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EXHIBIT 10.18 CONFIDENTIAL PROVISIONS REDACTED AMENDED AND RESTATED LICENSE AGREEMENT

License Agreement

EXHIBIT 10.18 CONFIDENTIAL PROVISIONS REDACTED AMENDED AND RESTATED LICENSE AGREEMENT | Document Parties: Australian Cancer Technology Limited | Australian Cancer Technology, Ltd | Avantogen Limited | Avantogen Oncology Ltd | Resistys INC | SCICLONE INC | SciClone Pharmaceuticals, Inc You are currently viewing:
This License Agreement involves

Australian Cancer Technology Limited | Australian Cancer Technology, Ltd | Avantogen Limited | Avantogen Oncology Ltd | Resistys INC | SCICLONE INC | SciClone Pharmaceuticals, Inc

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Title: EXHIBIT 10.18 CONFIDENTIAL PROVISIONS REDACTED AMENDED AND RESTATED LICENSE AGREEMENT
Governing Law: New York     Date: 8/8/2007
Industry: Biotechnology and Drugs     Law Firm: DLA Piper;Mayer Brown     Sector: Healthcare

EXHIBIT 10.18 CONFIDENTIAL PROVISIONS REDACTED AMENDED AND RESTATED LICENSE AGREEMENT, Parties: australian cancer technology limited , australian cancer technology  ltd , avantogen limited , avantogen oncology ltd , resistys inc , sciclone inc , sciclone pharmaceuticals  inc
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EXHIBIT 10.18

CONFIDENTIAL PROVISIONS REDACTED

AMENDED AND RESTATED

LICENSE AGREEMENT

This Agreement, dated as of April 25, 2007 (“2007 Effective Date”), is by and between (i) SciClone Pharmaceuticals, Inc. (“SciClone”), a Delaware corporation having its principal place of business at 901 Mariners Island Blvd., San Mateo, California 94404, and (ii) RESprotect GmbH, a German corporation having an office at Fiedlerstr. 34, D-01307 Dresden, GERMANY (hereinafter “RESprotect”).

RECITALS

WHEREAS, RESprotect possesses certain intellectual property rights related to RP101 ((E)-5-(2-bromovinyl-)2’-deoxyuridine – also known as BVDU); and

WHEREAS, Resistys INC., having an office at 2121 Avenue of the Stars, Suite 2550, Los Angeles, California 90067 including any Affiliates of Resistys (“Resistys”), Australian Cancer Technology Limited, an Australian corporation having an office at Aurora Place, Suite 4, Level 36, 88 Philip Street, Sydney 2000, Australia including any Affiliates of ACT, and RESprotect GmbH, entered into a license agreement, effective as of September 13, 2004 (“2004 License Agreement”) and, effective on the same date, Resistys and RESprotect entered into a supply agreement for Clinical Trial Material related to the 2004 License Agreement (“2004 Supply Agreement”);

WHEREAS, effective May 31, 2005, Australian Cancer Technology, Ltd. underwent a name change to “Avantogen Limited” (“Avantogen”);

WHEREAS, effective August 30, 2004, Resistys, was formed as a wholly-owned subsidiary of Avantogen for the principal purpose of entering into the 2004 License Agreement and 2004 Supply Agreement and, after several share transfers, the sole shareholder of Resistys is now Avantogen Oncology Ltd (“AOI”);

WHEREAS, Resistys and Avantogen, immediately prior to the entering into this Agreement assigned their respective interest in the 2004 License Agreement and the 2004 Supply Agreement to SciClone as of the 2007 Effective Date;

WHEREAS, SciClone desires to engage in research, development, marketing, sale and distribution of BVDU; and

WHEREAS, SciClone desires to acquire from RESprotect, and RESprotect is willing to grant to SciClone, an exclusive license in the Territory, as hereinafter defined, under RESprotect’s intellectual property rights relating to BVDU, including patents and know-how, upon the terms and conditions set forth herein.

