COMMERCIAL SUPPLY AGREEMENT By and Between CORERX, INC. and AIMMUNE THERAPEUTICS, INC. May 10, 2019

ARTICLE 1: DEFINITIONS

5

ARTICLE 2: PROCESSING; SALE AND PURCHASE OF PRODUCT

16

  2.1

Processing.

16

  2.2

CoreRx Responsibilities.

17

  2.3

Aimmune Responsibilities.

18

ARTICLE 3: COORDINATORS & MEETINGS

19

ARTICLE 4: EQUIPMENT; CORERX FACILITY; PEANUT FLOUR; RAW MATERIALS; ARTWORK

19

  4.1

Equipment.

19

  4.2

Facilities.

19

  4.3

Peanut Flour and Aimmune Materials.

20

  4.4

Raw Materials.

23

  4.5

Artwork.

23

ARTICLE 5: REPRESENTATIONS, WARRANTIES & COVENANTS; SPECIFICATION CHANGES; QUALITY AGREEMENT

23

  5.1

Representations, Warranties and Covenants of CoreRx.

23

  5.2

Representations and Warranties by Aimmune.

24

  5.3

Mutual Representations and Warranties.

25

  5.4

Limitations.

26

  5.5

Specification Changes.

26

  5.6

Quality Agreement.

26

  5.7

Duty of Cooperation.

27

ARTICLE 6: MINIMUM COMMITMENT PERCENTAGE; FORECASTS; FIRM COMMITMENTS

27

  6.1

Minimum Manufacturing Commitment Percentage.

27

  6.2

Minimum Testing Commitment Percentage.

28

  6.3

Forecast.

29

  6.4

Firm Manufacturing Commitment.

29

  6.5

Firm Testing Commitment.

30

  6.6

Second Source Supplier.

31

ARTICLE 7: PURCHASE OF PRODUCT; DELIVERIES; ADDITIONAL WORK

31

  7.1

Purchase Orders.

31

  7.2

Delivery Timing.

33

  7.3

Delivery Shortfall / Overage.

34

  7.4

Delivery Terms.

34

  7.5

Product Storage.

35

  7.6

Additional Work.

35

ARTICLE 8: RELEASE TESTING; ACCEPTANCE AND REJECTION; NON-CONFORMITY; LATENT DEFECT; DEFECTIVE PRODUCT

35

  8.1

Disposition for Release; Release Testing; Timely Delivery.

35

  8.2

Acceptance and Rejection; Non-conformity; Latent Defect; Defective Product.

36

ARTICLE 9: PRICE; TAXES; INVOICES; METHOD OF PAYMENT; ANNUAL RECONCILIATION

38

  9.1

Product Price Schedule; Release Testing Price Schedule.

38

  9.2

Taxes.

39

  9.3

Invoices.

39

  9.4

Payment Procedure.

40

  9.5

Monthly Reporting.

40

  9.6

Inventory and Physical Asset Counts.

40

ARTICLE 10: RECORDS; AUDITS; REGULATORY MATTERS; RECALLS

40

10.1

Production Records.

40

10.2

Recordkeeping.

40

10.3

Quality Audits and Inspections.

41

10.4

Representatives for Inspection of Processing and Release Testing.

41

10.5

Governmental Inspections and Requests.

42

10.6

Quality Agreement.

43

10.7

Recall.

43

ARTICLE 11: ▇▇▇▇▇▇▇▇▇▇▇▇▇/▇▇▇▇▇▇▇▇▇▇; ▇▇▇ ▇▇▇▇▇▇▇▇▇

▇▇

11.1

Qualification.

44

11.2

PLI Readiness.

44

ARTICLE 12: TERM; TERMINATION

44

12.1

Initial Term.

44

12.2

Renewal Term.

45

12.3

Termination by Mutual Agreement.

45

12.4

Termination for Default.

45

12.5

Regulatory.

46

12.6

Bankruptcy; Insolvency.

46

12.7

Low Yield.

46

12.8

Unilateral Termination by Aimmune.

47

12.9

Expiration; Termination; Consequences.

47

ARTICLE 13: INDEMNIFICATION

49

13.1

Indemnification by Aimmune.

49

13.2

Indemnification by CoreRx.

50

13.3

Indemnification Procedures.

50

13.4

Survival of Indemnification Obligations.

51

13.5

Limitation of Liability.

51

ARTICLE 14: CONFIDENTIALITY

52

14.1

Confidentiality and Non-Use.

52

14.2

Access to Confidential Information.

52

14.3

Exceptions to Confidential Information.

52

14.4

Return.

53

14.5

Enforcement.

53

14.6

Permitted Disclosures.

53

14.7

Confidentiality of Agreement.

54

ARTICLE 15: INTELLECTUAL PROPERTY

55

15.1

Background IP.

55

15.2

Work Product and Agreement Inventions.

55

15.3

Licenses to Perform under this Agreement.

55

15.4

No Third Party IP.

56

ARTICLE 16: FORCE MAJEURE

56

16.1

Effects of Force Majeure.

56

ARTICLE 17: PRESS RELEASES; USE OF NAMES

56

56

17.1

Press Releases.

56

17.2

Use of Names.

57

ARTICLE 18: DISPUTE RESOLUTION

57

18.1

Dispute Resolution.

57

ARTICLE 19: MISCELLANEOUS

58

19.1

Independent Contractors.

58

19.2

Insurance.

58

19.3

Further Actions.

60

19.4

Assignment; Subcontractors.

60

19.5

Waiver.

60

19.6

Severability.

61

19.7

Headings.

61

19.8

Construction.

61

19.9

Exhibits, Schedules and Attachments.

61

19.10

Notices.

62

19.11

Counterparts.

63

19.12

Governing Law; Entire Agreement.

63

19.13

Schedules.

63

ARTICLE 1:  

DEFINITIONS

1.1

“Acquisition Cost” shall mean the actual invoiced price paid by either Party to any Third Party for acquiring Peanut Flour or Raw Materials hereunder, including, but not limited to, shipping and handling costs and customs duties incurred and paid by such Party to any Third Party in connection with the acquisition of Peanut Flour or Raw Materials, as the case may be.

1.2

“Affiliate” shall mean any entity that directly or indirectly controls, is controlled by, or is under common control with a Party where control means the direct or indirect ownership of voting securities entitled to cast at least fifty percent (50%) of the votes in the election of directors, or such other relationship as results in the power to control the management, business, assets and affairs of an entity.

1.3

“Agreement” shall mean this Commercial Supply Agreement.

1.4

“Agreement Inventions” shall mean all Inventions [***] related to the Product or the Processing and Release Testing of the Product conceived, reduced to practice, discovered or made by CoreRx, either alone or with Aimmune or with any other person, in each case solely under this Agreement, and all copies and tangible embodiments thereof (in whatever form or medium).

1.5

“Aimmune Background IP” shall mean all Background IP owned or controlled by Aimmune or its Affiliates.

1.6

“Aimmune Materials” shall mean any samples or other tangible materials, including without limitation Peanut Flour, provided by Aimmune or on behalf of Aimmune to CoreRx for Processing under this Agreement.

1.7

“Annual Lot Forecast” shall mean the total number of Lots for a Contract Year as set forth in the first Forecast of each Contract Year.

1.8

“Applicable Laws” shall mean all laws, rules, regulations, ordinances, guidance, guidelines, and standards, within the countries of the Territory applicable to the Processing, Release Testing and supply of Product, including, without limitation, (i) all applicable federal, state and local laws and regulations of each country of the Territory; (ii) the rules of and regulations of applicable Regulatory Authorities, (iii) cGMP; and (iv) Environmental Laws.

1.9

“Artwork” shall have the meaning set forth in Section 4.5 hereof.

1.10

“Background IP” shall mean any Intellectual Property owned or controlled by a Party or its Affiliates prior to the Effective Date or otherwise developed independently by a Party or its Affiliates outside the scope of the MSA or this Agreement without use of the other Party’s Confidential Information.

1.11

“Batch Record” shall mean an accurate reproduction of the master batch record documenting and providing instructions for those parts of Processing comprising the manufacturing steps required to convert the Peanut Flour and Raw Materials into the Bulk Product, and/or holding of a particular Lot of Product.

1.12

“BLA” shall mean the biologics license application submitted to the FDA by Aimmune relating to Product, and any supplements or amendments to such BLA as may be filed during the Term hereof.

1.13

“Bulk Product” shall mean Product Lots packaged in bulk drums or containers.

1.14

“Bulk Yield” shall mean the yield of Acceptable Units of Bulk Product resulting from utilizing a quantity of Peanut Flour to produce such Bulk Product.

1.15

“cGMP” or “cGMP Regulations” shall mean the regulatory requirements for current good manufacturing practices with respect to the Processing, storage and Release Testing of Bulk Product under this Agreement, including (as applicable): the United States current Good Manufacturing Practices pursuant to the FDCA and pursuant to the relevant regulations found in Title 21 of the U.S. Code of Federal Regulations (including Parts 11, 210, 211, 610 and 611), the European Union’s current Good Manufacturing Practices pursuant to EC Directive 2003/94/EC of 8 October 2003, and the International Conference on Harmonisation Guidance for Industry, as applicable, including Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, in the case of Q7 as applicable to the activities carried out by CoreRx under this Agreement, and any comparable regulatory requirements designated by the Parties in a Purchase Order, as such regulatory requirements may be amended from time to time.

1.16

“Commercial Facility” shall mean the portion of the Facility that is to be used to carry out the manufacturing steps required to convert the Peanut Flour and Raw Materials into the Bulk Product for Processing of the Bulk Product and is located at ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇, as described in more detail in Schedule E.

1.17

“Confidential Information” shall mean any and all technical, business or other Information, of a Party or its Affiliates provided orally, visually, in writing, graphically, electronically, by observation or in another form by or on behalf of such Party or its Affiliates to the other Party or its Affiliates in connection with this Agreement, including the terms of this Agreement, the Product, any know-how with respect thereto developed by or on behalf of the Disclosing Party or its Affiliates, or the scientific, regulatory or business affairs or other activities of the Disclosing Party or its Affiliates.

1.18

“Contract Year” shall, except in Contract Year one (1), mean each twelve (12) month period during the Term of this Agreement, commencing on January 1^st and ending on the following December 31^st. Contract Year one (1) shall mean that period, beginning on the Effective Date, and ending on December 31, 2019.

