Supply Agreement, by and between Registrant and Gerresheimer Regensburg GMBH, dated as of May 8, 2018

DEFINITIONS

In this Agreement, each of the following terms shall have the respective meaning set forth below:

In this Agreement unless it is inconsistent with the context:

Words denoting the singular include the plural and vice versa; words denoting one gender include all genders; words denoting persons include corporations and vice versa.

References to the word “including” are to be construed without limitation.

The Schedules attached hereto shall form part of this Agreement and a reference to a particular Clause, Sub-Clause, paragraph or Schedule shall be a reference to the Clause, Sub-Clause, paragraph or Schedule in or to this Agreement.

The headings are inserted for convenience only and are to be ignored for the purposes of construction.

DURATION

GERRESHEIMER’S AND CLEARSIDE BIOMEDICAL’S OBLIGATIONS

In accordance with the terms of this Agreement, GERRESHEIMER shall manufacture and supply to CLEARSIDE BIOMEDICAL and/or CLEARSIDE BIOMEDICAL Affiliates such quantities of Product as ordered in accordance with the terms of this Agreement. For the avoidance of doubt, (i) CLEARSIDE BIOMEDICAL may re-sell Product purchased hereunder to its Third Party licensees or collaboration partners, and (ii) all purchase of Product pursuant to this Agreement shall be made directly by CLEARSIDE BIOMEDICAL or its Affiliates.

GERRESHEIMER undertakes to ensure that it has at all times sufficient manufacturing capacity at the Manufacturing Site to satisfy the Sprint Capacity and Product requirements set out in each Firm Order and Forecast Schedule.  

Each Party shall be entitled to request changes and modifications to the Specifications and/or Products. The Party proposing a change shall make a proposal to the other Party in writing explaining the objectives of the change and expected cost and other impacts. The Parties shall discuss the proposed change including the allocation of cost and the impact of supply of the Product. Any change should only be implemented upon prior mutual written agreement of the scope, cost and impact of the change; PROVIDED, HOWEVER, that in no event may

GERRESHEIMER refuse to make a change for which CLEARSIDE BIOMEDICAL agrees to pay for the mutually agreed upon costs and impacts.

Subject to Clause 3.3, (i) the Specifications and Third Party Material suppliers may only be changed by GERRESHEIMER with the prior written consent of CLEARSIDE BIOMEDICAL and the approval of any applicable Regulator (if applicable), (ii) CLEARSIDE BIOMEDICAL shall not unreasonably withhold its agreement to any change in the Specifications or Third Party Material suppliers requested by GERRESHEIMER, (iii) any amendment to the Specifications shall be subject to the rules regarding confidentiality as expressed in this Agreement, and (iv) any change in the Specifications or Third Party Material suppliers should only be implemented upon prior mutual written agreement of the scope, cost and impact of the change.

FORECASTS AND ORDERS

Beginning no later than six (6) Months prior to placing its initial Purchase Order for Product (it being understood that a forecast for a Calendar Quarter may be zero), prior to the first day of each calendar quarter (beginning each 1^st January, 1^st April, 1^st July and 1^st October and each referred to herein as a “Calendar Quarter”), CLEARSIDE BIOMEDICAL shall provide GERRESHEIMER with a rolling forecast schedule of its projected orders for the Products for at least the following four (4) Calendar Quarters (“Forecast Schedule”). The initial forecast will be provided by July 1, 2018 and is expected to reflect projected orders of between [***] units of Product for the following (4) Calendar Quarters. Beginning with the first Forecast Schedule submitted after the one year anniversary of the first commercial sale of the Product to a Third Party (the “Commercial Launch Anniversary”), with CLEARSIDE BIOMEDICAL to notify GERRESHEIMER forthwith in writing of the date of the Commercial Launch. Subject to Clause 4.4, CLEARSIDE BIOMEDICAL can only vary the forecast amounts for the second Calendar Quarter of a Forecast Schedule in the next subsequent Forecast Schedule by +/- [***], and can only vary the forecast amounts for the third Calendar Quarter of a Forecast Schedule in the next subsequent Forecast Schedule by +/- [***]. If CLEARSIDE BIOMEDICAL desires to vary the forecasted amounts by an additional [***] up to [***] or up to [***] respectively, then (i) in case of an increase, GERRESHEIMER agrees to notify Buyer within five (5) Business Days after receipt of such request, whether the ordered additional quantities of Products set forth in the request are exceeding the Sprint Capacity and whether such exceeding quantities can be delivered or not. In any event GERRESHEIMER will use reasonable efforts to fulfill this additional demand. In the event such excess quantities of Product directly results in additional costs, such costs shall be documented by GERRESHEIMER and the Parties shall discuss in good faith such costs and what part thereof CLEARSIDE BIOMEDICAL may need to reimburse before any such costs are incurred and/or committed. If GERRESHEIMER, despite using reasonable efforts, cannot meet such excess quantities, the failure to supply the excess quantities shall not be regarded as a Failure to Supply; or (ii) in case of a decrease, if such decrease directly results in additional costs, such costs shall be documented by GERRESHEIMER and the CLEARSIDE BIOMEDICAL shall reimburse to GERRESHEIMER all such documented costs. For the avoidance of doubt, the maximum quantities of Products to be supplied by GERRESHEIMER during any six (6) Month period prior to the Commercial

Launch Anniversary shall be [***] units of Product and GERRESHEIMER shall be under no obligation whatsoever to supply any quantities of Product beyond that amount.

In addition to the Forecast Schedule, prior to the 1^st September of each Year after the commencement of the issuance of Forecast Schedules, CLEARSIDE BIOMEDICAL shall provide on an annual basis a two (2) Year non-binding forecast of projected orders for the Products to be used by GERRESHEIMER solely for planning purposes.  

The Products detailed in the first Calendar Quarter of each Forecast Schedule (“Firm Order”) will be binding on both Parties. CLEARSIDE BIOMEDICAL shall issue purchase orders against each Firm Order (each a “Purchase Order”), which Purchase Order shall include the requested delivery dates. GERRESHEIMER shall respond to each Purchase Order received from CLEARSIDE BIOMEDICAL within ten (10) Business Days of receipt. The response of GERRESHEIMER shall include confirmation of the delivery dates; PROVIDED, HOWEVER, that GERRESHEIMER may not reject any quantities forecasted in a Firm Order or any delivery date that is more than thirty (30) days from the date the applicable Purchase Order is submitted.  GERRESHEIMER’s failure to reject any portion of a Purchase Order within the applicable ten (10) Business Day period shall be deemed to be GERRESHEIMER’s acceptance thereof. In the event that either Party requires amendments to the quantities ordered, the timing of production and/or delivery, the relevant planning personnel from both Parties shall within ten (10) Business Days of receipt of a Forecast Schedule, Firm Order or Purchase Order discuss in good faith and agree amendments to the Forecast Schedule, Firm Order or Purchase Order.

CLEARSIDE BIOMEDICAL and/or its Affiliates shall use commercially reasonable endeavours not to, at any one time, collectively place Firm Orders at a level that would require an aggregate capacity at GERRESHEIMER greater than the maximum manufacturing capacity of the Manufacturing Site as set forth in the applicable Product Schedule (“Sprint Capacity”) and GERRESHEIMER shall not be obliged to supply Products in excess of the Sprint Capacity. In the event that the aggregate CLEARSIDE BIOMEDICAL demand is greater than the Sprint Capacity CLEARSIDE BIOMEDICAL shall promptly instruct GERRESHEIMER the order of preference for the deliveries.

It is understood that the remaining three (3) Calendar Quarters of the Forecast Schedule constitutes an estimate of the future Product requirement of CLEARSIDE BIOMEDICAL and its Affiliates and does not constitute a binding commitment by CLEARSIDE BIOMEDICAL or its Affiliates to order or purchase such Product.

For certain long lead time materials, as defined in good faith between the Parties, which requires GERRESHEIMER to place orders with a minimum lead time longer than three (3) Months in advance of manufacturing, GERRESHEIMER will be entitled to place those orders based on the projections set forth in a Forecast

Schedule, and CLEARSIDE BIOMEDICAL agrees to pay for any such Materials which are not used in Firm Orders of Products placed by CLEARSIDE BIOMEDICAL and/or its Affiliates and cannot otherwise be used by GERRESHEIMER.

CLEARSIDE BIOMEDICAL may from time to time provide GERRESHEIMER with individual purchase orders for Products in addition to the quantities set forth in Firm Orders. GERRESHEIMER shall respond to each such individual purchase order received from CLEARSIDE BIOMEDICAL or an Affiliate of CLEARSIDE BIOMEDICAL within ten (10) Business Days of receipt. The response shall include confirmation or not of the Delivery dates and quantity as set out in such individual purchase order. GERRESHEIMER’s failure to reject any portion of such Purchase Order within the applicable ten (10) Business Day period shall be deemed to be GERRESHEIMER’s acceptance thereof.

If a CLEARSIDE BIOMEDICAL Affiliate desires to purchase the Product from GERRESHEIMER under the terms of this Agreement the Parties will consider the appropriate contractual mechanisms for the CLEARSIDE BIOMEDICAL Affiliate to receive Product from GERRESHEIMER or its Affiliates (as the case may be) and benefit from the terms of this Agreement, taking into account the CLEARSIDE BIOMEDICAL Affiliate may need to enter into separate legal agreements with GERRESHEIMER. For the avoidance of doubt, before the aforementioned contractual mechanism has been agreed by the Parties, GERRESHEIMER shall not be obliged to sell (and/or deliver) any Products to CLEARSIDE BIOMEDICAL Affiliates or fulfil or accept purchase orders from CLEARSIDE BIOMEDICAL Affiliates. GERRESHEIMER shall confirm promptly to CLEARSIDE BIOMEDICAL whether such CLEARSIDE BIOMEDICAL Affiliate is covered by GERRESHEIMER’s trade credit insurance. If such COMPANY Affiliate is not covered by GERRESHEIMERs trade credit insurance, then GERRESHEIMER shall only provide such CLEARSIDE BIOMEDICAL Affiliate with the named Product upon receipt of a payment security from CLEARSIDE BIOMEDICAL by means of a payment guarantee of CLEARSIDE BIOMEDICAL or a bank guarantee of an internationally business bank rated with triple B.

