BMRN » Topics » 1. DEFINITIONS

This excerpt taken from the BMRN 10-Q filed May 3, 2007.

Article I. DEFINITIONS

As used in this Agreement, the following terms, whether used in the singular or plural, shall have the following meanings:

1.1 “Affiliate” means any person, corporation, company, partnership, joint venture, firm or other entity which controls, is controlled by or is under common control with a Party. For purposes of this Section 1.1, “control” shall mean: (a) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) (or such lesser percentage that is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction) of the stock or shares entitled to vote for the election of directors; and (b) in the case of non-corporate entities, direct or indirect ownership of at least fifty percent (50%) of the equity interest with the power to direct the management and policies of such non-corporate entities.

1.2 “BioMarin Improvement” means variations, updates, modifications, and enhancements developed, conceived or reduced to practice by BioMarin as related to the use of rhASB, including, without limitation, any and all developments, enhancements, modifications, inventions or discoveries, to methods of treatment, purification and production for rhASB to the extent such methods of treatment, purification or production are not related to the host cell line which expresses rhASB. For the avoidance of doubt, any improvements or inventions related to or made in the course of developing the Licensed Products and during the term of the License Agreement are either BioMarin Improvements or Licensed Technology, as applicable.

1.3 “BioMarin Improvement Patent Rights” means any United States or foreign patent or patent application which discloses or claims a BioMarin Improvement.

1.4 “BioMarin Indemnitee(s)” shall have the meaning set forth in Section 9.4(b).

1.5 “Commercially Reasonable Efforts” means, with respect to the research, development, manufacture, or commercialization of Licensed Product, efforts and resources commonly used in the research-based pharmaceutical industry for a compound or product of similar commercial potential at a similar stage in its lifecycle, taking into consideration its safety and efficacy, its cost of development, the competitiveness of alternative products, its proprietary position, the likelihood, expense and time required to obtain regulatory and reimbursement approval, its profitability, and other relevant factors. Commercially Reasonable Efforts shall be determined on a market-by-market basis.


1.6 “Confidential Information” means trade secrets, know how and other confidential information (including, without limitation, technical and business information, patent information, structures, models, techniques, formula, processes, compositions, compounds, apparatus, specifications, samples, inventions and ideas) of either Party which relates to the subject matter of this Agreement, including without limitation the Licensed Product, Licensed Technology and any BioMarin Improvements, whether or not marked as proprietary or confidential, disclosed by the disclosing Party or obtained through observation or examination of the disclosing Party’s information or developments, or which, although not related to such subject matter, is nevertheless disclosed as a result of the Parties’ discussions but only to the extent that such information is maintained as confidential by the disclosing Party. Confidential Information may be disclosed orally, visually or in tangible form (whether by document, electronic media, or other form).

1.7 “Indemnify” shall have the meaning set forth in Section 9.4(a).

1.8 “Indemnifying Party” shall have the meaning set forth in Section 9.4(c).

1.9 “Indemnitee(s)” shall have the meaning set forth in Section 9.4(c).

1.10 “Inventions” shall have the meaning set forth in Section 5.1.

1.11 “Licensed Product” means recombinant human enzyme N-acetylgalactosamine-4- sulfatase (rhASB) and its precursor (collectively and separately referred to herein as rhASB) and compositions comprising same that are developed from or utilizes any part of the Licensed Technology.

1.12 “Licensed Technology” means all developments, enhancements, know-how, modifications, inventions, improvements, and discoveries in the control of WCH as of August 14, 1998 related to the Licensed Product development before August 14, 1998 and methods of production or purification of Licensed Product developed after August 14, 1998, but only to the extent applicable to the host cell line which expresses rhASB or a daughter cell line thereof, including the patent and patent applications listed in Exhibit A, attached hereto.

1.13 “Losses” shall have the meaning set forth in Section 9.4(a).

