This excerpt taken from the TRGT 10-K filed Mar 14, 2008.
ARTICLE 1- DEFINITIONS
The following terms as used in this Agreement shall have the meanings set forth below:
SECTION 1.1 Acquired Assets means (a) the Trademarks as set forth in Schedule A, (b) any and all of Sellers worldwide right, title and interest in the Intellectual Property as of the Closing Date, (c) the Documentation, and (d) all United States Food and Drug Administration New Drug Applications for the Product as set forth in Schedule B, but specifically excluding all Excluded Assets.
SECTION 1.2 Affiliate of a person means (i) any corporation or business entity fifty (50%) percent or more of the voting stock or other equity interest of which is owned directly or indirectly by such Person; or (ii) any corporation or business entity which directly or indirectly owns fifty (50%) percent or more of the voting stock or other equity interest of such Person; or (iii) any corporation or business entity under the direct or indirect control of a Person described in clause (i) or (ii), but Affiliate shall not include, as to Seller, any joint venture, partnership or similar entity in which Seller owns an equity interest of fifty percent (50%) or less and shall not include Banyu Pharmaceutical Co., Limited.
SECTION 1.3 Agreement or this Agreement means this Asset Purchase and Trademark Assignment Agreement, including all Schedules hereto.
SECTION 1.4 Assumed Liabilities means the liabilities to be assumed by Purchaser pursuant hereto, namely all claims and complaints (including, without limitation, all damages, losses, expenses and liabilities) relating to any or all of the Acquired Assets, made or brought after the Closing Date including, without limitation, (i) all liabilities arising out of the sale, purchase, consumption or use of the Product in the Territory and (ii) all liabilities arising out of any generation, treatment, storage, transportation, disposal or release, of any hazardous material, substance, waste or any toxic or other material regulated by any federal, state, provincial or local environmental statute, rule or regulation (except as provided in Section 8.2 hereof); provided, however that Assumed Liabilities shall not include claims and complaints (A) arising out of the sale, purchase, consumption or use of the Product prior to the Closing Date, (B) arising out of the consumption or use of Product sold or otherwise transferred by Seller to Persons other than Purchaser, or (C) asserting and establishing a breach of a specific warranty given by Seller in this Agreement.
SECTION 1.5 Closing Date means the date on which the Closing occurs as defined in Section 3.1 below.
SECTION 1.6 Developments shall mean all developments, improvements, enhancements or additions to or of the Acquired Assets or the Product, including without limitation any rights, patents, research, documents, intellectual property or other property developed, generated, or acquired by Purchaser or its successors or assigns after the date hereof with respect to the Acquired Assets or the Product.
SECTION 1.7 Documentation means the documents, papers, files and other Recorded Information described in Schedule C hereto.
SECTION 1.8 Excluded Assets means all assets, property, rights and interests of Seller other than the Acquired Assets, including without limitation all patents, information, know-how, trademarks, trade names, good will, intellectual property and proprietary rights, new drug applications and their equivalents, NDC numbers and their equivalents, product registrations, or other assets of Seller.
SECTION 1.9 Excluded Liabilities means the liabilities retained by Seller pursuant hereto, namely all claims and complaints (including, without limitation, all damages, losses, expenses and liabilities) relating to any or all of the Acquired Assets, made or brought prior to the Closing Date including, without limitation, all liabilities (A) arising out of the sale, purchase, consumption or use of the Product prior to the Closing Date or (B) arising out of the consumption or use of Product sold or otherwise transferred by Seller to Persons other than Purchaser.
SECTION 1.10 Intellectual Property means any and all of the following, but only to the extent that, in each case, they relate directly to the Product in the Territory and are set forth or embodied the Documentation: Know-how, Patents, Marks, methods, processes, formulae, techniques, trade secrets, copyrights, copyright applications, copyright registrations, inventions, inventors notes, molecular compositions, mechanisms of activity, and works of authorship; and specifically excludes (A) any information known or to become known to Seller or any of its employees, contractors or agents which is not in the form of Recorded Information, and (B) any Know-how, Patents, methods, processes, formulae, techniques, trade secrets, copyrights, copyright applications, copyright registrations, inventions, inventors notes, molecular compositions, mechanism of activity, works of authorship or Information to the extent that they are used for purposes other than manufacturing, marketing, selling, producing, licensing or in any way exploiting mecamylamine hydrochloride in the Territory.
