Document:

Liquidia LGM Yonsung SA

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT
IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF
PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.

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Exhibit 10.44
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LIQ861 API SUPPLY AGREEMENT
BETWEEN
LGM Pharma LLC
Yonsung Fine Chemicals Co., Ltd.
AND
Liquidia Technologies, Inc. 
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DATED AS OF
January 10, 2020
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EXHIBITS TO AGREEMENT
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AAPI, Facility, and Territory
B Product Specifications
CAPI Shelf Life and Required Remaining Shelf Life Upon Shipment
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CDA.000XX.M.000                                                              LGM Pharma and Liquidia Technologies, Inc.‌     Page 2 of 5

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SUPPLY AGREEMENT
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THIS SUPPLY AGREEMENT (the “Agreement”) is made and entered into as of January 10, 2020 (the “Effective Date”) by and between LGM Pharma LLC, a limited liability corporation organized under the laws of Delaware, with offices at 2758 Circleport Dr., Erlanger, Kentucky, 41018, USA (hereinafter “Supplier”); Yonsung Fine Chemicals co., Ltd, a corporation organized under the laws of Republic of Korea with offices at 207 Sujeong-ro, Jangan-myeon, Hwaseong-si, Gyeonggi-do 18581 Republic of Korea (hereinafter “Manufacturer”) (collectively Supplier and Manufacturer as “Supply Party”) and Liquidia Technologies, Inc., a corporation organized under the laws of Delaware, with offices at 419 Davis Drive, Suite 100, Morrisville, NC 27560 (“Purchaser”).
Supplier, Manufacturer and Purchaser are sometimes referred to herein individually as a “Party” and collectively as “Parties”, as the case may be. 
Supplier and Manufacturer are sometimes referred to herein collectively or individually as “Supply Party”, as the case may be. 
RECITALS
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WHEREAS, Manufacturer is a pharmaceutical company engaged in the development, manufacture and sale of Active Pharmaceutical Ingredients (“API(s)”);
WHEREAS, Supplier is a pharmaceutical company engaged in the marketing, distribution and sale of Active Pharmaceutical Ingredients (“API(s)”);
WHEREAS, Supply Party is willing to manufacture and supply the API(s) to Purchaser upon the terms and conditions set forth herein.
WHEREAS, Purchaser is a company that is engaged in the development, distribution and sale of certain pharmaceutical products utilizing the API;
NOW, THEREFORE, in consideration of the foregoing recitals, mutual covenants, agreements, representations and warranties contained herein, the Parties hereby agree as follows:
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1.Definitions.

		1.1	“Active Pharmaceutical Ingredient” or “API” shall have the meaning given such term in the preamble hereof and as shown on Exhibit A.

		1.2	“Affiliate” shall mean any person or entity that, directly or indirectly, through one or more intermediaries, Owns, is Owned by or is under common Ownership with, a Party, where “Own,” “Owned” or “Ownership” refers to (i) direct or indirect possession of at least fifty percent (50%) of the outstanding voting securities of a corporation or a comparable ownership in any other type of entity; or (ii) the actual ability of an entity, person or group to control and direct the management of the person or entity, whether by contract or otherwise.

CDA.000XX.M.000                                                              LGM Pharma and Liquidia Technologies, Inc.‌     Page 3 of 5

		1.3	“Applicable Law” shall mean the laws, regulations, rules and guidelines pertaining to the development, manufacture, packaging, labeling, storage, import, export, distribution, marketing, sale and/or intended use of the API or the Finished Product.

		1.4	“Batch” means a specific quantity of API that is intended to be of uniform character and quality, within specified limits, and is produced during the same cycle of Manufacture as defined by the applicable Batch Records.

		1.5	“Batch Record” shall mean a batch manufacturing record, prepared according to applicable cGMP guidelines, for every production Batch of API.

		1.6	“Business Day” means a day on which banking institutions in New York City, New York are open for business.

		1.7	“Certificate of Suitability of Monographs of the European Pharmacopoeia (CEP)” shall mean the document showing that a manufacturer of a substance has provided proof that the quality of the substance is suitably controlled by the relevant monographs of the European Pharmacopoeia. A CEP is granted by the Certification Secretariat of the European Directorate for the Quality of Medicines (EDQM) and confirms that pharmaceutical substances or active pharmaceutical ingredients (API) are produced according to the monographs of the EP. 

		1.8	 “Certificate of Analysis” and “Certificate of Conformance” shall mean documents identified as such and provided by Supply Party to Purchaser that (i) sets forth the analytical test results for a specified Batch of API shipped to Purchaser hereunder, (ii) is in conformance with all Applicable Laws and (iii) states whether such API is Manufactured in accordance with the Product Specifications, Quality Agreement and cGMPs.

		1.9	“Confidential Information” shall mean all the commercial, business and/or technical non-public information, whether tangible or intangible, including (without limitation) any and all data, techniques, discoveries, inventions, processes, know-how, patent applications, inventor certificates, trade secrets, methods of production and other proprietary information, suppliers' lists, customers' lists,  that either Party or its Affiliates have ownership rights to (as either owner, licensee or sub-licensee), or may hereafter obtain rights.

		1.10	“Current Good Manufacturing Practices” or “cGMP” shall mean current Good Manufacturing Practice as set forth by the FDA and other applicable Regulatory Agencies as well as current good manufacturing practices applicable to the API, or the making thereof at Supply Party’s Manufacturing Facility, set forth by the relevant Regulatory Agencies.

		1.11	“Defect” with respect to the API shall mean failure of the API to comply with the Product Specifications (Exhibit B), Applicable Laws, and Supply Party's DMF. 

		1.12	“Drug Master File” or “DMF” shall mean a qualified submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The DMF shall also mean such a qualified European CEP submission to the relevant European agency, as may be applicable under this Agreement for use, marketing, sale and 

CDA.000XX.M.000                                                              LGM Pharma and Liquidia Technologies, Inc.‌     Page 4 of 5

			the like of Purchaser’s Finished Product in such Territory. In the case of this Agreement at the Effective Date, the DMF refers to Supply Party’s DMF Number(s) as shown on Exhibit A.

		1.13	“Facility” shall mean Manufacturer’s Manufacturing facility(ies) located at the address(es) as listed in Exhibit A. 

		1.14	“FDA” shall mean the U.S. Food and Drug Administration, and any successor thereto, or, as applicable in non-U.S. jurisdictions the relevant foreign equivalent thereof. 

		1.15	“Finished Product” shall mean the Purchaser’s finished dosage form combination drug or device product that contains the API ready for commercial sale.

		1.16	 “Manufacture” or “Manufacturing” means activities directed to and processes used by Supplier and/or Manufacturer, as the case may be, in producing, manufacturing, processing, packaging, labeling, quality assurance testing and release, shipping and storage of the API.

		1.17	“Markets” or “Market” or “Territory” or “Territories” shall mean those specific markets or territories set forth in Exhibit A of this Agreement, it being understood that the Parties shall agree upon particular specifications and price adjustments with respect to Markets having unique requirements such as the Japanese market which shall be set forth in the relevant product schedule.

		1.18	“Marketing Authorization” shall mean, on a country by country basis, a permission issued by the competent Regulatory Agency to bring a drug product to the market.

		1.19	“Master Batch Record” means the template Batch Record to be used by Manufacturer to guide and document the production of each Batch of API Manufactured hereunder.

		1.20	 “Person” means any natural person, corporation, firm, business trust, joint venture, association, organization, company, partnership or other business entity, or any government, or any agency or political subdivision thereof.

		1.21	“Product Specifications” shall mean, with respect to the API, all specifications for materials, approved suppliers, formula, manufacturing, analytical and testing procedures, release, packaging and other processes relating to the manufacture of the API, all as set forth on Exhibit B to this Agreement.

		1.22	“Quality Agreement” shall mean that certain Quality Assurance Agreement by and between Purchaser and Supply Party, showing (a) the roles and responsibilities of the Parties with respect to the quality assurance for the API and (b) how the Parties’ quality operations shall interact with each other in connection with the same.

		1.23	“Regulatory Agency” shall mean the relevant national or other government entities regulating or otherwise exercising authority with respect to the API to Supply Party’s manufacturing facilities including, without limitation, manufacturing, packaging, re-packaging and warehousing and the Territories listed in Exhibit A where the Purchaser will seek Marketing Authorization for the drug product manufactured with the API.

CDA.000XX.M.000                                                              LGM Pharma and Liquidia Technologies, Inc.‌     Page 5 of 5

		1.24	“Reprocess” or “Reprocessing” means introducing API back into Manufacturing and repeating any manipulation step(s) that are part of the established Manufacturing. For clarity, continuation of Manufacturing after an in-process control test showing the process to be incomplete is not considered Reprocessing.

		1.25	“Rework” or “Reworking” means subjecting API to one or more processing step(s) that are different from the established Manufacturing with the intention of Manufacturing API that meets the Specifications and the requirements of this Agreement.

		1.26	 “Term” shall have the meaning assigned to such term in Section 9.

		1.27	“Territory” means different geographic regions that are governed under different Applicable Laws, as may be further defined in Exhibit A. 

		1.28	“Third Party” means any Person other than a Party or any of its Affiliates.

		1.29	“US” means the United States of America.

		1.30	“Price Agreement” means two separate agreements, the first between Purchaser and Supplier titled “LIQ861 Liquidia-LGM Pricing Agreement” that details the pricing, delivery and payment terms and conditions of this Supply Agreement. The second, agreement between Supplier and Manufacturer titled “LIQ861 LGM-Yonsung Pricing Agreement” that details the pricing, delivery and payment terms and conditions.

2.Manufacture and Sale.
2.1.Supply.  For the API specified and Territory set out in Exhibit A hereunder, during the term of this Agreement and subject to the terms and conditions set forth herein, Manufacturer shall Manufacture and Supplier shall supply API to Purchaser (or a third party designated by Purchaser) in such quantities as from time to time may be ordered by Purchaser. Subject to Manufacturer’s and Supplier's full and timely compliance with any and all of its undertakings under this Agreement, Purchaser intends to purchase all of its annual API requirement for Finished Products to be sold in the US from Supplier. Beginning with the first year Purchaser provides a Rolling Forecast under Section 3.2(b), Purchaser will order and purchase a minimum of [***] grams of API. The Parties may negotiate API supply for other territories on a case-by-case basis. For the avoidance of doubt, the Parties expressly agree that Purchaser will agree to purchase a minimum of [***] of the Purchaser’s annual requirements from the Supply Party for the length of the Term. 
2.2.Product Specifications.  The specifications of the API are set out in Exhibit B to this Agreement (the “Product Specifications”); as such Exhibit may be amended or superseded according to the terms of the Quality Agreement between the Parties. 
2.3.Costs.  Manufacturer shall be responsible for all costs and expenses related to (i) the Manufacture of API, and (ii) the maintenance of the DMF for the API. The cost of additional submissions, technical work, documents, data or materials requested by Purchaser for other territories will be negotiated in good faith between the Parties.
2.4.Records. Supply Parties will keep complete and accurate records (including without limitation reports, accounts, data, and records of all information and results obtained from performance of services) of all work done by it under this Agreement, in form and substance as specified in the Quality Agreement and this Agreement (collectively, the “Records”). While in the 

CDA.000XX.M.000                                                              LGM Pharma and Liquidia Technologies, Inc.‌     Page 6 of 5

possession or control of Supply Parties, Records will be available at reasonable times for inspection, examination and copying by FDA, other applicable Regulatory Agency and Purchaser. Supply Parties will ensure that all Records of the Manufacture of API under this Agreement will be retained and archived in accordance with cGMP and Applicable Law, but in no case for less than a period of five (5) years following completion of the applicable Manufacturing cycle.