To compensate GERRESHEIMER for Direct Labour Costs associated with the planned manufacturing of the Firm Order, and to the extent such direct labour is not assignable to other GERRESHEIMER projects, CLEARSIDE BIOMEDICAL shall pay GERRESHEIMER all direct labour associated with the planned manufacturing of Products pursuant to the then-applicable Firm Order not

purchased;

Notwithstanding any other provisions in this Agreement, after production readiness (i.e. being after successful qualification of the equipment), CLEARSIDE BIOMEDICAL shall pay GERRESHEIMER [***] per square foot of clean room space dedicated to CLEARSIDE BIOMEDICAL’s equipment per Month in which CLEARSIDE BIOMEDICAL fails to purchase more than [***] units of Products per Month.

In the event that CLEARSIDE BIOMEDICAL fails to purchase Product for [***] following the Commercial Launch Anniversary CLEARSIDE BIOMEDICAL shall purchase all Materials purchased by GERRESHEIMER and all work in process and finished Product manufactured by GERRESHEIMER, in each case as purchased or manufactured in reasonable reliance on the previously submitted Forecast Schedules.

GERRESHEIMER will use reasonable efforts to mitigate expenses, including reasonable efforts to secure business sufficient to reactivate the idle plant space as soon as practicable and/or reassignment of direct labour. CLEARSIDE BIOMEDICAL shall not reimburse GERRESHEIMER for any period while such plant space and direct labour are in use for the benefit of a third party

DELIVERY, PASSING OF TITLE AND RISK IN THE PRODUCT

Delivery shall be made in accordance with the applicable Delivery Terms. The risk for each shipment of the Product, as for destruction or any case of deterioration or change in quality or loss of shipment, shall pass to CLEARSIDE BIOMEDICAL in accordance with the agreed Delivery Terms. [***]. Notwithstanding anything to the contrary in the applicable Delivery Terms to the contrary, GERRESHEIMER shall at all times arrange for shipment of the Product, including clearing the Product for export and import. To the extent CLEARSIDE BIOMEDICAL is financially responsible for shipment, GERRESHEIMER shall include the cost thereof as a separate line item.

GERRESHEIMER retains title to all Products until Delivery in accordance with the Delivery Terms. CLEARSIDE BIOMEDICAL shall have the right to dispose of the PRODUCTS delivered by GERRESHEIMER in the ordinary course of business, including reselling Products to Third Party licensees or collaboration partners of CLEARSIDE BIOMEDICAL. CLEARSIDE BIOMEDICAL shall also have the right to process the Products delivered by GERRESHEIMER.

PRICES

GERRESHEIMER will supply to CLEARSIDE BIOMEDICAL the Product at the Selling Price. GERRESHEIMER shall invoice CLEARSIDE BIOMEDICAL at the Selling Price. New Products may be added to this Agreement from time to time and will be supplied at the Selling Price set out in the respective Product Schedule.

On or before 1^st October each Year, the Parties will meet and discuss in good faith any applicable adjustment to the Selling Price (an “Annual Price Review”). [***].  

Irrespective of the aforementioned, (i) GERRESHEIMER shall be entitled to adjust the Selling Price effective as the beginning of a Year by providing no less than sixty (60) days prior written notice in the event and to the extent of a cost increase with respect to labour and energy that exceeds, [***]; PROVIDED, HOWEVER, that such Selling Price adjustments described in subsection (iii) will be limited to twice annually.

In case CLEARSIDE BIOMEDICAL reasonably believes that an adjustment to the Selling Price pursuant to Clause 7.3 is not accurate and proper, CLEARSIDE BIOMEDICAL may request, and GERRESHEIMER shall provide, additional documentation supporting the adjustment. If CLEARSIDE BIOMEDICAL reasonably considers such response as not being reasonably satisfactory, the Parties shall endeavour to resolve any dispute that may arise pursuant to this Clause. If the Parties fail to agree, [***] of being notified pursuant to this Clause 7.4, whether the adjustment to the Selling Price in question is accurate and proper, CLEARSIDE BIOMEDICAL will have the right, acting reasonable, during regular business hours and upon reasonable [***].  The Third Party independent accounting firm shall only be entitled to disclose in its audit report to CLEARSIDE BIOMEDICAL whether the reported adjustment to the Selling Price pursuant to Clause 7.3 is accurate and proper and the amount of any inaccuracies.  Within thirty (30) days after both Parties have received a copy of such audit report, which has to be forwarded simultaneously to both Parties by the Third Party independent accounting firm, GERRESHEIMER or CLEARSIDE BIOMEDICAL, as applicable, will compensate the other Party for payment errors or omissions revealed by the audit.  

INVOICE AND PAYMENT

The Selling Price shall be in USD. GERRESHEIMER shall invoice CLEARSIDE BIOMEDICAL or CLEARSIDE BIOMEDICAL Affiliates (as appropriate, depending on who placed the order for the relevant Product) in USD

Each invoice issued by GERRESHEIMER hereunder shall specify:

The Selling Price in respect of the Product Delivered;

The quantity of Product Delivered;

The applicable order number;

The amount of VAT due in respect of the Product Delivered (if any); and

Any other amounts reimbursable to GERRESHEIMER pursuant to this Agreement.

CLEARSIDE BIOMEDICAL shall pay all invoices not disputed in good faith within [***] days after date of receipt of such invoice. In the event that CLEARSIDE BIOMEDICAL defaults on payment of amounts not disputed in good faith, interest is to be paid on the invoiced amount with [***] per Year.  

The Selling Price, and any other amounts payable pursuant to this Agreement, shall be as stated and are exclusive of VAT (or equivalent).

For the purpose of a potential risk of payment default by CLEARSIDE BIOMEDICAL CLEARSIDE BIOMEDICAL shall be obliged to provide an adequate bank guarantee of an internationally business bank rated with triple B upon GERRESHEIMER written request if CLEARSIDE BIOMEDICAL cannot be covered by GERRESHEIMER’s trade credit insurance. In the event such bank guarantee is limited in time, CLEARSIDE BIOMEDICAL shall provide the subsequent bank guarantee under the same conditions no later than thirty (30) days before the expiry of the bank guarantee in place.  The Parties agree to evaluate on an annual basis and in good faith GERRESHEIMER’s requirement that CLEARSIDE BIOMEDICAL continue the bank guarantee.

FAILURE TO SUPPLY

Save Force Majeure, if GERRESHEIMER is unable, or anticipates that it will be unable to Deliver in whole or in part the quantities of Product required under any Firm Order or any other Purchase Order accepted by GERRESHEIMER, the following provisions shall apply:

GERRESHEIMER shall, as soon as it becomes aware of that fact and in any event not less than fifteen (15) Business Days prior to the Delivery date, give written notice to CLEARSIDE BIOMEDICAL or CLEARSIDE BIOMEDICAL Affiliates (as the case may be) setting out the reasons for such shortfall or failure.  

Without prejudice to CLEARSIDE BIOMEDICAL’s other rights and remedies under this Agreement, at law or in equity, the Parties shall use reasonable endeavours to negotiate an alternative Delivery schedule for the shortfall or failed Delivery.

Without prejudice to CLEARSIDE BIOMEDICAL’s other rights and remedies under this Agreement, at law or in equity with respect to GERRESHEIMER missing the original Delivery Date, in the event that an alternative Delivery schedule is agreed pursuant to paragraph (ii) above GERRESHEIMER shall Deliver the Product in accordance with such alternative Delivery schedule.

Save Force Majeure, without prejudice to GERRESHEIMERs obligations under this Agreement, in the event that the Parties fail to agree on alternative Delivery schedule pursuant to Clause 9.1 (ii) above, whether it be due to a disruption in the manufacture of the Product at the Manufacturing Site or otherwise CLEARSIDE BIOMEDICAL’s Firm Order commitment shall be deemed to be cancelled with

respect to the affected amount of the shortfall or failed Delivery and CLEARSIDE BIOMEDICAL would be relieved of its obligation to purchase any of such quantities.

CLEARSIDE BIOMEDICAL shall, within fifteen (15)  Business Days from Delivery inform GERRESHEIMER if it determines, acting reasonably, that the wrong Product has been delivered or if there is any visible external Defects or damage to the pallets and/or outer packaging or if there is a quantitative deficiency in any shipment with respect to the Product volumes indicated on the applicable Firm Order (i.e. the number of pallets delivered does not correspond to the number of pallets on the relevant delivery note). If GERRESHEIMER is notified by telephone or in person then such notification shall be confirmed by CLEARSIDE BIOMEDICAL or CLEARSIDE BIOMEDICAL Affiliates (as appropriate) in writing. Subject to Force Majeure and without prejudice to CLEARSIDE BIOMEDICAL’s other rights and remedies under this Agreement, at law or in equity with respect to the failure to Delivery conforming Product, GERRESHEIMER shall then be obliged to rectify the incomplete Delivery within thirty (30) Business Days, running from the respective first date of notification.

[***].  GERRESHEIMER shall promptly issue to CLEARSIDE BIOMEDICAL a detailed written explanation for the delay and actions taken to remedy any delay in the supply of Product reasonably acceptable to CLEARSIDE BIOMEDICAL.

[***], GERRESHEIMER shall, where relevant, promptly notify CLEARSIDE BIOMEDICAL thereof and GERRESHEIMER shall perform best efforts to resolve the Failure to Supply and to resume its supply obligations as soon as possible to the best interest of CLEARSIDE BIOMEDICAL; GERRESHEIMER shall continuously keep CLEARSIDE BIOMEDICAL informed of the status and the corrective actions performed by it with respect thereto.  

