Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,
IRS Employer Identification No. 30-0793665
Precluded Party is defined in clause 21.1.
Price is set out in Schedule 5.
Product means the product set out in Schedule 4, and any other product agreed by the parties in writing for the purposes of this Agreement from time to time (at which time the parties must also agree in writing related amendments to Schedule 4 and Schedule 5). The parties acknowledge and agree that the term Product may include products covering different medical indications developed under the Development Plan, provided the same are included within the scope of the Field, and ***.
Product Specification means the specification with respect to the manufacture, packaging, quality and characteristics (including the raw materials and product specification) and testing of the Product, as set out in Schedule 4.
Proposed Publication means any proposed scientific public disclosure (including a manuscript or abstract intended for publication, a paper or abstract intended to be orally presented, any poster presentation, or oral disclosure) that includes, describes or refers to the use of the Product for the treatment of human patients with cancer via oral administration.
Quality Agreement means the technical agreement between the parties detailing the specification and technical terms for the manufacture of the Product as set out in the Marketing Authorisation.
Quarter means a 3 month period starting 1 January, 1 April, 1 July or 1 October.
reasonable commercial efforts means ***.
Recipient is defined in clause 17.2.
Relevant Regulatory Authority, in relation to a country or region, means any governmental authority (whether federal, state or local) regulating the manufacture, importation, storage, promotion, sale, distribution or use of therapeutic substances, and in the case of Australia and the USA includes the Therapeutic Goods Administration (TGA) and the Food and Drug Administration (FDA) respectively, or any successor body.
Safety Data Exchange Agreement (SDEA) means the agreement between the parties setting out the rules and procedures for exchanging information concerning certain safety and pharmacovigilance issues.
Sales Forecast is set out in item 1.2 of Schedule 5.
Start Date is set out in Schedule 1.
Sub Licensee is defined in clause 3.4.
Tax means any tax (including any GST or VAT), withholding tax, duties, levies, charges, fees and other imposts of any kind (including any fine, interest, penalty and expenses in connection with those items) levied, assessed, charged or collected in connection with this Agreement or the performance of services under this Agreement, but does not include any income or capital gains tax.
Term means the Initial Term and any extensions under clause 2.2.
Territory is set out in Schedule 1.
Trade Mark means US trade mark (number 77793077) SUBA for goods and services in class 5 (pharmaceutical and veterinary preparations having enhanced bioavailability excluding pharmaceutical products for the treatment of opioid addiction) and any other trademarks (whether registered or unregistered) notified in writing by Mayne Pharma to HPPI for the purposes of this Agreement from time to time.
Third Amended and Restated Supply and License Agreement Mayne Pharma and HPPI | page 12