Full Press Release Details
CONFIDENTIAL TREATMENT REQUESTED: Certain portions of this document have been omitted pursuant to a request for confidential treatment and, where applicable, have been marked with an asterisk ("[***]") to denote where omissions have been made. The confidential material has been filed separately with the Securities and Exchange Commission.
Dated as of 6 June 2017
CONFIDENTIAL TREATMENT REQUESTED: Certain portions of this document have been omitted pursuant to a request for confidential treatment and, where applicable, have been marked with an asterisk ("[***]") to denote where omissions have been made. The confidential material has been filed separately with the Securities and Exchange Commission.
| ARTICLE 1 DEFINITIONS | 1 | ||
| ARTICLE 2 GRANT OF RIGHTS | 14 | ||
| 2.1. | Grants to Midatech | 14 | |
| 2.2. | Sublicenses | 14 | |
| 2.3. | Retention of Rights; Limitations Applicable to License Grants | 14 | |
| 2.4. | Grant to Novartis | 15 | |
| ARTICLE 3 DEVELOPMENT, REGULATORY AND COMMERCIALIZATION ACTIVITIES; REPRESENTATIVE | 15 | ||
| 3.1. | Development | 15 | |
| 3.2. | Regulatory Activities | 17 | |
| 3.3. | Commercialization | 18 | |
| 3.4. | Supply of API | 19 | |
| 3.5. | Statements and Compliance with Applicable Law | 19 | |
| 3.6. | Subcontracting | 19 | |
| 3.7. | Representatives | 19 | |
| ARTICLE 4 PAYMENTS AND RECORDS | 20 | ||
| 4.1. | Upfront Payment | 20 | |
| 4.2. | Milestones | 20 | |
| 4.3. | Royalties | 21 | |
| 4.4. | Royalty Payments and Reports | 22 | |
| 4.5. | Voucher Payment | 22 | |
| 4.6. | Mode of Payment; Offsets | 23 | |
| 4.7. | Currency Exchange Rate | 23 |
CONFIDENTIAL TREATMENT REQUESTED: Certain portions of this document have been omitted pursuant to a request for confidential treatment and, where applicable, have been marked with an asterisk ("[***]") to denote where omissions have been made. The confidential material has been filed separately with the Securities and Exchange Commission.
| 4.8. | Taxes | 23 | |
| 4.9. | Interest on Late Payments | 24 | |
| 4.10. | Financial Records | 24 | |
| 4.11. | Audit | 24 | |
| 4.12. | Audit Dispute | 24 | |
| ARTICLE 5 INTELLECTUAL PROPERTY | 25 | ||
| 5.1. | Ownership of Intellectual Property | 25 | |
| 5.2. | Maintenance and Prosecution of Patents | 25 | |
| 5.3. | Enforcement of Patents | 25 | |
| 5.4. | Invalidity or Unenforceability Defenses or Actions | 26 | |
| 5.5. | Corporate Names | 27 | |
| 5.6. | Orange Book Listing | 27 | |
| ARTICLE 6 CONFIDENTIALITY AND NON-DISCLOSURE | 27 | ||
| 6.1. | Confidentiality Obligations | 27 | |
| 6.2. | Permitted Disclosures | 28 | |
| 6.3. | Use of Name | 29 | |
| 6.4. | SEC Filings and Other Disclosures | 29 | |
| 6.5. | Public Announcements | 30 | |
| 6.6. | Publications | 30 | |
| 6.7. | Return of Confidential Information | 31 | |
| ARTICLE 7 REPRESENTATIONS AND WARRANTIES | 31 | ||
| 7.1. | Mutual Representations and Warranties | 31 | |
| 7.2. | Additional Representations and Warranties of Novartis | 32 |
CONFIDENTIAL TREATMENT REQUESTED: Certain portions of this document have been omitted pursuant to a request for confidential treatment and, where applicable, have been marked with an asterisk ("[***]") to denote where omissions have been made. The confidential material has been filed separately with the Securities and Exchange Commission.
