Commercial Supply and Manufacturing Agreement, dated April 1, 2019, by and between Dermavant Sciences GmbH and GlaxoSmithKline

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SCHEDULE 1 PRODUCTS AND PRICES

SCHEDULE 2 SCOPE OF WORK FOR DEVELOPMENT SERVICES

SCHEDULE 3 TOLL MANUFACTURE PROVISIONS

SCHEDULE 4 FEES

EXHIBIT 1 CAPITAL WORK AT [***]

GlaxoSmithKline Trading Services Limited a company registered in Ireland (company registration number 406446), whose registered office is at Currabinny, Carrigaline, Cork, Ireland (“GSK”);

Dermavant Sciences GmbH, a company incorporated under the laws of Switzerland (company registration number CHE-449.750.216) whose registered office is at Viaduktstrasse 8, 4051 Basel, Switzerland (the “Purchaser”).

The GSK Group is engaged in, among other things, the manufacture of medicinal products and consumer healthcare products.

The Purchaser is engaged in, among other things, the development, distribution and sale of medicinal products and/or consumer healthcare products.

The Purchaser wishes to engage the services of a third party contract manufacturer for the Products and GSK is willing to (i) provide certain development services required to prepare for the Manufacture of Commercial Products and Commercial API at the Manufacturing Sites, (ii) to manufacture (or have manufactured), as applicable, the Commercial API for use in the Manufacture of Commercial Product for the Purchaser, and (iii) to manufacture (or have manufactured) such Commercial Product using Commercial API on a toll basis, in each case in accordance with the terms and conditions of this Agreement.

DEFINITIONS AND INTERPRETATION

Each capitalized term used but not otherwise defined in this Agreement has the meaning given to such term in the Purchase Agreement. The following additional terms have the respective meanings set forth in the preamble to this Agreement or below. This Agreement shall control to the extent any conflict exists between any defined term used in this Agreement and any defined term used in the Purchase Agreement.

sets forth the analytical test results for each specified lot of Products Delivered to the Purchaser under this Agreement; and

confirms that such Products have been Manufactured in accordance with the applicable Specifications.

[***];

[***];

[***]; and

[***].

all information (including but not limited to trade secrets, protocols, specifications, techniques, source and object code, business and marketing plans and projections, capital investment plans, arrangements and agreements with third parties and the content thereof, customer information, Intellectual Property, formulae, suppliers and customer lists, financial data, designs and models) passing from the Disclosing Party to the Receiving Party (or its Personnel), whether deliberately or inadvertently, before, on or after the date of this Agreement, relating to the business affairs or finances of the Disclosing Party that is designated, marked, or described as confidential, or might be reasonably regarded by the Disclosing Party as confidential to it; and

the existence, provisions and subject matter of this Agreement (in respect of which each Party shall be deemed to be a Disclosing Party).

with respect to any Know-How, Patents, Regulatory Documentation or other information, the possession by a Party, including its Affiliates, of the ability (without taking into account any rights granted by one Party to the other Party under the terms of this Agreement) to disclose, licence, or sublicense such Know-How, Patents, Regulatory Documentation or other information without violating the terms of any Contract or other arrangement with, or necessitating the consent of, any Third Party; and

as to a Person, the power to direct or cause the direction of the management and policies of such Person, whether, through the ownership of voting securities, by contract or otherwise.

if the Manufacturing Site is within the European Union or the Product is to be supplied to a country within the European Union, by the provisions of Chapter II of EC Commission Directive 2003/94/EC together with the Guide to Good Manufacturing Practice published by the EC Commission in 1992 (ISBN ###-###-####-X) (as the same may be amended from time to time); or

if the Product is to be supplied to a region covered by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”), by the relevant ICH Quality Guidelines relating to good manufacturing practice (as the same may be amended from time to time); or

if the Manufacturing Site is in any other part of the world and the Product is not to be supplied to a country within the European Union, by such standards as may be agreed in writing between the Parties to reflect the requirements of a Regulatory Authority in the country where the Product is Manufactured or supplied; or

by such other requirements as may be agreed between the Parties and set forth in the Quality Agreement,

for Commercial API, FCA ([***]) (Incoterms 2010), except for Commercial API that the Parties agree will be left in GSK’s possession [***] pursuant to Clause 11 (Delivery of Product); and

for Commercial Product, FCA ([***]) (Incoterms 2010).

if the Commencement Date is on or before 30 June, on 31 December of the Calendar Year in which the Commencement Date falls; or

if the Commencement Date is on or after 1 July of a Calendar Year, on 31 December of the Calendar Year following that in which the Commencement Date falls.

war, threat of or preparation for war, armed conflict;

terrorist attack, civil war, civil commotion or riots;

epidemic or pandemic;

any law or government order, rule, regulation or direction, or any action taken by a Governmental Entity, including but not limited to imposing an embargo, export or import restriction, quota or other restriction or prohibition, or failing to grant a necessary licence or consent; and

to the extent beyond the reasonable control of the Affected Party, any labour dispute, including strikes, industrial action or lockouts.

owned (or licensed to) the GSK Group at the Effective Date; or

developed or acquired by, or licensed to (other than by the Purchaser), the GSK Group on or after the Effective Date.

it is, or is deemed for the purpose of any Applicable Law, to be insolvent or unable to pay its debts as they fall due;

it admits an inability to pay debts as they fall due;

it suspends making payments on any of its debts or announces an intention to do so;

by reason of actual or anticipated financial difficulties, it begins negotiations with any creditor for the rescheduling of any of its indebtedness outside the ordinary course of business;

it is in breach of any covenant or other term of a loan or financial facility and a counterparty accelerates, or calls for repayment of, any outstanding indebtedness as a result of such breach;

the fair value of its assets is less than its liabilities (taking into account contingent and prospective liabilities and disregarding inter-company loans between Affiliates); or

a moratorium is declared in respect of any indebtedness.

any step is taken with a view to a moratorium or a composition or similar arrangement with its creditors;

a meeting of its shareholders or directors is convened for the purpose of considering any resolution for, to bring an application for, or to file documents with a court or any registrar for, its winding-up, judicial management or dissolution or any such resolution is passed;

any Person brings an application for, or files documents with a court or any registrar for, its winding-up, judicial management or dissolution or such order is made; or

a liquidator, judicial manager, administrator or similar officer is appointed in respect of any of its assets.

in relation to Commercial API (including any Safety Stock Fee in respect of raw materials for use in the Manufacture of Commercial API and any Storage Fee), [***]; and

otherwise (including in relation to any Safety Stock Fee in respect of raw materials for use in the Manufacture of Commercial Product), [***].

[***];

[***]; and

[***]; and

[***].

in respect of Commercial API, the manufacturing site operated by GSK or its Affiliate at [***]; and

in respect of Commercial Products, the manufacturing site operated by GSK or its Affiliate at [***].

in respect of a Product, the price set forth in (or determined in accordance with) Part B of Schedule 1 (Products and Prices) and Clause 12 (Price); and

in respect of a Development Service, the price set forth in (or determined in accordance with) Schedule 2 (Scope of Work for Development Services) and the applicable Scope of Work.

owned by (or licensed to) the Purchaser or its Affiliates at the Effective Date, including the Transferred IP; or

developed or acquired by, or licensed to (other than by GSK), the Purchaser or its Affiliates on or after the Effective Date.

sets forth the analytical test results for each specified lot of Purchaser Materials provided by or on behalf of Purchaser; and

confirms that such Purchaser Materials have been manufactured in accordance with the applicable Specifications.

In this Agreement, unless otherwise specified:

any Schedules form part of this Agreement and shall have the same force and effect as if set forth in the body of this Agreement, and references to this Agreement include them;

references to Recitals, Clauses and Schedules are to recitals and clauses of, and schedules to, this Agreement and references in a Schedule or part of a Schedule to paragraphs are to paragraphs of that Schedule or that part of that Schedule;

the headings and contents table in this Agreement are for convenience only and do not affect its interpretation;

references to the singular include the plural and vice versa;

words denoting persons include individuals, companies, partnerships, unincorporated associations and other bodies (in each case, wherever resident and whether or not having separate legal personality) and references to a company shall include any company, corporation or other body corporate wherever or however incorporated or established;

a reference to:

a statute, statutory provision, regulation, directive or other enactment shall be construed as including a reference to any subordinate legislation or instrument made from time to time under that statute, provision, regulation, directive or enactment whether before, on or after the date of this Agreement; and

a statute, statutory provision, regulation, directive, enactment or subordinate legislation shall be construed as including a reference to that statute, provision, regulation, directive, enactment or subordinate legislation as in force at the date of this Agreement and as from time to time amended, modified, consolidated, superseded, re-enacted or replaced (whether with or without modification) after the date of this Agreement;

general words shall not be given a restrictive meaning by reason of the fact that they are preceded by or followed by particular examples intended to be embraced by the general words and accordingly:

the rule known as ejusdem generis shall not apply; and

the words “includes”, “including” and “in particular” (or similar term) are not to be construed as implying any limitation and shall be read and construed as if immediately followed by the words “without limitation”;

any reference to this Agreement or any other document is to this Agreement or that document as in force for the time being and as amended from time to time in accordance with this Agreement and/or that document (as the case may be);

if a payment under this Agreement is due on a day which is not a Business Day, the due date for that payment shall be the next Business Day; and

terms other than those defined in this Agreement shall be given their plain English meaning and those terms, acronyms and phrases known in the pharmaceutical/ healthcare industry shall be interpreted in accordance with their generally accepted meanings.

GSK’S OBLIGATIONS

With effect from the Commencement Date and in consideration of the Price, GSK shall Manufacture (or have Manufactured) and supply to the Purchaser, as applicable, Commercial API and the Commercial Products, as ordered from time to time by the Purchaser in accordance with Clause 10 (Product Forecasts and Orders), in each case subject to the terms of this Agreement.

GSK shall Manufacture (or have Manufactured), as applicable, the Commercial API and Commercial Products at the Manufacturing Site, in each case in accordance with:

Current Good Manufacturing Practice;

the Specifications;

the Manufacturing Licence;

the Quality Agreement; and

all laws and regulations relevant to the Manufacture of the relevant Product at the Manufacturing Site.