3.Price, Orders and Terms of Payment. 
3.1.Pricing. Supplier shall, deliver, and Purchaser shall purchase the API pursuant to the Price Agreement entered into between Purchaser and Supplier (“LIQ861 Liquidia-LGM Pricing Agreement”).
3.2.Forecasting.  
(a)Initial Forecast. Upon execution of this Agreement, Purchaser will provide Supply Party with Purchaser’s good faith estimate of its projected requirements for supply of API for delivery during the remaining calendar year (such estimate, the “Initial Forecast”). The [***], which was ordered under [***] placed on [***]. The first three (3) months of the Initial Forecast (or portion of the remaining calendar year if less than three months remain) will be binding upon execution of this Agreement and Purchaser shall issue a purchase order, in the manner set forth in the LIQ861 Liquidia-LGM Pricing Agreement (“Purchase Order”) for this first supply period of API within thirty (30) days of execution of this Agreement. The remaining months of this Initial Forecast will be a good faith estimate of Purchaser’s needs over the remaining Initial forecast period. For any remainder of the Initial Forecast term following the first supply period, if Purchaser requires API then Purchaser shall provide Supplier a Purchase Order for each successive three (3) month term(s) (including any fragment thereof that may be remaining) at least sixty (60) days prior to the expiration of the then current supply period.  
(b)Rolling Forecast. Following the Initial Forecast term, beginning with the next calendar year, Purchaser shall submit a twelve (12) month rolling forecast updated on a quarterly basis, broken down on a quarterly basis covering Purchaser’s anticipated requirements of API (“Rolling Forecast”). Such Rolling Forecast to be provided to Supply Party at least sixty (60) days prior to the start of the successive quarter. The first three (3) months of each rolling forecast shall be a binding commitment (the “Firm Forecast”), and the last nine (9) months will be for information purposes only and non-binding. Purchaser shall place all Purchase Orders with Supplier at least sixty (60) days in advance of required delivery to Purchaser. Supplier may not reject a Purchase Order which falls within the scope of the applicable Initial Forecast or Rolling Forecast.  
(c)Long-Term Forecasts. On or before the last business day of each calendar year during the term of this Agreement, Purchaser shall provide to Supply Party the anticipated annual volumes of API to be Manufactured for Purchaser under this Agreement for the next succeeding twenty-four (24) months (or shorter period remaining under the term of this Agreement). The requirements for the API as set forth in each Long-Term Forecast shall be a projection only and shall not be binding on either party. 
(d)Discontinuance of API by Supplier or Manufacturer. Supplier and/or Manufacturer shall provide Purchaser with six (6) months advance written notice of its intent to discontinue API Manufacture or supply of API. Upon receipt of such notice of discontinuance, Purchaser shall be entitled to purchase up to a [***] supply of such API prior to effectiveness of such discontinuance and Purchaser’s issuance of a Purchase Order for such shall be binding on Supplier and Manufacturer. Purchase Orders.  Each Purchase Order described herein shall be binding on 

CDA.000XX.M.000                                                              LGM Pharma and Liquidia Technologies, Inc.‌     Page 7 of 5

Purchaser and Supplier when issued by Purchaser, each a “Firm Order” when issued by Purchaser. Supplier shall be required to timely supply each such Firm Order.  Supplier shall acknowledge receipt of any Purchase Order within five (5) days of delivery. Supplier shall exercise its commercially reasonable efforts to comply with any changes to a Purchase Order that Purchaser may request up to shipment of that respective order. Purchaser shall be able to delay or cancel any Purchase Order prior to shipment by Supplier. Purchase Orders may be amended by mutual agreement of the Parties.

3.3.Acceleration of Quantities. At any time under this Agreement Purchaser shall be able to place a Purchase Order for an acceleration of quantity up to one year’s supply for its commercial needs and such Purchase Order shall become binding upon its issuance. The Parties shall promptly meet and negotiate a reasonable delivery schedule for the accelerated quantity, which delivery schedule shall not be unreasonable delayed.  
3.4.Scope of Agreement.  In no event shall any terms or conditions included on any Purchase Order, invoice or acknowledgement thereof or any other document, whether paper, electronic or otherwise, relating thereto, apply to the relationship between the Parties under this Agreement, unless such terms are expressly agreed to by the Parties in writing. If there is a conflict between the terms of any Purchase Order or other document and this Agreement, the terms of this Agreement shall control, except only with respect to product quality that will be governed by the Product Specification (Exhibit B) and. The Parties further agree that no course of dealing between the Parties shall in any way modify, change or supersede the terms and conditions of this Agreement without a signed written document intentionally amending this Agreement.
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4.Manufacture of API.
4.1.Manufacture.  The API shall be Manufactured by the Manufacturer at its Facility in accordance with all relevant current Good Manufacturing Practices (“cGMPs”), the Product Specifications, and Applicable Laws, and pursuant to the Manufacturer’s Drug Master File (“DMF”), prepared by the Manufacturer and filed with the FDA and other applicable Regulatory Agencies as applicable. Supply Party shall advise Purchaser in writing in advance of making any changes to the Product Specifications or any changes in the methods, processes or procedures in Manufacturing the API. Any such changes will be made according to the terms of the Quality Agreement between the Parties. Supply Party shall provide sufficient notice of any such change to Purchaser to allow Purchaser to make any required notices to and obtain any required approvals from any Regulatory Agency prior to the implementation of such change.
4.2.Quality Agreement.  Purchaser and Supply Party have entered into a quality agreement for the APIs having an initial effective date October 3, 2017, and as amended thereafter (“Quality Agreement”). The Quality Agreement is incorporated by reference herein in its entirety and is a material part of this Agreement. In the event of a conflict between the terms of the Quality Agreement and the terms of this Agreement, the terms of this Agreement shall control unless and to the extent related to the quality and/or specifications of the API. The Quality Agreement shall establish the procedure to be followed if either Party desires to change any aspect of the Manufacturing procedure for any API, including but not limited to any change in the Specifications as described in Section 4.6 below. The Quality Agreement shall contain a mechanism to assure that any applicable Regulatory Agency have approved the Specifications, to the extent necessary, and that Supply Party is given a reasonable period of time to implement any changes required by any such applicable Regulatory Agency with regard to the Specifications.

CDA.000XX.M.000                                                              LGM Pharma and Liquidia Technologies, Inc.‌     Page 8 of 5

4.3.Right of Audit. Purchaser and its representatives shall have the right to audit Supply Parties for compliance with applicable regulatory requirements and Applicable Laws, including, but not limited to, cGMPs, at reasonable intervals and upon a 30 day written notice.  Such audits shall be scheduled at mutually agreeable times and shall not be more frequent than twice per year. Notwithstanding the aforesaid, in case of an action taken by any Regulatory Agency and/or by any other governmental agency operating under any Applicable Law against either or both Supply Party with regard to non-compliance with applicable regulatory requirements and/or in case that any audit discovers a breach of Supply Party's undertakings under this Agreement, Purchaser may conduct such audits on a more frequent basis and without prior notice.   
4.4.Certificate of Analysis and Certificate of Conformance; Product Release.  The quality control(s) and the release(s) of API (including documentation) shall be done by the Manufacturer in accordance with the Quality Agreement. Supply Party shall provide certificates of analysis or conformance to Purchaser for each Batch of API delivered under this Agreement. API designated for delivery shall have remaining shelf life no less than that indicated in Exhibit C. 
4.5.Cooperation.  During the term of this Agreement, Supply Party shall assist and cooperate in a timely manner with Purchaser in its preparation of any documents or other materials which may be reasonably required to validate, test, sell and/or distribute the API to be supplied by Supply Party under this Agreement or the Finished Product. The Manufacturer shall file with the FDA and shall maintain at all times as current, a DMF for the API. Supply Party shall also provide Purchaser with a referral letter permitting Purchaser to use the Manufacturer’s DMF. Supply Party shall also assist and cooperate in a timely manner with Purchaser in its preparation of any documents or other materials which may be required by the FDA and EMA to validate, test, sell, and/or distribute the Finished Product which uses API Manufactured by Manufacturer or supplied by Supplier under this Agreement. Supply Party and Purchaser agree to discuss any plan either Party may have for advancing the API or Purchasers product candidate into regulatory territories outside the US, which may include a CEP filing with the EMA and / or relevant EU national authority as the case may be.
4.6.Required Changes. Each Party shall deliver to the other written notice of any required changes to the Product Specifications requested by the Regulatory Authorities. The relevant Supply Party shall use its commercially reasonable efforts to make such changes to the Product Specifications in a diligent and timely manner, provided Purchaser be fully informed prior to and following any such changes with the right to review and comment on such changes. If the change required by the Regulatory Authority is a result of a Supply Party deficiency then the cost for such required change shall be the responsibility of the respective Supply Party. If the change required by the Regulatory Authority is other than a result of a Supply Party deficiency then the cost for such required change shall be shared between the Purchaser and the Supply Parties. No other changes to the Manufacturing or Product Specifications shall be introduced without Purchaser’s prior written consent. If any change to Product Specifications asked by Purchaser as a result of a specific request by the Regulatory Authorities materially affects Supply Party’s costs of producing the API, then Supplier shall promptly so inform Purchaser in writing and the Parties shall negotiate, in good faith, an adjustment to the pricing to be paid by Purchaser for API under this Agreement. If the Parties cannot mutually agree, following good faith negotiations, on an equitable adjustment to pricing or on the shared cost of the required change (above), then either Supplier or Purchaser may bring this dispute to third party arbitration under a nationally recognized independent arbitration board for prompt resolution. The outcome of the third party arbitration shall be binding on the Parties. 
4.7.Inspection of API. 

CDA.000XX.M.000                                                              LGM Pharma and Liquidia Technologies, Inc.‌     Page 9 of 5

(a)Within forty-five (45) Business Days of the arrival of each Batch of API at the designated facility by Purchaser, Purchaser shall inspect and/or test each Batch of API at its own cost and expense. If, upon inspecting and/or testing the API, Purchaser determines that a Batch of API does not conform to the Product Specifications, then Purchaser shall, within such forty-five (45) Business Day period, give Supplier written notice of such non-conformity (setting forth the details of such non-conformity). Unless Supplier objects within twenty (20) Business Days from the notice by Purchaser to the non-conformity, Purchaser will return the non-conforming API to Supplier. Supplier shall incur all freight-related expenses and shall issue a credit note for the rejected API. Any API rejected by Purchaser may not be reshipped to Purchaser. Supplier’s sole responsibility shall be to replace any non-conforming as soon as possible.  Replacement of material shall not exceed sixty (60) Business Days of receiving the notice of non-conformity.   
(b)In case of any disagreement between the Parties as to whether API conforms to the applicable Product Specifications, the quality assurance representatives of the Parties will discuss in good faith to attempt to resolve any such disagreement and Purchaser and Supplier will follow their respective standard operating procedures to determine the conformity of the API to the Product Specifications. If the foregoing discussions do not resolve the disagreement in a reasonable time, which will not exceed thirty 30 days, a sample of Supply Party’s FDA retained sample and a sample of the API in question will be submitted for retesting by Supplier and Purchaser on a side-by-side basis for final determination of whether such API conforms to the Product Specifications.  
(c)Such retesting will be performed in a laboratory designated by Purchaser and agreeable to by Supplier using the test methods referenced in the Product Specifications contained in this Agreement and with representatives from both Parties present at all retesting. The determination of conformance or nonconformance by such retesting with respect to all or part of such API will be final and binding on the Parties. Supply Party shall pay all the fees of the retesting, unless the laboratory determines that the delivered API conforms to the Product Specifications, in which case Purchaser shall pay all the fees of such retesting and also any additional direct and documented costs that Supplier incurred in providing replacement material. 
(d)Purchaser will promptly notify Supplier in writing of loss, damage, or non-delivery of any part of a shipment of API after receipt of such shipment by Purchaser, or its designee, provided, however, that Purchaser shall notify Supplier within ten (10) Business Days after receipt of such shipment if Purchaser is rejecting such shipment due to obvious external physical damage or quantity discrepancies that are, or would be, evident upon visual inspection of such packaged API as shipped by Supplier. Purchaser shall have ten (10) Business Days to reject any API upon the discovery of any latent defect. Either Party may cause any damaged or defective API to be retested in accordance with this Section 4.7.  

4.8.Regulatory Communications.  During the Term, either Supply Party shall promptly notify Purchaser after receipt of any communication from any Regulatory Agency in connection with or that may affect Purchaser’s use of the API, IND, NDA or any Marketing Authorization of Purchaser’s Finished Product. 
4.9.Liability.  It is understood that Supply Parties have no control over the ultimate use of the API once it leaves the Supply Party’s Facility. Supply Parties shall have no liability arising out of or in connection with the sale or use of the API or any product or material made from or incorporating the API, except to the extent that the API was not Manufactured in accordance with the Product Specifications, cGMPs, Quality Agreement or Applicable Law or the liability otherwise arises from a 

CDA.000XX.M.000                                                              LGM Pharma and Liquidia Technologies, Inc.‌     Page 10 of 5

breach of this Agreement by either Supply Party, including but not limited to the Supply Party’s representations and warranties in Section 5.2.
4.10.Recall.  Purchaser shall be responsible for conducting any recall of Finished Product, and Supply Party shall co-operate with and give all reasonable assistance to Purchaser in conducting any such recall to the extent it relates to the API. Supply Party shall bear the expense of any recall resulting from a breach of its obligations hereunder and/or of the Quality Agreement and/or from its negligence or willful misconduct and from its failure to comply with the Product Specifications, subject to the limits set out in Section 7. Otherwise, Purchaser shall bear such expenses. In the event of such recall or similar action, each Party shall use commercially reasonable efforts to mitigate the costs associated therewith. In the case of a disagreement as to the existence or level of nonconforming API, then the Parties shall utilize the process set out in Section 4.7 herein. 
4.11.Retention of Documentation.  All documentation related to the Manufacturing of the API shall be archived with the respective Supply Party after Manufacturing in accordance with cGMP’s and Applicable Laws.
4.12.Safety of API.  Each Party shall immediately notify the other Party upon becoming aware of any unusual health or environmental occurrence relating to API.  Each Party shall advise the other Party immediately of any safety or toxicity problems of which it becomes aware regarding API.
4.13.Reprocessing and/or Reworking. Manufacturer shall not perform any Reprocessing or Reworking without first providing notice to and receiving prior written consent from Purchaser.  