WHEREAS, on March 15, 2007, RESprotect, Resistys, Avantogen , AOI and SciClone, signed a non-binding Term Sheet (the “March 2007 Term Sheet”) agreeing to complete certain definitive agreements by the 2007 Effective Date, including: (1) an assignment by Resistys and Avantogen to SciClone of the (a) 2004 License Agreement; (b) all assets owned or controlled by them

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related to the 2004 License Agreement or the RP101 program, including, without limitation, all (i) intellectual property rights, including inventions and know-how, whether or not patentable, (ii) data and information, (iii) regulatory filings, and (iv) agreements; (2) an assignment by Resistys to SciClone of the 2004 Supply Agreement; and (3) an agreement between Resistys/AOI and RESprotect relating to certain consideration to be paid by Resistys/ AOI to RESprotect and (4) this Agreement and the 2007 Supply Agreement between RESprotect and SciClone.

NOW, therefore, in consideration of the promises and mutual covenants herein, RESprotect and SciClone hereby amend and restate the 2004 License Agreement in its entirety to read in full as follows:

ARTICLE I

GENERAL DEFINITIONS

SECTION 1.1 The term “2007 Effective Date” shall mean the date set forth in the first and opening paragraph of this Agreement. The term “2004 Effective Date” shall mean the Effective Date of the 2004 License Agreement which was September 13, 2004.

SECTION 1.2 The term “2007 Supply Agreement” shall mean the Supply Agreement between RESprotect and SciClone concluded with equal date as this Agreement.

SECTION 1.3 The term “Affiliate” shall mean any corporation or other entity, which directly or indirectly controls, is controlled by or is under common control with a party to this Agreement. A corporation or other entity shall be regarded as in control of another corporation or entity if it owns or directly or indirectly controls more than [****] of the voting stock or other ownership interest of the other corporation or entity, or if it possesses, directly or indirectly, the power to direct or cause the direction of the management and policies of the corporation or other entity or the power to elect or appoint [****] or more of the members of the governing body of the corporation or other entity.

SECTION 1.4 The term “API” shall mean active pharmaceutical ingredient.

SECTION 1.5 The term “Asia” shall mean the countries listed under “Asia” in Exhibit A.

SECTION 1.6 The term “Clinical Trial Costs” shall mean [****].

SECTION 1.7 The term “Development” shall have the meaning set forth under Section 4.1(a).

SECTION 1.8 The term “Development Plan” shall have the meaning set forth under Section 4.1(a).

 


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SECTION 1.9 The term “Europe” shall mean the countries listed under “Europe” in Exhibit A .

SECTION 1.10 The term “FDA” shall mean the United States Food and Drug Administration and its successor agencies, if any.

SECTION 1.11 The term “First Commercial Sale” shall mean the first sale of Licensed Product by SciClone, and/or it’s Sublicensees.

SECTION 1.12 The term “Grant-Back License” shall have the meaning set forth in Section 8.1.

SECTION 1.13 The term “Improvements” shall mean any amendments, modifications of and additions to the RESprotect Patent Rights and RESprotect Know-How which are made, developed, reduced to practice or acquired by RESprotect during the term of this Agreement, including, but not limited to, such that: (i) improve the performance or efficacy of the Licensed Product, (ii) reduce any side effects, drug interactions or other adverse effects of the Licensed Product, (iii) reduce the cost and/or increase the efficiency or productivity of the manufacturing and production processes for the Product, or (iv) increase bio-availability or improve drug delivery.

SECTION 1.14 The term “Initiation of a Phase II Trial” shall mean the date when the first patient is enrolled in a Phase II Trial.

SECTION 1.15 The term “Joint Technology” shall mean any inventions made jointly by employees of SciClone or any of its Sublicensees and RESprotect or any of its Affiliates and/or it’s Other Licensees.

SECTION 1.16 The term “License” shall have the meaning set forth in Section 2.1.

SECTION 1.17 The term “Licensed Finished Product” shall mean the finished form medicinal product including the Licensed Product.

