These excerpts taken from the PDLI 10-Q filed May 5, 2009.
Section 1.1 Definitions. As used in this Agreement, the following terms shall have the meanings ascribed to them below. Terms used in this Agreement that are not otherwise defined herein shall have their respective meanings as set forth in the Asset Purchase Agreement.
Acquisition has the meaning set forth in the recitals.
Affiliate means, with respect to any Person, any other Person that directly or indirectly Controls, is Controlled by or is under common Control with such first Person. A Person will be deemed to Control another Person if such first Person has the power to direct or cause the direction of the management and policies of such other Person, whether through ownership of securities, by contract or otherwise.
Governmental Rules means any applicable law, judgment, order, award, decree, statute, ordinance, rule or regulation issued or promulgated by any Governmental Entity.
Losses means any and all damages, losses, Taxes, Liabilities, Claims, judgments, penalties, costs and expenses, including reasonable attorneys fees and litigation expenses.
PDL has the meaning set forth in the introductory paragraph.
Person means any individual, corporation, partnership, limited liability company, joint venture, trust, business association, organization, Governmental Entity or other entity.
Term has the meaning set forth in Section 5.1.
Transaction Documents mean any and all agreements between PDL and Buyer executed in connection with or arising under the Acquisition.
Transfer Taxes means any sales, use, services, transfer or similar taxes imposed on PDLs provision of Transition Services to Buyer.
Transition Services mean those services set forth on Exhibit A, which shall be consistent with PDLs practices during the six (6) months prior to the Effective Date for similar services performed by PDL in connection with the Business.
Transition Services Team has the meaning set forth in Section 2.2(c).
Section 1.2 Interpretation.
(a) When used in this Agreement, the words include, includes and including shall be deemed to be followed by the words without limitation.
(b) Any terms defined in the singular shall have a comparable meaning when used in the plural, and vice-versa.
(c) All references to any introductory paragraph, recitals, Articles, Sections, Exhibits and Schedules shall be deemed references to the introductory paragraph, recitals, Articles, Sections, Exhibits and Schedules to this Agreement unless otherwise specifically set forth herein.
(d) This Agreement shall be deemed drafted jointly by Buyer and PDL and shall not be specifically construed against either party based on any claim that such party or its counsel drafted this Agreement.
All terms used herein without definition shall have the meanings assigned to them in the Purchase Agreement.
These excerpts taken from the PDLI 10-K filed Mar 2, 2009.
All references to Exhibits, Articles and Sections shall be references to Exhibits, Articles and Sections of this Agreement. In addition, except as otherwise expressly provided herein, the following terms in this Agreement shall have the following meanings:
1.01 Affiliate shall mean, with respect to a party hereto, any corporate or other entity which, directly or indirectly, controls, is controlled by, or is under common control with such party where control means the ownership of not less than 50% of the voting shares of a
corporation, or decision-making authority as to an unincorporated entity; provided that such entity shall be an Affiliate only so long as such control exists.
1.02 Combination Product(s) shall mean any product containing both a pharmaceutically active agent or ingredient which constitutes a Licensed Product and one or more other pharmaceutically active agents or ingredients which do not constitute Licensed Products.
1.03 Licensed Product(s) shall mean human therapeutic products of ELAN or ELANs sublicensees that include an Antibody developed by ELAN binding to the alpha subunit of the VLA-4 integrin whose development, manufacture, import, use or sale would, but for a license under this Agreement, infringe a Valid Claim. Antibody as used herein shall include, without limitation, monospecific and bispecific antibodies; less than full-length antibody forms such as Fv, Fab, and F(ab)2; single-chain antibodies; and antibody conjugates bound to a toxin, label or other moiety.
1.04 Net Sales shall mean the aggregate gross revenues, whether in cash or in kind, derived by or payable from or on account of the sale of Licensed Products by ELAN, its Affiliates and its sublicensees to an independent third party not an Affiliate or sublicensee of either ELAN or ELANs sublicensee, less amounts actually incurred or provided for (a) credits, allowances, discounts or rebates, if any, granted on account of price adjustments, recalls, rejection or return of items previously sold, (b) excise and sales taxes, duties or other taxes imposed on and paid with respect to such sales (excluding income or franchise taxes of any kind) and (c) outer packing, freight and freight insurance costs. If ELAN or any of its Affiliates or sublicensees receive any consideration (whether in cash or otherwise) in lieu of all or part of any royalties otherwise payable for any Licensed Product sold or otherwise transferred to an independent third party not an Affiliate of the seller or transferor, the fair market value of such consideration on the date of such transfer as known to ELAN, or as reasonably estimated by ELAN if unknown, shall be included in the definition of Net Sales. For purposes of the foregoing sentence, consideration paid to Elan from its Affiliates or sublicensees in the form of fees, milestones, collaboration payments or supply payments shall not be deemed consideration in lieu of royalties (i.e., not part of Net Sales) hereunder if such consideration is not intended to and does not result in a reduction, credit, allowance, rebate or other offset against payment of any royalties otherwise payable for any Licensed Product sold or otherwise transferred to an independent third party.