1.14 “Net Sales” means [****]

1.15 “Party” means WCH or BioMarin; “Parties” means WCH and BioMarin.

1.16 “rhASB” means recombinant human enzyme N-acetylgalatosamine 4-sulfatase.

1.17 “Term” shall have the meaning set forth in Section 8.1.

1.18 “Territory” means the entire world.

1.19 “Third Party” means any entity other than WCH, BioMarin, and their respective Affiliates.

1.20 “WCH Indemnitee(s)” shall have the meaning set forth in Section 9.4(a).

This excerpt taken from the BMRN 8-K filed Jul 6, 2005.

1. DEFINITIONS

 

The following terms shall have the following meanings, unless otherwise clearly required by the context:

 

1.1 “Affiliate” means any entity that directly or indirectly controls, is controlled by, or is under common control with a specified entity. An entity is deemed to be in control of another entity if the former has the direct or indirect power to control the management and policies of the latter.

 

1.2 “Applicable Law(s)” means all applicable laws, rules, regulations and guidelines that apply to the import, export, development, manufacturing, marketing, distribution or sale of Drug Substance and Drug Product as contemplated in this Agreement or the performance of either Party’s obligations under this Agreement, to the extent


applicable and relevant, including without limitation cGMP (as hereinafter defined) and current Good Clinical Practices standards or similar guidelines promulgated by the Regulatory Authorities (as hereinafter defined).

 

1.3 BioMarin Data” means any and all developments, enhancements, modifications, inventions or discoveries in the Other Field relating to Drug Product and under the control of BioMarin that are developed or created by BioMarin or its Affiliates or sub-licensee(s) at any time during the term of this Agreement, whether patentable or not, including, but not limited to, non-clinical and clinical data, marketing and other similar information relating to the Drug Product or Drug Substance.

 

1.4 “cGMP” means current good manufacturing practices and standards as promulgated under ICH Q7A - Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, and US Federal Food Drug and Cosmetic Act at 21 CFR and the EEC Guide to Good Manufacturing Practices for Medical Products (Vol. IV - rules governing medical products in the European Community 1989) in the most recent version.

 

1.5 “Clinical Study” means each of the pharmaceutical development studies using humans beginning at the first administration of the Drug Substance to the first volunteer or patient and ending on the completion of the final report of such study.

 

1.6 “Commercially Reasonable Efforts” means those diligent efforts that an ordinary pharmaceutical company would reasonably devote to a product of similar market potential, profit potential or strategic value resulting from its own research efforts, based on conditions then prevailing, consistent with the exercise of prudent scientific and/or business judgment in accordance with generally accepted practices in the pharmaceutical industry.

 

1.7 “Development Plan” means BioMarin’s development plan for an Indication in the Other Field, which contains at least a timeline including IND filing, major milestones of clinical development and NDA application.

 

1.8 Drug Master File” means the drug master file, as defined in 21 CFR Section 314.420, or successor provision, filed with the U.S. FDA with respect to the Drug Substance, and other filings in other countries in the Territory similar to such drug master file.

 

1.9 “Drug Substance” means the chemical substance identified as 6R-BH4 in its code name (generic name “Sapropterin”) and (6R)-2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydro-4-(3H)-pteridinone dihydrochloride in its chemical name and also known as (6R)-L-erythro-5,6,7,8-tetrahydrobiopterin dihydrochloride, for use in the Drug Product.

 

1.10 “Drug Product” means finished pharmaceutical preparations for human use containing the Drug Substance as an active ingredient.

 

1.11 DSP Drug Product Manufacturing Know-How” means all know-how and protocols relating to manufacturing and formulation of the Drug Product now in the possession of DSP and which DSP has the right to disclose and license to BioMarin.

 

1.12 DSP Drug Substance Manufacturing Know-How” means all know-how related to the manufacturing of the Drug Substance now or hereafter in the possession of DSP and Shiratori and which DSP has the right to disclose and license to BioMarin including development, enhancements, modifications, inventions or discoveries thereon.


