1.

Definitions and Interpretation

2

2.

Term

6

3.

Agreement Structure

6

5.

Anti-Bribery and Corruption

8

6.

Modern Slavery

8

7.

Relationship of Parties

8

9.

Audit Rights

10

10.

Invoicing and Taxation

11

11.

Intellectual Property Rights

12

12.

Insurance

12

13.

Warranties

13

14.

Limits of Liability

14

15.

Indemnity

14

16

Termination

15

17

Consequences of Termination or Expiry

16

18

Force Majeure

17

19

Notice

17

20

Quality Technical Agreement and Safety Data Exchange Agreement

19

21

General

19

22

Dispute Resolution

21

24

Governing Law

21

1)

CLINIGEN HEALTHCARE LTD a company incorporated in England (registered number 06252720), whose registered office is at Pitcairn House, Crown Square, Centrum 100, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom (Clinigen):

2)

Eiger BioPharmaceuticals, Inc., a Delaware company with its principal place of business located at 350 Cambridge Avenue, Suite 350, Palo Alto, CA 94306, USA (Client),

A.

Clinigen has expertise in the provision and distribution of unlicensed pharmaceutical products and associated services prior to the grant of marketing authorisation and/or commercial launch in the country of supply, as permitted under applicable local laws and regulations.

B.

Clinigen is also in the business of procuring and supplying certain pharmaceutical products for use in clinical trials and investigator initiated studies and providing associated services thereto.

C.

Client wishes to engage Clinigen to provide certain pharmaceutical products and/or services, as described in the relevant Service Specific Terms and/or SOW/s.

1.

Definitions and Interpretation

1.1.

In this Agreement the following words have the following meanings:

1.2.

Headings to the Clauses of any Exhibits to this Agreement are for convenience only and shall not affect its construction or interpretation.

1.3.

References to Clauses are to the Clauses of these Conditions and references to Sections are to Sections of the Exhibits.

1.4.

The word “indemnify” in this Agreement will mean to indemnify, keep indemnified and hold harmless the indemnified party from and against all costs (including the cost of enforcement), expenses, liabilities (including any tax liability), injuries, damages, claims, demands, proceedings or legal costs (on a full indemnity basis) and judgements which the indemnified party incurs or suffers and “indemnity”, indemnities and “indemnifies” have a corresponding meaning.

1.5.

Any reference to “person” means a natural or legal person, firm or unincorporated association.

1.6.

The terms “including”, “include”, “in particular” or any similar expression shall be construed as illustrative and shall not limit the sense of the words preceding those terms.

1.7.

Words importing the singular the plural and vice versa.

2.

Term

2.1.

This Agreement will start on the Effective Date and will continue in force for the Term unless earlier terminated as provided herein.

2.2.

A SOW will start on the SOW Effective Date and will continue in force for the SOW Term unless earlier terminated as provided herein.

3.

Agreement Structure

3.1.

This Agreement and any SOW entered into between the Parties are set up in a framework structure to allow the Client and its Affiliates to order various Products and/or Services from Clinigen and/or its Affiliates, from time to time which will be documented in an SOW.

3.2.

Each SOW will constitute a separate agreement incorporating these Conditions and the relevant Service Specific Terms. Clinigen shall perform the Services in accordance with the applicable SOW, this Agreement and all applicable laws and regulations, and shall keep Client reasonable informed on the progress and results of the Services.

3.3.

In the event of a conflict between any provision of these Conditions, the Service Specific Terms and/or any provision of a SOW;

a)

the provisions of these Conditions shall take precedence over the Service Specific Terms; and

b)

the Service Specific Terms shall take precedence over the provision of the SOW, in the event of any inconsistencies.

4.

Confidentiality

4.1.

Subject to Clause 4.3 each Party agrees that, during the Term of this Agreement and for a period of ten (10) years after the date of expiration or termination of this Agreement for any reason whatsoever, neither Party shall in any fashion, form or manner, either directly or indirectly, divulge, disclose or communicate to any individual or entity or utilise for such Party’s own benefit or the benefit of any individual or entity in any manner whatsoever, any non-public information of any kind, nature or description disclosed by the other Party to such Party or obtained by such Party from the other Party under this Agreement, including such information concerning any matters affecting or relating to the business of the other Party of any kind, nature or description, which is by its nature confidential (regardless of whether the same has been marked “confidential”) and any information obtained or resulting from the conduct of any audit which many be conducted in accordance with the provisions of this Agreement except with the express written consent of the other Party or as otherwise provided in this Agreement. The information described above shall be hereinafter collectively referred to as Confidential Information. For the purposes of this Agreement, a party divulging, disclosing or communicating Confidential Information shall be referred to as the Disclosing Party and the party receiving Confidential Information shall be referred to as the Recipient. Client New IP shall be deemed Confidential Information of Client and Clinigen shall be deemed the Recipient of such information, notwithstanding the fact that such information may be generated and disclosed by Clinigen to Client.

