Full Press Release Details
Certain identified information has been excluded from this document because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| Article 1 Interpretation | 1 |
| Article 2 Grant of Rights | 13 |
| Article 3 Restrictions | 17 |
| Article 4 Joint Development Committee | 19 |
| Article 5 Technology Transfer | 21 |
| Article 6 Development | 22 |
| Article 7 Commercialization | 24 |
| Article 8 Manufacturing | 24 |
| Article 9 Payments and Accounting | 25 |
| Article 10 Intellectual Property | 30 |
| Article 11 Enforcement of Patent Rights | 32 |
| Article 12 Warranties and Covenants | 34 |
| Article 13 Confidentiality | 38 |
| Article 14 Indemnification | 41 |
| Article 15 Term and Termination | 42 |
| Article 16 Consequences of Termination | 43 |
| Article 17 Dispute Resolution | 46 |
| Article 18 Miscellaneous | 48 |
Certain identified information has been excluded from this document because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| Riptide Aurinia Collaboration License Agreement Table of Contents | |
| Article 1 Interpretation | 1 |
| 1.1 Definitions | 1 |
| 1.2 Headings | 13 |
| 1.3 No Strict Construction | 13 |
| 1.4 Exhibits | 13 |
| 1.5 Certain References | 13 |
| Article 2 Grant of Rights | 13 |
| 2.1 License | 13 |
| 2.2 Sublicenses | 14 |
| 2.3 Expansion of the Field | 14 |
| 2.4 Riptide's Exclusivity in CD206 Peptide Therapeutics Outside the Field | 15 |
| 2.5 No Additional Rights | 17 |
| 2.6 Third-Party Performances of Aurinia Activities | 17 |
| Article 3 Restrictions | 17 |
| 3.1 Restrictions on Aurinia | 17 |
| 3.2 Restrictions on Riptide | 18 |
| 3.3 Consequences of Acquisitions | 18 |
| 3.4 Protected Operations | 19 |
| Article 4 Joint Development Committee | 19 |
| 4.1 Joint Development Committee Chair Minutes | 19 |
| 4.2 Meetings of the JDC | 19 |
| 4.3 Responsibilities of the JDC | 20 |
| 4.4 Duration of the JDC | 20 |
Certain identified information has been excluded from this document because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
| 4.5 Areas Outside the JDC's Authority | 20 |
| 4.6 Aurinia Authority for Decisions | 20 |
| Article 5 Technology Transfer | 21 |
| 5.1 Initial Transfer | 21 |
| 5.2 Ongoing Information Transfer | 21 |
| 5.3 Development Cooperation and Assistance | 21 |
| 5.4 Riptide's Indication Research Activities | 21 |
| 5.5 Expense of Tech Transfer and Research | 22 |
| Article 6 Development | 22 |
| 6.1 Development Activities | 22 |
| 6.2 Development Costs | 22 |
| 6.3 Primary Indication | 22 |
| 6.4 Secondary Indication | 23 |
| 6.5 Development Reports | 23 |
| 6.6 Ownership of Regulatory Approvals | 23 |
| 6.7 Development Diligence Safe Harbor | 23 |
| Article 7 Commercialization | 24 |
| 7.1 Commercialization Activities | 24 |
| 7.2 Primary Indication | 24 |
| 7.3 Commercialization Costs | 24 |
| Article 8 Manufacturing | 24 |
| 8.1 Assumption of Manufacturing | 24 |
| 8.2 Manufacturing Cooperation and Assistance | 24 |
| Article 9 Payments and Accounting | 25 |
| 9.1 Milestone Payments | 25 |
| 9.2 Provisions Applicable to all Milestone Events | 26 |
| 9.3 Royalties on Net Sales | 26 |
| 9.4 Payments and Reports | 27 |
| 9.5 Blocked Currencies | 27 |
| 9.6 Generic Competition | 27 |
| 9.7 Anti-Stacking | 27 |