1.13 “DSP Information” means collectively the DSP Patents, DSP Drug Product Manufacturing Know-How, DSP Drug Substance Manufacturing Know-How and Informative Know-How.

 

1.14 DSP Patents” means the patents and patent applications relating to the manufacturing, use or administration of the Drug Product and manufacturing of Drug Substance, as stipulated in Exhibit A, and any continuations, continuations-in-part, provisionals, divisionals, reissues, reexaminations, extensions, substitutions, or improvements thereon, and any patents or patent applications subsequently issued or filed related to the Drug Product and Drug Substance, in each case which is in the possession of DSP and Shiratori (as hereinafter defined) and which DSP has the right to disclose to BioMarin. .

 

1.15 Field” means all Indications (hereinafter defined) for all biochemical genetic disorders that are caused by single gene defects, but only to the extent that such biochemical genetic disorder also meets the Orphan Drug regulation requirements.

 

1.16 Indication” means a generally acknowledged disease or medical condition, a significant manifestation of a disease or medical condition, symptoms associated with a disease or medical condition or a risk for a disease or medical condition.

 

1.17 Informative Know-How” means non-clinical and clinical data, Drug Master File, and CMC information needed for all regulatory filings related to the Drug Substance or the Drug Product for the Other Field in possession of DSP and which DSP has the right to disclose and license to BioMarin.

 

1.18 “Merck Eprova Technology” means the technology licensed to BioMarin from Merck Eprova Co., Ltd. (hereinafter referred to as Merck Eprova”), under the certain License Agreement between BioMarin and Merck Eprova dated October 15, 2004, as amended January 25, 2005 (the “Merck Eprova License”), as stipulated in Exhibit B.

 

1.19 “Net Sales” means, [****]


1.20 “Orphan Drug” means a pharmaceutical drug as set forth in the Orphan Drug Act of 1983 in the USA or any corresponding laws or regulations in other countries in the Territory.

 

1.21 “Other Field” means all therapeutic, diagnostic and preventative uses of Drug Product or Drug Substance that are not Orphan Drugs applied to biochemical single gene defects (i.e., everything other than the Field as defined in the PKU agreement).

 

1.22 “Regulatory Approval” means authorization granted by a Regulatory Authority (hereinafter defined) to market and sell Drug Product in a country in the Territory that is required before Drug Product may be commercially marketed and sold in such country, including without limitation any pricing and/or reimbursement approval(s) which must be obtained before placing a Drug Product on the market in any country in the Territory in which such approval(s) is required.

 

1.23 “Regulatory Authority(ies)” means any regulatory agency, department, bureau, or other governmental entity, including without limitation the U.S. Food and Drug Administration (hereinafter referred to as “FDA”), which is responsible for issuing approvals, licenses, registrations, clearances, or authorizations necessary for the manufacture, use, storage, import, transport, marketing or sale of Drug Substance and/or Drug Product in a country in the Territory.

 

1.24 Shiratori” means Shiratori Pharmaceutical Co., Ltd., the manufacturer of the Drug Substance.

 

These excerpts taken from the BMRN 10-K filed Mar 16, 2005.

1. Definitions.

 

Unless otherwise defined herein or the context otherwise requires, the capitalized terms appearing herein shall have the respective meanings ascribed to them in the Securities Purchase Agreement dated as of May 18, 2004 by and among the Parties (the “Securities Purchase Agreement”).