1.05 PDL Patent Rights means the patent applications or patents (as well as any foreign counterparts thereto filed by PDL before or during the term of this Agreement) identified on Exhibit A, including any additions, continuations, continuations-in-part or divisions thereof or any substitute applications therefor; any patents issued with respect to such patent applications, any reissues, extensions or patent term extensions of any such patents, and any confirmation patents or registration patents or patents of addition based on any such patents.
1.06 Valid Claim means (a) any claim in any issued patent included in the PDL Patent Rights which would be infringed but for the license granted under Section 2.01, and which claim has not been disclaimed or held unenforceable or invalid by a governmental agency or court of competent jurisdiction by a decision beyond right of review; and (b) any pending claim under
PDL Patent Rights which, if granted, would be infringed but for the license granted under Section 2.01, and which pending claim would be a Valid Claim if the pending claim were treated as granted.
All references to Exhibits, Articles and Sections shall be references to Exhibits, Articles and Sections of this Agreement. In addition, except as
1.02 Combination Product(s) shall mean any product containing both a pharmaceutically active agent or
ELANs sublicensees that include an Antibody developed by ELAN binding to the alpha subunit of the VLA-4 integrin whose development, manufacture, import, use or sale would, but for a license under this Agreement, infringe a Valid Claim.
Antibody as used herein shall include, without limitation, monospecific and bispecific antibodies; less than full-length antibody forms such as Fv, Fab, and F(ab)2FACE="Times New Roman" SIZE="2">; single-chain antibodies; and antibody conjugates bound to a toxin, label or other moiety.
1.05 PDL Patent Rights means the patent applications or patents (as well as any foreign
1.06 Valid Claim means (a) any claim in any issued patent included in the PDL Patent Rights which would be infringed but for
This excerpt taken from the PDLI 8-K filed Dec 23, 2008.
As used in this Agreement, the following capitalized terms shall have the following meanings:
1.1 Additional Service shall have the meaning set forth in Section 2.7(a).
1.2 Agreement Dispute shall have the meaning set forth in Section 11.
1.3 Business shall mean the PDL Business or the Facet Business, as applicable.
1.4 Default Interest Rate shall have the meaning set forth in Section 3.2(b).
1.5 Due Date shall have the meaning set forth in Section 3.2(a).
1.6 Facet Project Manager shall have the meaning set forth in Section 2.9.
1.7 Facet Services shall mean the enumerated services described on Schedule B attached hereto.
1.8 Fee or Fees shall have the meaning set forth in Section 3.1(a).
1.9 Force Majeure shall mean, with respect to a Party, an event beyond the reasonable control of such Party (or any Person acting on its behalf), which by its nature could not have been foreseen by such Party (or such Person), or, if it could have been foreseen, was unavoidable, and includes acts of God, storms, floods, earthquakes, hurricanes, riots, pandemics, fires, sabotage, strikes, lockouts, civil commotion or civil unrest, interference by civil or military authorities, acts of war (declared or undeclared) or armed hostilities or other national or international calamity or one or more acts of terrorism.
1.10 PDL Project Manager shall have the meaning set forth in Section 2.9.
1.11 PDL Services shall mean the enumerated services described on Schedule A attached hereto.
1.12 Schedules shall mean Schedule A and Schedule B attached hereto.
1.13 Service shall mean any of the Facet Services or the PDL Services, as applicable.
1.14 Service Provider shall mean PDL with respect to the PDL Services, and Facet with respect to the Facet Services.
1.15 Service Recipient shall mean Facet with respect to the PDL Services, and PDL with respect to the Facet Services.
1.16 Services Group shall mean any Services or group of Services identified on one of the Schedules for which a single, separate Fee is specified on such Schedule.
1.17 Services Term shall have the meaning set forth in Section 4.1.
This excerpt taken from the PDLI 10-Q filed Nov 7, 2008.
Capitalized terms used in this Agreement (other than the headings of the Sections or Articles) have the following meanings set forth in this Article 1, or, if not listed in this Article 1, the meanings as designated in the text of this Agreement.
This excerpt taken from the PDLI 8-K filed Dec 17, 2007.
1.1 Accounts Payable shall mean all of Sellers trade accounts payable, and all notes payable by Seller created or arising in respect of the Product.
1.2 Accounts Receivable shall mean all of Sellers trade accounts receivable, and all notes receivable or evidences of indebtedness payable to Seller created or arising in respect of the sale of the Product.
1.3 Affiliate with respect to any party means any entity that is directly or indirectly controlling, controlled by or under common control with such party.