| 9.8 Compulsory Licenses | 28 |
| 9.9 Royalty Term | 28 |
| 9.10 Payments in United States Dollars | 28 |
| 9.11 Late Payment | 28 |
| 9.12 Taxes | 29 |
| 9.13 Records Audits | 29 |
| Article 10 Intellectual Property | 30 |
| 10.1 Ownership | 30 |
| 10.2 Modifications | 30 |
| 10.3 Licensed Patents Prosecution | 30 |
| 10.4 Abandonment and Assumption | 30 |
| 10.5 Option for Assumption of Prosecution | 31 |
| 10.6 Consultation in Prosecution | 31 |
| 10.7 Cooperation | 31 |
| 10.8 Patent Term Extensions | 32 |
| 10.9 Costs of Prosecution | 32 |
| 10.10 Aurinia Trademarks | 32 |
| Article 11 Enforcement of Patent Rights | 32 |
| 11.1 Notice | 32 |
| 11.2 Invalidation Proceedings | 32 |
| 11.3 Infringement Actions | 33 |
| 11.4 Collaboration | 33 |
| 11.5 Allocation of Recovery | 34 |
| 11.6 Enforcement of Other Government-Conferred Rights | 34 |
| 11.7 Infringement of Third Party Patents or Know-How | 34 |
| Article 12 Warranties and Covenants | 34 |
| 12.1 Warranties of the Parties | 34 |
| 12.2 Warranties of Riptide | 35 |
| 12.3 Warranty Limitation | 38 |
| 12.4 Existing License | 38 |
| Article 13 Confidentiality | 38 |
| 13.1 Treatment of Confidential Information | 38 |
| 13.2 Exceptions | 39 |
| 13.3 Authorized Disclosures | 39 |
| 13.4 Press Release Public Disclosures | 40 |
| 13.5 Terms of the Agreement Confidential | 40 |
| 13.6 Termination of Prior Confidentiality Agreement and Certain Confidential Information | 40 |
| Article 14 Indemnification | 41 |
| 14.1 Indemnification by Aurinia | 41 |
| 14.2 Indemnification by Riptide | 41 |
| 14.3 Allocation of Responsibility | 42 |
| 14.4 Procedure | 42 |
| 14.5 Limitation of Liability | 42 |
| Article 15 Term and Termination | 42 |
| 15.1 Term | 42 |
| 15.2 Unilateral Early Termination by Aurinia | 42 |
| 15.3 Early Termination for Material Breach | 43 |
| Article 16 Consequences of Termination | 43 |
| 16.1 Partial Early Termination | 43 |
| 16.2 Effect of Any Early Termination | 43 |
| 16.3 Costs of Transition Activities | 44 |
| 16.4 Reasonable Royalty | 44 |
| 16.5 Rights on Riptide Bankruptcy | 45 |
| 16.6 Confidential Information | 45 |
| 16.7 Survival Accrued Rights | 46 |
| Article 17 Dispute Resolution | 46 |
| 17.1 Disputes | 46 |
| 17.2 Jurisdiction, Disputes and Arbitration | 46 |
| Article 18 Miscellaneous | 48 |
| 18.1 Amendments | 48 |
| 18.2 Assignment | 49 |
| 18.3 Counterparts | 49 |
| 18.4 Entire Agreement | 49 |
| 18.5 Fees and Expenses | 49 |
| 18.6 Force Majeure | 49 |
| 18.7 Further Assurances | 49 |
| 18.8 Governing Law | 50 |
| 18.9 Independent Contractors | 50 |
| 18.10 Notice | 50 |
| 18.11 Performance by Affiliates | 51 |
| 18.12 Severability | 51 |
This Riptide Aurinia Collaboration License Agreement (the "Agreement") is entered into as of August 16, 2021 (the "Effective Date"), by Aurinia Pharmaceuticals Inc., an Alberta corporation having offices at #1203-4464 Markham Street, Victoria, BC V8Z 7X8 Canada ("Aurinia") and Riptide Bioscience, Inc., a corporation duly organized and existing under the laws of Delaware, having offices at 941 Railroad Avenue, Vallejo, California 94592 USA ("Riptide"). Both Aurinia and Riptide are referred to individually as a "Party" and collectively as the "Parties."