SECTION 1.18 The term “Licensed IP Rights” shall mean, collectively, the RESprotect Patent Rights and the RESprotect Know-How.

SECTION 1.19 The term “Licensed Product” shall mean the API RP101 ((E)-5-(2- bromovinyl-)2’-deoxyuridine—also known as BVDU), a salt of BVDU or a prodrug of BDVU (if developed by RESprotect) for use under the RESprotect Patent Rights, (i) which incorporates, embodies, utilizes or is based on RESprotect Know-How or (ii) the manufacture, use, importation or sale of which would, but for the rights granted hereunder, constitute infringement of a Valid Claim under the RESprotect Patent Rights.

SECTION 1.20 The term “Market Sales” shall mean with regard to all sales of Licensed Product in the Territory, the gross amount invoiced for sales of Licensed Product only and does not include any amounts invoiced to customers for customs duties or sales taxes directly related to the sale of Licensed Product, or for transportation, shipping and insurance costs.

 

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SECTION 1.21 The term “Net Sales” shall mean with respect to all sales of Licensed Product by SciClone or Sublicensees in the Territory, the gross invoiced sales price of Licensed Product less [****].

SECTION 1.22 The term “Other Licensee” shall mean any Third Party who receives a license from RESprotect under the RESprotect Patent Rights and RESprotect Know-How in relation to the Licensed Product for the territory of Europe and/ or Asia.

SECTION 1.23 The term “Patent Rights” shall mean the rights under any patent applications, issued patents and any and all substitutions, divisions, continuations, continuations-in-part, reissues, renewals, reexaminations or extensions that have issued or in the future issue from such patent applications, including utility model and design patents and certificates of invention as well as any patent term extensions, such as pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984 and any foreign equivalents.

SECTION 1.24 The term “Phase II Trial” shall mean a phase II clinical trial as defined by the FDA rules and regulations.

SECTION 1.25 The term “Preclinical and Clinical Data” shall have the meaning set forth in Article V.

SECTION 1.26 The term “RESprotect Know-How” shall mean any of RESprotect’s confidential proprietary information and materials relating to the research, development, manufacture, approval, marketing, use or sale of Licensed Product which during the term of this Agreement are or prior to this Agreement were developed by RESprotect and which RESprotect is permitted to disclose to SciClone without violating any Third Party agreements.

SECTION 1.27 The term “RESprotect Patent Rights” shall mean any Patent Rights under U.S. Patent No. 6,589,941, a patent or patents issuing on U.S. patent applications published as 20040127454 and 20060178338 only to the extent they relate to RP 101 and any US and/or Canadian patents or patent applications claiming priority to, or directly related to, the above patents or patent applications filed by RESprotect only to the extent they relate to RP 101.

SECTION 1.28 The term “SciClone Invention(s)” shall have the meaning set forth in Section 8.1.

SECTION 1.29 The term “Scale-Up Plan” shall have the meaning set forth in the 2007 Supply Agreement.

 


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SECTION 1.30 The term “Sublicensee” shall mean any Affiliate of SciClone or Third Party who receives a sublicense from SciClone relating to the License upon entering into any of the following agreements with SciClone: a sublicense agreement, research and development agreement, or alternative form of collaboration or commercialization agreement, such as, but not limited to, a co-promotion or co-marketing arrangement to research, develop, import, make (subject to Article VI of this Agreement and the provisions of the 2007 Supply Agreement), use, offer for sale, and/or sell Licensed Product in the Territory.

SECTION 1.31 The term “Territory” means the United States of America and Canada.

SECTION 1.32 The term “Third Party” shall mean any entity other than RESprotect or SciClone and their respective Affiliates.

SECTION 1.33 The term “USPTO” shall mean the United States Patent and Trademark Office

SECTION 1.34 The term “Valid Claim” shall mean a claim of an issued and unexpired patent within the RESprotect Patent Rights, which has not been held permanently revoked, unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise.

