BEMA FENTANYL SUPPLY AGREEMENT

CONFIDENTIAL TREATMENT REQUESTED

WITH RESPECT TO CERTAIN PORTIONS HEREOF

DENOTED WITH “***”

Exhibit 10.2

BEMA FENTANYL SUPPLY AGREEMENT

This BEMA Fentanyl Supply Agreement (the “Agreement”) is made as of September 5, 2007 (the “Effective Date”) by and between BioDelivery Sciences International, Inc., a Delaware corporation with an office at 2501 Aerial Center Parkway, Suite 205, Morrisville, North Carolina 27560 USA (“Parent”), its wholly-owned subsidiary Arius Pharmaceuticals, Inc., a Delaware corporation with an office at the same address (“Arius”, and together with Parent, “BDSI”), and Meda AB, a Swedish corporation with its principal office at Pipers väg 2 A, SE-170 09, Solna, Sweden (“Meda”). BDSI and Meda are sometimes referred to collectively herein as the “Parties” or singly as a “Party.”

RECITALS

WHEREAS, BDSI has proprietary technology, know how, other proprietary information, and intellectual property relating to the manufacture, use, and sale of a proprietary bioerodible, mucoadhesive multi-layer polymer film for transmucosal delivery of fentanyl; and

WHEREAS, Meda has obtained a license to practice such technology and know how and other proprietary information in order to develop and sell a product based on such technology, pursuant to the terms of that certain License and Development Agreement, dated as of the Effective Date, between BDSI and Meda (the “License Agreement”); and

WHEREAS, as required by the License Agreement in exchange for the payment of certain amounts hereunder, BDSI shall supply Products (as defined below) to Meda for clinical use and commercial sale pursuant to the terms of this Agreement.

NOW, THEREFORE, in consideration of the foregoing recitals and the mutual covenants and agreements contained herein, the Parties hereto, intending to be legally bound, do hereby agree as follows:

1. Definitions . All capitalized terms not otherwise defined in this Agreement shall have the meanings set forth in the License Agreement, and, in addition to the capitalized terms defined elsewhere in this Agreement, the following terms used in this Agreement shall have the meaning set forth below:

1.1 “BEMA Fentanyl Products” means Commercial Products and Clinical Products.

1.2 “Commercial Product” means Fentanyl Product, as further described in the Product Specifications and Packaging Specifications, intended for commercial sale.

1.3 “Clinical Product” means the Fentanyl Product intended for use in the Phase IIIB or Phase IV studies to be conducted by or on behalf of Meda as contemplated and permitted by the License Agreement, as further described in the Product Specifications and Packaging Specifications.

CONFIDENTIAL TREATMENT REQUESTED

WITH RESPECT TO CERTAIN PORTIONS HEREOF

DENOTED WITH “***”

1.4 “Conforming Product” shall mean any Product which was manufactured, packaged, and supplied in accordance with this Agreement, all applicable laws, rules, guidelines, and regulations, and the applicable Product Specifications and Packaging Specifications

1.5 “Forecast” means the written forecast describing Meda’s anticipated requirements with respect to Products for a given time period, including the proposed delivery schedule with respect to such Products.

1.6 “Fully-Burdened Manufacturing Costs” means BDSI’s total direct and indirect costs of supplying a particular Product to Meda hereunder, which shall include but not be limited to *** .

1.7 “GMP” means, as relevant to the Products, the regulatory requirements for current good manufacturing practices promulgated by the FDA under the U.S. Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, particularly 21 C.F.R. Section 210 et seq., and 21 C.F.R. Sections 600-610, as the same may be amended from time to time.

1.8 “Launch Stocks” shall mean the Commercially Reasonable quantities of stocks of the BEMA Fentanyl Product and Demonstration Samples ordered by Meda under this Agreement to support the commercial introduction of the Fentanyl Product in a jurisdiction in the Territory following receipt of appropriate Governmental Approval from the applicable Competent Authority(ies) with respect to the Fentanyl Product.

1.9 “Order” means a written purchase order for the Products, which order shall include a delivery schedule specifying the requested delivery date and quantity for each Product ordered, and the location to which shipment of the Product is to be delivered.