| 7.3. | Additional Representations and Warranties of Midatech | 32 | |
| 7.4. | DISCLAIMER OF WARRANTIES | 33 | |
| 7.5. | ADDITIONAL WAIVER | 33 | |
| ARTICLE 8 INDEMNITY | 33 | ||
| 8.1. | Indemnification of Novartis | 33 | |
| 8.2. | Indemnification of Midatech | 34 | |
| 8.3. | Indemnification Procedures | 34 | |
| 8.4. | Special, Indirect and Other Losses | 36 | |
| 8.5. | Insurance | 36 | |
| ARTICLE 9 TERM AND TERMINATION | 37 | ||
| 9.1. | Term and Expiration | 37 | |
| 9.2. | Termination | 37 | |
| 9.3. | Rights in Bankruptcy | 38 | |
| 9.4. | Consequences of Termination | 38 | |
| 9.5. | Remedies | 38 | |
| 9.6. | Accrued Rights; Surviving Obligations | 38 | |
| ARTICLE 10 MISCELLANEOUS | 39 | ||
| 10.1. | Force Majeure | 39 | |
| 10.2. | Export Control | 39 | |
| 10.3. | Assignment | 40 | |
| 10.4. | Severability | 40 | |
| 10.5. | Dispute Resolution | 40 | |
| 10.6. | Governing Law, Jurisdiction and Service | 40 |
CONFIDENTIAL TREATMENT REQUESTED: Certain portions of this document have been omitted pursuant to a request for confidential treatment and, where applicable, have been marked with an asterisk ("[***]") to denote where omissions have been made. The confidential material has been filed separately with the Securities and Exchange Commission.
| 10.7. | Notices | 41 | |
| 10.8. | Entire Agreement; Amendments | 43 | |
| 10.9. | English Language | 43 | |
| 10.10. | Equitable Relief | 43 | |
| 10.11. | Waiver and Non-Exclusion of Remedies | 44 | |
| 10.12. | No Benefit to Third Parties | 44 | |
| 10.13. | Further Assurance | 44 | |
| 10.14. | Relationship of the Parties | 44 | |
| 10.15. | References | 44 | |
| 10.16. | Construction | 45 | |
| 10.17. | Counterparts | 45 | |
| 10.18. | Midatech Parent Co. Guaranty | 46 |
Schedule 1.58 - Licensed Patents
Schedule 3.1.2 - Development Plan
Schedule 6.5 - Announcement of License
Schedule 7.2.3 - Licensed Patents [***]
CONFIDENTIAL TREATMENT REQUESTED: Certain portions of this document have been omitted pursuant to a request for confidential treatment and, where applicable, have been marked with an asterisk ("[***]") to denote where omissions have been made. The confidential material has been filed separately with the Securities and Exchange Commission.
This License Agreement (the "Agreement") is made and entered into effective as of 6 June 2017 (the "Effective Date") by and between Novartis Pharma AG, a company organized under the laws of Switzerland, having its principal place of business at Forum 1, Novartis Campus, 4056 Basel, Switzerland ("Novartis") and Midatech Limited, a company incorporated in England and Wales under registration number 04097593, whose registered office is at 65 Innovation Drive, Milton Park, Abingdon, Oxfordshire, OX14 4RQ United Kingdom ("Midatech"). Novartis and Midatech are sometimes referred to herein individually as a "Party" and collectively as the "Parties."
WHEREAS, Novartis owns and controls certain Licensed Patents (as defined herein) in the Territory (as defined herein); and
WHEREAS, Novartis wishes to grant a [] license to Midatech and Midatech wishes to take a [] license under such Licensed Patents to develop and commercialize Licensed Products (as defined herein) in the Territory, in each case in accordance with the terms and conditions set forth below.
NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions set forth herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:
Unless otherwise specifically provided herein, the following terms shall have the following meanings:
1.1 "Accounting Standards" means, with respect to Midatech, the IFRS (International Financial Reporting Standards), as generally and consistently applied throughout Midatech's organization. Midatech shall promptly notify Novartis in the event that it changes its Accounting Standards pursuant to which its records are maintained, it being understood that Midatech may only use internationally recognized accounting principles.
1.2 "Affiliate" means, with respect to a Party, any Person that controls, is controlled by, or is under common control with that Party. For the purpose of this definition, "control" shall mean, direct or indirect, ownership of more than fifty percent (50%) of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or more than fifty percent (50%) of the equity interest in the case of any other type of legal entity, status as a general partner in any partnership, or any other arrangement whereby the entity or person controls or has the right to control the board of directors or equivalent governing body of a corporation or other entity, or the ability to cause the direction of the management or policies of a corporation or other entity.