1.19

“Coordinators” shall have the meaning set forth in Article 3 hereof.

1.20

“Core Parameters” shall mean those “core” parameters for Peanut Flour set forth in Schedule F hereof, as may be revised from time to time by the mutual written agreement of the Parties.

1.21

“CoreRx Background IP” shall mean all Background IP owned or controlled by CoreRx or its Affiliates as of the Effective Date and during the Term, including but not limited to all Inventions developed by CoreRx in connection with other projects or its own process improvements or other Inventions independent of this Agreement that are not Agreement Inventions.

1.22

“CoreRx Maximum Capacity” shall mean CoreRx’s annual maximum commercial production capacity in the Commercial Facility set forth in Schedule G.

1.23

“Defective Product” shall mean Product that possesses a Non-conformity and/or a Latent Defect.

1.24

“Delivery Date” shall mean a date for which delivery of Product is stated in a Purchase Order.

1.25

“Disclosing Party” shall have the meaning set forth in Section 14.1 hereof.

1.26

“Discharge” shall mean any release, spill, emission, leaking, pumping, pouring, injection, escaping, deposit, disposal, discharge, dispersal, dumping, leaching or migration of any Hazardous Material into or through the indoor or outdoor environment (including the abandonment or disposal of any barrels, containers or other closed receptacles containing any Hazardous Material).

1.27

“Disposition(ed) for Release” shall mean formal approval indicating suitability of the Product for release to Aimmune, as evidenced by CoreRx or a designated Third Party performing Release Testing, CoreRx issuing a Certificate of Analysis and generating a Certificate of Compliance (as such terms are defined in the Quality Agreement) provided to Aimmune by CoreRx, all as provided in greater detail under the Quality Agreement.

1.28

“Dosage Strength” shall means the amount of Peanut Flour expressed as mg peanut protein in a capsule or sachet of Product.

1.29

“Effective Date” shall have the meaning set forth in the first paragraph of this Agreement.

1.30

“Environmental Laws” shall mean all Applicable Laws that regulate or relate to the protection or clean-up of the environment, the use, treatment, storage, transportation, generation, Processing, Release Testing, processing, distribution, handling, labeling or disposal of, or emission, discharge or other Discharge or threatened Discharge of, or exposure to, Hazardous Materials or otherwise dangerous substances, wastes, pollution or materials (whether, gas, liquid or solid), the preservation or protection of waterways, groundwater, drinking water, air, wildlife, plants or other natural resources, or the health and safety of persons or property, including without limitation protection of the health and safety of employees. Environmental Laws shall include, without limitation, the Federal Insecticide, Fungicide, Rodenticide Act, Resource Conservation & Recovery Act, Clean Water Act, Safe Drinking Water Act, Atomic Energy Act, Occupational Safety and Health Act, Toxic Substances Control Act, Clean Air Act, Comprehensive Environmental Response, Compensation and Liability Act, Emergency Planning and Community Right-to-Know Act, Hazardous Materials Transportation Act and all analogous or related federal, state or local laws, each as amended.

1.31

“Equipment” shall have the meaning set forth in Section 4.1.1 hereof.

1.32

“Equipment Maintenance Schedule” shall have the meaning set forth in Section 4.1.1 hereof.

1.33

“EMA” shall mean the European Medicines Agency, or any successor agency.

1.34

“Executed Batch Record” shall mean the executed manufacturing instructions containing the complete documentation of all activities and measurements associated with production of a Lot of Bulk Product.

1.35

“Expected Bulk Yield” shall have the meaning set forth in Section 4.3.3 hereof.

1.36

“Facility” shall mean the manufacturing facility located at ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇, which is [***] and which comprises the ML3 Facility (which includes the Warehouse) and the Commercial Facility.

1.37

“FDCA” shall mean the United States Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. Sec. 301 et seq.), relevant regulations promulgated thereunder (including, without limitation, 21 C.F.R. parts 11, 210 and 211) and all applicable FDA guidelines, guidance documents and other administrative interpretations and rulings, as may be amended from time to time.

1.38

“FDA” shall mean the United States Food and Drug Administration, or any successor entity.

1.39

“Firm Manufacturing Commitment” shall mean the binding Forecast defined in Section 6.4 hereinafter.

1.40

“Firm Testing Commitment” shall mean the binding Forecast defined in Section 6.5 hereinafter.

1.41

“Forecast” shall mean the forecast defined in Section 6.3.1 hereinafter.

1.42

“For Cause Audit” shall have the meaning set forth in Section 10.3 hereof.

1.43

“Hazardous Materials” shall mean any material, substance or waste that is listed, classified, regulated, characterized or otherwise defined as “hazardous,” “toxic,” “radioactive,” a “pollutant, or “contaminant” (or words of similar intent or meaning) under applicable Environmental Law.

1.44

“Information” shall mean all technical, scientific, business and other know-how and information, Inventions, discoveries, trade secrets, knowledge, technology, means, methods, processes, formulations, practices, formulae, instructions, skills, techniques, procedures, experiences, expressed ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results, materials (including biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical), pre-clinical, clinical, safety, manufacturing and quality control data and information (including study designs and protocols) and assays and biological methodology, in each case, whether or not confidential, proprietary or patentable and in written, oral, electronic or any other form now known or hereafter developed.

1.45

“Initial Term” shall have the meaning set forth in Section 12.1 hereof.

1.46

“Intellectual Property” shall mean (i) know-how and trade secrets, (ii) all Inventions (whether patentable or unpatentable and whether or not reduced to practice) and all Patent Rights thereof, (iii) all copyrightable works, all copyrights, and all applications, registrations and renewals in connection therewith, (iv) trademarks, service marks, trade dress, logos, trade names, and corporate names, together with all translations, adaptations, derivations, and combinations thereof and including all goodwill associated therewith, and (v) all other proprietary rights.

1.47

“In-Process Materials” shall mean combinations of one or more Raw Materials with Peanut Flour that have not been completely processed to Bulk Product.

1.48

“In-Process Testing” shall mean all testing activities of In-Process Materials performed during the Processing to ensure that such In-Process Materials conform to in-process specifications.

1.49

“Invention” shall mean any composition of matter, device, process, method, technique, procedure, protocol, treatment, formulation, discovery, know-how, concept or idea, or any improvement thereof, whether patentable or not, or subject to copyright or not.

1.50

“Latent Defect” shall mean a Non-conformity that was (i) not reasonably discoverable within the period specified in Section 8.2.1 using the quality control procedures outlined in the Product Specifications or the Quality Agreement; (ii) are attributable to CoreRx’s Processing or Release Testing; and (iii) could not reasonably been deemed to have: (a) been caused by use of Peanut Flour that did not meet the Core Parameters, or (b) occurred after delivery of Product to the carrier.

1.51

“Losses” shall have the meaning set forth in Section 13.1 hereof.

1.52

“Lot” shall mean a single Lot of Bulk Product having uniform character and quality within specified limits, is Processed according to a single manufacturing order during the same cycle of manufacture and is of a specific quantity, all as specifically set forth in Schedule D.

1.53

“MAA” shall mean the marketing authorization application submitted to the EMA by Aimmune relating to Product, and any supplements or amendments to such MAA as may be filed during the Term hereof.

154

“Minimum Manufacturing Commitment Percentage” shall have the meaning set forth in Section 6.1 hereof.

1.55

“Minimum Testing Commitment Percentage” shall have the meaning set forth in Section 6.2 hereof.

1.56

“ML3 Facility” shall mean that portion of the Facility located at ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇, which, [***] and which includes the Warehouse.

1.57

“[***] Manufacturing Firm Amount” shall have the meaning set forth in Section 6.4.1 hereof.

1.58

“[***] Testing Firm Amount” shall have the meaning set forth in Section 6.5.1 hereof.

1.59

“MSA” shall mean the Master Services Agreement between Aimmune and CoreRx dated November 29, 2016.

1.60

“Non-conformity” shall mean a defect or circumstance(s) that causes Bulk Product not to satisfy the warranties set forth in Section 5.1.2.

1.61

“Non-Routine Maintenance Activities” shall mean all non-routine maintenance activities necessary or useful to maintaining, pursuant to this Agreement, the Equipment and Commercial Facility and the Warehouse [***] in good working order, including without limitation the following activities: [***].

1.62

“Order Shortfall” shall have the meaning set forth in Section 9.3.2 hereof.

1.63

“Order Shortfall Amount” shall have the meaning set forth in Section 9.3.2 hereof.

1.64

“Order Shortfall Payment” shall have the meaning set forth in Section 9.3.2 hereof.

1.65

“Order Shortfall Penalty” shall mean $[***] per Lot.

1.66

“Patent Rights” shall mean (a) patents and patent applications anywhere in the world, (b) all divisionals, continuations, continuations in-part thereof or any other patent application claiming priority, or entitled to claim priority, directly or indirectly to (i) any such patents or patent applications, or (ii) any patent or patent application from which such patents or patent applications claim, or is entitled to claim, direct or indirect priority, and (c) all patents issuing on any of the foregoing anywhere in the world, together with all registrations, reissues, re-examinations, patents of addition, renewals, substitutions, validations, and re-validations, supplemental protection certificates or extensions of any of the foregoing anywhere in the world, and (d) all provisional and any other priority patent applications filed worldwide.

1.67

“PLI” shall mean any pre-licensing or pre-approval inspection by any Regulatory Authority.

1.68

“Peanut Flour” shall mean the peanut flour used to produce Product under this Agreement.

1.69

“Peanut Flour Specification” shall mean the specification for the Peanut Flour set forth in the Quality Agreement, as such specification may be revised from time to time by Aimmune with prior written notice to CoreRx.

1.70

“Pricing Tier” shall have the meaning set forth in Schedule A of this Agreement.

1.71

“Process”, “Processed”, or “Processing” shall mean the conduct of the procedure(s) described in Schedule B.

1.72

“Process Requirements “shall have the meaning set forth in Section 5.7 hereof.

1.73

“Producer Price Index (PPI)” means the index known as the United States Bureau of Labor Statistics, Producer Price Index, Pharmaceutical Preparation Manufacturing (Series ID: PCU325412325412), not seasonally adjusted, as it appears in the periodical PPI Detailed Report as published for the region in which the Facility is located, or a comparable successor index. Any PPI adjustment to pricing under Section 9.1.2 will be capped at [***]% per year. Notwithstanding the foregoing, if CoreRx reasonably determines that its costs will exceed the [***]% cap per year, then CoreRx and Aimmune agree to negotiate in good faith to revise the cap for the relevant period.