ARTICLE II

GRANT OF LICENSE/OPTION

SECTION 2.1 Grant of License Rights by RESprotect to SciClone . RESprotect hereby grants to SciClone the exclusive license to use the RESprotect Patent Rights and the RESprotect Know-how to develop, use, make (subject to Article VI of this Agreement and the provisions of the 2007 Supply Agreement), have made (subject to Article VI of this Agreement and the provisions of the 2007 Supply Agreement), sell, offer for sale and import the Licensed Product and Improvements under the RESprotect Patent Rights in the Territory (“License”).

SECTION 2.2 Sublicenses . SciClone shall have the right to grant sublicenses to the License to Sublicensees upon notification to RESprotect. Any such sublicense shall be at arm’s length and conform to the terms hereof, and SciClone shall be responsible for the performance by its Sublicensee of all obligations imposed under the terms of this Agreement.

SECTION 2.3 [****]

 


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ARTICLE III

PAYMENTS

SECTION 3.1 Milestone Payments . In consideration of the License provided hereunder, SciClone shall compensate RESprotect by paying to RESprotect by wire transfer within fifteen (15) business days after the achievement of each of the milestones set forth below, the following payments:

 

Milestone   Payment to RESprotect
Initiation of a Phase II Trial by SciClone or Sublicensees in the Territory or outside the Territory covering Licensed Product   $1.32 million US
[****]   [****]
[****]   [****]
[****]   [****]

Payments made by SciClone to RESprotect pursuant to this Section 3.1 are not refundable under any circumstances, will not be credited against royalty payments due to RESprotect pursuant to Section 3 and apply as well in the event SciClone sublicenses to a Sublicensee.

SECTION 3.2 Royalties . Following the First Commercial Sale of a Licensed Product, SciClone will pay, on a calendar quarterly basis, without offset or deduction except as set forth in this Agreement, a royalty in the amounts set forth in Section 3.3 below on Net Sales of the Licensed Product, as the case may be, during the previous quarter, calculated in U.S. Dollars.

SECTION 3.3 Royalty Calculation .

(a) In consideration of the License granted to SciClone, SciClone shall pay to RESprotect a royalty at the rates set forth below of the Net Sales of Licensed Product sold by SciClone or its Sublicensees as follows:

 

Annual Market Sales   [****]   [****] of Net Sales
Annual Market Sales   [****]   [****] of Net Sales

 


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(b) Royalty Payment Reports; Exchange Rates . During the term of this Agreement following the First Commercial Sale of a Licensed Product, SciClone shall within forty-five (45) days after each calendar quarter pay to RESprotect the royalties due under the Agreement for such quarter and furnish to RESprotect a written quarterly report showing: (i) the Market Sales of the Licensed Product sold by SciClone and its Sublicensees during the reporting period and the calculation of Net Sales from such Market Sales; (ii) the royalty due thereon; (iii) withholding taxes, if any, required by law to be deducted in respect of such royalties (for the sake of clarification withholding taxes shall not be deducted from the Market Sales); and (iv) the exchange rates used in determining the amount of United States dollars. All sales in currencies other than United States dollars shall be converted into United States dollars calculated at the exchange rate published in THE WALL STREET JOURNAL on the last day of the calendar quarter. If no royalty is due for any royalty period hereunder, SciClone shall so report. SciClone shall keep complete and accurate records in sufficient detail to properly reflect all Market Sales and Net Sales to enable the royalties payable hereunder to be determined.