1.10 “Packaging Specifications” means the specifications for the packaging of the various Products, which shall be as mutually agreed upon by the Parties reasonably (but no later than four months) in advance of Meda’s placement of an Order for Launch Stocks and in a manner reasonably consistent with the form of Fentanyl Product and labeling therefor approved in the initial Governmental Approval approved in the Territory and the relevant terms of the License Agreement. Upon the establishment of Packaging Specifications for Products by the Parties consistent with the foregoing, such Packaging Specifications shall be attached to this Agreement as Exhibit A and incorporated herein by this reference, and such specifications may be amended or augmented from time to time as mutually agreed upon by the Parties. If and as such Packaging Specifications for Products are amended consistent with this Section 1.10, the existing Exhibit A shall be amended to reflect such changes, and such amended Exhibit A shall be provided to the Parties and deemed to be part of this Agreement.

1.11 “Placebo” means a bioerodible, mucoadhesive polymer film product that does not contain fentanyl, *** .

1.12 “Products” means BEMA Fentanyl Products, Placebos, and Demonstration Samples.

2

CONFIDENTIAL TREATMENT REQUESTED

WITH RESPECT TO CERTAIN PORTIONS HEREOF

DENOTED WITH “***”

1.13 “Purchase Price” means an amount equal to *** .

1.14 “Product Specifications” means the manufacturing and product specifications for the applicable Product, which shall be as mutually agreed upon by the Parties reasonably (but not later than four months) in advance of Meda’s placement of an Order for Launch Stocks and in a manner reasonably consistent with the form of Fentanyl Product and labeling therefor approved in the initial Governmental Approval approved in the Territory and the relevant terms of the License Agreement. Upon the establishment of Product Specifications for Products by the Parties consistent with the foregoing, such Product Specifications shall be attached to this Agreement as Exhibit B and incorporated herein by this reference, and such specifications may be amended or augmented from time to time as mutually agreed upon by the Parties. If and as such Product Specifications for Products are amended consistent with this Section 1.14, the existing Exhibit B shall be amended to reflect such changes, and such amended Exhibit B shall be provided to the Parties and deemed to be part of this Agreement.

1.15 “Regulatory Filing” shall mean any regulatory filings or correspondence necessary to procure or maintain any Governmental Approvals in the Territory for the Fentanyl Product, including any supplements or amendments thereto.

2. Effectiveness; Term . This Agreement shall be effective for a period beginning on the HSR Date and continue until the earlier of (i) any termination of the License Agreement with respect to the Fentanyl Product, (ii) an Arius Two Termination Event (as defined in that certain Sublicensing Consent between Arius Two, Inc. (“Arius Two”), Arius, CDC, and Meda dated September 5, 2007), (iii) a CDC Termination Event (as defined in that certain Sublicensing Consent and Amendment between Parent, Arius, Meda, and CDC dated September 5, 2007) (termination of this Agreement resulting from the occurrence of the events described in clause (ii) above or this clause (iii), a “Licensor Termination”), or (iv)  *** .

3. Testing and Registration of the Product .

3.1 Subject to the terms of the License Agreement, Meda shall, following receipt of any Governmental Approval, be the holder of such Governmental Approval granted for the Fentanyl Product, and responsible for interaction with Competent Authorities in a particular country following such Governmental Approval therein. Meda shall reasonably advise BDSI regarding the status of or developments with respect to the Regulatory Filings and Governmental Approvals in accordance with terms of the License Agreement.

3.2 BDSI shall provide to Meda information regarding BDSI’s (or its Third Party contractors’) manufacturing facilities, methods and process controls for the manufacture of the Products, and will reasonably assist Meda in compilation of information for the chemistry, manufacturing and control documentation which Meda reasonably determines in good faith is needed for maintenance or updating of the Regulatory Filings. In the event that BDSI reasonably determines that any such information constitutes proprietary, confidential, or trade secret information belonging to BDSI or its Third Party contractor(s), the parties will cooperate to take appropriate steps to preserve the confidential, proprietary and/or trade secret status of such information.

3

CONFIDENTIAL TREATMENT REQUESTED

WITH RESPECT TO CERTAIN PORTIONS HEREOF

DENOTED WITH “***”

3.3 Meda shall provide to BDSI reports and other written communications received by Meda from any Competent Authority in accordance with the terms of the License Agreement. On or after the date of First Commercial Sale of the Fentanyl Product, each Party shall provide the other Party with a status update with regard to any audit or inspection conducted by any Competent Authority which relates directly to the Products.