In the event the Failure to Supply lasts or is anticipated by the GERRESHEIMER to last for more than [***] or such longer timeframe as agreed between the Parties, then GERRESHEIMER shall, at its costs (unless the Failure to Supply is solely due to CLEARSIDE BIOMEDICAL in which event such shall be at the cost of CLEARSIDE BIOMEDICAL; in the event the Failure to Supply is at least partly the responsibility of CLEARSIDE BIOMEDICAL, Parties shall share such costs at a ratio to be agreed between the Parties and in proportion to either Party’s contribution to the Failure to Supply), promptly submit a CAPA plan to CLEARSIDE BIOMEDICAL, for CLEARSIDE BIOMEDICAL’s approval. The CAPA plan shall set forth in detail the actions to be taken by GERRESHEIMER to solve the Failure to Supply and the anticipated timelines for implementing these actions. This plan shall also state which percentage of quantities of Product requested by CLEARSIDE BIOMEDICAL can continue to be delivered by GERRESHEIMER in accordance with this Agreement and the anticipated timelines for resuming full compliance. In the event CLEARSIDE BIOMEDICAL approves the CAPA plan, GERRESHEIMER shall forthwith implement such plan and continuously keep CLEARSIDE BIOMEDICAL updated on the status thereof.

QUALITY

GERRESHEIMER shall comply with the terms of the Quality Agreement.

CLEARSIDE BIOMEDICAL shall promptly examine each Delivery and shall have the right, exercisable within five (5) Business Days after Delivery, to reject such Product that it determines to be Defective Product as a result of the exercise of careful diligence upon such examination. For the avoidance of doubt Product shall not be Defective Product if non-compliance with the Specification is attributed to operating instructions, maintenance regulations or installation regulations not having been adhered to by CLEARSIDE BIOMEDICAL or Third Parties. However, the foregoing rejection time limit shall not apply to Defective Product not reasonably detectable or discoverable during the examination by CLEARSIDE BIOMEDICAL as defined above (“Latent Defect”). Where CLEARSIDE BIOMEDICAL and CLEARSIDE BIOMEDICAL Affiliates (as the case may be) do not reject any such Product but such Product becomes a Defective Product subject to Latent Defects as defined above within a period of [***] after Delivery, CLEARSIDE BIOMEDICAL shall inform GERRESHEIMER of such Defective Product within five (5) Business Days from detecting the Latent Defect. Failing the notification deadlines outlined above, CLEARSIDE BIOMEDICAL shall be deemed to have accepted the relevant shipment of Product.

In case the CLEARSIDE BIOMEDICAL rejects a Product according to Clause 10.2 above:

CLEARSIDE BIOMEDICAL shall issue a written complaint to GERRESHEIMER (detailing any asserted Defective Product and, if applicable, submitting a sufficient number of affected Product samples);

the Parties shall promptly use good faith efforts to agree whether or not the Delivery in question complies with the Firm Order, Quality Agreement, the

Specifications, cGMP and any other requirements set forth in this Agreement (or any one of them); and

GERRESHEIMER shall be entitled at all reasonable times to inspect and/or analyse the Delivery in question.

The Parties shall use their commercially reasonable endeavours to resolve any dispute that may arise pursuant to this Clause. If the Parties fail to agree, within thirty (30) days of being notified pursuant to Clause 10.3 (i) whether the applicable Product in question is non-compliant with the Specifications, this dispute shall be resolved by a mutually agreed independent laboratory/expert and the decision of the independent laboratory/expert shall be final and binding on the Parties. For the avoidance of doubt, the independent laboratory/expert shall not decide on any other question or matter other than whether the Product is a Defective Product. Unless agreed otherwise, the independent laboratory/expert’s fees shall be borne by the Party against whom the independent laboratory/expert’s decision is given. In case of a split decision, costs shall be split between the Parties accordingly.

In the event that GERRESHEIMER acknowledges the Product to be a Defective Product pursuant to Clause 10.4 (“Agreed Defective Product”) or the independent laboratory/expert concludes it is Defective Product (in which case, it shall be deemed to be “Agreed Defective Product” for purposes of this Agreement), GERRESHEIMER shall at CLEARSIDE BIOMEDICAL’s option, either (a) replace or rework the Agreed Defective Product at GERRESHEIMER´s risk and expense to the extent possible and reasonable; or (b) refund such portion of the price attributable to the Agreed Defective Product. In the first former case (replacement according to (a)), GERRESHEIMER shall be entitled to require CLEARSIDE BIOMEDICAL to dispose of the Agreed Defective Product according to Applicable Law with any expenses or costs reasonably incurred by CLEARSIDE BIOMEDICAL to be borne by GERRESHEIMER. The remedy described in this Clause 10.5 shall be in addition to, and not in lieu of, any other remedies available under this Agreement, at law or in equity.  For the avoidance of doubt, (i) in the event CLEARSIDE BIOMEDICAL elects a refund with respect to the Agreed Defective Product, CLEARSIDE BIOMEDICAL shall have no obligation to purchase the quantity of Product in relation thereof and the Firm Order and any applicable Purchase Order shall be reduced accordingly, and (ii) the remedies set forth herein shall not be applied against the limitation of liability provisions of this Agreement, including Clause 23.3.  

If the independent laboratory/expert finds that the Product is not an Agreed Defective Product, CLEARSIDE BIOMEDICAL shall pay any expenses or costs reasonably incurred by GERRESHEIMER in connection with the rejection in accordance with the payment provisions contained in this Agreement. In no event shall GERRESHEIMER be responsible for non-compliances with Specification  in the Product if such non-compliances are caused (partly or in whole) by deficiencies in the design or Specifications provided by CLEARSIDE BIOMEDICAL.

SUPPLY AND STORAGE OF MATERIALS AND PRODUCTS

GERRESHEIMER shall be solely responsible for the ordering and supply of the relevant quantities of Materials necessary in order to manufacture the Products, and for the timely delivery of such Materials, in accordance with CLEARSIDE BIOMEDICAL’S Forecast Schedules and Firm Orders.

CLEARSIDE BIOMEDICAL may during the Term of this Agreement and after mutual agreement, provide certain Pharmaceutical Components to GERRESHEIMER. In such case, as gesture of goodwill on a voluntary basis and without acknowledging any legal obligations on behalf of GERRESHEIMER in connection therewith, GERRESHEIMER will visually inspect deliveries of Pharmaceutical Component as advised by CLEARSIDE MEDICAL and within three (3) Business Days notify CLEARSIDE BIOMEDICAL  in writing (with email being sufficient) of visual defects detected during such visual inspection, and will not use any Pharmaceutical Component that is subject to such visual defects without the prior written consent of CLEARSIDE BIOMEDICAL.

GERRESHEIMER shall at all times store and warehouse all Materials and Product manufactured by GERRESHEIMER pursuant to this Agreement (including the Quality Agreement) in premises that are secure, clean, and in line with industry

standard, Applicable Law, including cGMP, and the conditions mutually agreed between the Parties.

If GERRESHEIMER, acting reasonably, considers that a delivery of Materials which has been supplied by any supplier is Defective, GERRESHEIMER acting reasonably shall reject such delivery, and shall procure that substitute Materials complying with the Specification are promptly supplied by the relevant supplier in substitution.

RESPONSIBLE PERSON

TOOLING AND EQUIPMENT

The Parties shall agree on any new Equipment reasonably required for the manufacture the Product at the Manufacturing Site that shall be purchased. Where GERRESHEIMER sources new Equipment from a Third Party, CLEARSIDE BIOMEDICAL shall pay GERRESHEIMER for the actual cost of such Equipment on the same terms offered by the Third Party plus an additional sum for GERRESHEIMER’s time and resources in sourcing such Equipment, such additional sum to be agreed in advance in writing between the Parties in advance of GERRESHEIMER carrying out any such work in relation to such Equipment. Where Equipment is to be provided by GERRESHEIMER and not sourced from a Third Party, CLEARSIDE BIOMEDICAL shall reimburse GERRESHEIMER for the actual costs of GERRESHEIMER’s time and materials in creating such Equipment, such costs again to be agreed in advance in writing between the Parties in advance of GERRESHEIMER carrying out any such work or making any commitment to any Third Party in relation to such materials.

Title in the Equipment purchased or created by GERRESHEIMER shall pass to CLEARSIDE BIOMEDICAL on completion of payment due by CLEARSIDE BIOMEDICAL and GERRESHEIMER will mark all Equipment with appropriate plates identifying it as being owned by CLEARSIDE BIOMEDICAL, and maintain an asset register containing details of the Equipment. For the avoidance of doubt, as between CLEARSIDE BIOMEDICAL and GERRESHEIMER, CLEARSIDE BIOMEDICAL shall own all drawings and specifications for the Equipment necessary to effectively use, maintain, repair and/or modify the Tooling and Equipment (hereinafter referred to as “Documentation”) and as set forth in Schedule 4 to this Agreement.

GERRESHEIMER will maintain a lifetime record for each item of Equipment detailing all procedures carried out on the Equipment (including, without limitation, servicing, maintenance and parts changes) during the period of use by GERRESHEIMER at the Manufacturing Site.

GERRESHEIMER will use the Equipment exclusively for the manufacture and supply of the Product to CLEARSIDE BIOMEDICAL and CLEARSIDE BIOMEDICAL Affiliates, unless otherwise agreed in writing between the Parties. Without limiting the foregoing, the manufacturing line that incorporates the Equipment shall be dedicated to the use of manufacturing Product for and on behalf of CLEARSIDE BIOMEDICAL.

GERRESHEIMER will conduct at CLEARSIDE BIOMEDICAL’s sole cost routine maintenance of the Equipment and shall also be responsible for repair of the Equipment with all proven costs to be borne by CLEARSIDE BIOMEDICAL. For the avoidance of doubt GERRESHEIMER shall replace any wear parts and repair any damage caused by GERRESHEIMER’s negligent act or omission at its own cost. GERRESHEIMER undertakes to follow the technical specification for the use of the CLEARSIDE BIOMEDICAL Equipment and to use the CLEARSIDE BIOMEDICAL Equipment with all due and reasonable care.

Notwithstanding Clause 13.5, GERRESHEIMER will take responsibility for all repairs and relationship with the supplier of the Equipment for the period under which the Equipment is covered by a warranty, as specified in the respective Product Schedule (“Tooling & Equipment Warranty Period”). CLEARSIDE BIOMEDICAL expressly authorises GERRESHEIMER to exercise its rights with the supplier of the CLEARSIDE BIOMEDICAL Equipment in respect of such warranty. If repairs or changes to the Equipment need to be made that are not covered under the warranty or if the supplier of the Equipment rejects a warranty claim, CLEARSIDE BIOMEDICAL will discuss with the GERRESHEIMER what costs are payable.