1.74

“Product” shall mean AR101 in bulk, capsule or sachet dosage form resulting from Processing Peanut Flour and Raw Materials, in accordance with the Batch Record.

1.75

“Product Approval” shall mean the approval of Product by the FDA or the EMA.

1.76

“Product Price” shall mean the price for Processing of Bulk Product as set forth in Schedule A, as applicable, attached hereto and made a part hereof, as such price may be amended from time to time in accordance with this Agreement.

1.77

“Product Specification” shall mean the specifications for the Product set forth in the Quality Agreement, including any test methods and in-process specifications relating thereto, as such specifications may be amended from time to time by mutual written agreement of the Parties.

1.78

“Production Records” shall mean all documentation pertaining to the manufacture and testing of a completed Lot of Bulk Product, including but not limited to Executed Batch Records, sampling documentation, test results and raw data for all Raw Material testing, Peanut Flour testing, In-Process Materials testing, and Bulk Product Release Testing performed at CoreRx or its contract laboratories and related OOS results and other quality incidents, investigative reports, deviations reports, and all applicable manufacturing process data (including any pertinent output from instrumentation and all documentation of cleaning performed in association with manufacture of the previous product in the equipment to be used for manufacture of Product or performed following installation, maintenance, or cleaning expiration of equipment to be used for manufacture of Product.

1.79

“Purchase Order” shall mean a firm purchase commitment detailing the Bulk Product quantity and required Delivery Dates, as further described in Section 7.1.

1.80

“Qualified Lot” shall mean a Lot produced by CoreRx that (a) will conform to the Product Specifications, as then in effect, and will have been Processed in accordance with the master Batch Record; (b) will have been Processed in accordance with cGMP Regulations and the Quality Agreement (c) is free from any deviation, special sampling requirement or other assignable cause that results in a lower than anticipated Bulk Yield for such Lot.

1.81

“Quality Agreement” shall mean the Quality Agreement of even date herewith (including all schedules and appendices attached thereto), as further defined in Section 5.6 and setting forth the guidelines and responsibilities of the Parties in connection with the Product as they are related to quality control, quality assurance, In-Process Testing, qualification, validation, and Disposition for Release, and authorization for shipment, as such Quality Agreement may be amended from time to time by the Parties in accordance with the terms thereof.

1.82

“Raw Materials” shall mean all the materials, supplies, components, and packaging, including empty capsule shells and sachet foil laminate, but excluding Peanut Flour, required to Process the Bulk Product in accordance with the Product Specifications and as listed on Aimmune’s Regulatory Applications for the Product.

1.83

“Raw Material Specifications” shall mean the specifications relating to the Raw Materials outlined in Aimmune’s Regulatory Applications for the Product, including any test methods relating thereto, as provided by CoreRx and approved in advance in writing by Aimmune.

1.84

“Recall” shall have the meaning set forth in Section 10.7.1 hereof.

1.85

“Receiving Party” shall have the meaning set forth in Section 14.1 hereof.

1.86

“Regulatory Application” shall mean, for a particular country or Regulatory Authority, an application or other submission by Aimmune or its Affiliate for Regulatory Approval, or for approval or permission to conduct human clinical trials (as applicable), by the applicable Regulatory Authority regarding the Product.

1.87

“Regulatory Approval” shall mean, for a particular country or Regulatory Authority, all approvals from the applicable Regulatory Authority required for the commercial marketing or sales of a pharmaceutical product in such country, along with satisfaction of any related applicable regulatory requirements.

1.88

“Regulatory Authority” shall mean any governmental regulatory authority within a country of the Territory involved in regulating any aspect of the development, manufacture, market approval, sale, distribution, packaging or use of drug products, including, but not limited to, the FDA, Health Canada, the Medicines and Healthcare Products Regulatory Agency, Swissmedic, the Therapeutic Goods Administration and the EMA.

1.89

“Release Test”, “Release Tested”, “Release Testing” shall mean the conduct of the procedure(s) described in Schedule B, including, but not limited to, release testing and analysis of Bulk Product or the conduct of analytical testing of Peanut Flour in accordance with the Peanut Flour Specification, as applicable, all of the foregoing in accordance with the Quality Agreement, any Applicable Laws, and the Product Specifications.

1.90

“Renewal Term” shall have the meaning set forth in Section 12.2 hereof.

1.91

“[***]” shall have the meaning set forth in [***].

1.92

“Routine Maintenance Activities” shall mean all routine maintenance activities necessary or useful to maintaining the Equipment, Commercial Facility and the Warehouse (and those activities related to the ML3 Facility to the extent necessary or useful for the Processing and Testing of Bulk Product and usage of the Commercial Facility and the Warehouse) in good working order as further defined in section 4.1.3, including without limitation the following activities:  [***].

1.93

“Supplier Readiness Fee” shall mean [***] expenses reasonable and necessary for the storage, Processing and Testing of Bulk Product at the Commercial Facility for a single calendar quarter as required under this Agreement and the Quality Agreement, as set forth in Schedule A.

1.94

“Term” shall have the meaning set forth in Section 12.2 hereof.

1.95

“Territory” shall mean the United States, Canada, the European Union, including the United Kingdom (whether or not the United Kingdom is a member of the European Union), Norway, Switzerland and Australia, and any other country or countries identified by Aimmune in a written notice provided to CoreRx at least [***] ([***]) months prior to the date that Aimmune intends for such country or countries to be included within the Territory. Any reasonable costs for upgrades or licenses required to meet the requirements of any new Territory that CoreRx does not already supply to will be paid for in accordance with Section 4.2.3 hereof.

1.96

“Testing” shall mean, collectively, all In-Process Testing and Release Testing activities.

1.97

“Testing Facility” shall have the meaning set forth in Section 4.2.3 hereof.

1.98

“Third Party” shall mean any Party other than Aimmune, CoreRx and their respective Affiliates.

1.99

“Unit” shall mean the specified quantity of Product expressed as a number of capsules or sachets, as the case may be.

1.100

“Unit Cost” for a Dosage Strength shall mean its Product Price as set forth in Schedule A.

1.101

“Warehouse” shall mean that portion of the ML3 Facility that is being used by the Parties to receive, sample, and store (separate from other Third-Party materials) incoming Raw Materials, ship Bulk Product, and store QA retain samples.

1.102

“Work Product” shall mean all deliverables (other than Product), Information, documents, Production Records (e.g., executed Batch Records, analytical raw data, environmental monitoring data, etc.) or materials, including without limitation any analytical methods, plans, works of authorship, techniques, manufacturing instructions  and processes, product formulations and operating procedures, test procedures, cleaning procedures, and all other scientific or technical information or materials whether in written, graphic, or electronic form, developed, edited or otherwise created by during the Term by CoreRx or its subcontractors, or jointly by CoreRx or its subcontractors and Aimmune and which is [***] related to Processing and Testing of the Product.

1.103

“[***]” shall have the meaning set forth in [***].

ARTICLE 2:  

PROCESSING; SALE AND PURCHASE OF PRODUCT

2.1

Processing.

2.2

CoreRx Responsibilities.

2.2.1

maintaining all required registrations or licenses with applicable Regulatory Authorities per Section 4.2.3, such as but not limited to, the FDA, and any other Federal, state or local agencies so that CoreRx can perform its obligations as set forth in this Agreement and CoreRx will promptly, within [***] ([***]) [***], notify Aimmune if any such registrations or licenses lapse or when it determines that it is not in compliance with the requirements for maintaining such registrations or licenses;

2.2.2

operating in accordance with the Quality Agreement and being responsible for all items designated as its responsibility on the Quality Agreement;

2.2.3

reasonably maintaining the Equipment, as set forth in more detail in Article 4 below;

2.2.4

unloading, handling, sampling, testing, dispositioning and storing Raw Materials in accordance with the Raw Material Specifications and Peanut Flour in accordance with the Peanut Flour Specification, Quality Agreement, Raw Material Specifications, and with the manufacturing instructions provided in the Batch Record(s) for In-Process Testing all at the Commercial Facility;

2.2.5

Processing the Bulk Product in accordance with Aimmune’s Regulatory Applications, the Quality Agreement, the Raw Material Specifications, the Peanut Flour Specification, and with the manufacturing instructions provided in the Batch Record(s) for In-Process Testing;

2.2.6

Release Testing of the Bulk Product in accordance with Aimmune’s Regulatory Applications, the Quality Agreement, and current versions of the analytical test methods listed in the Product Specifications;

2.2.7

collecting and retaining samples of the Raw Materials and Bulk Product as provided in greater detail in the Quality Agreement;

2.2.8

collecting and testing samples of In-Process Materials according to manufacturing instructions provided in the Batch Records and in accordance with the current version of the analytical test methods listed in the in-process specifications;

2.2.9

collecting and submitting samples for Bulk Product Release Testing whether such testing is performed at CoreRx, at another pre-approved CoreRx facility, or at a Third-Party testing laboratory;

2.2.10

handling and storing In-Process Materials and Bulk Product;

2.2.11

preparing the Bulk Product for shipment;

2.2.12

making the Bulk Product available to a common carrier;

2.2.13

cooperating with Aimmune in the preparation and submission of the CMC section of the BLA or the MAA, and/or other manufacturing-related sections of other Regulatory Applications with foreign Regulatory Authorities in the Territory in which Aimmune may be seeking Foreign Regulatory Approval for the Product, as detailed to a greater extent in the Quality Agreement;

2.2.14

cooperating with Aimmune in the preparation for PLIs as detailed to a greater extent in the Quality Agreement;

2.2.15

keeping records and reporting to Aimmune and applicable governmental agencies as may be required by Applicable Laws;

2.2.16

handling, storing, treating, and disposing of Hazardous Materials generated by CoreRx in connection with CoreRx’s performance under this Agreement in accordance with Environmental Laws; and providing final Product Dispositioned for Release in accordance with the Quality Agreement.

2.3

Aimmune Responsibilities.