5.Representations and Warranties.  
5.1.Mutual. 
(a)No Conflict. Supplier, Manufacturer and Purchaser each represents and warrants to the other Party that the execution and delivery of this Agreement by such Party and the performance of such Party’s obligations hereunder (i) do not conflict with or violate any requirement of Applicable Law existing as of the Agreement Effective Date applicable to such Party and (ii) do not conflict with, violate, breach or constitute a default under any contractual obligations of such Party or any of its Affiliates existing as of the Agreement Effective Date;
(b)Enforceability. Supplier, Manufacturer and Purchaser each represents and warrants to the other Party that, as of the Agreement Effective Date, this Agreement is a legal and valid obligation binding upon it and is enforceable against it in accordance with its terms;
(c)Each Party represents and warrants to the other Party that it holds all necessary and required permits and authorizations, including, but not limited to, those required by the relevant Regulatory Agencies, and shall undertake throughout the term of this Agreement to maintain the same in full force and effect. Each Party further covenants that it shall use commercially reasonable efforts to obtain all such other permits and authorizations as may be required from time to time to operate their respective facilities and/or businesses and in order to manufacture, provide, distribute and/or sell API hereunder.

5.2.Supplier’s and Manufacturer’s Warranties.  Supplier and Manufacturer represent separately as follows:

5.2.1Supplier’s Warranties.  Supplier represent and warrant to Purchaser that:

CDA.000XX.M.000                                                              LGM Pharma and Liquidia Technologies, Inc.‌     Page 11 of 5

Supplier has the full right and power to enter into this Agreement and perform its obligations hereunder in accordance with its terms; 
5.2.2Manufacturer’s Warranties.  Manufacturer represents and warrants to Purchaser that:
(a)Manufacturer has full right and power to enter into this Agreement and perform its obligations hereunder in accordance with its terms; 
(b)The API and all components and ingredients thereof shall be manufactured and delivered in strict compliance with: (i) the Product Specifications; (ii) cGMP’s; and (iii) the Manufacturing methods, processes and procedures, including the site manufacture, as set forth in the DMF, together with all applicable regulatory requirements relating to the Manufacture of the API;
(c)The Facility(ies) for Manufacture of the API is and shall be in compliance with all applicable cGMPs and that such plant(s) is and shall continue to be available for inspection if and when the relevant Regulatory Agencies so requests or per Purchaser’s requests hereunder;
(d)The production and supply of the API under this Agreement, to the best of Manufacturer’s knowledge after reasonable investigation and analysis has not and will not violate any patents, copyrights, trade secrets and/or other proprietary rights of any third party, including but not limited to US patents: US9593066 and US9604901; and
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(e)The DMF is sufficient for reference and any/all deficiencies have been rectified such that Purchaser may rely on the DMF for seeking and obtaining marketing approval from the FDA.

5.3.Purchaser’s Warranties.  Purchaser represents and warrants to Supplier that:
(a)It has the full right and power to enter into this Agreement and perform its obligations hereunder in accordance with its terms; and 
(b)That it will purchase the API in strict compliance with the terms of this agreement, as set forth under Section 2.1.

6.Confidentiality.
6.1.Confidentiality.  Each Party agrees to retain in confidence all Confidential Information disclosed to it pursuant to this Agreement, whether such disclosure occurred before or after the Effective Date hereof. Disclosed information shall not be deemed Confidential Information hereunder if: (a) it is now or later becomes publicly known, other than through the fault of the receiving party; (b) it is lawfully known without restriction to the receiving party at the time of disclosure as evidenced by written documentation; (c) it is rightfully obtained by the receiving party from a third party without restriction and without breach of this Agreement or any similar agreement; and/or (d) it is independently developed by the receiving party without access, use or reliance on the disclosing party’s Confidential Information, as evidenced by written documentation. If either Party is required under Applicable Law and/or by any other applicable law, regulation or rule applicable to either Party to disclose Confidential Information by any court, to any Regulatory Agency or otherwise, the Party so required to disclose the Confidential Information shall, to the extent that it is not legally prevented from doing so, prior to such disclosure, notify the other Party of such requirement and all particulars related to such requirement. The notified Party shall have the right, at its expense, to object to such 

CDA.000XX.M.000                                                              LGM Pharma and Liquidia Technologies, Inc.‌     Page 12 of 5

disclosure and to seek confidential treatment of any Confidential Information to be so disclosed, and the other Party shall reasonably cooperate with the notified Party (at the notified Party's expense) in this regard. If the Party subject to such law is not permitted to notify the other Party or it is not timely to notify the other Party or if the confidential treatment request is not successful, the Party required to make such disclosure may timely disclose the limited amount of Confidential Information to satisfy the law, rule or regulation. The confidentiality of disclosed Confidential Information and the obligation of confidentiality hereunder shall survive any expiration or termination of this Agreement for a period of ten (10) years. The Parties specifically agree that all terms of this Agreement, all sales and API requirements and costs and all purchase orders shall be deemed to be confidential.   
6.2.Separate Confidentiality Agreement.  If the Parties entered into one or more separate confidentiality agreements or non-disclosure agreements (each, a “Confidentiality Agreement”), such Confidentiality Agreement(s) shall be and remain in full force and effect as provided therein.  In the event of any conflict between the terms of this Agreement and the terms of any such Confidentiality Agreement, the terms of this Agreement shall control.   
6.3.Public Announcements.  During the term of this Agreement, no Party hereto shall issue or release, directly or indirectly, any press release, marketing material or other communication to or for the media or the public that pertains to this Agreement, the API, the Finished Product or the transactions contemplated hereby (collectively, a “Press Release”) unless the content of such Press Release has been approved by the other Party hereto, such approval not to be unreasonably withheld or delayed; provided, however, that nothing contained in this Agreement shall prevent or preclude any Party from making such disclosures as may be required by Applicable Law, including, but not limited to, any disclosures required under applicable securities laws.  

7.Indemnification and Limitation of Liability.  
7.1.Purchaser shall indemnify, defend and hold Supplier and Manufacturer, as the case may be, and its or their officers, directors, affiliates, agents and employees harmless from and against any and all claims, demands, costs, expenses, losses, liabilities and/or damages (including, but not limited to, court costs, reasonable attorneys’ fees and court costs) of every kind and nature caused by, arising out of or resulting from Purchaser’s negligence relating to, or breach of, this Agreement, and any claim for personal or bodily injury arising from the use of the Finished Product or any substance, dosage composition or compound manufactured therefrom; provided, however, that in no event shall this Section apply to any claim covered by Sections 7.2 or 7.3 below.  
7.2.Supplier shall indemnify, defend and hold Purchaser and its officers, directors, affiliates, agents and employees harmless from and against any and all claims, demands, costs, expenses, losses, liabilities and/or damages (including, but not limited to, reasonable attorneys’ fees and court costs), arising out of or resulting from Supplier’s breach of, this Agreement and/or of the Quality Agreement. Notwithstanding the foregoing, the Parties recognize that (i) the actual Manufacturing of the API is under the exclusive control of the Manufacturer and therefore Supplier shall have no liability for any claim for personal or bodily injury arising from the API manufactured by the Manufacturer and (ii) the manufacturing of the Finished Product is under the exclusive control of the Purchaser and therefore Supplier shall have no liability for any claim for personal or bodily injury arising from the Finished Product manufactured by the Purchaser. This indemnification obligation does not apply to any claim for personal or bodily injury arising from the use or administration of the API except to the extent such injury is attributable to a defect in the API arising out of  Manufacturer’s negligence, willful misconduct, or failure to Manufacture and deliver the API 

CDA.000XX.M.000                                                              LGM Pharma and Liquidia Technologies, Inc.‌     Page 13 of 5

in accordance with the Product Specifications, Quality Agreement, this Agreement and all Applicable Law.  
7.3.Manufacturer shall indemnify, defend and hold Purchaser and its officers, directors, affiliates, agents and employees harmless from and against any and all claims, demands, costs, expenses, losses, liabilities and/or damages (including, but not limited to, reasonable attorneys’ fees and court costs), arising out of or resulting from Manufacturer’s breach of, this Agreement and/or of the Quality Agreement. This indemnification obligation does not apply to any claim for personal or bodily injury arising from the use or administration of the API except to the extent such injury is attributable to a defect in the API arising out of  Manufacturer’s negligence, willful misconduct, or failure to Manufacture and deliver the API in accordance with the Product Specifications, Quality Agreement, this Agreement and all Applicable Law.  
7.4.Each Party will promptly notify the other of any actual or threatened judicial or other proceedings which could involve either or both Parties or impact the API, Manufacture of API, supply of API or Purchaser’s Finished Product. Each Party reserves the right to defend itself in any such proceedings; provided, however, that, if indemnity is sought, then the Party from whom indemnity is sought shall have the right to control the defense of the claim, and the indemnified Party may participate with counsel of its choice at its own expense. The Parties shall cooperate with each other to the extent reasonably necessary in the defense of all actual or potential liability claims and in any other litigation relating to the API supplied pursuant to this Agreement. Each Party will supply information to the other relevant to any product liability claims and litigation affecting the API and/or the Finished Product, as the case may be. Neither Party shall settle any claim which may give rise to an indemnification under this Section 7 without the prior written consent of the other Party (which shall not be unreasonably withheld or delayed, provided however that the consent of the Party seeking indemnification shall not be required where the proposed settlement does not include any admission of such Party's fault and/or liability and does not impose any restriction and/or liability on such Party). 
7.5.Purchaser shall have sole control over any and all disputes arising from or affecting the Finished Product as it relates to third parties, including but not limited to any the enforcement and/or defense of any legal action; provided that Purchaser has no authority to bind or obligate any other Party with respect to any legal action.
7.6.NOTWITHSTANDING ANYTHING IN THIS AGREEMENT TO THE CONTRARY, IN NO EVENT WILL EITHER PARTY BE LIABLE FOR ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR INDIRECT DAMAGES ARISING OUT OF THIS AGREEMENT, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY. THIS LIMITATION WILL APPLY EVEN IF THE OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE; PROVIDED, HOWEVER, THE LIMITATION IN THIS SECTION 7.6 WILL NOT APPLY TO DAMAGES RESULTING FROM BREACHES BY A PARTY OF ITS DUTY OF CONFIDENTIALITY AND NON-USE IMPOSED UNDER THIS AGREEMENT OR THE CONFIDENTIALITY AGREEMENT OR GROSSLY NEGLIGENT ACTS, INTENTIONAL ACTS OR OMISSIONS OF A PARTY OR SUCH PARTY’S INDEMNIFICATION OBLIGATIONS STATED ABOVE. THE TOTAL LIABILITY PER YEAR OF SUPPLIER UNDER THIS AGREEMENT, BUT FOR THE ABOVE PROVISO, SHALL BE LIMITED TO THE GREATER OF [***] TIMES THE TOTAL DOLLAR AMOUNT OF API PURCHASED AND SUBJECT TO AN OBLIGATION TO PURCHASE PER YEAR OR APPLICABLE INSURANCE MAXIMUM. 

8.Insurance.  Unless the Parties otherwise agree in writing, the following terms shall apply:   

CDA.000XX.M.000                                                              LGM Pharma and Liquidia Technologies, Inc.‌     Page 14 of 5

8.1.During the term of this Agreement and for a period three (3) years after any expiration or termination of this Agreement, each of Purchaser, Manufacturer and Supplier shall maintain in full force and effect a comprehensive general liability insurance policy, including Products Liability coverage, with minimum limits of Three Million Dollars ($3,000,000) for bodily injury including death.

9.Term and Termination.
9.1.Term.

Unless terminated in accordance with the provisions of Section 9.2 below, the term of this Agreement shall commence from the Effective Date and shall continue in effect for FIVE (5) years from first Marketing Authorization approval of Purchaser’s Finished Product. Purchaser shall have the right to extend this term for additional five (5) year terms upon providing Supplier written notice of extension prior to expiration of this initial term. 
9.2.Grounds for Termination.

Either Party shall have the right to terminate this Agreement upon the occurrence of any of the following events: (i) the failure of the other Party to comply with any of the terms of this Agreement or otherwise discharge its duties hereunder in any material respect, or the breach by the other Party of any of its representations or warranties herein in any material respect, if such failure or breach is not cured within thirty (30) days of such breaching Party’s receipt of written notice specifying the nature of such failure or breach with reasonable particularity; or (ii) the making by the other Party of an assignment for the benefit of its creditors, or the filing by or against such other Party of any petition under any federal, state or local bankruptcy, insolvency or similar laws, if such filing has not been stayed or dismissed within sixty (60) days after the date thereof.  
9.3.Purchaser shall also have the right to suspend further performance under this Agreement and/or terminate this Agreement in its entirety, without liability except for unpaid previously delivered API that conforms with the terms hereof, if: (i) Supplier or Manufacturer loses any approval(s) from the FDA and / or the EMA and / or other relevant national Regulatory Agency required to perform its obligations under this Agreement, (ii) in the event that Purchaser loses any license or approval for the Finished Products or terminates sale or further development of the Finished Product, (iii) if the API is in breach of third party intellectual property rights, (iv) if it is suspected that Supplier or Manufacturer are involved in felonious or fraudulent activities or other material breach of this Agreement, or (v) if Manufacturer’s DMF is found deficient and not timely remedied by Manufacturer. 
9.4.Continuing Obligations; Survival.  In no event shall any termination or expiration of this Agreement excuse either Party from any breach or violation of this Agreement which took place prior to such termination or expiration and full legal and equitable remedies shall remain available therefore, nor shall it excuse either Party from making any payment due under this Agreement with respect to any period prior to the date of expiration or termination, nor shall it revoke or reduce the confidentiality period specified in Section 6.