3.4 Subject to the terms of the License Agreement, Meda shall be responsible for obtaining and maintaining all Governmental Approvals necessary for Meda to contract with BDSI to manufacture and package the Commercial Product into final marketing packaging, except for those approvals BDSI is required to obtain and maintain pursuant to Section 5.4. Subject to the terms of the License Agreement, Meda shall be responsible for obtaining and maintaining all applicable Governmental Approvals for the commercial marketing, sale, and distribution of the Fentanyl Product in the Territory.

4. Supply .

4.1 Subject to the terms of this Agreement, BDSI shall use Commercially Reasonable Efforts to supply to Meda its requirements of the Products for use, sale, or distribution in the Territory. BDSI shall be the sole and exclusive supplier of the Products to Meda during the term of this Agreement, and Meda shall purchase solely from BDSI all of its requirements for Products to be used, sold, or distributed in the Territory unless a Back-Up Trigger occurs as set out in Section 4.10. Meda shall not manufacture or have manufactured on its behalf any Products except as may be permitted by Section 4.10. Subject to Section 4.11, BDSI shall be entitled to engage Third Parties as necessary to fulfill BDSI’s obligations under this Agreement; provided that BDSI shall continue to be responsible for such Third Party’s performance of BDSI’s obligations hereunder.

4.2 The manner and style of the labeling and trade dress of the Products shall be as described in the Packaging Specifications, subject to any further changes (i) reasonably requested by Meda or (ii) necessary to conform such Packaging Specifications to the regulatory requirements necessary to obtain and maintain Governmental Approvals with respect to the Fentanyl Products and to comply with all Applicable Laws, subject in each case to Sections 3.04 and 5.03 of the License Agreement. To the extent approved by relevant Competent Authorities and permitted by Applicable Law, and subject to (i) Meda’s compliance with Sections 3.04 and 5.03 of the License Agreement and (ii) BDSI’s or Commercialization Committee’s approval, as applicable, of such change or modification pursuant to Sections 3.04 and 5.03 of the License Agreement, BDSI shall use Meda’s specified labeling (and only such labeling) on the Products. BDSI shall be solely responsible for the contents of any product label and Meda shall not be responsible in any manner, including but not limited to under any provision of this Agreement, for any error, mistake, violation of any Applicable Law or any other problem with the content of the label, except to the extent content was specified by Meda or Meda does not follow label instructions provided by BDSI, with respect to which content Meda shall be responsible . Any Meda-requested change or modification to a Product’s label shall, subject to (i) Meda’s compliance with Sections 3.04 and 5.03 of the License Agreement and (ii) BDSI’s or the Commercialization Committee’s approval, as applicable, of such change or modification pursuant to Section 3.04 or 5.03 of the License Agreement, be implemented by BDSI as soon as reasonably practicable. Meda shall reimburse BDSI for the reasonable total direct and indirect cost of any Product labels rendered obsolete by such change.

4

CONFIDENTIAL TREATMENT REQUESTED

WITH RESPECT TO CERTAIN PORTIONS HEREOF

DENOTED WITH “***”

4.3 Meda shall place an Order for Launch Stocks on a date not less than *** before the date on which it intends to commercially launch the Fentanyl Product (the “Date for Launch”), and shall use commercially reasonable efforts to avoid placing such Order more than *** before the Date For Launch (notwithstanding that such date may not be capable of determination at the time for the order). Upon receipt of such Orders, BDSI shall use commercially reasonable efforts to deliver the Commercial Product and Demonstration Samples in accordance therewith. However, for the avoidance of doubt, the Parties hereby confirm that BDSI’s manufacturing obligations under this Section 4.3 shall only arise on receipt of Orders.

4.4 Within *** following submission of the initial application for Governmental Approval to a Competent Authority in the Territory with respect to the Fentanyl Product, Meda shall provide BDSI with a nonbinding Forecast of Meda’s requirements for Products for the *** period following receipt of the anticipated Governmental Approval. The Forecast shall be updated *** until the date on which Meda places an Order for Launch Stocks. Except as otherwise provided herein, all Forecasts made hereunder shall, except as further described below, be nonbinding and made to assist BDSI in planning its production and Meda in planning marketing and sales.

