DEVELOPMENT AND LICENSE AGREEMENT

1.

DEFINITIONS.

1.1

Additional License Opportunity . “Additional License Opportunity” shall mean an opportunity to enter into a license under any Patent Rights and Know-How Controlled by SCOLR, other than the Licensed Technology, relating to the modification of the duration of the activity or effectiveness of active pharmaceutical ingredients with respect to any product containing ibuprofen or any enantiomer or salt thereof, either alone or in combination with one or more other active ingredients.

1.2

Affiliate(s). “ Affiliate(s)” shall mean, with respect to any person or entity, any other person or entity that controls, is controlled by or is under common control with such person or entity. A person or entity shall be regarded as in control of another entity if it owns or controls at least fifty percent (50%) of the equity securities of the subject entity entitled to vote in the election of directors (or, in the case of an entity that is not a corporation, for the election of the corresponding managing authority), provided, however , that the term “Affiliate” shall not include subsidiaries or other entities in which a Party or its Affiliates owns a majority of the ordinary voting power necessary to elect a majority of the board of directors or other governing board, but is restricted from electing such majority by contract or otherwise, until such time as such restrictions are no longer in effect.

1.3

ALO. “ALO” shall have the meaning set forth in Section 3.3.

1.4

CDT . “CDT” shall mean the technology Controlled by SCOLR relating to (a) compositions, compounds, ingredients or formulations of drugs characterized by or causing extended release delivery of a therapeutically effective amount of active pharmaceutical ingredient or (b) manufacturing or delivery technologies that enhance the profile of a drug to deliver an extended release of a therapeutically effective amount of drug, or both.

1.5

Combination Product. “Combination Product” shall mean any pharmaceutical product that consists of any combination of the Product sold together with another pharmaceutical product for a single invoiced price. For the avoidance of doubt, Product that contains a combination of ibuprofen or any enantiomer or salt thereof and one or more other active ingredients in a single tablet, caplet, capsule or similar unit shall not be a Combination Product unless that Product is sold together with another pharmaceutical product for a single invoiced price.

1.6

Commercialization. “Commercialization” shall mean any and all activities of using, importing, exporting, marketing, promoting, distributing, offering for sale and selling a Product. When used as a verb, “Commercialize” shall mean to engage in Commercialization.

1.7

Commercially Reasonable Efforts. “Commercially Reasonable Efforts” shall mean [***]

1.8

Confidential Information. “Confidential Information” shall mean with respect to each Party, non-public proprietary data or information that belong in whole or in part to such Party or its Affiliates or information designated as Confidential Information of such Party hereunder or both of the foregoing.

1.9

Control or Controlled. “Control” or “Controlled” shall mean with respect to any (a) item of information, including, without limitation, Know-How, or (b) intellectual property right, the possession (whether by ownership or license, other than pursuant to this Agreement) by a Party of the ability to grant to the other Party access or a license as provided herein under such item or right without violating the terms of any agreement or other arrangements with any Third Party.

1.10

Copyright. “Copyright” shall mean any copyright Controlled by Wyeth, which copyright pertains to the promotional materials and literature utilized by Wyeth in connection with the Commercialization of Products in the Territory.

1.11

Development . “Development” shall mean, on a country-by-country basis, all activities performed by or on behalf of Wyeth with respect to a Product from the effective date of an IND for such Product until Regulatory Approval of such Product is obtained in such country for the indication under study. When used as a verb, “Develop” shall mean to engage in Development.

1.12

Development Program. “Development Program” shall mean any one or all of the Initial Development Programs (which shall have the meaning set forth in Section 4.2), an Additional Development Program (which shall have the meaning set forth in Section 4.2) or an Additional Prescription Development Program (which shall have the meaning set forth in Section 4.2), as the context requires.

1.13

Diligence Cure Period . “Diligence Cure Period” shall have the meaning set forth in Section 4.1.

1.14

Execution Date. “Execution Date” shall have the meaning set forth in the preamble to this Agreement.

1.15

FDA. “FDA” shall mean the United States Food and Drug Administration or any successor agency thereto.

1.16

FD&C Act. “FD&C Act” shall mean the United States Federal Food, Drug, and Cosmetic Act, as amended, and the rules and regulations promulgated thereunder.

1.17

First Commercial Sale. “First Commercial Sale” shall mean, with respect to any Licensed Product and any country of the world, the first sale of such Licensed Product under this Agreement to a Third Party in such country, after such Licensed Product has been granted Regulatory Approval by the competent Regulatory Authorities in such country.