1.4 API shall mean the active pharmaceutical ingredient busulfan.
1.5 Assets shall have the meaning given in Article 2.
1.6 Assumed Contracts shall have the meaning given in Section 2.1(q) and shall include the agreements, purchase orders and change orders listed in Attachment 2.1(q)(2).
1.7 Books and Records shall mean all pricing lists, material customer correspondence and related material books and records used solely and specifically with respect to the Business in the Territory by Seller or any of Sellers Affiliates.
1.8 Business shall mean the business as conducted at the Closing Date by Seller of using, making or having made, selling, marketing and supporting the Product.
1.9 Buyer Indemnitee(s) shall have the meaning given in Section 13.2.
1.10 Claim shall have the meaning given in Section 13.3.
1.11 Clinical Data shall have the meaning given in Section 2.1(k).
1.12 Closing shall have the meaning given in Section 4.1.
1.13 Closing Date shall have the meaning given in Section 4.1.
1.14 Closing Date Inventory Value Schedule shall have the meaning given in Section 3.1.
1.15 Confidential Information shall have the meaning ascribed to it in the Confidentiality Agreement.
1.16 Confidentiality Agreement shall mean that certain Mutual Confidentiality Agreement between Buyer and Seller dated September 6, 2007.
1.17 Customer Orders mean orders for Packaged Product from customers of Seller or any of Sellers Affiliates in the Territory.
1.18 Drug Product shall mean labeled or unlabelled vials containing API.
1.19 Effective Date shall mean the date first set forth in the opening paragraph of this Agreement.
1.20 Excluded Assets shall have the meaning given in Section 2.2.
1.21 Expiration Date shall have the meaning given in Section 11.1.
1.22 FDA shall mean the United States Food and Drug Administration, or any successor agency or entity thereto that may be established hereafter which has the responsibilities with respect to pharmaceutical products such as the Product.
1.23 FD&C Act shall mean the Federal Food, Drug and Cosmetic Act, 21 USC § 321 et seq.
1.24 Governmental Entity shall mean any court, tribunal, arbitrator, authority, agency, commission, regulatory, official or other instrumentality of the government of the United States or of any foreign country, any state or any political subdivision of any such government (whether state, provincial, county, city, municipal or otherwise).
1.25 HSR shall mean the United States Hart-Scott-Rodino Antitrust Improvements Act of l976, as amended, and related rules.
1.26 IND shall mean investigational new drug application number IND 46,232, initially filed September 16, 1994.
1.27 Knowledge shall mean, whenever any representation or warranty is made by Seller or Buyer to the Knowledge of the Seller or Buyer, (i) the actual knowledge of the officers of the Seller or Buyer, respectively, and (ii) the knowledge that any such person referenced in clause (i) hereof, as a prudent business person, would have obtained in the usual course of the performance of his or her professional responsibilities to such party.
1.28 Liabilities shall mean liabilities of any kind or nature, primary or secondary, direct or indirect, absolute or contingent, known or unknown, liquidated or unliquidated, including but not limited to any liabilities for claims of product liability, personal injury or death, liability in tort or contract (including unripened liabilities due to past actions or sales), indebtedness, and any FDA or other Governmental Entity action or notification, and all costs and expenses (including reasonable attorneys fees), incurred in connection with the defense of any such claims.
1.29 Licensed IP Rights shall have the meaning given in Section 2.1(b).
1.30 Material Adverse Change and Material Adverse Effect shall mean any event or situation that has a material adverse change or effect, respectively, on the operations, assets, Liabilities, results of operations, cash flows or financial condition, or relations with material customers or material suppliers, of the Business, taken as a whole, other than any such change or effect resulting from or arising in connection with (i) the announcement, performance or pendency of this Agreement or the transactions contemplated hereby, (ii) changes or conditions affecting the pharmaceutical industry, generally, (iii) changes in economic, regulatory or political conditions generally, (iv) changes in financial markets, including prevailing interest rates or market conditions; (v) developments or announcements, including product approvals and clinical trial results with respect to competitive or potentially competitive therapies or products, (vi) resignations or departures of employees engaged in the Business, (vii) fluctuations in foreign currency exchange rates, (viii) any failure to meet internal or published projections, estimates or forecasts of revenues, earnings, development timelines or other measures of financial or operating performance for any period, (ix) changes in applicable laws or interpretations thereof by Governmental Entities or (x) changes or effects that are the result of actions taken by Buyer that have an effect on the Business.
1.31 Marketing and Promotional Documents shall have the meaning given in Section 2.1(i).
1.32 NDA shall mean new drug application number NDA 20-954, initially approved February 4, 1999.
1.33 Non Product-Specific Manufacturing Information shall have the meaning given in Section 2.1(g).
1.34 Non-U.S. Marketing Approvals shall have the meaning given in Section 6.10.
1.35 Notice of Objection shall have the meaning given in Section 3.4.
1.36 Packaged Product shall mean Product in the Product Inventory purchased by Buyer hereunder that is packaged and labeled for sale to the end user.