CONFIDENTIAL TREATMENT REQUESTED: Certain portions of this document have been omitted pursuant to a request for confidential treatment and, where applicable, have been marked with an asterisk ("[***]") to denote where omissions have been made. The confidential material has been filed separately with the Securities and Exchange Commission.
1.3 "Agreement" has the meaning set forth in the preamble hereto.
1.4 "Anti-Corruption Laws" means the U.S. Foreign Corrupt Practices Act, as amended, the UK Bribery Act 2010, as amended, and any other applicable anti-corruption laws and laws for the prevention of fraud, racketeering, money laundering or terrorism.
1.5 "API" means panobinostat, panobinostat lactate, or any other salt, ester or form of panobinostat.
1.6 "Applicable Law" means applicable laws, rules and regulations, including any rules, regulations, guidelines or other requirements of the Regulatory Authorities, that may be in effect from time to time, including the FFDCA and the Anti-Corruption Laws.
1.7 "Auditor" has the meaning set forth in Section 4.12.
1.8 "Authorized Generic Version" means:
(i) in the United States, with respect to a pharmaceutical product that has been approved under Section 505(c) of the FFDCA (i.e., a "full" application under 505(b)(1) or an application under 505(b)(2)), any other pharmaceutical product that is sold under the Drug Approval Application for the first product or any supplement or amendment to such Drug Approval Application, and that is marketed, sold or distributed directly or indirectly to retail class of trade with labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses or similar packaging for use in institutions), product code, labeler code, trade name or Trademark that differs from that of the listed pharmaceutical product; or
(ii) with respect to a pharmaceutical product sold outside the United States, any other pharmaceutical product that is identical in terms of the qualitative and quantitative composition of the active substance(s) and the pharmaceutical form to the first product and that is sold under the Drug Approval Application for the first product or any supplement or amendment to such Drug Approval Application, and that is marketed, sold or distributed directly or indirectly to retail class of trade with labeling, packaging, product code, labeler code, trade name or Trademark that differs from that of the listed pharmaceutical product.
1.9 "Breaching Party" has the meaning set forth in Section 9.2.1.
1.10 "Business Day" means a day other than a Saturday or Sunday or a day on which banking institutions in New York, New York, U.S.A., Basel, Switzerland or London, England are permitted or required to be closed.
CONFIDENTIAL TREATMENT REQUESTED: Certain portions of this document have been omitted pursuant to a request for confidential treatment and, where applicable, have been marked with an asterisk ("[***]") to denote where omissions have been made. The confidential material has been filed separately with the Securities and Exchange Commission.
1.11 "Calendar Quarter" means each successive period of three (3) calendar months commencing on January 1, April 1, July 1 and October 1, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1 or October 1 after the Effective Date and the last Calendar Quarter shall end on the last day of the Term.
1.12 "Calendar Year" means each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31, except that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Calendar Year of the Term shall commence on January 1 of the year in which the Term ends and end on the last day of the Term.
1.13 "CED Device" means any medical device(s), the Intellectual Property Rights to which are Controlled by Midatech, which is(are) used to administer Licensed Products, to the human brain via Convection-Enhanced Delivery.
1.14 "Clinical Trial" means, as to a specific Licensed Product for a specific Indication, (i) a clinical study conducted in humans in accordance with GCP to demonstrate or confirm the therapeutic benefit of the Licensed Product in such Indication and to provide an adequate basis for obtaining Regulatory Approval, as described in ICH Guideline E8, General Considerations for Clinical Trials or (ii) such other clinical study conducted in humans in accordance with GCP for the intended purpose of obtaining Regulatory Approval of the Licensed Product.
1.15 "cGMP" means current good manufacturing practices as set forth in 21 C.F.R. Parts 210 and 211, and comparable regulatory standards promulgated by the EMA or other Regulatory Authority in the Territory, as applicable, as such standards may be updated from time to time.
1.16 "Combination Product" means a product that is comprised of a Licensed Product together with one (1) or more other products and is sold either as a fixed dose or as separate doses in a single package.