A. Riptide has been developing the Licensed Peptide as an anti-fibrotic compound for the prevention and treatment of autoimmune and fibrotic diseases
B. Aurinia has acquired significant expertise within the area of drug development for autoimmune diseases and has recognized the potential for Licensed Peptide for the treatment of autoimmune and fibrotic indications and
C. Riptide grants to Aurinia the exclusive right to develop, market and promote the Product for the Field on all the terms and conditions set forth herein below.
NOW THEREFORE, the Parties agree as follows
Article 1 Interpretation
1.1.1 "$" means United States dollars.
1.1.2 "Acquirer" shall have the meaning set out in Section 3.3
1.1.3 "Additional Indication" has the meaning set out in Section 9.2.1.
1.1.4 "Affiliate" means (a) an entity that owns, directly or indirectly, a controlling interest in a Person, by stock ownership or otherwise, (b) any entity in which a Person owns a controlling interest, by stock ownership or otherwise, or (c) any entity under common control with a Person, directly or indirectly. For purposes of this paragraph, "controlling interest" and "control" mean ownership of fifty percent (50%) or more of the voting stock permitted to vote for the election of the board of directors or any other arrangement resulting in control of or the right to control the management and the affairs of the entity or Person in question.
1.1.5 "Agreement Wind-Down Period" shall have the meaning set out in Section 16.2.5.
1.1.6 "Annual Net Sales" shall have the meaning set out in Section 9.3.
Certain identified information has been excluded from this document because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
1.1.7 "Applicable Accounting Principles" means the accounting principles (including accounting methods, practices and procedures) used by a Person in the preparation of the financial statements of such Person applied consistently with historical practices and procedures. As of the Effective Date, Applicable Accounting Principles for Aurinia means generally accepted accounting principles as in effect in the United States of America.
1.1.8 "Applicable Law" means all laws, statutes, ordinances, codes, rules, and regulations that have been enacted by a Regulatory Authority or other government authority and which are in force as of the Effective Date or come into force during the Term, in each case to the extent that the same are applicable to the performance by the Parties of their respective obligations under this Agreement, including, with respect to the United States, the Prescription Drug Marketing Act, the Federal Food, Drug and Cosmetics Act of 1938, the Health Insurance Portability and Accountability Act, and including the European General Data Protection Regulation (Regulation (EU) 2016 679) and all other applicable data protection legislation and laws with respect to the collection, use, transfer, storage, deletion, processing (both by computer and manually), combination, or other use of subject or patient or other personal data, cGLP, cGCP and cGMP and laws or regulations of a Securities Authority, or for appropriate market disclosure.
1.1.9 "Auditor", "Audited Party" and "Auditing Party" shall each have the meaning set out in Section 9.13.1.
1.1.10 "Aurinia Indemnitees" shall have the meaning set out in Section 14.2.
1.1.11 "Aurinia Trademarks" means
(a) the corporate name(s) of Aurinia and its Affiliates, and their trade names, service marks, domain names, and associated logos and designs and
(b) the Aurinia brand name(s) to be used in connection with the Commercialization of the Product in the Field, and all other trademarks used by Aurinia or its Affiliates during the Term in connection with the marketing or sale of the Product in the Field in the Territory.
1.1.12 "Basket Trial" means the Clinical Trial that may involve studying the Product across multiple Indications or multiple disease states.
1.1.13 "Calendar Quarter" means each respective period of three (3) consecutive months ending on March 31, June 30, September 30, and December 31 provided that (a) the first Calendar Quarter of the Term shall begin on the Effective Date and end on the first to occur of March 31, June 30, September 30 or December 31 thereafter and the last Calendar Quarter of the Term shall end on the last day of the Term, and (b) the first Calendar Quarter of a Royalty Term for a Product shall begin on the First Commercial Sale of such Product in the Field and end on the first to occur of March 31, June 30, September 30 or December 31 thereafter and the last Calendar Quarter of a Royalty Term for a Product shall end on the last day of such Royalty Term.