1.37 Packaging Inventory shall have the meaning given in Section 2.1(o).
1.38 Patents shall have the meaning given in Section 2.1(a).
1.39 Product shall mean each presentation of any pharmaceutical preparation (including formulation changes and production intermediates) containing the API, whether registered, marketed or in development by Seller, as of the Closing Date, including Product marketed under the name IV Busulfex® (busulfan).
1.40 Product Inventory shall mean all of the inventory owned by Seller of bulk API, Packaged Product and Drug Product, in existence as of the Closing each of which shall have a remaining shelf-life of at least six (6) months as of the Closing Date.
1.41 Product-Specific Manufacturing Information shall have the meaning given in Section 2.1(f).
1.42 Product Specifications shall mean the specifications for bulk API, and for Drug Product, as set forth in Attachments 1.42 (a) and (b), respectively.
1.43 Purchase Price shall have the meaning given in Section 3.1.
1.44 Raw Materials and WIP shall mean all of the raw materials and work in progress owned by Seller for use in the manufacture of the Product, in existence as of the Closing, as identified in Attachment 1.44, each of which shall have a remaining shelf-life of at least six (6) months as of the Closing Date.
1.45 Registrations shall have the meaning given in Section 2.1(e).
1.46 Research and Development Materials shall have the meaning given in Section 2.1(h).
1.47 SEC shall mean the United States Securities and Exchange Commission.
1.48 Seller Indemnitees shall have the meaning given in Section 13.1.
1.49 Shared Contracts shall mean contracts and agreements to which Seller is a party which relate to the Product or the Business, but also relate to other products and businesses of Seller.
1.50 Tangible Assets shall have the meaning given in Section 2.1(l).
1.51 Tax and Taxes shall mean all present or future taxes, charges, fees, levies, duties or other assessments including, without limitation, income, excise, property, value added, real estate, sales, payroll, transfer, social security and franchise taxes imposed by any federal, state, county, or local government, or a subdivision or agency thereof. Such term shall include any interest, penalties, or additions payable in connection with such taxes, charges, fees, levies, duties, or other assessments.
1.52 Territory shall mean all the countries in the world.
1.53 Third Party Accounting Firm shall have the meaning given in Section 3.4.
1.54 Trademarks shall mean all trademarks, service marks, trade names, names, slogans, taglines, logos, design marks, trade dress, product designs, and product packaging, including all applications for and registrations of the foregoing, and including those at common law that are related to the Product.
1.55 Trademark Registrations shall have the meaning given in Section 2.1(c).
1.56 Transition Services Agreement shall mean the agreement entered into by Buyer and Seller relating to the transition of the Business, whereby Seller shall provide certain regulatory, supply chain management, intellectual property, product development and other services to Buyer, to the extent and for the periods of time and at the costs as specified therein.
1.57 Worldwide Safety Reports shall have the meaning given in Section 2.1(j).
This excerpt taken from the PDLI 10-Q filed Nov 8, 2005.
The following capitalized terms, whether used in the singular or the plural, shall have the following meanings as used in this Agreement unless otherwise specifically indicated:
*Certain information on this page has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portions.
This excerpt taken from the PDLI 8-K filed Jun 14, 2005.
Definitions. Whenever used herein, the following terms shall have their respective meanings set forth below:
(a) Affiliate means (i) an entity, other than a Parent Corporation, that directly, or indirectly through one or more intermediary entities, controls the Company or (ii) an entity, other than a Subsidiary Corporation, that is controlled by the Company directly, or indirectly through one or more intermediary entities. For this purpose, the term control (including the term controlled by) means the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of the relevant entity, whether through the ownership of voting securities, by contract or otherwise; or shall have such other meaning assigned such term for the purposes of registration on Form S-8 under the Securities Act.
(b) Award means any Option, Stock Appreciation Right, Restricted Stock Purchase Right, Restricted Stock Bonus, Restricted Stock Unit, Performance Share, Performance Unit, Deferred Compensation Award, Cash-Based Award or Other Stock-Based Award granted under the Plan.
(c) Award Agreement means a written or electronic agreement between the Company and a Participant setting forth the terms, conditions and restrictions of the Award granted to the Participant.
(d) Board means the Board of Directors of the Company.
(e) Cash-Based Award means an Award denominated in cash and granted pursuant to Section 12.
This excerpt taken from the PDLI 8-K filed Feb 16, 2005.
(a) Capitalized terms used herein without definition shall have the meanings ascribed to them in the Purchase Agreement. As used in this Agreement, the following defined terms shall have the following meanings:
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