10.Agreement to Consummate; Further Assurances.  Subject to the terms and conditions of this Agreement, each of the Parties hereto agrees to use commercially reasonable efforts to do all things necessary, proper or advisable under this Agreement, applicable laws and regulations to consummate and make effective the transactions contemplated hereby. If, at any time after the date hereof, any further action is necessary, proper or advisable to carry out the purposes of this Agreement, then, as 

CDA.000XX.M.000                                                              LGM Pharma and Liquidia Technologies, Inc.‌     Page 15 of 5

soon as is reasonably practicable, each Party to this Agreement shall take, or cause its proper officers to take, such action. Notwithstanding anything to the contrary, Supplier and Manufacturer agree to use its best efforts to maintain API Manufacture consistent with the Product Specifications, Quality Agreement and DMF and to establish and maintain the DMF sufficient to requirements for successful reference. 
11.Force Majeure.  Any delay in the performance of any of the duties or obligations of either Party hereto (except for the payment of money, unless such is affected by the force majeure) caused by an event outside the affected Party’s reasonable control shall not be considered a breach of this Agreement and the time required for performance shall be extended for a period equal to the period of such delay. Such events shall include, but will not be limited to, acts of God, acts of a public enemy, wars, acts of terrorism, insurrections, riots, injunctions, embargoes, fires, explosions, floods, or other unforeseeable causes beyond the reasonable control and without the fault or negligence of the Party so affected. The Party so affected shall give prompt written notice to the other Party of such event. The suspension of performance shall be of no greater scope and no longer duration than is reasonably required and the nonperforming Party shall use its commercially reasonable efforts to remedy its inability to perform and promptly resume performance upon removal of the force majeure; provided, however, that in the event the suspension of performance continues for sixty (60) days after the date of the occurrence, and such failure to perform would constitute a material breach of this Agreement in the absence of such force majeure event, the non-affected Party may terminate this Agreement immediately, without incurring any liability to the other Party, by written notice to the affected Party.
12.General Provisions.
12.1.Assignment.  Neither this Agreement nor any interest herein may be assigned, in whole or in part, by either Party without the prior written consent of the other, which consent shall not be unreasonably withheld or delayed, except that either Party may assign its rights and obligations under this Agreement: (a) to an Affiliate of such Party; and/or (b) to any third Party that acquires all or substantially all of the stock or assets of such Party to which this Agreement relates, whether by asset sale, stock sale, merger or otherwise, and, in any such event such assignee shall assume the transferring Party’s obligations hereunder. However, notwithstanding any such assignment, in the case of an assignment to an Affiliate, the transferring Party shall remain liable under this Agreement (in addition to the transferee) unless such liability is specifically waived in writing by the other Party hereto.  Subject to the foregoing, this Agreement shall be binding upon and inure to the benefit of the Parties hereto, and their respective successors and permitted assigns. Notwithstanding the foregoing, neither Supplier or Manufacturer shall assign this Agreement to a competitor or potential competitor of Purchaser without Purchaser’s prior written consent.  
12.2.Notice.  Any notice or request required or permitted to be given under or in connection with this Agreement shall be deemed to have been sufficiently given if in writing and sent by: (a) personal delivery against a signed receipt therefor, (b) nationally recognized overnight delivery service (signature required), (c) confirmed facsimile transmission, or (d) electronic mail (with any notices to be sent by facsimile transmission or electronic mail to also be sent by one of the other methods set forth in this Section), addressed as follows:

CDA.000XX.M.000                                                              LGM Pharma and Liquidia Technologies, Inc.‌     Page 16 of 5

	If to Purchaser, then to:
	Liquidia Technologies, Inc. 
419 Davis Drive, Suite 100
Morrisville, North Carolina 27560 
Attn: Legal   
Facsimile: (919) 328-4402 

	If to Supplier, then to:
	LGM Pharma LLC
6400 N Congress Ave., Suite 1400
Boca Raton, FL 33487
Attn: COO 
Facsimile: (615) 250-9817

	If to Manufacturer, then to:
	Yonsung Fine Chemicals Co., LTD. 207 Sujeong-ro, Jangan-myeon, Hwaseong-si, Gyeonggi-do 18581 Republic of Korea
Attn: COO 
Facsimile: (82) 31-351-6624

​
​​
Any party may alter the address to which communications are to be sent by giving notice of such change of address in conformity with the provisions of this Section providing for the giving of notice.  Notice shall be deemed to be effective, if personally delivered, when delivered; if sent by nationally recognized overnight delivery service, on the next business day following delivery to such delivery service; and if sent by confirmed facsimile transmission or electronic mail, on the next business day following transmission (so long as any notices sent by facsimile transmission or electronic mail are also sent by one of the other methods set forth in this Section).
12.3.Entire Agreement.  This Agreement sets forth the entire agreement and understanding between the Parties as to the subject matter hereof and merges all prior discussions and negotiations between them, and neither Party shall be bound by any conditions, definitions, warranties, understandings or representations with respect to such subject matter other than as expressly provided herein or as duly set forth on or subsequent to the date hereof in writing and signed by a proper and duly authorized officer or representative of the Parties to be bound thereby, except that this Agreement shall not supersede any separate confidentiality or non-disclosure agreement that may have been, or that may be, entered into by the Parties. To the extent that any conflict arises among the documents that comprise this Agreement (including any schedules or exhibits), the terms and conditions of this Agreement shall govern. The terms and conditions of this Agreement shall control over and supersede any contrary term in any purchase order.
12.4.Amendment and Modification.  This Agreement may be amended, modified and supplemented only by written agreement duly executed by an authorized representative of each Party and delivered by each of the Parties hereto.  
12.5.Waiver.  The failure of any Party to exercise any right or to demand the performance by the other Party of duties required hereunder shall not constitute a waiver of any rights or obligations of the Parties under this Agreement. A waiver by any Party of a breach of any of the terms of this 

CDA.000XX.M.000                                                              LGM Pharma and Liquidia Technologies, Inc.‌     Page 17 of 5

Agreement by any other Party shall not be deemed a waiver of any subsequent breach of the terms of this Agreement.  
12.6.Governing Law.  This agreement shall be governed by and interpreted in accordance with laws of Switzerland. The prevailing party in any distribute or legal action regarding the subject matter of this Agreement shall be entitled to recover reasonable attorney’s fees and costs.  
12.7.Severability.  Whenever possible, each provision of this Agreement shall be interpreted in such manner as to be effective and valid under Applicable Law, but if any provision of this Agreement is held to be invalid, illegal or unenforceable in any respect under any Applicable Law or rule in any jurisdiction, such invalidity, illegality or unenforceability shall not affect any other provision of this Agreement or any action in any other jurisdiction, but this Agreement shall be reformed, construed and enforced in such jurisdiction as if such invalid, illegal or unenforceable provision had not been contained herein. 
12.8.Construction.  The Parties have participated jointly in the negotiation and drafting of this Agreement. In the event of any ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the Parties and no presumption or burden of proof shall arise favoring or disfavoring any Party by virtue of the authorship of any of the provisions of this Agreement. As used in this Agreement, the singular shall include the plural and vice versa, and the terms “include” and “including” shall be deemed to be immediately followed by the phrase “but not limited to.” The terms “herein” and “hereunder” and similar terms shall be interpreted to refer to this entire Agreement, including any schedules attached hereto or amendments made to this agreement from time to time and incorporated herein by reference.  
12.9.Parties/Relationship.  Neither Party shall hold itself out to third parties as possessing any power or authority to enter into any contract or commitment on behalf of any other Party. This Agreement is not intended to, and shall not; create any agency, partnership or joint venture relationship between or among the Parties. Each Party is an independent contractor with respect to the others. No Party is granted any right or authority to assume or create any obligation or responsibility, express or implied, on behalf of, or in the name of any other Party hereto, or to bind any other Party hereto in any manner or with respect to anything, whatsoever.  
12.10.Captions.  The captions and headings in this Agreement are inserted for convenience and reference only and in no way define or limit the scope or content of this Agreement and shall not affect the interpretation of its provisions.  
12.11.Counterparts.  This Agreement may be executed in multiple counterparts, each of which shall be deemed an original and all of which together shall constitute one and the same instrument.  
12.12.Subcontractors.  Supplier and Manufacturer shall not subcontract any work that is to be done by such Party under this Agreement to any third party, however, each may subcontract between each other for respective aspects of their obligations hereunder, provided, however, that the subcontracting Party shall be and remain responsible for all acts and omissions of any such subcontractor as if giving effect to such activities itself hereunder. 
12.13.Schedules and Exhibits.  All Schedules and Exhibits referenced in this Agreement, if any, are hereby incorporated by reference into, and made a part of, this Agreement.

CDA.000XX.M.000                                                              LGM Pharma and Liquidia Technologies, Inc.‌     Page 18 of 5

12.14.Currency.  All sums set forth in this Agreement and ay appendices, exhibits or schedules hereto are, and are intended to be, expressed in U.S. Dollars.

​
Signature Page to Follow
​

CDA.000XX.M.000                                                              LGM Pharma and Liquidia Technologies, Inc.‌     Page 19 of 5

​
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their respective duly authorized officers as of the Effective Date.
​
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	SUPPLIER: 
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By:  ​ ​
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Name:  ​ ​
                           ​
Its:  ​ ​
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Date:  ​ ​
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	PURCHASER:
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By:  ​ ​
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Name:     ​ ​
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Its:          ​ ​
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Date:  ​ ​
​

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MANUFACTURER: 
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By:  ​ ​
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Name:  ​ ​
                           ​
Its:  ​ ​
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Date:  ​ ​
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	​

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​
​

CDA.000XX.M.000                                                              LGM Pharma and Liquidia Technologies, Inc.‌     Page 20 of 5

EXHIBIT A
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API, Facility, and Territory
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[***]
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​

CDA.000XX.M.000                                                              LGM Pharma and Liquidia Technologies, Inc.‌     Page 21 of 5

EXHIBIT B
​
Product Specifications
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Treprostinil Sodium
[***]
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EXHIBIT C
​

CDA.000XX.M.000                                                              LGM Pharma and Liquidia Technologies, Inc.‌     Page 22 of 5

	API
	Registered Shelf Life (months)
	Shipment Shelf Life
(no less than)

	Treprostinil Sodium
	[***]
	[***]

API Shelf Life and Required Remaining Shelf Life Upon Shipment

CDA.000XX.M.000                                                              LGM Pharma and Liquidia Technologies, Inc.‌     Page 23 of 5CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT
IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF
PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
​

Exhibit 10.45
​
COMMERCIAL MANUFACTURING SERVICES AND SUPPLY AGREEMENT
​
This Commercial Manufacturing Services and Supply Agreement (the “Agreement”) is made and entered into as of November 12, 2020 (“Effective Date”), by and between Liquidia Technologies, Inc., with a principal place of business at 419 Davis Drive, Suite 100, Morrisville NC 27560 (“Customer”), and Xcelience, LLC, with principal place of business at 5415 West Laurel Street, Tampa, Florida 33607, USA (“Lonza”), a wholly owned subsidiary of Lonza Group, Ltd.  Each of Lonza and Customer may be referred to herein individually as a “Party,” and Lonza and Customer may be referred to collectively as the “Parties.”
WHEREAS, Customer is engaged in the research and development of pharmaceutical products; and
​
WHEREAS, Lonza possesses the expertise to manufacture commercial pharmaceutical products; and 
WHEREAS, Customer wishes to engage Lonza, and Lonza wishes to be engaged by Customer, to manufacture quantities of Product (defined below), pursuant to the terms and subject to the conditions of this Agreement for human pharmaceutical use in the Territory (defined below), and in accordance with cGMP (defined below). 
NOW THEREFORE, in consideration of the representations, covenants and warranties set forth herein, and for other good and valuable consideration, the Parties agree as follows:
1.DEFINITIONS AND GENERAL MATTERS 
​
1.1Defined Terms.  As used in this Agreement, the following words and phrases shall have the meanings set forth below. 
​
	●	“Affiliate” means any Person who, directly or indirectly through one or more intermediaries, Controls, is Controlled by, or is under common Control with any other Person. For purposes of this definition, “Control” means (a) the direct or indirect legal or beneficial ownership of more than fifty percent (50%) of (i) the ownership interests in a Person or (ii) the outstanding voting rights in a Person or (b) the power to otherwise direct the business activities of a Person.

​
	●	“Annual Minimum Commitment” shall mean the minimum quantity of Product to be ordered by Customer in each Contract Year as set forth in Exhibit A, attached hereto.

​
	●	“Baseline Forecast” shall be set forth in Exhibit A, attached hereto.

​
	●	“Bulk Powder” means treprostinil processed by Customer using proprietary PRINT technology, also referred to as LIQ861. 

​
	●	“Cancellation Fee”has the meaning given in Section 3.6.

​
	●	“Claim or Proceeding” means any third party claim, action, suit, proceeding or arbitration, including any governmental authority action or investigation for death, bodily injury or property damage. 

