LICENSING AND DISTRIBUTION AGREEMENT

1.

Definitions . In addition to various terms defined throughout the Agreement, the following capitalized terms shall have the meanings set forth below:

1.1

“Act” means the Food, Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.), as amended, and the regulations promulgated thereunder.

1.2

“Affiliate” means with respect to a Party (a) any corporation or business entity of which fifty percent (50%) or more of the securities or other ownership interests representing the equity, the voting stock or general partnership interest are owned, controlled or held, directly or indirectly, by the Party; or (b) any corporation or business entity which, directly or indirectly, owns, controls or holds fifty percent (50%) or more of the securities or other ownership interests representing the equity, the voting stock or, if applicable, the general partnership interest, of the Party; or (c) any corporation or business entity of which fifty percent (50%) or more of the securities or other ownership interests representing the equity, the voting stock or general partnership interest are owned, controlled or held, directly or indirectly, by a corporation or business entity described in (a) or (b).

1.3

“Amphotericin Product”- Any product developed, licensed, distributed or sold by TEAMM containing Amphotericin B in any formulation intended for use in the treatment of Chronic Rhinosinusitis.

1.4

“Calendar Year” means the successive twelve (12) months beginning on January 1 and ending on December 31 of each year.

1.5

“Competitive Product” means any product that is administered nasally for the indication of allergic rhinitis regardless of the active Ingredient but not including the Amphotericin Product.

1.6

“Contract Manufacturer” means any third party with whom Collegium contracts for the manufacture of Product on its or TEAMM’s behalf.

1.7

“Cost of Goods Sold” means the direct cost of goods sold with respect to each Product invoiced by the Contract Manufacturer, as determined in accordance with generally accepted accounting principals, consistently applied, and specifically not including any additional fees added by TEAMM or Collegium.

1.8

“Development Plan” means the plan attached as Exhibit A being carried out by Collegium to obtain FDA approval of the Product.

1.9

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

1.10

“FDA Approval Date” means the date that Collegium receives final notice from the FDA that the Product can be sold in the Territory.

1.11

“Good Manufacturing Practices” or “GMP” means the applicable current good manufacturing practices promulgated from time to time by the FDA in accordance with the Act.

1.12

“Launch Year” shall mean the Calendar Year in which the Product is first introduced for commercial sale by TEAMM.

1.13

“Minimum Annual Royalty Payment” means the minimum royalty payment that is due to Collegium for the Launch Year or for each Calendar Year thereafter as described in Exhibit C.

1.14

“Minimum Royalty Reconciliation Payment” means the amount to be paid Collegium that is equal to the difference between the Minimum Annual Royalty Payment (as set forth in Exhibit C) for the Launch Year or a given Calendar Year and the royalty due to Collegium in such Launch Year or Calendar Year in accordance with Section 7.2. For the sake of clarity, if the Minimum Annual Royalty Payment is $1,000,000 and the royalty due to Collegium in such Calendar Year is $800,000, the Minimum Royalty Reconciliation payment is $200,000.

1.15

“Net Sales” means the gross amount invoiced for sales of the Products sold hereunder by TEAMM to unrelated third parties commencing with

the first commercial sale of the Products, after deduction of the following items which are actually incurred and paid:

(a)

packing, transportation and insurance charges for shipment of product to TEAMM from the Contract Manufacturer and from TEAMM to its customers.

(b)

discounts or rebates actually allowed and taken to the extent customary in the trade including any term discounts offered to and applied by TEAMM’s customers.

(c)

credits or allowance given or made for return of the Product by TEAMM’s customer.

(d)

any tax or other governmental charge levied directly on the sale, transportation or delivery of Product and borne by TEAMM (to the extent not refundable in accordance with applicable law)

(e)

charge backs and rebates granted to managed care health organizations, federal and state government agencies, and/or other purchasers, including, for example, group purchasing organization administrative fees; and

1.16

“Net, Net Sales” of the Product shall mean Net Sales in a given period of time less the Purchase Price of Product sold in that same period of time as defined in Section 7.3. An example of the calculation of Net, Net Sales is attached as Exhibit E and is for illustrative purposes only.

1.17

“Phase IV Growth Study” means the mandatory clinical study required by the FDA post-approval of the Product that is required to be done under all FDA guidelines, guidance and regulations.

