, Volume IV Good Manufacturing Practice for Medicinal Products” as may be amended
from time to time.

 

1.4           This
QA Agreement shall be attached to and incorporated in the Manufacturing Services Agreement. In the event of a conflict between
any of the provisions of this QA Agreement and the Manufacturing Services Agreement, the provisions of the QA Agreement shall prevail
in respect of specific quality matters, for all other matters the Manufacturing Services Agreement shall prevail.

 

2.            Procedures
for revision 

 

This QA Agreement can be
modified as needed, with prior written approval of both Parties. This QA Agreement must be modified if any term fails to meet future
revisions of applicable regulations and guidelines.

 

     

     

    

 

3.            Term
of the QA Agreement 

 

3.1           This
QA Agreement shall commence as of the Effective Date of the Manufacturing Services Agreement and shall terminate or expire upon
the termination or expiration of the Manufacturing Services Agreement.

 

3.2           Q-BIOLOGICALS’s
obligations for record and sample retention shall survive termination or expiration of this QA Agreement for the period provided
in the relevant provisions of this QA Agreement.

 

4.            Regulatory
Submissions 

 

4.1           COMPANY
will be responsible for the submission of documentation to regulatory authorities in support of the Products.

 

4.2           COMPANY
and Q-BIOLOGICALS will mutually agree upon responses, which Q-BIOLOGICALS will make, to questions and/or requests of regulatory
authorities regarding production processes and Product testing relevant to COMPANY.

 

4.3           Q-BIOLOGICALS
will cooperate with COMPANY in support of all regulatory filings involving Products including participation in meetings with regulatory
authorities as appropriate. The cost related to such support will be carried by COMPANY.

 

5.            Regulatory
Audit Exchange 

 

5.1           Q-BIOLOGICALS
shall inform COMPANY in writing within five (5) business days of notification of any communication or action (e.g. Facility inspection,
record or sample request, etc.) initiated by a regulatory authority directly related to the Facility or manufacturing and quality
control operations which may impact on the Products.

 

Q-BIOLOGICALS shall provide
COMPANY with a copy of any regulatory inspection report, deficiency letter, or regulatory compliance observation arising from the
foregoing inspection excluding any Confidential Information, within ten (10) calendar days of receipt.

 

If as a result of any such
inspection, Q-BIOLOGICALS is required to take any corrective action in order to comply with any applicable Law, Q-BIOLOGICALS shall
inform COMPANY in writing of any such action it has taken in response to such requirement.

 

5.2           COMPANY
will inform Q-BIOLOGICALS in a timely fashion when regulatory agencies are seeking to schedule inspections concerning the Products
at Q-BIOLOGICALS’s Facility.

 

COMPANY will be permitted
two representatives during the opening, closing and daily wrap up portions of the inspection at Q-BIOLOGICALS’s Facility.

 

5.3           Q-BIOLOGICALS’s
communication and commitments with regulatory inspectors will be limited to matters outside of COMPANY’s regulatory submissions,
and COMPANY will be informed of all such communication and commitments that could impact COMPANY’s regulatory submissions.
COMPANY and Q-BIOLOGICALS will mutually agree upon responses, which COMPANY will make, to the questions and requests of a regulatory
authority regarding production processes and Product testing. COMPANY will determine and make all other responses to regulatory
authorities.

 

     

     

    

 

6.            Audits

 

6.1           COMPANY
or a person or firm acting on behalf of COMPANY has the right to perform one audit of Q-BIOLOGICALS Facility, laboratories and
warehouses each year for the purposes of verification Q-BIOLOGICALS compliance with cGMPs and Q-BIOLOGICALS SOPs related to the
manufacturing and testing of the Products. The audit will be limited to 2 business days to occur on mutually agreed dates.

 

6.2           COMPANY
or a person or firm acting on behalf of COMPANY may also perform an annual audit of each Q-BIOLOGICALS Authorized Subcontractors
involved in the manufacture, testing and validation of the Products, providing that COMPANY provides Q-BIOLOGICALS with prior written
notification of its intent to audit. Q-BIOLOGICALS will provide commercially reasonable efforts to facilitate the scheduling and
execution of COMPANY’s audits of subcontractors.

 

6.3           In
addition to the annual compliance audit, COMPANY or a person or firm acting on behalf of COMPANY may also audit Q-BIOLOGICALS and
its Authorized Subcontractors in the event of failure or recall of a Product lot.