1.17 "Commercialization" means any and all activities directed to the preparation for sale of, offering for sale of or sale of a Licensed Product, including activities related to marketing, promoting, selling, distributing and importing such Licensed Product and interacting with Regulatory Authorities regarding any of the foregoing. When used as a verb, "to Commercialize" and "Commercializing" means to engage in Commercialization and "Commercialized" has a corresponding meaning.
1.18 "Confidential Information" has the meaning set forth in Section 6.1.
1.19 "Contingent Voucher Proceeds" has the meaning set forth in Section 4.5.
CONFIDENTIAL TREATMENT REQUESTED: Certain portions of this document have been omitted pursuant to a request for confidential treatment and, where applicable, have been marked with an asterisk ("[***]") to denote where omissions have been made. The confidential material has been filed separately with the Securities and Exchange Commission.
1.20 "Control" means, with respect to any item of Information, Regulatory Documentation, material, Patent or other Intellectual Property Right, possession of the right, whether directly or indirectly and whether by ownership, license or otherwise (other than by operation of the license and other grants in Section 2.1), to grant a license, sublicense or other right (including the right to reference Regulatory Documentation) to or under such Information, Regulatory Documentation, material, Patent or other Intellectual Property Right as provided for herein without violating the terms of any agreement with any Third Party.
1.21 "Convection-Enhanced Delivery" means the delivery of a pharmaceutical or biologic product to the brain or to brain tumors via catheters through which such pharmaceutical or biologic product is delivered using low-positive-pressure bulk flow.
1.22 "Corporate Names" means the Trademarks, names and logos as Novartis may designate in writing from time to time, including any Trademarks used by Novartis or its Affiliates for the commercialization of the Reference Product.
1.23 "Development" means all activities related to pre-clinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, clinical studies, including Manufacturing in support thereof, statistical analysis and report writing, the preparation and submission of Drug Approval Applications, regulatory affairs with respect to the foregoing and all other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining a Regulatory Approval. When used as a verb, "Develop" means to engage in Development.
1.24 "Development Plan" has the meaning set forth in Section 3.1.2.
1.25 "Dispute" has the meaning set forth in Section 10.5.
1.26 "Dollars" or "$" means United States Dollars.
1.27 "Drug Approval" means an approval granted by the appropriate Regulatory Authority to market a Licensed Product or Reference Product (as the context admits) in the Field in any particular jurisdiction in the Territory; provided, "Drug Approval" includes any and all marketing authorizations, but excludes any and all Pricing Approvals and Reimbursement Approvals.
1.28 "Drug Approval Application" means a New Drug Application as defined in the FFDCA or any corresponding foreign application in the Territory, including, with respect to the European Union, a Marketing Authorization Application filed with the EMA pursuant to the centralized approval procedure or with the applicable Regulatory Authority of a country in Europe with respect to the decentralized or mutual recognition or any other national approval, but excluding any and all applications for Pricing Approvals and Reimbursement Approvals.
1.29 "Effective Date" has the meaning set forth in the preamble hereto.
CONFIDENTIAL TREATMENT REQUESTED: Certain portions of this document have been omitted pursuant to a request for confidential treatment and, where applicable, have been marked with an asterisk ("[***]") to denote where omissions have been made. The confidential material has been filed separately with the Securities and Exchange Commission.
1.30 "EMA" means the European Medicines Agency and any successor agency thereto.
1.31 "European Union" or "EU" means the economic, scientific and political organization of member states as it may be constituted from time to time, which as of the Effective Date consists of Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom of Great Britain and Northern Ireland and that certain portion of the Republic of Cyprus included in such organization.
1.32 "Exploit" means to research, Develop, Commercialize, register, Manufacture, have Manufactured, hold or keep (whether for disposal or otherwise), use, have used, export, or transport. "Exploitation" means the act of Exploiting a compound, product or process.
1.33 "FDA" means the United States Food and Drug Administration and any successor agency thereto.
1.34 "FFDCA" means the United States Federal Food, Drug, and Cosmetic Act, as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions and modifications thereto).
1.35 "Field" means the treatment of brain cancer in humans, administered by Convection-Enhanced Delivery.