Following expiry of the Tooling & Equipment Warranty Period, by the end of second quarter of each Year GERRESHEIMER agrees to make a proposal to CLEARSIDE BIOMEDICAL to address any complete overhauls and repairs (“Refurbishment Program”) to the CLEARSIDE BIOMEDICAL Equipment to be carried out specifying their respective cost, lead-time and capacity impact. Any agreed repair and/or refurbishment program shall be carried out by GERRESHEIMER at CLEARSIDE BIOMEDICAL’s sole cost, except where the repairs or refurbishment is necessitated by GERRESHEIMER’s wilful negligence or omission, in which case GERRESHEIMER shall be responsible for such costs. GERRESHEIMER shall not be deemed to be at fault as defined above if the repairs or refurbishments in question were a result of an explicit instruction from CLEARSIDE BIOMEDICAL to use such Equipment outside of its intended use or recommended purpose.

Spare parts for the Equipment shall be ordered by GERRESHEIMER before commercial production starts and shall be funded by CLEARSIDE BIOMEDICAL. Any spare parts used shall be replaced by GERRESHEIMER during the Tooling & Equipment Warranty Period at GERRESHEIMER’s cost and thereafter at CLEARSIDE BIOMEDICAL’s cost, in accordance with Clauses 13.6 and 13.7. Following expiry of the Tooling & Equipment Warranty Period, spare parts inventory shall be maintained at the same levels as prior to commercial production.

REGULATORY COMPLIANCE

GERRESHEIMER shall respond in an effective and prompt manner to any questions of a regulatory nature relating to the Product, its manufacture or the Manufacturing Site raised either by CLEARSIDE BIOMEDICAL, its Affiliates (PROVIDED, HOWEVER, that such Affiliate is supplied with Products pursuant to Clause 4.8), or by a Regulator.  GERRESHEIMER shall within twenty-four (24) hours deliver to CLEARSIDE BIOMEDICAL any documentation received by Regulators alleging the Products, its manufacture or the Manufacturing Site is not in compliance with Applicable Laws, including cGMP.  GERRESHEIMER shall within twenty-four (24) hours notify CLEARSIDE BIOMEDICAL in writing of any proposed investigation or inspection by a Regulator of the Manufacturing Site and keep CLEARSIDE BIOMEDICAL reasonably updated about the progress of such investigation or inspection.  GERRESHEIMER shall within twenty-four (24) hours notify CLEARSIDE BIOMEDICAL if it receives any adverse event reports related to the Product.

GERRESHEIMER shall, at its sole cost and expense, obtain and hold all consents, authorizations, permits, certificates, licenses or approvals of, exemptions by, or filings or registrations with, any Regulator required for the performance of its obligations under this Agreement (“Consents”). At all times, GERRESHEIMER shall maintain and comply with all the Consents to permit the performance of its then current obligations under this Agreement.

GERRESHEIMER shall provide to CLEARSIDE BIOMEDICAL all documents and information requested by a Regulator in support of CLEARSIDE BIOMEDICAL’s regulatory filings. Upon the reasonable prior written request, GERRESHEIMER may in its sole discretion reasonably assist CLEARSIDE BIOMECIAL with regulatory filings of CLEARSIDE BIOMEDICAL’s licensees and Third Party collaboration partners, with all proven costs to be borne by CLEARSIDE BIOMEDICAL. For the avoidance of doubt, GERRESHEIMER shall have no obligation whatsoever to assist CLEARSIDE BIOMEDICAL with respect of the aforementioned licensees and Third Party collaboration partners.

GERRESHEIMER shall maintain, in accordance with and for the period required cGMPs, complete and adequate records pertaining to all activities in connection with, and facilities used for, the manufacture, generation, storage, testing, treatment, holding, transportation, distribution, or other handling or receiving of the Product or Materials.

If GERRESHEIMER is notified that Product or the portion of the Manufacturing Site will be subject to an inspection by any Regulator including as part of the pre-approval inspection for the Product, GERRESHEIMER shall:

INTELLECTUAL PROPERTY RIGHTS

Each Party shall continue to own and/or control (as the case may be) its own Intellectual Property and Know-How existing prior to the Effective Date or generated independently of the services under this Agreement (“Background IP”).

For the term and sole purpose of this Agreement and solely to the extent necessary to fulfil the obligations arising out of this Agreement, CLEARSIDE BIOMEDICAL shall grant GERRESHEIMER and its Affiliates a worldwide, royalty free, fully-paid up and irrevocable for the term of this Agreement, non-exclusive licence to Background IP of CLEARSIDE BIOMEDICAL and its Affiliates.

The Parties agree that the manufacture of the initial Product specified on Schedule 2 in accordance with the Specifications referred to in Schedule 2 does not incorporate or otherwise involve the use of any GERRESHEIMER Results.  GERRESHEIMER undertakes all reasonable efforts not to incorporate any GERRESHEIMER Results into the Products.

However, if during the performance of the Agreement, GERRESHEIMER and CLEARSIDE BIOMEDICAL come to the conclusion that specific and specifically defined GERRESHEIMER Results might be useful in or for the manufacturing of the Product, GERRESHEIMER shall inform CLEARSIDE BIOMEDICAL and shall comprehensively disclose to CLEARSIDE BIOMEDICAL if and to what extent GERRESHEIMER wants to include into or use such GERRESHEIMER Results for the manufacture of the

Product including conditions suggested for its use (including but not limited to the purpose and the amount of the license fee to be paid by CLEARSIDE BIOMEDICAL). CLEARSIDE BIOMEDICAL shall review such suggested conditions and if necessary discuss with GERRESHEIMER what would be the consequences of not using such specific GERRESHEIMER Results. If then CLEARSIDE BIOMEDICAL decides, in its own and sole discretion, that specific and specifically defined GERRESHEIMER Results shall be used in or for the manufacturing of the Product, then the Parties shall promptly negotiate in good faith an amendment to this Agreement which sets forth the licensed Gerresheimer Results, the license fee payable for the use of GERRESHEIMER Results and other reasonable and customary agreed-upon terms and conditions. If Gerresheimer incorporates GERRESHEIMER Results into a Product without such written agreement, CLEARSIDE BIOMEDICAL shall have an irrevocable, transferable, royalty-free license to utilize those GERRESHEIMER Results as necessary or helpful to commercialize the affected Product or Products.

15.4Without regard to inventorship GERRESHEIMER or its Affiliates (as the case may be) shall become the sole owner of all right, title and interest in and to all Intellectual Property relating to improvements to GERRESHEIMER Background IP and/or to any new manufacturing and/or production processes (or parts thereof) that is discovered in the course of this Agreement (“GERRESHEIMER Results”). CLEARSIDE BIOMEDICAL hereby agrees to, and does hereby assign all right, title and interest to GERRESHEIMER Results to GERRESHEIMER. For the avoidance of doubt CLEARSIDE BIOMEDICAL shall have no right to patent any of the GERRESHEIMER Results.  For the avoidance of doubt, GERRESHEIMER Results shall not include any CLEARSIDE BIOMEDICAL Results.

Without regard to inventorship, CLEARSIDE BIOMEDICAL shall become sole owner of all right, title and interest in and to all Intellectual Property relating to improvements to CLEARSIDE BIOMEDICAL Background IP and/or the Product discovered and/or generated in the course of this Agreement and that are not GERRSHEIMER Results (“CLEARSIDE BIOMEDICAL Results”). GERRESHEIMER hereby agrees to, and does hereby assign all right, title and interest to CLEARSIDE BIOMEDICAL Results to CLEARSIDE BIOMEDICAL. For the avoidance of doubt GERRESHEIMER shall have no right to patent any of the CLEARSIDE BIOMEDICAL Results.

GERRESHEIMER will promptly notify CLEARSIDE BIOMEDICAL in writing and with full details of any CLEARSIDE BIOMEDICAL Results or Product-  specific GERRESHEIMER RESULTS generated or acquired. Same applies vice versa in case CLEARSIDE BIOMEDICAL generates or acquires GERRESHEIMER Results.

CUSTOMER COMPLAINTS AND RECALL

GERRESHEIMER shall notify CLEARSIDE BIOMEDICAL’s Quality Manager by telephone and in writing without undue delay upon becoming aware of any problem relating to

the Product which could reasonably have negative effects on CLEARSIDE BIOMEDICAL, including, but not limited to:

where any Product or its labelling may have been mistaken for or applied to another product;

where any Product may be affected by significant contamination, significant chemical, physical or any other change or deterioration;  

where any Product is the subject of a complaint by a Third Party or customer; or

where any Product may not comply with the Specification.

Notwithstanding the provisions and procedures set forth in Clause 10 but in no way limiting CLEARSIDE BIOMEDICAL rights thereunder, CLEARSIDE BIOMEDICAL shall without undue delay notify GERRESHEIMER about any Products that are subject to a complaint by Third Parties including customers and, if available, send a reasonable quantity of the relevant suspected  Products to GERRESHEIMER and issue a written report of this suspected non-conformance.

If any of the circumstances described in Clause 16.1 above arise, whether notified to CLEARSIDE BIOMEDICAL or not, GERRESHEIMER shall take, at CLEARSIDE BIOMEDICAL’s written request and, except as otherwise stated herein, at CLEARSIDE BIOMEDICALs cost, all such reasonable acts as CLEARSIDE BIOMEDICAL may direct. If CLEARSIDE BIOMEDICAL deems that a recall of or other corrective action with respect to the Product or the Pharmaceutical Component (a “Recall”) is required, CLEARSIDE BIOMEDICAL shall notify GERRESHEIMER immediately in advance and without delay and both Parties shall promptly develop the Recall strategy and GERRESHEIMER shall provide all reasonably necessary cooperation to support the implementation of the Recall strategy. In the event that a Recall is caused by Agreed Defective Product, all reasonable direct costs of such Recall shall be borne by GERRESHEIMER. To the extent a Recall is caused in party by Agreed Defective Product and in part by some other reasons, the portion of the cost of the Recall shall be allocated to GERRESHIEMER based on its comparative fault.  For the avoidance of doubt where the Recall is not caused by Agreed Defective Product, CLEARSIDE BIOMEDICAL shall bear all costs of such Recall. For the avoidance of doubt CLEARSIDE BIOMEDICAL shall be obliged to use commercially reasonable efforts to mitigate any expenses or costs of such Recall. For the avoidance of doubt GERRESHEIMER’s compensation obligation pursuant to this Clause 16.3 shall be subject to the limitations on liability as set out in Clause 23.3.  Notwithstanding anything in this Clause to the contrary, the strategy with respect to, and any communications with the Regulators or other Third Parties associated with, any Recall of Product or the Pharmaceutical Component shall be conducted solely by CLEARSIDE BIOMEDICAL.

