LICENSE AGREEMENT

EXHIBIT 10.3

Execution Version

LICENSE AGREEMENT

by and between

ALTUS PHARMACEUTICALS INC.

and

CYSTIC FIBROSIS FOUNDATION THERAPEUTICS, INC.

DATED FEBRUARY 20, 2009

Portions of this Exhibit are omitted and have been filed separately with the Secretary of the
Commission pursuant to the Registrant’s application requesting confidential treatment under Rule
24b-2 of the Exchange Act

TABLE OF CONTENTS

Portions of this Exhibit are omitted and have been filed separately with the Secretary of the
Commission pursuant to the Registrant’s application requesting confidential treatment under Rule
24b-2 of the Exchange Act

Portions of this Exhibit are omitted and have been filed separately with the Secretary of the
Commission pursuant to the Registrant’s application requesting confidential treatment under Rule
24b-2 of the Exchange Act

LICENSE AGREEMENT

This License Agreement (this “ Agreement ”), is made as of February 20, 2009 (the “Effective Date” ), by and between Altus Pharmaceuticals Inc., a Delaware corporation ( “Altus” ), and Cystic Fibrosis Foundation Therapeutics, Inc., a Maryland corporation ( “CFFT” ) and collectively, with Altus, the “Parties,” and each a “Party” ).

Recitals

NOW, THEREFORE, in consideration of the foregoing and of the respective covenants and undertakings hereunder and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Parties hereto do hereby agree as follows:

1. DEFINITIONS.

      1.1. “ AAA ” has the meaning assigned to it in Section 13.10 .

      1.2. “ Affiliate” of any Party means any Person, directly or indirectly controlling, controlled by, or under common control with that Party. For purposes of this definition, “ control ” means (a) in the case of corporate entities, direct or indirect ownership of more than 50% of the stock or shares having the right to vote for the election of directors and (b) in the case of non-corporate entities, direct or indirect ownership of at least 50% of the equity interest with the power to direct the management and policies of that non-corporate entity, provided , however , that the term “Affiliate” shall not include subsidiaries or other entities in which a Party owns a majority of the ordinary voting power necessary to elect a majority of the board of directors or

Portions of this Exhibit are omitted and have been filed separately with the Secretary of the
Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 
24b-2 of the Exchange Act

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. “ Agreement” has the meaning assigned to it in the preamble.

      1.4. “Alliance Agreement” has the meaning assigned to it in Recital A.

      1.5. “ Altus Patent Rights ” means each of those Patent Rights described on Schedule 1.5 , which constitute all Patent Rights included in the Intellectual Property.

      1.6. “Altus Trademark” means each of those trademarks, trademark applications, brand names, or trade names listed on Schedule 1.6 , which constitute the only such trademarks, trademark applications, brand names or trade names used exclusively or principally in association with Trizytek as of the Effective Date.

      1.7. “ Applicable Law” means, in relation to any Person, transaction or event, all relevant laws, statutes, regulations and orders of all governmental bodies having jurisdiction (whether administrative, legislative, executive or otherwise), and all judgments, orders and decrees of all courts, arbitrators, commissions or bodies exercising similar functions having jurisdiction over the Person, transaction or event in question.

      1.8. “Approval Date” means (i) in the case of Product that is regulated as a drug by the FDA, the earlier of the date on which CFFT or its Sublicensee receives from the FDA an approvable letter under 21 C.F.R. § 314.110 or an approval letter under 21 C.F.R. § 314.105, or (ii) in the case of Product that is regulated as a biologic by the FDA, the earlier of the date on which CFFT or its Sublicensee receives from the FDA an approval letter or biologics license under 21 C.F.R. § 601.4.

      1.9. “Assigned Patent Right” means each of those Patent Rights described on Schedule 1.9 , which constitute those Patent Rights that (i) are owned by Altus immediately prior to the Effective Date and (ii) would otherwise have been included in the Altus Patent Rights but which exclusively Cover (x) the composition of any Product, (y) any method of making any Product, or (z) any method of using any Product, and are therefore being assigned to CFFT pursuant to Section 2.9 .

      1.10. “Authorized Representatives” has the meaning assigned to it in Section 7.1.

      1.11. “Calendar Quarter ” means a three-month period ending on the last day of March, June, September or December in any year.