1.18

“Product” means Collegium’s AllerNase AQ ([  *  ]) that is the subject to the NDA, sNDA and Development Plan described in this Agreement and any intellectual property that is required for TEAMM to perform its obligations under this Agreement, as described in Exhibit B , attached hereto and incorporated herein by reference.

1.19

“Product Availability Date” means the date upon which Collegium notifies TEAMM that the product is deemed ready for commercial sale by

Collegium and has been produced under cGMP and all other applicable regulatory guidelines.

1.20

“Proprietary Information” means all financial information, marketing information, sales information, customer information, raw materials, know-how, drawings, compositions, manufacturing and other specifications, analytical procedures, flow sheets, reports, market studies, preclinical and clinical test results, FDA and other regulatory submissions, software and other medical, research, technical, and marketing information disclosed, directly or indirectly, by either party to the other party designated “Confidential”, “Proprietary” or the like, or which by its nature is information normally intended to be held in confidence, unless the receiving party demonstrates that such information: (a) is or becomes public knowledge through no fault of the receiving party; (b) is legally in the possession of the receiving party prior to receipt from the disclosing party, as shown by receiving party’s written records; or (c) is subsequently and lawfully received without obligation of confidentiality from a third party under no nondisclosure obligation with respect to such information.

1.21

“Purchase Price” means the final invoice price to be paid by TEAMM to the Contract Manufacturer for the Product or samples of the Product per the Supply Agreement.

1.22

“Supply Agreement” means the mutually agreed upon agreement that is to be entered in between the Contract Manufacturer, TEAMM and Collegium regarding the commercial manufacturing of the Product.

1.23

“Territory” means the United States of America.

2.

Development Approval . Collegium shall use commercially reasonable efforts to develop and fully fund the development of the final form of the Product and obtain any required regulatory approval from FDA for the sale of the Product in the Territory as described in the Development Plan in Exhibit A . Collegium shall own all rights to all filings with and approvals received from the FDA.

3.

Distribution of Product .

3.1

License Grant . Subject to the limitations contained in this Agreement, effective as of the Effective Date, Collegium hereby grants to TEAMM the exclusive license to sell, market, promote, distribute, and otherwise transfer, dispose, provide and place (“sell”) the Product in the Territory in all fields. The license includes any and all patents, patent applications, continuations in part, know-how, trade secrets, manufacturing processes, formulations, trade marks, clinical information, regulatory documents and filings, and other technology associated with or relating to the Product in development by Collegium solely as they relate to the Product. For clarification purposes,

the license is limited to any Proprietary Information required by TEAMM to operate under this Agreement.

3.2

Right of First Refusal . Collegium shall grant TEAMM the First Right of Refusal to expand the Territory to those territories that are available upon the Effective Date provided that for any expansion of the Territory, TEAMM must either: (i) be actively marketing a minimum of one other product in the additional territory at the time of exercise of the First Right of Refusal or (ii) reasonably demonstrate to Collegium’s satisfaction TEAMM’s ability to market and distribute the products in the expanded Territory. Collegium will provide notice to TEAMM of its intent to pursue a licensing agreement with a third party in a country or countries outside the Territory. TEAMM will then have thirty (30) days to notify Collegium of its intent to pursue such license. Collegium and the TEAMM will have thirty (30) days from the time of notification by TEAMM of its intent to pursue the expanded territory to engage in good-faith negotiations in order to mutually agree upon terms. Should no agreement be reached during such time despite such good-faith negotiations, Collegium will be free to pursue licensing agreements in such country or countries at its sole discretion.

3.3

Co-Promotion Option . Both Collegium and TEAMM reserve the right throughout the Term to co-promote the Product under mutually agreed upon terms and conditions. Both parties agree that they will negotiate in good faith should either party desire this option.

3.4

Exclusivity . During the Term of this Agreement and one (1) year post-termination of the Agreement for any reason, TEAMM or its affiliates will not develop, produce, market or caused to be developed, produced or marketed any “Competitive Product”. During the term of the Agreement, Collegium or its affiliates will not develop or sell any competitive nasal spray product containing the same active ingredients as the Product for the same indications except as described in Section 3.3.