1.1.14 "Calendar Year" means each respective period of twelve (12) consecutive months ending on December 31 provided that (a) the first Calendar Year of the Term shall begin on the Effective Date and end on the first December 31 thereafter and the last Calendar Year of the Term shall end on the last day of the Term, and (b) the first Calendar Year of a Royalty Term for a Product shall begin on the First Commercial Sale of such Product in the Field and end on the first December 31 thereafter and the last Calendar Year of a Royalty Term for a Product shall end on the last day of such Royalty Term.
1.1.15 "cGCP" means all current good clinical practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of Clinical Trials, including, as applicable (a) ICH Harmonized Tripartite Guideline for Good Clinical Practice (CPMP ICH 135 95) (b) FDA regulations and guidelines for good clinical practice, as promulgated by the FDA 21 CFR Parts 50, 54, 56 and 312 (c) European Commission Directive 2001 20 EC, brought into law by European Commission Directive 2005 28 EC, and related guidelines and (d) any amendments, updates or clarifications with respect to any of the foregoing and any equivalents thereto in the country in which Clinical Trials of the Product are conducted.
1.1.16 "cGLP" means all current good laboratory practice standards, including, as applicable (a) FDA regulations and guidelines for good laboratory practice, as promulgated by the FDA under 21 CFR Part 58 (b) European Commission Directive 2004 10 EC relating to the application of the principles of good laboratory practices and (c) any amendments, updates or clarifications with respect to any of the foregoing and any equivalents thereto in the country in which Non-clinical studies of Licensed Peptide or Clinical Trials of the Product are conducted.
1.1.17 "cGMP" means all applicable current good manufacturing practices, including, as applicable (a) the applicable part of quality assurance to ensure that products are consistently produced and controlled in accordance with the quality standards appropriate for their intended use, as defined in European Commission Directive 2003 94 EC laying down the principles and guidelines of good manufacturing practice (b) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 CFR Parts 210 and 211 (c) the Rules Governing Medicinal Products in the European Community, Volume IV Good Manufacturing Practice for Medicinal Products (d) the principles detailed in the ICH Q7A guidelines (e) the guidelines of good manufacturing control and quality control based on the requirements of the Pharmaceuticals and Medical Devices Act of Japan and (f) any amendments, updates or clarifications with respect to any of the foregoing and any equivalents thereto in the country in which Licensed Peptide or any Product is Manufactured.
1.1.18 "Claims" shall have the meaning set out in Section 14.1.
1.1.19 "Clinical Trial" means a Phase Ia Clinical Trial, a Phase Ib Clinical Trial, a Phase II Clinical Trial, a Phase III Clinical Trial or a Phase IV Clinical Trial.
1.1.20 "Commercialize" means any and all activities relating to the commercialization of the Product, including the promotion, detailing, distribution, sale (including launch), offer
for sale, securing reimbursement and patient access, marketing (including pre-launch and launch, as well as advertising activities), promotion, storage, transportation, and importation of the Product and, after Regulatory Approval of the Product in respect of any country, pharmacovigilance in respect of such country, but shall not extend to Development or Manufacture of the Product. "Commercialize" and "Commercializing" shall have their corresponding meanings.
1.1.21 "Commercially Reasonable Efforts" means with respect to each Party, commercially reasonable efforts and resources as typically used by such Party in its reasonable business, legal, medical and scientific judgment, and in accordance with the efforts and resources such Party would use for a product owned by it or to which it has rights (or if the Party does not engage in that activity for other products or compounds, by biotechnology and or pharmaceutical companies that are similar in size), which is of similar market potential, at a similar stage in its product life, taking into account the competitiveness of the marketplace, the proprietary position of the product (including patent coverage and regulatory exclusivity), the regulatory considerations involved, the market potential and profitability of the product and all other relevant factors, including the timeliness of such efforts. It is anticipated that the level of effort will be different for different markets, and will change over time, reflecting changes in the status of the Product and the market(s) involved.