 

2. Amendment. The Securities Purchase Agreement is hereby amended as follows:

 

2.1 The first clause of Section 1.3 of the Securities Purchase Agreement is hereby amended to read in its entirety as follows:

 

“The aggregate consideration for the Option Shares shall be Seventy Million Six Hundred Thousand Dollars ($70,600,000) payable as follows:”

 

2.2 Section 1.3(b) of the Securities Purchase Agreement is hereby amended to read in its entirety as follows:

 

(b) Eight Million Six Hundred Thousand Dollars ($8,600,000), payable at the Option Closing in that number of shares of BioMarin Common Stock with an aggregate value, as of the Option Closing Date, of Eight Million Six Hundred Thousand Dollars ($8,600,000) (the “Additional Payment”), as measured by the average closing sales price per share of BioMarin Common Stock over the twenty trading days immediately preceding the Option Closing Date (or to the extent the Option Closing Date is accelerated pursuant to Section 1.2(c), (d) or (e), as measured by the average closing sales price per share of BioMarin Common Stock over the twenty (20) trading days immediately preceding the Target Closing Date) (the “BioMarin Payment Shares”); provided, however, (1)(i) if BioMarin is unable to deliver such BioMarin Payment Shares on the Option Closing Date (or the Target Closing Date, if applicable), or (ii) if BioMarin determines that the representations and warranties in Section 3.12 or 3.14 are not accurate as of the Option Closing Date (or the Target Closing Date, if applicable), then in cash

 

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and, in such event, BioMarin shall have no further obligation under Section 4.8; and (2) if BioMarin delivers such BioMarin Payment Shares on the Option Closing Date (or the Target Closing Date, if applicable) and the registration statement for BioMarin Payment Shares described in Section 4.8(a) is not effective on the Option Closing Date (or the Target Closing Date, if applicable) then BioMarin shall either: (i) pay to Medicis the Additional Payment in cash; or (ii) deliver to Medicis the unregistered BioMarin Payment Shares; provided that (x) if the BioMarin Payment Shares are not registered within thirty (30) days of the Option Closing Date (or the Target Closing Date, if applicable) BioMarin shall pay the Additional Payment in cash and Medicis shall surrender to BioMarin the certificates representing the BioMarin Payment Shares delivered to Medicis on the Option Closing Date (or the Target Closing Date, if applicable) and, in such event, BioMarin shall have no further obligation under Section 4.8 and (y) if the BioMarin Payment Shares are registered within thirty (30) days of the Option Closing Date (or the Target Closing Date, if applicable) and the average closing sales price per share of BioMarin Common Stock over the twenty (20) trading days preceding the effective date of the registration statement for BioMarin Payment Shares (the “Effective Date Price”) is less than the average closing sales price per share of BioMarin Common Stock over the twenty (20) trading days immediately preceding the Option Closing Date (or the Target Closing Date, if applicable) (the “Closing Date Price”) then BioMarin shall pay to Medicis an amount in cash equal to the product of (A) the number of BioMarin Payment Shares multiplied by (B) the Closing Date Price minus the Effective Date Price; and”

 

2.3 Section 4.8(a) of the Securities Purchase Agreement is hereby amended to read in its entirety as follows:

 

(a) Registration. On or before the Option Closing Date or, in the event that the Option Closing Date is accelerated pursuant to Section 1.2(c), (d) or (e), the Target Closing Date, BioMarin shall prepare and file a registration statement on Form S-3 under the Securities Act, covering the BioMarin Payment Shares (collectively, the “Restricted Stock“) and shall use its best efforts to cause such registration statement to become effective as expeditiously as possible and to remain effective until the earliest to occur of (i) the date the Restricted Stock covered thereby has been sold (but in any event not before the expiration of any longer period required under the Securities Act) or (ii) the date by which all Restricted Stock covered thereby may be sold under Rule 144 without restriction as to volume.”

 

2.4 The definition of “License Agreement” in Exhibit A to the Securities Purchase Agreement is hereby amended to read in its entirety as follows:

 

“‘License Agreement’ shall mean that certain License Agreement by and among BioMarin, BioMarin Acquisition, Medicis and Ascent, dated as of the date hereof, as modified or amended from time to time in accordance therewith.”