SECTION 1.11 Know-how means any and all technical Information and know-how which relates directly to the Product, including, without limitation, biological, chemical, pharmacological, toxicological, clinical, assay, control and manufacturing data.
SECTION 1.12 Liens and Encumbrances means, with respect to the Acquired Assets, any mortgage, lien, pledge, charge, security interest or encumbrance of any kind, including, without limitation, the interest of a vendor or lessor under any conditional sale agreement, capital lease or other title retention agreement relating to such asset.
SECTION 1.13 Marks means any trademarks, service marks or names used for the Product in the Territory, and all trademark and service mark registrations (and any applications therefor) associated therewith in the Territory, together with all associated good will, including without limitation the name INVERSINE.
SECTION 1.14 Net Sales means total sales volume of the Product in the United States during a Payment Year multiplied by the unit price for the Product in effect in the United States during such Payment Year (weighted as appropriate to reflect price increases or decreases during such Payment Year), less (a) any taxes and/or duties based on the selling price of the Product which fall due and are paid during such Product Year as a consequence of sales during such Product Year, and (b) all rebates and returns with respect to the Product in the United States during such Payment Year, in each case determined in accordance with generally accepted accounting practices consistently applied. Sales between or among Purchaser and its Affiliates or sublicensees shall be excluded from the computation of Net Sales except where such Affiliates or sublicensees are end user, but Net Sales shall include the subsequent final sales to Third Parties by such Affiliates or sublicensees.
SECTION 1.15 New Drug Applications and NDAs mean the applications for the Product filed with the U.S. Food and Drug Administration (FDA) for marketing authorization of the Product within the United States, as described in Schedule B, and all legal rights and privileges belonging or accruing to the owner or holder of such applications.
SECTION 1.16 Patents shall mean all patents and patent applications which generically or specifically claim the Product and (A) in which Seller has an ownership interest as of the date hereof or (B) to which Seller, as of the date hereof, has or shall in the future have the right to grant licenses. Included within the definition of Patents are all continuations, continuations-in-part, divisions, patents of addition, reissues, renewals or extensions thereof and all SPCs with respect thereto. The list of patent applications and patents encompassed within Patents is set forth in Schedule D hereto.
SECTION 1.17 Payment Year means each twelve-month period after the Closing Date, with the first Payment Year, if any, commencing on the date of the first sale of the Product to a customer in the United States and later Payment Years commencing on the same day of each succeeding year.
SECTION 1.18 Person means an individual, a corporation, a partnership, an association, a trust, or other entity or organization, including a government or political subdivision or an agency or instrumentality thereof.
SECTION 1.19 Product means (A) the chemical compound mecamylamine hydrochloride, and (B) as of the Closing Date, the formulated tablet containing mecamylamine hydrochloride as heretofore marketed by Seller in the United States under the trademark INVERSINE®, and (C) after the Closing Date, any tablet or other formulation of mecalmylamine hydrochloride or any derivative thereof (including but not limited to any stereoisomers, either separated or combined, any hydrates, any solvates and any crystal forms).
SECTION 1.20 Proprietary Information means Recorded Information which discloses methods, processes, methodologies, ideas, formulae, techniques, Know-how, marketing data, product pricing, listing, product plans, procedures and techniques used by Seller prior to the date of this Agreement in connection with the Product, where such information derives Independent economic value, actual or potential, from not being generally known to and not being readily ascertainable by proper means by other persons who can obtain economic value from its disclosure or use, and which has heretofore been the subject of efforts by Seller that were reasonable under the circumstances to maintain its secrecy.
SECTION 1.21 Qualified Successor means (A) any individual, corporation or partnership that has a net worth of $50,000,000 or greater at the time of evaluation, or (B) any individual, corporation or partnership that has a net worth of less than $50,000,000 at the time of evaluation if Seller has consented in writing to such entity being classified as a Qualified Successor, which consent shall not be unreasonably withheld. For purposes of this definition, net worth shall mean total assets minus total liabilities as shown in a financial statement for such individual, corporation or partnership which has been prepared in accordance with generally accepted accounting principles consistently applied.
SECTION 1.22 Recorded Information means information or data that is physically recorded or stored in a readable or retrievable form, e.g., writing microfiche, computer disk, etc.