Notwithstanding Clause 31.1, GSK shall not be required to use in the Manufacture of Commercial Product any API that has not been Manufactured by or for GSK under this Agreement. For the avoidance of doubt, Commercial API Manufactured by or for GSK under this Agreement and subsequently stored by or on behalf of Purchaser (including by a Third Party) shall be considered ‘Manufactured by or for GSK under this Agreement’.

Subject to Clause 3 (Development Services), with effect from the Effective Date GSK shall perform the Development Services, if any are requested and agreed by the Parties, in accordance with the Scope of Work and all laws and regulations relevant to the performance of the Development Services.

Subject to Clause 2.2 and without prejudice to the generality of Clause 38 (Sub-Contractors), the Parties hereby acknowledge that GSK may:

use the Person(s) who from time to time own and operate the relevant Manufacturing Site to Manufacture the Commercial API and Commercial Products for and on behalf of GSK, provided that:

such Manufacture shall take place at the Manufacturing Site; and

GSK shall remain primarily liable to the Purchaser as principal obligor for the performance of its obligations under this Agreement in respect of such Manufacture; and

nominate any member of the GSK Group to act as its Nominated Supplier under this Agreement to supply Products to, and receive payment from, the Purchaser, provided that GSK shall remain primarily liable to the Purchaser as principal obligor for the performance of its obligations under this Agreement in respect of such supply.

Notwithstanding the entry into force of this Agreement in accordance with Clause 32.1, but subject to Clause 2.7, the commencement of GSK’s obligations under this Agreement with respect to the Manufacture and supply of the Products, as applicable, is subject to, and conditional on satisfaction of each of the following conditions (the “Commencement Conditions”):

successful completion (including release) of Commercial API and Commercial Product validation batches;

the Specifications have been agreed between the Parties;

the Parties and/or their Affiliates have agreed and signed the Quality Agreement; and

the Purchaser has filed the first Regulatory Approval Application.

Clause 2.6 shall not prevent the Manufacture and supply of any validation batches of Product that may be Manufactured and supplied pursuant to any Scope of Work as part of the Development Services prior to the satisfaction of the Commencement Conditions.

The Purchaser acknowledges that, unless otherwise agreed in writing or otherwise expressly set forth in this Agreement, GSK will cease performing the Development Services and the Manufacture and supply of the Products at the latest on expiry of the Term. For the avoidance of doubt, without prejudice to Clause 33 (Consequences of Expiry or Termination) and except as otherwise provided for under Clause 31 (Technology Transfer), the Purchaser shall be solely responsible for making alternative arrangements for the Manufacture and supply of the Products and the performance of any development services in connection with the Products following the expiry or termination of this Agreement.

DEVELOPMENT SERVICES

The Parties may agree that GSK shall perform certain development work in connection with:

the process scale up for the Manufacture of Commercial API at the Manufacturing Site;

knowledge transfer from GSK’s R&D facilities to the Manufacturing Sites in respect Commercial API and Commercial Product;

analytical methods transfer from the Third Party responsible for undertaking analytical testing in respect of Commercial API and Commercial Product to the Manufacturing Sites;

the validation of commercial Manufacturing processes for Commercial API and Commercial Product (including the Manufacture of validation batches); and

CMC (chemistry, manufacturing and controls) development activities in support of obtaining or maintaining Regulatory Approval(s),

The Purchaser may from time to time request that GSK perform Development Services, provided that:

if prior to receipt of NDA Approval, GSK shall [***];

if on or after receipt of NDA Approval, GSK shall [***]; and

if GSK agrees to perform the requested Development Services, GSK shall (subject to the Parties agreeing the applicable Scope of Work in accordance with Clause 3.2(A) or 3.2(B) (as applicable) and Clause 3.3) perform such Development Services in accordance with the terms of this Agreement and the associated Scope of Work.

Any Development Services agreed between the Parties pursuant to Clause 3.2 shall be documented in a scope of work in the form set forth in Schedule 2 signed on behalf of each of the Parties (each a “Scope of Work”) which shall define the roles and responsibilities of the Parties in the performance of such Development Services, including the tasks to be completed, any deliverables to be delivered by GSK and the fees payable by the Purchaser (as determined in accordance with Schedule 2 (Scope of Work for Development Services)), together with an agreed timeline for the performance, completion and/or delivery of the applicable Development Services.

If GSK is unable or unwilling to perform Development Services requested pursuant to Clause 3.2, GSK shall provide a reasonably detailed justification setting forth why it is not able or willing to perform such Development Services.

For the avoidance of doubt but without prejudice to Clause 3.12, GSK shall not be required to perform any Development other than Development Services agreed pursuant to this Clause 3 (Development Services).

Each Party shall use its Commercially Reasonable Efforts to perform the Development Services in accordance with the applicable Scope of Work and the timelines for the performance, completion and/or delivery of such Development Services set forth in the applicable Scope of Work.

Any deliverables (including Purchaser Materials) required to be provided by the Purchaser for the purposes of any Development Services shall be provided [***].

Neither GSK nor any of its Affiliates shall bear any liability under or in relation to this Agreement in connection with any failure to perform, complete or deliver, or delay in performing, completing or delivering, any Development Services to the extent resulting from any failure, default or delay on the part of the Purchaser in performing the tasks and obligations, or delivering the deliverables (including any Purchaser Materials required for the performance of the Development Services by GSK), assigned to the Purchaser under the applicable Scope of Work or to the extent resulting from any delay in supply, or defect in, the Purchaser’s deliverables, provided that this Clause 3.8 is without prejudice to any liability GSK may have (whether under this Agreement or under the Clinical Supply Agreement) in respect of any defect in Purchaser Materials required as deliverables for the purposes of any Development Services.

The Purchaser shall pay to GSK (or its nominated Affiliate) such fees, costs, expenses, payments and other sums as may be specified in a Scope of Work. Insofar as a Scope of Work provides for fees to be determined by reference to the FTE Rate, such FTE Rate shall be payable only in respect of time spent engaged in the activities covered by such Scope of Work. In the event that the Scope of Work does not provide for the payment of fees, costs, expenses, milestone payments or other sums, the Purchaser shall reimburse to GSK (or its nominated Affiliate) all costs and expenses incurred in respect of the Development Services undertaken pursuant to such Scope of Work, provided that such costs and expenses are agreed in advance by the Parties.

Any proposed change or addition to the Development Services or the timeline for the performance, completion or delivery of such Development Services shall be deemed a proposal to change the Scope of Work (a “Scope Change”). Either Party may propose a Scope Change, but no Scope Change shall be implemented without the prior written agreement of the other Party. If a Scope Change is agreed by the Parties, the Parties shall document the Scope

At the end of each month, GSK and the Purchaser shall review the status of the Development Services (and each Party shall share any relevant information for the purposes of such review) and, in the event of any Scope Change and/or delay in the performance of the Development Services, each Party shall use Commercially Reasonable Efforts to agree on new timeframes for the applicable Development Services. If the Parties fail to agree on new timeframes for the applicable Development Services within [***] of commencing discussions and a dispute arises, such dispute shall be determined in accordance with the provisions of Clause 46 (Dispute Resolution).

The Purchaser acknowledges that, save for the Development Services and with effect from the Effective Date, the GSK Group will not support any development work in respect of the Manufacture of any Product (including variations to Product Licences required as a result of such work), unless such work is required by Applicable Law or GSK otherwise agrees to the performance of such development work in writing. The Purchaser shall [***] in respect of any such development work undertaken pursuant to this Clause 3.12 and the implementation of such development work, provided that [***].

In the event that the Purchaser fails to pay any undisputed sum in respect of any Development Services, or any development work (or its implementation) for which the Purchaser is to bear the cost pursuant to Clause 3.12, then in such an event:

neither GSK nor its Affiliates shall bear any liability under this Agreement for any breach of its terms resulting from any failure to carry out, or delay in carrying out, such Development Services or other development work; and

the Purchaser shall indemnify each member of the GSK Group against all actions, Proceedings, demands and claims by any Third Party arising from any failure to carry out, or delay in carrying out, such work.

PURCHASER’S OBLIGATIONS

Subject to Clauses 4.3 and 31.4, during the Term, the Purchaser shall purchase:

in respect of Commercial API:

during the First Supply Period, [***] of its requirements for Commercial API during that First Supply Period (and in any event not less than [***]);

in the Calendar Year following the First Supply Period (“Year 2”), not less than the greater of (a) [***] of its requirements for Commercial API during Year 2 and (b) [***];

in the Calendar Year following Year 2 (“Year 3”), not less than the greater of (a) [***] of its requirements for Commercial API during Year 3 and (b) [***]; and

in each subsequent Calendar Year during the Term, not less than the greater of (a) [***] of its requirements for Commercial API during that Calendar Year and (b) [***] batches; and

in respect of Commercial Product:

during the First Supply Period, [***] of its unit requirements for Commercial Product during that First Supply Period (and in any event not less than [***]);

in Year 2, not less than the greater of (a) [***] of its unit requirements for Commercial Product during Year 2 and (b) [***];

in Year 3:

if Clause 4.2 does not apply, not less than the greater of (1) [***] of its unit requirements for Commercial Product during Year 3 and (2) [***]; or

if Clause 4.2 does apply, not less than the greater of (1) [***] of its unit requirements for Commercial Product during Year 3 and (2) [***]; and

in each subsequent Calendar Year during the Term

if Clause 4.2 does not apply, not less than the greater of (a) [***] of its unit requirements for Commercial Product during that Calendar Year and (b) [***]; or

if Clause 4.2 does apply, not less than the greater of (1) [***] of its unit requirements for Commercial Product during that Calendar Year and (2) [***],

For the purposes of Clauses 4.1(B)(iii) and 4.1(B)(iv), this Clause 4.2 applies if, but only if, in Year 3 or a subsequent Calendar Year during the Term (as applicable), the Purchaser’s total aggregate demand for Commercial Product (whether Manufactured by GSK or by a Third Party) is less than [***].