4.5 All Orders for Products other than Orders for Launch Stocks shall be governed by this Section 4.5. Meda shall, not less than *** before the beginning of each calendar quarter, give BDSI (i) its Order for the Products to be delivered to Meda during that calendar quarter and (ii) a Forecast for the following *** . Notwithstanding the foregoing, Meda shall have no obligation to deliver Forecasts pursuant to this Section 4.5 until it places an Order for Launch Stocks. BDSI shall not be obligated to accept any Order for a calendar quarter to the extent that it, with respect to any specific form of Product, exceeds by more than *** % the amounts forecast for such Product in that quarter in the previous Forecast. However, BDSI shall make commercially reasonable efforts, but not be obligated, to also deliver such exceeding quantities. Meda may request amendment to an Order within *** after such Order is given and BDSI shall use its commercially reasonably efforts to accept such amendment provided, however, BDSI shall not be obligated to accept such amendment to the extent quantities of a particular Product specified in the amended Order (i) are increased by more than *** % over the original Order, (ii) cause the amount of a particular Product scheduled for delivery in a quarter to exceed by more than *** % the amounts most recently Forecast for such Product in that quarter, or (iii) are decreased by more than *** % compared to the original Order. However, BDSI shall make commercially reasonable efforts, but not be obligated, to also deliver any quantities exceeding the aforementioned limitations. BDSI shall deliver according to the delivery schedule contained in any Order. The Commercialization Committee will discuss delivery and scheduling issues as necessary. Each Forecast shall be deemed a binding commitment of Meda to purchase in the first calendar quarter thereof (i.e. the first quarter following the quarter covered by the accompanying Order) at least *** of the quantity of each Product set forth with respect to such first calendar quarter. No terms and conditions contained in any Order, acknowledgment, invoice, bill of lading, acceptance or other preprinted form issued by either Party shall be

5

CONFIDENTIAL TREATMENT REQUESTED

WITH RESPECT TO CERTAIN PORTIONS HEREOF

DENOTED WITH “***”

effective to the extent they are inconsistent with, modify or add to the terms and conditions contained herein; all Orders and Forecasts shall specify Product quantities by NDC number (in the case of Orders of Commercial Products for the United States) or similar identifiers for each individual form of all other Products.

4.6 Meda shall be entitled at its option to reject such part of any delivery of the Products which does not comply with the applicable Product Specifications, Packaging Specifications, or applicable regulatory requirements (including those contained in applicable Governmental Approvals and GMP), provided that Meda shall be deemed to have accepted any delivery of the Products unless it gives BDSI notice of its rejection within *** of delivery, or in case of a latent defect, within *** after the date Meda could have reasonably discovered such latent defect. BDSI shall, at BDSI’s option, promptly replace (without additional cost) or refund to Meda the amount actually paid by Meda to BDSI with respect to any such Products which do not comply with the applicable Product Specifications, Packaging Specifications, or applicable regulatory requirements (including but not limited to those contained in applicable Governmental Approvals).

4.7 Meda shall return to BDSI, at BDSI’s cost, any Products rejected properly in accordance with this Article 4, in which case BDSI shall, consistent with Section 4.6 above, refund the amount actually paid by Meda to BDSI for such Products or promptly replace such Products at no additional charge, and pay to Meda the actual, reasonable, documented cost incurred by Meda in effecting the return of such Products.

4.8 If, with respect to any Products which have been replaced and/or for which the amount actually paid by Meda therefore has been refunded is, following investigation, found by reasonable, independent, neutral, third party laboratory analysis pursuant to generally-accepted scientific methods, to have complied with the applicable Product Specifications, Packaging Specifications, and all regulatory requirements (including but not limited to those described in applicable Governmental Approvals and GMP), Meda shall:

(a) accept those Products as part of the next order and, if no Order will be placed before the termination of this Agreement, pay BDSI the applicable amount therefore pursuant to this Agreement, and

(b) refund any additional amount paid by BDSI to Meda with respect thereto.

4.9 If BDSI determines that it will not be able to supply Products to Meda in material satisfaction of the most recent Orders and/or Forecast, BDSI shall promptly notify Meda in writing of such determination, which notice shall provide Meda with the details on the extent of the expected shortfall of supply, the causes of such inability to supply, and BDSI’s proposed solution to the problem. Upon such notice of a supply problem, or in any event upon occurrence of any Back-Up Trigger (as defined below), (i) Meda and BDSI will immediately meet and work together, in good faith, to identify an appropriate resolution to the supply problem, provided that Section 4.10 shall remain applicable with respect to the occurrence of such Back-Up Trigger in the absence of any such resolution, and (ii) BDSI shall, during any such shortfall of supply, use Commercially Reasonable Efforts to continue to supply to Meda Products in an amount that is

6

CONFIDENTIAL TREATMENT REQUESTED

WITH RESPECT TO CERTAIN PORTIONS HEREOF

DENOTED WITH “***”

proportionate to or, if so elected by BDSI in its sole discretion, greater than the quantity of Products ordered by Meda under this Agreement consistent with such Order and/or Forecast divided by the total demand during the same time period for Products by BDSI, its Affiliates, their sublicensees (including but not limited to Meda), and any other third parties to whom BDSI is obligated to supply Products. Any agreed resolution to the supply problem will be set forth in a writing executed by both parties.