4.2.

Notwithstanding any other provision of this Agreement, Confidential Information shall not include information that: (a) as shown by dated written or electronic records, the Recipient possessed prior to disclosure by the Disclosing Party free of any duty of confidence; (b) at the time of disclosure is or thereafter becomes known to or generally available to the public through no breach of this Agreement by the Recipient; (c) as shown by dated written or electronic records, is developed by the Recipient independent from any Confidential Information disclosed hereunder; (d) becomes available to the Recipient from a source, other than the Disclosing Party, which has represented to the Recipient (and which the Recipient has no reason to disbelieve after due inquiry and competent proof) that such source is not bound by a confidentiality agreement or any other obligation of confidentiality or fiduciary duty with the Disclosing Party; or (e) is explicitly, in writing, made exempt from the provisions of this Agreement by the Disclosing Party.

4.3.

Notwithstanding any other agreement or any other provision of this Agreement, the Recipient may disclose Confidential Information which is required to be disclosed by law, rule, regulation, administrative or legal process or is requested to be disclosed by any governmental agency, including to the extent required to provide the Services (Compelled Request); provided, however, that the Recipient gives prompt prior written notice (if permitted by law) of any Compelled Request to the Disclosing Party and agrees to limit the scope of disclosure to the extent permitted by law and takes commercially reasonable measures to co-operate with the Recipient, if the Recipient seeks to challenge the Compelled Request.

4.4.

Notwithstanding any other agreement or any other provision of this Agreement, the Parties may use and disclose Confidential Information to its Affiliates, employees, agents, subcontractors, professional advisers and auditors (or any of them) for the purposes of carrying out their respective obligations or exercising any of their respective rights under or in connection with under this Agreement and subject to each Party ensuring that the person in question complies with obligations of confidentiality no less onerous than those set out in this Clause 4.

4.5.

Each Party recognises that the damages at law to the other Party may be an insufficient remedy to the other Party in the event that a Party breaches the terms of this Clause 4, and in the event a Party breaches or threatens to breach this Clause 4, the other Party shall be entitled to seek, upon application to a court of competent jurisdiction, a preliminary restraining order and permanent and temporary injunctions restraining the other Party from breaching this Clause 4, in addition to damages or any other relief the court may find appropriate.

5.

Anti-Bribery and Corruption

5.1.

Each Party shall not, and shall procure that its respective directors, employees, agents, representatives, contractors or sub-contractors shall not, engage in any activity, practice or conduct which would constitute an offence under any anti-bribery and anti-corruption laws, regulations and codes in any jurisdiction, including but not limited to the Bribery Act 2010 and, where applicable, the Foreign Corrupt Practices Act 1977.

5.2.

Each Party shall have in place adequate procedures designed to prevent any person working for or engaged by that Party or any other Third Party in any way connected to this Agreement, any SOWs or Supply Orders, from engaging in any activity, practice or conduct which would infringe any anti-bribery and anti-corruption laws, regulations and codes in any jurisdiction, including but not limited to the Bribery Act 2010 and, where relevant, the Foreign Corrupt Practices Act 1977.

6.

Modern Slavery

6.1.

Clinigen shall and shall procure (where relevant) that all persons who are performing services or providing goods in connection with, or which will or may be used in performing or to support the performance of this Agreement or any SOW in any part of the world (collectively, its Supply Chain) shall at all relevant times:

a)

comply with the provisions of the Modern Slavery Act 2015 and ensure that all of its relevant staff have received appropriate training on the same:

b)

not engage in any activity, practice or conduct that would constitute an offence under the Modern Slavery Act 2015 if such activity, practice or conduct were carried out in the UK:

c)

take all reasonable steps to ensure that Slavery and Human Trafficking are not taking place in its business or its Supply Chain:

d)

immediately notify the Client if it has reason to believe that it or any person in its Supply Chain is engaged in Slavery and Human Trafficking or is in breach, or is likely to breach, the Modern Slavery Act 2015 or any provision of this Clause 6.1 (or would do so if it were a party to this Agreement), or if it receives a communication from any person alleging any of the foregoing.