      1.12. “ Calendar Year” means a twelve-month period from January 1 through December 31 of any particular year.

Portions of this Exhibit are omitted and have been filed separately with the Secretary of the
Commission pursuant to the Registrant’s application requesting confidential treatment under Rule
24b-2 of the Exchange Act

      1.13. “ Commercialize ” means to promote, market, distribute, sell or use for commercial purpose any product, and “ Commercializing ” and “ Commercialization ” shall be interpreted accordingly.

      1.14. “ Commercially Reasonable Efforts” means, with respect to the efforts to be expended by any Party with respect to any objective, reasonable, diligent, good faith efforts to accomplish such objective. With respect to any objective relating to the Development, Manufacture or Commercialization of a Product by any Party, “Commercially Reasonable Efforts” shall mean those efforts and resources normally used by a biotech or pharmaceutical company with respect to a product owned by such company or to which such company has similar rights which is of similar market potential at a similar stage in the development or life cycle of such product, taking into account issues of safety, efficacy, product profile, the competitiveness of the marketplace, the proprietary position of the product, the regulatory structure involved, profitability of the product and other relevant commercial factors. Commercially Reasonable Efforts shall be determined on a market-by-market basis and the level of effort may change over time, reflecting changes in the status of the Product and of the market involved.

      1.15. “Competitor Infringement” means Third Party infringement of any Altus Patent Right through the actual or proposed manufacture, use or sale of a pharmaceutical product that contains one or more of the following enzymes: lipase, protease or amylase, alone or in combination.

      1.16. “ Confidential Information” means, with respect to each Party, all Know-How or other information, including proprietary information and materials (whether or not patentable), regarding such Party’s technology, products, business information or objectives, that is communicated in any way or form by the Disclosing Party to the Receiving Party, on or after the Effective Date of this Agreement, and whether or not such Know-How or other information is identified as confidential at the time of disclosure; provided that, information not identified as confidential by the Disclosing Party shall be deemed to be Confidential Information of the Disclosing Party if the Receiving Party knows, or should have had a reasonable expectation, that the information communicated by the Disclosing Party is Confidential Information of the Disclosing Party. The terms and conditions of this Agreement shall be considered Confidential Information of both Parties. Information disclosed by a Party under the Alliance Agreement or under any other prior agreement between the Parties that was required thereunder to be kept confidential shall be treated as Confidential Information under this Agreement.

      1.17. “ Control” or “Controlled” means, with respect to any item of information, material or intellectual property right, the possession, ownership, lease, license (other than a license granted pursuant to this Agreement), use or having held for use, directly or indirectly, by, on behalf of or for the account of a Person, or by control over an Affiliate by such Person, of the ability to grant to another Person access or a license or sublicense as provided herein without violating the terms of any agreement with any Third Party.

Portions of this Exhibit are omitted and have been filed separately with the Secretary of the
Commission pursuant to the Registrant’s application requesting confidential treatment under Rule
24b-2 of the Exchange Act

      1.18. “ Cover,” “Covered,” or “Covering” means, with respect to a Patent Right, that, in the absence of a license granted to a Person under a Valid Claim included in such Patent Right, the practice by such Person of an invention claimed in such Patent Right would infringe such Valid Claim (or, in the case of a Patent Right that is a patent application, would infringe a Valid Claim in such patent application if it were to issue as a patent).

      1.19. “ Develop” means to engage in Development.

      1.20. “ Development” shall mean any pre-clinical, non-clinical or clinical research and any drug development activity, including discovery, research, toxicology, pharmacology and other similar efforts, test method development and stability testing, process development, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, clinical studies (including pre- and post-approval studies), regulatory affairs, pharmacovigilance and all activities directed to obtaining any Regulatory Approval, including any marketing, pricing or reimbursement approval, and to “ Develop ” shall be interpreted accordingly.

      1.21. “ Disclosing Party” has the meaning assigned to it in Section 7.1 .

      1.22. “ Effective Date” has the meaning assigned to it in the preamble.

      1.23. “ FDA” means the United States Food and Drug Administration or any successor agency having comparable jurisdiction.

      1.24. “ Field” means all uses and all indications.

      1.25. “GAAP” means generally accepted accounting principles.

      1.26. “HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the rules and regulations promulgated thereunder.