1.1.22 "Compulsory License" means a compulsory license under the Licensed Patents obtained by a Third Party through the order, decree, or grant of a Regulatory Authority authorizing such Third Party to manufacture, use, sell, offer for sale or import a product competitive with the Product in one or more countries within the Territory.
1.1.23 "Confidential Information" of a Party means all information and materials (including data, results, technical or economic information, and strategies for development and commercialization, intellectual property, regulatory communications, and financial information) disclosed by such Party (or its Affiliates and Representatives) to the other Party (or its Affiliates and Representatives) during the Term. "Confidential Information" of a Party also includes information deemed to be Confidential Information of such Party under this Agreement by operation of Section 13.6.
1.1.24 "Confidentiality Agreement" means the confidentiality agreement made and entered into as of the 4th day of February, 2021 between the Parties.
1.1.25 "Control" means, with respect to technology, information, know-how or patent or intellectual property rights, Regulatory Filings, or Regulatory Approvals, the possession by a Party of the right to grant access, a license or sublicense to such technology, information, know-how or patent or intellectual property rights or Regulatory Filings or Regulatory Approvals as provided herein, through ownership or otherwise, without violating the terms of any agreement with any Third Party and without violating any Applicable Law.
1.1.26 "Cover," "Covering" or "Covers" means as to a compound or product, a Patent, that, in the absence of a license granted under, or ownership of, such Patent, the making, using, selling, offering for sale or importation of such compound or product would infringe any Valid Claim of such Patent or, as to a pending claim included in such Patent, the making, using, selling, offering for sale or importation of such compound or product would infringe such Patent if such pending claim were to issue in an issued patent without modification, in each case, without regard to the validity or enforceability of such Patent.
1.1.27 "CRO" means a contract research organization.
1.1.28 "Debarred" shall have the meaning set out in Section 12.1.3.
1.1.29 "Developed Product" shall have the meaning set out in Section 2.
1.1.30 "Development Plan" means the preliminary outlines for a phase 1b study for the Product in the Primary Indication and a multiple ascending dose study for the Product in healthy volunteers, all as set out in Exhibit 1.1.30, as may be updated from time to time.
1.1.31 "Development" means, with respect to each Product, all non-clinical and clinical activities designed to obtain Regulatory Approval of such Product in accordance with this Agreement, including regulatory toxicology studies, statistical analysis and report writing, clinical trial design and operations, preparing and filing Regulatory Filings with any Regulatory Authority in the Territory, and all regulatory affairs related to the foregoing. "Developed" and "Developing" have their correlative meanings.
1.1.32 "Diagnostic" means any product or service for the diagnosis of a disease, condition, or state, or ascertaining the presence or absence of any anything.
1.1.33 "Disclosing Party" shall have the meaning set out in Section 13.1.
1.1.34 "Early Termination Date" shall have the meaning set out in Section 16.2.1.
1.1.35 "Existing License" means the Exclusive License Agreement dated and effective as of redacted between redacted and Riptide.
1.1.36 "Existing Sequences" means the sequences set out in Exhibit 1.1.36.
1.1.37 "FDA" means the United States Food and Drug Administration, or any successor organization.
1.1.38 "Field" means all human uses in redacted and redacted indications, as modified pursuant to Section 2.3.
1.1.39 "First Commercial Sale" means, on a country-by-country basis, the first sale of Product under this Agreement by Aurinia, its Affiliates or its Sublicensees to a Third Party in such country, after such Product has been granted Regulatory Approval in such country.
1.1.40 "FTE Rate" means with respect to Riptide employees, a rate of redacted per hour.
1.1.41 "Generic Product" means any product containing a Licensed Peptide not authorized by Aurinia, an Affiliate or Sublicensee and the marketing or sale of which is approved in reliance on the prior approval of a Product as determined by the applicable Regulatory Authority. Generic Product includes any pharmaceutical product obtained via a bioequivalence or bioavailability showing such as those covered by section 505(b)(2) or under 5050(j) of the U.S. Federal Food, Drug, and Cosmetic Act or an equivalent outside the United States.
1.1.42 "Homologous Sequence" shall have the meaning set out in Exhibit 1.1.53.