3.5

Supply Requirements . TEAMM will be obligated to comply with the terms of the manufacturing agreement between Collegium and Collegium’s present contract manufacturer. Collegium and TEAMM shall cooperate with regard to any agreement with the Contract Manufacturer that is in existence at the time of this Agreement. TEAMM shall be a party to any agreement with manufacturers that is entered into after the Effective Date. In the event that the terms of any manufacturing agreement to which both Collegium and TEAMM are parties shall be in conflict with any term(s) of this Agreement, Collegium and TEAMM agree to negotiate in good faith to adjust the terms hereof to make this Agreement consistent with the manufacturing agreement. TEAMM acknowledges that all of TEAMM’s supply requirements of Product for marketing, sample, and resale purposes within the Territory will be

purchased by TEAMM from the Contract Manufacturer. During the term of this Agreement, so long as the Contract Manufacturer is not in material uncured breach of the Supply Agreement TEAMM shall not (i) manufacture or cause to manufacture any such Product or (ii) purchase any such Product from a supplier other than the Contract Manufacturer without the written approval of Collegium.

3.6

Performance Requirements .

(a)

TEAMM shall use commercially reasonable best efforts to promote the sale of the Product. TEAMM’s promotional efforts may include, but not be limited to, developing the marketing and sales strategy, preparing and distributing promotional materials to be used in the Territory by TEAMM, actively and regularly participating in and/or sponsoring appropriate trade shows and conferences, advertising in trade or consumer publications applicable to the Territory, and directly soliciting healthcare providers, distributors, payors, and customers within the Territory by the TEAMM sales force.

(b)

TEAMM shall commit to launching the Product with its sales force no later than [  *  ] ([  *  ]) days from the Product Availability Date.

(c)

TEAMM shall dedicate a commercially reasonable portion of its sales force’s efforts to the promotion and sale of Product upon launch of the Product. On the Product Availability Date, the number of its trained sales representatives so dedicated shall equal or exceed the minimum of two hundred (200) sales reps calling on high prescribing target physicians (PCP, ENT, Allergists), increasing to two hundred fifty (250) within twenty-four (24) months after launch and three hundred (300) within thirty-six (36) months after launch. Twenty-five (25) percent of TEAMM’s sales representatives may be outsourced, provided that these minimums are met and further provided that such out-sourced sales reps are of similar quality and background as TEAMM’s internal sales representatives, and are trained to represent the Product and are subject to all provisions of the Licensing Agreement.

(d)

TEAMM shall commit to achieving the Minimum Annual Royalty Payment for the Product as defined in Exhibit C . If TEAMM does not achieve the Minimum Annual Royalty Payment for the Product for the Launch Year or any Calendar Year as defined in Exhibit C, TEAMM may do one of the following within thirty (30) days of the end of such Launch Year or Calendar Year:

(i)

Subject to the payment terms described in Section 7.6, TEAMM will pay Collegium the Minimum Royalty Reconciliation Payment for such Launch Year or Calendar Year; or

(ii)

Elect not to pay Collegium the Minimum Royalty Reconciliation Payment for such Launch Year or Calendar Year, in which case TEAMM shall be in breach of this Section 3.6(d) except as described in Section 3.6(e), and in addition to and without limiting any legal remedies Collegium may have for such breach, Collegium shall, by written notice to TEAMM within sixty (60) days (the date of any such notice, the “Termination Date”), be entitled to immediately terminate this Agreement in accordance with Section 12 or convert the grant of rights under Section 3 to non-exclusive, and enter into alternative distribution agreements in the Territory.

(e)

In the event that a significant change in market conditions occurs specific to the Product that is beyond TEAMM’s commercially reasonable control and causes TEAMM to be unable to meet the Minimum Annual Royalty Payment set forth in Section 3.6(d), TEAMM and Collegium agree that the Steering Committee will meet to review and make mutually agreed upon adjustments to Section 3.6(c) and 3.6(d). For the purposes of this Section (e), a significant change in the market is defined as a greater than thirty-three

percent (33%) decline in total market dollars of Nasal Inhaled Steroids (“NIS”) as defined by IMS Health from the base Calendar Year of 2006 and/or a thirty-three percent (33%) decline in the market dollars of NIS as defined above available to the specific products making up the NIS market in base Calendar Year 2006, after the entry of one or more competitive products. As soon as reasonably possible in Calendar Year 2007, Collegium and TEAMM will mutually agree on the NIS products and sales for Calendar Year 2006 as defined above and add such list of NIS products and sales for Calendar Year 2006 as Exhibit F.