SECTION 1.23 SPC means a right based upon a patent to exclude others from making, using or selling the Product, such as a Supplementary Protection Certificate.
SECTION 1.24 Territory means all the countries and territories of the world.
SECTION 1.25 Technical Package means a specific collection of Recorded Information relating to the manufacture of the Product by Seller prior to the date of this Agreement. The Technical Package is expected to contain such items as: process flow diagrams, material safety data sheets, bulk drug specifications, finished product specifications.
SECTION 1.26 Third Party means any Person other than a party to this Agreement or an Affiliate of either party.
SECTION 1.27 Trademarks means the trademarks and trademark registrations for the Product as set forth in Schedule A. Trademark means any one of the Trademarks. The Trademark shown on Schedule A as being currently registered in Somalia is referred to hereinafter as the Somali Trademark.
These excerpts taken from the TRGT 10-K filed Mar 22, 2007.
ARTICLE 2 DEFINITIONS
The following terms used in this Agreement shall be defined as set forth below:
2.1. AFFILIATE shall mean, with respect to any entity (including, without limitation, either party hereto), any entity or person that directly or indirectly controls, is controlled by or is under common control with such entity. For purposes of this definition, control means possession of the power to direct the management of an entity, whether through ownership of more than fifty percent (50%) of voting securities, by contract or otherwise.
2.2. CONFIDENTIAL INFORMATION shall mean all information disclosed by one party to the other during the negotiation of, or under, this Agreement in any manner, whether orally,
visually or in tangible form, that directly relates to LICENSED PATENTS, LICENSED PRODUCTS or LICENSED METHODS or the Agreement itself, unless such information is subject to an exception described in Article 8.2; provided, however, that CONFIDENTIAL INFORMATION that is disclosed in tangible form shall be marked Confidential at the time of disclosure and CONFIDENTIAL INFORMATION that is disclosed orally or visually shall be identified as confidential at the time of disclosure and subsequently reduced to writing (including, for this purpose, email), marked confidential and delivered to the other party within thirty (30) days after such disclosure. Subject to Article 8.2, CONFIDENTIAL INFORMATION shall include, without limitation, materials, know-how and data, technical or non-technical, trade secrets, inventions, methods and processes, whether or not patentable.
2.3. EARNED ROYALTY is defined in Article 6.1.
2.4. EFFECTIVE DATE is defined in the introductory paragraph of this Agreement.
2.5. FIELD shall mean all therapeutic uses in humans.
2.6. FIRST SALE shall mean, with respect to a LICENSED PRODUCT or LICENSED METHOD, the first sale, that results in NET SALES, to a third party of such LICENSED PRODUCT or LICENSED METHOD after all regulatory approvals necessary for the commercialization of such LICENSED PRODUCT or LICENSED METHOD in the country in which such sale is made have been obtained. For purposes of clarity, for each LICENSED PRODUCT developed by LICENSEE, there can only be one FIRST SALE under this Agreement.
2.7. INSOLVENT shall mean that LICENSEE is insolvent as defined by the United States Bankruptcy Code, as amended from time to time
2.8. INVENTION and INVENTOR are defined in Article 1.1.
2.9. LICENSE refers to the license granted under Article 3.1.
2.10. LICENSED INFORMATION shall mean all preclinical and clinical data controlled by Yale as of the EFFECTIVE DATE and directly relating to the INVENTION.
2.11. LICENSED METHODS shall mean any method, procedure, service or process the practice of which, in the absence of a license from YALE, would infringe a VALID CLAIM of a LICENSED PATENT.
2.12. LICENSED PATENTS shall mean: (i) the patent applications listed in Appendix A, together with all continuations, divisionals and continuations-in-part that include any claim that is directed to subject matter described in the patent applications listed on Appendix A (collectively, the Applications); (ii) all patents issuing from or claiming priority to any of the Applications during the TERM, together with all reissues, re-examinations or extensions thereof or substitutes therefor (the Patents) and (iii) the relevant international counterparts of each of the Applications and Patents. Appendix A is incorporated into this Agreement herein by reference.
2.13. LICENSED PRODUCT shall mean any product (including any apparatus or kit), or component part thereof, the manufacture, use or sale of which, in the absence of a license from YALE, would infringe a VALID CLAIM of a LICENSED PATENT.