1.1.43 "IND" or "Investigational New Drug Application" means an investigational new drug application submitted to the FDA in respect of a new drug or its foreign equivalent.
1.1.44 "Indemnified Party" and "Indemnifying Party" shall have the meaning set out in Section 14.4.
1.1.45 "Indication" means any human disease or condition in the Field which can be treated, prevented, or cured or the progression of which can be delayed. The Parties agree that the treatment, control and or prevention of separate varieties of the same diseases or medical conditions and all variants of the same diseases or conditions, including separate stages or forms, regardless of the cause, severity, stage, grade, histology, disease spread, recurrence, regimen or route of administration, combination with other drugs, dosage strength, patient class, age or population for which Regulatory Approval is being sought and which will be referenced on any Product labeling, shall not be a separate Indication. Without limiting the generality of the foregoing, a new Indication requires an IND in the United States and at least one new Clinical Trial and a new NDA. For clarity, a supplemental NDA or an amendment to an existing NDA (or foreign equivalents) are not considered to be a new NDA.
1.1.46 "Infringement Action" shall have the meaning set out in Section 11.2.
1.1.47 "Invalidation Proceeding" shall have the meaning set out in Section 11.1.
1.1.48 "JAMS" means Judicial Arbitration and Mediation Services, Inc. or any successor thereto.
1.1.49 "JDC" or "Joint Development Committee" shall have the meaning set forth in Article 4.
1.1.50 "Knowledge" means with respect to a Party, the actual knowledge of such Party after reasonable inquiry.
1.1.51 "Licensed Know-How" means all present and future technology, knowledge and information Controlled by Riptide or its Affiliates and Useful for the Product in the Field as of the Effective Date or during the Term, whether or not patentable, including techniques, know-how, inventions, practices, formulations, specifications, processes,
techniques, discoveries, improvements, trade secrets, methods, methodologies, knowledge, skill, experience, data pertaining to Licensed Peptide or Product, or the Development or Manufacture of any Product, (including intellectual property, pharmacological, toxicological and clinical test data, analytical data, quality control and testing data, marketing and market research data and data contained in any Regulatory Filing), software, algorithms, promotional materials, assays and biological materials, including
(a) methods of manufacture or use of, and structural and functional information pertaining to, compounds
(b) compositions of matter, know-how and results (including any negative results) and
(c) all data and Regulatory Filings
in each case Controlled by Riptide or its Affiliates as of the Effective Date or during the Term that is Useful for the Development, Manufacture, Regulatory Approval or Commercialization of the Product, including the know-how listed in Exhibit 1.1.50. Riptide shall ensure that it Controls any know-how arising from the performance of its obligations under this Agreement, including Riptide's Indication research activities pursuant to Section 5.4.
1.1.52 "Licensed Patents" means all Patents that Cover the Licensed Peptide (including incorporation of the Licensed Peptide into any Product in the Field in the Territory) or the Development, Manufacture or Commercialization of the Product in the Field in the Territory that are Controlled by Riptide or its Affiliates as of the Effective Date or during the Term, including the Patents disclosing the Licensed Know-How. As of the Effective Date, the Licensed Patents include the Patents set forth on Exhibit 1.1.52 and "Licensed Patents" shall include any non-provisional patent applications that claim priority to any provisional patent applications listed in Exhibit 1.1.52 (iii) any and all any continuations, divisions or continuations-in-part that claim priority to the patent applications listed in Exhibit 1.1.52 (iv) any and all foreign patent applications, foreign patents or related foreign patent documents that claim priority to the patents and or patent applications listed in Exhibit 1.1.52 (v) any and all registrations, confirmations, divisionals, term restorations, continuations, reissues, re-examinations, renewals, substitutions, additions and extensions or any like filing and (vi) any and all patents issuing from the foregoing. Riptide shall ensure that it Controls any Patents arising from the performance of its obligations under this Agreement, including Riptide's Indication research activities pursuant to Section 5.4.
1.1.53 "Licensed Peptide" or " redacted " means a Peptide Therapeutic described in Exhibit 1.1.53.