​
	●	“Commencement Date” means the date of commencement of the Services.

​
	●	“Commercial Launch Date” means the date Customer receives notice from the FDA of Regulatory Approval.

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	●	“Contract Year” means the period beginning on the date of Regulatory Approval and ending on the twelve (12) months anniversary thereafter. 

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	●	“Current Good Manufacturing Practices” or “cGMPs” mean all applicable Laws in the Territory relating to manufacturing practices of medicinal products for human use promulgated by any relevant governmental authority, as may be updated, supplemented or amended from time to time. 

​
	●	“Facility” means (i) for encapsulation, Lonza’s manufacturing facilities located at 5415 West Laurel Street, Tampa, Florida 33607, USA; (ii) for packaging, 4901 W Grace St, Tampa, Florida 33607, USA; or for storage and distribution, 5709 John’s Rd, Tampa, Florida 33634, USA.   

​
	●	“FDA” means the U.S. Food and Drug Administration, and any successor agency thereof.

​
	●	“Hidden Defect” means those deviations from the Specifications that are not visible or readily identifiable at the time of delivery.

 ​
	●	“Law” means all applicable treaties, laws, and regulations in the Territory.

​
	●	“Losses” means any and all losses, fines, fees, settlements, payments, obligations, penalties, deficiencies, liabilities, damages, costs and expenses (including reasonable attorneys’ fees).

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	●	“Person” means an individual, partnership, corporation, association, trust, joint venture, or unincorporated organization.

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	●	“Price” means the price for Product referred to in Section 4.1.

​
	●	“Product” means the finished drug product for commercial sale and distribution to end users which complies with FDA approved labeling that is packed in the final market configuration that Lonza manufactures for Customer hereunder in accordance with cGMPs, containing the Bulk Powder and other Raw Materials identified in the Specifications for human pharmaceutical use in the Territory. 

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	●	“Quality Agreement” means the Quality Agreement, dated August 24, 2020 by and between the Parties.

​
	●	“Raw Materials” means any materials, other than Active Materials, as specified in the Specifications .

​
	●	“Regulatory Approval” means the receipt of all approvals, licenses, registrations or authorizations from the FDA necessary to market and sell the Product in the United States.

​
	●	“Services” means the commercial manufacturing services and related services to be performed by Lonza under this Agreement, particulars of which are set out in each Purchase Order. 

​
	●	“SKU” means stock keeping units in Product weights of 5 mg of Bulk Powder, 10 mg of Bulk Powder, 15 mg of Bulk Powder, and 20 mg of Bulk Powder.

 ​
	●	“Specifications” means the release specifications for the manufacture, processing, bulk packaging, testing and testing procedures, shipping, storage and supply of the Product, any Raw Material requirements, analytical procedures and standards of quality control and quality assurance, established by the Parties for the Product. The Specifications are incorporated by reference from the Quality Agreement.. 

November 2020Page 2 of 21‌CONFIDENTIAL

​
	●	“Territory” means the United States of America, and any other countries or jurisdictions that are mutually agreed to by the Parties in writing.

​
	●	“Units” shall mean a finished labeled kit ready for commercial sale and distribution to end users which complies with the FDA approved labeling, containing 7 individual blister cards, containing 4 capsules in each blister card, a DPI and a package of cleaning brushes or other agreed upon packaging configuration.  

​
1.2Exhibits.  The attached Exhibits are incorporated into and form part of this Agreement:
​
EXHIBIT ACOMMERCIAL TERMS
EXHIBIT BENVIRONMENTAL AND HEALTH AND SAFETY INFORMATION
EXHIBIT CSDS OF MATERIALS PROVIDED BY CUSTOMER 
​
2.TERM; FACILITY; AFFILIATES
​
2.1Term.  The term of this Agreement shall commence on the Effective Date and, subject to the rights of earlier termination contained in this Agreement, shall remain in effect for five (5) years from Regulatory Approval (“Initial Term”).  The Initial Term may thereafter be extended for subsequent years upon the mutual written agreement of the Parties (the Initial Term, together with such subsequent periods, the “Term”). 
​
2.2Facility.  Lonza shall perform all manufacturing activities and all storage activities at the Facility.  Lonza may use other facilities for the manufacture and storage of Product provided that (i) such facilities have been approved for such manufacture and storage by all applicable governmental authorities and (ii) Customer written approval is obtained prior to the use of such facilities, such approval not to be unreasonably withheld by Customer. 
​
2.3Affiliates.  Lonza may instruct one or more of its Affiliates to perform any of Lonza’s obligations contained in this Agreement and any particular Purchase Order (defined below in Section 3.2) as mutually agreed to by the Parties in writing, provided, however, that Lonza shall remain fully responsible in respect of those obligations.  Such Affiliate shall be entitled to submit invoices to Customer for the specific Services performed by such Affiliate under the applicable Purchase Order. Any of said Affiliates so used by Lonza shall be subject to all of the terms and conditions applicable to Lonza under this Agreement and shall be entitled to all rights and protections afforded Lonza under this Agreement.
​
3.FORECASTS AND ORDERS
​
3.1Forecasts.  Each quarter by the 10th business day Customer shall submit to Lonza a good faith, estimated [***] rolling forecast of the quantity of Product that Customer expects to order for production commencing with the month following the month in which such forecast is provided (“Forecast”).  Each Forecast shall be non-binding, with the exception of the Forecast for the nearest [***] of the Forecast, which shall be considered a firm order for Product (“Firm Order”). For clarity, Customer is obligated to purchase the volumes of Product that are included in the Firm Order regardless of whether Customer issues Purchase Order for such amounts.  Lonza shall notify Customer immediately in writing if at any time Lonza has reason to believe that it will not be able to fill a Firm Order. No Forecast shall amend any previous Firm Order.  In order to ensure optimal production planning Customer will use its best efforts to reach an accuracy [***] of the non-binding portion of any Forecast.  
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November 2020Page 3 of 21‌CONFIDENTIAL

3.2Purchase Orders.  Customer shall submit a purchase order corresponding to the Firm Order (“Purchase Order”) no less than six (6) months in advance of the requested delivery date for Product that is not subject to a previous Purchase Order .  For the avoidance of doubt, Purchase Orders will be issued every quarter to include the next three (3) months of the Firm Order such that at any given time Customer has issued Purchase Orders for the nearest six (6) month period.  Each Purchase Order shall specify the quantity of Product ordered, Customer’ purchase order number, the requested delivery date, the invoice address, the shipping address and any further information necessary or reasonably requested by Lonza to facilitate the shipment of Product.  Lonza shall acknowledge receipt of Purchase Orders within ten (10) business days. Customer shall be permitted to adjust the Product SKU allocation at the packaging level no later than [***] prior to the requested delivery date with revised Purchase Order to be issued if there are changes to the version submitted previously.  
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3.3Forms and Inconsistencies.  Any term or condition of a Purchase Order, acceptance form used by Lonza, or any other correspondence between the parties that is different from, inconsistent with or contrary to the terms and condition of this Agreement shall be void. All Purchase Orders submitted by Customer shall be deemed to incorporate and be subject to the terms and conditions of this Agreement.  Lonza’s failure to object to any provisions contained in any communication from Customer shall not be deemed a waiver of the provisions herein.
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3.4Annual Minimum Commitment.  Customer undertakes to purchase from Lonza a minimum quantity of Product per Contract Year as set forth on Exhibit A.  If Customer fails to purchase such minimum quantity of Product, Customer shall pay [***]. 
Commencing on the twelve (12) month anniversary of the first commercial sale, Customer shall have the right to make a one-time adjustment to the Baseline Forecast as set forth on Exhibit A; provided, however, that in no event shall such adjustment result in the Annual Minimal Commitment to be less than [***] of the Baseline Forecast for Contract Year 1 and Contract Year 2, and less than [***] of the Baseline Forecast for the subsequent Contract Years.  In addition, in the event Customer fails to purchase the Annual Minimum Commitment [***], then the Parties, in good faith will [***]; provided, however, that for the avoidance of doubt, the Parties agree that the then current [***] shall continue to be in effect during the period of time that the Parties are renegotiating such provisions.
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3.5Delayed Launch.  Commencing on [***], in the event that the Customer fails to commence ordering of Product under this Agreement for any reason whatsoever, any reason, then the Parties, in good faith will renegotiate the rights and obligations under this Agreement. 
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3.6Cancellation of a Binding Purchase Order.  Customer may cancel a binding Purchase Order upon written notice to Lonza, subject to the payment of a cancellation fee of one hundred percent (100%) of the cancelled Purchase Order (the “Cancellation Fee”). 
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3.7 Payment of Cancellation Fee.  Any Cancellation Fee shall be payable within thirty (30) days following the written notice of cancellation associated with the cancelled batch.  
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3.8Capacity Reservation; Capital Expenditures.  Lonza agrees, that subject to Customer meeting its Annual Minimum Purchases and its payment obligations herein, it (i) shall maintain capacity to manufacture the quantity of Product as set forth on Exhibit A hereto; and (ii) incur reasonable additional capital expenditures, at Lonza’s cost (other than as set forth in Section 3.11), as determined in Lonza’s sole discretion in order to meet its obligations under this Agreement.
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3.9Continuous Improvement Program.  The Parties together shall use commercially reasonable efforts to identify and target any potential areas of cost reduction and process improvements (i.e., cycle time reductions, inventory reductions, yield improvements, collaborative procurement) relating to its obligations hereunder. Lonza and Customer shall meet from time to time, but at least annually, to review objectives and to share ideas for these improvements.  As opportunities are identified along with potential cost and savings impact an implementation plan and project budget shall be jointly defined and agreed on by the Parties. The allocation of any costs and expenses for new capital equipment addition or investment necessary to the same implementation plan and the resulting modified process shall be agreed by both Parties, which will also include prior written regulatory assessment and approval by both the Parties. The resulting costs benefits will be shared equally between the two Parties. No price adjustment will be applied unless such cost improvement plans are agreed on, successfully implemented and applied on commercial scale for the Product.
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3.10Secondary Source.  No later than the [***], Lonza shall use commercially reasonable efforts to develop a written plan for a secondary or alternative source of manufacturing for the Product by an Affiliate of Lonza.  Such written plan shall contain sufficient details as to preparation, ramp-up, qualification and validation of the alternative Lonza facility in order to perform the Services contemplated herein. No later than the third (3rd) anniversary of the date of Regulatory Approval, Lonza shall have finalized the aforementioned plan and be prepared to execute the plan upon mutual agreement of the Parties.   
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4.PRICE; PAYMENT TERMS; TITLE
4.1Price.  Customer agrees to pay Lonza for the Product provided hereunder at the Price set forth on Exhibit A hereto.  
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4.2Taxes.  The Price is exclusive of taxes, which taxes shall be for the account of Customer.  Taxes that Lonza is required by Law to collect from Customer, e.g., V.A.T., will be separately stated in Lonza’s invoice and will be paid by Customer to Lonza. 
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4.3Payment Terms.  The payment terms are set forth in Exhibit A as [***] days from the date of invoice upon release of Product and with appropriate release documentation as set forth in Section 4.6 hereof. Lonza shall invoice Customer at the time Product is released by Lonza QA at the Facility. Each shipment shall constitute an independent transaction, and Customer shall pay for the same in accordance with the specified payment terms and without deduction or set-off.
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4.4Late Payment Interest. If Customer is in default of payment of any undisputed invoice on the due date, interest shall accrue on any amount overdue at the lesser of (i) one percent (1%) per month or (ii) the maximum rate allowable by applicable Law, interest to accrue on a day to day basis until full payment; and Lonza shall, at its sole discretion, and without prejudice to any other of its accrued rights, be entitled to suspend the provision of the Services and/or delivery of Product until all overdue amounts have been paid in full including interest for late payments.
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4.5Price adjustments. 
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		4.5.1
	Commencing on the  second anniversary of the Effective Date, not more than once per Contract Year, Lonza may adjust the Price in accordance with the US Department of Labor’s Bureau of Labor Statistics Pharmaceutical Preparations Index, ethical PCU 325414 (https://www.bls.gov/ppi) or any successor index, for the previous Contract Year.  The new Price reflecting such adjustment shall be 

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effective for any manufacture of Product for which the Commencement Date is on or after the date of Lonza’s notice to Customer of the Price adjustment.
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		4.5.2
	In addition to the above, the Price may be changed by Lonza, upon prior written consent of Customer, such consent shall not be unreasonable delayed or withheld(providing reasonable detail in support thereof), to reflect (i) a change in variable costs (such as energy) by more than [***] (based on the initial Price or any previously amended Price), or for a process adjustment or assumption changes, and (ii) any material change in an environmental, safety or regulatory standard that substantially impacts Lonza’s cost and ability to perform the Services. 