1.36 "First Commercial Sale" means, with respect to a Licensed Product and a country, the first sale by Midatech or an Affiliate, or a sublicensee or distributor of Midatech or an Affiliate for monetary value for use or consumption by the end user of such Licensed Product in such country after Drug Approval for such Licensed Product has been obtained in such country. Supply of Licensed Product for clinical trial purposes or prior to receipt of Regulatory Approval for such Licensed Product, such as so-called "treatment IND supply," "named patient supply," and "compassionate use supply," shall not be construed as a First Commercial Sale. Notwithstanding the foregoing, in the event that a particular country in the Territory authorizes the sale of a Licensed Product prior to Drug Approval based on an unsolicited request from a treating institution, and such request leads to a commercial sale of Licensed Product, such sale would be included within the definition of First Commercial Sale.
1.37 "Good Clinical Practices" or "GCP" means the then-current standards, practices and procedures promulgated or endorsed by the FDA as set forth in the guidelines entitled "Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance," including related regulatory requirements imposed by the FDA and comparable regulatory standards, practices and procedures promulgated by the EMA or other Regulatory Authority in the Territory, as applicable, as such standards, practices and procedures may be updated from time to time, including applicable quality guidelines promulgated under the ICH.
CONFIDENTIAL TREATMENT REQUESTED: Certain portions of this document have been omitted pursuant to a request for confidential treatment and, where applicable, have been marked with an asterisk ("[***]") to denote where omissions have been made. The confidential material has been filed separately with the Securities and Exchange Commission.
1.38 "Good Distribution Practices" or "GDP" means the regulatory standards and principles and guidelines of good distribution practice as in force from time to time relating to the warehousing, storage and physical distribution of medicinal products established by the relevant Regulatory Authority, including without limitation the guidelines for Good Distribution Practice as promulgated in "Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use" (2013/C 343/01), as amended from time to time.
1.39 "Good Laboratory Practices" or "GLP" means the then-current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, and comparable regulatory standards promulgated by the EMA or other Regulatory Authority applicable to any country in the Territory, as such standards may be updated from time to time, including applicable quality guidelines promulgated under the ICH.
1.40 "Governmental Authority" means any multi-national, federal, state, local, municipal, provincial or other governmental authority of any nature (including any governmental division, prefecture, subdivision, department, agency, bureau, branch, office, commission, council, court or other tribunal).
1.41 "Government Official" means (i) any Person employed by or acting on behalf of a government, government-controlled agency or entity or public international organization, (ii) any political party, party official or candidate, (iii) any Person who holds or performs the duties of an appointment, office or position created by custom or convention or (iv) any Person who holds himself out to be the authorized intermediary of any of the foregoing.
1.42 "Guarantor" has the meaning set forth in Section 10.18.
1.43 "Hatch-Waxman Act" means the U.S. "Drug Price Competition and Patent Term Restoration Act" of 1984.
1.44 "ICH" means the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.
1.45 "ICH Guidelines" means the guidelines of the ICH.
1.46 "IIT" has the meaning set forth in Section 6.2.4.
1.47 "IFRS" shall mean International Financial Reporting Standards, consistently applied.
1.48 "Improvement" means any invention, discovery, development or modification with respect to a Licensed Product or relating to the Exploitation thereof, whether or not patented or patentable, including any enhancement in the efficiency, operation, Manufacture, ingredients, preparation, presentation, formulation, means of delivery or dosage of such Licensed Product, any discovery or development of any new Indication or expansion of an Indication for such Licensed Product, or any discovery or development that improves the stability, safety or efficacy of such Licensed Product.
CONFIDENTIAL TREATMENT REQUESTED: Certain portions of this document have been omitted pursuant to a request for confidential treatment and, where applicable, have been marked with an asterisk ("[***]") to denote where omissions have been made. The confidential material has been filed separately with the Securities and Exchange Commission.
1.49 "IND" means (i) an investigational new drug application filed with the FDA, and its equivalent in other countries or regulatory jurisdictions, for authorization to commence clinical studies and (ii) all supplements and amendments that may be filed with respect to the foregoing.
1.50 "Indemnification Claim Notice" has the meaning set forth in Section 8.3.1.
1.51 "Indemnified Party" has the meaning set forth in Section 8.3.1.