The volumes taken into account in determining whether the Purchaser has complied with its obligations under Clause 4.1 in respect of the First Supply Period or any other Calendar Year shall include:

with respect to the First Supply Period only, any validation batches of Commercial API and/or Commercial Product (including any failed batches) Manufactured during or prior to the First Supply Period pursuant to Development Services performed under this Agreement;

with respect to any Calendar Year after the First Supply Period, any validation batches of Commercial API and/or Commercial Product (including any failed batches) Manufactured in such Calendar Year pursuant to Development Services performed under this Agreement;

any samples of Commercial Product Delivered under this Agreement during that First Supply Period or other Calendar Year; and

any quantities of Commercial API and/or Commercial Product for which there is a Firm Order for Delivery during that First Supply Period or other Calendar Year but which GSK fails to Deliver.

Within [***] following the end of (i) the First Supply Period and (ii) each subsequent Calendar Year, the Purchaser shall provide GSK with documented evidence of the total quantity of Commercial API (in kilograms) and the total quantity of Commercial Product (in number of units) Manufactured by GSK and any Third Party during such First Supply Period or subsequent Calendar Year (as applicable).

If, in respect of the First Supply Period or any subsequent Calendar Year, the Purchaser does not purchase at least the quantity of Commercial Product required by Clause 4.1(B), then GSK shall invoice the Purchaser for a sum equal to the difference (in tubes, regardless of size) between the quantity of Commercial Product actually purchased by the Purchaser (or otherwise taken into account pursuant to Clause 4.3) during that First Supply Period or other Calendar Year and the quantity of Commercial Product required to be purchased during that First Supply Period or other Calendar Year pursuant to Clause 4.1(B) multiplied by:

in respect of the First Supply Period, Year 2 or any other Calendar Year in which (by virtue of Clause 4.2 and ignoring the effect of any pro rata reduction applied in accordance with Clause 4.1) the quantity required to be purchased pursuant to Clause 4.1(B) is less than [***]), [***]; or

in respect of any other Calendar Year during the Term, [***],

The Purchaser shall not (itself or through any Third Party):

expressly or implicitly market, advertise or otherwise promote in any way the sale of any Product as a GSK Group product or as containing any GSK Group product; or

use the name or logo of any member of the GSK Group in connection with any Product,

prior to doing any such act or thing, provide GSK with a copy of all relevant materials; and

consider in good faith any comments GSK may have in respect of the manner in which the name of any member of the GSK Group is used in such materials; and

if such materials include the logo of any member of the GSK Group, not use such materials without GSK’s prior written approval (such approval not to be unreasonably withheld).

the avoidance of doubt, a breach of this Clause 4.6 will constitute a material breach of this Agreement.

NEW PRODUCT SKUS

The Purchaser may, from time to time and in accordance with this Clause 5, request that GSK Manufacture (or have Manufactured) and supply (or have supplied) New Product SKUs under this Agreement. Any such request shall be accompanied by reasonable details of:

the characteristics of the New Product SKU;

the anticipated market(s) to supply: and

a volume plan for a period equal to [***].

Upon receipt of a request pursuant to Clause 5.1, GSK will conduct an impact assessment as soon as reasonably practicable, The Joint Steering Team shall review the Purchaser’s request and GSK’s impact assessment and, following such review (and subject to any amendments that may be agreed between the Parties), may agree upon the proposal for the New Product SKU, on a basis consistent with the terms of this Agreement in respect of the Manufacture of such New Product SKU and a budget for the estimated costs to be incurred in connection with such New Product SKU, provided that:

if so agreed, any development work required to be performed by GSK to prepare for the Manufacture and supply of a New Product SKU (including new configurations of the Products) shall be deemed a Development Service and Clause 3 (Development Services) shall apply;

[***], no member of the GSK Group shall be obliged to [***] unless otherwise agreed by the Parties); and

any incremental costs incurred by any member of the GSK Group associated with such New Product SKU shall be [***] unless otherwise agreed by the Parties.

Any New Product SKU that is introduced in accordance with this Clause 5 shall be subject to the terms of this Agreement and shall, with effect from the date on which the Parties record in writing their agreement to add such New Product SKU to this Agreement, be deemed to be a Product, provided that, prior to such addition in writing, such New Product SKU shall not be deemed a Product hereunder.

CAPITAL EXPENDITURE

The Parties acknowledge and agree that certain capital expenditure at the Manufacturing Site operated by GSK or its Affiliate at [***] in respect of Commercial API is governed by, and is subject to the terms and conditions of, the CapEx Letter Agreement and nothing in this Clause 6 (Capital Expenditure) shall apply in relation to such capital expenditure.

Subject to Clause 6.1, where capital expenditure is required in respect of the Manufacture of Products under this Agreement, including in connection with:

any technology transfer, tooling or equipment or Artwork required to enable Manufacture to commence at the Manufacturing Site; and

a request from the Purchaser for a change to the Specification, source of Materials or Purchaser Materials, development work, revised Artwork or the introduction of any new SKU by agreement between the Parties,

to the extent such expenditure relates exclusively to the Products or their Manufacture, be [***]; and

to the extent such expenditure is incurred in respect of regulatory compliance of the Manufacturing Site and does not relate exclusively to the Products, be borne by the Parties in such proportions as they may agree (each acting reasonably and in good faith) such that [***].

For the avoidance of doubt, any asset, equipment or improvement installed or effected at the Manufacturing Site shall belong to GSK or the Nominated Manufacturer, irrespective of which Party bears the cost of the capital expenditure associated with such asset, equipment or improvement.

The Parties understand and agree that, as of the Effective Date, certain capital expenditures are expected to be required at the Manufacturing Site operated by GSK or its Affiliate at [***] in respect of the Manufacture of Commercial Product in [***], and that the terms of such capital improvements shall be negotiated in good faith and implemented in a Scope of Work covering specific Development Services related to anticipated capital improvements required as of the Effective Date that will be performed pursuant to and in accordance with the terms of Clause 6.1 and the specific agreed terms set forth in Exhibit 1 (Capital Work at [***]).

In the event that the Purchaser fails to pay any sum in respect of capital expenditure for which the Purchaser is to bear the cost pursuant to Clause 6.2:

[***]; and

[***].

MATERIALS

GSK (or the Nominated Manufacturer) shall be responsible for ordering and purchasing all Materials required to enable GSK to meet its Development Services, Manufacturing and supply obligations under this Agreement; provided that for the purposes of Manufacturing Commercial Product the Purchaser shall provide Commercial API on a [***]. The costs of the Materials and the management and procurement of such Materials that are specifically required for or specifically allocated to the Manufacture of Commercial API or Commercial Product hereunder shall be [***].

GSK shall not [***]

without the Purchaser’s prior written consent (not to be unreasonably withheld or delayed).

Subject to the terms of the Quality Agreement and Clause 18.1, GSK may at any time change the supplier of any Delegated Shared Source Material to which Clause 7.2 does not apply provided that GSK will consult with the Purchaser prior to changing or introducing any such Delegated Shared Source Material to meet its Manufacturing and supply obligations under this Agreement.

Notwithstanding anything to the contrary in the Quality Agreement, the Purchaser shall not for the purposes of this Agreement be deemed to be directly responsible for performing quality assurance audits and oversight in respect of a Delegated Shared Source Material.

During the Term, GSK shall (having regard to the applicable Firm Zone and the lead times for the raw materials concerned) manage its stock quantities of raw materials that are specifically required for or specifically allocated to the Manufacture of Commercial API or Commercial Product such that GSK will be able to support the Purchaser’s Firm Orders for Products. If the Purchaser requires GSK to hold additional quantities of raw materials as safety stock, the Purchaser shall pay GSK a storage fee to cover any GSK costs and expenses incurred in connection with holding and storing such safety stock that is not required for Manufacture in support of Firm Orders (the “Safety Stock Fee”). The Safety Stock Fee is set forth on Schedule 4 (Fees). For the avoidance of doubt, such safety stock may not be used for the manufacture of any products other than Commercial API or Commercial Product (as applicable) under this Agreement, and notwithstanding Clause 25 (Capacity Constraints), all such raw materials held as safety stock and for which the Purchaser has paid (or is liable to pay) a Safety Stock Fee shall be used solely to fulfil Firm Orders from the Purchaser until exhausted.

PURCHASER MATERIALS

The Purchaser shall supply the Purchaser Materials to GSK at the designated Manufacturing Site in respect of Commercial Product in a timely manner [***] on a [***].

GSK will not (and will procure that the Nominated Manufacturer does not) use the Purchaser Materials for any purpose other than the Manufacture of Commercial Products for the Purchaser under this Agreement (including for testing, quality and compliance purposes).

GSK shall not be liable for any failure to meet, or for any delay in meeting, any Firm Order for Commercial Products if such failure is as a result of any failure by the Purchaser to supply, or delay by the Purchaser in supplying, in a timely manner sufficient quantities of Purchaser Materials that comply with all applicable requirements of Applicable Law, cGMP and the applicable Specifications and have sufficient unexpired shelf life to enable such Purchaser Materials to be the Manufacture of Products in accordance with the schedule of Deliveries of any Commercial Products contemplated by the Forecast Schedule; except in the event that such failure is due to the failure of GSK to supply Commercial API in a timely manner or that meets cGMP (taking due account of the applicable Lead Time for such Commercial API).

Each quantity of Purchaser Materials will be accompanied by Certificate of Analysis relating to such Purchaser Materials, which, to the extent required by Applicable Law in the relevant jurisdiction, shall be signed by the Purchaser’s Qualified Person in respect of Commercial API.

The Purchaser shall retain title to the Purchaser Materials at all times. From the time Purchaser Materials are delivered to GSK’s loading dock at the relevant Manufacturing Site to the time such Purchaser Materials are returned (or Product is delivered) to the Purchaser’s designated carrier at GSK’s loading dock, GSK shall bear the risk of loss of or damage to such Purchaser Materials arising from GSK’s [***] and shall be responsible for compensating the Purchaser for the lost or damaged Purchaser Materials (up to an amount not exceeding the Actual Cost of such Purchaser Materials to the Purchaser). At all other times and in all other circumstances, the Purchaser and shall bear the risk of loss or destruction to the Purchaser Materials.