 

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2.5 Revise Exhibit A to the Securities Purchase Agreement to add a definition of “Primsol Transaction”, which definition shall read in its entirety as follows:

 

Primsol Transaction” shall mean that certain license and option agreement by and between Medicis and Taro Pharmaceuticals, North America, Inc., dated January 14, 2003, as the same may be amended solely with regard to the Primsol Rights (as defined in the License Agreement).”

 

2.6 The definition of “Permitted Encumbrances” in Exhibit A to the Securities Purchase Agreement is hereby amended to read in its entirety as follows:

 

Permitted Encumbrances” shall mean the Lyne License, Permitted Liens, the Security Agreement and the Primsol Transaction.”

 

3. No Other Amendments. Except as expressly provided in Section 2 hereof, the Securities Purchase Agreement is not otherwise being amended, modified or supplemented, and it shall remain in full force and effect in accordance with its terms.

 

4. Incorporation by Reference. Sections 9.2, 9.3, 9.4, 9.7, 9.8, 9.9, 9.10, 9.11, 9.12, 9.13, and 9.14 of the Securities Purchase Agreement are hereby incorporated by reference herein and are made a part of this Amendment to the same extent and with the same force as if fully set forth herein.

 

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IN WITNESS WHEREOF, the Parties have caused this Amendment to be executed and delivered by their duly authorized representatives as of the day and year first above written.

 

MEDICIS PEDIATRICS, INC.   BIOMARIN PEDIATRICS INC.

By:

 

/s/ Mark A Prygocki, Sr.


 

By:

 

/s/ G. Eric Davis


Its:

 

Chief Financial Officer/Sec./Treasurer

 

Its:

 

Vice President

MEDICIS PHARMACEUTICAL CORPORATION   BIOMARIN PHARMACEUTICAL INC.

By:

 

/s/ Mark A Prygocki, Sr.


 

By:

 

/s/ Jeffrey H. Cooper


Its:

 

Executive Vice President,

Chief Financial Officer

 

Its:

 

Vice President, Controller/

Chief Financial Officer

 

[Amendment to Securities Purchase Agreement Signature Page]

Article 1.0 DEFINITIONS

 

The following terms shall have the following meanings, unless otherwise clearly required by the context:

 

1) “Affiliate” means any entity that directly or indirectly controls, is controlled by, or is under common control with a specified entity. An entity is deemed to be in control of another entity if the former has the direct or indirect power to control the management and policies of the latter.

 

2) “Applicable Law(s)” means all applicable laws, rules, regulations and guidelines that apply to the import, export, development, manufacturing, marketing, distribution or sale of Drug Substance and Drug Product as contemplated in this Supply Agreement or the performance of either Party’s obligations under this Supply Agreement, to the extent applicable and relevant, including without limitation cGMP and current Good Clinical Practices standards or similar guidelines promulgated by the Regulatory Authorities.


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3) “cGMP” means current good manufacturing practices and standards as promulgated under ICH Q7A - Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, US Federal Food Drug and Cosmetic Act at 21 CFR and the EEC Guide to Good Manufacturing Practices for Medical Products (Vol. IV - rules governing medical products in the European Community 1989) in the most recent version.

 

4) “Drug Substance” means the chemical substance identified as 6R-BH4 in its code name (generic name “Sapropterin”) and (6R)-2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydro-4-(3H)-pteridinone dihydrochloride in its chemical name and also known as (6R)-L-erythro-5,6,7,8-tetrahydrobiopterin dihydrochloride, for use in the Drug Product and to be manufactured in accordance with all applicable regulatory requirements related to pharmaceutical products, including U.S. cGMP and European EP requirements.

 

5) “Drug Product” means finished pharmaceutical preparations for human use containing the Drug Substance as an active ingredient.

 

6) “Genetic Disorders” means all biochemical genetic disorders that are caused by single gene defects, but only to the extent that such biochemical genetic disorder also meets the Orphan Drug (hereinafter defined) regulation requirements.