2.3.1

providing the Aimmune Materials and Artwork in a timely manner as required for CoreRx to perform its obligations for Processing Bulk Product under this Agreement;

2.3.2

approving analytical test methods relating to In-Process Testing of In-Process Materials and Release Testing of Peanut Flour and Bulk Product in accordance with the Quality Agreement;

2.3.3

providing Product Specifications and the Peanut Flour Specification, and providing Aimmune Materials in compliance with the applicable Specifications for such Aimmune Materials;

2.3.4

operating as set forth in the Quality Agreement and being responsible for all items designated as its responsibility in this Agreement or the Quality Agreement; and

2.3.5

providing CoreRx with authorization to ship Product that has been Dispositioned for Release by CoreRx.

ARTICLE 3:  

COORDINATORS & MEETINGS

ARTICLE 4:  

EQUIPMENT; CORERX FACILITY; PEANUT FLOUR; RAW MATERIALS; ARTWORK

4.1

Equipment.

4.1.1

CoreRx shall maintain the equipment listed on Schedule C hereto (“Equipment”) in accordance with the maintenance schedule for each piece of such Equipment, as set forth on Schedule C (“Equipment Maintenance Schedule”) and house the Equipment in the Commercial Facility, separate from equipment used for purposes other than performance of this Agreement.

4.1.2

Title to any Equipment purchased by Aimmune for use by CoreRx hereunder, including [***] shall be retained by Aimmune and CoreRx shall not obtain any ownership interest, legal or equitable, in the Equipment by virtue of its use of the Equipment as set forth herein. CoreRx shall [***] and will, if requested, [***].  

Such Equipment shall be [***] hereunder except for [***] (e.g. [***]), which may be [***] so long as such Equipment [***] and [***].

4.1.3

[***] shall be responsible for, and bear the cost of, [***] and [***] such Equipment so long as it remains at the Commercial Facility, Testing Facility, or Warehouse. During the [***], Aimmune and CoreRx will [***] the costs of [***] for Equipment in the Warehouse. For [***], Aimmune shall bear or reimburse CoreRx [***] of [***] and [***] the Equipment (such as [***]), to the extent [***] and [***].  CoreRx shall notify Aimmune in writing (email acceptable) [***] the performance of any [***], and Aimmune shall directly pay or CoreRx shall invoice Aimmune and Aimmune shall promptly reimburse CoreRx for any such [***] costs actually incurred by CoreRx and which Aimmune has authorized in writing to be incurred or for which it is responsible.

4.2

Facilities.

4.2.1

During the Term of this Agreement, CoreRx agrees to maintain and operate its ML3 Facility, the Commercial Facility, the Testing Facility, and any other facilities and/or equipment necessary for CoreRx to perform its obligations under this Agreement and the Quality Agreement, (a) in a manner that complies with all Applicable Laws, including, without limitation, Environmental Laws, the FDCA and cGMP Regulations and (b) as necessary to perform its obligations under this Agreement and the Quality Agreement. The Commercial Facility shall be dedicated solely to Aimmune and shall not be used by CoreRx for any other purpose without the prior written consent of Aimmune.

4.2.2

[***] is solely responsible for, and bears the cost of, performing [***], with regard to [***]. During the [***], Aimmune and CoreRx will [***] the costs of [***] for the [***]. For [***], Aimmune shall bear or reimburse CoreRx [***] of [***] for [***], to the extent [***] and [***]. In addition, CoreRx shall engage a contractor [***] to [***] of, and [***] on, the [***]. CoreRx and Aimmune will share all [***] costs for [***] on a [***] basis, unless a different allocation shall be agreed to in the future by mutual written agreement. Notification and payment mechanisms shall be as set forth in Section 4.1.3 above.

4.2.3

CoreRx agrees to maintain a valid FDA Establishment Number for the ML3 Facility, the Commercial Facility, and any other CoreRx facility utilized for the testing of Raw Materials, Peanut Flour, In-Process Materials, or the Bulk Product (the “Testing Facility”).  CoreRx shall maintain such valid FDA license for the ML3 Facility, the Commercial Facility and the Testing Facility, together with all other permits and licenses required under all Applicable Laws in order to perform

its obligations under this Agreement and the Quality Agreement.  CoreRx will keep and maintain all records as required by all Applicable Laws including, without limitation, Environmental Laws, the FDCA and cGMP Regulations.  At Aimmune’s request, CoreRx shall provide copies of such records and reports to Aimmune [***].  [***] any registration fees for any licenses or permits that CoreRx is required to obtain as a [***] under this Agreement in [***].  [***] any registration fees for any licenses or permits that CoreRx is required to obtain as a [***] under this Agreement in [***].  [***] any registration fees for any licenses or permits that CoreRx is required to obtain as a [***] under this Agreement in any country other than [***] as follows:  (a) if CoreRx does not supply to a specific [***] country, Aimmune will pay [***] registration fees for any licenses or permits that CoreRx is required to obtain in that country; (b) if CoreRx supplies to a specific country for [***], Aimmune and CoreRx will [***] the registration fees for any licenses or permits that CoreRx is required to obtain in that country; and (c) if CoreRx supplies to a specific country for [***], [***] will pay all registration fees for any licenses or permits that CoreRx is required to obtain in that country.    CoreRx will promptly notify Aimmune when it is required to obtain or maintain an [***] license or permit for another CoreRx customer or any proprietary CoreRx product.  If a new country is added to the Territory after the Effective Date and CoreRx will be required under Applicable Law to upgrade or modify the Commercial Facility or the ML3 Facility, [***] the costs incurred to implement such upgrades or modifications.

4.2.4

CoreRx will notify Aimmune in writing within [***] ([***]) [***] if any Regulatory Authority or any other governmental entity issues a finding or order that CoreRx expects will materially and negatively impair CoreRx’s ability to perform its obligations, including without limitation any finding or order that causes or CoreRx expects will cause  (a) [***], (b) [***] or (c) [***].

4.2.5

CoreRx shall permit representatives of Aimmune to visit the Warehouse, the Commercial Facility and the Testing Facility (a) (with at least [***] advance notice) with representatives of any Regulatory Authorities or other governmental entities to inspect the Warehouse, the Commercial Facility and the Testing Facility, all in accordance with the Quality Agreement and (b) with at least [***] advance notice and at times that do not interfere with CoreRx’s ability to operate these facilities in accordance with the Agreement to observe Processing, Release Testing or Equipment.  CoreRx will also permit representatives of Aimmune [***] in the Commercial Facility; Aimmune agrees that any such representatives will be required to comply with all workplace rules and policies that apply to CoreRx employees who operate the Commercial Facility [***].

4.3

Peanut Flour and Aimmune Materials.  

4.3.1

Supply of Peanut Flour.  Aimmune shall supply Peanut Flour for use by CoreRx in the Processing of Bulk Product hereunder. Aimmune shall supply CoreRx with an inventory of Peanut Flour sufficient for at least [***] production of Product based on the then-current Forecast.

4.3.2

Peanut Flour Specifications; Core Parameters.  CoreRx will only use Peanut Flour that meets the Peanut Flour Specifications to Process Bulk Product under this Agreement.  If Peanut Flour meets the Peanut Flour Specifications but does not meet the Core Parameters, CoreRx will provide prompt written notice thereof to Aimmune.  CoreRx can only use Peanut Flour that meets the Peanut Flour Specifications but does not meet the Core Parameters to Process Bulk Product hereunder if Aimmune provides prior written approval to CoreRx of such use.  

4.3.3

Expected Bulk Yield.  CoreRx shall use the Peanut Flour solely for the Processing of Bulk Product hereunder.  The theoretical Bulk Yield shall be the number of Units of Bulk Product produced according to the formulae provided in the Batch Records as illustrated in Schedule D.  For each Dosage Strength, the expected yield of Bulk Product to be produced by CoreRx (the “Expected Bulk Yield”) shall equal the average actual Bulk Yield [***], determined as the [***] acceptable Units of Bulk Product produced [***] and expressed as a percentage. Between the Effective Date and the date that the Expected Bulk Yield is determined in accordance with the previous sentence, the Parties agree that the interim Expected Bulk Yield for each Dosage Strength shall be the percentage values listed in Schedule D.  The Expected Bulk Yield may be adjusted from time to time during the Term upon the mutual written agreement of the Parties. If after the Effective Date there is a material change to either the Equipment used in the Processing of Bulk Product or the methods used to Process the Bulk Product, the Parties will discuss in good faith whether to re-evaluate the Expected Bulk Yield.

4.3.4

Aimmune Materials.  Aimmune retains all right, title and interest in and to the Aimmune Materials. CoreRx shall not use the Aimmune Materials for any purpose other than performing its obligations under this Agreement, without Aimmune’s express prior written permission. In addition, CoreRx shall not take or send the Aimmune Materials to any Third Party, without Aimmune’s express prior written permission, except as otherwise required to perform Release Testing of Peanut Flour.

4.4

Raw Materials.

4.5

Artwork.  

ARTICLE 5:  

REPRESENTATIONS, WARRANTIES & COVENANTS; SPECIFICATION CHANGES; QUALITY AGREEMENT

5.1

Representations, Warranties and Covenants of CoreRx.  

5.1.1

CoreRx will perform the Processing, Release Testing of Peanut Flour, and any Aimmune-requested Release Testing of Bulk Product in conformance with all Applicable Laws, the Quality Agreement, the Batch Records, and the Product Specifications, and in accordance with the terms and conditions of this Agreement.

5.1.2

All Bulk Product, at the time of sale and shipment to Aimmune or its designee by CoreRx:  (a) will conform to the Product Specifications, as then in effect, and will have been Processed in accordance with the master Batch Record; (b) will have been Processed in accordance with cGMP Regulations, this Agreement and the Quality Agreement; (c) will be Processed, transported, stored, handled and disposed of in accordance with all Applicable Laws, including without limitation Environmental Laws; (d) will be conveyed with good title, free and clear from any

security interest, lien or encumbrance; and (e) will not be (i) adulterated or misbranded by CoreRx (excluding any Artwork which is the responsibility of Aimmune, provided that any such Artwork used by CoreRx is consistent with Aimmune’s instructions) within the meaning of the FDCA or comparable Applicable Laws in any country in the Territory or (ii) an article that may not be introduced into interstate commerce under the provisions of Sections 404 or 505 of the FDCA or comparable Applicable Laws in any country in the Territory.  

5.1.3

to CoreRx’s knowledge, it has all necessary authority and all right, title and interest in and to any technology related to the Release Testing of Peanut Flour, the In-Process Testing of In-Process Materials, and the Processing, Release Testing and supply of Bulk Product or that is otherwise required by CoreRx to perform its obligations as set forth under this Agreement.