      1.27. “HSR Filing” means filings by each of Altus and CFFT 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.

      1.28. “ IND” means an Investigational New Drug Application filed with the FDA in the United States with respect to Product and “IND Equivalent” means any similar application filed with the Regulatory Authority in any other country in the Territory with respect to Product.

      1.29. “Initial Priority Amount” has the meaning assigned to it in Section 5.2 .

      1.30. “Intellectual Property” means all Altus Patent Rights, trademarks, trademark applications, brand names, trade names, trade secrets, software, copyrights, copyright applications, inventions, technologies, Know-How, formulae, processes, all other intellectual

Portions of this Exhibit are omitted and have been filed separately with the Secretary of the
Commission pursuant to the Registrant’s application requesting confidential treatment under Rule
24b-2 of the Exchange Act

property and applications for any of the foregoing Controlled by Altus and all proprietary rights to such Intellectual Property Controlled by Altus, in each case as of the Effective Date, which are used or useful for the Development, Manufacture or Commercialization of Product. For clarity, “Intellectual Property” includes (i) all such intellectual property Controlled by Altus as of the Effective Date that covers the composition of, formulation of, or any method of making, method of delivering, or method of using, any or all of the following enzymes: lipase, protease or amylase, individually or in any combination and (ii) all developments to, enhancements in, and new versions or improvements of the Intellectual Property, whether or not patentable, which were invented, developed, discovered or otherwise acquired by or for Altus as a result of the development activities under the Alliance Agreement.

      1.31. “ Know-How” means any inventions, discoveries, data, information, trade secrets, processes, methods, techniques, materials (including biological materials), technology, developments, enhancements, improvements, results, cell lines, biological materials, compounds, probes, sequences or other know-how, whether or not patentable.

      1.32. “Letter Agreement” has the meaning assigned to it in Recital B.

      1.33. “ Licensed Activities ” has the meaning assigned to it in Section 8.1(c)(i) .

      1.34. “ Manufacturing ” means activities directed to producing, manufacturing, processing, filling, finishing, packaging, labeling, quality assurance testing and release, shipping and storage of a product and the “ Manufacture ” shall be interpreted accordingly.

      1.35. “ NDA” means a New Drug Application as described in 21 C.F.R. § 314 or a Biological License Application (BLA) as described in 21 C.F.R. § 601.2 filed with the FDA in the United States with respect to Product and “ NDA Equivalent ” means any similar regulatory marketing approval application filed with the Regulatory Authority in any other regulatory jurisdiction in the Territory with respect to Product.

      1.36. “Net Profits” means, on an Product-by-Product basis, the amount, if any, by which Net Sales obtained from the sale of such Product in the Territory exceeds the sum of the Selling Person’s:

      (a) manufacturing costs;

      (b) sales and marketing expenses, including all costs of marketing, promotion and advertising, including sample costs, detailing costs, costs for preparing and reproducing detailing aids, Product promotional materials and other promotional materials, costs of professional education, Product related public relations, relationships with opinion leaders and professional societies, market research, healthcare economics studies, marketing studies related to the Product, and other similar activities directly related to the Product. direct and indirect expenses, such as samples, medical education;

Portions of this Exhibit are omitted and have been filed separately with the Secretary of the
Commission pursuant to the Registrant’s application requesting confidential treatment under Rule
24b-2 of the Exchange Act

      (c) distribution expenses;

      (d) clinical and regulatory expenses for such Product incurred after marketing approval;

      (e) intellectual property expenses, including all expenses of (i) filing, prosecuting, maintaining and enforcing patents, trademarks, copyrights and other intellectual property rights necessary or useful for Development, Manufacture or Commercialization of such Product, (ii) any third party license fees, including any license fee, royalty or other amount payable to any Third Party under any current or future agreement to obtain any such intellectual property right, and (iii) any additional intellectual property related costs (such as litigation costs and settlements); and

      (f) all other similar, post-approval costs and expenses properly allocable to the Product under GAAP,

in each case to the extent allocable under GAAP to such Net Sales of such Product in the Territory.