4.10 (a) BDSI shall use Commercially Reasonable Efforts to have *** . If, following the First Commercial Sale of the Commercial Product, the Parties reasonably determine that *** , BSDI shall, at the request of Meda, also use Commercially Reasonable Efforts to transfer to Meda, at Meda’s reasonable expense, copies of all information, including technical information, that is Controlled by BDSI, that is useful or necessary in the manufacture of the Products and is reasonably necessary to enable Meda or any alternative supplier (designated in accordance with Section 4.10(e)) to manufacture such Products. Such transfer shall commence and be completed by BDSI as soon as reasonably practicable, but in any event BDSI shall use Commercially Reasonable Efforts to complete such transfer prior to ninety (90) days after BDSI’s receipt of notice from Meda. BDSI shall provide Meda reasonable assistance, at Meda’s request and BDSI expense, with respect to understanding such manufacturing information.

(b) In the event (i) BDSI cannot or does not properly supply on a timely basis in accordance with this Article 4 Commercial Products conforming to all warranties and other requirements hereunder in quantities of at least *** % of the amount of Commercial Products specified in accepted Orders (other than the Initial Supply Order) properly forecasted in any *** or (ii) of the occurrence of a breach of this Agreement by BDSI that, despite Meda’s compliance with Section 4.12 below, materially adversely affects Meda’s (or Meda’s Affiliates’) ability to sell Commercial Products for a single consecutive period greater than *** (each of the foregoing, a “Temporary Back-Up Trigger”), Meda may, upon written notice to BDSI, render this Agreement nonexclusive, enabling Meda to manufacture Products or have them manufactured on its behalf as contemplated by this Section 4.10 , provided that such nonexclusivity shall only be effective during the period of time during which BDSI is unable to supply all of Meda’s reasonably forecasted needs of Products; once BDSI is able to supply all of Meda’s reasonably forecasted needs of Commercial Products for the Territory, or is able to reasonably able to demonstrate its capacity to do so, the exclusivity of this Agreement shall be restored and Meda shall not longer be entitled to manufacture Products or have them manufactured on its behalf as contemplated by this Section 4.10, unless and until a new Temporary Back-Up Trigger occurs and Meda exercises its rights hereunder with respect thereto. In the event of a Temporary Back-Up Trigger and notice from Meda exercising its rights with respect thereto, Meda shall (i) at all times purchase from BDSI as many Products as BDSI can supply to Meda hereunder, provided such amount to be purchased from BDSI shall not in any event be required to exceed Meda’s reasonably forecasted total needs for Products in the Territory, and (ii) use Commercially Reasonable Efforts to restore BDSI as the exclusive supplier of Products as quickly as possible.

(c) In the event BDSI cannot or does not properly supply on a timely basis in accordance with this Article 4 Commercial Products conforming to all warranties and other

7

CONFIDENTIAL TREATMENT REQUESTED

WITH RESPECT TO CERTAIN PORTIONS HEREOF

DENOTED WITH “***”

requirements hereunder in quantities of at least *** % of the amount of Commercial Products specified in accepted Orders (other than the Initial Supply Order) properly forecasted in any *** ( “Termination Back-Up Trigger”; a Temporary Back-Up Trigger or Termination Back-Up Trigger, a “Back-Up Trigger”), Meda may, upon *** notice to BDSI given within *** of the occurrence of such Termination Back-Up Trigger, terminate this Agreement or render it permanently nonexclusive (provided that BDSI’s continued obligations to supply Products hereunder in the case of such nonexclusivity shall be subject to BDSI’s ability to procure such supply from Third Party manufacturers under such conditions of nonexclusivity or any reduced supply requirements resulting therefrom on commercially reasonable terms).