The Purchaser shall inform and keep GSK and the Nominated Manufacturer informed of all safety hazards and changes in regulations and guidance (statutory or otherwise) which the Purchaser or its Affiliate knows or believes affect or may affect the use, handling, storage, labelling, transport, treatment and disposal of any Purchaser Materials.

INTELLECTUAL PROPERTY

Each Party shall at all times remain the owner of its respective GSK Background IP or Purchaser Background IP.

All Intellectual Property or Know-How generated by or on behalf of GSK (whether alone or together with Purchaser or Purchaser’s Affiliate) in the course of the performance of the obligations, services and activities under this Agreement (including Intellectual Property, Know-How or improvements relating to the manufacture of pharmaceutical products generally or related to the Manufacturing Site), other than Intellectual Property or Know-How that is exclusive to Developing, Manufacturing, or Commercialising the API, Commercial API, Commercial Products or the Purchaser Background IP, shall be owned by GSK (the “GSK Arising IP”). For clarity, GSK Arising IP shall not include Purchaser Background IP or Purchaser Arising IP.

All Intellectual Property or Know-How generated by or on behalf of the Parties (or either of them) in the course of the performance of the obligations, services and activities under this Agreement that is exclusive to Developing, Manufacturing, or Commercialising the API, Commercial API, Commercial Products or the Purchaser Background IP shall be owned by the Purchaser (the “Purchaser Arising IP”). For clarity, Purchaser Arising IP shall not include GSK Background IP or GSK Arising IP.

The Purchaser hereby grants to GSK and its Affiliates a non-exclusive, worldwide, fully paid-up and royalty free licence (with the right to grant sub-licences to Nominated Manufacturers) to use the Purchaser Intellectual Property solely as necessary for the performance of GSK’s obligations under this Agreement, including supplying and Manufacturing (or having Manufactured) the applicable Products and the performance of the Development Services. GSK will not use any Purchaser Background IP, Purchaser Know-How or Purchaser Arising IP for any other purpose nor will it disclose or otherwise share any Purchaser Background IP, Purchaser Know-How or Purchaser Arising IP with any Third Party.

To the extent that the output of the Development Services or any deliverables or results produced by GSK in connection with its performance under this Agreement incorporates any GSK Background IP, GSK Know-How or GSK Arising IP, GSK hereby grants to the Purchaser a non-exclusive, perpetual, fully paid-up and royalty free licence (with the right to grant sub-licences, including through multiple tiers) to use any such GSK Background IP, GSK Know-How or GSK Arising IP solely and exclusively to the extent necessary for the purposes of Developing, Manufacturing or Commercialising the Products. Except as otherwise expressly provided for under the Purchase Agreement, the Purchaser shall not use any GSK Background IP, GSK Know-How or GSK Arising IP anywhere else or for any other purpose and shall not disclose or otherwise share GSK Background IP, GSK Know-How or GSK Arising IP with any Third Party.

At the other Party’s reasonable expense, each Party shall do all such further acts and things, and execute all such other documents as the other Party may from time to time reasonably require in order to give full effect to the assignments and licences of rights granted under this Agreement.

Nothing in this Agreement shall be deemed or implied to be, and each Party disclaims all implied rights to, the grant by a Party to the other Party of any right, title or interest in such Party’s Confidential Information or Intellectual Property, except as are expressly set forth in this Agreement.

PRODUCT FORECASTS AND ORDERS

Within [***] of the Effective Date, and thereafter on a [***] basis until the date on which the Purchaser files the first Regulatory Approval Application, the Purchaser shall provide to GSK or (if GSK so directs) the Nominated Manufacturer a non-binding rolling projection of the Purchaser’s expected volume requirements for Commercial API and Commercial Products for at least the following [***] (the “Volume Projection”). For the avoidance of doubt, the Volume Projection is not a Forecast Schedule and the Purchaser shall not be required to provide any further Volume Projection with effect from the date on which the Purchaser files the first Regulatory Approval Application.

On the first day of the month following the filing of the first Regulatory Approval Application, and thereafter on the first day of each subsequent month during the Term (or on such other date or at such frequency, as the Parties may agree in writing), the Purchaser shall provide to GSK or (if GSK so directs) the Nominated Manufacturer a rolling forecast schedule of volume requirements for:

Commercial API; and

Commercial Products on a SKU-by-SKU basis,

The quantity requirements shown:

in the first [***] in respect of Commercial API; and

in the first [***] in respect of Commercial Product,

The Purchaser shall deliver purchase orders or equivalent documentation, corresponding to the Commercial API and Commercial Product volumes shown in each month of the Firm Zone to GSK on a [***]. Each purchase order shall, as applicable, unless otherwise agreed between the Parties:

comprise of quantities equivalent to the applicable MOQ (or to for that MOQ plus one or more applicable IOQs). If GSK does (in its discretion) accept a purchase order for a quantity of Product that is not equivalent to the applicable MOQ (or to the MOQ plus one or more IOQs), the Purchaser shall remain liable under Clause 19 (Write Offs) for [***]; and

specify the quantities of Product ordered (by SKU and by country, and required Delivery date, which shall:

in respect of Commercial Product, not be less than the applicable Lead Time (as set forth on Schedule 1) from the date of the relevant purchase order; and

in respect of Commercial API, not be less than [***] from the date of the relevant purchase order.

Purchase orders issued by the Purchaser under Clause 10.4 shall be delivered either electronically or by such other means, and to such location or contact person or system, as GSK shall specify in writing. GSK or the Nominated Manufacturer shall respond to each such purchase order received from the Purchaser within [***] of receipt. Provided that the quantity requirements for any purchase order comply with the restrictions set forth in Clause 10.4 and subject to Clause 10.6, GSK shall accept the purchase order (each such order then becoming a “Firm Order”) and its response shall include confirmation of the quantity and the date for Delivery. If GSK does not respond to any purchase order received within such [***] period, then such purchase order shall be deemed to be accepted.

In the event that discussion is required regarding the timing of Manufacture and Delivery of any Firm Order (or any adjustment to the quantities set forth in the Firm Order), including if the quantities of Commercial API in the Firm Zone exceed the quantities shown API shown in the Forecast Schedule for the period corresponding to the Lead Time for Commercial API, the

GSK shall use Commercially Reasonable Efforts during Working Hours to satisfy any changes in quantity, Delivery phasing or Delivery dates requested by the Purchaser in respect of a Firm Order or any additional order, provided that:

the Purchaser shall [***] in the event it is able to meet such change; and

without prejudice to Clause 10.7(A), if the Purchaser wishes to reduce the quantities of Product in any Firm Order and GSK (or the Nominated Manufacturer) agrees to such reduction, the Purchaser shall in any event [***].

It is understood that, subject to Clause 10.9 and without prejudice to Clause 19 (Write Offs), the remaining [***] in respect of Commercial Product, and [***] in respect of Commercial API, of each Forecast Schedule (i.e., the period after the applicable Firm Zone) constitutes an estimate of the future Product requirement of the Purchaser and does not comprise a specific purchase requirement or a commitment by the Purchaser to purchase such Product (except as otherwise provided in this Agreement). It is further understood that each such Forecast Schedule does not constitute a commitment by GSK to Manufacture or supply such Product.

The quantity requirements shown:

in the subsequent [***] following the Firm Zone in respect of Commercial API; and

in the subsequent [***] following the Firm Zone in respect of Commercial Product;

the Unused Capacity Fee shall be [***] (whether for GSK or its Affiliates or for any Third Party); and

GSK shall use Commercially Reasonable Efforts to reduce, avoid or otherwise mitigate any such Unused Capacity Fee by so reallocating capacity at the Manufacturing Site as far as practicable.

For the avoidance of doubt, no Unused Capacity Fee shall be payable pursuant to Clause 10.9 in respect of Missing Products that are Commercial Products for which the Purchaser is required to pay the sum specified in Clause 4.5.

Without prejudice to Clause 7.5, the provisions of this Clause 10 (Product Forecasts and Orders) are subject to the provisions of Clause 25 (Capacity Constraints) in the event that an Allocation is required to be made.

In order to facilitate a successful commercial launch of Products in each Relevant Launch Market and to provide flexibility on Delivery phasing and timing for each Launch Product in each Relevant Launch Market, the Parties agree as follows:

On Purchaser’s reasonable request, Purchaser may elect to require GSK to hold additional safety stock of raw materials required to Manufacture Commercial Product in accordance with Clause 7.3, provided that for clarity, the Safety Stock Fee will be payable.

Having regard to the safety stock held pursuant to Purchaser’s instructions, and provided that sufficient Commercial API is or is expected to be available to GSK on a timely basis, GSK will use Commercially Reasonable Efforts to reduce the Lead Time required for the Manufacture of Launch Product.

GSK will use Commercially Reasonable Efforts to expedite the finalisation of Artwork for, and the printing of, packaging materials required for Launch Products to comply with any anticipated launch timelines, including by reserving capacity at printing service providers and committing to the purchase of such services on an expedited basis.

On Purchaser’s request, GSK will use Commercially Reasonable Efforts to make Manufacturing capacity available at the Manufacturing Site in respect of Commercial Product on short notice and/or to reserve capacity for Manufacture in excess of that required for the forecast volumes that Purchaser can release at short notice.

[***].

During a Launch Period, Purchaser will be released from its binding commitments in the Firm Zone in respect of the Launch Product to the extent that changes are permitted in accordance with this Clause 10.10.

The additional flexibility arrangements agreed pursuant to Clauses 10.10 (A)-(F) above will not affect:

the Manufacture of Commercial API in any way; or

the MOQ and IOQ applicable to the Manufacture of Commercial Product.