5.1.4

to CoreRx’s knowledge, (x) any CoreRx Background IP utilized in the Release Testing of Peanut Flour, the In-Process Testing of In-Process Materials, and the Processing, Release Testing and supply of the Bulk Product by CoreRx under this Agreement will not infringe or misappropriate any Intellectual Property rights of any Third Party, (y) CoreRx’s performance of its obligations under this Agreement will not infringe or misappropriate any Intellectual Property rights of any Third Party and (z) CoreRx will comply with all Applicable Laws in its performance under this Agreement.

5.1.5

the Commercial Facility and Warehouse will remain in compliance with Applicable Laws during the Term.

5.1.6

CoreRx will not use or incorporate any Third Party technology, components or Intellectual Property in Processing, In-Process Testing, or Release Testing without obtaining Aimmune’s prior written consent.

5.2

Representations and Warranties by Aimmune.

5.2.1

(a) to Aimmune’s knowledge, Aimmune has all necessary authority (including rights under any Intellectual Property rights related to the Product) to provide the Peanut Flour to CoreRx under this Agreement and to authorize CoreRx to Process the Product in accordance with this Agreement; (b) all Artwork and the content thereof provided to CoreRx shall comply with Applicable Laws; (c) Aimmune will provide CoreRx with all material safety data sheets applicable to the Peanut Flour; (d) all Product provided to Aimmune by CoreRx under this Agreement will be held, used and/or disposed of by Aimmune or its designee in compliance with Applicable

Laws; (e) Aimmune will comply with all Applicable Laws in its performance under this Agreement and (f) any Raw Material furnished by Aimmune will conform to the specifications for such Raw Material set out in all applicable marketing approval authorizations.

5.3

Mutual Representations and Warranties.

5.3.1

It is duly organized and validly existing under the laws of the state or jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof.

5.3.2

It is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder.  The person executing this Agreement on its behalf has been duly authorized to do so by all requisite corporate action.

5.3.3

It has obtained all necessary consents, approvals and authorizations required to be obtained by it in connection with the execution of and performance under the Agreement.

5.3.4

This Agreement is a legal and valid obligation binding upon it and enforceable in accordance with its terms.  The execution, delivery and performance of this Agreement does not conflict with, or constitute a default under, any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any Applicable Laws or order of any court, governmental body or administrative or other agency having jurisdiction over it.

5.3.5

None of its officers, directors, agents, Affiliates or employees (i) was or is presently debarred or disqualified under Section 306(a) or (b) of the FDCA (21 U.S.C. §§ 335(a) or (b)), (ii) has been debarred or excluded from participation in the Medicare program, any state Medicaid program or any federal health care program, (iii) has been charged with, indicted for, or convicted of a criminal offense that would lead to debarment or exclusion under the FDCA, or from participation in the Medicare program, any state Medicaid program or any other federal health care program, or (iv) has been or is under investigation by any government authority for debarment or exclusion action.  Each Party shall notify the other Party immediately upon any inquiry or the commencement of any investigation or proceeding or of any circumstance that would cause its representations under this Section 5.3.5 to become false or inaccurate.  The obligation to notify the other Party in accordance with the preceding sentence shall survive termination or expiration of this Agreement for [***] ([***]) years, unless a longer notification period is required by Applicable Laws.  

5.4

Limitations.  

5.5

Specification Changes.  

5.6

Quality Agreement.

5.7

Duty of Cooperation.

ARTICLE 6:  

MINIMUM COMMITMENT PERCENTAGE; FORECASTS; FIRM COMMITMENTS

6.1

Minimum Manufacturing Commitment Percentage.

6.1.1

Minimum Manufacturing Commitment Percentage (Contract Year 1): 100%

6.1.2

Minimum Manufacturing Commitment Percentage (Contract Year 2): [***]%

6.1.3

Minimum Manufacturing Commitment Percentage (Contract Year 3): [***]%

6.1.4

Minimum Manufacturing Commitment Percentage (Contract Year 4): [***]%

6.1.5

Minimum Manufacturing Commitment Percentage (Contract Year 5): [***]%

6.2

Minimum Testing Commitment Percentage.

6.2.1

Minimum Testing Commitment Percentage (Contract Year 1): 100%

6.2.2

Minimum Testing Commitment Percentage (Contract Year 2): [***]%

6.2.3

Minimum Testing Commitment Percentage (Contract Year 3): [***]%

6.2.4

Minimum Testing Commitment Percentage (Contract Year 4): [***]%

6.2.5

Minimum Testing Commitment Percentage (Contract Year 5): [***]%

6.3

Forecast.

6.3.1

At least [***] ([***]) days prior to the first [***] during which Aimmune requires Bulk Product to be delivered by CoreRx hereunder, unless otherwise agreed to by the parties in writing, Aimmune shall submit to CoreRx the first written detailed forecast (the “Forecast”) of its [***] requirements for Bulk Product from CoreRx for each of the next succeeding [***].  The Forecast shall be updated [***] thereafter by the [***].  CoreRx will review each Forecast and inform Aimmune within [***] ([***]) days of receipt of the Forecast if CoreRx believes the Forecast does not comply with requirements of this Article 6.  Starting in [***], Aimmune shall also submit to CoreRx no later than [***] of the applicable Contract Year [***] for such Contract Year.  

6.3.2

As part of each Forecast, Aimmune shall submit to CoreRx for [***] ([***]) of the Forecast a detailed forecast of Aimmune’s Bulk Product requirements, further specified [***] as to the [***].  For [***] ([***]) of the Forecast, Aimmune shall submit only the [***]. For [***] ([***]), Aimmune shall be required to submit to CoreRx only a [***].

6.4

Firm Manufacturing Commitment.  

6.4.1

For [***] ([***]), Aimmune will be required to purchase from CoreRx, and CoreRx will be required to Process and supply to Aimmune (as long as [***] forecasted in the Forecast is consistent with Section 6.3), [***] percent ([***]%) of the forecasted amount(s) of the Bulk Product set forth in the forecast for each of the [***] ([***] [***]) of each Forecast delivered hereunder.  The forecasted amount(s) for each of the first [***] of each Forecast is hereinafter referred to as the “[***] Manufacturing Firm Amount”.

6.4.2

Aimmune shall have no obligation to purchase any forecasted amounts in any Forecast for [***] ([***]) of such Forecast, other than to the extent required to fulfill its Minimum Manufacturing Commitment Percentage for the Contract Year covered by that Forecast.  

6.4.3

Firm Commitments provided by Aimmune will order Bulk Product in number of Lots.  

6.4.4

Aimmune may from time to time (a) request [***] that are [***] in any Firm Manufacturing Commitments or (b) [***] that are [***] to the Firm Manufacturing Commitments.  In each such case, CoreRx will [***] to honor such requests.

6.4.5

All Firm Manufacturing Commitments will be in writing and will be confirmed by CoreRx in writing at the latest [***] ([***]) days after receipt of each Firm Manufacturing Commitment.

6.4.6

CoreRx will be obligated to accept all Firm Manufacturing Commitments that are within the limits of the applicable Forecast provided to CoreRx.

6.4.7

In the event Aimmune cancels a Firm Manufacturing Commitment, Aimmune shall pay to CoreRx an amount [***].

6.4.8

For clarification, the amount of Aimmune’s overall commercial requirements under this Agreement for Bulk Product, as further described in Schedule G, in a Contract Year cannot exceed the CoreRx Maximum Capacity in effect for that Contract Year without CoreRx written approval CoreRx agrees that it will supply Bulk Product under this Agreement up to the CoreRx Maximum Capacity in effect for a given Contract Year if requested to do so by Aimmune in accordance with this Article 6 and Article 7.

6.5

Firm Testing Commitment.  

6.5.1

For [***] ([***]), Aimmune will be required to purchase from CoreRx, and CoreRx will be required to perform Release Testing services for [***] percent ([***]%) of Lots of Bulk Product requested to be tested as set forth in the Forecast for each of the first [***] ([***]) of each Forecast delivered hereunder.  The forecasted amount of testing for each of the first [***] of each Forecast is hereinafter referred to as the “[***] Testing Firm Amount”.

6.5.2

Firm Testing Commitments provided by Aimmune for [***] ([***]) will specify the [***] that require Release Testing during [***] ([***]) of each Forecast delivered hereunder.  Firm Testing Commitments provided by Aimmune for [***] ([***]) will specify only the [***] that require Release Testing over [***] ([***]) of each Forecast delivered hereunder.

6.5.3

Aimmune may from time to time place requests for testing Product that are separate from and in addition to the Firm Testing Commitments.  In each such case, CoreRx will use commercially reasonable efforts to honor such requests.

6.5.4

All Firm Testing Commitments will be in writing and will be confirmed by CoreRx in writing at the latest [***] ([***]) days after receipt of each Firm Testing Commitment.

6.5.5

CoreRx will be obligated to accept all Firm Testing Commitments that are within the limits of the applicable Forecast provided to CoreRx.

6.5.6

In the event Aimmune cancels a Firm Testing Commitment, Aimmune shall [***] or pay to CoreRx the initial batch testing price for each Lot of Product below the Minimum Testing Commitment Percentage.

6.6

Second Source Supplier.

ARTICLE 7:  

PURCHASE OF PRODUCT; DELIVERIES; ADDITIONAL WORK

7.1

Purchase Orders.  

7.1.1

Submitting Purchase Orders. Together with each Forecast submitted by Aimmune pursuant to Section 6.3 above, Aimmune shall submit to CoreRx one (1) or more Purchase Orders for [***] ([***]) of such Forecast (unless such Purchase Order(s) have previously been provided to CoreRx by Aimmune) such that the Purchase Orders submitted with the current Forecast, combined with all previously submitted Purchase Orders, constitute an aggregate firm order for the [***] Manufacturing Firm Amount and [***] Testing Firm Amount of Product for at least the first [***] of the accompanying Forecast.  Although [***] ([***]) of each Forecast are [***] percent ([***]%) firm for manufacturing pursuant to Section 6.4.1, Aimmune only has to submit Purchase Orders for [***] ([***]) of each Forecast.

7.1.2

Details of Purchase Order. Any Purchase Order submitted by Aimmune to CoreRx under this Section 7.1 shall state (i) [***] and (ii) [***], and (iii) [***].  If a Purchase Order contains a quantity of Bulk Product that is greater than the [***] Manufacturing Firm Amount or [***] Testing Firm Amount set forth in the most recent Forecast or requests a Delivery Date that is earlier than the date set forth in the most recent Forecast, CoreRx will use commercially reasonable efforts to honor any such additional quantities and/or earlier Delivery Dates, subject to the terms outlined in Sections 6.4.4 and 6.5.3.

7.1.3

Late Purchase Orders.  If Aimmune submits any Purchase Order hereunder to CoreRx after the [***] ([***]) day of the [***] covered by such Purchase Order, such Purchase Order shall be considered late, and CoreRx may treat such late Purchase Order as an optional Purchase Order under Section 7.1.5 below.  

7.1.4

Purchase Order Confirmation.  Within [***] ([***]) days after the date of CoreRx’s receipt of any Purchase Order from Aimmune under this Section 7.1, CoreRx shall confirm to Aimmune, in writing, that CoreRx received such Purchase Order.  Notwithstanding the foregoing, irrespective of any such confirmation (or lack thereof), CoreRx shall be deemed to have accepted any and all Purchase Orders submitted by Aimmune to CoreRx on a timely basis under Section 7.1.1, so long as the amount of the Product ordered and Release Testing to be performed by CoreRx, requested by Aimmune for any [***], does not exceed the [***] Manufacturing Firm Amount or [***] Testing Firm Amount for such month in the Forecast.  

7.1.5

Additional Purchase Orders.  In addition to Purchase Orders submitted with a Forecast under Section 7.1.1 above, Aimmune may elect (but shall not be obligated) to submit to CoreRx one (1) or more additional Purchase Orders, at any time or from time to time during the Term of this Agreement.  Each such Purchase Order from Aimmune hereunder shall state (i) [***] and (ii) [***].  Within [***] ([***]) days after the date of CoreRx’s receipt of any Purchase Order (if any) from Aimmune under this Section 7.1.5, CoreRx shall confirm to Aimmune, in writing, that CoreRx received such Purchase Order and shall inform Aimmune, in writing, whether or not CoreRx accepts such Purchase Order. CoreRx shall use all commercially reasonable efforts to accept additional Purchase Orders and supply all amounts of the Product ordered by Aimmune and accepted by CoreRx under this Section 7.1.5 on a timely basis.

7.2

Delivery Timing.

7.2.1

Supply on Timely Basis.  CoreRx shall use all commercially reasonable efforts to supply all amounts of the Bulk Product ordered by Aimmune under Section 7.1 on a timely basis. CoreRx shall provide Aimmune with as much advance notice as possible (and will [***] provide at least [***] ([***]) days advance notice where possible) if CoreRx determines that the delivery of any Bulk Product or the performance of any additional work will be delayed for any reason, stating the reasons for the delay.  In the event that the Parties cannot agree on a new Delivery Date, Aimmune may reschedule or [***], provided such delays were not due to CoreRx supporting additional Purchase Orders.  In the event that the late delivery by CoreRx results in an order change, including reschedules or cancellations by Aimmune not due to additional Purchase Orders, CoreRx [***] accommodate, [***], such schedule changes as required by Aimmune, and [***].  Further, in the event that [***] determines that performance of Release Testing of a Lot of Product by CoreRx will be delayed and if such delay in Release Testing [***] result in a late delivery by CoreRx, Aimmune shall have the option to [***]. For such delays [***] due to CoreRx, and which are not due to [***], CoreRx shall also be responsible for [***].  Bulk Product shipped to Aimmune [***] and without [***] and any [***] may be returned to CoreRx at [***] or held at Commercial Facility [***].  No shipment will be deemed complete until all ordered Units have been delivered and accepted.  No payment or other obligations of Aimmune will accrue on partial or incomplete shipments where CoreRx is the cause of such partial or incomplete shipment.

7.2.2

Failure to Supply by Delivery Date.  If CoreRx fails to supply all or part of any shipment of Bulk Products ordered by Aimmune under Section 7.1 by the Delivery Date for such shipment for reasons solely within the control of CoreRx and not due to any failure or delay of Aimmune or a Third Party lab performing Release Testing, then Aimmune will be entitled to receive a discount applied against the Purchase Price of such delayed Products, in accordance with the following schedule (which refund CoreRx acknowledges as liquidated damages reflecting a reasonable measure of actual damages and not a penalty): (a) if Bulk Product(s) are delivered anywhere from [***] ([***]) to [***] ([***]) days following the Delivery Date  for such shipment, then Aimmune will receive a [***] percent ([***]%) discount off of the Purchase Price for such Bulk Products; (b) if Bulk Product(s) are delivered anywhere from [***] ([***]) to [***] ([***]) days following the Delivery Date for such shipment, then Aimmune will receive a [***] percent ([***]%) discount off of the Purchase Price for such Bulk Products; or (c) if Bulk Product(s) are delivered more than [***] ([***]) days following the Delivery Date for such shipment, then Aimmune may elect either to (i) receive a [***] percent ([***]%) discount off of

the Purchase Price for such Bulk Products or (ii) [***] and [***] and [***], with [***].  

7.3

Delivery Shortfall / Overage.

7.4

Delivery Terms.  

7.4.1

CoreRx will only supply and deliver Product that it declares to be Dispositioned for Release in accordance with the procedures set forth in the Quality Agreement, including any required documentation.  

7.4.2

Each delivery will be accompanied by a certificate of compliance and a certificate of analysis (only in cases where CoreRx is performing Release Testing) and other Lot documentation showing the conformity of the delivered Lot as specified and defined in the Quality Agreement

7.4.3

All Bulk Products and other materials provided by CoreRx are delivered EXW (Incoterms 2010) at the Warehouse and title and risk of loss or damage shall pass to Aimmune upon such delivery to the common carrier at the Warehouse.

7.4.4

Aimmune may request that CoreRx warehouses Bulk Product in accordance with Section 7.5 below, in which case title and risk of loss or damage for such stored Bulk Product shall transfer upon CoreRx’s delivery of the Dispositioned for Release Bulk Product to Aimmune at the [***].

7.4.5

All Bulk Product that has been Dispositioned for Release by CoreRx shall be properly prepared for safe and lawful shipment by CoreRx; shall be shipped to Aimmune’s distribution center or other location designated by Aimmune (only after Aimmune has authorized CoreRx to ship Product that has been Dispositioned for Release by CoreRx), via the common carrier designated by Aimmune; and shall be accompanied by appropriate documentation.  No products of any Third Party shall be shipped with the Bulk Product. Only Bulk Product that has been Dispositioned

for Release by CoreRx shall be delivered by CoreRx to the common carrier at the Warehouse under this Section 7.4.

7.5

Product Storage.

7.6

Additional Work.

ARTICLE 8:  

RELEASE TESTING; ACCEPTANCE AND REJECTION; NON-CONFORMITY; LATENT DEFECT; DEFECTIVE PRODUCT

8.1

Disposition for Release; Release Testing; Timely Delivery.

8.2

Acceptance and Rejection; Non-conformity; Latent Defect; Defective Product.

8.2.1

Aimmune shall have [***] ([***]) days from the receipt of Bulk Product and all associated Production Records to inspect the Bulk Product, review the certificates of analysis and other documents and/or perform or have performed any or all of the quality control procedures outlined in the relevant Specifications or the Quality Agreement to determine if the Bulk Product meets the Product Specifications.

8.2.2

If Aimmune has evidence to indicate that Bulk Product contains a Non-conformity, Aimmune shall promptly notify CoreRx in writing and CoreRx shall initiate an investigation of the alleged Non-conformity.  If so requested by CoreRx, Aimmune will send to CoreRx a sample of the rejected shipment.

8.2.3

In the case of Bulk Product with a Non-conformity that is a Latent Defect, Aimmune shall promptly, and in no event more than [***] ([***]) [***] after discovery or notification of such Latent Defect, notify CoreRx of such Latent Defect. The remedies for Bulk Product with a Latent Defect shall be as set forth in Section 8.2.5 below.

8.2.4

CoreRx shall reasonably cooperate with Aimmune to determine whether any Lot that is a Defective Product is attributable to CoreRx’s failure to adhere to the requirements of the Product Specifications, compliance with the Quality Agreement, this Agreement including CoreRx’s warranties under Section 5.1 hereof or Applicable Law.

8.2.5

If the Bulk Product contains a Non-conformity or Latent Defect, but it is determined under the Quality Agreement that such Non-conformity or Latent Defect is due [***] caused by Aimmune or its agents or is due [***], then CoreRx shall have no liability to Aimmune with respect thereto, and Aimmune shall promptly pay CoreRx for the Bulk Product per the pricing defined in Schedule A of this Agreement.  If the Non-conformity or Latent Defect is otherwise caused by CoreRx, then CoreRx shall promptly, at [***] option, either (a) [***], or (b) [***] and [***].  In addition, regardless of whether [***] chooses a [***], CoreRx will also promptly reimburse Aimmune for (x) the cost of [***], (y) the cost [***] and (z) the [***]. The number of Defective Product Lots shall [***] and [***], even if [***] elects [***] under clause (a).

8.2.6

Any dispute between the Parties regarding whether a Lot of Bulk Product is a Defective Product shall be resolved by discussion between the Parties, and absent resolution, discussion between senior executives of each Party.  If the dispute is still not resolved, the Parties agree that the matter will be resolved by an independent expert to be agreed upon by the Parties, who shall have at least [***] ([***]) years of experience in the pharmaceutical manufacturing industry. The decision of such expert will be binding on both Parties.

8.2.7

The fees of the expert will be borne by CoreRx if the Bulk Product in dispute is deemed by the expert to be Non-conforming and such Non-conformity is [***] to CoreRx.  The fees of the expert will be borne by Aimmune if the Bulk Product in dispute is not deemed by the expert to be Non-conforming, or where such Non-conformity is [***] to CoreRx. The Party that is obligated to pay the fees of the expert will also pay the costs, if any, incurred by the other Party for third-party testing, packaging and/or shipping.

8.2.8

In any case where either Party possesses Bulk Product that such Party knows or suspects is a Defective Product, such Party shall not dispose of such Defective Product without written authorization and instructions of the other Party to either dispose of the Defective Product or to return the Defective Product to the other Party.

ARTICLE 9:  

PRICE; TAXES; INVOICES; METHOD OF PAYMENT; ANNUAL RECONCILIATION

9.1

Product Price Schedule; Release Testing Price Schedule.