7.

Relationship of Parties

7.1.

The Parties hereby agree and intend that the relationship of each to the other is that of independent contractors and that neither this Agreement nor any SOW or Supply Order shall be construed as an agreement of franchise, employment, partnership, joint venture or any other form of business entity. Neither Party shall exercise any direction or control over the methods by which the other Party (or such other Party’s personnel) shall perform their work and duties while performing the obligations hereunder. The Parties agree that neither shall have the power or right to bind the other, nor shall either hold itself out as having such authority, nor shall a Party pledge the other Party’s credit or extend credit to anyone in the other Party’s name.

8.

Data Protection

8.1.

The provision of the Services may require Clinigen to Process Personal Data for and on behalf of the Client from time to time, acting as a Data Processor. Where such Processing of Personal Data takes place in the EEA or the UK, or otherwise involves the Processing of Personal Data of citizens in the EEA or the UK, the Parties acknowledge and agree that Clinigen shall:

i)

process the Personal Data only on the documented instructions of the Client, except to the extent that any Processing of Personal Data is required by applicable laws to which Clinigen is subject;

ii)

notify the Client where Clinigen believes any documented instructions from the Client in respect of the Processing of Personal Data infringe any Data Protection Legislation or any other applicable laws to which Clinigen is subject;

iii)

ensure that its personnel who are authorised to Process the Personal Data have committed themselves to confidentiality;

iv)

taking into account the nature of the Processing, assist the Client by appropriate technical and organisational measures, insofar as this is possible, for the fulfilment of the Client's obligation to respond to requests for exercising the Data Subject's rights under the Data Protection Legislation;

v)

notify the Client without undue delay after becoming aware of any breach relating to the Personal Data;

vi)

assist the Client in its compliance with Clause 8.6 below, insofar as it is able taking into account the nature of the Processing and the information available to Clinigen;

vii)

at the Client's discretion, delete or return to the Client all of the Personal Data Processed under the applicable SOW at the end of the applicable SOW Term, and delete any copies of such Personal Data unless any applicable laws to which Clinigen is subject require that copies are kept; and

viii)

make available to the Client all information, and submit to such audits (in each case to the extent reasonably necessary) as are required to demonstrate compliance with its obligations in this Clause 8.1.

8.2.

Clinigen shall not sub-contract its Processing of Personal Data to a Third Party without the Client's prior specific or general written authorisation (not to be unreasonably withheld, conditioned or delayed). Clinigen shall inform the Client of any intended changes concerning the addition or replacement of any authorised sub-contractors, and the Client shall notify Clinigen of its approval or any objections it has to any such changes in writing within ten (10) Business Days, after which any such changes which the Client has not objected to in accordance with this Clause 8.2 shall be deemed to be accepted.

8.3.

Where Clinigen sub-contracts its Processing of Personal Data to a Third Party in accordance with Clause 8.2 above, Clinigen shall ensure that the Third Party has necessary qualification and authorization to Process such Personal Data and is engaged on terms equivalent to those set out in this Clause 8, and Clinigen shall remain liable to the Client for any Processing of Personal Data by any such Third Party.

8.4.

The Parties shall co-operate with any applicable regulator of the Data Protection Legislation on request in respect of the performance of its tasks under this Agreement and any SOW.

8.5.

The Parties shall each implement appropriate technical and organisational measures to ensure a level of security appropriate to the risk of Processing in accordance with Article 32 of the GDPR.

8.6.

To the extent required by the relevant Data Protection Legislation, Clinigen shall provide all reasonable assistance to the Client that is necessary to facilitate the Client’s compliance with:

a)

its breach notification requirements under the Data Protection Legislation; and

b)

its obligations relating to conducting privacy impact assessments and (where applicable) liaising with the relevant regulator in relation to the same.

9.

Audit Rights

9.1.

Clinigen shall create and maintain complete and accurate records of all Services performed, including any data and information generated from such Services. If the Client gives at least 20 (twenty) Business Days' written notice (or in the event of a suspected material breach by Clinigen of the terms of this Agreement or a relevant SOW/s on 5 (five) Business Days’ written notice), Clinigen will permit the Client or its representatives, no more than once in any

12 month period (excluding for cause audit) subject to Clause 9.2, access to the records maintained by Clinigen which specifically relate to the services provided, for the purposes of auditing, inspection or any other purpose required or permitted by applicable law, rule or regulation, at reasonable times during normal business hours provided always that Client undertakes to ensure that its representatives adhere to the confidentiality provisions contained in this Agreement.