DELIVERY OF PRODUCT

Subject to Clause 25 (Capacity Constraints), GSK (or the Nominated Supplier) shall Deliver the Products on the date specified in the relevant Firm Order, provided that:

the quantity of Product Delivered by GSK may vary by [***] from the quantity specified in the relevant Firm Order; and

the date of Delivery may vary by [***] from the date specified in the relevant Firm Order,

In respect of Commercial API, the Parties may agree that some or all of the quantities of such Commercial API Delivered pursuant to Clause 11.1 shall remain in the possession of GSK or its Affiliate on [***]. The Purchaser shall pay GSK a storage fee to cover any GSK costs and expenses incurred in connection with holding and storing such [***] stock (“Storage Fee”). The Storage Fee is set forth in Schedule 4 (Fees). For the avoidance of doubt, no Storage Fee is payable in respect of quantities of Commercial API required for the Manufacture of the Commercial Product shown in the Firm Zone and that are held by GSK at designated Manufacturing Site in respect of Commercial Product for the purposes of such Manufacture.

Subject to paragraph 2 of Schedule 3 (Toll Manufacturing Provisions), the risk in and title to the Commercial Products shall remain with GSK (or its Affiliate) until Delivered, at which point it shall pass to the Purchaser. Title to Commercial API shall pass to the Purchaser when such Commercial API is purchased by Purchaser, but risk in such Commercial API shall remain with GSK in accordance with Clause 8.5 for so long as such Commercial API is in GSK’s possession as Purchaser Materials.

Other than in respect of Commercial API that the Parties agree shall be retained by GSK on Consignment, the Purchaser shall collect the Products Delivered from the Manufacturing Site on the date of Delivery, or such date as GSK, the Nominated Supplier or the Nominated Manufacturer may notify to the Purchaser (provided that, and if the Delivery date notified to the Purchaser is earlier or later than the Delivery window contemplated by Clause 11.1, the Delivery date must be agreed with the Purchaser). Notwithstanding the foregoing, and without limiting Clause 20.2, Purchaser may, [***], elect to obtain Delivery at any point within [***] of the notified date of Delivery by providing notice to GSK of such revised Delivery date.

Commercial API that the Parties agree shall be retained by GSK [***] at the Manufacturing Site in respect of Commercial API shall be collected by the Purchaser from such Manufacturing Site on such date as may be agreed between the Parties.

For the avoidance of doubt, irrespective of whether or not any quantity of Commercial API is retained by GSK [***] for a period of time after Delivery, the Purchaser shall be responsible for the delivery of Toll Materials to the designated Manufacturing Site in respect of Commercial Product.

PRICE

The Purchaser shall pay:

the applicable Price (as determined in accordance with this Clause 12 (Price)) for Products supplied under this Agreement;

the fees in respect of Development Services supplied under this Agreement as set forth in (or determined in accordance with) the applicable Scope of Work;

the fees payable in respect of any Technology Transfer undertaken pursuant to this Agreement (except as otherwise expressly set forth in this Agreement); and

any Storage Fee and/or Safety Stock Fee and/or Unused Capacity Fee payable pursuant to this Agreement.

The Price and other fees payable pursuant to this Agreement shall be exclusive of Sales Tax imposed on or with respect to such payments, which the Purchaser shall pay in addition to the Price or other fee upon presentation by GSK of a valid Sales Tax invoice.

The Price for the Commercial API shall be equal to the Commercial API Base Cost (as determined in accordance with Part B of Schedule 1) [***] and the Price for Commercial Products shall be equal to the Commercial Product Base Cost (as determined in accordance with Part C of Schedule 1) [***].

INVOICE AND PAYMENT

GSK (or the Nominated Supplier) shall invoice the Purchaser upon each Delivery of Products or performance of the Development Services. Each invoice shall specify, as applicable:

the Price in respect of the Products Delivered or the Development Services performed (or the development work undertaken pursuant to Clause 3.12 and the implementation of such development work);

the quantity of Products Delivered;

the amount of Sales Tax due in respect of the Products Delivered or Development Services performed (or the development work undertaken pursuant to Clause 3.12 and the implementation of such development work); and

any other fees payable or amounts reimbursable to GSK pursuant to this Agreement.

Any amounts reimbursable to GSK pursuant to this Agreement other than the Price for Product Delivered or Development Services performed and any associated Sales Tax may be invoiced separately from any invoice relating to the Price for Product Delivered or Development Services performed and any associated Sales Tax.

The Purchaser shall pay the invoices issued by GSK or the Nominated Supplier in the applicable Invoice Currency within [***] from the date of receipt of the respective invoice by electronic transfer to the account nominated by GSK or the Nominated Supplier in writing.

If Purchaser fails to make any payment pursuant to this Agreement when due, simple interest shall thereafter accrue on the sum due to GSK (or the Nominated Supplier) until the date of payment at the per annum rate of [***] above the then-current prime rate reported in The Wall Street Journal or the maximum rate allowable by Applicable Laws, whichever is the lower.

All payments by the Purchaser under this Agreement shall be made without any deduction or withholding of any monies, unless required by Applicable Law. In the event that monies are deducted or withheld, the Purchaser shall promptly pay the amount withheld to the appropriate Governmental Entity and shall provide GSK (or the Nominated Supplier) with the original receipt issued by that Governmental Entity or other sufficient evidence of payment. To the extent that amounts are so withheld and paid to the proper taxing authority, such amounts shall be treated for all purposes of this Agreement as having been paid to GSK (or the applicable Nominated Supplier) with respect to whom such amounts were withheld. Each Party agrees to cooperate with the other Party in claiming refunds or exemptions from such deductions or withholdings under any relevant agreement or treaty which is in effect. The Parties shall discuss and cooperate regarding applicable mechanisms for minimizing such Taxes to the extent possible in compliance with Applicable Law. In addition, the Parties shall cooperate in accordance with Applicable Law to minimize indirect Taxes (including Sales Tax) in connection with this Agreement.

ELECTRONIC SYSTEMS

GSK hereby grants, or shall procure the grant of, a limited licence (being a royalty-free licence under the GSK System IP, for the Term and revocable by GSK in the event of a breach by the Purchaser of the obligations set forth in this Clause 14 (Electronic Systems)) to use the GSK Group’s “Collaborate” information technology system or such successor or alternative demand management software or system as the GSK Group may deploy (the “GSK System”). Such licence shall permit the Purchaser to use the GSK System only for the purposes of complying with its obligations under this Agreement and meeting GSK’s requirements for demand planning, management and Delivery of Products. The use of such GSK System shall be subject to the following further conditions:

other than the warranty set forth in Clause 28.1(B), GSK gives no representation or warranty as to the GSK System, including that it shall be available at any time, or shall operate in error-free fashion, and the Purchaser agrees that any failure of such GSK System shall not limit or exclude any obligation or responsibility on the part of the Purchaser;

the Purchaser shall remain responsible for maintaining (i) such internet or telecommunications connectivity and (ii) such minimum IT hardware requirements as may be necessary to enable the Purchaser to access such GSK System; and

if the GSK Group provides the Purchaser with passwords or other access or authentication credentials, to use the GSK System, the Purchaser shall provide those credentials only to named personnel (and shall communicate the names of such personnel to GSK and/or its Affiliate), and shall procure that the named personnel shall not share their credentials with any other Purchaser personnel.

The Purchaser shall take reasonable care to ensure that:

nothing done by its employees shall contaminate, corrupt, impair or adversely affect any of the GSK Group’s computers, computer software and computer data and, without prejudice to the generality of the foregoing, shall take due care to ensure that no invasive programs, “computer viruses” or “logic bombs” shall be introduced to any of the GSK Group’s computers, computer software or data; and

it operates reasonably up to date commercially available anti-virus software, including regularly updating the virus signature files of such software (as recommended by the relevant licensor), and an electronic firewall and such other technical safeguards as good IT practice requires in relation to the Purchaser’s network or IT infrastructure (in each case to the extent that such network or infrastructure may connect to the GSK System).

QUALITY ASSURANCE

GSK shall maintain such records as are necessary and appropriate to demonstrate compliance with cGMP in connection with the supply of the Development Services and the Manufacture of the Commercial API and Commercial Products.

GSK shall be responsible for devising and implementing any corrective actions and/or preventative actions (“CAPAs”) that may be required in connection with the Manufacture and technical release of Products, other than any CAPAs relating to analytical testing and release, which shall be the responsibility of the Purchaser.

The respective responsibilities of each Party in relation to technical and quality matters are further set forth in the Quality Agreement. In the event of a conflict between the terms of the Quality Agreement and the terms of this Agreement with respect to the quality or monitoring of the Product, the terms of the Quality Agreement shall, to the extent of such conflict, prevail.

DEFECTIVE PRODUCTS

The Purchaser shall notify GSK or the Nominated Supplier (or ensure that GSK or the Nominated Supplier is notified) in writing of any Delivery that is (in whole or in part) incomplete in accordance with the terms of this Agreement within:

[***] following Purchasers receipt of possession and control of any shipment of Products from any common carrier following Delivery thereof (including, if applicable, the expiration or final release of any holds instituted by any governmental authority in connection with the import or export of any Product); or

in respect of Commercial API that the Purchaser elects on Delivery to leave in GSK’s possession [***] pursuant to Clause 11.2, within [***] of Delivery (or, if the relevant Manufacturing Site cannot accommodate a visit by the Purchaser during that [***] period, such later date as may be agreed between the Parties),

work in good faith with the Purchaser on a plan to complete the incomplete Delivery; and

use Commercially Reasonable Efforts to rectify the incomplete delivery as soon as possible and in any event within [***] of receipt of the Rejection Notice.

Without limiting Clause 16.1, the Purchaser shall have the right to reject any allegedly Defective Products upon written notice to GSK, such notice to include the reason(s) for the rejection and to be accompanied with any supporting documentation or other evidence, such right to be exercised within the period stipulated in the Quality Agreement (or, if no such period is stipulated):

in respect of Defects that ought to be detected pursuant to the incoming inspections required pursuant to the Quality Agreement, the period specified in Clause 16.1(A) or 16.1(B) (as applicable);

in respect of Defects not covered by Clause 16.2(A) but which are not Latent Defects, within [***] following Purchaser’s receipt of possession and control any shipment of Products from any common carrier following Delivery thereof (including, if applicable, the expiration or final release of any holds instituted by any governmental authority in connection with the import or export of any Product); or

in the case of Latent Defects, within [***] after discovery of the Latent Defect.