1.1.54 "Licensed Technology" means the Licensed Patents and the Licensed Know-How.
1.1.55 "Major Market" means each of the United States, the United Kingdom, the European Union, China and Japan.
1.1.56 "Manufacture" means the storage, handling, assembly, fill, production, processing, labelling, testing, disposition, packaging and quality control of raw materials and components and the Product, the release and supply of the resulting Product. For clarity, Manufacturing shall include the manufacture of preclinical, engineering, validation, and clinical batches of Product. "Manufacturing" has a correlative meaning.
1.1.57 "MHRA" means the Medicines and Healthcare Products Regulatory Agency of the UK's Department of Health, or any successor organization.
1.1.58 "Modifications" shall have the meaning set out in Section 10.2.
1.1.59 " redacted Reserved Sequences" means peptides redacted , which, as of the Effective Date, are subject to the Existing License, each as further described below
| Peptide | Sequence |
| redacted | redacted |
| redacted | redacted |
| redacted | redacted |
1.1.60 "NDA" means (a) a New Drug Application submitted to the FDA pursuant to 21 U.S.C. Section 355(b)(1), and or Section 355(b)(2) or any successor application or procedure and (b) all supplements and amendments, including supplemental New Drug Applications that may be filed with respect to the foregoing.
1.1.61 "Negotiation Period" shall have the meaning set out in Section 16.2.5.
1.1.62 "Net Sales" means the gross amount invoiced for sales of the Product in the Territory in the Field by Aurinia, its Affiliates, and their respective Sublicensees (each, a "Selling Person") to Third Parties that are not Affiliates or Sublicensees of the Selling Person (except where such Affiliates or Sublicensees are end users), less the following items, as allocable to the Product (if not previously deducted from the amount invoiced or separately invoiced) and each as consistently applied by Aurinia to its products (a) the amounts actually allowed as trade, volume, quantity or cash discounts, commissions, retroactive price adjustments, and any other allowances that effectively reduce the net selling price (b) rebates (including mandatory rebates, price reductions, rebates to social and welfare systems, clawbacks, chargebacks or reserves for chargebacks, cash rebate incentives, government mandated rebates and similar types of rebates, granted or credited to any governmental Authority or pricing authority, including governmental agencies, reimbursers and purchasers, or to any Third Party payor, administrator, purchaser, including trade customer, or contractee, including managed health care organizations and pharmacy benefit managers (or equivalents thereof), and including those requested by any governmental authority or pricing authority any time after the actual sale of a Product, for example,
Pharmaceutical Price Regulation Scheme, Medicaid), (c) returns and return reserves, if applicable (including allowances actually given for spoiled, damaged, out-dated, rejected, or returned Product, withdrawals and recalls), rejections, defects, price adjustments, billing errors, or trial prescriptions, including amounts repaid, discounted or credited by reason of risk sharing schemes with respect to the Product with any governmental authority or pricing authority (d) costs of freight, carrier insurance, and other transportation charges paid to wholesalers or otherwise related to the distribution of such Product (e) taxes, tariffs, duties or other government charges, including value added or sales taxes, consumption taxes or similar taxes, government mandated exceptional taxes and other taxes directly linked to the gross sales amount (other than income taxes) and (f) discounts paid under any discount prescription drug programs or reductions or coupon and voucher programs and (g) any other similar and customary deductions from gross invoiced amounts in accordance with Applicable Accounting Principles consistently applied by the Selling Person across all of its business. Such amounts shall be determined from the books and records of the Selling Person maintained in accordance with Applicable Accounting Principles consistently applied and using the Selling Person's then-current standard procedures and methodology, including, in respect of each Sublicensee, notwithstanding Section 9.10, its then-current standard exchange rate methodology for the translation of foreign currency sales into U.S. Dollars. In addition, the Parties will discuss in good faith amendments to the foregoing deductions that may be permitted to be taken as appropriate on a country-by-country or region-by-region basis in accordance with Applicable Accounting Principles consistently applied by a seller. Notwithstanding the above, the following shall not be included in the computation of Net Sales the sale, distribution or supply of Product (a) as promotional or other samples, for use in non-clinical studies or Clinical Trials, or for use in any test or studies reasonably necessary to comply with any Applicable Laws or as is otherwise normal and customary in the industry or (b) for compassionate use, humanitarian and charitable donations, named-patient use, or expanded access, indigent or other patient access programs in each case so long as Seller does not receive payment for such Product. Net Sales shall exclude amounts invoiced for Products by any Compulsory Licensee. Where the Licensed Product is sold in combination with other pharmaceutical products, diagnostic products or active ingredients (collectively, "Combination Components"), Net Sales will be calculated by multiplying the Net Sales of the Combination Components by the fraction A (A+B), where A is the gross invoice price of the Licensed Product if sold separately in a country and B is the gross invoice price of the other product(s) included in the Combination Components if sold separately in such country. If no such separate sales are made by Aurinia, its Sublicensees in a country, Net Sales of the Combination Components will be calculated in a manner determined by Aurinia acting reasonably, based upon the relative value of the active components of such Combination Components. The weighted average sale price for a Combination Product shall be calculated no more than once each Calendar Year and such price shall be used during all applicable royalty reporting periods for the entire following Calendar Year.