      1.37. “ Net Sales” means the [*] for any sale of any Product by CFFT or any CFFT Affiliate as applicable (a “ Selling Person ”), to a non-Affiliate of the Selling Person, less the following deductions, in each case to the extent specifically related to the Product and taken by the Selling Person or otherwise paid for or accrued by the Selling Person (“ Permitted Deductions ”):

      (a) trade, cash, promotional and quantity discounts and wholesaler fees;

      (b) taxes on sales (such as excise, sales or use taxes or value added taxes) [*];

      (c) freight, insurance, packing costs and other transportation charges [*];

      (d) amounts repaid or credits taken by reason of damaged goods, rejections, defects, expired dating, recalls or returns or because of retroactive price reductions;

      (e) charge back payments and rebates granted to [*]; and

      (f) documented custom duties actually paid by the Selling Person.

Sales of Products between or among CFFT and its Affiliates for resale, or for use in the production or manufacture of any Product, shall not be included within Net Sales; provided , however , that any subsequent sale of such Product (or any Product produced or manufactured using such Product) by CFFT or its Affiliate to a non-Affiliate Third Party shall be included within Net Sales.

Portions of this Exhibit are omitted and have been filed separately with the Secretary of the
Commission pursuant to the Registrant’s application requesting confidential treatment under Rule
24b-2 of the Exchange Act

If a Product is sold as part of a bundle of distinct products ( i.e. , one price is charged for a number of distinct products that are not packaged together with another Product, the Net Sales for such Product shall be based on the ratio of the Wholesale Acquisition Cost for such Product to the sum of the Wholesale Acquisition Costs for each product in such bundle. By way of example, if the Wholesale Acquisition Cost for such Product when sold separately is $10, and the sum of the Wholesale Acquisition Costs for each product in such bundle when sold separately is $40, then the Net Sales attributable to the Product when sold as part of the bundle would be twenty-five percent (25%) of the Net Sales of the bundle of products sold by the Selling Person.

      1.38. “Non-Compete Period” has the meaning set forth in Section 2.7.

      1.39. “ Out-of-Pocket Costs” means costs and expenses either (a) paid to Third Parties by either Party or its Affiliates, (b) payable to Third Parties and accrued by either Party or its Affiliates in accordance with GAAP applied in a manner consistent with the accruing entity’s standard accounting for such costs generally or (c) paid to Altus by CFFT pursuant to this Agreement or the Letter Agreement with respect to the purchase of raw materials or paid to Altus by CFFT for the fulfillment of any obligations to Third Parties for services rendered for the benefit of CFFT pursuant to a Non-Assignable Trial Agreement (as defined in the Letter Agreement) or for any other work specifically related to Development of the Product. Such costs include, without limitation, clinical grants, materials, the costs of prosecuting and maintaining Patent Rights and costs of a similar nature. Capital equipment costs (other than depreciation) associated with chemical or process development shall not be treated as Out-of-Pocket Costs.

      1.40. “Patent Right” means any (a) patent, (b) pending patent application, including, without limitation, any provisional application, substitution, continuation, continuation-in-part, division or renewal, or any patent granted thereon, (c) any patent-of-addition, reissue, reexamination or extension or restoration by any existing or future extension or restoration mechanism, including, without limitation, any supplementary protection certificate or the equivalent thereof, (d) inventor’s certificate, (e) other form of government-issued right substantially similar to any of the foregoing or (f) any United States or foreign counterpart of any of the foregoing. Patent Rights existing as of any specified date shall include any patent or other Patent Right based on, claiming priority to or arising from any Patent Right existing on such date.

      1.41. “ Person” means any natural person, corporation, firm, business trust, joint venture, association, organization, company, partnership or other business entity, or any government, or any agency or political subdivisions thereof.

      1.42. “Proceeds” has the meaning provided in Section 5.1 .

      1.43. “ Product” means any pharmaceutical product that contains one or more of the following enzymes: lipase, protease or amylase, alone or in combination including, without limitation, the product currently identified by Altus as “Trizytek” and any derivatives thereof.

Portions of this Exhibit are omitted and have been filed separately with the Secretary of the
Commission pursuant to the Registrant’s application requesting confidential treatment under Rule
24b-2 of the Exchange Act

      1.44. “ Receiving Party” has the meaning assigned to it in Section 7.1 .

      1.45. “ Regulatory Approval ” shall mean any technical, medical, scientific, marketing or other license, registration, authorization or approval of any local, state, national or international regulatory authority (including, without limitation, any approval of a New Drug Application or Biologic License Application) necessary for the Development, Manufacture or Commercialization of a pharmaceutical product in any jurisdiction.