2.14. LICENSED TERRITORY shall mean the entire world.
2.15. NDA shall mean a new drug application filed with the United States Food and Drug Administration to obtain marketing approval for a LICENSED PRODUCT in the United States.
2.16. NET SALES shall mean:
(a) gross invoice price from the sale or other transfer or disposition of the LICENSED PRODUCTS or LICENSED METHODS, or from services performed using LICENSED PRODUCTS or LICENSED METHODS, by LICENSEE, SUBLICENSEES or its AFFILIATES to third parties, except as set forth in Article 2.16(b), less the following deductions, provided they actually pertain to the disposition of the LICENSED PRODUCTS or LICENSED METHODS:
(i) all discounts (including chargebacks), credits and allowances on account of returns;
(ii) all amounts repaid or credited by reason of rejection, returns or recalls of goods, rebates or bona fide price reductions determined by LICENSEE or a SUBLICENSEE or an AFFILIATE in good faith;
(iii) all rebates and similar payments made with respect to sales paid for by any governmental or regulatory authority such as, by way of illustration and without limitation, Federal or state Medicaid, Medicare or similar state program in the United States or equivalent governmental program in any other country;
(iv) all invoiced amounts that are not collected by LICENSEE or a SUBLICENSEE or an AFFILIATE, including bad debts (provided that deductions for bad debt in any calendar quarter shall not exceed [********]of aggregate gross sales for such quarter pursuant to clause (a) (i.e., before application of sub clauses (i-v)));
(v) all duties, taxes and other governmental levies, fees or charges levied on the sale, transportation or delivery of LICENSED PRODUCTS or practice of the LICENSED METHODS (to the extent included separately on the applicable invoice), but not including income taxes; and
(vi) [********]of the amount arrived at after application of the provisions of items (i) through (v) above as an allowance for transportation costs, distribution expenses, special packaging and related insurance charges; provided that, if such costs, expenses and charges are itemized separately on the applicable invoice, such deduction shall instead be equal to the aggregate amount therefor shown on such invoice.
No deductions shall be made for any other costs or expenses, including but not limited to commissions to independents, agents or those on LICENSEEs, SUBLICENSEEs or an AFFILIATEs payroll or for the cost of collection.
NET SALES shall be calculated using the selling partys (LICENSEEs or a SUBLICENSEEs or an AFFILIATEs) internal audited systems used to report such sales, as adjusted for any of items (i) to (vi) (inclusive) above not taken into account in such systems. Deductions pursuant to clause (iv) above shall be taken in the quarter in which such sales are no longer recorded as a receivable.
For purposes of clarity, sales of a LICENSED PRODUCT or LICENSED METHOD in any country in the LICENSED TERRITORY in which the sale of such LICENSED PRODUCT or LICENSED METHOD would not infringe a VALID CLAIM of a LICENSED PATENT shall not be taken into account in determining NET SALES.
(b) NET SALES shall not include the gross invoice price for LICENSED PRODUCTS or LICENSED METHODS sold to, or services performed using LICENSED PRODUCTS or LICENSED METHODS for, any SUBLICENSEE or AFFILIATE unless such SUBLICENSEE or AFFILIATE is the end user of any LICENSED PRODUCT or LICENSED METHOD, in which case such consideration shall be included in NET SALES at the average selling price charged to a third party during the same quarter. Also, none of (i) the use of any LICENSED PRODUCT in a clinical trial, preclinical study or other research or development activity, (ii) the disposal or transfer of a LICENSED PRODUCT for purposes of a sampling program or for charitable, manufacturing, testing or qualification, regulatory or governmental purposes, or (iii) the sale, disposal or transfer of a LICENSED PRODUCT on a treatment investigational new drug application, named patient or compassionate use or other similar basis, shall give rise to any NET SALES.
2.17. QUALIFIED SUBLICENSEE shall mean any entity that is, or is an Affiliate of, either (i) one of the [********] largest biotechnology or pharmaceutical companies in the world, as measured by annual sales, or (ii) any other entity that has assets of at least $[********].
2.18. REASONABLE COMMERCIAL EFFORTS shall mean documented efforts that are consistent with those typically utilized by companies of similar size and with similar resources and expertise in the development of products and services with market potential similar to LICENSED PRODUCTS and LICENSED METHODS, taking into account all relevant scientific, clinical, regulatory, financial, competitive and commercial factors.