(d) Any notice by Meda under Sections 4.10(b) and (c) shall describe the applicable Back-Up Trigger. Upon receipt of such notice and except to the extent already done pursuant to Section 4.10(a), BDSI shall use Commercially Reasonable Efforts to transfer to Meda, at Meda’s reasonable expense, copies of all information, including technical information, that is controlled by BDSI, that is useful or necessary in the manufacture of the Products and is reasonably necessary to enable Meda or any alternative supplier (designated in accordance with Section 4.10(e)) to manufacture such Products. Such transfer shall commence and be completed by BDSI as soon as reasonably practicable but in any event shall be completed prior to ninety (90) days after BDSI’s receipt of notice from Meda. BDSI shall provide Meda reasonable assistance, at Meda’s request and BDSI expense, with respect to understanding such manufacturing information. Meda shall, subject to the terms hereof, use Commercially Reasonable Efforts to mitigate the adverse effects of any failure to supply Products by BDSI.

(e) With respect to any exercise by Meda of its rights under this Agreement or the License Agreement to secure any Products from any party other than BDSI, (i) Meda shall use Commercially Reasonable Efforts to secure such supply by its own manufacture, in lieu of securing such supply through a Third Party manufacturer, (ii) Meda shall provide BDSI written notice of its intent to secure its supply through a Third Party manufacturer and provide BDSI a reasonable opportunity to discuss, review, and comment on any potential Third Party manufacturers opportunity prior to Meda entering into any discussions with any potential Third Party manufacturer, and (iii) Meda shall not enter into any discussions with any potential Third Party manufacturer or manufacturing agreement with any potential Third Party manufacturer without, in each case, BDSI’s prior written approval, such approval not to be unreasonably withheld.

4.11 Contract Manufacturer(s) . BDSI may, in its sole discretion, contract with Third Parties for the manufacture or supply of Products as it may determine necessary to enable it to satisfy its obligations hereunder; provided , that, with respect to any Third Party *** , Meda approves such Third Party and its facility(ies), which approval shall not be unreasonably withheld. For purposes of clarification but not limitation, the performance of any of BDSI’s obligations hereunder by any such Third Parties shall be deemed to satisfy such obligations of BDSI. Meda shall have the same rights hereunder to inspection, audit, reports, records and others matters relating to quality assurance and control and confidentiality as provided hereunder in respect of BDSI.

8

CONFIDENTIAL TREATMENT REQUESTED

WITH RESPECT TO CERTAIN PORTIONS HEREOF

DENOTED WITH “***”

4.12 Inventory . Meda acknowledges the inherent risk that a batch of bulk or finished Products may be lost in production or shipment, and agrees to maintain an inventory of Products reasonably sufficient, consistent with industry standards, to supply at least *** worth of its requirements at all times.

5. Quality; Regulatory .

5.1 BDSI warrants that all Products supplied pursuant to this Agreement shall on the date of delivery (i) comply with the Product Specifications and all applicable regulatory requirements (including but not limited to those included in applicable Governmental Approvals and GMP); (ii) not, in the case of Commercial Products, be misbranded or adulterated (as such terms are defined by Applicable Laws); and (iii) be packaged according to the Packaging Specifications and all regulatory requirements (including but not limited to those included in applicable Governmental Approvals and GMP), provided that Product Specifications and Packaging Specifications may be amended as (a) reasonably requested by Meda and agreed upon by BDSI, (b) necessary to conform such Product Specifications and Packaging Specifications to the regulatory requirements necessary to obtain and maintain Governmental Approvals with respect to the Products in the reasonable discretion of BDSI, or (c) or otherwise effected in accordance with Section 5.2 below. BDSI shall, at Meda’s option, immediately replace (without additional cost) or refund to Meda the amount actually paid by Meda for any such Products which do not meet the foregoing warranty. Replacement or refund, as elected by BDSI in its sole discretion, shall be Meda’s sole remedy for breach of such warranty unless such breach is the result of BDSI’s gross negligence or willful misconduct.

5.2 BDSI shall, as soon as reasonably possible, provide written notice of any changes proposed by BDSI to the Product or method of manufacture of the Products, the Product Specifications, or Packaging Specifications, and, to the extent reasonably practicable, provide Meda a reasonable opportunity to review and comment thereon, which shall not in any event be required to exceed five (5) business days. Unless (i) such change is required by any Competent Authority or Applicable Law or (ii) such change does not require approval of any Competent Authority, is not reasonably likely to increase the applicable Product Price or Purchase Price, and does not materially affect the Product or Packaging Specifications, in which cases BDSI shall be entitled to make such changes (or non-material changes) in its reasonable discretion without prior written approval of Meda (and, if applicable, the relevant Product Specifications or Packaging Specifications shall be deem