1.18

HSR Act. “HSR Act” shall mean the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the rules and regulations promulgated thereunder (16 C.F.R. §§ 801.1 et seq .), and any similar, applicable law, statute, rule or regulation of a non-U.S. jurisdiction.

1.19

HSR Filing. “HSR Filing” shall mean filings by Wyeth and SCOLR with the United States Federal Trade Commission and the Antitrust Division of the United States Department of Justice of a Notification and Report Form for Certain Mergers and Acquisitions (as that term is defined in the HSR Act) with respect to the matters set forth in this Agreement, together with all required documentary attachments thereto, and any similar filing that must be made in a non-U.S. jurisdiction.

1.20

HSR Clearance Date. “HSR Clearance Date” shall mean the earliest date on which the Parties have actual knowledge that all applicable waiting periods under the HSR Act with respect to the transactions contemplated hereunder have expired or have been terminated.

1.21

Improvements. “Improvements” shall mean any modification, enhancement or refinement, whether patentable or not and whether made by SCOLR alone or jointly with Wyeth, to any Product, the SCOLR Patent Rights, the SCOLR Know-How, the Joint Patent Rights or Joint Know-How or the Manufacture or use of any of the foregoing.

1.22

IND. “IND” shall mean an Investigational New Drug Application, as defined in the FD&C Act, that is required to be filed with the FDA before beginning clinical testing of a Product in human subjects, or an equivalent foreign filing.

1.23

Joint Know-How. “Joint Know-How” shall mean any Know-How that is jointly owned by the Parties pursuant to Section 7.1.

1.24

Joint Patent Rights. “Joint Patent Rights” shall mean those Patent Rights that are jointly owned by the Parties pursuant to Section 7.1.

1.25

Know-How. “Know-How” shall mean inventions, discoveries, improvements, adaptations, enhancements, data, results, information, processes, methods, techniques, materials, technology, results or other proprietary know-how, whether or not patentable.

1.26

Licensed Product. “Licensed Product” Shall Mean Any Product That (a) Contains Ibuprofen Or Any Enantiomer Or Salt Thereof, Either Alone Or In Combination With One Or More Other Active Ingredients; (b) Comprises Or Is Manufactured Using Cdt; And (c) Meets The Release Profile. “initial Licensed Product” Shall Mean The Licensed Product Identified On Exhibit 1.26 Attached Hereto And “additional Licensed Product” Shall Mean Any Licensed Product Other Than The Initial Licensed Product.

1.27

License Effective Date. “License Effective Date” shall mean the later to occur of (a) the determination made by Wyeth that a notification of this Agreement is not required to be made under the HSR Act, and (b) if notification of this Agreement is required to be made under the HSR Act, the HSR Clearance Date.

1.28

Licensed Technology . “Licensed Technology” shall mean the SCOLR Know-How, the SCOLR Patent Rights, Improvements and SCOLR’s interest in the Joint Patent Rights and Joint Know-How.

1.29

Major Market Country . “Major Market Country” shall mean (i) the United States, (ii) France, (iii) Canada, (iv) Australia, (v) the United Kingdom, (vi) Germany, (vii) Colombia, (viii) Mexico, (ix) The Netherlands, and (x) China.

1.30

Manufacture, Manufactured or Manufacturing. “Manufacture”, “Manufactured” or “Manufacturing” shall mean all activities undertaken by or on behalf of Wyeth or its Affiliates or sublicensees that are involved in the production of a Product.

1.31

Market Exclusivity . “Market Exclusivity” shall mean, with respect to each Licensed Product, the period of time during which there is no product, including without limitation any generic product, containing ibuprofen or any enantiomer or salt thereof with the same or substantially the same dosage regimen and ibuprofen content as such Licensed Product and incorporating controlled delivery or timed-release technology being sold by a Third Party other than a sublicensee or distributor of Wyeth, which product could reasonably be expected to be sold for use in the treatment of any indication for which such Licensed Product is approved by a Regulatory Authority.