 

7) “Orphan Drug” means pharmaceutical drug as set forth in the Orphan Drug Act of 1983 in the USA or any corresponding laws or regulations in other countries in the Territory.

 

8) “Regulatory Authority(ies)” means any regulatory agency, department, bureau, or other governmental entity, including without limitation the U.S. Food and Drug Administration (“FDA”), which is responsible for issuing approvals, licenses, registrations, clearances, or authorizations necessary for the manufacture, use, storage, import, transport, marketing or sale of Drug Substance and/or Drug Product in a country in the Territory.

 

9) “Territory” shall mean all countries of the world other than Japan.

 

SECTION 2 - DEFINITIONS

 

In addition to the terms defined elsewhere in this Agreement, the as used in this Agreement the following terms, whether used in the singular or plural, shall, have the following respective meanings:

 

2.1 “Affiliates” means any individual, company, partnership or other entity, which directly or indirectly, at present or in the future, controls, is controlled by or is under common control with a Party.

 

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2.2 “BioMarin Field of Use” means use of the Product in the field of single gene disorders, including the indication of phenylketonuria (“PKU”). Specifically excluded is any single-gene disorder based on mutation or deletion of the nitric oxide synthase gene.

 

2.3 “Development Agreement” means that certain Development and Initial Supply Agreement by and between the Parties and dated November 19, 2003.

 

2.4 “Dollars” or “$” means United States dollars.

 

2.5 “Drug Product” means a finished pharmaceutical ready for application and containing the (6R)-5,6,7,8-Tetrahydro-L-biopterin dihydrochloride (Tetrahydrobiopterin, BH4) as the active ingredient.

 

2.6 “Epro’s Field of Use” means use of the Drug Product in the field of endothelial dysfunctions using modulation of nitric oxide synthase.

 

2.7 “Epro Technology” means Epro’s rights under the provisional patent application titled “Crystalline Forms of (6R)-L-erythro-tetrahydrtobiopterin dihydrochloride” as filed with the U.S. Patent and Trademark Office, Serial No. 60/520,377 and any continuations, continuations-in-part, provisionals, divisionals, reissues, reexaminations, extensions, substitutions or improvements thereon and any patents or patent applications subsequently filled or issued based on such patent or Epro’s technology related to the stabilization of the active ingredient of the Drug Product.

 

2.8 “Net Sales” means the gross sales price for sales, or other transfers of Drug Product, sold world-wide, calculated in US Dollars, received by BioMarin or its Affiliates or sublicensees, from a purchaser of Drug Product, who is not an Affiliate of BioMarin, less (to the extent appropriately documented the following reasonable amounts: (a) credits and allowances for price adjustment, rejection, or return of Drug Product previously sold; (b) rebates, quantity and cash discounts to purchasers allowed and taken; (c) amounts for third party transportation, insurance, handling or shipping charges to purchasers; and (d) taxes, duties and other governmental charges levied on or measured by the sale of Drug Product, whether absorbed by BioMarin or paid by the purchaser so long as BioMarin’s respective price is reduced thereby, but not franchise or income taxes of any kind whatsoever. Net Sales also includes the fair market value of any non-cash consideration received by BioMarin or its Affiliates or sub-licensees, as applicable, for the sale or transfer of Drug Product. Transfer of Drug Product between BioMarin and its Affiliates or sub-licensees shall not be considered a Net Sale for purposes of ascertaining royalty charges. In such circumstances, the gross sales price and resulting Net Sales price shall be based upon the sale of Drug Product by the transferee.

 

2.9 “Project Intellectual Property Rights” has the meaning assigned to such term in the Development Agreement.

 

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ARTICLE 1. DEFINITIONS

 

The following terms shall have the following meanings, unless otherwise clearly required by the context:

 

1) “Affiliate” means any entity that directly or indirectly controls, is controlled by, or is under common control with a specified entity. An entity is deemed to be in control of another entity if the former has the direct or indirect power to control the management and policies of the latter.