Upon notification from CLEARSIDE BIOMEDICAL that it has received a complaint as described in Clause 16.1 (c) in respect of the Product, GERRESHEIMER will promptly and at its own expense conduct all such necessary internal investigations as may be reasonably necessary to determine the validity of such complaint. The initial findings of such investigations shall be reported in writing to CLEARSIDE BIOMEDICAL within fifteen (15) Business Days of the detailed original notification. In the case of a more detailed investigation being necessary, GERRESHEIMER shall promptly submit with due consideration a final report indicating the root cause and corrective/preventative actions. GERRESHEIMER.  For the avoidance of doubt, CLEARSIDE BIOMEDICAL shall have the sole right and authority to respond to any complaint made by a Third Party, and GERRESHEIMER shall not communicate with such Third Party without the prior written consent of CLEARSIDE BIOMEDICAL.

DOCUMENTATION AND REPORTS

CONFIDENTIALITY

Any Confidential Information to be disclosed by the Disclosing Party to the Receiving Party in or as a result of the Agreement shall remain the Disclosing Party's property.  

The Receiving Party shall not disclose (directly or indirectly) any Confidential Information of the Disclosing Party to, or permit it to be accessed by, any person except a Permitted User.

Each Party shall cause its Affiliates and Permitted Users to abide by the terms of this Agreement. Each Party shall be liable for the breach of this Agreement by any of its Affiliates and Permitted Users. In the event the Receiving Party becomes aware of any breach of this Agreement by it, its Affiliates or any of its Permitted Users, the Receiving Party shall promptly notify the Disclosing Party of such breach and all facts known to the Receiving Party regarding same.

The Receiving Party shall use, and shall cause its Affiliates and Permitted Users to use, the Confidential Information only for the purpose of this Agreement and for no other purpose whatsoever.

The duty of confidentiality, nondisclosure and non-use under this Clause owed in relation to the Confidential Information of the Disclosing Party shall not extend to any information which:

the Receiving Party thereof can show by competent proof that it knew prior to disclosure; or

is or comes into the public domain other than in breach of this Clause; or

is obtained from a Third Party that is lawfully entitled to possession of such Confidential Information and is under no obligation of confidentiality to the Disclosing Party; or

was independently developed by or for the Receiving Party without any reference to, aid from or reliance upon the Confidential Information of the Disclosing Party.

If the Receiving Party is legally compelled to disclose Confidential Information of the Disclosing Party or the substance of this Agreement in connection with a legal or administrative proceeding with a requirement under Applicable Law, the U.S. Securities and Exchange Commission, the Nasdaq market or any other securities exchange or market, the Receiving Party shall give the Disclosing Party prompt notice of such request so that the Disclosing Party may seek an appropriate protective order or other remedy. If the Disclosing Party seeks a protective order or other remedy, the Receiving Party shall reasonably cooperate with and assist the Disclosing Party in such efforts, at the Disclosing Party’s expense.  Subject to any protective order obtained, the Receiving Party shall be permitted to disclose only that portion of Confidential Information which its legal counsel determines it is required to disclose.

The obligations of each Party in this Clause 18 shall survive for a term of five (5) Years the expiration or earlier termination, for any reason, of this Agreement.

Upon termination of this Agreement or earlier if requested by the Disclosing Party, the Receiving Party shall return or destroy, at the Disclosing Party’s own choice and at its sole discretion, all Confidential Information which it has in its possession or under its control, save that the Receiving Party can keep one (1) copy for compliance purposes. Notwithstanding anything to the contrary in this Agreement, the Receiving Party shall not be required to destroy any computer files stored securely by the Receiving Party that are created during automatic system back-up.  

INTENTIONALLY LEFT BLANK

FORCE MAJEURE

Force Majeure shall mean any event beyond the control of the Party claiming the Force Majeure, which could not be reasonably foreseen at the time of the Effective Date of the Agreement. Force Majeure therefore may include without limitation any Act of God including, but not limited to, fire, earthquake, flood or other natural disaster, accidents or equipment failure which are not the fault of the Party relying upon such circumstances; act of any sovereign including, but not limited to, riot, war, invasion; acts of terrorism and any measures to combat terrorism; imposing of government sanctions embargo or similar action; law, judgment, order, decree, blockade; labour dispute including, but not limited to, strike, lockout or boycott;

interruption or failure of utility service including, but not limited to, electric power, gas, water or telephone service; failure of the transportation of any personnel, equipment, machinery, supply of materials required by GERRESHEIMER for the purposes of this Agreement; other similar events.

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

Neither Party shall be deemed to be in breach of this Agreement, or shall be otherwise liable to the other Party, by reason of any delay in performance, or the non-performance of any of its obligations hereunder, to the extent that the delay or non-performance is due to any Force Majeure of which it has duly notified the other Party, and the time for performance of that obligation shall be extended accordingly and reasonably (and in any event equal to the period of Force Majeure).

If the performance by either Party of any of its obligations under this Agreement is prevented or delayed by Force Majeure for a continuous period in excess of fifteen (15) Business Days, 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 performance by either Party of any of its obligations under this Agreement is prevented or delayed by Force Majeure for three (3) Months or more, consecutively during any one (1) Year period, then the other Party shall in its discretion have the right to terminate the Agreement forthwith upon written notice.

INSPECTION / AUDIT RIGHTS

CLEARSIDE BIOMEDICAL shall have the right to inspect the Manufacturing Site from time to time with at least a six (6) month hiatus during the first two (2) full Years during the Term and at least a twelve (12) Month hiatus between such inspections (which can be shortened for critical issues) at normal business hours, upon at least fifteen (15) Business Days prior written notice (which can be shortened for critical issues) to GERRESHEIMER to ensure GERRESHEIMERs compliance with the terms of this Agreement and the Quality Agreement. Where CLEARSIDE BIOMEDICAL requires the inspection is to be undertaken by a designated Third Party GERRESHEIMER agrees to arrange for the audit to take place but CLEARSIDE BIOMEDICAL shall pay all the fees of the designated Third Party for such inspection; PROVIDED, HOWEVER, that such Third Party shall be duly authorized and shall be bound by the same confidentiality obligations as CLEARSIDE BIOMEDICAL and provided that such Third Party is not a competitor of GERRESHEIMER. Time of such inspections shall be mutually agreed upon by both Parties. For the avoidance of doubt, CLEARSIDE BIOMEDICAL shall be entitled

to perform additional inspections in the event GERRESHIEMER has delivered Defective Product in two (2) or more deliveries in any consecutive twelve (12) Month period, or it has received reports from Regulator(s) that said Regulator(s) have audited GERRESHEIMER with respect to the Product and after such audit have concluded that the Manufacturing Site is not in compliance with Applicable Laws.

If after such inspections, CLEARSIDE BIOMEDICAL reasonably believes that GERRESHEIMER is in material violation of any of its obligations, warranties, covenants or representations under this Agreement, CLEARSIDE BIOMEDICAL may request additional information from GERRESHEIMER and if CLEARSIDE BIOMEDICAL reasonably considers such response as not being reasonably satisfactory, CLEARSIDE BIOMEDICAL may request GERRESHEIMER to implement certain changes or provide a written explanation of its unwillingness to implement such changes. GERRESHEIMER shall be required to consider implementing any requested changes but not to actually act upon or implement any changes that may have been requested. It shall be a satisfactory explanation either that GERRESHEIMER demonstrates that its processes comply with cGMP requirements, the relevant regulations and/or the Specifications.

GERRESHEIMER shall use reasonable efforts to cause its sub-contractors to provide the same access as set forth in Clause 21.1 In the event access is not granted to CLEARSIDE BIOMEDICALS, GERRESHEIMER may perform the audit on CLEARSIDE BIOMEDICALs behalf, with all incurring proven costs to be borne by CLEARSIDE BIOMEDIAL, and shall share the results of the audit with CLEARSIDE BIOMEDICAL, subject to compliance with confidentiality obligations.

WARRANTIES AND INDEMNITY

GERRESHEIMER hereby represents and warrants that:

it is a corporation duly organised and validly existing and in good standing under the laws of its jurisdiction of organisation;

it has the corporate power and authority to negotiate, execute, deliver and perform its obligations under this Agreement;

the Product supplied hereunder shall conform to the Specifications;

[***];

that the Product will be delivered free from any security, interest, lien or encumbrance;

it shall comply with Applicable Laws;

[***];

GERRESHEIMER has not used, and will not use, in any capacity associated with or related to the manufacture of the Product, the services of any Persons who have been, or are in the process of being, (i) debarred under 21 U.S.C. § 335a(a) or (b) or any comparable laws of a foreign jurisdiction, or (c) excluded from participation in the Medicare program, any state Medicaid program or any other health care program. Furthermore, neither GERRESHEIMER nor any of its officers, employees, or consultants has been convicted of an offense under (a) either a federal or state law that is cited in 21 U.S.C. § 335(a) as a ground for debarment, denial of approval or suspension, (b) any other law cited in any comparable Applicable Laws as a ground for debarment, denial of approval or suspension.  GERRESHIEMER shall notify CLEARSIDE BIOMEDICAL immediately upon learning of any circumstance that would cause this certification under this Clause 22.1(viii) to become false or inaccurate.  

[***].

The warranties set forth in Clause 22.1 above shall not apply to any Product that has been misused, neglected, improperly handled, stored, abused or used for any purpose other than the one for which it was manufactured.