1.32

Net Sales. “Net Sales” shall mean the gross amounts charged for sales of Licensed Products (on which payments are due under this Agreement) by Wyeth or its sublicensees, as appropriate, to Third Parties, less the sum of (a) and (b) where (a) is a provision, determined under Generally Accepted Accounting Principles in the United States, for (i) trade, cash and quantity discounts or trade or consumer rebates, service allowances and broker’s or agent’s commissions, if any, actually allowed or paid, (ii) credits or allowances actually given or made for rejection or return of, previously sold Licensed Products or for retroactive price reductions (including Medicaid, managed care and similar types of rebates), (iii) taxes, duties or other governmental charges levied on or measured by the billing amount (excluding income and franchise taxes), as adjusted for rebates and refunds, (iv) credits or allowances actually given or made for wastage replacement, and (v) charges actually incurred for packing, freight, and shipping from Wyeth’s or its sublicensees’ distribution center and insurance directly related to such packing, freight, and shipping of such Licensed Product and (b) is a periodic adjustment (positive or negative, as applicable) of the provision (a) to reflect amounts actually incurred for (i), (ii), (iii), (iv), and (v). In the case of any sale of Licensed Products for consideration other than cash, such as barter or counter trade, Net Sales shall be calculated on the fair market value of the consideration received. Notwithstanding the foregoing, if a Licensed Product is a Combination Product, the calculation of “Net Sales” from such Combination Product in a country shall be determined by multiplying the actual Net Sales in such country of such Combination Product, calculated as set forth above, by the fraction A/(A+B), where: A is the invoice price, in such country, of the Licensed Product contained in the Combination Product, if sold separately in such country, by Wyeth or its sublicensees, as applicable, and B is the invoice price, in such country, of any other active component or components in the Combination Product if sold separately, in such country, by Wyeth or its sublicensees, as applicable.

1.33

Paragraph IV Certification. “Paragraph IV Certification” shall have the meaning set forth in Section 7.2.4.

1.34

Patent Rights. “Patent Rights” shall mean any and all U.S. and foreign (a) patents, (b) pending patent applications, including, without limitation, all provisional applications, substitutions, continuations, continuations-in-part, divisions, renewals, and all patents granted thereon, and (c) all patents-of-addition, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms, including, without limitation, supplementary protection certificates or the equivalent thereof.

1.35

Pilot Study/FDA Meeting Milestone. “Pilot Study/FDA Meeting Milestone” shall have the meaning set forth in Section 6.2.1.

1.36

Product. “Product” Shall Mean Any Product That (a) Contains Ibuprofen Or Any Enantiomer Or Salt Thereof, Either Alone Or In Combination With One Or More Other Active Ingredients; And (b) Comprises Or Is Manufactured Using Cdt.

1.37

Regulatory Approval. “Regulatory Approval” shall mean the technical, medical and scientific licenses, registrations, authorizations and approvals (including, without limitation, approvals of New Drug Applications (“NDAs”), investigational new drug applications (“INDs”), supplements and amendments, pre- and post- approvals, pricing approvals, and labeling approvals) of any national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, necessary for the commercial manufacture, distribution, marketing, promotion, offer for sale, use, import, export and sale of Licensed Product(s) in a regulatory jurisdiction. If an explicit regulatory approval as defined above is not required, then “Regulatory Approval” shall mean all the regulatory requirements to permit the above cited activities must be met, as confirmed by Wyeth through review of the related data and documentation. For the sake of clarity, Regulatory Approval shall not be deemed to have been obtained in a country until any applicable governmental pricing and governmental reimbursement approvals have also been obtained in such country.

1.38

Regulatory Approval Application. “Regulatory Approval Application” shall mean an application submitted to the appropriate Regulatory Authority seeking Regulatory Approval of a Product for use in one or more therapeutic indications in a regulatory jurisdiction within the Territory, including with out limitation an IND application or similar filing.

1.39

Regulatory Authority. “ Regulatory Authority” shall mean any national (e.g., the FDA), supra-national (e.g., the European Commission, the Council of the European Union, or the European Medicines Agency), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity in each country of the world involved in the granting of Regulatory Approval for the Product.

1.40

Release Profile. “Release Profile” shall mean for the Initial Licensed Product the release profile set forth on Exhibit 1.40 attached hereto and for each Additional Licensed Product the release profile set forth in the Development Plan for such Additional Licensed Product.

1.41

Research. “ Research” shall mean those discovery and preclinical activities undertaken by or on behalf of Wyeth or its Affiliates with respect to a Product prior to the Development of such Product, including, without limitation, medicinal chemistry, pharmacology, preclinical toxicology, and formulation of such Product. When used as a verb “Research” shall mean to engage in Research.