      1.46. “Sublicensee” shall mean any Person who has received, directly or indirectly, from CFFT a sublicense or other grant of rights with respect to any right licensed to CFFT by Altus pursuant to Section 2.3 .

      1.47. “Sued Party” has the meaning assigned to it in Section 8.1(c)(ii) .

      1.48. “Territory” means all countries of the world.

      1.49. “Third Party” means any Person other than a Party or an Affiliate of a Party.

      1.50. “Third Party License Agreement” means any Third Party agreement pursuant to which Altus in-licenses Intellectual Property. All material Third Party License Agreements are described on Schedule 1.50 hereof.

      1.51. “Third Party IP Rights” has the meaning assigned to it in Section 8.1(c)(ii) .

      1.52. “Trizytek” means liprotamase, a non-sterile, orally administered biotechnology product that contains highly purified preparations (drug substances) of amylase (from Aspergillus oryzae ), a crystallized protease (from Aspergillus melleus ), and a crystallized, cross-linked form of lipase (from Burkholderia cepacia ) referred to as Lipase-CLEC, each prepared individually. The three drug substances are blended together along with inactive excipients to prepare the final drug product.

      1.53. “Valid Claim” means a claim (a) of any issued, unexpired patent that has not been revoked or held unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction from which no appeal can be taken, or with respect to which an appeal is not taken within the time allowed for appeal, and that has not been disclaimed or admitted to be invalid or unenforceable through reissue, disclaimer, or otherwise, or (b) of any patent application that has not been cancelled, withdrawn, or abandoned or been pending for more than ten years.

      1.54. [*] has the meaning assigned to it in Schedule 1.50.

      1.55. [*] has the meaning assigned to it in Schedule 1.50.

Portions of this Exhibit are omitted and have been filed separately with the Secretary of the
Commission pursuant to the Registrant’s application requesting confidential treatment under Rule
24b-2 of the Exchange Act

      1.56. “ Wholesale Acquisition Cost ” for any product means the list price for wholesalers, distributors and other direct accounts before any rebates, discounts, allowances or other price concessions that might be offered by the supplier of the product.

2. GRANTS OF RIGHTS.

      2.1. License Grant by Altus. Subject to the terms and conditions of this Agreement, Altus hereby confers upon CFFT an exclusive, [*] license to practice and use the Intellectual Property to Develop, have Developed, Manufacture, have Manufactured and Commercialize Products for use in the Field in the Territory. The license granted hereby shall be [*]. To the extent that the Intellectual Property includes copyrights covering software or other documentation, CFFT shall have the right to make, retain and use such copies of such software and documentation as are reasonably necessary to exercise its rights hereunder.

      2.2. Retained Rights of Altus. Nothing in this Agreement grants to CFFT any right to any use of the name Altus or any similar trademark or trade name.

      2.3. Sublicenses. CFFT shall have the right to sublicense [*] under the license granted under Section 2.1 above to [*]. Prior to granting any such sublicense, CFFT shall ensure that all of the terms and conditions of this Agreement for the benefit of Altus, to the extent applicable, shall apply to such Sublicensee to the same extent as they apply to CFFT for all purposes of this Agreement. Notwithstanding the foregoing [*]. CFFT shall promptly provide Altus with a copy of any such sublicense agreement, provided that such copy may be redacted to remove any confidential information not related to the royalty rate, milestones or any other economic terms of the sublicense.

      2.4. Third Party License Agreements.

      (a) License Grant Subject to Agreements. CFFT acknowledges and agrees that any Intellectual Property Controlled by Altus under any Third Party License Agreement is being licensed by Altus to CFFT hereunder subject and subordinate to the terms of such Third Party License Agreement in effect as of the Effective Date. CFFT shall provide Altus, on Altus’ written request, any information required to be provided by Altus to any Third Party under the terms of a Third Party License Agreement.

      (b) CFFT Payments. CFFT shall pay to Altus or, at CFFT’s option, directly to any Third Party licensor under each Third Party License Agreement, all payments required to be made to such Third Party by Altus as a result of (i) the achievement by CFFT or its Affiliates or Sublicensees of any event requiring payment by Altus to the Third Party, or (ii) the sale of any Product by CFFT, its Affiliates or Sublicensees.