 

6.4           At
the conclusion of each audit, COMPANY or a person or firm acting on behalf of COMPANY will hold a wrap up meeting with Q-BIOLOGICALS
and/or its Authorized Subcontractors to review all significant audit observations.

 

6.5           Within
30 days of each audit it performs at Q-BIOLOGICALS and its Authorized Subcontractors, COMPANY will provide Q-BIOLOGICALS with a
written report of its observations and recommendations. Within 30 days of receipt of COMPANY’s audit report, Q-BIOLOGICALS
and/or its subcontractors will provide a written response to COMPANY including a response to all COMPANY observations.

 

6.6           In
the event that COMPANY finds any contractual or regulatory deficiencies during such audit, Q-BIOLOGICALS shall take a course of
action and resolution acceptable to COMPANY in accordance with a time-plan which shall be agreed upon between COMPANY and Q-BIOLOGICALS.

 

7.            Documentation

 

7.1           Q-BIOLOGICALS
is responsible for generating and maintaining records of equipment usage, cleaning and maintenance.

 

     

     

    

 

7.2           Q-BIOLOGICALS
shall draw up the manufacturing and quality control documents according to its own format. Upon COMPANY’s written request,
Q-BIOLOGICALS will send these manufacturing and quality control documents to COMPANY for approval and sign off prior to production
of the Products. Q-BIOLOGICALS shall use a documentation system for the Products which contains information about the phases of
manufacture to the degree that enables COMPANY an assessment for compliance with the registration files.

 

7.3           Q-BIOLOGICALS
will provide COMPANY with copies of documents used in the manufacturing process and testing of the Products upon request.

 

7.4           Q-BIOLOGICALS
will provide COMPANY with copies of the completed batch records and overview of associated deviation reports, test reports, Certificate
of Analysis and Confirmation of Compliance created for each batch of Product produced by Q-BIOLOGICALS.

 

7.5           Changes
to documentation will be implemented according to Section 12 of this QA Agreement.

 

7.6           Q-BIOLOGICALS
is responsible for maintaining Product batch production and testing records for a period of minimum ten (10) years. Written authorization
from COMPANY is required prior to the movement or destruction of Product records. If Q-BIOLOGICALS is no longer willing or able
to store Product records, COMPANY may have the records destroyed, or transferred to an alternate storage location at COMPANY’s
expense.

 

8.            Manufacture
and Testing 

 

8.1           Q-BIOLOGICALS
will perform manufacture and testing of the Products in the Facility.

 

8.2           COMPANY
is authorized to have one (1) representative present at the Facility during Product manufacture and testing. Additional COMPANY
representatives may be permitted if agreed beforehand by Q BIOLOGICALS.

 

8.3           Q-BIOLOGICALS
is responsible for installation, qualification, calibration, and maintenance of equipment, instruments and Facility utilized in
the manufacture and release testing of the Products.

 

8.4           Prior
to the start of the production of the Products, the assigned production rooms and relevant equipment will be changed over with
proper cleaning and documented when changing from one product to another. Rooms and equipment changeover shall be reviewed and
released by Q-BIOLOGICALS’s quality unit prior to the start of the production.

 

8.5           All
manufacturing operations shall be performed according to the manufacturing documents and the procedures set forth in the Manufacturing
Services Agreement and this QA Agreement.

 

8.6           Q-BIOLOGICALS
is responsible for control and monitoring of the Product manufacturing process and production rooms.

 

8.7           Q-BIOLOGICALS
is responsible for assigning and tracking unique identifier numbers to each lot of raw material, component, product intermediate
and Product. From this information Q-BIOLOGICALS will develop a trace tree for each lot of Product. Q-BIOLOGICALS will send to
COMPANY the trace tree for the Product lot.

 

     

     

    

 

8.8           Q-BIOLOGICALS
will utilize raw materials, products and packaging articles according to its own internal specifications and procedure. Q-BIOLOGICALS
will establish and maintain a BSE/TSE assessment for all relevant materials.

 

8.9           Q-BIOLOGICALS
is responsible for ensuring that all raw materials purchased by Q-BIOLOGICALS and used in the manufacturing process are tested
according to Q-BIOLOGICALS’s approved specifications and the Specifications. Q-BIOLOGICALS is responsible for maintaining
critical raw materials retain samples according to the specifications.