1.42

RFN Notice. “RFN Notice” shall have the meaning set forth in Section 3.3.

1.43

Royalty Period. “Royalty Period” shall mean the period of time beginning on the License Effective Date and, on a Licensed Product-by-Licensed Product and country-by-country basis, extending until the earlier of (a) the termination of this Agreement, pursuant to Article 10 hereof, either in its entirety or with respect to such Licensed Product in such country, and (b) the twenty (20) year anniversary of the First Commercial Sale of such Licensed Product in such country.

1.44

SCOLR Know-How . “SCOLR Know-How” shall mean all Know-How Controlled by SCOLR as of the Execution Date or that comes under the Control of SCOLR during the term of the Agreement relating to CDT, including, without limitation, all data, results or other Know-How arising from or invented, created or made in the course of the Development Program and all other data, results, studies, clinical trials and other similar items relating to the Products and all of the foregoing submitted to any Regulatory Authority, and also including, without limitation, any joint interest of SCOLR in any of the foregoing, but excluding any of the foregoing that is or becomes generally available to the public without cost or license.

1.45

SCOLR Patent . “SCOLR Patent” shall mean any patent or patent application listed on Exhibit 1.45 and any patent granted on any such application.

1.46

SCOLR Patent Rights . “SCOLR Patent Rights” shall mean any and all Patent Rights claiming or relating to CDT or SCOLR Know-How, which Patent Rights are Controlled by SCOLR as of the Execution Date or that come under the Control of SCOLR during the term of the Agreement, including, without limitation, the SCOLR Patents, and also including, without limitation, any joint interest of SCOLR in any of the foregoing other than the Joint Patent Rights.

1.47

SCOLR Trademarks and Copyrights. “SCOLR Trademarks and Copyrights” shall mean the CDT ^® mark and any other trademark, service mark or copyright right Controlled by SCOLR and necessary for Wyeth to meet its obligation under Section 7.3 hereof or any other provision of this Agreement.

1.48

Territory. “Territory” shall mean the entire world.

1.49

Third Part(y/ies). “Third Part(y/ies)” shall mean any person(s) or entit(y/ies) other than Wyeth, SCOLR or their respective Affiliates.

1.50

Trademark. “Trademark” shall mean those trademarks and service marks used in connection with the Commercialization of any Product by Wyeth hereunder.

1.51

Valid Claim. “Valid Claim” shall mean a claim that (a) in the case of any unexpired United States or foreign patent, shall not have been donated to the public, disclaimed, nor held invalid or unenforceable by a court or government agency of competent jurisdiction in an unappealed or unappealable decision, or (b) in the case of any United States or foreign patent application, (i) shall not have

been cancelled, withdrawn or abandoned, without being refiled in another application in the applicable jurisdiction, (ii) shall not have been finally rejected by an administrative agency or other governmental action from which no appeal can be taken and (iii) shall not have been pending for more than five (5) years, and in either case which claim (if issued) would be infringed by the sale of any Licensed Product. For purposes of this definition, the time period for which a claim is pending shall begin on the priority date for such claim and shall continue until such claim is either issued or is no longer deemed to be a Valid Claim in accordance with the preceding sentence regardless of whether such claim is amended or refiled in another application in the applicable jurisdiction. If a claim of a patent application that ceased to be a Valid Claim under (b) due to the passage of time later issues as part of a patent described within (a) then it shall again be considered to be a Valid Claim effective as of the issuance of such patent.

2.

TRANSFER OF TECHNOLOGY.

2.1

Technology Transfer .

2.1.1

Initial Technology Transfer . Within thirty (30) days after the License Effective Date, SCOLR shall provide Wyeth with tangible embodiments of the Licensed Technology to the extent practicable for Wyeth’s and its sublicensees’ and subcontrators’ use in the Research, Development, Manufacturing and Commercialization of Products under this Agreement, as more fully described in Exhibit 2.1.1.

2.1.2

Additional Technology Transfer . At Wyeth’s request from time to time, SCOLR shall provide full technical assistance to Wyeth and shall provide Wyeth with any additional documentation or information deemed necessary or desirable by Wyeth to transfer the Licensed Technology to Wyeth, including without limitation, assistance, documentation and information relating to process and manufacturing technology, analytical methods, scale up, and process and equipment validation. SCOLR shall provide up to [***] per employee-hour plus reasonable travel and other reasonable, related expenses approved by Wyeth in writing in advance, for a total reimbursement not to exceed [***] in the aggregate unless approved by Wyeth in writing in advance. All travel by SCOLR representatives must be in accordance with Wyeth’s travel and entertainment policies as in effect from time to time.