9.2.

Notwithstanding Clause 9.1 above, Clinigen may take reasonable measures to restrict Client, or its representatives, access to and inspection and audit of Clinigen’s facilities in order to protect the confidentiality of Clinigen’s other clients and their products and processes and Clinigen’s books of accounts or financial records relating to its underlying costs.

9.3.

Within twenty (20) Business Days of conducting an inspection requested pursuant to Clause 9.1, Client will provide Clinigen with a summary of its findings from such inspection.

9.4.

Any information about Clinigen, Clinigen’s facilities or otherwise obtained by Client as a result of inspections conducted by or on behalf of Client pursuant to Clause 9.1 above shall be treated as treated as the Confidential Information of Clinigen and shall be subject to the confidentiality obligations in Clause 4.

10.

Invoicing and Taxation

10.1.

All amounts set out in a SOW (and any Charges) are stated exclusive of any Value Added Tax (VAT) or similar tax, which if applicable, shall be payable in addition to the sum in question at the rate in force under the relevant law.

10.2.

All customs duties, charges and/or taxes incurred by Clinigen in relation to Customer Order shipments which cannot be reclaimed by Clinigen or passed on to the relevant Customer will be charged by Clinigen to the Client and the Client will pay the same in accordance with the payment terms set out in this Clause 10.

10.3.

Unless otherwise set out in the SOW, Clinigen shall invoice the Client on a monthly basis in relation to each SOW for the Charges in the amounts and at the times due in accordance with that SOW. Such Charges shall be paid by the Client to Clinigen within 30 (thirty) days' from the date of such invoice (unless otherwise set out in the SOW) by transfer to such bank account as Clinigen may from time to time notify in writing to the Client.

10.4.

Each Party shall be entitled to set-off any outstanding Charges due to it against its payment due to the other Party under this Agreement.

10.5.

If a Party disputes any invoices (or any part thereof), that Party shall provide the other Party with written notice of such dispute within seven (7) days of receipt of such invoice. The Parties shall negotiate in good faith to resolve any such dispute promptly. The Party disputing the invoice shall, however, pay that portion of the invoice not in dispute. Once the dispute is resolved, and if payment is due by a Party, the payment shall be made within thirty (30) days of the date of resolution.

10.6.

If any undisputed sum payable under a SOW is not paid when due then, without prejudice to its other rights under a SOW, Clinigen shall have the right to charge interest from the date on which the relevant invoice is due for payment, until the date on which the payment is made in full, both before and after any judgment, at a rate of four per cent (4%) per annum over HSBC Bank plc UK base rate from time to time.

11.

Intellectual Property Rights

11.1.

Subject to the provisions of this Clause 11, nothing in this Agreement or any SOW shall operate to assign or transfer any title or interest in any Intellectual Property Rights existing prior to the Effective Date of this Agreement or any relevant SOW.

11.2.

The Client grants Clinigen a royalty free licence to use the Client Trade Marks in the Territory in relation to the performance of the Services for the purposes only of exercising its rights and performing its obligations under this Agreement and any and all SOW/s (including, without limitation, supplying, distributing and selling the Products (as applicable)). Subject to the aforesaid licence, Clinigen shall have no rights in respect of any Client Trade Marks or of the goodwill associated therewith.

11.3.

Clinigen shall not without the prior written consent of the Client alter, remove or tamper with any Client Trade Marks.

11.4.

All Clinigen Background Intellectual Property (including all and any improvements and developments thereto during the term of this Agreement and all SOWs) shall belong to Clinigen exclusively.

11.5.

Subject to Clause 11.4, all Intellectual Property created during the term of this Agreement and all SOWs shall belong to the Client exclusively (“Client New IP”). Clinigen shall promptly disclose all Client New IP to Client. Clinigen shall and hereby does assign to Client all right, title and interest in and to all Client New IP, and agrees to take (and procure its employees, agents and contractors to take) such further actions reasonably requested by Client to evidence such assignment and to obtain and maintain patent and other intellectual property protection for Client New IP.

12.

Insurance

12.1.

During the Term of this Agreement and for six (6) years thereafter, each Party shall maintain with insurers or underwriters of good repute, such insurance relating to its business as is normally maintained by comparable businesses sufficient to meet its obligations under this Agreement or any SOW (including, in the case of the Client, commercial general liability insurance and product liability insurance) for any occurrence or series of occurrences within a twelve (12) month period covering: (i) all legal liability for death, personal injury and damage to or loss of property arising directly or indirectly out of the use, possession or operation of the Products supplied to Clinigen pursuant to this Agreement or any SOW.

12.2.

On the written request of a Party, the other Party shall have its insurers furnish and provide the requesting Party with insurance certificates specifying the types and amounts of coverage in effect and the expiration dates of each policy upon written request.

13.

Warranties

13.1.

Clinigen represents and warrants that:

i)

It shall hold and maintain all relevant licences and regulatory authorisations and shall comply with all applicable legal and regulatory requirements in relation to the supply and distribution of Products and the provision of the Services (where applicable) in the relevant Territories:

ii)

all Services will be performed in a professional, workmanlike and timely manner and in compliance with these Conditions, the Service Specific Terms, the SOW and all applicable laws and regulatory requirements, and it will not infringe or misappropriate any intellectual property rights of any third party during its performance of the Services:

iii)

it will inform the Client on a timely basis of any Product complaints that it receives from Customers;

iv)

unless otherwise provided for in a Safety Data Exchange Agreement between the Parties, it will inform the Client of any adverse reaction(s) to the Products reported to it by any person within one (1) Business Day of cognisance.

v)

neither it nor any of its employees are presently debarred, suspended, proposed for debarment or declared ineligible for the award of contracts by any government authority; and

vi)

It is under no obligation to any Third Party which would prevent Client from carrying out its duties and other obligations under this Agreement or any SOW or which is inconsistent with the provisions herein contained.

13.2.

The Client represents and warrants that:

i)

It shall hold and maintain all licences necessary, and is authorised, to manufacture, assemble, package and label, export from the country of manufacture (if applicable) and supply the Client Products to Clinigen for Clinigen to distribute within the Territory in accordance with the terms of this Agreement and all relevant SOWs;

ii)

It will comply with all applicable laws and regulatory requirements including, but without prejudice to the generality of the foregoing, those in relation to the manufacture, assembly, packaging, packing, labelling, export from the country of manufacture (if applicable) and/or supply of each of the Client Products to Clinigen;

iii)

To Client’s knowledge, the Client’s Products, their manufacture, assembly, packaging and labelling, export from the country of manufacture (if relevant), use, supply to Clinigen and sale, supply or distribution of the Products and the use by Clinigen of the Client’s Trade Marks in the Territory by Clinigen will not infringe the Intellectual Property Rights of any third party;

iv)

the Client’s Products and their packaging and labelling shall conform to their description, specification and data sheet or summary of product characteristics;

v)

it has title to the Client’s Products;

vi)

neither it nor any of its employees are presently debarred, suspended, proposed for debarment or declared ineligible for the award of contracts by any government authority; and

vii)

it is under no obligation to any Third Party which would prevent Client from carrying out is duties and other obligations under this Agreement or any SOW or which is inconsistent with the provisions herein contained.

14.

Limits of Liability

14.1.

Nothing in this Agreement and/or any SOW shall limit or exclude the liability of a Party for:

i)

personal injury or death caused by its negligence;

ii)

indemnification obligations under Clause 15;

iii)

breach of confidentiality obligations under Clause 4; or iv)fraud or fraudulent misrepresentation.

14.2.

Except as otherwise provided in this Agreement and/or SOW, neither Party shall be liable to compensate the other Party whether in contract, tort (including negligence) breach of statutory duty, misrepresentation or otherwise for any

i)

special, indirect or consequential loss or damage;

ii)

loss of profit;

iii)

loss of business; or

iv)

loss of goodwill.

14.3.

Subject to Clauses 14.1 and 14.2, the maximum aggregate liability of Clinigen and/or its Affiliates under or in connection with this Agreement and/or any SOW in respect of all acts and omissions whether in contract, tort (including, without limitation, negligence), under statute, breach of statutory duty or otherwise shall not exceed the sum set out in the relevant Service Specific Terms.

15.

Indemnity

15.1

Clinigen shall indemnify the Client and/or its Affiliates and their respective officers, directors, employees, agents and subcontractors against and from all liabilities, in relation to Third Party claims that arise out of or in connection with the following:

15.1.1

fraud, wilful misconduct or negligence by Clinigen and/or its Affiliates and their respective officers, directors, employees, agents and subcontractors in relation to any SOW;

15.1.2

breach of the provisions of Clause 13.1 above.

15.2

Client shall indemnify Clinigen and and/or its Affiliates and their respective officers, directors, employees, agents and subcontractors against and from all liabilities including in relation to third party claims, that arise out of or in connection with any one or more of the following:

15.2.1

breach of the provisions of Clause 13.2 above;

15.2.2

fraud, wilful misconduct or negligence of the Client and/or its Affiliates and their respective officers, directors, employees, agents and subcontractors in relation to any SOW; and

15.2.3

any allegation or finding that the use of the Trade Marks or supply or sale of the Products by Clinigen in the Territory in accordance with this Agreement infringes the Intellectual Property Rights of any third party.

15.3

The process for claiming under an indemnity is set out in Clause 15.4 below.

15.4

Any indemnity given by a Party in the Service Specific Terms shall be conditional in each case upon the indemnified Party:

15.4.1

promptly giving written notice of any claim to be indemnified to the indemnifying Party;

15.4.2

providing the indemnifying Party with the absolute discretion to conduct, take or resist any proceedings as it sees fit at its own expense;

15.4.3

providing the indemnifying Party on request with such information and assistance in relation to such proceedings as it may reasonably require, subject to the indemnifying Party indemnifying the other Party against all costs reasonably incurred by it in the provision of such information or assistance; and

15.4.4

not making any settlement, compromise or prejudicial admission in relation to such claim without the prior consent of the indemnifying Party (such consent not to be unreasonably withheld or delayed).

16

Termination

16.1

Subject to any Initial Term, the Agreement or a SOW may be terminated by either Party at any time without cause by giving a minimum one hundred and eighty (180) day’ written notice to the other Party of its intention to terminate the Agreement or a SOW (as the case may be).

16.2

Either Party shall have the right to terminate this Agreement or any SOW immediately (as applicable) by notice to the other if the other Party:

16.2.1

ceases, or threatens to cease to carry on business or suspends all or substantially all of its operations, or suspends payment of its debts; or

16.2.2

Is unable to pay its debts or becomes insolvent or an order is made or a resolution passed for the administration, winding-up or dissolution of the other Party (otherwise than for the purposes of a solvent amalgamation or reconstruction) or an administrative or other receiver, manager, liquidator, administrator, trustee or similar officer is appointed over all or any substantial part of the assets of the other Party or it enters into or proposes any composition or arrangement with its creditors generally or anything analogous to the foregoing occurs in any applicable jurisdiction;

16.2.3

commits any material breach of the Agreement or any SOW, or any Quality Technical Agreement or any Safety Data Exchange Agreement if, in the case of a breach capable of remedy, the other Party fails to remedy such breach within 30 (thirty) days after receipt of a notice giving full particulars of the breach and requiring it to be remedied.

16.3

The rights to terminate this Agreement given by Clauses 16.1 and 16.2 shall be without prejudice to any other right or remedy of either party in respect of the breach concerned (if any) or any other breach.

17

Consequences of Termination or Expiry

17.1

Termination or expiry of this Agreement will not affect a SOW unless such SOW is also terminated in accordance with the terms of that SOW.

17.2

Notwithstanding the expiry or the termination of this Agreement pursuant to Clause 16, the Parties agree that it shall remain in full force and effect in relation to any existing SOW/s until such time as all such SOWs are terminated or have expired.

17.3

Upon termination of this Agreement and/or a SOW for any reason at the written request of a Party and at that Party’s expense, the other Party shall return or destroy any Confidential Information provided by the Disclosing Party under the Agreement and/or that SOW (whichever is terminated), save that each Party shall be entitled to retain copies of the other Party’s Confidential Information to the extent necessary to comply with its regulatory or legal obligations (which copies shall remain subject to the confidentiality obligations set forth herein).

17.4

On expiry or the termination of this Agreement and all SOW/s for any reason the Quality Technical Agreement shall immediately terminate subject to any provisions therein which are expressly stated to remain in full force and effect on its expiry or termination.

17.5

Upon termination of a SOW Clinigen shall:

17.5.1

invoice Client for all outstanding Charges due for Services properly performed under the applicable SOW prior to and up to the date of termination;

17.5.2

be entitled to complete all Customer Orders in respect of Products held by Clinigen as Consignment Stock placed with Clinigen prior to the date of termination; and

17.5.3

in respect only of Consignment Stock of Products, at the request of the Client and subject to the Client paying the costs of transport and insurance in advance, return all or any part of the remaining Consignment Stock in relation to that SOW then held by Clinigen to the Client at the Client’s risk. In such cases Clinigen will be responsible for arranging transportation and insurance. Alternatively, Clinigen will make available for collection by the Client all or any part of the remaining Consignment Stock in relation to that SOW then held by Clinigen. Any such Consignment Stock which the Client does not wish to be returned or collected may be destroyed by Clinigen on notice to the Client at the Client’s expense.

17.6

Provisions in this Agreement which are either expressly stated to remain in force after the expiry or termination of this Agreement, or which should be deemed to do so by implication, shall continue to have full effect, including Clauses 1 (Definitions), 4 (Confidentiality), 8 (Data Protection), 10 (Invoicing and Taxation), 11 (Intellectual Property), 12 (Insurance), 13 (Warranties), 14 (Limits of Liability), 15 (Indemnities), 17 (Consequences of Termination), 19 (Notices), 21 (General), 22 (Dispute Resolution), 23 (Arbitration) and 24 (Governing Law).

18

Force Majeure

18.1

If either Party is affected by Force Majeure it shall forthwith notify the other Party of the nature and extent thereof.

18.2

Neither Party shall be deemed to be in breach of this Agreement and/or a SOW, or otherwise be liable to the other, by reason of any delay in performance, or non- performance, of any of its obligations under this Agreement and/or a SOW to the extent that such delay or non-performance is due to any Force Majeure of which it has notified the other Party, and the time for performance of that obligation shall be extended accordingly.

18.3

If the Force Majeure in question prevails for a continuous period in excess of 3 (three) months, the Parties shall enter into bona fide discussions with a view to alleviating its effects, or to agreeing upon such alternative arrangements as may be fair and reasonable in the circumstances.

19

Notice

19.1

All notices to be given to a party under this Agreement and/or a SOW shall be in writing in English and shall be marked for the attention of the person, and delivered by hand, sent by registered prepaid post to the registered office from time to time of the relevant party or to such other address in the United Kingdom as the relevant party may notify to the other party in accordance with this Clause or sent by electronic mail to the address specified below (or as otherwise agreed between the parties).

19.2

A notice shall be treated as having been received:

19.2.1

if delivered by hand between 9.00 am and 5.00 pm on a Business Day (which time period is referred to in this clause as Business Hours), when so delivered; and if delivered by hand outside Business Hours, at the start of the next Business Day;

19.2.2

if sent by registered prepaid post, at 9.00 am on the second Business Day after posting if posted on a Business Day and at 9.00 am on the third Business Day after posting if not posted on a Business Day; and

19.2.3

if sent by electronic mail between 9.00 am and 5.00 pm on a Business Day when so delivered; and if delivered by hand outside Business Hours, at the start of the next Business Day.

20

Quality Technical Agreement and Safety Data Exchange Agreement

20.1

Where applicable the Parties will enter into a separate Quality Technical Agreement and a separate Safety Data Exchange Agreement on such terms as the Parties shall agree. The terms of such agreements shall take precedence over all other rights and obligations of the Parties in this Agreement and related SOW/s in so far as such rights and obligations relate to quality or safety issues (as the case may be), but not otherwise.

21

General

21.1

A person who is not a party to this Agreement may not enforce any of its provisions under the Contracts (Rights of Third Parties) Act 1999.

21.2

Clinigen may not assign or transfer, or purport to assign or transfer to any other person any of its rights or obligations under this Agreement or a SOW (except to its Affiliates or successors to all or substantially all of Clinigen’s business to which this Agreement relates) without the prior written consent of the Client save that this Agreement and any SOW will be binding upon and inure to any successor(s) to the business of Clinigen.

21.3

Client may assign this Agreement or a SOW upon prior written notice to Clinigen.

21.4

Either Party may subcontract the performance of any its obligations to any of its Affiliates or a third party without the consent of the other Party. Notwithstanding such subcontracting, the relevant Party shall at all times remain primarily liable for the full and proper performance of all of its obligations under this Agreement and/or any SOW including any obligations provided through any permitted subcontractor.

21.5

This Agreement (together with all other documents to be entered into pursuant to it) sets out the entire agreement and understanding between the Parties, and supersedes all proposals and prior agreements, arrangements and understandings between the Parties, relating to its subject matter.

21.6

Each Party acknowledges that in entering into this Agreement and/or a SOW it does not rely on any representation, warranty, collateral contract or other assurance of any person (whether party to this Agreement and/or a SOW or not) that is not set out in this Agreement and/or a SOW. Each party waives all rights and remedies which, but for this Clause, might otherwise be available to it in respect of any such representation, warranty, collateral contract or other assurance. The only remedy available to any party in respect of any representation, warranty, collateral contract or other assurance that is set out in this Agreement and/or a SOW is for breach of contract under the terms of this Agreement and/or a SOW.