2.19. ROYALTY TERM is defined in Article 3.4.
2.20. SUBLICENSE INCOME shall mean all amounts (excluding Excluded Amounts, as described below) received by LICENSEE from a SUBLICENSEE, but only if the sublicense to LICENSED PATENTS or LICENSED METHODS is not combined, whether or not in the same agreement, with (i) a license to issued patents or pending patent applications owned or licensed by LICENSEE or its AFFILIATES (other than LICENSED PATENTS) that claim or cover compounds or their use in the FIELD or (ii) an agreement by LICENSEE or its AFFILIATES to collaborate with such SUBLICENSEE to discover, research, develop or commercialize compounds or products for use in the FIELD.
Excluded Amounts means all payments made to LICENSEE or its AFFILIATES: (i) as royalties on the sale of products; (ii) upon the achievement of, or based on, clinical, regulatory, commercialization or sales milestones; (iii) under a credit facility; (iv) in consideration of (A) any issuance of equity or debt securities by LICENSEE or its AFFILIATES, (B) any supply of compounds or related materials by or on behalf of LICENSEE or its AFFILIATES, or (C) any research, development or other activities that LICENSEE or its AFFILIATES may perform on behalf of a SUBLICENSEE, provided that such payments do not exceed the fair market value of such securities, supply or activities, as applicable; (v) that LICENSEE or its AFFILIATES may be required to repay (e.g., a loan); (vi) as reimbursement of actual patent prosecution and maintenance costs and expenses; or (vii) in connection with awards or judgments in patent or other intellectual property right enforcement.
2.21. SUBLICENSEE shall mean any third party sublicensed by LICENSEE to make, have made, use, sell, have sold, import or export any LICENSED PRODUCT or to practice any LICENSED METHOD; provided that a contract research organization or contract manufacturer contracted by LICENSEE or a SUBLICENSEE or an AFFILIATE to perform services on a fee-for-service basis related to the manufacturing and/or research or development of LICENSED PRODUCTS only, and not sales of LICENSED PRODUCTS, shall not be a SUBLICENSEE.
2.22. TARGACEPT PATENT shall mean all issued and unexpired patents or pending patent applications owned or licensed by LICENSEE or any of its AFFILIATES during the TERM that contain a VALID CLAIM that would be infringed by the manufacture, use, sale or other exploitation of a LICENSED PRODUCT by a third party in the absence of a license from LICENSEE (or such AFFILIATE); provided that (i) LICENSED PATENTS are not TARGACEPT PATENTS, (ii) no pending patent application that solely covers a method of manufacture or delivery shall be a TARGACEPT PATENT and (iii) no issued patent that solely covers a method of manufacture or delivery shall be a TARGACEPT PATENT unless, with respect to a particular LICENSED PRODUCT, no third party could reasonably be expected to manufacture and market such LICENSED PRODUCT to treat the indication for which LICENSEE or any of its AFFILIATES or SUBLICENSEES is commercializing such LICENSED PRODUCT without infringing such patent in the absence of a license from LICENSEE or any of its AFFILIATES.
2.23. TERM is defined in Article 3.4.
2.24. VALID CLAIM shall mean a claim of a pending or issued and unexpired LICENSED PATENT so long as such LICENSED PATENT (i) if a pending patent application, is being prosecuted in good faith and shall not have been irrevocably abandoned or finally disallowed without the possibility of appeal or re-filing or (ii) if an issued and unexpired patent, shall not have been finally canceled, withdrawn, abandoned or rejected by any administrative agency or other authority of competent jurisdiction, shall not have been permanently revoked, declared to be invalid, unpatentable or unenforceable in an unappealable (or unappealed within the time allowed for appeal) decision of a court or other authority or competent jurisdiction through no challenge by LICENSEE.
§ 8.1 DEFINITIONS
§ 8.1.1 Unless otherwise provided, Contract Time is the period of time, including authorized adjustments, allotted in the Contract Documents for Substantial Completion of the Work.
§ 8.1.2 The date of commencement of the Work is the date established in the Agreement.
§ 8.1.3 The date of Substantial Completion is the date certified by the Architect in accordance with Section 9.8.