(f)

TEAMM shall provide Collegium with a reasonably detailed report of its activities pursuant to this Section 3.6 (c) during the preceding calendar quarter not later than 20 days after the end of each such calendar quarter.

(g)

TEAMM will commit the resources required to provide commercially reasonable and industry standard trade and payor relations, distribution, and contracting with customers including but not limited to Wholesalers, Chains, Managed Care, GPO’s, Government, etc.

(h)

TEAMM shall comply with the Act and all other applicable, legal, health and safety requirements, laws and regulations in all marketing and sales activities. TEAMM shall not promote the Product for any uses not approved for the Product by applicable regulatory agencies or the Product labeling.

(i)

TEAMM’s failure to meet any of its obligations under this Section 3.6 shall be deemed a material breach of the Agreement hereunder and be grounds for termination under Section 12.2.

4.

Marketing and Support Activities .

4.1

Marketing Meetings: Reports . The Joint Steering Committee as described in Section 8 shall meet at least quarterly to discuss TEAMM’s marketing plans, product improvement suggestions, status of the Phase IV Growth Study, and any other information concerning the marketing and development of the Product. TEAMM shall provide information available to it about the Product and its ability to compete with other products for related uses and to meet customer needs. TEAMM shall provide Collegium information regarding sales of the Product and any market trends affecting the sale of the product.

4.2

Promotional Material . TEAMM shall prepare promotional literature and advertisements for the product, copies of which shall be provided to Collegium at Collegium’s request, and TEAMM shall utilize such materials

in its marketing efforts. TEAMM shall comply with all requirements of the Act and applicable federal, state, and local laws rules, and regulations in their advertising and other promotional activities. TEAMM shall cease and desist using any such materials to the extent Collegium notifies TEAMM of its good faith belief that any such materials violate any such laws, rules, or regulations.

4.3

Packaging, Labeling . Collegium shall cause the Contract Manufacturer(s) to manufacture, label, and package, the Product in final form for initial Product distribution by TEAMM at launch. In addition to all applicable legal requirements, the labels shall (i) comply with the requirements set forth in Section 4.4 below, (ii) prominently and clearly display the Trademarks, as defined below and (iii) prominently and clearly display the distributor of the Product. TEAMM shall not repackage or label any Product and shall not alter any Product or any package or label used in connection with any Product except as specifically requested and authorized in writing by Collegium. TEAMM shall not use Collegium’s name on any package or label for the Product without Collegium’s prior written approval, which may be withheld in Collegium’s sole discretion.

4.4

Trademarks and Trade Names . Effective upon the Effective Date, Collegium hereby grants TEAMM the nontransferable, nonexclusive right to use in the Territory the trademarks and trade names listed on Exhibit D, attached hereto and incorporated herein by reference, and any other trademarks owned by Collegium which it may designate in writing for use by TEAMM (collectively, the “Trademarks”) in connection with the marketing and sale of the Product for the term of this Agreement. Collegium shall be responsible for the filing and maintenance of Trademarks for the Product. The Product shall be marketed and sold only under the Trademarks as required under Section 4.3. TEAMM acknowledges that it has and will obtain no proprietary interest in the Trademarks and agrees not to use the same as part of its corporate or business name. TEAMM further agrees that all goodwill arising from TEAMM’s use of the Trademarks will inure to the benefit of Collegium who will be the sole and exclusive owner of such goodwill. TEAMM agrees not to contest or attack Collegium’s exclusive rights in the Trademarks. TEAMM’s right to the use of any Trademark or other property of Collegium shall terminate immediately upon termination of this Agreement. TEAMM shall use the Trademarks only in the manner prescribed by Collegium. The Product is offered for sale and sold subject in every case to the condition that such sale does not convey any licenses, express or implied, to manufacture, duplicate or otherwise copy or reproduce any Product. In the event of termination of this Agreement, TEAMM shall not manufacture or have manufactured any products utilizing any information belonging to Collegium.

4.5

Marketing Assistance/Training . Collegium agrees to provide technical training and technical assistance to TEAMM personnel at periodic intervals, with the frequency, content and reimbursement to be determined by mutual agreement.