THE WARRANTIES EXPRESSLY SET FORTH IN THIS AGREEMENT ARE IN LIEU OF ALL OTHER WARRANTIES, AND TO THE EXTENT ALLOWED BY APPLICABLE LAW GERRESHEIMER DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. GERRESHEIMER EXPRESSLY DISCLAIMS ANY REPRESENTATIONS AND WARRANTIES REGARDING THE PERFORMANCE, SAFETY OR EFFICACY OF THE PRODUCT IN COMBINATION WITH ANY PRODUCTS, AGENTS, DRUGS, COMPOUNDS OR COMPONENTS  OF CLEARSIDE BIOMEDICAL IN THE FINAL PHARMACEUTICAL PRODUCT OR THE PHARMCEUTICAL COMPONENT. CLEARSIDE BIOMEDICAL EXPRESSLY ACCEPTS THESE DISCLAIMERS.

GERRESHEIMER shall indemnify, defend, release and hold harmless CLEARSIDE BIOMEDICAL, its Affiliates, and their respective directors, employees, contractors and agents, from and against any and all actual Third Party claims, judgments, damages, losses, liabilities, penalties, suits, costs and expenses (including reasonable attorney’s fees and court costs) incurred after the Effective Date and to the extent arising out of or relating to: (a) a breach of this Agreement or the Quality Agreement by GERRESHEIMER; (b) the negligent or willful misconduct of by GERRESHEIMER, its Affiliates, or their respective employees, agents or contractors. For the sake of clarity, GERRESHEIMER shall not be responsible to indemnify, defend, release or hold harmless CLEARSIDE BIOMEDICAL as provided for above for that portion of any claims, judgments, damages, losses, liabilities, penalties, suits, costs or expenses for which CLEARSIDE bears contributory liability as agreed to by the Parties or determined by a court of competent jurisdiction.

Subject to Clause 11.2, CLEARSIDE BIOMEDICAL shall indemnify, defend, release and hold harmless GERRESHEIMER, its Affiliates, directors, employees and agents or sub-contractors from and against any and all actual Third Party claims, judgments, damages, losses, liabilities, penalties, suits, costs and expenses (including reasonable attorney’s fees and court costs) incurred after the Effective Date and to the extent arising out of or relating to: (a); a breach of this Agreement or the Quality Agreement by CLEARSIDE BIOMEDICAL , or (b) the sale, distribution, supply, use or operation of the Product including, but not limited to, any claims resulting from filling, storing, packaging, testing, using or selling Product or relating to the adequacy of the labelling, warnings and instructions. For the sake of clarity, CLEARSIDE BIOMEDICAL shall not be responsible to indemnify, defend, release or hold harmless GERRESHEIMER as provided for above for that portion of any claims, judgments, damages, losses, liabilities, penalties, suits, costs or expenses for which GERRESHEIMER bears contributory liability as agreed to by the Parties or determined by a court of competent jurisdiction.

In the event that a Party (the “Indemnified Party”) receives a claim or demand from a Third Party in respect of a matter which is the subject of an indemnity under this Clause it shall give the other Party (the “Indemnifying Party”) written notice thereof as soon as reasonably practicable and shall permit the Indemnifying Party and its insurers the opportunity to assume direction and control of the defence against such claims, at its sole expense, including without limitation, the selection of counsel to the extent that the Indemnified Parties’ liability is not thereby invoked.

The Parties shall cooperate with one-another and their insurers in the disposition of any such matter.

[***].

[***].

LIMITATIONS ON LIABILITY

Neither Party excludes or limits liability to the other Party for:

fraud or fraudulent misrepresentation;

death or personal injury caused by negligence or willful misconduct ; or

any matter in respect of which it would be unlawful for the Parties to exclude liability.

[***].

Subject to Clause 23.1, in no event shall the collective and aggregate liability of GERRESHEIMER and its Affiliates to CLEARSIDE BIOMEDICAL and its Affiliates for all claims under this Agreement, and any renewals or extensions thereof, whether in connection with a warranty claim, a Recall, an indemnity claim, a combination thereof, or otherwise, and whether arising under contract, warranty, tort (including negligence), strict liability, product liability, a combination thereof, or any other theory of liability or indemnification [***].

Subject to Clause 23.1 and subject to Clause 11.2, in no event shall the collective and aggregate liability of CLEARSIDE BIOMEDICAL or CLEARSIDE BIOMEDICAL Affiliates to GERRESHEIMER and its Affiliates for all claims under this Agreement, and any renewals or extensions thereof, whether in connection with a warranty claim, a Recall, an indemnity claim, a combination thereof, or otherwise, and whether arising under contract, warranty, tort (including negligence), strict liability, product liability, a combination thereof, or any other theory of liability or indemnification [***].

INSURANCE

TERMINATION AND CONSEQUENCES OF TERMINATION

In the event that either Party should be in material breach of this Agreement (being a single event or series of events that are together defined as a material breach) and either:

the breach is capable of remedy and the breaching Party has failed to substantially remedy the breach within sixty (60) days of written notice specifying the breach and requiring the same to be remedied; or

the breach is not capable of remedy within sixty (60) days from the receipt of written notice specifying the breach and requiring the same to be remedied; then

If one Party shall compound or make any arrangement with its creditors, or an insolvency administrator is appointed over all or any part of its assets or goes into liquidation (whether voluntary or otherwise) save as part of a bona fide reconstruction not involving insolvency or shall take or suffer to be taken any

similar action as a result of its inability to pay its debts or its insolvency it shall promptly so notify the other Party in writing giving particulars of the circumstances whereupon the other Party may terminate the Agreement immediately by written notice. For the avoidance of doubt the other Party may terminate the Agreement upon the occurrence of any of the circumstances described in this Clause 25.2 notwithstanding that Party may not have given notice to the other Party as required.

If at any time during the term of the Agreement there shall be any Change of Control of a Party or in case of Clearside, of an Affiliate party to an Affiliate Agreement pursuant to Clause 4.8:

The Party shall immediately so notify the other Party in writing. GERRESHEIMER shall confirm promptly after receipt of a Change of Control notification whether CLEARSIDE BIOMEDICAL is still covered by GERRESHEIMER’s trade credit insurance after such Change of Control. If CLEARSIDE BIOMECDICAL is not covered by GERRESHEIMER’s trade credit insurance, then GERRESHEIMER shall sell (and/or Deliver) any Products to CLEARSIDE BIOMEDICAL or fulfil or accept any Purchase Orders only upon receipt of a payment security from CLEARSIDE BIOMEDICAL by means of a payment guarantee of CLEARSIDE BIOMEDICAL or a bank guarantee of an internationally business bank rated with triple B; and

Either Party may upon receiving notice or otherwise becoming aware of a Change of Control of the Party have the right, exercisable within ten (10) days after receipt of notice or becoming aware, to terminate the Agreement by notice in writing to the Party; PROVIDED, HOWEVER, that such Party may only terminate this Agreement upon a Change of Control of the other Party if it considers, acting reasonable, that such Change of Control is prejudicial to its interests; PROVIDED FURTHER, HOWEVER, that such termination shall become effective twenty four (24) Months from the date of the Change of Control notice, unless the Parties mutually agree in writing on a shorter period of time. With respect to GERRESHEIMER, such Change of Control shall always be deemed prejudicial, if CLEARSIDE BIOMEDICAL’s acquiror’s primary business is in direct competition with GERRESHEIMER (it being understood that for the avoidance of doubt, such acquirer of CLEARSIDE BIOMEDICAL shall not be construed as having a primary business in direct competition with GERRESHEIMER by virtue of the fact that it manufactures the Product by itself for use with its own pharmaceutical products). The same terms and conditions shall apply to agreements pursuant to Clause 4.8.

If CLEARSIDE BIOMEDICAL ceases to sell the final pharmaceutical product which incorporates Product supplied under this Agreement, CLEARSIDE BIOMEDICAL may terminate this Agreement on giving thirty (30) days prior written notice if it is ceasing to sell the Product as a result of a market withdrawal in the USA by requirement of a Regulator, and three (3) Month prior written notice in any other circumstances. In case CLEARSIDE BIOMEDICAL’s decision is due to significant

technical, or any regulatory reasons with respect to the Product, CLEARSIDE BIOMEDICAL shall notify GERRESHEIMER immediately upon learning of such technical or regulatory impact, and, as appropriate, work together with GERRESHEIMER to remedy such impact during the notice period.

The applicable Party may terminate this Agreement in accordance with Clause 20.5 (Force Majeure).

Either Party may terminate this Agreement by electing not to renew the Agreement in accordance with Clause 2.

For the avoidance of doubt in the event of any termination of this Agreement, the respective Product Schedules will terminate, unless the Parties expressly agree in writing that the terms of this Agreement shall continue to apply to a Product Schedule following termination of this Agreement.

On termination of the Agreement, GERRESHEIMER shall, not later than forty five (45) Business Days after CLEARSIDE BIOMEDICAL’s prior written request but at CLEARSIDE BIOMEDICALs cost deliver to CLEARSIDE BIOMEDICAL (or as CLEARSIDE BIOMEDICAL shall direct) all quantities of the Product already produced (based on the agreed Selling Prices in the Product Schedule), semi- finished Products (based on the purchase price of the Materials plus manufacturing costs, and where available such costs shall be those identified in the cost breakdown in the Product Schedule), the Material and consumables (purchase price of the Materials plus [***] where available such price can be that identified in the cost breakdown in the Product Schedule), in its possession for the binding quantities for the next six (6) Months in the most recent Forecast Schedule or as otherwise agreed.

For the avoidance of doubt, upon termination of this Agreement by GERRESHEIMER pursuant to Clauses 25.1 or 25.2 or by CLEARSIDE BIOMEDICAL pursuant to Clause 25.4, CLEARSIDE BIOMEDICAL shall be obliged to reimburse GERRESHEIMER for all binding quantities for the next six (6) Months in the most recent Forecast Schedule or as otherwise agreed, provided they are not Agreed Defective Products.