 

8.10         The
dates of manufacture will be determined by, and documented in, the Batch Records Documents (BRD’s).

 

8.11         The
expiration date of the Products will be determined by COMPANY.

 

8.12         Q-BIOLOGICALS
will label the Products.

 

8.13         Q-BIOLOGICALS
will store the Products in a controlled area according to written COMPANY instructions and in compliance with cGMP.

 

Q-BIOLOGICALS shall be
responsible for establishment and maintenance of an environmental monitoring program to assure adherence to such specified storage
conditions.

 

8.14         Q-BIOLOGICALS
is responsible for retaining samples from each lot for testing in accordance with cGMP. Q-BIOLOGICALS shall retain sufficient samples
from each batch to allow retesting to be performed.

 

8.15         Q-BIOLOGICALS
will maintain these samples for each lot until the lot reaches its expiry date + 1 year. COMPANY will provide Q-BIOLOGICALS with
written instructions regarding the disposition of retention samples from expired lots. When Q-BIOLOGICALS is no longer willing
or able to store retention samples, COMPANY may have the samples destroyed, or transferred to an alternate storage location at
COMPANY’s expense.

 

8.16         Testing
of the Products performed by Q-BIOLOGICALS will be done in accordance with test methods approved by COMPANY using calibrated equipment.

 

8.17         Test
results must be evaluated against the specifications as stated in the Product monograph drafted by Q-BIOLOGICALS.

 

8.18         Test
records must be written to enable full reconstruction of the testing performed.

 

9.            Shipment

 

9.1           Q-BIOLOGICALS
will ship the Products to COMPANY in accordance with the Manufacturing Services Agreement and according to written COMPANY instructions.

 

     

     

    

 

9.2           Q-BIOLOGICALS
will not ship Products to any destination until written approval has been received from COMPANY.

 

9.3           All
units of Product will be accounted for prior to shipping.

 

9.4           The
documentation of the shipping amounts will be forwarded to COMPANY.

 

10.          Subcontracting

 

10.1         Q-BIOLOGICALS
agrees not to subcontract any of the manufacturing, packaging, labeling, inspection, testing and/or handling of Products to a third
party unless permitted under, and done in accordance with, the terms of the Manufacturing Services Agreement.

 

11.         PRODUCT
Release 

 

11.1         COMPANY
and Q-BIOLOGICALS will each identify a Quality Assurance (QA) representative who will function as the points of contact between
the PARTIES for the purposes of communication regarding Product release and regulatory compliance activities.

 

11.2         COMPANY
and Q-BIOLOGICALS will mutually agree upon testing specifications for the Products. The PARTIES will mutually agree in writing
to all changes to such specifications prior to implementation.

 

11.3         Q-BIOLOGICALS
is responsible for reviewing Product lot records, test results performed by Q-BIOLOGICALS and corresponding specifications and
determining whether or not the Product complies with Specifications.

 

11.4         Q-BIOLOGICALS
will issue a Certificate of Analysis and Confirmation of Compliance to COMPANY. The Certificate of Analysis will contain a summary
of the Product test results performed by or for Q-BIOLOGICALS, specifications, date of manufacture, date of expiry and lot size.
The Confirmation of Compliance will contain a statement signed by Q-BIOLOGICALS’s Qualified Person stating that the lot has
been manufactured and tested by Q-BIOLOGICALS in compliance with cGMP and Q-BIOLOGICALS SOP’s and the Product Specifications
set forth in the Product specification file; any revision of the Product specification file that has an impact on the Product Specifications
shall require Q-BIOLOGICAL’s prior written consent.

 

11.5         Q-BIOLOGICALS
will provide per Product lot at least the following documents to the COMPANY:

 

		·	the Certificate of Analysis

		·	the Confirmation of Compliance

		·	Lot/Batch genealogy

		·	a copy of the completed production records and overview associated investigation/deviation reports

		·	environmental monitoring data during filling

 

     

     

    

 

		·	copies of all laboratory data including raw data and overview associated laboratory investigation
reports (OOS).

 

11.6         COMPANY
will make reasonable efforts to inspect each lot within sixty (60) days of receipt of the Certificate of Analysis, Confirmation
of Compliance and requested documents.