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4.6Shipping Term; Title.  All Product shall be delivered ExW (as defined by Incoterms® 2010) the Facility. Title and risk of loss or damage to the Product shall pass to Customer at the time Product is released by Lonza’s QA department together with appropriate release documentation as set forth in the Quality Agreement, according to the terms of shipment set forth in Exhibit A. Lonza shall provide necessary documentation to allow shipment from Lonza’s premises to those detailed in the Purchase Order. Customer shall arrange for shipment and take delivery of such Product from the Facility, at Customer’s expense, within fifteen (15) days after release of the Product by Lonza or pay applicable storage costs of [***] per pallet per month.  Lonza shall provide storage on a bill and hold basis for such batch(es) at no charge for up to fifteen (15) days; provided that any additional storage beyond fifteen (15) days will be subject to availability and, if available, will be charged to Customer and will be subject to a separate bill and hold agreement. Within five (5) days following a written request from Lonza, Customer shall provide Lonza with a letter in form satisfactory to Lonza confirming the bill and hold status of each stored batch.
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4.7Credit. Lonza shall have the right to cancel any Purchase Order accepted by Lonza, or to delay the shipment of the Product ordered therein, if Customer fails to meet payment schedules or other credit or financial requirements established by Lonza. Customer agrees to make available to Lonza such statements of Customer’s financial condition as Lonza may, from time to time, request.  Lonza reserves the right at all times, either generally or with respect to any specific Purchase Order, to vary, change or limit the amount or duration of credit to be allowed to Customer.
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5.OBLIGATIONS OF THE CUSTOMER
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5.1Manufacture and Supply of Bulk Powder.  Customer shall comply with all applicable Laws related to the manufacture of Bulk Powder and the delivery of Bulk Powder to Lonza.  Customer shall identify, qualify, purchase and deliver the Bulk Powder to the Facility. Customer shall be responsible for the quality of the Bulk Powder, Quality Assurance and management of Bulk Powder vendor relationship. Customer shall supply Lonza with the quantity of Bulk Powder required to manufacture the Product in the amount specified in Customer’s Purchase Order, [***] (excluding material for lab testing and retain) (“Loss Allowance”) to allow for normal waste and breakage, not less than three (3) weeks prior to the Commencement Date. Delivery shall take place DDP Facility Incoterms 2010. Lonza shall not be responsible for any failure to deliver or any delivery delay of Product due to (i) the failure of Customer to deliver or cause delivery of Bulk Powder in the time specified in this Section, or (ii) the delivery of defective Bulk Powder, and Customer shall be responsible for all additional costs and expenses arising out of such delay or defect, including, if applicable, reasonable idle Facility capacity costs and any Cancellation Fees if such delay or defect results in Lonza not being able to manufacture Product in the manufacturing slots reserved for Customer at the Facility.  In the event of any loss or damage to Bulk Powder while in the possession of Lonza in excess of the Loss Allowance due to Lonza’s negligence, Lonza’s liability to Customer related to or arising out of such loss shall be limited to the greater of (i) reimbursement of Customer for the most recent actual incurred manufacturing cost per kilo of Bulk Powder, up to [***]/kg, 

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applied pro-rata to the amount of Bulk Powder concerned or (ii) [***] the value of the Purchase Order creating such liability. 
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5.2Health & Safety Data.  (a) Customer has provided to Lonza certain information relating to the Bulk Powder, attached hereto as Exhibit C.  To the extent Customer has not provided the information in Exhibit C and to the extent it possesses the information, Customer shall provide to Lonza, prior to the shipment of any Bulk Powder to Lonza hereunder, the environmental, health and safety information described in Exhibit B as it relates to the Bulk Powder.  To the extent the information contained in paragraphs 2 and 3 of Exhibit B has not yet been generated by Customer, tests, analyses and/or research necessary to collect such information and data shall be conducted, at the expense of Customer, by Customer internally or by an outside laboratory retained by Customer.  Customer shall properly document all such test results and shall provide such documentation to Lonza prior to the delivery of any Bulk Powder to Lonza.  If the data indicates that Lonza cannot safely manage the Bulk Powder without the addition of certain engineering controls or other changes to its facilities and/or equipment, the Parties will discuss cost allocation for required changes.
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(b)  Customer shall provide to Lonza promptly upon receipt by Customer (i) any information needed to clarify, correct, supplement or amend any of the information described in Exhibit B or provided in Exhibit C and (ii) any other information reasonably related to the environmental, health and safety implications, including employee health and safety, of the handling, manufacture, distribution, use and disposal of the Bulk Powder. Lonza shall not be responsible for any failure to deliver or delivery delay due to Customer’s failure to deliver such results or documentation.
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5.3Compliance with Law; Use and Disposal of Product.  Customer is responsible for (a) the use, packaging, labeling, distribution, marketing, promotion, sale and disposal of Product, including compliance with all present and future Laws related to the same; (b) communicating with any governmental authority concerning the Product, including without limitation with respect to the registration, classification or notification of a new Product or substance, or the use, packaging, labeling, distribution, marketing, promotion, sale or disposal of the same or any adverse events related to the Product (for the avoidance of doubt, Lonza may interact with governmental authorities for the purpose of fulfilling its obligations hereunder); (c) storing and handling Product in appropriate conditions following its delivery; and (d) determining the Specifications for the Product to permit its sale in each country in the world. Customer shall conduct all such activities at all times in compliance with applicable Laws. The Parties acknowledge and agree that Lonza has no control, role, or other form of influence in Customer’s use, packaging, labeling, distribution, marketing, promotion, sale and disposal of Product, nor does it control or influence any payments or transfers of value that may be made by Customer to health care professionals, health care institutions, or any other customer or third party.  Customer is responsible for participation and compliance in all government health care programs such as Medicare and Medicaid, and any rebate liability, mandatory pricing, or reporting obligations resulting therefrom. 
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5.4Additional Obligations. Customer shall manage, direct and be responsible for all intellectual property decisions and being responsible for all litigation costs which result solely from the filing of the Products. Customer shall maintain pharmacovigilance infrastructure as required by a distributor of Product. Customer will own and control all regulatory approvals in the Territory (including all associated contents and correspondences) and applications therefore related to the Product and any other marketing authorizations within the Territory.
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6.OBLIGATIONS OF LONZA AND CUSTOMER
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6.1Materials.  Lonza shall be responsible for procuring Raw Materials identified in the Specifications other than the Bulk Powder.  Lonza will destroy unused Bulk Powder following instructions provided by Customer, consistent with Lonza’s environmental, health and safety guidelines. Customer shall pay for the costs of destruction. 
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6.2Lonza Regulatory Obligations. Lonza is responsible for (a) manufacturing and supplying the Product in compliance with all applicable Laws, including but not limited to environmental health and safety laws and cGMP, and (b) storing and handling Product in appropriate conditions before its delivery to Customer in accordance with Section 4.6. Lonza shall obtain and maintain during the Term all regulatory approvals necessary in the jurisdiction in which the Facility is located for Lonza to operate the Facility.  
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6.3Inspections and Audits.  Subject to the terms of the Quality Agreement, Customer and its representatives shall have the right to visit or audit, or request a reputable third party to visit or audit the Facility to verify that the documentation, equipment and material relating to the Product is maintained in accordance with applicable Laws and that Lonza is performing its obligations hereunder. Customer shall bear all costs related to any such audit,or inspection, above one (1) audit or inspection during a contiguous 12 month period. This Section 6.3 is subject in all cases to any such party executing a confidentiality agreement with Lonza, in form and substance reasonably acceptable to Lonza. 
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Subject to the terms of the Quality Agreement, Lonza will allow full access to any governmental regulatory inspection and shall promptly inform Customer of the results of such inspections to the extent such inspection directly affects Lonza’s performance under this Agreement.
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6.4Customer Regulatory Obligations.  Customer is responsible for compiling the registration dossiers (with reasonable and necessary assistance from Lonza), filing the marketing applications with the regulatory authorities in the Territory, and maintaining marketing authorizations for the Product and the costs associated with the same. Lonza shall reasonably assist Customer in obtaining and maintaining marketing authorizations for the Product. Customer is responsible for (a) the formulation, use, packaging, labeling, distribution and disposal of Product, including compliance with all Laws related to the same; (b) communicating with any governmental authority concerning the Product (for the avoidance of doubt, Lonza may interact with governmental authorities for the purpose of fulfilling legal obligations); and (c) storing and handling Product in appropriate conditions following its delivery; and (d) determining that the Product is permitted for human use.  Customer is responsible for developing all Product labeling,  and for labeling content.
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6.5Adverse Events.  Lonza shall promptly notify and forward to Customer any information concerning any potentially serious or unexpected side effect, injury, toxicity or sensitivity reaction or any unexpected incidence or other adverse experience related to the Product (an “Adverse Experience”) reported to it. Customer agrees that it shall be solely responsible to review, analyze and respond to any Adverse Experience.  Lonza shall have no obligation with respect to an Adverse Experience other than the obligation to notify Customer.
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6.6 Debarment. Lonza certifies that it has not been debarred, and has not been convicted of a crime that could lead to debarment, under the Generic Drug Enforcement Act and that it will use its reasonable efforts not to employ any person or entity that has been debarred or convicted to perform any services under this Agreement. Lonza shall promptly notify Customer in writing of any breach or expected breach of this Section 6.6 and its remedy thereto.   
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7.REPRESENTATIONS AND WARRANTIES
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7.1Regarding the Product.  Lonza represents and warrants to Customer that, as of the date of delivery to Customer, the Product released by Lonza has been manufactured (a) in conformity with the Specifications and Quality Agreement and (b) in all material respects in accordance with cGMP. 
7.2Rejection of Product; Disposal of Rejected Shipments.  (a) Customer may reject any Product that does not meet the warranties set forth in Section 7.1 (“Non-Complying Product”) by providing written notice of rejection to Lonza within thirty (30) days following Lonza’s release of the Product for delivery hereunder; provided that such period for rejection shall in the case of Hidden Defects in the Product be two years following Lonza’s release of the Product for delivery hereunder. Failure by Customer to provide notice of rejections within the applicable timeframe shall constitute irrevocable acceptance of the Product by Customer. 
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(b)  Lonza shall have the right to examine and test any Product that Customer claims to be a Non-Complying Product and shall notify Customer in writing of the results of such examination.  
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(c)  In the event the Parties cannot agree as to whether or not any shipment of Product is a Non- Complying Product, the Parties shall appoint a third party, a mutually acceptable independent reputable laboratory to complete and report the relevant testing within thirty (30) days, the findings of which shall be binding on the Parties, absent manifest error.  The Parties shall ensure that such independent laboratory is bound to the Parties by obligations of confidentiality no less exacting than those applying between the Parties. Expenses of such laboratory testing shall be borne by the Party whose position is determined to have been in error or, if the laboratory cannot place the fault noticed and complained about, then the Parties shall share equally the expenses of the laboratory.
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(d)  Customer agrees that Lonza shall have no liability if the Non-Complying Product is due to any action or inaction on the part of Customer, any Affiliate of Customer or any third party under contract with or subject to the control or direction of Customer or any Affiliate of Customer.
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7.3Remedy for Non-Complying Product.  Customer shall return any shipments of Non-Complying Product (or portions thereof) rejected pursuant to Section 7.2 to Lonza at Lonza’s expense. As Lonza’s sole liability and Customer’ sole remedy with respect to such Non-Complying Product, upon Customer’s request, Lonza shall re-perform the Services hereunder and replace such rejected Non-Complying Product as soon as practicable, but no later than one hundred eighty (180) days from date of Bulk Powder manufacture with additional Bulk Powder supplied by Customer at Customer’s cost but at no additional charge (including any freight charge) to Customer.  The provisions of this Section 7.3 shall survive termination or expiration of this Agreement, provided that, subsequent to the termination or expiration of this Agreement, Lonza may, in lieu of replacing any rejected or missing quantities of Product, elect in its sole discretion to reimburse Customer for the amounts paid by Customer to Lonza for such rejected quantities of Non-Complying Product (including any applicable freight charges). 
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7.4Disclaimer of Other Warranties.  EXCEPT AS STATED IN THIS ARTICLE 7 LONZA MAKES NO WARRANTIES, EXPRESS OR IMPLIED, AND TO THE FULLEST EXTENT PERMITTED UNDER APPLICABLE LAW LONZA SPECIFICALLY DISCLAIMS ALL OTHER WARRANTIES INCLUDING WITHOUT LIMITATION WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
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7.5Lonza advises, and Customer acknowledges that, the Products resulting from the Services performed under this Agreement may not be used in the production, encapsulation, packaging or marketing of any product which is in violation of any applicable Laws or with any person or entity on any applicable government sanction, restricted party or denial list without a license or otherwise in violation of applicable Laws.