4.6

Support . Collegium will use reasonable efforts to support the sale of Products by TEAMM where requested by TEAMM through its input at meetings of the Joint Steering Committee. Such support shall be provided in the sole discretion of Collegium.

5.

Compliance and Manufacturing .

5.1

Registrations .

(a)

Collegium shall use commercially reasonable efforts to maintain necessary regulatory approvals and requirements for it to sell the Product in the Territory. Collegium shall have sole discretion as to the commercial reasonableness of any acts required on its part to maintain any regulatory approval or requirement.

(b)

Collegium shall promptly provide to TEAMM copies of all required Product notifications and registrations to regulatory agencies including copies of all communications received from the FDA regarding the Product.

(c)

During the term of the Agreement, TEAMM shall have the right to review any regulatory documents and communications regarding the Product.

5.2

Reporting Obligations . TEAMM shall maintain, or cause to be maintained, all complaint files and other records required to be maintained by the FDA and other regulatory agencies with respect to Product. Collegium shall promptly provide to TEAMM copies of all complaints received with respect to the Product that it may receive, if any. TEAMM shall promptly provide Collegium with copies of any complaints relating to the Product received by TEAMM as well as responses sent, if any. TEAMM, expect where its required by law to submit directly to the FDA, shall submit to Collegium for submission to the FDA reports of complaints, malfunctions, failures or deterioration in the characteristics or performance or instructions for use or inadequacy in labeling which may have led or lead to death or serious injury and all other information about the Product required to be submitted to the FDA.

5.3

Manufacturing . After such time as the initial launch quantities of the Product are manufactured, TEAMM is responsible for commercial

manufacturing. TEAMM shall use commercially reasonable efforts to cause the Contract Manufacturer to comply with all GMP requirements. TEAMM and the Contract Manufacturer shall have sole discretion as to the commercial reasonableness of any acts required on their part with respect to GMP compliance, provided, however, TEAMM shall notify Collegium of any citations from discussions with a regulatory body where such discussions and citations relate to a material aspect of GMP compliance. TEAMM shall use commercially reasonable efforts to cause the Contract Manufacturer to timely order all necessary ingredients, components, etc to insure adequate commercial supply of the Product.

5.4

Samples . TEAMM shall cause the Contract Manufacturer to retain samples of each lot of the Product for time periods which are in accordance with GMP.

5.5

Product Recalls and Field Corrective Actions . In the event (i) any government authority issues a directive or order that a Product be recalled, (ii) a court of competent jurisdiction orders such a recall, or (iii) TEAMM or Collegium determines that a Product should be recalled or that a field corrective action should occur, the parties shall take all appropriate corrective actions. TEAMM will, upon mutual agreement with Collegium, provide notice to customers of the recall of the Product and Collegium and TEAMM shall consult to determine the corrective actions to be taken. TEAMM will make every effort possible to cause the Contract Manufacturer to replace recalled Product in order to prevent a back order situation. The party who was responsible for causing the recall shall be responsible for the cost of notifying end users and for the reasonable costs associated with such actions. In the event that TEAMM and Collegium conclude that Contract Manufacturer is responsible for the recall, and after commercially reasonable efforts to hold the Contract Manufacturer accountable under the Supply Agreement, the Contract Manufacturer fails and refuses to accept responsibility for such recall costs, TEAMM and Collegium shall share the cost as a deduction from Net Sales and the deduction will occur in the immediate next calendar quarter. TEAMM and Collegium shall fully cooperate with one another and provide all reasonable assistance in conducting any recall or field corrective action under this Section 5.5 and where applicable hold the Contract Manufacturer responsible for any costs associated with a recall. TEAMM shall maintain complete records of all distribution and sales of the Product sufficient to carry out a recall with respect to Product.

5.6

General Obligations of Collegium and TEAMM .

(a)

Collegium shall use commercially reasonable efforts to carry out, complete and fund all required pre-approval development work including filing the supplement to the NDA consistent with the Development Plan. Collegium will be responsible for preparing the

Product for the commercial launch in the United States, including the following activities up to commercial launch: formulation development, stability, pre-approval regulatory filings, production of the validation lots and coordination of the manufacturing of the Product at a Contract Manufacturer to cGMP specifications. Collegium will also transfer the coordination of commercial manufacturing to TEAMM in an efficient manner post launch of the Product. Collegium will hold and maintain the NDA and the sNDA throughout the term of the Agreement and be responsible for filing the Annual Reports.