If the Purchaser purports to reject any Products pursuant to Clause 16.2:

the Purchaser shall store the rejected Products in quarantine in accordance with GSK’s reasonable instructions and shall allow GSK (or its nominated representatives) to inspect and/or analyse the same;

the Parties shall use reasonable endeavours to agree whether or not the rejected Products are Defective; and

if, within [***] of GSK or the Nominated Supplier being notified pursuant to Clause 16.2, the Parties fail to agree whether or not the rejected Products are Defective, the dispute shall be referred to and determined by an Independent Expert whose decision shall be final and binding on the Parties. The Independent Expert shall act as an expert and not as an arbitrator and (unless the Independent Expert otherwise determines) his or her fees shall be paid by the Party against whom the Independent Expert’s decision is given.

If the Parties agree, or if the Independent Expert finds, that any Products are Defective and have been properly rejected, then, subject to Clause 16.5 and without limiting Clause 16.7, GSK shall, at Purchaser’s option, either:

replace the Defective Products at GSK’s sole cost and expense and as soon as reasonably possible (provided that the original Defective Product has been paid for by Purchaser) (which replacement may, in respect of Commercial API, comprise the same batch(es) of Commercial API following the reprocessing of that Commercial API at GSK’s sole cost); or

refund to the Purchaser the Price paid for such Defective Products [***].

In respect of Commercial API, if GSK is able to reprocess that Commercial API within [***] of the date on which the Parties agree, or the Independent Expert finds, that such Commercial API is Defective, GSK shall have the right to undertake such reprocessing (and the Purchaser shall not make any contrary election pursuant to Clause 16.4).

If any rejected Products are found by the Independent Expert not to be Defective, the Purchaser shall pay for such Products in accordance with the payment provisions set forth in this Agreement.

For the avoidance of doubt, if any Commercial Product is finally determined to be Defective, then, to the extent that the applicable Defect is determined to [***], then [***].

PRODUCT LICENCE

The Purchaser shall (or shall procure that its Affiliate shall), at its own expense, obtain and maintain all Product Licences in the Territory which may from time to time be required by any Regulatory Authority or other Governmental Entity. The Purchaser shall be responsible for responding to all requests for information related to such Product Licences made by, and for making all legally required filings relating to such Product Licences with, any Regulatory Authority or other Governmental Entity having jurisdiction to make such requests or require such filings.

Without prejudice to the Purchaser’s obligations under Clause 17.1, if any Product Licence relating directly to any of the Products is suspended or revoked after the Effective Date, the Purchaser shall promptly notify GSK (and, if applicable, each of the Nominated Manufacturer and the Nominated Supplier) of the event and shall promptly inform GSK of the anticipated impact on the Purchaser’s purchases of the affected Product and the Purchaser’s general intentions with respect to the affected Product.

PRODUCT SPECIFICATIONS

Subject to the provisions of Clause 2 (GSK’s Obligations) and unless otherwise required to do so by a Governmental Entity, GSK shall not without the prior written consent of the Purchaser, make any change to the Specifications that might reasonably be expected to impact the Product Licence.

Each application by GSK for any consent pursuant to Clause 18.1 shall be submitted in writing and assessed by the Purchaser in accordance with the Technical Change Procedure. Any agreed change made under this Clause 18.2 shall be implemented at GSK’s cost.

The Purchaser shall bear the costs of any change to the Specifications or the Manufacturing process required by Applicable Law or a Governmental Entity (including the cost of any write-off in accordance with Clause 19 (Write Offs) and/or any related development work in accordance with Clause 3 (Development Services)). Notwithstanding the foregoing, if a required change to the Specifications or any Manufacturing process is such that GSK cannot reasonably implement the change without significant interference with its other operations at the Manufacturing Site, the provisions of Clause 32.2 shall apply.

Prior to implementation of any change referred to in this Clause 18 (Product Specifications), the Parties shall agree on a procedure to ensure that the change is approved by the relevant Governmental Entity, and that GSK is given a reasonable period of time to implement any changes which such Governmental Entity may approve.

All Products Delivered hereunder will be suitably packed for shipment by GSK in accordance with the terms of this Agreement, the Quality Agreement and Applicable Law. Without limiting the foregoing, each Product delivered hereunder will be shipped packaged in containers in accordance with the applicable Specifications or as otherwise agreed by the Parties in writing. Each such container will be individually labeled with a description of its contents, including the manufacturer lot number, quantity of Product, date of Manufacture, required storage conditions and expiration date.

WRITE OFFS

Where:

the Purchaser submits a purchase order for a quantity of Product other than the MOQ (or the MOQ plus one or more IOQs) and GSK agrees to Deliver such quantity;

any changes to the Manufacture of the Products and/or Specification are implemented pursuant to a request of any Regulatory Authority or pursuant to Applicable Law; provided that the foregoing shall be limited to Product deliverable [***];

GSK or the Nominated Manufacturer agrees to any changes requested by the Purchaser in accordance with this Agreement; or

solely in relation to long-lead time Materials and safety stock of Materials held pursuant to Clause 7.5, the quantity requirement for a Product shown for any month in any Forecast Schedule varies from the quantity requirements forecast for that month in any previous Forecast Schedule, [***],

Where this Clause 19.2 applies, the Purchaser shall reimburse to GSK or the Nominated Manufacturer the cost of write-off (calculated in accordance with IFRS) of:

Materials reasonably purchased or ordered by GSK or the Nominated Manufacturer in view of quantities indicated in any Forecast Schedule and the terms agreed with the supplier of such Materials, including any applicable minimum order quantity and/or lead times (which may exceed the Firm Zone);

Purchaser Materials reasonably purchased or ordered by GSK or the Nominated Manufacturer in view of quantities indicated in any Forecast Schedule;

safety stock quantities of Materials as required pursuant to Clause 7.5; and

work-in-progress and/or Products Manufactured in light of the quantity requirements shown in the Forecast Schedule (taking due account of the applicable Lead Time),

in the Manufacture of Products to meet Firm Orders (or in the case of certain Materials with long lead times and/or safety stock of Materials held pursuant to Clause 7.5, prior to the Firm Zone); or

in the case of Materials not used by GSK or the Nominated Manufacturer at the Manufacturing Site exclusively in the Manufacture of Products, in the manufacture at the relevant Manufacturing Site of other products for GSK, its Affiliates or Third Parties,

For the avoidance of doubt, it is acknowledged that Purchaser Materials are held by GSK or the Nominated Manufacturer on a [***] and, accordingly, the cost to GSK or the Nominated Manufacturer of writing off Purchaser Materials will not exceed the cost (if any) incurred by GSK of the Nominated Manufacturer in destroying or otherwise disposing of such Purchaser Materials or in storing such Purchaser Materials pending collection by, or shipment to, the Purchaser (or its designee) from the Manufacturing Site.

REGULATORY COMPLIANCE

GSK or the Nominated Manufacturer shall:

provide to the Purchaser all such documents and information available to GSK or the Nominated Manufacturer as may be required by a Regulatory Authority from the Purchaser with respect to the Manufacture of the Product; and

allow such inspections of the Manufacturing Site as may be requested by such Regulatory Authority.

Prior to any Commercial API or Commercial Products being Delivered to Purchaser (including, for clarity, making such Product available for pick-up by the Purchaser (or its designee)), GSK (or the Nominated Manufacturer) shall:

perform batch investigations (if applicable); and

following the testing of such Commercial API or Commercial Products, a review of the relevant batch documentation and confirmation of compliance with cGMP:

issue a Manufacturer’s Batch Certificate; and

perform the technical release of the Product for Delivery to the Purchaser and issue a Certificate of Analysis.

Each Party shall maintain in accordance with and for the period required under cGMP and Applicable Law all such records relating to the Manufacture and distribution of the Products as it may be required to hold under such Applicable Law.

PRODUCT EVENTS

Any and all complaints of which GSK becomes aware relating to the quality or efficacy any Product shall promptly be forwarded to the Purchaser’s senior quality officer or that person’s designee. The Purchaser shall promptly inform GSK and/or the Nominated Manufacturer of any and all complaints that the Purchaser receives which may relate to manufacturing or other processes at the Manufacturing Site. Notification shall be given by telephone, with a written confirmation immediately following.

In the event that a Regulatory Authority requires, or the Purchaser decides to initiate, a recall, withdrawal or field correction (each, a “Product Event”) with respect to any Product Manufactured and supplied under this Agreement, the Purchaser shall immediately notify GSK and each Party shall fully cooperate with the other Party to implement the same.

If (and only if and to the extent that) the Product Event is:

required by Applicable Law or customary industry practice; and

necessitated by a failure on the part of GSK to comply with all its obligations under this Agreement,

replace the Product recalled; or

(at the Purchaser’s election or where it is not reasonably practicable for GSK to replace the Product) refund the Purchaser for the recalled Product; and

within [***] of receipt of an invoice for the same, reimburse the Purchaser for its reasonable out of pocket expenses incurred in carrying out the Product Event, provided that:

such expenses are evidenced in writing; and

GSK shall not be liable for any costs or expenses arising to the extent of attributable to the acts or omissions of the Purchaser, its Affiliates or its or their distributors, wholesalers or other customers.

Subject to Clause 21.3, all costs relating to a Product Event shall be [***]. The Purchaser shall reimburse to GSK all costs and expenses incurred by GSK and its Affiliates in respect of a Product Event within [***] of receipt of an invoice for the same.

In the event of a dispute between the Parties in relation to the allocation of costs between the Parties in relation to a Product Event in accordance with this Clause 21 (Product Events), the matter shall be determined by an Independent Expert and the decision of the Independent Expert shall be final and binding on the Parties. The Independent Expert shall act as an expert and not as an arbitrator and (unless the Independent Expert otherwise determines) its fees shall be borne between the Parties in the same proportion as the costs of the Product Event are allocated between them by the Independent Expert.

For the avoidance of doubt, any Toll Materials used in the Manufacture of such Commercial Product [***] shall be taken into account in determining [***] in respect of the relevant Reporting Year.