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7.6Customer represents and warrants that the Products will not be made available to any person or entity on any sanction, restricted party or denied party list of the United States of America, Switzerland, the European Union or United Nations without a license or otherwise in violation of applicable Laws.
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8.MANUFACTURING STANDARDS
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8.1Quality Agreement.  The Parties have delivered and executed a Quality Agreement relating to the manufacture of the Product. Specifications and Product conformance shall be set forth in the Quality Agreement. Lonza shall manufacture and supply the Product in accordance with the Quality Agreement as reasonably updated by the Parties from time to time, notably to take into consideration any marketing authorization(s) for the Product.  If there are any conflicts between the Quality Agreement and this Agreement, the provisions of this Agreement shall govern and control, with the exception that the Quality Agreement shall control with respect to all matters relating to the quality and disposition of the Product.
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8.2Modifications in Specifications.  Any changes to the Specifications shall be agreed between the Parties in writing.  Costs for amendments to the Specifications (including without limitation any additional Product or procurement costs) shall be borne by the Customer.
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8.3Modifications in Materials. Customer shall notify Lonza of any change related to the Bulk Powder that may affect the validated process including but not limited to supplier changes, process changes, regulatory changes, and environment health safety characteristics. Customer should provide to Lonza a written notification of such change at least ninety (90) days before implementation of the change. If the change warrants validation batches, then the costs associated with such change will be borne by the Customer.
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		9.	INDEMNIFICATION

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9.1Indemnification of Customer.   Lonza shall indemnify, defend and hold Customer, its Affiliates and their respective officers, directors, employees and agents (each, a “Customer Indemnified Party”) harmless from and against any and all Losses suffered, incurred or sustained by any Customer Indemnified Party, by reason of any Claim or Proceeding to the extent arising out of or resulting from Lonza’s: (i) breach of the representation and warranties in this Agreement or (ii) negligence or willful misconduct in connection with this Agreement; provided however, that Lonza shall have no obligation of indemnity hereunder with respect to any Losses to the extent caused by the negligence or willful misconduct on the part of Customer.  
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9.2Indemnification of Lonza.  Customer shall indemnify, defend and hold Lonza, its Affiliates and their respective directors, officers, employees and agents (each, a “Lonza Indemnified Party”) harmless from and against any and all Losses suffered, incurred or sustained by any Lonza Indemnified Party, by reason of any Claim or Proceeding to the extent arising out of or resulting from Customer’s (i) breach of the representation and warranties in this Agreement; (ii) negligence or willful misconduct in connection with this Agreement; (iii) the use, packaging, labeling, distribution, marketing, promotion, sale and disposal of Product or Bulk Powder; or (iv) resulting from the inherent risk of the Product or Bulk Powder; provided however, that Customer shall have no obligation of indemnity hereunder with respect to any Losses to the extent caused by the negligence or willful misconduct on the part of Lonza. 
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Customer shall also indemnify, defend and hold each Lonza Indemnified Party harmless from and against any and all claims, suits, and/or proceedings (including any assertion of an intellectual property 

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right, regardless of whether the assertion has been or will be adjudicated), as well as all damages, losses, liabilities, and expenses (including reasonable attorneys’ fees and costs), of whatever nature resulting from, arising out of, or relating to a claim or allegation that the Product, or any part thereof, or any intellectual property, information or material supplied by or on behalf of Customer infringes, misappropriates, or otherwise violates a patent, copyright, trade secret, trademark or other intellectual property right of any third party.
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9.3Indemnification Procedures.  In the event that any Claim or Proceeding is asserted or imposed against a Party, and such Claim or Proceeding involves a matter which is subject to a claim for indemnification under this Article 9, then such Party (the “Indemnified Party”) shall promptly give written notice to the other Party (the “Indemnifying Party”) of such Claim or Proceeding.  The Indemnifying Party shall assume, at its cost and expense, the defense of such Claim or Proceeding through its legal counsel selected and reasonably acceptable to the Indemnified Party, except that the Indemnified Party may, at its option and expense, select and be represented by separate counsel.  The Indemnifying Party shall have control over the Claim or Proceeding, including the right to settle; provided, however, that the Indemnifying Party shall not, absent the prior written consent of the Indemnified Party, consent to the entry of any judgment or enter into any settlement that (1) provides for any relief other than the payment of monetary damages for which the Indemnifying Party shall be solely liable, and (2) where the claimant or plaintiff does not release the Indemnified Party, its Affiliates and their respective directors, officers, employees, agents and representatives, as the case may be, from all liability in respect thereof.  In no event shall the Indemnified Party be liable for any claims that are compromised or settled in violation of this Section.  
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9.4Waiver of Certain Losses.  In no event shall Lonza OR ITS AFFILIATES be liable to Customer OR ITS AFFILIATES for any LOSS OF OPPORTUNITY, LOSS OF PROFITS, LOSS OF ANTICIPATED SALES, OR FOR ANY punitive, Incidental, consequential, indirect or special LOSSES OR damages whether or not foreseeable, or whether or not Lonza has been advised of the possibility of such damages, OF ANY KIND HOWEVER CAUSED, whether based on contract, negligence, INDEMNITY or other theory of law, ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT (or the termination hereof) or any PURCHASE ORDER, as applicable.
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9.5Limitation of Liability. Notwithstanding any other provision in this Agreement or a Purchase Order, as applicable, the total liability, in the aggregate, of Lonza and its Affiliates, to Customer and anyone claiming by or through Customer, for any and all claims, losses, costs, damages or fees, including without limitation, attorneys’ fees resulting from or in any way related to this Agreement or a Purchase Order from any cause or causes shall not exceed [***] the purchase price of the Product with respect to which damages are claimed.
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9.6Insurance.  Each Party shall, during the Term and for five (5) years after the later of (i) delivery of the last Product manufactured, or (ii) Services provided under this Agreement, obtain and maintain at its own cost and expense from a qualified insurance company, comprehensive general liability insurance including, but not limited to product liability coverage in the amount of at least five (5) million USD per claim.  Each Party shall provide the respective other Party with a certificate of such insurance upon reasonable request.
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10.CONFIDENTIALITY  
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10.1Non-disclosure and Non-use.  Neither Party shall disclose to any third party nor use for its own purposes (other than those contemplated by this Agreement) any information of the other Party that is not in the public domain and that was disclosed to it by the other Party in connection with this Agreement 

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(“Confidential Information”).  For purposes of this Agreement, Confidential Information shall mean all proprietary information, trade secrets, business plans, pharmaceuticals, materials, operations, equipment, processes, methods, strategies and systems, and financial information, prices, materials, building techniques and any drawings, specifications, designs and other information or data, or any fact with respect to any of the foregoing relating to this Agreement or the preceding agreements and work conducted by and between the Parties and relating to the Product prior to entering this Agreement.  If information is disclosed in written form, the receiving Party’s obligations of non-disclosure and non-use shall apply only to information which is, at the time of the disclosure, identified in writing by the disclosing party as being “Confidential”, or that which the receiving Party should reasonably know is confidential due to its nature and the work begin conducted between the Parties. Notwithstanding the above, either Party may disclose Confidential Information to those of its and its Affiliates’ directors, officers, employees, agents, consultants, representatives and advisors (collectively, “Agents”) and to those approved subcontractors who have a need to know for the purposes of this Agreement.  Each Party shall ensure that all of its Agents and subcontractors are bound by confidentiality obligations no less stringent than those stated herein.  The receiving Party shall be liable for any failure of any of its Agents and subcontractors to (a) maintain the confidentiality of the disclosing Party’s Confidential Information, or (b) otherwise comply with the terms of this Article 10 to the same extent as the receiving Party is obligated to do so.
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10.2Exclusion of Confidential Information.  The obligations of confidentiality and non-use set forth in Section 10.1 shall not apply to Confidential Information that: (a) is or becomes part of the public domain without a violation of this Agreement; (b) was already in possession of a receiving Party or its Affiliates at the time of receipt from the disclosing Party, as shown by documentary evidence, without violating an obligation of confidentiality; (c) after the date of this Agreement is received from a third party whose direct or indirect source is not the disclosing Party; or (d) the receiving Party can demonstrate was independently developed by or for the receiving Party or its Affiliates without the use or reliance on the disclosing Party’s Confidential Information or violating the terms of this Agreement.
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10.3Information Required by Law.  If the receiving Party is requested to disclose the Confidential Information of the disclosing Party or the substance of this Agreement in connection with a legal or administrative proceeding or otherwise to comply with a requirement under applicable Law, the receiving Party will, to  the extent legally permissible, give the disclosing Party prompt written notice of such request so that the disclosing Party may seek an appropriate protective order or other remedy, or waive compliance with the relevant provisions of this Agreement.  If the disclosing Party seeks a protective order or other remedy, the receiving Party, at the disclosing Party’s expense, will cooperate with and assist the disclosing Party in such efforts.  If the disclosing Party fails to obtain a protective order or waives compliance with the relevant provisions of this Agreement, the receiving Party will disclose only that portion of the Confidential Information which its legal counsel determines it is required by applicable Law to disclose. 
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10.4Confidentiality Period.  All obligations of confidentiality under this Article 10 will terminate seven (7) years after the expiration or termination of this Agreement; provided however that the obligations of confidentiality for Confidential Information identified as a trade secret will survive indefinitely until such trade secret information no longer qualifies as a trade secret.
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10.5Publicity. Neither Party shall use or reference in any advertising, sales promotion, press release or other communication, the endorsement, direct or indirect quote, code, drawing, logo, trademark, specification, or picture of the other Party or the other Party’s Affiliates without the prior written consent of the other Party. Customer and Lonza agree to coordinate external communications (e.g., a joint press release) regarding the Parties’ collaboration promptly following execution of this Agreement. Notwithstanding anything herein, Lonza acknowledges that Customer is a publicly traded entity and as such has certain reporting requirements related to material events and contracts, of which this Agreement may 

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be material to Customer. 
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10.6Document Retention. In case of termination of this Agreement, all technical documents of Customer shall be returned in original form without retaining any copies except for such copies as are required for regulatory purposes. All executed documents of exhibit and commercial batches shall be kept by Lonza as per regulatory requirements and shall be destroyed after the applicable retention period without retaining any copies.
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10.7Reservation of Rights. Except as specifically set forth herein, this Agreement does not (i) give either Party any license, right, title, interest in or ownership to any Confidential Information of the other Party; or (ii) grant any license, ownership or other right under any intellectual property rights except that solely necessary to carry out the activities contemplated by this Agreement.
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11.INTELLECTUAL PROPERTY
11.1All claims, expenses or damages (including attorneys' fees) in connection with any litigation instituted by a third party relating to a claim or claims of infringement of patents against either of the Parties, relating to or arising from the filings and/or the manufacturing, marketing, use or offer to sell of the Products in the Territory shall be the responsibility of Customer. Lonza shall support Customer with all necessary relevant information required by Customer for intellectual property evaluation and in case of any related legal notice and/or litigation, to the extent of providing supporting data and information related to such legal notice and/or litigation. 
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11.2Customer acknowledges that it shall be solely and fully responsible for doing any and all freedom to operate assessments regarding possible infringement of third party intellectual property rights for any and all products and processes for any Product which it makes, has made, uses, sells, offers for sale or imports, except for any processes that are proprietary to Lonza or that Lonza conducts under a license right. 
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11.3The marketing of Products shall be carried out by Customer under its own trademark. A Party shall acquire no rights or license on the other Party’s trademarks, unless such other Party provides prior written consent under separate written agreement signed by an authorized officer of such Party.
​
11.4Lonza shall assign and hereby does so assign to Customer all rights, title and interest in all data, discoveries, inventions, improvements, new uses, processes, copyrights, trade secrets, techniques and compounds (“Inventions”), whether patentable or not, arising from work performed under the Agreement and related to or enabled by Customer’s Product. Lonza shall timely communicate in full detail and disclose to Customer all data, information, reports, results and other work product collected, generated, prepared or derived by Lonza during the course of services performed under this Agreement. 
​
12.TERMINATION

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12.1Breach; Insolvency.  If either Party is in material breach of any of its obligations, including its representations, warranties or covenants, under this Agreement, and fails to remedy such breach within ninety (90) days (thirty (30) days for non-payment) of receipt of written notice from the other Party, the non-breaching Party may terminate this Agreement with immediate effect with written notice of termination to the breaching Party, without liability to the other Party and without prejudice of any other rights or remedies; provided however, that if the breaching party is diligently pursuing in good faith the remedy of the breach at the expiration of such ninety (90) day cure period, then, at the consent of the non-breaching party which consent shall not be unreasonably withheld or delayed, such ninety (90) day cure period shall be extended as reasonably required to effect the cure. Subject to any limitations under applicable Law, either Party shall have the right to terminate this Agreement by giving notice to the other Party in the event that the other Party becomes insolvent or goes into bankruptcy, liquidation or receivership, or is admitted to the benefits of any procedure for the settlement of debts or becomes a party to dissolution proceedings. For purposes of clarity, Lonza shall have the right to terminate this Agreement in the event Customer (i) breaches its payment obligations and fails to cure in such aforementioned cure period; or (ii) becomes insolvent.
12.2Termination by Customer.
		12.2.1
	Termination for FDA Rejection. In the event that the application for Regulatory Approval for the Product is rejected by the FDA with no commercially viable method to resubmit an application for Regulatory Approval or secure Regulatory Approval of the Product, and such FDA decision is not caused by the fault of Customer, this Agreement may be terminated by Customer upon sixty (60) days’ prior written notice to Lonza.

		12.2.2
	Termination for Withdrawal of Regulatory Approval. In the event Customer withdraws its Regulatory Approval or the FDA issues a final non-appealable order to the Customer to withdraw its Regulatory Approval, Customer may terminate this Agreement upon sixty (60) days’ prior written notice to Lonza. 