3.

LICENSES.

3.1

License Grants.

3.1.1

Exclusive License to Wyeth. SCOLR, effective as of the License Effective Date, hereby grants to Wyeth an exclusive (exclusive even as to SCOLR) license, with the right to grant sublicenses, under the Licensed Technology to Research, Develop, formulate, use, have used, Manufacture, make, have made, offer for sale, sell, have sold, import and otherwise Commercialize Products in the Territory. Wyeth shall notify SCOLR of any sublicenses granted by Wyeth pursuant to this Section 3.1.1 periodically.

3.1.2

Non-Exclusive License to Wyeth. SCOLR, effective as of the License Effective Date, hereby grants to Wyeth a nonexclusive license under any Patent Rights and Know-How that (i) are not included in the Licensed Technology, (ii) are Controlled by SCOLR as of the License Effective Date or come into the Control of SCOLR during the term of this Agreement and (iii) but for the license granted under this Section 3.1.2 would be infringed by the exercise of any of the rights or licenses granted to Wyeth under Section 3.1.1 hereof, with the right to grant sublicenses, to Research, Develop, formulate, use, have used, Manufacture, make, have made, offer for sale, sell, have sold, import and otherwise Commercialize Products in the Territory. Wyeth shall notify SCOLR of any sublicenses granted by Wyeth pursuant to this Section 3.1.2 periodically.

3.1.3

Grant Back to SCOLR. Wyeth, effective as of the License Effective Date, hereby grants to SCOLR a limited, non-exclusive, non-transferable sublicense under the Licensed Technology for the sole purpose of permitting SCOLR to perform its Licensed Product Development obligations described in this Agreement.

3.1.4

Retention of Rights. Wyeth acknowledges that SCOLR shall retain the right to use and have used the SCOLR Know-How and the SCOLR Patent Rights in connection with products other than Products.

3.2

Right of Reference. SCOLR hereby grants to Wyeth an exclusive “Right of Reference,” as that term or any similar term is defined in 21 C.F.R. § 314.3(b) or any foreign counterpart to such regulation, to and an exclusive right to use Product related pre-clinical, clinical, manufacturing and technical data and results, and related regulatory documents Controlled by SCOLR, including without limitation all data and results from any Development Program, and SCOLR shall provide a signed statement to this effect, if requested by Wyeth, in accordance with 21 C.F.R. § 314.50(g)(3) or any foreign counterpart to such regulation.

3.3

Right of First Negotiation . If at any time during the term of this Agreement SCOLR proposes or intends to enter into any Additional License Opportunity with any Third Party, or if SCOLR receives any proposal or indication of interest from a Third Party with respect to any Additional License Opportunity that

SCOLR intends to pursue (an “ALO”), SCOLR shall provide written notice to Wyeth of such proposal or intent, along with reasonable details regarding such Additional License Opportunity (such notice from SCOLR to Wyeth referred to as a “RFN Notice”). SCOLR hereby grants to Wyeth a right of first negotiation with respect to each ALO. With respect to each ALO, during the period of [***] from the date of the relevant RFN Notice, SCOLR shall provide to Wyeth all information reasonably requested by Wyeth with respect to such ALO and Wyeth shall inform SCOLR whether Wyeth desires to negotiate an agreement between SCOLR and Wyeth relating to such ALO. If Wyeth notifies SCOLR that it desires to negotiate an agreement between SCOLR and Wyeth relating to an ALO, SCOLR and Wyeth shall in good faith negotiate transaction terms and conditions and an agreement relating to the relevant Additional License Opportunity during the [***] period (or such longer period as may be agreed to by Wyeth and SCOLR) following the date of the notice by Wyeth referred to in clause (a) or (b) above, and during such period SCOLR and its directors, officers, representatives and agents shall discontinue all, and shall not initiate, encourage or engage in any, discussions with any Third Party with respect to such Additional License Opportunity. If Wyeth and SCOLR do not execute an agreement with respect to such Additional License Opportunity despite their good faith efforts to do so in the period of time referred to in the preceding sentence, SCOLR shall be free to enter into an agreement, within [***] after the discontinuation of negotiations between SCOLR and Wyeth, for such Additional License Opportunity with one or more Third Parties on terms no less favorable to SCOLR than the terms last offered by SCOLR to Wyeth. In order to keep Wyeth fully informed of potential Additional License Opportunities, SCOLR shall notify Wyeth promptly after becoming aware of any invention, development, license or acquisition that could be the subject of an Additional License Opportunity. In addition to the foregoing, from time to time, SCOLR shall disclose any new technology relating to the modification of the duration of the activity or effectiveness of active pharmaceutical ingredients suitable for use with any product containing ibuprofen or any enantiomer or salt thereof, either alone or in combination with one or more of the active ingredients, that SCOLR Controls and, if requested by Wyeth, negotiate in good faith with Wyeth the license rights with respect thereto.