(c) Audits . Upon written request and advance notice of not less than thirty (30) days, SciClone shall permit an internal auditor or independent public accountant selected by RESprotect and acceptable to SciClone, which acceptance shall not be unreasonably withheld or delayed, to have access during normal business hours to such records of SciClone as may be reasonably necessary to verify the accuracy of the royalty reports described herein, in respect of any calendar year ending not more than thirty-six (36) months prior to the date of such request. All such verifications shall be conducted at RESprotect’s expense and not more than once in each calendar year. In the event such RESprotect representative concludes, providing sufficient evidence, that additional royalties were owed to RESprotect during such period, the additional royalty shall be paid by SciClone within thirty (30) days of the date RESprotect delivers to SciClone such representative’s written report so concluding. The fees charged by such representative shall be paid by RESprotect unless the audit discloses that the royalties payable by SciClone for the audited period are underpaid by more than 5%, in which case SciClone shall pay the reasonable fees and expenses charged by such representative and a further amount equal to the amount of the additional royalty. Any overpay will be refundable or credited against future royalties. SciClone shall include in each sublicense granted by it pursuant to this Agreement a provision requiring the Sublicensee to make reports to SciClone, to keep and maintain records of sales made pursuant to such sublicense and to grant access to such records by RESprotect’s representatives to the same extent required of SciClone under this Agreement. RESprotect agrees that all information subject to review under this Section 3.3(c) or under any sublicense agreement will be confidential and that RESprotect will cause its representatives to retain all such information in confidence.

SECTION 3.4 Form of Payment .

(a) Any milestone payment required to be made by SciClone to RESprotect pursuant to the terms of Section 3.1, shall be made in U.S. Dollars. SciClone shall make each milestone payment in cash when due and payable by wire transfer in immediately available funds to an account designated by RESprotect reasonably prior to the time of such payment.

(b) All royalties payable pursuant to Section 3.2 and 3.3 are calculated in U.S. Dollars and all royalty payments made by SciClone to RESprotect will be paid in cash in US dollars ($) calculated on the basis of the exchange rate as published in THE WALL STREET JOURNAL on the last day of the calendar quarter.

 

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SECTION 3.5 Third-Party License .

(a) In the event that a license from a Third Party [****] is necessary, in the sole opinion of SciClone, for SciClone to fully use the RESprotect Patent Rights under the License, SciClone shall so inform RESprotect in writing and thereafter SciClone and RESprotect will cooperate in order to conclude a license agreement with the Third Party which is reasonably acceptable to SciClone and RESprotect. RESprotect undertakes not to unreasonably withhold its acceptance and consent. The Parties shall also agree on who shall lead the negotiations with the Third Party, taking into consideration, inter alia, their respective experience and/or standing with this Third Party, if any, and geographic, language and nationality advantages. In the event that upon the consent of RESprotect SciClone enters into a license agreement with a Third Party for the Territory and is obligated to pay royalties to such Third Party [****], [****].

[****]

However, in no event shall the royalties due to RESprotect under Section 3.3 of this Agreement be reduced to less than [****] of total Net Sales.

(b) [****]

(c) For the sake of clarification, this Section 3.5 does not apply in case SciClone decides to take a Third Party license which has the purpose of combining the Licensed Product with [****]. For all costs related to any such Third Party license, SciClone shall bear the sole financial and commercial responsibility.

SECTION 3.6 Interest . Any late payment by SciClone shall bear interest at 2 percentage points over the 1 year LIBOR rate applicable at the time the payment is made.

ARTICLE IV

SCICLONE’S DEVELOPMENT OBLIGATIONS

SECTION 4.1 SciClone Diligence .

(a) At its own cost and expense, SciClone shall conduct such clinical trials and apply for all governmental approvals necessary to manufacture (unless otherwise provided herein), sell, market, and distribute Licensed Product, and to develop, submit regulatory applications for, manufacture and commercialize the Licensed Product (such activities cumulatively referred to as “Development”). SciClone is fully committed to expediting the clinical development of the Licensed Product. To that end, SciClone will undertake the

 


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development of the Licensed Product according to Protocol Number RP101-II, incorporated in IND [****] (“Phase 2 Protocol”). The development plan which is attached as Exhibit B (“Development Plan”) is a proposal by RESprotect for purposes of discussion at the first meeting of the Development Committee. SciClone and RESprotect agree to work diligently to complete the initial Development Plan at the first meeting of the Development Committee. The Development Plan may be amended from time to time in response to additional clinical and non-clinical studies which may be required by the FDA. Topics related to the Development Plan will be determined in the Development Committee (Section 4.2.)