21.7

This Agreement and/or a SOW may not be modified except in writing signed by the duly authorised representatives of each Party.

21.8

Neither Party shall use the name of the other Party in any announcements, press releases, marketing materials nor advertisements, except as may be required by law, judicial order or regulatory governance, without the prior written consent of the other Party.

21.9

If any term, covenant or condition contained in this Agreement and/or a SOW is deemed to be invalid, illegal or unenforceable, then the rights and obligations of the Parties hereto shall be construed and enforced with that term, covenant or condition limited so as to make it valid, legal or enforceable to the greatest extent allowed by law; or, if it is totally invalid, illegal or unenforceable, then as if this Agreement and/or a SOW did not contain that particular term, covenant or condition. In such event, the remaining provisions of this Agreement and/or a SOW shall be valid and enforceable to the extent permitted by law.

21.10

Delay in exercising, or failure to exercise, any right or remedy in connection with this Agreement and/or a SOW shall not operate as a waiver of that right or remedy. The waiver of a right to require compliance with any provision of this Agreement and/or a SOW in any instance shall not operate as a waiver of any further exercise or enforcement of that right and the waiver of any breach shall not operate as a waiver of any subsequent breach.

21.11

The rights and remedies of the Parties in connection with this Agreement and/or a SOW are cumulative and, except as expressly stated in this Agreement and/or a SOW, are not exclusive of any other rights or remedies provided by law or equity or otherwise. Except as expressly stated in this Agreement and/or a SOW (or at law or in equity in the case or rights and remedies provided by law or equity) any right or remedy may be exercised (wholly or partially) from time to time.

21.12

This Agreement and/or any SOW may be executed in any number of counterparts, each of which when executed shall be construed as an original, but together will constitute one agreement, in relation to this Agreement or a SOW. Signature transmitted by industry standard electronic signature software and/or by electronic mail in “portable document format” (“pdf”) shall have the same legal force and effect as physical delivery of the paper document bearing the original signature.

22

Dispute Resolution

22.1

If any dispute arises out of this Agreement and/or a SOW, in the first instance, the Parties’ account managers shall attempt to resolve the dispute amicably within thirty (30) days.

22.2

If a dispute cannot be resolved by the Parties’ account managers, the Parties shall promptly refer the matter to their respective Chief Executive Officer. If either Party refuses to make such referral or participate in good faith in this dispute resolution procedure and in any event, if the dispute is not resolved within thirty (30) days of such referral or the date such referral could have been made, then either Party may commence proceedings in accordance with Clause 23.

22.3

Where either Party reasonably believes that a dispute relates to a material breach or potential breach of this Agreement, that Party shall notify its and the other Party’s account managers and each Party shall then refer the dispute directly to their Chief Executive Officers and the provisions of Clause 22.2 shall apply.

23

Arbitration

23.1

Any dispute that cannot be settled amicably shall be resolved by arbitration before a sole arbitrator, which shall be the exclusive method of dispute resolution under this Agreement and/or any SOW. Such arbitration shall be held in New York City, New York, USA, and in accordance with the ICC Rules of Arbitration. Nothing herein shall, however, prohibit a Party from seeking temporary or preliminary injunctive relief in a court of competent jurisdiction. The parties expressly consent to arbitration and waive any right of appeal to any court from any arbitral award (which shall be final and binding upon the parties).

24

Governing Law

24.1

This Agreement and any SOW shall be governed by, and construed in all respects in accordance with the laws of the State of New York, USA.

24.2

Subject to Clause 23, the courts of New York City, New York, USA will have exclusive jurisdiction to settle any disputes which may arise out of or in connection with this Agreement and/or any SOW, save that either Party may seek injunctive relief in any court of competent jurisdiction.

/s/ John Ferraro

[signature]

John Ferraro

[printed name]

VP, Clinical Operations

[position in company]

27 Apr 2018

[date]

DocuSigned by:

DocuSigned by:

John Lagus

Lee Mainwaring

Signer Name: John Lagus

Signer Name: Lee Mainwaring

Signing Reason: I approve this document

Signing Reason: I approve this document

Signing Time: 26-Apr-2018

Signing Time: 26-Apr-2018

19F51008EB7A4EDB9F0A7E116ED422FB

01C6D73EA86348FFAD8417807CB5A5D5

[signature]

[signature]

John Lagus

Lee Mainwaring

[Printed name]

[Printed name]

Head of Managed Access

Finance Director

[position in company]

[position in company]

26-Apr-2018

26-Apr-2018

[date]

[date]

1

Definitions

2

Nature of Services