3.4

Exclusivity . During the Term of this Agreement, SCOLR shall not, and shall not authorize or grant any rights or licenses to any Third Party to, research, develop, manufacture or commercialize any product, whether over-the-counter or prescription, that contains ibuprofen or any enantiomer or salt thereof, either alone or in combination with one or more other active ingredients, including without limitation any product that contains an amount of active ingredient(s) that is different from the amount contained in a particular Product. For the avoidance of doubt, the Parties acknowledge and agree that this Agreement confers upon Wyeth exclusive rights under the license grants contained above to both prescription and over the counter Products, and SCOLR shall not grant to any Third Party any rights with respect to products the development, manufacture, sale, importation or use of which would violate or conflict with the exclusive rights granted to Wyeth hereunder.

4.

RESEARCH AND DEVELOPMENT.

4.1

Conduct of Research and Development Activities. Subject to Section 4.2, Wyeth shall have the sole authority and responsibility with respect to the Research and Development of Products and shall use Commercially Reasonable Efforts to Research and Develop at least one (1) Licensed Product for purposes of seeking Regulatory Approval for the Commercialization of such Licensed Product in one or more countries in the Territory, either itself or through Third Parties. If Wyeth fails to use such Commercially Reasonable Efforts as set forth in the preceding sentence, SCOLR shall send written notice of such failure to Wyeth and if Wyeth does not cure such failure within [***] days after receiving such notice from SCOLR (the “Diligence Cure Period”), SCOLR shall have the right, exercisable during the [***] day period following the end of the Diligence Cure Period, to convert the exclusive licenses granted to Wyeth under Section 3.1 to semi-exclusive licenses (i.e., SCOLR would be permitted to grant a license under the Licensed Technology to one other Party to commercialize time-released ibuprofen). Such conversion to semi-exclusive licenses shall be SCOLR’s sole and exclusive remedy in the event that Wyeth fails to use Commercially Reasonable Efforts to Research and Develop at least one (1) Licensed Product for purposes of seeking Regulatory Approval for the Commercialization of such Licensed Product in one or more countries in the Territory. Wyeth shall have no other diligence obligations with respect to the Research or Development of Products. [***]. Wyeth acknowledges that the conversion of Wyeth’s rights to semi-exclusive will allow SCOLR to compete with Wyeth with products that contain ibuprofen or any enantiomer or salt thereof and comprises or is manufactured using CDT.

4.2

Research and Development Program. Within a reasonable period of time after the License Effective Date, SCOLR and Wyeth shall establish a coordinated development program (the “Initial Development Program”) to complete the formulation and clinical development of the Initial Licensed Products. Exhibit 4.4 sets forth a description of the Initial Development Program for the Initial Licensed Product, and includes the roles and responsibilities of Wyeth and SCOLR with respect to Development.

4.3.

Dispute Resolution. In the event of any disagreement between SCOLR and Wyeth with respect to any matter concerning the Initial Development Program, or any Additional Development Program or Additional Prescription Development Program added to this Agreement by amendment, which disagreement the Parties are unable to resolve despite their good faith efforts to do so, the matter shall be referred to the heads of research and development of Wyeth Consumer Healthcare and SCOLR. If these individuals cannot reach agreement on the issue, the matter shall be referred to the President of Wyeth Consumer Healthcare (or an executive officer of Wyeth Consumer Healthcare designated by such president) and the Chief Executive Officer of SCOLR (or an executive officer of SCOLR designated by such chief executive officer). If these individuals cannot reach agreement on the issue, then the President of Wyeth Consumer Healthcare (or an executive officer of Wyeth designated by such president) shall have authority to make the final decision.

4.4.