9.1.1

All Product manufactured under this Agreement will be priced according to the Product Price schedule set forth in Schedule A. All Product that is Release Tested

by CoreRx under this Agreement will be priced according to the Release Testing price schedule set forth in Schedule A.

9.1.2

The pricing in Schedule A shall be adjusted annually [***], beginning with start of the second Contract Year.  

9.1.3

In addition, starting [***] Aimmune shall pay to CoreRx in accordance with Section 9.1.4 the difference between (a) the total Supplier Readiness Fee per calendar quarter and (b) the total amount invoiced for that calendar quarter, including fees pursuant to any FTE agreement and analytical personnel, between CoreRx and Aimmune, as well as any other separately invoiced items that comprise the Supplier Readiness Fee. [***]. If the amount invoiced in a particular calendar quarter exceeds the number required to cover the Supplier Readiness Fee for that calendar quarter, Aimmune will not owe any Supplier Readiness Fee for that particular quarter.

9.1.4

CoreRx shall provide an accounting of the quarterly Supplier Readiness Fee on a quarterly basis no later than the [***] ([***]) day of the next quarter. If the accounting shows that Aimmune is required to pay a Supplier Readiness Fee for a particular quarter, then CoreRx shall send an invoice to Aimmune along with the accounting document. All such invoices shall be payable in accordance with Section 9.4.

9.1.5

No later than the [***] ([***]) day from the end of each Contract Year, CoreRx shall provide a detailed accounting to Aimmune showing (a) the actual amount invoiced to Aimmune under this Agreement for each quarter of such Contract Year, (b) the annual value of the Supplier Readiness Fee and (c) all quarterly Supplier Readiness Fees paid by Aimmune in such Contract Year.  If the [***] exceeds the [***], then [***] will [***] by [***].  [***] will be [***], and [***] the [***]. If Aimmune disagrees with a quarterly or annual accounting, then the Parties agree to cooperate and discuss in good faith to reach a prompt and reasonable resolution.

9.1.6

From time to time, [***] may [***] with [***].  As part of the [***], the Parties agree to [***] in a manner that [***], taking into account the [***].

9.2

Taxes.  

9.3

Invoices.

9.3.1

Product Processed and Dispositioned for Release.  For all Bulk Product Processed and Dispositioned for Release by CoreRx in accordance with this Agreement, the Quality Agreement, and Section 8.1 above, CoreRx may invoice Aimmune for the Product Price for such Bulk Product once Dispositioned for Release, irrespective of whether after such Disposition for Release the Bulk Product is warehoused at CoreRx or shipped by CoreRx to Aimmune or its designee. CoreRx will invoice for the Unit Cost of the actual Bulk Yield listed in the Product Price in Schedule A. CoreRx shall provide any invoice hereunder to Aimmune to the attention of Aimmune Accounts Payable via email ([***]) referencing the Aimmune PO number, with a copy to the attention of Aimmune’s [***].  Invoices will be due net [***] ([***]) days after receipt of invoice.

9.3.2

Order Shortfalls.  If the number of Lots in a given [***] of a Purchase Order is less than the [***] Manufacturing Firm Amount for such [***], then the difference between the number of Lots for that [***], as set out in the Purchase Order and in the [***] Manufacturing Firm Amount, represents an “Order Shortfall”. If Aimmune fails, within that same month, to order additional Lots in an aggregate quantity sufficient to eliminate the Order Shortfall, then Aimmune shall pay CoreRx an amount [***] “Order Shortfall Payment” and such amount, the “Order Shortfall Amount”).  Aimmune shall pay to CoreRx the full amount of the Order Shortfall Amount in one (1) lump sum payment net [***] ([***]) days after receipt of invoice for such Order Shortfall Payment, provided that CoreRx has invoiced Aimmune no earlier than the [***] day of the month following the month in which the Order Shortfall occurs. Further, Aimmune shall include additional Lots within future Purchase Orders, to be manufactured in months 3, 4, or 5 of the Firm Manufacturing Commitment following the Order Shortfall, so as to cancel out such Order Shortfall.

9.4

Payment Procedure.  

9.5

Monthly Reporting.

9.6

Inventory and Physical Asset Counts.

ARTICLE 10:  

RECORDS; AUDITS; REGULATORY MATTERS; RECALLS  

10.1

Production Records.  

10.2

Recordkeeping.  

10.3

Quality Audits and Inspections.

10.4

Representatives for Inspection of Processing and Release Testing.  

10.4.1

Quality.  Aimmune may [***] representatives at the Facility to [***] that portion of the CoreRx Facility where Product is manufactured or stored, or to review Product documents as reasonably necessary. Such Aimmune representatives shall liaise with CoreRx regarding technical issues pursuant to the Quality Agreement, including but not limited to compliance matters associated with Batch Records, cGMP Regulations, Raw Material Specifications, Peanut Flour Specification, Product Specification, Applicable Laws, Environmental Laws, and Process Requirements. Such Aimmune representatives may provide input and advice to CoreRx personnel based on their observation of Processing and/or Release Testing, and may, commensurate with their authority, grant approvals, or take other actions required by the Quality Agreement.

10.4.2

Governmental Inspections. Aimmune may [***] representatives at the Facility for any governmental inspections as outlined in Section 10.3 with reasonable prior written notice to CoreRx (email acceptable) to be available for consultation as

needed during such inspection.  Aimmune’s representatives may elect to be on-site for consultation only during a regulatory inspection specifically related to Aimmune’s Peanut Flour or Product.  Direct interaction with Regulatory Authorities during inspection of the Commercial Facility, Warehouse, and Testing Facility shall be the sole responsibility of CoreRx personnel; provided that CoreRx shall notify Aimmune prior to sending any responses to any Regulatory Authorities that implicates in any way the Product and Aimmune shall have the right to review and suggest changes to such responses, in advance in writing, such approval of changes not to be unreasonably withheld or delayed or conditioned by CoreRx with regard to incorporating such reasonable Aimmune comments. CoreRx will have final say on responses sent to any Regulatory Authority with regard to inspection of CoreRx.  Aimmune shall indemnify and hold harmless CoreRx for any action or activity of such Aimmune representatives while on CoreRx’s premises, except to the extent arising from CoreRx’s negligence, willful misconduct or breach of this Agreement.

10.4.3

[***].

10.5

Governmental Inspections and Requests.  

10.6

Quality Agreement.  

10.7

Recall.  

10.7.1

In the event CoreRx believes a recall from the market, field alert, Product withdrawal, withdrawal from clinical testing or field correction (“Recall”) may be necessary with respect to any Product provided under this Agreement, CoreRx shall promptly, within [***], notify Aimmune in writing.  CoreRx will not act to initiate a Recall without the express prior written approval of Aimmune. In the event Aimmune believes a Recall may be necessary with respect to a Product provided under this Agreement, Aimmune shall immediately notify CoreRx in writing and CoreRx shall provide all necessary cooperation and assistance to Aimmune.

10.7.2

CoreRx and Aimmune shall fully cooperate regarding any proposed Recall; and the Parties agree to keep each other advised, and to exchange copies of such documentation as may be required to assure regulatory compliance. Any decision for a Recall and all communications with the Regulatory Authorities relating to any such Recall, shall be the sole responsibility of, and under the control of, Aimmune.  Aimmune shall be responsible for coordinating all necessary activities relating to a potential Recall.  The Quality Agreement will set forth in detail each Party’s obligations in the event of a Recall.  Aimmune acknowledges and understands that CoreRx, as manufacturer of the Bulk Product, has significant regulatory obligations and each Party shall only act consistent with such obligations in connection with such Recall.  

10.7.3

Except as provided in Section 10.7.4 below, CoreRx shall bear the cost of, and shall reimburse Aimmune for all direct costs and expenses of Aimmune and of any Aimmune agents, contractors, Affiliates, licensees, sublicensees, co-marketers, co-promoters and distributors incurred in connection with any Recall related to the Product, including but not limited to [***] in the event such Recall is [***] by (a) negligence or willful misconduct of CoreRx (or any of its directors, officers, employees agents or Affiliates); or (b) supply by CoreRx of Bulk Product that does not comply with (w) this Agreement, (x) the Quality Agreement; (y) with the Product Specifications in effect at the time the Bulk Product was Processed; or (z) Applicable Laws.

10.7.4

Aimmune shall bear the cost of and shall reimburse CoreRx and any of its agents, contractors, Affiliates, and distributors costs and expenses incurred in connection with any Recall related to the Product, including but not limited [***] in the event such Recall is [***] by (i) Aimmune’s negligence or willful misconduct, (ii) the acts or omissions of any Third Party except those contractors or vendors selected by CoreRx, (iii) the use of Artwork, Peanut Flour or other Aimmune Materials that do not comply with this Agreement, the Quality Agreement or Applicable Law, (iv) [***], or (v) [***].

10.7.5

If each Party contributes to the cause for a Recall, [***].  Aimmune shall give CoreRx prompt written notice of any Product Recalls that Aimmune believes were caused or may have been caused in whole or in part by CoreRx’s failure to comply with this Agreement or the Product Specifications.  

ARTICLE 11:  

QUALIFICATION/VALIDATION; PLI READINESS

11.1

Qualification.  

11.2

PLI Readiness.

ARTICLE 12:  

TERM; TERMINATION

12.1

Initial Term.  

12.2

Renewal Term.

12.3

Termination by Mutual Agreement.  

12.4

Termination for Default.  

12.5

Regulatory.

12.5.1

If [***] is delayed by more than [***] ([***]) months due [***] or due [***], this delay shall be considered an incurable material breach of this Agreement, entitling Aimmune to terminate this Agreement in accordance with Section 12.4. Notwithstanding the foregoing, in the event of [***] because [***], Aimmune will not be entitled to terminate in relation to the PLI failure pursuant to Section 12.4 of this Agreement.

12.5.2

If Aimmune receives a [***], and if the [***] is [***] to [***], then Aimmune may terminate this Agreement effective immediately upon notice in writing to CoreRx.  

12.5.3

Notwithstanding the provisions of Sections 12.5.1 and 12.5.2, if the [***] in Section 12.5.1 or the [***] are due [***], and [***] less than [***] ([***]) months prior to the event that would otherwise have permitted Aimmune to terminate the Agreement under Sections 12.5.1 or 12.5.2, then Aimmune’s right to terminate the Agreement in such circumstance will not apply.  