 

2) “Applicable Law(s)” means all applicable laws, rules, regulations and guidelines that apply to the import, export, development, manufacturing, marketing, distribution or sale of Drug Substance and Drug Product as contemplated in this Agreement or the performance of either Party’s obligations under this Agreement, to the extent applicable and relevant, including without limitation cGMP (as hereinafter defined) and current Good Clinical Practices standards or similar guidelines promulgated by the Regulatory Authorities.

 

3) “BIOMARIN Improvement” means any and all developments, enhancements, modifications, inventions or discoveries in the Field relating to Drug Product and under the control of BIOMARIN that are developed or created by or on behalf of BIOMARIN at any time during the term of this Agreement, whether patentable or not, including, but not be limited to, developments, inventions or discoveries intended to enhance the safety or efficacy of Drug Product, and all intellectual property rights thereto which are necessary or useful for BIOMARIN to exercise the rights licensed to it under Section 2.1 (License Grant) of this Agreement.

 

4) “cGMP” means current good manufacturing practices and standards as promulgated under ICH Q7A - Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, US Federal Food Drug and Cosmetic Act at 21 CFR and the EEC Guide to Good Manufacturing Practices for Medical Products (Vol. IV - rules governing medical products in the European Community 1989) in the most recent version.

 

5) “Commercially Reasonable Efforts” means those diligent efforts that an ordinary pharmaceutical company would reasonably devote to a product of similar market potential, profit potential or strategic value resulting from its own research efforts, based on conditions then prevailing, consistent with the exercise of prudent scientific and/or business judgment in accordance with generally accepted practices in the pharmaceutical industry.

 

6) “Drug Master File” means the drug master file, as defined in 21 CFR Section 314.420, or successor provision, filed with the U.S. FDA with respect to the Drug Substance, and other filings in other countries in the Territory similar to such drug master file.

 

7) “Drug Substance” means the chemical substance identified as 6R-BH4 in its code name (generic name “Sapropterin”) and (6R)-2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydro-4-(3H)-pteridinone dihydrochloride in its chemical name and also known as (6R)-L-erythro-5,6,7,8-tetrahydrobiopterin dihydrochloride, for use in the Drug Product and to be manufactured in accordance with all applicable regulatory requirements related to pharmaceutical products, including U.S. cGMP and European EP requirements.

 

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8) “Drug Product” means finished pharmaceutical preparations for human use containing the Drug Substance as an active ingredient.

 

9) “Drug Product Patent” means the patent applications relating to the manufacturing of the Drug Product, as stipulated in Exhibit A, and any continuations, continuations-in-part, provisionals, divisionals, reissues, reexaminations, extensions, substitutions, or improvements thereon, and any patents or patent applications subsequently issued or filed related to the Drug Product, in each case that is in the possession of DSP and which DSP has the right to disclose to BIOMARIN.

 

10) “Drug Substance Patent” means the patents relating to the manufacturing of the Drug Substance, as stipulated in Exhibit B, and any continuations, continuations-in-part, provisionals, divisionals, reissues, reexaminations, extensions, substitutions, or improvements thereon, and any patents or patent applications subsequently issued or filed related to the Drug Substance, in each case which is in the possession of DSP and SHIRATORI and which DSP has the right to disclose to BIOMARIN.

 

11) “DSP Drug Product Manufacturing Know-How” means all know-how and protocols relating to manufacturing and formulation of the Drug Product now in the possession of DSP and which DSP has the right to disclose and license to BIOMARIN.

 

12) “DSP Drug Substance Manufacturing Know-How” means all know-how related to the manufacturing of the Drug Substance now or hereafter in the possession of DSP and SHIRATORI and which DSP has the right to disclose and license to BIOMARIN including development, enhancements, modifications, inventions or discoveries thereon.