1.1.63 "Option Period" shall have the meaning set out in Section 2.4.4.
1.1.64 "Out-of-Field Results" shall have the meaning set out in Section 2.4.2.
1.1.65 "Patents" means (a) unexpired letters patent (including inventor's certificates) in any country of the Territory that have not been held invalid or unenforceable by a court of competent jurisdiction from which no appeal can be taken or has been taken within the required time period, including any and all registrations, confirmations, divisionals, term restorations, continuations, reissues, re-examinations, renewals, substitutions, additions and extensions or any like filing thereof and (b) pending applications for letters patent in any country of the Territory, including any continuation, division or continuation-in-part thereof and any provisional applications.
1.1.66 "Peptide Therapeutic" means a polymer composed of 40 or fewer amino acids.
1.1.67 "Person" means any individual, corporation, limited liability company, trust, joint venture, association, company, limited or general partnership, unincorporated organization or other entity.
1.1.68 "Phase Ia Clinical Trial" means a clinical study of an investigational product in patients and or healthy volunteers with the primary objective of identifying the maximum tolerated dose of an investigational product, as further described in 21 CFR 312.21(a). The investigational product can be administered to patients as a single agent or in combination with other investigational or marketed agents.
1.1.69 "Phase Ib Clinical Trial" means a clinical study of an investigational product in patients and or healthy volunteers with the primary objective of characterizing its safety, tolerability and pharmacokinetics and identifying a recommended dose and regimen for future studies, as further described in 21 CFR 312.21(a). For clarity, an expansion cohort of a Phase I Clinical Trial shall be deemed a Phase Ib Clinical Trial. The investigational product can be administered to patients as a single agent or in combination with other investigational or marketed agents.
1.1.70 "Phase II Clinical Trial" means a clinical study of an investigational product in patients with the disease being studied that has the primary objective of establishing the safety and initial efficacy of a product as well as generating more detailed safety, tolerability, and pharmacokinetics information as described in 21 C.F.R. 312.21(b). For clarity, a Phase Ib Clinical Trial or expansion cohort of a Phase I Clinical Trial shall not be a Phase II Clinical Trial. The investigational product can be administered to patients as a single agent or in combination with other investigational or marketed agents.
1.1.71 "Phase III Clinical Trial" means a clinical study of an investigational product in patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to obtain Regulatory Approval in any country as described in 21 C.F.R. 312.21(c). The investigational product can be administered to patients as a single agent or in combination with other investigational or marketed agents.
1.1.72 "Phase IV Clinical Trial" means a post-registrational Clinical Trial conducted in any country or countries and required as a condition to, or for the maintenance of, any Regulatory Approval for a Product.
1.1.73 "Primary Indication" means redacted .
1.1.74 "Product" means finished product containing Licensed Peptide, in all formulations and presentations, including any improvements and alternate delivery mechanisms.