(b) The parties acknowledge that lack of diligence in Development of the Licensed Product will diminish the value of this Agreement to RESprotect; accordingly, SciClone shall at all times put forth good faith commercially reasonable efforts in connection with Development of the Licensed Product in the Territory. SciClone agrees to make good faith commercially reasonable efforts and to use sound scientific judgment in Development of the Licensed Product; provided, however, that the parties understand and agree that the Development process and Development Plan may from time to time be subject to reasonable adjustment by SciClone in coordination with RESprotect as set forth in Section 4.2. Any substantial deviation from the Development Plan shall be submitted to the Development Committee for consideration and decision as set forth in Section 4.2.

(c) In addition, SciClone shall use good faith commercially reasonable efforts and sound scientific judgment to fully exploit the Licensed Product to the extent of its commercial potential in the Territory.

(d) Subject to Section 4. l(b) above, the parties acknowledge and agree that all decisions including, without limitation, decisions relating to SciClone’ research, development, registration, manufacture (unless otherwise provided herein), sale, commercialization, design, price, distribution, marketing and promotion of the Licensed Product in the Territory, shall be within the sole discretion of SciClone. Notwithstanding Section 4.1(b), nothing in this Agreement shall be construed as imposing on SciClone the duty to market and/or sell and exploit Licensed Product for which royalties are payable hereunder to the exclusion of, or in preference to, any other product, or in any way other than in accordance with its normal commercial practices and subject to Section 4.1(b) above.

SECTION 4.2 Development Committee .

(a) General . SciClone and RESprotect shall establish a Development Committee consisting of two representatives for each of SciClone and RESprotect. The responsibilities of the Development Committee shall be to oversee the Development Plan and the Scale-up Plan and render periodic reports at least every calendar quarter covering the status of SciClone’ Development of Licensed Product, RESprotect’s execution of the Scale-up Plan and related matters. The representatives of the Development Committee of SciClone and RESprotect shall be in a position to report on behalf of the represented parties about these matters. The Development

 


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Committee shall hold meetings at least one time every calendar quarter. The meetings may be conducted either in person or by conference call; provided, however, that at least one meeting in each calendar year will be held in person in the United States at a location to be determined by the Development Committee. Each party shall bear its costs related to participation on the Development Committee. The Development Committee shall also coordinate the development efforts by SciClone within the Territory and RESprotect’s scale-up efforts. RESprotect shall report to the Development Committee its development efforts with regard to the Licensed Product outside the Territory unless it is prevented from this by law or by confidentiality or other agreements with Third Parties.

(b) Decision-Making . The Development Committee shall have the initial right to consider any adjustments of and deviation by SciClone from the Development Plan. If within thirty (30) days after submission, the Development Committee does not reach a unanimous decision in the proposed change in the Development Plan, the proposed change in the Development Plan shall be submitted to the CEOs of SciClone and RESprotect for their consideration. If they do not agree within thirty (30) days following submission of the proposed change by the Development Committee, SciClone shall have the right of final decision.

ARTICLE V

ACCESS TO CLINICAL TRIAL DATA

The results and other data from any preclinical and clinical trials (“Preclinical and Clinical Data”) undertaken by SciClone and/ or its Sublicensees and/ or Third Parties in the United States or elsewhere in relation to the Licensed Product or otherwise generated in relation to this Agreement will be available at no cost for RESprotect for its research, regulatory and commercialization purposes outside of the Territory. SciClone will share Preclinical and Clinical Data with RESprotect’s Other Licensees in Asia and Europe for their research, regulatory and commercialization purposes in their respective territories on the following terms: (i) with respect to Asia, the Other Licensee will pay SciClone a fee equal to [****], and (ii) with respect to Europe, the Other Licensee will pay SciClone a fee equal to [****]; provided that SciClone will have thirty (30) days to review and approve all regulatory filings or other use involving Third Parties of RESprotect and its Other Licensees which rely on Preclinical and Clinical Data to ensure that such regulatory filings or other use involving Third Parties do not conflict with or otherwise adversely effect SciClone’s regulatory filings in the Territory, such approval to be provided in writing, not to be unreasonably withheld. The fee payable by RESprotect’s Other Licensees for the Preclinical and Clinical Data will be due upon receipt of the Preclinical and Clinical Data by the RESprotect’s Other Licensee, and shall be payable in installments over a period of five years from the due date. Should a RESprotect Other Licensee for