      (c) No Modification. No Third Party License Agreement shall be modified or otherwise amended by Altus after the Effective Date in any way that would increase

Portions of this Exhibit are omitted and have been filed separately with the Secretary of the
Commission pursuant to the Registrant’s application requesting confidential treatment under Rule
24b-2 of the Exchange Act

any payment or other obligation of CFFT under this Agreement without CFFT’s prior written consent.

      2.5. License Grant by CFFT. Subject to the terms of this Agreement, CFFT hereby grants to Altus and its Affiliates a non-exclusive license under the Intellectual Property to Develop, have Developed, Manufacture and have Manufactured Products in the Field, solely to the extent required in order for Altus to perform its obligations under this Agreement or the Letter Agreement.

      2.6. No Implied Rights. Except and only to the extent expressly provided for in this Agreement, neither Party grants to the other Party any license or other right under any intellectual property right.

      2.7. Competing Products. Until the earlier of [*] (the “Non-Compete Period” ), neither Altus nor any of its Affiliates shall (a) [*] compete with any Product ( “Competing Product” ), or (b) [*]; provided that notwithstanding the foregoing, this Section 2.7 shall not allow Altus to [*] if doing so would breach the terms of the exclusive license grant to CFFT pursuant to Section 2.1 . The prohibitions of this Section 2.7 shall not apply to any future Affiliate of Altus to the extent that such future Affiliate is [*] solely on the basis of [*], provided that with regard to each of clause (a) and (b), such future Affiliate is not a direct or indirect subsidiary of Altus and Altus does not otherwise hold, directly or indirectly, a majority of the equity securities or other voting power in such future Affiliate.

      2.8. Section 365(n) of Bankruptcy Code. All rights and licenses now or hereafter granted under or pursuant to any Section of this Agreement, including Section 2.1 , are rights to “intellectual property” (as defined in Section 101(35A) of Title 11 of the United States Code, as amended (such Title 11, the “ Bankruptcy Code ”)). In the event of the commencement of a bankruptcy proceeding by or against Altus under the U.S. Bankruptcy Code, Altus hereby grants to CFFT a right of access to and to obtain possession of and to benefit from (a) copies of pre-clinical and clinical research data and results, (b) laboratory samples, (c) product samples and inventory, (d) Intellectual Property, (e) copies of laboratory notes and notebooks, all of which constitute “embodiments” of intellectual property pursuant to Section 365(n) of the Bankruptcy Code, and (j) copies of all other embodiments of such intellectual property in Altus’ Control. Altus agrees not to interfere with CFFT’s exercise of rights and licenses to intellectual property licensed hereunder and embodiments thereof in accordance with this Agreement and agrees to use Commercially Reasonable Efforts to assist CFFT to obtain such intellectual property and embodiments thereof in the possession or control of Third Parties as reasonably necessary or desirable for CFFT to exercise such rights and licenses in accordance with this Agreement. The Parties acknowledge and agree that all payments by CFFT to Altus hereunder constitute royalties within the meaning of Section 365(n) of the Bankruptcy Code or relate to licenses of intellectual property hereunder.

      2.9. Assignment of Assigned Patent Rights and Altus Trademarks. Altus hereby assigns to CFFT as of the Effective Date, pursuant to assignments in the form attached as

Portions of this Exhibit are omitted and have been filed separately with the Secretary of the
Commission pursuant to the Registrant’s application requesting confidential treatment under Rule
24b-2 of the Exchange Act

Exhibit 2.9, (i) the Assigned Patent Rights and (ii) the Altus Trademarks. All expenses incurred in recording or otherwise effecting any such assignment shall be paid by CFFT.

3. PRODUCT DEVELOPMENT.

      3.1. General . Subject to the terms and conditions of this Agreement and the Letter Agreement, CFFT shall be responsible for Development of Products under this Agreement in the Territory and the costs and expenses of such Development.

      3.2. Clinical Development. Subject to the terms and conditions of this Agreement and the Letter Agreement, CFFT shall have control of all clinical Development of Products under this Agreement in the Territory and the authority to make all decisions and regulatory filings in connection with Development of Products in the Territory.

      3.3. Clinical and Regulatory Matters in the Territory. Any IND, IND Equivalent,