PHARMACOVIGILANCE

If a Party becomes aware of any action that may be or will be taken or required by any Regulatory Authority for safety reasons connected with any product containing the same active substance as the Product, it shall immediately, and in any event not later than [***] after so becoming aware, notify the other Party’s senior quality officer in writing and provide all available relevant details.

Without prejudice to Clause 22.1, GSK shall notify the Purchaser promptly following its receipt of information of a possible Adverse Event with respect to any Product. To the extent an Adverse Event of which the Purchaser becomes aware may relate to manufacturing or other processes at the Manufacturing Site, the Purchaser shall inform GSK of such Adverse Event and shall disclose to GSK any information it has regarding that Adverse Event.

Upon receipt of notification of a Product complaint and/or Adverse Event in respect of any of the Products, GSK will conduct an internal investigation to determine the validity of such complaint. The findings of such investigation shall be reported in writing to the Purchaser within three (3) Business Days of such finding, or such other time as may be set forth in the Quality Agreement.

CONFIDENTIALITY

All Confidential Information disclosed by a Party (together with its Affiliates, the “Disclosing Party”) to the other Party (together with its Affiliates, the “Receiving Party”) shall be used by the Receiving Party solely in connection with the activities contemplated by this Agreement, shall be maintained in confidence by the Receiving Party, and shall not otherwise be disclosed by the Receiving Party to any other Person, firm or agency, governmental or private (other than a Party’s Affiliates), without the prior written consent of the Disclosing Party.

The Receiving Party may disclose Confidential Information to (a) its Affiliates, directors, officers, employees, consultants, attorneys, vendors, suppliers, contractors, collaborators and advisors (“Personnel”) who have a need to know for the Development, Manufacture, and Commercialisation of Products in accordance with this Agreement, prosecution and maintenance of any Patent or to enforce or exercise rights under this Agreement, including in connection with Regulatory Approval Applications and obtaining Regulatory Approvals or (b) to actual or potential investors, acquirers, permitted licensees/sublicensees and other financial or commercial partners who need to know such Confidential Information in connection with their evaluating or carrying out an actual or potential investment, acquisition, collaboration, public offering, merger or other similar transaction, in each case relating to the Transferred Assets (“Authorised Third Parties”), provided that each of GSK and the Purchaser shall:

procure that its Personnel and Authorised Third Parties shall be bound by confidentiality obligations at least as strict as this Clause 23 (Confidentiality) (except, in respect of Confidential Information that is not Know-How or Intellectual Property, to the extent that a shorter confidentiality period is customary in the industry); and

each remain liable for the compliance of its Personnel or Authorised Third Parties with the obligations of confidentiality set out in this Clause 23 (Confidentiality).

The obligations of confidentiality set forth in Clauses 23.1 and 23.2 shall not extend to any information which (as evidenced by competent documentation):

was known or used by the Receiving Party prior to its date of disclosure to the Receiving Party;

either before or after the date of the disclosure to the Receiving Party, is lawfully disclosed to the Receiving Party by sources (other than the Disclosing Party) not known by the Receiving Party to be subject to a duty of confidentiality to the Disclosing Party with respect to such Confidential Information;

either before or after the date of the disclosure to the Receiving Party, becomes published or generally known to the public (including information known to the public through the sale of products in the ordinary course of business) through no fault or omission on the part of the Receiving Party or its Affiliates; or

is independently developed by or for the Receiving Party without reference to or reliance upon the Confidential Information.

Subject to Clause 23.3, the obligations of confidentiality set forth in Clauses 23.1 and 23.2 shall expire

in respect of Confidential Information that is Know-How or Intellectual Property, when such Know-How or Intellectual Property ceases to be confidential; and

in respect of other Confidential Information, [***] after the expiry or termination of this Agreement.

Clauses 23.1 and 23.2 shall not preclude the Receiving Party from disclosing Confidential Information to the extent the Receiving Party reasonably concludes, after consultation with counsel, that the disclosure of such Confidential Information is necessary (a) to comply with Applicable Laws or any Order, including complying with the Securities Act of 1933, as amended, the Securities Exchange Act of 1934, as amended, the rules and regulations of the U.K. Financial Conduct Authority or other applicable securities laws, (b) to defend or prosecute litigation or to comply with governmental regulations, (c) in connection with the filing of documentation in order to obtain or maintain Regulatory Approvals or (d) in connection with any filing with a Governmental Entity with respect to a Patent; provided that, unless prohibited by Applicable Laws or any Order, the Receiving Party provides prior written notice of such disclosure to the Disclosing Party and takes reasonable and lawful actions to avoid and/or minimize the degree of such disclosure.

Subject to Clauses 23.3, and save to the extent necessary to comply with any continuing obligations under this Agreement or Applicable Law, the Receiving Party shall, upon expiry or termination of this Agreement and at the other Party’s request, return or destroy all of the Disclosing Party’s Confidential Information which it has in its possession or under its control, provided that:

the Receiving Party may retain one confidential copy in the Receiving Party’s confidential files solely for purposes of monitoring compliance with the terms of this Clause 23 (Confidentiality); and

nothing in this Clause 23.6 shall require the Receiving Party or its Personnel to delete or otherwise destroy any copies of the Disclosing Party’s Confidential Information that is stored in electronic form in back-up archives of its information technology systems that are not accessible to such Personnel in the ordinary course of business.

For clarity, the provisions of this Clause 23 (Confidentiality) shall not prejudice the rights or obligations of either Party (or their respective Affiliates) under the Purchase Agreement.

FORCE MAJEURE

If any Force Majeure Event occurs in relation to either Party which affects or may affect the performance of any of its obligations under this Agreement, it shall notify the other Party as soon as practicable as to the nature and extent of the circumstances in question.

The Affected Party shall not be deemed to be in breach of this Agreement, and shall not otherwise be liable to the other Party, by reason of any delay in performance, or the non-performance of any of its obligations under this Agreement, to the extent that the delay or non-performance is due to any Force Majeure Event, and the time for performance of that obligation shall be extended accordingly.

If the performance by the Affected Party of any of its obligations under this Agreement is prevented or delayed by a Force Majeure Event for a continuous period in excess of [***], 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.

If the Affected Party is prevented or delayed from performance of any of its obligations under this Agreement by a Force Majeure Event for [***] or more, the other Party shall in its discretion have the right to terminate this Agreement with immediate effect by giving written notice to the Affected Party.

CAPACITY CONSTRAINTS

If GSK or the Nominated Manufacturer is unable to Manufacture the quantities of Products forecasted or ordered by the Purchaser due to:

shortages of Materials that are used both in the Manufacture of Products and in the manufacture of products for the GSK Group or its Third Party customers; or

constraints on the capacity at:

the Manufacturing Site; or

any manufacturing site operated by the GSK Group at which any Materials are manufactured,

In the circumstances contemplated by Clause 25.1, GSK shall (or shall procure that its Affiliate shall), subject to Clause 25.5, allocate the available Materials, or available capacity at the Affected Site, between:

the Products;

products manufactured by the GSK Group for Commercialisation by the GSK Group that rely on the same Materials or Affected Site; and

products manufactured by the GSK Group for Commercialisation by its Third Party customers that rely on the same Materials or Affected Site,

In the circumstances contemplated by Clause 25.1:

the Purchaser shall, on request, provide GSK or its Affiliate with such information as GSK or its Affiliate may reasonably require in order to determine the Allocation in accordance with Clause 25.2;

notwithstanding anything to the contrary in Clause 10 (Product Forecasts and Orders), each Firm Order shall be deemed to be revised (as to quantities of Products and/or Delivery dates, as applicable) to the extent necessary to accord with the Allocation (and the Purchaser shall be deemed to agree with such revision); and

for the purposes of Clause 11 (Delivery of Product), the due date for Delivery in respect of any Firm Order shall reflect any revision to the such Firm Order made pursuant to this Clause 25.3.

Following any Allocation, the Parties shall, at the Purchaser’s request, co-operate in good faith (each acting reasonably) to devise a plan for the re-supply of Products in greater quantities than contemplated by the then-current Forecast Schedule once the circumstances giving rise to the Allocation cease to apply (and, notwithstanding anything to the contrary in Clause 10 (Product Forecasts and Orders), future Forecast Schedules may be revised to accord with such agreed plan).

Any Materials for which the Purchaser is paying any Safety Stock Fee under this Agreement shall (notwithstanding any overall shortages of such Materials and any Allocation that is or would otherwise be implemented in accordance with this Clause 25 (Capacity Constraints)) be used solely in the Manufacture of Products under this Agreement. For the avoidance of doubt, no Toll Materials in GSK’s possession may be used by GSK for any purposes other than the Manufacture of Commercial Products.

AUDIT AND INSPECTION RIGHTS

The Parties acknowledge and agree that, in accordance with Applicable Law, [***].

Notwithstanding Clause 26.1, the Purchaser may [***] in relation to the Third Party and Third Party facility from which a Shared Source Material is obtained for use in the Manufacture of Products. Clause 26.5(B) shall apply to Shared Source Materials in respect of which the Purchaser does so elect (each, a “Delegated Shared Source Material”).

[***]

For the avoidance of doubt, Materials that are, at any time during the Term:

Unique Source Materials may:

become Shared Source Materials if the GSK Group begins purchasing from the relevant Third Party and Third Party facility materials for purposes other than the Manufacture of Products; and/or

be deemed to be Shared Source Materials for the purposes of this Agreement if (and for so long as) the GSK Group is [***];

Shared Source Materials may become Unique Source Materials if:

the GSK Group ceases purchasing from the relevant Third Party and Third Party facility materials for purposes other than the Manufacture of Products; and/or

such Materials have been deemed to be Shared Source Materials for the purposes of this Agreement pursuant to Clause 26.4(A)(ii) and the GSK Group subsequently [***];

Delegated Shared Source Materials may become Non-Delegated Shared Source Materials if the Purchaser notifies GSK in writing that it will (from a date to be specified in such notice) no longer [***]; and

Non-Delegated Shared Source Materials may become Delegated Shared Source Materials if the Purchaser notifies GSK in writing that it will (from a date to be specified in such notice) [***].