In the event CLEARSIDE BIOMEDICAL terminates this Agreement pursuant to Clause 25.1, GERRESHEIMER shall, at its sole cost, provide reasonable assistance to CLEARSIDE BIOMEDICAL in the technical transfer of the manufacturing equipment to CLEARSIDE BIOMEDICAL’s or a Third Party’s manufacturing facility designated by CLEARSIDE BIOMEDICAL and shall grant to CLEARSIDE BIOMEDICAL a fully paid up non-exclusive worldwide license, with the limited right to grant sub-license to only such THIRD PARTY manufacturer, under the licensed GERRESHEIMER Results pursuant to Clause 15.3, or if not applicable, to new manufacturing and/or production processes relating directly to the Product required to use, sell, make and have made the affected Products (hereinafter

referred to as “Licensed IP”); PROVIDED, HOWEVER, that the license granted hereunder shall be effective only during the period of time of the supply of Products by said THIRD PARTY manufacturer (such period is hereinafter referred to as a “License Period”) and CLEARSIDE BIOMEDICAL shall not exercise its rights to use, sell, make or have made the Products or to utilize the Gerresheimer Results pursuant to such license other than during such a License Period. In all other cases and after the License Period if CLEARSIDE BIOMEDICAL desires that a THIRD PARTY manufacturer shall manufacture the Product by using Gerresheimer Results licensed pursuant to this Clause or pursuant to Section 15.3, CLEARSIDE BIOMEDICAL shall pay to GERRESHEIMER the licence fee, royalties or other amounts as negotiated between the Parties pursuant to Section 15.3 for as long as such manufacture continues.

With effect from termination of the Agreement, the Parties shall not make any use for any purpose whatsoever of any Intellectual Property which is the property of other Party except as it is expressly mentioned in this Agreement.

For the avoidance of doubt the Parties expressly acknowledge that any termination of this Agreement for whatever reason shall  not affect the effectiveness of any corresponding agreement pursuant to Clause 4.8 unless as otherwise agreed by the Parties in writing.

Following effectiveness of termination of the Agreement, CLEARSIDE BIOMEDICAL may remove the CLEARSIDE BIOMEDICAL Equipment from the Manufacturing Site (Removal). GERRESHEIMER shall, at the request of CLEARSIDE BIOMEDICAL, after prior written notification and without interruption of GERRESHEIMER’s business operations exceeding what is reasonably necessary to perform such Removal:

grant CLEARSIDE BIOMEDICAL access to the Manufacturing Site during normal business hours;

identify the CLEARSIDE BIOMEDICAL Equipment located within the Manufacturing Site; and

permit CLEARSIDE BIOMEDICAL to remove such Equipment.

The costs incurred by CLEARSIDE BIOMEDICAL in any removal of the CLEARSIDE BIOMEDICAL Equipment pursuant to this Clause 25 and, should the removal

directly result in any material damage to the Manufacturing Site or the CLEARSIDE BIOMEDICAL Equipment, the costs relating to the repair of the Manufacturing Site or the CLEARSIDE BIOMEDICAL Equipment (excluding damages caused by the negligence of a Party which shall be borne by that Party), shall be borne as follows:

in cases where CLEARSIDE BIOMEDICAL terminates pursuant to Clauses 25.1 (GERRESHEIMER material breach);25.2 (GERRESHEIMER insolvency); 25.3 (GERRESHEIMER Change of Control), by GERRESHEIMER; or

in cases where either Party terminates in accordance with Clause 20.5 (Force Majeure) equally by both Parties; or

in cases where GERRESHEIMER terminates pursuant to Clause 25.1 (CLEARSIDE BIOMEDICAL material breach); 25.2 (CLEARSIDE BIOMEDICAL insolvency); 25.3 (CLEARSIDE BIOMEDICAL Change of Control), by CLEARSIDE BIOMEDICAL.

WAIVER

No waiver or forbearance by either Party in enforcing any of its rights under this Agreement shall prejudice or affect the ability of the said Party to enforce such rights or any of its other rights at any time in the future. No waiver shall be effective unless in writing and signed by the Party concerned.  For the avoidance of doubt it is agreed that a waiver of a right on one occasion shall not constitute a waiver of the same right in the future.

NOTICE

SURVIVAL OF RIGHTS DUTIES AND OBLIGATIONS

Termination or expiry of this Agreement shall not release either Party hereto from any liability or right of action which at the time of termination has already accrued to either Party hereto or which may thereafter accrue in respect of any act or omission prior to such termination. Such rights shall include but not be limited to the recovery of any monies due hereunder,

Any provision of this Agreement which by its very nature imposes an obligation after termination or expiration of this Agreement shall survive the termination or expiration of this Agreement.  Without limiting the foregoing, expiration or earlier termination of the Agreement shall be without prejudice to the continuation in force of Clauses 10, 14, 15, 16, 17, 18, 22, 23, 25, 26, 27, 28, 38 and 39.

RELATIONSHIP OF THE PARTIES

Each Party is an independent contractor and neither is the agent of the other. Except as is specifically provided in this Agreement neither Party is authorised to incur any expenditure or cost for the other without the written consent of that Party.

ASSIGNMENT

The Parties’ rights and obligations under this Agreement may not be assigned in whole or in part without the prior written consent of the other Party (such consent not to be unreasonably withheld). Notwithstanding the foregoing, either Party may, even without the consent of the other Party, assign this Agreement or any of its rights or obligations (i) to any of its Affiliates, or (ii) in connection with a sale or transfer of all or substantially all of such Party’s business or assets relating to the subject matter of this Agreement, whether by merger, sale of assets or otherwise; PROVIDED, HOWEVER, that such Party’s rights and obligations under this Agreement shall be assumed in writing by its successor in interest in any such transaction and PROVIDED FURTHER that if in case of CLEARSIDE BIOMEDICAL said Affiliate or Third Party’s primary business is in direct competition with GERRESHEIMER, then GERRESHEIMER is entitled to terminate this Agreement in its sole discretion upon at least twenty four (24) Month written notice to CLEARSIDE BIOMEDICAL.

SUB-CONTRACTORS

GERRESHEIMER may not delegate or otherwise sub-contract its obligations under this Agreement without the prior written consent of CLEARSIDE BIOMEDICAL, such consent not to be unreasonably withheld or delayed. For the avoidance of doubt GERRESHEIMER may, in its sole discretion, sub-contract its rights and obligations under this Agreement to any of its Affiliates in which case GERRESHEIMER shall remain responsible for the performance of its Affiliates.

SOLE AGREEMENT

This Agreement represents the entire agreement between the Parties and supersedes and extinguishes all previous agreements and negotiations between the Parties in respect of the subject matter hereof and shall apply to the exclusion of all other standard conditions of sale or purchase, whether written, oral, express or implied which the Parties may purport to apply or which are endorsed upon any correspondence or documents issued by one Party irrespective of their date of communication to the other Party.

Each Party acknowledges that in entering into this Agreement, it is not relying upon any statement, draft, agreement, undertaking, warranty, promise, assurance or arrangement of any nature whatsoever, whether written or otherwise, relating to the subject matter of this Agreement made by any person prior to the date of this Agreement which is not set out in this Agreement.  Except in the case of fraud, no Party shall have any right of action against the other Party arising out of or in connection with any such statement, except to the extent it is repeated in this Agreement.

In the event of any conflict with, or inconsistency between any term or provision of this Agreement and any term or provision of its Schedules or other agreements entered into pursuant to it, the term or provision of this Agreement shall prevail.

EXPENSES

AMENDMENTS

No modification or amendment of this Agreement shall be valid or binding upon the Parties hereto unless made in writing and duly executed on behalf of both of the Parties by their respective duly authorised officers. This also applies to any waiver of the aforementioned written form requirement. Any modifications to the Specifications shall be agreed to in writing by both Parties. The last agreed version shall automatically supersede the previous one.

SEVERABILITY

Each clause of this Agreement is a distinct and severable clause and if any clause is deemed illegal, void or unenforceable, the validity, legality, or enforceability of any other clause or portion of this Agreement shall not be affected thereby to the exclusion of all other remedies.

If any provision of this Agreement is held to be invalid, illegal or unenforceable, in any respect, then such provision will be given no effect by the Parties and shall not form part of this Agreement. To the fullest extent permitted by Applicable Law and if the rights and obligations of any Party will not be materially and adversely affected all other provisions of this Agreement shall remain in full force and effect and the Parties shall use their commercially reasonable efforts to negotiate a provision in replacement of the provision held invalid, illegal or unenforceable that is consistent with Applicable Law and achieves, as nearly as possible, the original intention of the Parties.

ETHICAL STANDARDS AND HUMAN RIGHTS

Unless otherwise required or prohibited by law, GERRESHEIMER warrants, to the best of its knowledge, in relation to the supply of Product or services under the terms of this Agreement to:

provide employees with at least an amount of income necessary to meet their basic needs;

provide employees with the right to rest;

protect employees against discrimination in the workplace;

protect employees against coercion and degrading treatment;

respect employees’ right to freedom of association;

uphold the effective abolition of child labour;

provide employees safe and healthy working conditions;

protect and improve the environment; and

work against corruption in any form.

GERRESHEIMER is responsible for controlling its own supply chain and will encourage compliance with ethical standards and human rights by any subsequent supplier of goods and services that are used by GERRESHEIMER when performing its obligations under this Agreement.

COUNTERPARTS

This Agreement may be executed in any number of counterparts, and by the Parties in separate counterparts, but shall not be effective until each Party has executed at least one counterpart.

Each counterpart shall constitute an original of this Agreement, but all counterparts shall together constitute but one and the same instrument.

DISPUTE RESOLUTION

If either Party believes that there is a dispute between the Parties arising out of or in connection with this Agreement, including, without limitation, any non-contractual disputes or claims or any question regarding its existence, validity or termination (a “Dispute”), such Party may serve written notice on the other Party setting out details of the Dispute and the reasons why the Party serving the notice believes that the Dispute has arisen (a “Notice of Dispute”). Upon service of a Notice of Dispute, the Dispute shall be referred:

first to representatives of each Party with day-to-day responsibility for the management of matters relating to this Agreement, who shall discuss by phone or meeting at a mutually acceptable time and place and endeavour to resolve the Dispute (each acting reasonably and in good faith) within 5 (five) Business Days after service of the Notice of Dispute; and

failing resolution of the Dispute in accordance with the abovementioned, to the XXXXXXXX for GERRESHEIMER and the Chief Executive Officer for CLEARSIDE

BIOMEDICAL, who shall discuss by phone or meeting at a mutually acceptable time and place (the “Senior Representatives’ Meeting“) and endeavour to resolve the Dispute (each acting reasonably and in good faith) within 20 (twenty) days after the proceedings in accordance with Clause 38.1 (i).