 

13) “DSP Formulation” means the granule form of the Drug Product contemplated by the DSP Drug Product Manufacturing Know-How and/or the Drug Product Patent.

 

14) “DSP Improvement” means any and all developments, enhancements, modifications, inventions or discoveries in the Field indirectly relating to the Drug Product and under the control of DSP that are developed or created by or on behalf of DSP at any time during the term of this Agreement, whether patentable or not, including, but not be limited to, developments, inventions or discoveries intended to enhance the safety or efficacy of Drug Product, and all intellectual property rights thereto which are necessary or useful for BIOMARIN to exercise the rights licensed to it under Section 2.1 (License Grant) of this Agreement. It is expressly understood that the DSP Improvement does not include the Drug Product Patent, the Drug Substance Patent, the DSP Drug Product Manufacturing Know-How or the DSP Drug Substance Manufacturing Know-How.

 

15) “Field” means all indications for Genetic Disorders (hereinafter defined).

 

16) “Genetic Disorders” means all biochemical genetic disorders that are caused by single gene defects, but only to the extent that such biochemical genetic disorder also meets the Orphan Drug (hereinafter defined) regulation requirements.

 

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17) “Informative Know-How” means non-clinical and clinical data, Drug Master File, and CMC information needed for all regulatory filings related to the Drug Substance or the Drug Product for the Field in possession of DSP and/or SHIRATORI and which DSP has the right to disclose and license to BIOMARIN.

 

18) “Manufacturing Step” means the manufacturing steps of the Drug Substance as stipulated in Exhibit C.

 

19) “Net Sales” means, with respect to Drug Product, gross sales by BIOMARIN or its sub-licensees of the Drug Product to third parties in the applicable country in the Territory, less:

 

(a) bad debts related to the Drug Product; and

 

(b) sales returns, rebates and allowances, including, without limitation, trade, quantity and cash discounts; and

 

(c) any other adjustments, including, but not limited to, adjustments granted on account of price adjustments, billing errors, rejected goods, damaged or defective goods, recalls, returns, rebates, charge-back rebates, reimbursements or similar payments granted or given to wholesalers or other distributors, buying groups, health care insurance carriers or other institutions, adjustments arising from consumer discount programs, freight, postage, transportation, and insurance, customs or excise duties, sales tax, consumption tax, and other taxes (except income taxes) or duties relating to sales, and any payment in respect of sales to any governmental authority in respect of any government-subsidized program.

 

20) “Non-DSP Formulation” means a form of the Drug Product other than the DSP Formulation, such as a tablet or capsule. Notwithstanding the foregoing, simply repackaging the DSP Formulation, such as dispensing the DSP Formulation in a capsule as opposed to a sachet, shall be considered as the DSP Formulation.

 

21) “Orphan Drug” means pharmaceutical drug as set forth in the Orphan Drug Act of 1983 in the USA or any corresponding laws or regulations in other countries in the Territory.

 

22) “Regulatory Approval” means authorization granted by a Regulatory Authority (hereinafter defined) to market and sell Drug Product in a country in the Territory that is required before Drug Product may be commercially marketed and sold in such country, including without limitation any pricing and/or reimbursement approval(s) which must be obtained before placing a Drug Product on the market in any country in the Territory in which such approval(s) is required.

 

23) “Regulatory Authority(ies)” means any regulatory agency, department, bureau, or other governmental entity, including without limitation the U.S. Food and Drug Administration (FDA), which is responsible for issuing approvals, licenses, registrations, clearances, or authorizations necessary for the manufacture, use, storage, import, transport, marketing or sale of Drug Substance and/or Drug Product in a country in the Territory.

 

24) “SHIRATORI” means Shiratori Pharmaceutical Co., Ltd., the manufacturer of the Drug Substance.

 

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Execution Copy

 

25) “Territory” shall mean all countries of the world other than Japan.

 

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