1.52 "Indication" means a primary sickness or medical condition or any interruption, cessation or disorder of a particular bodily function, system or organ (each a "disease") requiring a separate Pivotal Registration Clinical Trial to obtain Regulatory Approval to market and sell a product for such disease.
1.53 "Information" means all technical, scientific and other know-how and information, trade secrets, knowledge, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, 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, assays and biological methodology, in each case (whether or not confidential, proprietary, patented or patentable) in written, electronic or any other form now known or hereafter developed.
1.54 "Infringement" has the meaning set forth in Section 5.3.1.
1.55 "Insolvency Event" has the meaning set forth in Section 9.2.4.
1.56 "Intellectual Property Rights" means all copyrights, trade secrets, Trademarks, Patents, Information and any and all other intellectual property or proprietary rights now known or hereafter recognized in any jurisdiction.
1.57 "Knowledge" means actual knowledge, but without any duty to conduct any investigation with respect to such facts and information.
1.58 "Licensed Patents" means the Patents listed on Schedule 1.58, as well as any reissues, reexaminations, continuations, continuations-in-part (but only to the extent the claims thereof are entirely supported in the specification of at least one of the Patents identified on Schedule 1.58 and entitled to the priority date thereof) or divisionals or corresponding foreign patents or applications thereof, or any Patents claiming priority to one or more applications to which one or more of the aforesaid Patents claim priority (including continuations-in-part, but only to the extent the claims thereof are entirely supported in the specification of at least one of the Patents identified on Schedule 1.58 and entitled to the priority date of the parent application).
CONFIDENTIAL TREATMENT REQUESTED: Certain portions of this document have been omitted pursuant to a request for confidential treatment and, where applicable, have been marked with an asterisk ("[***]") to denote where omissions have been made. The confidential material has been filed separately with the Securities and Exchange Commission.
1.59 "Licensed Product" means any product for use in the Field which, but for the licenses granted to Midatech under this Agreement would infringe, or is covered by, one or more Licensed Patents, in any and all forms, presentations, dosages and formulations
1.60 "Losses" has the meaning set forth in Section 8.1.
1.61 "Major Market" means one or more of France, Germany, Italy, Japan, Spain and the United Kingdom.
1.62 "Manufacture" and "Manufacturing" means all activities related to the production, manufacture, processing, filling, finishing, packaging, labeling, shipping and holding of a product or any intermediate thereof, including process development, process qualification and validation, scale-up, pre-clinical, clinical and commercial manufacture and analytic development, product characterization, stability testing, quality assurance and quality control.
1.63 "Material Anti-Corruption Law Violation" means a violation by Midatech or a Sublicensee of an Anti-Corruption Law relating to the subject matter of this Agreement that would, if it were publicly known, in the reasonable view of Novartis, have a material adverse effect on Novartis or on the reputation of Novartis because of its relationship with Midatech.
1.64 "MHLW" means the Ministry of Health, Labor and Welfare of Japan, and any successor agency thereto.
1.65 "Midatech" has the meaning set forth in the preamble hereto.
1.66 "Midatech Information and Improvements" has the meaning set forth in Section 5.1.1.
1.67 "Net Sales" means the gross amount billed or invoiced (for the avoidance of doubt, excluding VAT) by Midatech, its Affiliates or its or their respective Sublicensees (including distributors of Authorized Generic Versions of Licensed Product(s)) hereunder in the Territory for any Licensed Product sold to Third Parties (other than Sublicenses or distributors of Authorized Generic Versions of Licensed Product(s)), on a country-by-country basis, less the following deductions, applied in accordance with Midatech's Accounting Standards, for:
With respect to the calculation of Net Sales:
(i) Net Sales only include the value charged or invoiced on the first arm's length sale to a Third Party and sales between or among Midatech and its Affiliates and Sublicensees shall be disregarded for purposes of calculating Net Sales;
CONFIDENTIAL TREATMENT REQUESTED: Certain portions of this document have been omitted pursuant to a request for confidential treatment and, where applicable, have been marked with an asterisk ("[***]") to denote where omissions have been made. The confidential material has been filed separately with the Securities and Exchange Commission.
(ii) If a Licensed Product is delivered to the Third Party before being invoiced (or is not invoiced), Net Sales will be calculated at the time all the revenue recognition criteria under Midatech's Accounting Standards are met; and