 

12.         Change
Control 

 

12.1         All
changes by COMPANY to previously approved documents, to equipment used in the manufacturing process of the Product, to Product
Specifications and test methods used, or other contractual requirements must be mutually approved by COMPANY and Q-BIOLOGICALS
in writing prior to implementation.

 

12.2         Q-BIOLOGICALS
will inform COMPANY in writing within 10 working days of any major changes to its Facility.

 

12.3         Q-BIOLOGICALS
will inform COMPANY within 10 working days in writing of any major changes in quality systems.

 

12.4         Q-BIOLOGICALS
hereby declares that no major change to the production process, test methods, protocols and/or equipment with potential impact
on the Products will be made without prior written authorization of COMPANY.

 

13.         Validation

 

13.1         Q-BIOLOGICALS
will inform COMPANY about the validation status of the equipment used in the manufacturing or testing of the Products. Q-BIOLOGICALS
will ensure that the validation of the equipment is performed as agreed. Q-BIOLOGICALS will provide COMPANY with equipment validation
certificates upon request.

 

13.2         The
validation of the manufacturing process, test methods will be performed upon request of COMPANY and must be executed according
protocols approved prior to execution by COMPANY. Q-BIOLOGICALS will provide COMPANY with copies of process manufacturing and test
methods validation certificates upon request.

 

14.         Investigations

 

14.1         Q-BIOLOGICALS
will notify COMPANY of all excursions, deviations, observations and investigations which could impact past, current or future lots
of the Products.

 

COMPANY would like to be
notified of major deviations within 24 hours of discovery or as soon as is practically possible if corrective actions can prevent
a batch failure.

 

14.2         Q-BIOLOGICALS
will notify COMPANY of all Product testing failures within 2 business days, and prior to initiating retesting.

 

14.3         All
investigations concerning the Products and conducted at Q-BIOLOGICALS will be reviewed and approved by Q-BIOLOGICALS and provided
to COMPANY.

 

     

     

    

 

14.4         All
deviations, including but not limited to non-compliances and non-conformities, will be thoroughly investigated by Q-BIOLOGICALS
and, if applicable, corrective actions to prevent reoccurrence of the deviations will be suggested. Corrections to repair any deviation
will only be made after notification to COMPANY and after written approval by COMPANY.

 

Major deviations during
manufacturing and/or quality control will be reported by telephone and/or by e-mail to COMPANY within 24 hours of discovery or
as soon as is practically possible.

 

15.         Dispute
Resolution 

 

Disputes concerning the
acceptability of Product lots or general compliance issues will be resolved by the Quality Assurance representatives of the Parties.
If the dispute is not resolved after 30 days, either Party may upon written notification to the other request that the dispute
be resolved according to the provisions of the Manufacturing Services Agreement.

 

16.         Assignment
of the QA Agreement 

 

Q-BIOLOGICALS shall not
assign any rights and/or responsibilities given by this QA Agreement to a third party without prior written consent of the COMPANY
except according to the provisions of the Manufacturing Services Agreement.

 

17.         List
of people to contact 

 

	For COMPANY:	 
	
        Propanc Health Group Corporation

        Attn:  James Nathanielsz

        555 Riversdale Road

        Camberwell, Victoria, 3124

        Australia
	 
	 	 
	For Q-BIOLOGICALS:	 
	 	 
	
        CEO

        Dr. Annie Van Broekhoven

        Tel. +32 9/241 1103

        Email: annie.vanbroekhoven@q-biologicals.be
	 
	 	 
	
        Qualified Person

        Marijke Verhaeghe

        Tel. +32 9/241 1102

        Email: marijke.verhaeghe@q-biologics.be
	 

 

     

     

    

 

	Q-BIOLOGICALS	 	Propanc Health Group Corporation
	 	 	 
	By:	/s/ Marijke Verhaeghe	 	By:	/s/ James Nathanielsz
	 	 	 
	Name:	Marijke Verhaeghe	 	Name:	James Nathanielsz
	 	 	 
	Title:	Qualified Person	 	Title:	CEO
	 	 	 
	Date:	22 Aug 16	 	Date:	23 Aug, 2016

 

	Q-BIOLOGICALS	 
	 	 
	By:	/s/ Tanja Vandeputte	 
	 	 
	Name:	Tanja Vandeputte	 
	 	 
	Title:	QA Manager	 
	 	 
	Date:	22 Aug 16

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