12.6

Bankruptcy; Insolvency.  

12.6.1

The entry of a decree or order for relief by a court having jurisdiction in respect of the other Party in an involuntary case under the Federal Bankruptcy Code, as now constituted or hereafter amended, or under any other applicable federal or state insolvency or other similar law and the continuance of any such decree or order unstayed and in effect for a period of sixty (60) consecutive days; or

12.6.2

The filing by the other Party of a petition for relief under the Federal Bankruptcy Code, as now constituted or hereafter amended, or any other applicable federal or state insolvency or other similar law.

12.7

Low Yield.  

12.8

Unilateral Termination by Aimmune.

12.8.1

AR101 is not approved by the FDA on or before [***]; or

12.8.2

Aimmune discontinues development or commercialization of AR101 in the United States [***] in the United States.

12.9

Expiration; Termination; Consequences.

12.9.1

Options After Expiration or Termination by Aimmune. In the event that Aimmune terminates this Agreement other than pursuant to Section 12.4, then upon such termination, CoreRx shall Process, Release Test if requested by Aimmune, and ship, and Aimmune shall purchase in accordance with the provisions hereof, any and all amounts of Bulk Product ordered via Purchase Order by Aimmune hereunder prior to the date on which such notice is given. In such case, Aimmune shall pay CoreRx for the amount of any Bulk Product produced pursuant to such Purchase Order and for the value of the Raw Materials purchased in reasonable expectation of the Firm Commitment prior to the date of notification of termination.  These reasonable expenses for the Bulk Product shall not exceed [***], and CoreRx shall, in good faith, make prompt and reasonable efforts to reduce any avoidable costs.  Aimmune shall also compensate CoreRx for all other reasonable uncancellable commitments made by CoreRx to satisfy then-outstanding Purchase Orders or Firm Commitments, and [***], net of invoiced amounts charged to Aimmune.

12.9.2

On termination or expiration of this Agreement by Aimmune, Aimmune shall also have the option, subject to Section 12.9.1, to either (a) cease Processing of Bulk Product at the Facility and Warehouse or (b) [***]. CoreRx shall take reasonable measures to cease any ongoing Processing of Bulk Product and limit further expenses associated with such ongoing Processing.  

12.9.3

In the event that Aimmune ceases production of Bulk Product, CoreRx shall promptly return any remaining inventory of Peanut Flour, Product, Bulk Product or any other material being stored for Aimmune, to Aimmune or its designee at Aimmune’s cost and expense.  CoreRx shall either, at Aimmune’s option and cost and expense, (i) ship all any such remaining inventory of Peanut Flour, Product, Bulk Product or any other material to Aimmune as set forth in this Agreement or

(ii) allow Aimmune reasonable access to the Facility or other pre-approved CoreRx facility, as Aimmune requires, to remove such Peanut Flour, Product, Bulk Product or any other material.  

12.9.4

Removal of Equipment.  Upon expiration or any termination of this Agreement, the Parties shall within [***] ([***]) days agree on a procedure which allows Aimmune to gain reasonable access to the ML3 Facility, as Aimmune requires, to remove any Equipment that is owned by Aimmune from the ML3 Facility (with Aimmune paying all reasonable costs to access and remove such Equipment) or offer CoreRx to purchase such Equipment from Aimmune by paying Aimmune the depreciated book value thereof (calculated on a straight-line basis).

12.9.5

Purchase of Materials.  Upon termination of this Agreement by CoreRx under Section 12.4 or by Aimmune under Section 12.8, at CoreRx’s option, Aimmune [***] purchase from CoreRx (i) at CoreRx’s Acquisition Cost, all Raw Materials and other materials acquired by CoreRx hereunder, subject to the limitations set forth in Section 4.4 above, (ii) all work-in-progress for the Bulk Product at CoreRx’s cost, and (iii) all other finished Bulk Product then in CoreRx’s possession at the applicable Product Price under this Agreement; and (iv) Aimmune shall compensate CoreRx for all other reasonable uncancellable commitments made by CoreRx to satisfy then-outstanding Purchase Orders or Firm Commitments.  Notwithstanding the foregoing, if any applicable cancellation penalty amount is less than an actual expense for such commitment (including restocking fees for returnable materials), Aimmune shall be required to reimburse CoreRx solely for the amount of the cancellation penalty rather than for the applicable expense.

12.9.6

Accrued Rights/Obligations/Survival.  Termination or expiration of this Agreement for any reason shall be without prejudice to any rights, which shall have accrued to the benefit of either Party prior to such termination or expiration, and shall not relieve either Party from any of its obligations (including payment obligations) which shall have accrued prior to such termination or expiration.  The following Articles and Sections shall survive expiration or any termination of this Agreement:  Articles 1, 10, 13, 14, 15, 17, 18 and 19; and Sections 5.3.5, 5.4, 9.4 and 12.9.

12.9.7

Other Obligations.  Upon expiration or termination of this Agreement, Aimmune shall have the right to require CoreRx to transfer manufacturing documentation (except those required to be maintained and stored by CoreRx by law) that CoreRx has used in its performance of this Agreement.  CoreRx shall promptly provide to Aimmune copies of any such manufacturing documentation that CoreRx maintains or stores. Commencing promptly upon the effective date of expiration or termination of this Agreement, CoreRx shall transfer to Aimmune and/or its

designated alternative supplier(s) of Bulk Product copies of the most current versions of all such materials, regulatory and manufacturing documentation then at CoreRx, and shall make CoreRx’s personnel and other resources reasonably available, at Aimmune’s cost, as necessary to effect an orderly transfer to Aimmune or such alternative supplier(s), in each case subject to any restrictions or limitations owed by CoreRx to any Third Parties.  In the event that such documentation referenced in this paragraph include any CoreRx Background IP, CoreRx hereby grants to Aimmune under CoreRx’s Background IP a non-exclusive, worldwide, fully paid up, royalty-free, cancellable, perpetual license solely to use such documentation to Process and Test Bulk Product; provided that Aimmune shall reimburse CoreRx for any payments due for any Third Party components or Intellectual Property incorporated therein or necessary to use such documentation.

12.9.8

Exclusivity.  During the Term of this Agreement and for a period of [***] ([***]) years following the expiration or termination of this Agreement, CoreRx agrees that, other than pursuant to this Agreement, it will not [***], without the [***]: (a) [***] any [***] product for (i) the [***], or (ii) the [***] for which [***] to [***] product; or (b) [***] (collectively, “[***]”) any [***] product for (i) the [***], or (ii) the [***] for which [***] to [***] product. In addition, during the Term of this Agreement, CoreRx agrees that, other than pursuant to this Agreement, it will not [***], without the [***]: (a) [***] any [***] product for the [***], so long as such [***] appears on Schedule H hereof; or (b) [***] any [***] product for the [***], so long as such [***] appears on Schedule H hereof. [***].  CoreRx agrees that its employees, contractors, officers and directors will (a) remain subject to the restrictions set forth in this Section 12.9.8 after the closing of any such acquisition and (b) not share with or disclose to, or use on behalf of, the acquiring entity any Confidential Information, Agreement Inventions or Work Product related to the Product or the Processing or Release Testing of the Product.  

ARTICLE 13:  

INDEMNIFICATION; LIMITATION OF LIABILITY

13.1

Indemnification by Aimmune.  

13.2

Indemnification by CoreRx.  

13.3

Indemnification Procedures.  

13.4

Survival of Indemnification and Limitation of Liability Obligations.  

13.5

Limitation of Liability.  

ARTICLE 14:  

CONFIDENTIALITY

14.1

Confidentiality and Non-Use.  

14.2

Access to Confidential Information.  

14.3

Exceptions to Confidential Information.  

14.3.1

information which the Receiving Party can demonstrate by competent evidence was in the public domain when disclosed by the Disclosing Party to the Receiving Party hereunder, or subsequently becomes publicly known through no act or failure to act on the party of the Receiving Party in breach of this Article 14;

14.3.2

information that the Receiving Party can establish by competent evidence was already known by the Receiving Party prior to the time of disclosure by the Disclosing Party and was not acquired by the Receiving Party, directly or indirectly, from the Disclosing Party;

14.3.3

information that the Receiving Party lawfully receives from a Third Party; provided, however, that such Third Party was not obligated to hold such information in confidence; or

14.3.4

information that was independently developed by the Receiving Party without reference to or any other use of any Confidential Information of the Disclosing Party, as established by as evidenced by written records.

14.4

Return.

14.5

Enforcement.  

14.6

Permitted Disclosures.  

14.6.1

is required under a valid order of a court or other governmental body to which the Receiving Party is subject, provided that to the extent practicable (i) the Receiving Party shall have first given written notice to the Disclosing Party of the need for

such disclosure reasonably in advance so that the Disclosing Party may (if it elects) seek a protective order or other confidential treatment of its Confidential Information, and (ii) the Receiving Party shall limit the scope of disclosure of Confidential Information of the Disclosing Party to that reasonably necessary to comply with such applicable law, regulation or court order; or

14.6.2

is necessary for the Receiving Party to conduct financings, to file or prosecute patent applications, to prosecute or defend litigation, to comply with Applicable Laws (including without limitation securities laws, cGMP Regulations, the FDCA or regulations promulgated thereunder), to prepare or submit any filings with any Regulatory Authority relating to the Product or its Processing and Release Testing (including any BLA or MAA), to prepare for or undergo any inspections (including a PLI) by any Regulatory Authorities for the Product, to make any filing with the Securities and Exchange Commission or the securities regulators of any state or other jurisdiction or otherwise to establish rights or enforce obligations under this Agreement, but only to the extent that any such disclosure is reasonably necessary.

14.6.3

In the event either Party proposes to file with the Securities and Exchange Commission or the securities regulators of any state or other jurisdiction a registration statement or any other disclosure document which describes, discloses or refers to this Agreement under the Securities Act of 1933, as amended, the Securities and Exchange Act of 1934, or any other applicable securities law, such Party shall notify the other Party of such intention and shall provide, to the extent practicable, such other Party with a copy of relevant portions of the proposed filing reasonably prior to such filing (and any revisions to such portions of the proposed filing a reasonable time prior to the filing thereof), including without limitation any exhibits thereto, and shall use reasonable efforts to seek confidential treatment of any information concerning such other Party to the extent consistent with such Party’s disclosure obligations under applicable securities laws.

14.7

Confidentiality of Agreement.