 


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Europe and/or Asia license only part of the applicable territory, the [****] (for Asia) and [****] (for Europe) fee will be adjusted in view of the actual market size of the particular territory versus the full market size of Asia or Europe, as applicable. Except as set forth above, neither RESprotect nor its permitted Other Licensees will share or otherwise transfer Preclinical and Clinical Data to any Third Party without the prior written permission of SciClone.

ARTICLE VI

SUPPLY OF LICENSED PRODUCT; MANUFACTURE AND SUPPLY OF API

SECTION 6.1 Supply of Licensed Product for Clinical Trials . Until the appropriate application(s) are filed with the FDA and FDA approval of the Licensed Finished Product is obtained, it is agreed that RESprotect will manufacture and supply SciClone with the Licensed Product as required by SciClone for conducting clinical trials and SciClone will purchase Licensed Product from RESprotect. The Licensed Product for Phase II Clinical Trials will be supplied in [****], the Licensed Product for other phases of Clinical Trials will be supplied as API prior to tableting. The details of such purchase are set forth in the 2007 Supply Agreement.

SECTION 6.2 Supply of Licensed Product for Commercial Purposes . SciClone will purchase from RESprotect the Licensed Product which it requires for the manufacture of the Licensed Finished Product after FDA approval of the Licensed Product. The details of such purchase are set forth in the 2007 Supply Agreement.

SECTION 6.3 [****]

ARTICLE VII

REPRESENTATIONS AND WARRANTIES

SECTION 7.1 Mutual Representations . SciClone and RESprotect each represent and warrant to the other on the 2007 Effective Date as follows:

(a) Organization . It is a corporation duly organized, validly existing and, as for SciClone, in good standing under the laws of the jurisdiction of its incorporation and has all requisite power and authority, corporate or otherwise, to execute, deliver and perform this Agreement.

 


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(b) Authorization . The execution, delivery and performance by it of this Agreement has been duly authorized by all necessary corporate action and does not violate any provision of any law, rule, regulation, order, writ, judgment, injunction, decree, determination or award presently in effect having applicability to it or any provision of its charter documents or any agreement or other instrument or obligation to which it is bound or its assets are subject.

(c) Binding Agreement . This Agreement is a legal, valid and binding obligation of it enforceable against it in accordance with its terms and conditions.

(d) No Inconsistent Obligation . It is not under any obligation to any person, or entity, contractual or otherwise, that is conflicting or inconsistent in any respect with the terms of this Agreement or that would impede the diligent and complete fulfillment of its obligations hereunder.

SECTION 7.2 Representation of RESprotect regarding Title to Licensed Product; Mutual Representation regarding Performance .

(a) RESprotect is the sole owner of the RESprotect Patent Rights and RESprotect Know-how, free and clear of all liens, charges, encumbrances of Third Parties and RESprotect owns the exclusive, worldwide, royalty free, sublicensable, transferable right to use the Licensed Product under the RESprotect Patent Rights and RESprotect Know-how. To RESprotect’s knowledge the patentability or validity of the RESprotect Patent Rights have not been contested or threatened to be contested by any Third Party and to RESprotect’s knowledge, there is no legitimate basis for such a claim. No infringement proceedings have been initiated against Third Parties on the basis of the RESprotect Patent Rights. All patent applications which relate to the RESprotect Patent Rights have been filed in accordance with the applicable formal requirements and none of such patent applicati


 
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