Subject to Clauses 26.6 to 26.8, the Purchaser shall have the right, not more than [***] (other than “for cause” audits), to audit and inspect:

those parts of the Manufacturing Site and related plant and machinery used for the Manufacture of Products for the Purchaser under this Agreement; and

(i)        [***]

[***],

[***]; and

[***].

The Purchaser shall give GSK and/or the Nominated Manufacturer not less than [***] prior written notice of any inspection proposed to be undertaken pursuant to Clause 26.5, and each such inspection shall occur during Working Hours at the Manufacturing Site, provided that in the event of any “for cause” audit for which Applicable Law requires a shorter notice period, in which case the Purchaser shall provide GSK with as much notice as possible consistent with Applicable Law.

The Purchaser’s audit and inspection rights under this Clause 26 (Audit and Inspection Rights) shall not extend to any parts of the Manufacturing Site, or any documents, records or other information, which do not relate to the Manufacture of Products for the Purchaser under this Agreement. GSK shall be entitled to redact information relating to any other product, materials, plant, equipment or premises from any documentation made available to the Purchaser pursuant to this Clause 26 (Audit and Inspection Rights).

The Purchaser’s audit shall be conducted by one team only and shall not last more than [***].

The Purchaser shall:

within [***] of the date of this Agreement, provide GSK with a written summary of [***]; and

[***].

Subject to any obligations of confidentiality the Purchaser may have to a Third Party supplier of [***], the Purchaser shall provide GSK with a report of any [***], provided that:

[***]; and

[***].

RELATIONSHIP MANAGEMENT

The Parties shall as soon as reasonably practicable after the Effective Date each appoint a relationship manager with responsibility for managing the implementation of technical aspects

The Relationship Managers shall convene a joint steering team including other representatives of the Parties (such as technical or quality personnel) by invitation for each meeting (the “Joint Steering Team”). The Joint Steering Team shall meet once a month and be co-chaired by the Relationship Managers for the purposes of planning the technical and commercial implementation of this Agreement, including but not limited to:

agreeing the Scope of Works for Development Services and reviewing the progress of Development Services;

reviewing the progress of capital expenditure projects under the CapEx Letter Agreement and this Agreement;

reviewing the progress of the Commencement Conditions and agreeing when such conditions are satisfied;

reviewing and agreeing the proposed timelines for submission of the first Regulatory Approval Application and Manufacturing Site readiness;

reviewing any ongoing technical transfer activities;

setting up appropriate supply and demand planning for Manufacture once the Commencement Conditions have been met;

agree the Expected Losses; and

reviewing proposals for New Product SKUs and any associated Development Services.

WARRANTIES

GSK warrants that:

it has full capacity and authority to enter into this Agreement and to perform its obligations under this Agreement;

it has the title and/or right to grant the Purchaser the right to use the GSK System IP in accordance with the terms of this Agreement;

the use of GSK Background IP in the performance of the Development Services does not infringe the Intellectual Property of any Third Party; and

during the Term of this Agreement,

the Products will be Manufactured in accordance with cGMP and Applicable Laws and will on Delivery comply with the Specifications;

GSK shall at all times maintain necessary licences, certifications and approvals for the Manufacturing of the Commercial API and, Commercial Products at the Manufacturing Site; and

GSK shall maintain the Manufacturing Site and its records and personnel in accordance with cGMP.

The Purchaser warrants that:

it has full capacity and authority to enter into this Agreement and to perform its obligations under this Agreement;

it has the title and/or right to grant GSK the right to use the Purchaser Intellectual Property in accordance with the terms of this Agreement;

the use by GSK or the Nominated Manufacturer of the Purchaser Intellectual Property for the purposes of this Agreement will not infringe the Intellectual Property of any Third Party; provided that the Purchaser makes no representation regarding the Transferred IP;

it holds (and will throughout the Term continue to hold) all necessary Consents to perform its obligations as contemplated by this Agreement and:

it has paid (and will throughout the Term continue to pay) all fees due in relation to such Consents;

it is not (and will not during the Term be) in breach of any conditions under any such Consents where such breach would be likely to have an adverse effect on the Purchaser’s ability to perform its obligations under this Agreement; and

during the Term of this Agreement, it will perform its obligations under this Agreement in compliance with Applicable Laws.

Except as expressly stated in this Agreement, all warranties, representations and conditions whether express or implied by statute, common law or otherwise (including, without limitation, any implied warranties of quality or fitness for purpose) are excluded to the extent permitted by Applicable Law.

INDEMNITIES

Subject to Clause 30 (Liability), GSK shall indemnify the Purchaser, the Purchaser’s Affiliates and its or their respective employees, officers and directors (each a “Purchaser Indemnitee”), and keep them indemnified, on demand, from and against any and all Losses that any of them may suffer or incur arising out of or in connection with any Third Party Claim for any:

personal injury, illness or death; or

damage to Third Party property,

as a direct result of a breach of GSK’s warranty at Clause 28.1(D).

Subject to Clause 30 (Liability), the Purchaser shall indemnify GSK, GSK’s Affiliates and its or their respective employees, officers and directors (each a “GSK Indemnitee”), and keep them indemnified, on demand, from and against any and all Losses that any of them may suffer or incur arising out of or in connection with any Third Party Claim for any:

personal injury, illness or death; or

damage to Third Party property,

Subject to Clause 30 (Liability), the Purchaser shall indemnify the GSK Indemnitees, and keep them indemnified, on demand, from and against any and all Losses that any of them may suffer or incur arising out of or in connection with any Third Party Claim that any use of the Purchaser Intellectual Property infringes the Intellectual Property of a Third Party (other than with respect to Transferred IP).

The procedure for claiming under any indemnity under this Agreement shall be as follows:

if any Person (the “Indemnified Party”) receives a claim or demand in respect of a matter which is the subject of an indemnity in its favour under this Agreement (a “Claim”) it shall give promptly the Party obliged to indemnify it (the “Indemnifying Party”) a notice describing in reasonable detail the facts giving rise to the claim for indemnification hereunder, (if then known) the amount or the method of computation of the amount of such claim, and a reference to the provision of this Agreement upon which such claim is based;

the Indemnifying Party shall have the sole and absolute right to undertake the defence, negotiation, or settlement of any such Claim with legal counsel of its choice. The Indemnified Party shall cooperate in such defence, negotiation, or settlement and, at its expense, shall make available all records, materials and witnesses reasonably requested by the Indemnifying Party in connection with such Claim; and

if the Indemnifying Party assumes the defence of a Claim:

the Indemnifying Party shall not be liable to the Indemnified Party for any legal or other expenses subsequently incurred by the Indemnified Party in connection with the defence of such Claim;

the Indemnifying Party shall keep the Indemnified Party informed of, and shall from time to time consult with the Indemnified Party regarding the status of, any Proceedings and shall provide to the Indemnified Party copies of all documents filed in, and written communications relating to, any such Proceedings, provided that the Indemnifying Party shall not be obliged to do anything that it has been advised by external counsel would amount to a waiver of legal privilege in any information;

the Indemnifying Party shall obtain the written consent of the Indemnified Party (such consent not to be unreasonably withheld) prior to ceasing to defend, settling or otherwise disposing of any Claim if, as a result thereof, the Indemnified Party:

would become subject to injunctive or other equitable relief; or

may reasonably object to such disposition of such Claim based on a material adverse effect on the Indemnified Party (including any anticipated adverse effect on the Indemnified Party’s goodwill or reputation); and

the Indemnifying Party shall not be liable for any Claim settled by the Indemnified Party without its consent.

For clarity, the provisions of this Clause 29 (Indemnities) shall not prejudice the rights or obligations of either Party (or their respective Affiliates) under the Purchase Agreement, provided that no Party (together with its Affiliates) shall be entitled to recover any sum by way of damages or other compensation under this Agreement in respect of Losses for which it has been compensated under the Purchase Agreement (and vice versa).

LIABILITY

Notwithstanding any other provision of this Agreement, nothing in this Agreement shall exclude or limit either Party’s liability to the extent the same may not be excluded or limited as a matter of law, including (to such extent) liability for [***].

Subject to Clause 30.1, neither Party shall be liable to the other under or in relation to this Agreement (including, for the avoidance of doubt, under or in relation to any indemnity given in this Agreement), whether arising in contract, tort, negligence, breach of statutory duty or otherwise, for any:

loss of profits;

loss of revenue;

loss of savings or anticipated savings;

loss of business or business opportunities;

loss of or damage to goodwill;

any indirect or consequential loss or damage; or

any punitive or exemplary damages,

Subject to Clauses 30.1, 30.2 and 30.4, GSK’s total liability in respect of this Agreement (including, for the avoidance of doubt, under or in relation to any indemnity given in this Agreement), whether arising in contract, tort, negligence, breach of statutory duty or otherwise, shall be limited:

subject to Clause 30.3(B), in any Calendar Year, to [***] of sales, at the Price, of Products supplied to the Purchaser under this Agreement during that Calendar Year; and

in aggregate over the Term of this Agreement to [***] of sales, at the Price, of Products supplied to the Purchaser under this Agreement during the Term, provided that, such limitation on GSK’s total liability shall not apply if GSK’s liability arises from [***].

Subject to Clause 30.1, GSK shall further not be liable for any Losses suffered or incurred by Purchaser, Purchaser’s Affiliates or any of its or their respective employees, officers or directors, to the extent that such Losses arise from:

the use by GSK and/or the Nominated Manufacturer of the Purchaser Intellectual Property for the purposes of this Agreement (without prejudice to any liability that GSK or its Affiliate may have under the Purchase Agreement in respect of Transferred IP);

the implementation of, and compliance with, Specifications and Manufacturing instructions provided by the Purchaser to GSK (provided that GSK has complied with such Specifications and Manufacturing instructions);

any failure by the Purchaser to comply with its obligations under this Agreement;

any Commercialisation of the Product;

any other use of the Products outside of the Territory;

the late Delivery of any Products to the extent that such late Delivery was due to any failure by the Purchaser to comply with this Agreement; or

the negligence or wilful misconduct of the Purchaser or its Personnel.