(b)

Collegium’s responsibilities shall also include, to the extent required, completion at Collegium’s expense of any additional post approval genotoxicity and extractables testing that may be required by the FDA, as described in the FDA letter dated July 15, 2004 (i.e. Phase IV Muro commitments)

(c)

TEAMM shall price, invoice and have shipped the Product in the Territory. TEAMM shall maintain, store and ship the Product in accordance with all applicable GMP requirements.

(d)

TEAMM will, at TEAMM’s expense, be responsible for and fully fund all post-approval regulatory and registration requirements of the mandatory “Phase IV Growth Study” as well as any regulatory activities/filings required for advertising and marketing the Product in the Territory including but not limited to Safety Surveillance, Adverse Event reporting and all DDMAC requirements. TEAMM will comply with all reasonable requests by Collegium, as necessary, to support the maintenance of the NDA, sNDA and related regulatory filings and provide any requested information required for use in regulatory filings within five (5) business days of any request by Collegium.

than the mandatory Phase IV Growth Study requirements of the FDA.

(e)

Each party shall promptly notify the other party of, and shall provide the other party with copies of, any correspondence and other documentation received or prepared in connection with any of the following events: (1) receipt of any material correspondence from the FDA in connection with the development, manufacture, sale or use of the Product; (2) any recall of the Product; (3) the withdrawal of the Product from the market; (4) any regulatory comments relating to the manufacture of the Product requiring a response or action by either party (5) any customer complaints.

(f)

TEAMM, Collegium, and the Contract Manufacturer shall maintain all manufacturing and analytical records, all records of shipments of the Products from the Manufacturer, and all validation data relating to the Products for the time periods required by applicable laws and regulations, or provide for the same in the Supply Agreement for the Product with the Contract Manufacturer. TEAMM shall make such data available to the FDA upon request of the FDA, such request being made either directly to TEAMM or to Collegium, or otherwise as required by applicable law.

5.7

Orders .

(a)

Terms and Conditions . All orders for Product shall be initiated by written purchase orders by TEAMM directly to the Contract Manufacturer with a copy to Collegium. No order shall be binding unless consistent with this Agreement and the Supply Agreement. TEAMM’s purchase orders submitted to the Contract Manufacturer shall be governed by the terms of this Agreement and the Supply Agreement.

(b)

Rejection . TEAMM shall notify the Contract Manufacturer with a copy to Collegium of any and all damaged or nonconforming Product reasonably ascertainable as damaged or nonconforming by TEAMM or its designated inventory, warehousing, and/or supply chain management contractor, pursuant to the inspection criteria and processes attached hereto as Exhibit E and consistent with the Supply Agreement, within ten (10) days of its receipt of the Product, with such notice stating with particularity the reason for such rejection. Any such Product not rejected for obvious damage or nonconformity within ten (10) days after receipt by TEAMM or its designated inventory, warehousing, and/or supply chain management contractor (the “Rejection Period”) shall be deemed accepted. Pursuant to the terms of the Supply Agreement, Manufacturer shall promptly replace any rejected Product. After the

Rejection Period, TEAMM may not return any such obviously damaged Product for any reason, and neither Collegium nor the Contract Manufacturer shall have any liability with respect to such damaged Product. Collegium and TEAMM shall cooperate to ensure that the Supply Agreement with the Contract Manufacturer shall contain commercially reasonable and customary provisions for return and replacement (at Contract Manufacturer’s cost) of defective or nonconforming Product with “latent” defects not apparent or reasonably discoverable in the initial Rejection Period.

(c)

Validation Batches . TEAMM shall purchase salable initial validation batches (three (3) lots of commercial scale batches) as its initial Product purchase. These batches will be invoiced to TEAMM by Collegium or the Contract Manufacturer and paid for by TEAMM directly to the issuer of the Invoice consistent with the terms of the Supply Agreement and this Agreement, provided that the Product in these batches is in all respects suitable for commercial distribution.

(d)

Commercial Batches . TEAMM will also be responsible for fully funding and purchasing the production batches for commercial use and s