If a Dispute has not been resolved within 20 (twenty) days after the Senior Representatives’ Meeting, the Parties may, subject to Clause 39 below, take any action available to them at law, provided that the Parties may at any time seek a injunctive injunctive relief or other preliminary measures from a competent court provided that the final settlement is reserved for the court of arbitration pursuant to Clause 39.2.

GOVERNING LAW AND JURISDICTION

This Agreement and any dispute or claim arising out of or in connection with it or its subject matter or formation (including non-contractual disputes or claims) shall be governed by and construed in all respects in accordance with the laws of  [***], excluding any conflicts or choice of law rules or principle that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction. For the avoidance of doubt the provisions of the United Nations Convention for the International Sale of Goods (CISG) are explicitly excluded.

In relation to any legal action or proceedings to enforce this Agreement or any agreement pursuant thereto the Parties agree that all disputes arising out of or in connection with the present contract shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce (ICC) by one or more arbitrators appointed in accordance with the said Rules of Arbitration. The procedural law of [***] shall apply where the Rules of ICC are silent. The place of arbitration shall be [***], and the language of correspondence and the proceedings shall be conducted in English language. The costs of the arbitration court shall be borne by the unsuccessful Party, and each Party shall bear in full its own part of all other costs however arising. The Parties agree to accept the decision of the court of arbitration as final and binding on both of them, to the exclusion of all other remedies. Nothing in this Clause 39.2 shall be construed as limiting the right of the Parties to seek an injunctive relief or other preliminary measures from a competent court, provided that the final settlement is reserved for the court of arbitration.

LEGAL ENTITIES (CLEARSIDE BIOMEDICAL & GERRESHEIMER) for orders

DEVICE NAME

CLEARSIDE BIOMEDICAL PHARMA PRODUCT IN WHICH PRODUCT/DEVICE IS USED      

GERRESHEIMER MANUFACTURING SITE(S)

CLEARSIDE BIOMEDICAL DELIVERY SITE(S)

DELIVERY TERMS / INCO TERMS

DEVICE SHELF LIFE

LEAD-TIME FOR DELIVERIES

PRODUCT SPECIFICATION

Description

Manufacturing standards

Packaging (if applicable), storage

Specific quality standards (in addition to those set out in the general QA)

PERFORMANCE STANDARDS

Quality

Delivery

CLEARSIDE BIOMEDICAL EQUIPMENT

List of CLEARSIDE BIOMEDICAL Equipment

Payment schedule for CLEARSIDE BIOMEDICAL Equipment

Tooling & Equipment Warranty period (inc wear parts not covered by the piece cost)

Annual / Sprint Capacity (including lead time for capacity changes)

PRICING

Currency of orders and invoices

Exchange Rate

Selling Price

Raw Material prices

Minimum order quantities

Idle Costs

CLEARSIDE BIOMEDICAL Purchase Commitment (if different from standard 3 months Firm Orders)

LEGAL ENTITIES (CLEARSIDE BIOMEDICAL & GERRESHEIMER) for orders

DEVICE NAME

CLEARSIDE BIOMEDICAL Device Description and Use   

[***]    

Device Use – The final device is used to deliver pharmaceutical agents to the Suprachoroidal space of the eye.

CRITICAL MANUFACTURING SITE(S)

CLEARSIDE BIOMEDICAL DELIVERY SITE(S)

DELIVERY TERMS / INCO TERMS

DEVICE SHELF LIFE

LEAD-TIME FOR DELIVERIES

PRODUCT SPECIFICATION

Description

The Microinjector is a sterile, hand-held device  [***] designed for Suprachoroidal injection of Clearside Biomedical drug products. [***]. 

Manufacturing standards

Packaging, storage,

Specific quality standards (in addition to those set out in the general QA)

PERFORMANCE STANDARDS

CLEARSIDE BIOMEDICAL EQUIPMENT

List of CLEARSIDE BIOMEDICAL Equipment – to be updated by an attachment as additional equipment is received

[***]

[***]

[***]

Payment schedule for CLEARSIDE BIOMEDICAL Equipment

[***]

Automation – Complete per Quotation

[***]

[***]

[***]

[***]

Tooling & Equipment Warranty period (including wear parts not covered by the piece cost to be quoted and detailed)

Annual / Sprint Capacity (including lead time for capacity changes)

PRICING

Currency of orders and invoices

USD

Exchange Rate

Fixed on a monthly basis; no change if FX rate changes [***] or less

Selling Price

Volume Forecast

[***]

[***]

[***]

Exchange rate: 1.00 Euro = $1.1993 USD (Jan2018)

[***]

[***]

Additional packaging or alternate shipper totes etc. are not included.

Current shipping configuration: [***]

[***]

PURPOSE

SCOPE

TERMS OF AGREEMENT

DEFINITIONS

GENERAL RESPONSIBILITIES

QUALITY SYSTEMS

Establishment of Quality Systems

Technology Changes / Change Control

Deviations

Qualifications and Training

Identification & Traceability

REGULATORY

Manufacture

Regulatory Documentation

Regulatory Filings

Label Copy Approval / Label Usage

Audits

Recalls- See Section 16.3 of the Supply Agreement.

Product Complaints – See Section 16 of the Supply Agreement.

Medical Device Reporting

Device Listing/Registration

SUBCONTRACTING

GERRESHEIMER shall not to transfer or give its activity listed within the Quality Agreement, including the Checklist, to a sub-contractor without a prior written approval from CLEARSIDE BIOMEDICAL.

If authorised by CLEARSIDE BIOMEDICAL in writing, GERRESHEIMER may only sub-contract activities to sub-contractors approved and regularly evaluated. Requirements described in this Quality Agreement are applicable to GERRESHEIMER authorized subcontractors.

DOCUMENTATION CONTROL

GERRESHEIMER must develop, maintain and adhere to all of the Product control documentation including, but not limited to, manufacturing records, packaging instructions, drawings, specifications, and test methods.  Any deviations from GERRESHEIMER’s pre-established documentation must be pre-approved and agreed to by both Parties in writing, as defined in this Agreement and the Supply Agreement.  GERRESHEIMER must ensure that these requirements are governed by the GERRESHEIMER change control policy and are thoroughly understood, prior to production.

GERRESHEIMER shall conform its Product control documentation to be in compliance with the latest 21 CFR Part 820 and ISO 13485 requirements.  IF CLEARSIDE BIOMEDICAL has reason to believe GERRESHEIMER’s control does not so conform, CLEARSIDE BIOMEDICAL shall direct such concerns in writing to GERRESHEIMER who shall either remedy instances of non-conformance or respond to address such concerns.

Neither GERRESHEIMER nor CLEARSIDE BIOMEDICAL shall make changes to this Quality Agreement without prior notification and approval of the other party. All changes must be in writing and signed by both parties.

As supplied by CLEARSIDE BIOMEDICAL, GERRESHEIMER shall maintain official copies of CLEARSIDE BIOMEDICAL provided documentation as agreed upon herein or in the Supply Agreement.

FACILITY / EQUIPMENT CONTROLS

GERRESHEIMER shall have facilities, work flow and material handling such that components, packaging materials and products are protected from damage, contamination, or mix-up during production or storage.

GERRESHEIMER shall maintain all equipment used in the manufacture, packaging, testing, and supply of Products hereunder in good operating condition and shall maintain

the Manufacturing Site and such equipment in accordance with current Quality System Regulations (QSR) (21 CFR Part 820), specifications, and ISO 13485.  As deemed appropriate, equipment shall be qualified prior to use by performing Installation Qualification, Operation Qualification and Performance Qualification using protocols in accordance with 21 CFR Part 820 and ISO 13485.

GERRESHEIMER shall have a cleaning / sanitization program to assure that all equipment that has substantial contact with CLEARSIDE BIOMEDICAL’s product is controlled for contamination.  GERRESHEIMER shall have written procedures in place supporting this program.

GERRESHEIMER shall assure that any equipment used in connection with the manufacture of other product(s) containing highly potent or hazardous products shall have no contact with the CLEARSIDE BIOMEDICAL Product. GERRESHEIMER shall perform specific validation studies for equipment cleaning processes for products containing highly potent or hazardous components to demonstrate their cleaning effectiveness.  However, all non-product contact parts and equipment may be used in common for both the Product and highly potent or hazardous products.  

GERRESHEIMER shall maintain an environmental monitoring program for the evaluation of bioburden in areas of possible product exposure as necessary based on the susceptibility of the CLEARSIDE BIOMEDICAL products manufactured unless otherwise justified by historical data and the validated process.

Equipment and instruments used to produce or test the Product or components thereof shall be calibrated, where appropriate, at suitable intervals in accordance with an established written program.

PURCHASING CONTROLS

Approve Components / Packaging Materials & Suppliers pursuant to the Supply Agreement

Incoming Inspection

MATERIAL CONTROL & SPECIFICATIONS

Components / Packaging Materials

Storage

Product

Labels / Labeling

PRODUCTION CONTROLS

It is the responsibility of GERRESHEIMER to adopt the necessary techniques and/or controls during all phases of manufacturing / packaging to control the quality of the Product.  GERRESHEIMER shall maintain records of test performance sufficient to meet regulatory requirements.

As defined by the validated process, the Product will be evaluated throughout production to ensure Specifications are met.

GERRESHEIMER will reconcile all Product components and all finished Product labels in accordance with its standard operating procedures.

All Defective Product must be quarantined and the deviation investigated appropriately per GERRESHEIMER standard procedures.

QUALITY CONTROL

Sampling Plans

Verification of Quality

Records and Reports

Component receiving and test records

Manufacturing Records

Packaging Records

Quality Control Records (e.g., In-process checks, line clearance, etc.)

Label Reconciliation Records

Non-Conformance / Deviation Reports

Batch Release

Certificate of Compliance

Certificate of Analysis

VALIDATION

TECHNOLOGY CHANGES

RECORDS

LIFE CYCLE and TERMINATION