​
​
12.3Termination by Lonza.
12.3.1Termination for FDA Delay. In the event that the FDA does not issue a letter indicating that the application for Regulatory Approval for the Product is approvable within three (3) years after Customer submits such application for Regulatory Approval for the Product, but no later than January 31, 2023, this Agreement may be terminated by Lonza upon one hundred twenty (120) days’ prior written notice to Customer.
12.4 Consequences of Termination. 
		12.4.1
	In the event of termination herein, except in the event that Customer terminates for Lonza’s breach in accordance with Section 12.1 above, (a) Lonza shall be compensated for: (i) Services  rendered up to the date of termination, including in respect of any Product in-process; and (ii) all costs incurred through the date of termination, including Raw Materials costs for Raw Materials used or purchased for use in connection with the Purchase Orders ; and (b) all Purchase Orders shall be deemed cancelled and Customer shall pay the Cancellation Fee (in accordance with the terms of this Agreement) in respect of such cancelled manufacturing of Product due under Section  3.6, without proration of the final Contract Year.  In the case of termination by Lonza for Customer’s material breach, Cancellation Fees shall be calculated as of the date of written notice of termination.

November 2020Page 14 of 21‌CONFIDENTIAL

		12.4.2
	In the event of termination by Customer for Lonza's material breach in accordance with Section 12.1 above, Lonza shall be compensated for (i) Services rendered up to the date of termination, including in respect of any Product in-process and (ii) all costs incurred through the date of termination, including Raw Materials costs for Raw Materials used or purchased for use in connection with the Project Plan.  

​
12.5Environmental Effects; Health and Safety. Lonza reserves the right to terminate immediately this Agreement if, for any reason, (a) Lonza determines that the information provided by Customer pursuant to Section 5.2 is incomplete, inadequate, or inaccurate to protect the environment or the health, safety and well-being of Lonza’s employees (or those of its Affiliate) or (b) Lonza determines that continued performance of the Services hereunder may adversely affect the environment or the health, safety and well-being of Lonza’s employees (or those of its Affiliate). 
12.6Survival.  Termination or expiration of this agreement shall not relieve either Party of any liabilities, rights or obligations accruing prior to such termination or expiration. In the event of any termination or expiration of this Agreement, the provisions of this Section 12.6, and Sections 4, 5.2, 5.3, 6.1, 7, 9, 10, 15.1, and 15.3 shall survive such termination or expiration, together with any other provision hereof that by its terms survives termination or expiration hereof and any other obligations that have accrued prior to the termination or expiration of this Agreement.
13.NOTICES
​
13.1Notices hereunder shall be deemed given as of the date sent. All notices shall be in writing mailed via a reputable overnight courier, addressed as follows, or to such other address as may be designated from time to time:
​
If to Lonza: Xcelience, LLC
5415 West Laurel Street
Tampa, Florida 33607
Attention: Managing Director
​
Copy to: Lonza, Inc.
412 Mt. Kemble Avenue, Suite 200S
Morristown, New Jersey 07960
Attention: General Counsel, North America
​
​
If to Customer: Liquidia Technologies, Inc. 
419 Davis Drive, Suite 100
Morrisville, North Carolina 27560
Attention: Legal
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14.FORCE MAJEURE
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14.1If Lonza is prevented or delayed in the performance of any of its obligations under the Agreement by Force Majeure and gives written notice thereof to Customer specifying the matters constituting Force Majeure together with such evidence as Lonza reasonably can give and specifying the period for which it is estimated that such prevention or delay will continue, Lonza shall be excused from the performance or the punctual performance of such obligations as the case may be from the date of such notice for so long as such cause of prevention or delay shall continue, following the end of the Force Majeure event, Lonza promptly resume performance under this Agreement upon removal of the Force 

November 2020Page 15 of 21‌CONFIDENTIAL

Majeure; provided that, (i) if such Force Majeure persists for a period of [***] or more, Customer may terminate this Agreement by delivering written notice to Lonza.
​
14.2“Force Majeure” shall be deemed to include any reason or cause beyond Lonza’s reasonable control affecting the performance by Lonza of its obligations under the Agreement, including, but not limited to, any cause arising from or attributable to acts of God, pandemic event, strike, lockouts, labor troubles, restrictive governmental orders or decrees, riots, insurrection, war, terrorists acts, or the inability of Lonza to obtain any required raw material, energy source, equipment, labor or transportation, at reasonable prices and on terms deemed by Lonza to be reasonably practicable, from Lonza’s usual sources of supply .
14.3With regard to Lonza, any such event of Force Majeure affecting services or production at its Affiliates or suppliers that prohibit Lonza from otherwise performing under this Agreement shall be regarded as an event of Force Majeure.
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15MISCELLANEOUS
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15.1Entire Agreements; Amendments; Waivers.  The terms and provisions contained in this Agreement and all Exhibits hereto constitute the entire agreement between the Parties with respect to the commercial terms and conditions related to the commercial supply of Product, superseding all prior and contemporaneous agreements or understandings between the Parties with respect to the commercial terms and conditions related to the Product. In the event of a conflict between the terms of the Agreement, any Exhibit and the Quality Agreement, the terms of this Agreement shall control.  Any amendments of this Agreement must be in writing and signed by the Parties. A waiver of any breach or failure to enforce any of the terms or conditions of this Agreement shall in no way affect, limit or waive a Party’s rights at any time to enforce strict compliance therafter with every term or condition of this Agreement.
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15.2Successors and Assigns.  Neither Party may assign its interest under this Agreement without the prior written consent of the other Party, such consent not to be unreasonably withheld, conditioned or delayed, provided, however that (a) either Party may assign this Agreement to (i) any Affiliate of such Party or (ii) any third party in connection with the sale or transfer (by whatever method) of all or substantially all of the assets of the business related to this Agreement, and (b) Lonza shall be entitled to sell, assign and/or transfer its trade receivables resulting from this Agreement without the consent of the Customer.  For purposes of this Section 15.2, the terms “assign” and “assignment” shall include, without limitation (i) the sale of fifty percent (50%) or more of the outstanding stock of such Party to an Affiliate of such Party or an unrelated entity or natural person, (ii) the sale or transfer or other assignment of all or substantially all of the assets of the Party or the line of business or Product to which this Agreement relates, and (iii) a merger, consolidation, acquisition or other form of business combination.  Any purported assignment without a required consent shall be void.  No assignment shall relieve any Party of responsibility for the performance of any obligation that accrued prior to the effective date of such assignment.
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15.3Independent Contractor.  The relationship of the Parties under this Agreement is that of independent contractors and nothing contained herein shall be construed to create a partnership, joint venture or agency relationship between Customer and Lonza, nor shall either Party be authorized to bind the other in any way.
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15.4Governing Law; Dispute Resolution.   This Agreement is governed in all respects by the laws of the State of New York, without regard to its conflicts of laws principles.  The Parties agree to submit to the exclusive jurisdiction of the courts located in the Southern District of New York. The Parties shall have the right to proceed to a suitable jurisdiction for the purpose of enforcing a judgment, award, or order (including without limitation seeking specific performance) and injunctive reliefs. 

November 2020Page 16 of 21‌CONFIDENTIAL

​
15.5Severability.  If any provision of this Agreement is or becomes at any time illegal, invalid or unenforceable in any respect, neither the legality, validity nor enforceability of the remaining provisions hereof shall in any way be affected or impaired thereby.  The Parties undertake to substitute any illegal, invalid or unenforceable provision by a provision which is as far as possible commercially equivalent considering the legal interests and the purpose of this Agreement.
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15.6Counterparts; Electronic Signatures.  This Agreement may be executed in one or more counterparts, and by the Parties in separate counterparts, each of which when so executed shall be deemed an original, but all of which together shall constitute one and the same instrument.  This Agreement, to the extent signed and delivered by electronic means, shall be treated in all manner and respects as an original agreement or instrument and shall be considered to have the same binding legal effect as if it were the original signed version thereof delivered in person.  
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15.7No Third Party Beneficiaries.  No third party including any employee of a Party shall have or acquire any rights by reason of this Agreement whether by way of statute or otherwise. 
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15.8Miscellaneous.  The division of this Agreement into articles, sections, subsections and exhibits, and the insertion of headings, are for convenience of reference only and shall not affect the interpretation of this Agreement.  Unless expressly provided herein or unless the context otherwise requires, all references to the singular shall include the plural and vice versa. Any reference herein to a “day” or “days” shall be references to a calendar day or days. Any period of days specified in this Agreement ending on a Saturday, Sunday or public holiday shall automatically be extended to the first business day in the country of manufacture ending after such Saturday, Sunday or public holiday. 
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15.9Construction.  Each of the Parties agrees that it has read and had the opportunity to review this Agreement with its legal counsel and, accordingly, the rule of construction that any ambiguity contained in this Agreement shall be construed against the drafting Party shall not apply.
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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the Effective Date. 
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	Liquidia Technologies, Inc.
	XCELIENCE, LLC

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​
By:By:‌
Name:Name:  
Title:Title: 
Date:Date:
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​

November 2020Page 18 of 21‌CONFIDENTIAL

​

EXHIBIT A
COMMERCIAL TERMS
​
​
Price:
​
	Price per Unit* (US$) regardless of individual capsule strength 
	 Capsules/Batch 
	 Theoretical Number of Units per Batch 

	[***]
	[***]
	[***]

	[***]
	[***]
	[***]

	[***]
	[***]
	[***]

	[***]
	[***]
	[***]

	[***]
	[***]or greater
	[***]

​
* Price includes full conversion costs and cost of empty capsule shells and all packaging components except Patient Inserts, Desiccants, Brushes, and Inhalers. All packaging components are priced at cost plus [***] handling fee. 
​
​
Annual Minimum Purchases:
​
	Contract Year
	Annual Minimum Purchase (in capsules)

	1
	[***] converted into Units; equivalent to [***] of Baseline Forecast 

	2
	[***] converted into Units; equivalent to [***] of Baseline Forecast 

	3
	[***] converted into Units; equivalent to [***] of Baseline Forecast 

	4
	[***] converted into Units; equivalent to [***] of Baseline Forecast 

	5
	[***] converted into Units; equivalent to [***] of Baseline Forecast 

​
​
Lonza Capacity Guaranty:
​
	Year
	Capacity Guaranty (in capsules)

	1
	[***] converted into Units; equivalent to Baseline Forecast PLUS [***]

	2
	[***] converted into Units; equivalent to Baseline Forecast PLUS [***]

	3
	[***] converted into Units; equivalent to Baseline Forecast PLUS [***]

	4
	[***] converted into Units; equivalent to Baseline Forecast PLUS [***]

	5
	[***] converted into Units; equivalent to Baseline Forecast PLUS [***]

​
Shipping Terms:
​
Delivery terms shall be Ex-Works from Lonza’s Facility. 
​
​
Payment Terms:
​

​
​
​
​
October 2020‌CONFIDENTIAL 
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​

[***] from the date of invoice upon release of Product and the appropriate release documentation as set forth in Section 4.6 hereof.  For the avoidance of doubt, payment terms are further described in Section 4.2 hereof.  
​
​
Currency: 
​
US$
​
Baseline Forecast:
​
[***]
​
​
​
​
​
​
​

October 2020‌CONFIDENTIAL 
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​

​

EXHIBIT B
ENVIRONMENTAL AND HEALTH AND SAFETY INFORMATION
​
​
	1.	Safety Data Sheets (or the equivalent) for any drug substance, intermediate, pharmaceutical blend, or final drug product (“Material(s)”) provided to Lonza by Customer;

​
	2.	Any occupational exposure limit (OEL) or occupational exposure control technique applicable to the formulation of the Material(s) (e.g. occupational exposure band, hazard classification, etc.), including any OEL or occupational exposure control technique applicable to the manufacture of dietary supplement, drug substance or drug product, whether established by Customer or its contract manufacturer, regardless of whether it is required by any governmental authority;

​
	3.	Any monograph or compilation of data upon which  the OEL or occupational exposure control technique for the Material(s), its precursors, or intermediates, is based;

​
	4.	Any medical tests used to evaluate any biological condition or function of workers who may have been exposed to the Material(s), its precursors, or intermediates (to the extent such information is or becomes available);

​
	5.	Any biological exposure indices associated with the Material(s) or its precursors or intermediates (to the extent such information is or becomes available);

​
	6.	Any modeling related to any releases to the environment of the Material(s), its precursors, or intermediates (to the extent such information is or becomes available);

​
	7.	Any test results related to the identification of health or physical hazards, or understanding of the ecotoxicity of the Material(s), its precursors, or intermediates (to the extent such information is or becomes available);

​
	8.	Any quantitative or qualitative assessment of the environmental impact of the Material’s use, manufacture, storage, transportation, or disposal (to the extent such information is or becomes available); 

​
	9.	Any summary of the known physical and chemical properties, pharmacology, pharmacokinetics, and clinical and nonclinical toxicology data submitted to a government agency to obtain pre-marketing approval of the Material(s) (to the extent such information is or becomes available); 

​
	10.	Any reports of adverse reactions by employees or others exposed to the Material(s), its precursors, or intermediates, during its manufacture, storage or transportation (to the extent such information is or becomes available); and

​
	11.	Any process safety information, including but not limited to process hazard analyses and off-site consequences analyses related to a licensed process (to the extent such information is or becomes available).

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​
​
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October 2020‌CONFIDENTIAL 
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​

EXHIBIT C
Safety Data Sheets (SDS) 

October 2020‌CONFIDENTIAL 
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​

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