Reimbursement. Wyeth shall reimburse SCOLR for the actual costs of Initial Development Program activities for the Initial Licensed Product performed by SCOLR pursuant to the Initial Development Program after achievement of the Pilot Study/FDA Meeting Milestone, which reimbursable costs are set forth in Exhibit 4.4. For Additional Licensed Products and Additional Prescription Licensed Products, the Additional Development Program and the Additional Prescription Development Program, respectively, added to this Agreement by amendment, shall specify the costs of SCOLR, if any, that would be reimbursed by Wyeth.

4.5

Ownership of Data . All information, data and results (including, without limitation, all clinical and pre-clinical data) relating to the Licensed Products (including, without limitation, to the safety, efficacy and/or performance of the Licensed Products) generated during any Development Program by either Wyeth or SCOLR shall be the exclusive property of Wyeth and SCOLR shall execute such documents and perform such acts, at Wyeth’s expense, as may be necessary to vest title thereto in Wyeth. SCOLR shall not, and shall not authorize any Third Party to, use any such information, data or results without Wyeth’s prior written consent, which consent may not be unreasonably withheld. All other Know-How relating to any Development Program or any Licensed Product generated during the Term of this Agreement shall be treated as follows:

(i)

Know-How independently developed, discovered, invented or otherwise conceived by Wyeth, whether patentable or not, would be solely owned by Wyeth;

(ii)

Know-How independently developed, discovered, invented or otherwise conceived by SCOLR, whether patentable or not, would be solely owned by SCOLR, but would be licensed to Wyeth under Section 3.1.1; and

(iii)

Know-How jointly developed, discovered, invented or otherwise conceived by the Parties, whether patentable or not, would be jointly owned by the Parties, but SCOLR’s rights therein would be licensed to Wyeth under Section 3.1.1.

5.

MANUFACTURING AND COMMERCIALIZATION OF PRODUCTS; REGULATORY MATTERS.

5.1

Manufacturing and Commercialization. Pursuant to the licenses granted to Wyeth in Section 3.1, Wyeth shall have the exclusive right to (a) Manufacture, itself or through Third Parties selected by Wyeth or both, Products, and (b) Commercialize, itself or through Third Parties selected by Wyeth or both, Products (including all ingredients and components thereof). Wyeth shall notify SCOLR prior to having any Third Party Manufacture Product. Wyeth shall have sole authority and responsibility in all matters relating to the Manufacture and Commercialization of Products; provided, however , Wyeth shall use Commercially Reasonable Efforts to Commercialize at least one (1) Licensed Product in those countries where Wyeth has obtained Regulatory Approval for such Product. Wyeth shall have no other diligence obligations with respect to the Manufacture or Commercialization of Products.

5.2

Regulatory Approvals. Wyeth shall file, in its name (except as set forth below), and own all Regulatory Approval Applications and Regulatory Approvals for Products where Wyeth, in its sole discretion, determines it is commercially advantageous to do so. If requested by Wyeth, SCOLR shall file, at Wyeth’s expense, an NDA with FDA for the Initial Licensed Product and at Wyeth’s further request SCOLR shall transfer such NDA to Wyeth without any further compensation for such transfer. Wyeth shall have the sole responsibility for communicating with any Regulatory Authority regarding any Regulatory Approval Application or any Regulatory Approval once granted. As reasonably requested by Wyeth from time to time, SCOLR shall cooperate with Wyeth and provide support and assistance, without additional charge to Wyeth, in Wyeth’s efforts to obtain and maintain Regulatory Approvals for Products. In addition, SCOLR shall assign and transfer to Wyeth all Regulatory Approval Applications and Regulatory Approvals granted to, or applied for by, SCOLR or its Affiliates and shall provide hard copies of all documentation relating thereto, including without limitation clinical studies.

5.3

Regulatory Reporting. Wyeth shall be solely responsible for filing all reports required to be filed in order to maintain any Regulatory Approvals granted for Products in the Territory, including, without limitation, adverse drug experience reports (other than reports required to maintain Regulatory Approvals for Products that are owned by SCOLR pursuant to the mutual agreement of SCOLR and Wyeth). To the extent SCOLR has or receives any information regarding any adverse drug experience which may be related to the use of any Product, SCOLR shall immediately, and in no event later than three (3) calendar days of receipt by SCOLR, provide Wyeth with all such information in English as follows:

a.

Facsimile: [***]; or

b.

Overnight courier (only) to: