Common use of Quality; Regulatory Clause in Contracts

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 deemed amended in accordance with such change), no such change shall be implemented without Meda’s prior written approval, which shall not be unreasonably withheld. If the approval of Competent Authorities is required for any such change, the time for implementing such changes shall be reasonably agreed between the Parties in order to enable Meda to obtain, and Meda shall use commercially reasonable efforts to obtain, the relevant regulatory approvals prior to such implementation, provided that in any and all events, the period of time required for such implementation shall be no less than the length of time required by BDSI’s supplier of the Product. 5.3 BDSI shall provide Meda with certificates of quality assurance and quality control analysis with respect all deliveries of the Products, as customary in the industry, and with manufacturing and export documents as necessary for (i) import of the Products and (ii) compliance with all applicable regulatory requirements. BDSI shall keep complete, accurate and authentic accounts, notes, data and records of the work performed by it under this Agreement and shall maintain complete and adequate records pertaining to the methods and facilities used by it for the manufacture, processing, testing, packing, labeling, holding and distribution of Products in accordance with the applicable regulations. 5.4 BDSI shall, as between the Parties, be responsible for handling and responding to any appropriate governmental agency inspections with respect to manufacturing of Products during the term of this Agreement. To the extent available to BDSI, BDSI shall promptly provide to Meda copies of any (i) request or inquiry made by any regulatory agency with respect to Products or their manufacture or storage and (ii) any response thereto or information provided in response with respect to the foregoing, provided that, to the extent reasonably practicable and permissible under any relevant contracts between BDSI and Third Parties, Meda shall be provided an opportunity to review and comment on any and all such responses. BDSI shall use commercially reasonable efforts to promptly (i) advise Meda of any requests by any Competent Authority(ies) for any inspections with respect to the manufacturing of Products and (ii) provide Meda with copies of any correspondence related thereto. 5.5 BDSI shall retain (or cause any relevant Third Party contractors to retain) a reasonably sufficient quantity of each batch of Products to perform quality control testing. BDSI shall maintain samples of each batch in a reasonably suitable storage facility until at least the first anniversary of the end of the approved shelf life of the Product, or such longer period as may be required under applicable laws, rules, and regulations. Portions of all such samples shall be made reasonably available for testing by Meda, at Meda’s expense, upon request. 5.6 BDSI shall maintain (or shall use commercially reasonable efforts to ensure that any relevant Third Party contractors maintain) all records as necessary to comply with manufacturing regulations imposed by any regulatory authority. 5.7 Each Party agrees to notify the other forthwith of its knowledge or receipt of notice of the initiation of any inquiries, notices or inspection activity by any governmental or regulatory authority with respect to the Products and shall provide the other with a reasonable description of any such inquiries and documentation not later than *** after such visit or inquiry. 5.8 BDSI shall be responsible for assisting Meda in investigating complaints and “Lack of Effect” reports relating to the manufacture and/or packaging of Products which are supplied by BDSI. BDSI shall, as reasonably directed by Meda and at Meda’s expense, evaluate the nature of the complaint and document the evaluation on Products manufactured and/or packaged by BDSI for Meda. This evaluation may include but is not limited to providing assessments of: (i) returned sample(s) (where appropriate); (ii) retained samples; (iii) the manufacturing process; (iv) release tests; (v) receiving tests; (vi) complaint history; and (vii) conclusion/summary. The documented evaluation of the complaint will be provided by BDSI to Meda within *** from the date of BDSI’s receipt of the complaint. 5.9 Promptly following the execution of this Agreement, BDSI and Meda shall negotiate in good faith and enter into a mutually-agreeable Quality Agreement, which Quality Agreement shall be attached hereto as Exhibit C. In the event the terms of this Agreement and the Quality Agreement conflict, the terms of this Agreement shall govern.

Quality; Regulatory. 5.1 BDSI 6.1 Supplier warrants that all Products Supplied API supplied pursuant to this Agreement shall on the date of delivery (i) be manufactured in accordance with current GMP and (ii) comply with the Product Specifications and all applicable regulatory requirements Applicable Laws (including but not limited to those FDA regulations and requirements 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 GMPProduct Approvals), provided that Product Specifications and Packaging Specifications may be amended as (a) reasonably requested by Meda Cempra and agreed upon by BDSISupplier, such agreement not to be unreasonably withheld, or (b) necessary to conform such Product Specifications and Packaging Specifications to the regulatory requirements necessary to obtain and maintain Governmental Product Approvals with respect to Cempra Products, including but not limited to the Products approval of alternative dosages or indications of Cempra Products. In the event any change in the reasonable discretion Specifications materially increases or decreases the Manufacturing Costs, then the parties will meet and negotiate in good faith an increase or decrease in the Price. 6.2 For additions or changes to the Specifications or manufacturing processes that are required by GMP or Applicable Laws of BDSIthe United States or other applicable Regulatory Authority (including but not limited to those requirements of the FDA and Product Approvals) (collectively, “Required Manufacturing Changes”), the parties shall cooperate in making such changes in a timely fashion and amending the Specifications to reflect such additions or changes. Either Cempra or Supplier shall be free to propose changes to the Specifications or manufacturing processes that are not Required Manufacturing Changes (ccollectively, “Discretionary Manufacturing Changes”). Any Discretionary Manufacturing Changes proposed by Cempra shall only be effective upon the approval of FDA (or other applicable Regulatory Authority) or otherwise effected in accordance with Section 5.2 below. BDSI shalland Supplier’s written agreement to such changes and, at Meda’s optionsuch approval which shall not unreasonably be withheld, immediately replace (without additional cost) or refund to Meda and the amount actually paid by Meda for Supplier shall implement any such Products which do not meet Discretionary Manufacturing Changes agreed upon in writing by 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, parties as soon as reasonably possible, provide written notice of any changes practicable. Any Discretionary Manufacturing Changes proposed by BDSI to Supplier shall only be effective upon the Product approval of FDA (or method of manufacture of the Productsother applicable Regulatory Authority), 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 provided that no Discretionary Manufacturing Changes affecting any event be required to exceed five (5) business days. Unless (i) such change is required by any Competent Authority Specifications or Applicable Law process changes that are the result of Required Manufacturing Changes 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, Cempra Specifications may be effected unless approved by Cempra in advance 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 deemed amended in accordance with such change), no such change shall be implemented without Meda’s prior written approvalwriting, which approval shall not be unreasonably withheld. If Notwithstanding the approval of Competent Authorities is required for any such changeforegoing, the time for commercially reasonable, documented, direct costs, including, without limitation, obsolete raw materials, work-in-process, packaging and labeling materials (i) associated with implementing such changes any Required Manufacturing Changes shall be reasonably agreed between the Parties in order to enable Meda to obtain, and Meda shall use commercially reasonable efforts to obtain, the relevant regulatory approvals prior to such implementation, provided that in born by [*] (ii) associated with implementing any and all events, the period of time required for such implementation Discretionary Manufacturing Changes shall be no less than borne by [*]. In the length of time required event any Required Manufacturing Changes or Discretionary Manufacturing Changes materially increase or decrease the ongoing Manufacturing Costs, then the parties will negotiate in good faith an increase or decrease in the Price by BDSI’s supplier of an amount equal to the Productincrease or decrease in Manufacturing Costs. 5.3 BDSI 6.3 Supplier shall conduct quality control testing of every batch of Supplied API manufactured hereunder and provide Meda Cempra with certificates of quality assurance and quality control analysis with respect to all deliveries of the ProductsSupplied API, as customary in the industrypharmaceutical industry and in compliance with GMP and all applicable regulatory requirements of the United States (including those of the FDA) and other applicable Regulatory Authority, and with the manufacturing and export documents as necessary for (i) import of the Products Supplied API and (ii) compliance with GMP and all applicable regulatory requirementsApplicable Laws. BDSI Supplier shall keep complete, accurate and authentic accounts, notes, data and records of the work performed by it under this Agreement and shall maintain complete and adequate records pertaining to the methods and facilities used by it for the manufacture, processing, testing, packing, labeling, holding and distribution of Products Supplied API in accordance with the Applicable Laws and GMP. All raw data generated in the manufacturer, testing, and supply of Supplied API under this Agreement shall be maintained by the Supplier in a readily accessible manner for at least the longer of (i) [*] ([*]) [*] following the expiration date of the final Product into which the Supplied API is incorporated or (ii) such time as may be required by GMP or Applicable Law. 6.4 All facilities utilized by the Supplier to manufacture, store, or otherwise handle Supplied API manufactured for Cempra under this Agreement or utilized by Supplier Agent to store or otherwise handle Supplied API manufactured by Supplier for Cempra hereunder, or source intermediates therefore, shall comply with and satisfy all requirements under GMP and all Applicable Laws concerning the manufacture of Supplied API for use in pharmaceutical or biological products for human use (including but not limited to those of the FDA or included in the Product Approvals), including the maintenance of such standards or requirements sufficient to pass any inspection pursuant to such requirements. Without limiting the generality of the foregoing, the Supplier shall obtain and maintain all licenses, registrations, and other authorizations required to operate a GMP facility under Applicable Laws (including but not limited to those of the FDA). Supplier shall be responsible for all costs and fees related to obtaining and maintaining regulatory permits, certificates, approvals, or other authorizations required to manufacture Supplied API, and/or qualify any manufacturing sites for the manufacture of Supplied API, under this Agreement in compliance with all Applicable Laws (including but not limited to GMP and those of the FDA). Supplier shall comply with all Applicable Laws in performing their obligations hereunder, including but not limited to any applicable environmental, toxic or hazardous waste, or similar regulations. 5.4 BDSI 6.5 Supplier will be responsible for any reporting of matters regarding the general manufacture of Supplied API, as applicable, to the FDA and other applicable Regulatory Authority in accordance with GMP and Applicable Laws and may utilize Supplier Agent to perform such responsibilities. Supplier or Supplier Agent shall notify Cempra of any such matter within [*] ([*]) [*] and furnish copies of such reports to Cempra within [*] ([*]) [*]. Supplier or Supplier Agent also shall advise Cempra of any material occurrence or new information which arises out of the Supplier’s manufacturing, testing (including in process, release or stability), or other activities which may reasonably be expected to have adverse regulatory compliance and/or reporting consequences concerning any Product. Supplier or Supplier Agent shall promptly (and in any event, within the time period reasonably necessary to enable Cempra to comply with GMP and any Applicable Laws with respect to the clinical use or commercial sale of Products for human therapeutic use) report any adverse events, customer complaints, trend analysis, or other circumstances of which either Supplier or Supplier Agent becomes aware that may relate to the safety or efficacy of any Products. 6.6 Supplier shall, as between the Partiessubject to this paragraph, be responsible for handling and responding to any appropriate governmental agency FDA (or other applicable) Regulatory Authority inspections with respect to manufacturing of Products Supplied API during the term of this AgreementAgreement and may utilize Supplier Agent to perform such responsibilities. To the extent available to BDSI, BDSI Supplier or Supplier Agent shall promptly provide to Meda Cempra copies of any (i) request or inquiry made by any regulatory agency FDA (or other applicable Regulatory Authority) with respect to Products Supplied API or their manufacture its manufacture, testing, or storage for Cempra under this Agreement and (ii) any response thereto or information provided in response with respect to the foregoingforegoing by either Supplier or Supplier Agent, provided that, to the extent when reasonably practicable and permissible under any relevant contracts between BDSI and Third Partiespracticable, Meda Cempra shall be provided an opportunity to review and comment on any and all such responsesresponses reasonably in advance of their submission by either Supplier or Supplier Agent to FDA (or other applicable Regulatory Authority), provided that final discretion with respect to any such response remains with Supplier. BDSI Supplier and Supplier Agent shall use commercially reasonable best efforts to promptly (but in any event within [*] ([*]) [*]) (i) advise Meda Cempra of any requests by any Competent Authority(iesFDA (or other applicable Regulatory Authority) for any inspections with respect to the manufacturing of Products Supplied API under this Agreement and (ii) provide Meda Cempra with copies of any correspondence related thereto. 5.5 BDSI 6.7 Supplier certifies that they have not and covenant that they will not use in any capacity in connection with the manufacture of Supplied API under this Agreement the services of any person, including any firm or individual, debarred or subject to debarment under Applicable Laws (including but not limited to GMP or those of the FDA). Supplier and Supplier Agent agree to notify Cempra immediately in the event any person providing services to either Supplier or Supplier Agent under this Agreement is debarred or becomes subject to debarment. 6.8 Supplier shall retain (or cause any relevant Third Party contractors to retain) a reasonably sufficient quantity of each batch of Products Supplied API to perform quality control testingtesting and representative batches of Supplied API will be placed on stability testing as described in the current drug master file for Supplied API and as necessary to comply with GMP and FDA requirements and other Applicable Law. BDSI Supplier shall maintain samples of each batch in a reasonably suitable storage facility until at least the first anniversary later of (i) the end of the approved shelf life of the Product, [*] ([*]) [*] or (iii) such longer period as may be required under applicable lawsthe Specifications, rulesGMP, and/or Applicable Laws (including but not limited to those of the FDA and regulationsthe Product Approvals). Portions of all such samples and representative batches shall be made reasonably available (i) for testing by Meda, at Meda’s expenseCempra upon request and, upon requestCempra’s prior written consent, such consent not to be unreasonably withheld, (ii) to FDA and other applicable Regulatory Authority. Samples of any samples provided to FDA and other applicable Regulatory Authority shall be retained by the Supplier in quantities reasonably sufficient to allow quadruplicate replicatory testing by Cempra. 5.6 BDSI 6.9 Supplier shall maintain (or shall use commercially reasonable efforts to ensure that any relevant Third Party contractors maintain) all records as are necessary to comply with manufacturing regulations imposed by any regulatory authority. 5.7 Each Party agrees to notify the other forthwith of its knowledge or receipt of notice all Applicable Laws of the initiation of any inquiriesUnited States, notices or inspection activity by any governmental or regulatory authority with respect including but not limited to the Products all records reasonably necessary to support all GMP guidelines and shall provide the other with a reasonable description of any requirements. All such inquiries and documentation not later than *** after such visit or inquiry. 5.8 BDSI records shall be responsible available for assisting Meda in investigating complaints inspection, audit and “Lack copying by Cempra, its representatives, and FDA upon reasonable request during normal business hours. All such records shall be maintained for a period as required under GMP and the Applicable Laws of Effect” reports the United States, provided that all records relating to the manufacture and/or packaging manufacture, stability and quality control of Products which are supplied by BDSI. BDSI shalleach batch of Supplied API shall be retained at least until the later of (i) the [*] ([*]) [*], or (ii) such longer period as reasonably directed by Meda may be required under the Specifications, GMP, and at Meda’s expense, evaluate the nature of the complaint and document the evaluation on Products manufactured and/or packaged by BDSI for Meda. This evaluation may include all Applicable Laws (including but is not limited to providing assessments of: (i) returned sample(s) (where appropriate); (ii) retained samples; (iii) the manufacturing process; (iv) release tests; (v) receiving tests; (vi) complaint history; and (vii) conclusion/summary. The documented evaluation those of the complaint will be provided by BDSI to Meda within *** from the date of BDSI’s receipt of the complaint. 5.9 Promptly following the execution of this Agreement, BDSI and Meda shall negotiate in good faith and enter into a mutually-agreeable Quality Agreement, which Quality Agreement shall be attached hereto as Exhibit C. In the event the terms of this Agreement FDA and the Quality Agreement conflict, the terms of this Agreement shall governProduct Approvals).

Quality; Regulatory. 5.1 BDSI warrants that all Products supplied pursuant to this Agreement shall on the date of delivery (i) materially comply with the Product Specifications and all applicable regulatory requirements (including but not limited to those included in applicable Governmental Approvals and GMP); ) and (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, BDSI or (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 significant 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 deemed amended in accordance with such change), no such change shall be implemented without Meda’s prior written approval, which shall not be unreasonably withheld. If the approval of Competent Authorities is required for any such change, the The time for implementing such changes shall be reasonably agreed between the Parties in order to enable Meda to obtain, and Meda shall use commercially reasonable efforts to obtain, obtain the relevant regulatory approvals prior to such implementation, provided that in any and all events, the period of time required for such implementation shall be no less than the length of time required by BDSI’s supplier of the Product. 5.3 BDSI shall provide Meda with certificates of quality assurance and quality control analysis with respect all deliveries of the Products, as customary in the industry, and with manufacturing and export documents as necessary for (i) import of the Products and (ii) compliance with all applicable regulatory requirements. BDSI shall keep complete, accurate and authentic accounts, notes, data and records of the work performed by it under this Agreement and shall maintain complete and adequate records pertaining to the methods and facilities used by it for the manufacture, processing, testing, packing, labeling, holding and distribution of Products in accordance with the applicable regulations. 5.4 BDSI shall, as between the Parties, be responsible for handling and responding to any appropriate governmental agency inspections with respect to manufacturing of Products during the term of this Agreement. To the extent available to BDSI, BDSI shall promptly provide to Meda copies of any (i) request or inquiry made by any regulatory agency with respect to Products or their manufacture or storage and (ii) any response thereto or information provided in response with respect to the foregoing, provided that, to the extent reasonably practicable and permissible under any relevant contracts between BDSI and Third Parties, Meda shall be provided an opportunity to review and comment on any and all such responses. BDSI shall use commercially reasonable efforts to promptly (i) advise Meda of any requests by any Competent Authority(ies) for any inspections with respect to the manufacturing of Products and (ii) provide Meda with copies of any correspondence related thereto. 5.5 BDSI shall retain (or cause any relevant Third Party contractors to retain) a reasonably sufficient quantity of each batch of Products to perform quality control testing. BDSI shall maintain samples of each batch in a reasonably suitable storage facility until at least the first anniversary of the end of the approved shelf life of the Product, or such longer period as may be required under applicable laws, rules, and regulations. Portions of all such samples shall be made reasonably available for testing by Meda, at Meda’s expense, upon request. 5.6 BDSI shall maintain (or shall use commercially reasonable efforts to ensure that any relevant Third Party contractors maintain) all records as necessary to comply with manufacturing regulations imposed by any regulatory authority. 5.7 Each Party agrees to notify the other forthwith of its knowledge or receipt of notice of the initiation of any inquiries, notices or inspection activity by any governmental or regulatory authority with respect to the Products and shall provide the other with a reasonable description of any such inquiries and documentation not later than *** after such visit or inquiry. 5.8 BDSI shall be responsible for assisting Meda in investigating complaints and “Lack of Effect” reports relating to the manufacture and/or packaging of Products which are supplied by BDSI. BDSI shall, as reasonably directed by Meda and at Meda’s expense, evaluate the nature of the complaint and document the evaluation on Products manufactured and/or packaged by BDSI for Meda. This evaluation may include but is not limited to providing assessments of: (i) returned sample(s) (where appropriate); (ii) retained samples; (iii) the manufacturing process; (iv) release tests; (v) receiving tests; (vi) complaint history; and (vii) conclusion/summary. The documented evaluation of the complaint will be provided by BDSI to Meda within *** from the date of BDSI’s receipt of the complaint. 5.9 Promptly following the execution of this Agreement, BDSI and Meda shall negotiate in good faith and enter into a mutually-agreeable Quality Agreement, which Quality Agreement shall be attached hereto as Exhibit C. In the event the terms of this Agreement and the Quality Agreement conflict, the terms of this Agreement shall govern.

Quality; Regulatory. 5.1 BDSI 6.1 LTS warrants that all Products supplied pursuant to this Agreement shall on the date of delivery (i) comply have been manufactured in accordance with the Product Specifications, Packaging Specifications and all applicable legal and regulatory requirements at the place of manufacture (including including, but not limited to to, those included in applicable Governmental Approvals 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 . The 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 only with the regulatory requirements necessary to obtain and maintain Governmental Approvals with respect to the Products in the reasonable discretion prior written consent 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 LTS which do shall not meet the foregoing warranty. Replacement or refund, as elected by BDSI in its sole discretion, shall unreasonably be Meda’s sole remedy for breach of such warranty unless such breach is the result of BDSI’s gross negligence or willful misconductwithheld. 5.2 BDSI 6.2 LTS shall, as soon as reasonably possible, provide written notice of any significant changes proposed by BDSI LTS 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 Product(s)-related changes shall be entitled subject 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 deemed amended in accordance with such change), no such change shall be implemented without MedaBDSI’s prior written approval, which shall consent not to be unreasonably withheld. If the approval of Competent Authorities is required for any such change, the The time and costs for implementing such changes shall be reasonably agreed between the Parties in order to enable Meda to obtain, and Meda shall use commercially reasonable efforts to obtain, the relevant regulatory approvals prior to such implementation, provided that in any and all events, the period of time required for such implementation shall be no less than the length of time required by BDSI’s supplier of the ProductParties. 5.3 BDSI 6.3 LTS shall provide Meda BDSI (or its designee) with certificates LTS’ Certificates of quality assurance and quality control analysis Analysis with respect to all deliveries of the Products, as customary in the industrypharmaceutical industry and consistent with any applicable legal or regulatory requirements, and with manufacturing and export documents as necessary for for (i) import and export of the Products and and (ii) compliance with all applicable regulatory requirements. BDSI LTS shall keep complete, accurate and authentic accounts, notes, data and records of the work performed by it under this Agreement and shall maintain complete and adequate records pertaining to the methods and facilities used by it for the manufacture, processing, testing, packing, labeling, holding and distribution of Products in accordance with the applicable regulations. 5.4 BDSI shall, as between the Parties, 6.4 LTS shall be responsible for handling and responding to any appropriate governmental or regulatory agency inspections with respect to manufacturing of Products during the term of this Agreement. To the extent available to BDSILTS, BDSI LTS shall promptly as soon as is reasonably possible, provide to Meda BDSI copies of any any (ia) request or inquiry made by any regulatory agency with respect to Products or their manufacture or storage and and (iib) any response thereto or information provided in response with respect to the foregoing, provided that, to the extent reasonably practicable and permissible under any relevant contracts between BDSI LTS and Third Parties, Meda BDSI shall be Confidential Treatment Requested by BioDelivery Sciences International, Inc. IRS Employer Identification No. 35-208985 Confidential treatment requested with respect to certain portions hereof denoted with “***” provided an opportunity to review and comment on any and all such responses. BDSI LTS shall use commercially reasonable efforts to promptly Commercially Reasonable Efforts to (i) advise Meda BDSI of any requests by any Competent Authority(iesgovernmental or regulatory authority(ies) for any inspections with respect to the manufacturing of Products and and (ii) provide Meda BDSI with copies of any relevant correspondence related theretothereto in due time. 5.5 6.5 LTS and BDSI shall retain (or cause any relevant Third Party contractors to retain) a reasonably sufficient quantity of each batch of Products to perform quality control testing. BDSI shall maintain samples of each batch in a reasonably suitable storage facility until at least the first anniversary of the end of the approved shelf life of the Product, or such longer period as may be required under applicable laws, rules, due time negotiate and regulations. Portions of all such samples shall be made reasonably available for testing by Meda, at Meda’s expense, upon request. 5.6 BDSI shall maintain (or shall use commercially reasonable efforts to ensure that any relevant Third Party contractors maintain) all records as necessary to comply with manufacturing regulations imposed by any regulatory authority. 5.7 Each Party agrees to notify the other forthwith of its knowledge or receipt of notice of the initiation of any inquiries, notices or inspection activity by any governmental or regulatory authority with respect to the Products and shall provide the other with a reasonable description of any such inquiries and documentation not later than *** after such visit or inquiry. 5.8 BDSI shall be responsible for assisting Meda in investigating complaints and “Lack of Effect” reports relating to the manufacture and/or packaging of Products which are supplied by BDSI. BDSI shall, as reasonably directed by Meda and at Meda’s expense, evaluate the nature of the complaint and document the evaluation on Products manufactured and/or packaged by BDSI for Meda. This evaluation may include but is not limited to providing assessments of: (i) returned sample(s) (where appropriate); (ii) retained samples; (iii) the manufacturing process; (iv) release tests; (v) receiving tests; (vi) complaint history; and (vii) conclusion/summary. The documented evaluation of the complaint will be provided by BDSI to Meda within *** from the date of BDSI’s receipt of the complaint. 5.9 Promptly following the execution of this Agreement, BDSI and Meda shall negotiate agree in good faith and enter into a mutuallyupon an appropriate Quality Assurance Agreement (according to EU-agreeable Quality AgreementGMP Legislation Art. 12 2003/94/EC, which Quality Agreement shall be attached hereto related national laws such as Exhibit C. § 9 AMWHV). In the event the terms of this Agreement and the Quality Assurance Agreement conflict, the terms of this Agreement shall govern. In furtherance of LTS’ efforts in quality assurance and subject to a separate commercial agreement, if executed by the parties, LTS shall also perform any ongoing stability testing. 6.6 Nothing in this Agreement, however, shall be construed as limiting the right of LTS to develop and/or manufacture for Third Parties any product, other than a Product, developed by LTS and/or a Third Party independently of BDSI or the BEMA technology, whether or not such product contains the Active Principle, or is used for the same indication as Product, provided that the foregoing shall not be construed as any license, grant of rights, or covenant not to xxx for the benefit of LTS or any Third Party with respect to any of the BDSI Technology or any other patents or intellectual property rights of BDSI.

Quality; Regulatory. 5.1 BDSI 6.1 Supplier warrants that all Products Supplied API supplied pursuant to this Agreement shall on the date of delivery (i) be manufactured in accordance with current GMP and (ii) comply with the Product Specifications and all applicable regulatory requirements Applicable Laws (including but not limited to those FDA regulations and requirements 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 GMPProduct Approvals), provided that Product Specifications and Packaging Specifications may be amended as (a) reasonably requested by Meda Cempra and agreed upon by BDSISupplier, such agreement not to be unreasonably withheld, or (b) necessary to conform such Product Specifications and Packaging Specifications to the regulatory requirements necessary to obtain and maintain Governmental Product Approvals with respect to Cempra Products, including but not limited to the Products approval of alternative dosages or indications of Cempra Products. In the event any change in the reasonable discretion Specifications materially increases or decreases the Manufacturing Costs, then the parties will meet and negotiate in good faith an increase or decrease in the Price. 6.2 For additions or changes to the Specifications or manufacturing processes that are required by GMP or Applicable Laws of BDSIthe United States or other applicable Regulatory Authority (including but not limited to those requirements of the FDA and Product Approvals) (collectively, “Required Manufacturing Changes”), the parties shall cooperate in making such changes in a timely fashion and amending the Specifications to reflect such additions or changes. Either Cempra or Supplier shall be free to propose changes to the Specifications or manufacturing processes that are not Required Manufacturing Changes (ccollectively, “Discretionary Manufacturing Changes”). Any Discretionary Manufacturing Changes proposed by Cempra shall only be effective upon the approval of FDA (or other applicable Regulatory Authority) or otherwise effected in accordance with Section 5.2 below. BDSI shalland Supplier’s written agreement to such changes and, at Meda’s optionsuch approval which shall not unreasonably be withheld, immediately replace (without additional cost) or refund to Meda and the amount actually paid by Meda for Supplier shall implement any such Products which do not meet Discretionary Manufacturing Changes agreed upon in writing by 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, parties as soon as reasonably possible, provide written notice of any changes practicable. Any [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. Discretionary Manufacturing Changes proposed by BDSI to Supplier shall only be effective upon the Product approval of FDA (or method of manufacture of the Productsother applicable Regulatory Authority), 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 provided that no Discretionary Manufacturing Changes affecting any event be required to exceed five (5) business days. Unless (i) such change is required by any Competent Authority Specifications or Applicable Law process changes that are the result of Required Manufacturing Changes 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, Cempra Specifications may be effected unless approved by Cempra in advance 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 deemed amended in accordance with such change), no such change shall be implemented without Meda’s prior written approvalwriting, which approval shall not be unreasonably withheld. If Notwithstanding the approval of Competent Authorities is required for any such changeforegoing, the time for commercially reasonable, documented, direct costs, including, without limitation, obsolete raw materials, work-in-process, packaging and labeling materials (i) associated with implementing such changes any Required Manufacturing Changes shall be reasonably agreed between the Parties in order to enable Meda to obtain, and Meda shall use commercially reasonable efforts to obtain, the relevant regulatory approvals prior to such implementation, provided that in born by [*] (ii) associated with implementing any and all events, the period of time required for such implementation Discretionary Manufacturing Changes shall be no less than borne by [*]. In the length of time required event any Required Manufacturing Changes or Discretionary Manufacturing Changes materially increase or decrease the ongoing Manufacturing Costs, then the parties will negotiate in good faith an increase or decrease in the Price by BDSI’s supplier of an amount equal to the Productincrease or decrease in Manufacturing Costs. 5.3 BDSI 6.3 Supplier shall conduct quality control testing of every batch of Supplied API manufactured hereunder and provide Meda Cempra with certificates of quality assurance and quality control analysis with respect to all deliveries of the ProductsSupplied API, as customary in the industrypharmaceutical industry and in compliance with GMP and all applicable regulatory requirements of the United States (including those of the FDA) and other applicable Regulatory Authority, and with the manufacturing and export documents as necessary for (i) import of the Products Supplied API and (ii) compliance with GMP and all applicable regulatory requirementsApplicable Laws. BDSI Supplier shall keep complete, accurate and authentic accounts, notes, data and records of the work performed by it under this Agreement and shall maintain complete and adequate records pertaining to the methods and facilities used by it for the manufacture, processing, testing, packing, labeling, holding and distribution of Products Supplied API in accordance with the applicable regulationsApplicable Laws and GMP. All raw data generated in the manufacturer, testing, and supply of Supplied API under this Agreement shall be maintained by the Supplier in a readily accessible manner for at least the longer of (i) [*] ([*]) [*] following the expiration date of the final Product into which the Supplied API is incorporated or (ii) such time as may be required by GMP or Applicable Law. 5.4 BDSI 6.4 All facilities utilized by the Supplier to manufacture, store, or otherwise handle Supplied API manufactured for Cempra under this Agreement or utilized by Supplier Agent to store or otherwise handle Supplied API manufactured by Supplier for Cempra hereunder, or source intermediates therefore, shall comply with and satisfy all requirements under GMP and all Applicable Laws concerning the manufacture of Supplied API for use in pharmaceutical or biological products for human use (including but not limited to those of the FDA or included in the Product Approvals), including the maintenance of such standards or requirements sufficient to pass any inspection pursuant to such requirements. Without limiting the generality of the foregoing, the Supplier shall obtain and maintain all licenses, registrations, and other authorizations required to operate a GMP facility under Applicable Laws (including but not limited to those of the FDA). Supplier shall be responsible for all costs and fees related to obtaining and maintaining regulatory permits, certificates, approvals, or other authorizations required to manufacture Supplied API, and/or qualify any manufacturing sites for the manufacture of Supplied API, under this Agreement in compliance with all Applicable Laws (including but not limited to GMP and those of the FDA). Supplier shall comply with all Applicable Laws in performing their obligations hereunder, including but not limited to any applicable environmental, toxic or hazardous waste, or similar regulations. [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. 6.5 Supplier will be responsible for any reporting of matters regarding the general manufacture of Supplied API, as applicable, to the FDA and other applicable Regulatory Authority in accordance with GMP and Applicable Laws and may utilize Supplier Agent to perform such responsibilities. Supplier or Supplier Agent shall notify Cempra of any such matter within [*] ([*]) [*] and furnish copies of such reports to Cempra within [*] ([*]) [*]. Supplier or Supplier Agent also shall advise Cempra of any material occurrence or new information which arises out of the Supplier’s manufacturing, testing (including in process, release or stability), or other activities which may reasonably be expected to have adverse regulatory compliance and/or reporting consequences concerning any Product. Supplier or Supplier Agent shall promptly (and in any event, within the time period reasonably necessary to enable Cempra to comply with GMP and any Applicable Laws with respect to the clinical use or commercial sale of Products for human therapeutic use) report any adverse events, customer complaints, trend analysis, or other circumstances of which either Supplier or Supplier Agent becomes aware that may relate to the safety or efficacy of any Products. 6.6 Supplier shall, as between the Partiessubject to this paragraph, be responsible for handling and responding to any appropriate governmental agency FDA (or other applicable) Regulatory Authority inspections with respect to manufacturing of Products Supplied API during the term of this AgreementAgreement and may utilize Supplier Agent to perform such responsibilities. To the extent available to BDSI, BDSI Supplier or Supplier Agent shall promptly provide to Meda Cempra copies of any (i) request or inquiry made by any regulatory agency FDA (or other applicable Regulatory Authority) with respect to Products Supplied API or their manufacture its manufacture, testing, or storage for Cempra under this Agreement and (ii) any response thereto or information provided in response with respect to the foregoingforegoing by either Supplier or Supplier Agent, provided that, to the extent when reasonably practicable and permissible under any relevant contracts between BDSI and Third Partiespracticable, Meda Cempra shall be provided an opportunity to review and comment on any and all such responsesresponses reasonably in advance of their submission by either Supplier or Supplier Agent to FDA (or other applicable Regulatory Authority), provided that final discretion with respect to any such response remains with Supplier. BDSI Supplier and Supplier Agent shall use commercially reasonable best efforts to promptly (but in any event within [*] ([*]) [*]) (i) advise Meda Cempra of any requests by any Competent Authority(iesFDA (or other applicable Regulatory Authority) for any inspections with respect to the manufacturing of Products Supplied API under this Agreement and (ii) provide Meda Cempra with copies of any correspondence related thereto. 5.5 BDSI 6.7 Supplier certifies that they have not and covenant that they will not use in any capacity in connection with the manufacture of Supplied API under this Agreement the services of any person, including any firm or individual, debarred or subject to debarment under Applicable Laws (including but not limited to GMP or those of the FDA). Supplier and Supplier Agent agree to notify Cempra immediately in the event any person providing services to either Supplier or Supplier Agent under this Agreement is debarred or becomes subject to debarment. 6.8 Supplier shall retain (or cause any relevant Third Party contractors to retain) a reasonably sufficient quantity of each batch of Products Supplied API to perform quality control testingtesting and representative batches of Supplied API will be placed on stability testing as described in the current drug master file for Supplied API and as necessary to comply with GMP and FDA requirements and other Applicable Law. BDSI Supplier shall maintain samples of each batch in a reasonably suitable storage facility until at least the first anniversary later of (i) the end of the approved shelf life of the Product, [*] ([*]) [*] or (iii) such longer period as may be required under applicable lawsthe Specifications, rulesGMP, and/or Applicable Laws (including but not limited to those of the FDA and regulationsthe Product Approvals). Portions of all such samples and representative batches shall be made reasonably available (i) for testing by MedaCempra upon request and, at Meda[*] Confidential treatment requested; certain information omitted and filed separately with the SEC. upon Cempra’s expenseprior written consent, upon requestsuch consent not to be unreasonably withheld, (ii) to FDA and other applicable Regulatory Authority. Samples of any samples provided to FDA and other applicable Regulatory Authority shall be retained by the Supplier in quantities reasonably sufficient to allow quadruplicate replicatory testing by Cempra. 5.6 BDSI 6.9 Supplier shall maintain (or shall use commercially reasonable efforts to ensure that any relevant Third Party contractors maintain) all records as are necessary to comply with manufacturing regulations imposed by any regulatory authority. 5.7 Each Party agrees to notify the other forthwith of its knowledge or receipt of notice all Applicable Laws of the initiation of any inquiriesUnited States, notices or inspection activity by any governmental or regulatory authority with respect including but not limited to the Products all records reasonably necessary to support all GMP guidelines and shall provide the other with a reasonable description of any requirements. All such inquiries and documentation not later than *** after such visit or inquiry. 5.8 BDSI records shall be responsible available for assisting Meda in investigating complaints inspection, audit and “Lack copying by Cempra, its representatives, and FDA upon reasonable request during normal business hours. All such records shall be maintained for a period as required under GMP and the Applicable Laws of Effect” reports the United States, provided that all records relating to the manufacture and/or packaging manufacture, stability and quality control of Products which are supplied by BDSI. BDSI shalleach batch of Supplied API shall be retained at least until the later of (i) the [*] ([*]) [*], or (ii) such longer period as reasonably directed by Meda may be required under the Specifications, GMP, and at Meda’s expense, evaluate the nature of the complaint and document the evaluation on Products manufactured and/or packaged by BDSI for Meda. This evaluation may include all Applicable Laws (including but is not limited to providing assessments of: (i) returned sample(s) (where appropriate); (ii) retained samples; (iii) the manufacturing process; (iv) release tests; (v) receiving tests; (vi) complaint history; and (vii) conclusion/summary. The documented evaluation those of the complaint will be provided by BDSI to Meda within *** from the date of BDSI’s receipt of the complaint. 5.9 Promptly following the execution of this Agreement, BDSI and Meda shall negotiate in good faith and enter into a mutually-agreeable Quality Agreement, which Quality Agreement shall be attached hereto as Exhibit C. In the event the terms of this Agreement FDA and the Quality Agreement conflict, the terms of this Agreement shall governProduct Approvals).

Quality; Regulatory. 5.1 BDSI 8.1 Aveva warrants that all Products supplied pursuant to this Agreement shall on the date of delivery (i) be manufactured in accordance with cGMP, (ii) comply with the Product Specifications and all applicable regulatory requirements (including but not limited to all FDA regulations and those regulatory requirements included in applicable Governmental Approvals and GMP); (iior related to the Product Approvals) 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 all FDA regulations and those regulatory requirements included in applicable Governmental Approvals and GMPor related to the Product Approvals), provided that Product Specifications and Packaging Specifications may be amended as (a) reasonably requested by Meda and agreed upon by BDSI, Arius or (b) necessary to conform such Product Specifications and Packaging Specifications to the regulatory requirements necessary to obtain and maintain Governmental Product Approvals with respect to the Products in the reasonable discretion of BDSIArius, including but not limited to the approval of alternative dosages or indications, or (c) or otherwise effected Product Approvals in accordance foreign jurisdictions, with Section 5.2 belowrespect to Products. BDSI Aveva shall, at Meda’s Arius’ option, immediately replace (without additional cost) or refund to Meda Arius ***CONFIDENTIAL TREATMENT REQUESTED*** Note: The portions hereof for which confidential treatment are being requested are denoted with “*****”. the amount actually paid by Meda for Purchase Price of any such Products which do not meet the foregoing warranty. Replacement or refund, as elected by BDSI in its sole discretion, refund shall be Meda’s Arius’ sole remedy for breach of such warranty unless such breach is the result of BDSI’s gross negligence or willful misconductwarranty. 5.2 BDSI shall, as soon as reasonably possible, 8.2 Aveva shall provide written notice of any significant changes proposed by BDSI Aveva to the Product or method of manufacture of the Products, the Product Specifications, or Packaging Specifications, and, to and shall make any such changes only upon the extent reasonably practicable, provide Meda a reasonable opportunity to review prior written consent of Arius 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 regulatory authorities (including 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 deemed amended in accordance with such changeFDA), no such change shall be implemented without Meda’s prior written approval, which shall not be unreasonably withheld. If the approval of Competent Authorities is required for any such change, the time for implementing such changes shall be reasonably agreed between the Parties in order to enable Meda to obtain, and Meda shall use commercially reasonable efforts to obtain, the relevant regulatory approvals prior to such implementation, provided that in any and all events, the period of time required for such implementation shall be no less than the length of time required by BDSI’s supplier of the Product. 5.3 BDSI 8.3 Aveva shall provide Meda Arius with certificates of quality assurance and quality control analysis with respect all deliveries of the Products, as customary in the industry, and with the manufacturing and export documents as necessary for (i) import of the Products and (ii) compliance with all applicable regulatory requirements. BDSI Aveva shall keep complete, accurate and authentic accounts, notes, data and records of the work performed by it under this Agreement and shall maintain complete and adequate records pertaining to the methods and facilities used by it for the manufacture, processing, testing, packing, labeling, holding and distribution of Products in accordance with the applicable regulationsregulations in the United States and other jurisdictions. 5.4 BDSI shall8.4 All facilities utilized by Aveva to manufacture, store, or otherwise deal with Products manufactured for sale to Arius under this Agreement shall comply with and satisfy all requirements under all regulations applicable to the Products (including but not limited to those of the FDA), and shall comply with and satisfy in all respects any specific requirements of the appropriate regulatory authorities with respect to the manufacture of such Products for sale in any jurisdiction (including but not limited to such requirements as may be contained in the Product Approvals), including the maintenance of such standards or requirements sufficient to pass any inspection pursuant to such regulations or regulatory requirements. Without limiting the generality of the foregoing, Aveva shall obtain and maintain all licenses, registrations, and other authorizations required to operate a GMP facility under the applicable laws, rules and regulations (including but not limited to those promulgated by the FDA). Aveva shall be responsible for all costs and fees related to obtaining and maintaining regulatory permits, certificates, approvals, or other authorizations required to manufacture Products, and/or qualify any manufacturing sites for the manufacture of Products, under this Agreement in compliance with all applicable laws, rules, and regulations, provided, however, that Arius shall be responsible for obtaining and maintaining all regulatory approvals specifically relating to the manufacturer and sale of the Products. 8.5 Arius will be responsible for any reporting of matters regarding the general manufacture of Products, as between applicable, to the PartiesFDA and other relevant regulatory authorities, in accordance with applicable laws and regulations. Aveva shall notify Arius of any such matter within 2 working days and furnish complete copies of such reports to Arius within 4 working days. Aveva also shall advise Arius of any occurrence or new information which arises out of Aveva’s manufacturing or other activities which may reasonably be expected to have adverse regulatory compliance and/or reporting consequences concerning a Product. 8.6 Aveva shall be responsible for handling and responding to any appropriate governmental agency inspections with respect to manufacturing of Products during the term of this Agreement. To the extent available to BDSI, BDSI Aveva shall promptly provide to Meda Arius copies of any (i) request or inquiry made ***CONFIDENTIAL TREATMENT REQUESTED*** Note: The portions hereof for which confidential treatment are being requested are denoted with “*****”. by any regulatory agency with respect to Products or their manufacture or storage and (ii) any response thereto or information provided in response with respect to the foregoingforegoing by Aveva, provided that, to the extent when reasonably practicable and permissible under any relevant contracts between BDSI and Third Partiespracticable, Meda Arius shall be provided an opportunity to review and comment on any and all such responses. BDSI Aveva shall use commercially reasonable best efforts to promptly (but in any event within two (2) business days) (i) advise Meda Arius of any requests by any Competent Authority(ies) governmental agency for any inspections with respect to the manufacturing of Products and (ii) provide Meda Arius with copies of any correspondence related thereto. 5.5 BDSI 8.7 Aveva certifies it did not and will not use in any capacity in connection with the Products the services of any person, including any firm or individual, debarred or subject to debarment under applicable laws, rules, and regulations (including but not limited to those promulgated by the FDA). Aveva agrees to notify Arius immediately in the event any person providing services to Aveva under the scope of the work of this Agreement is debarred or becomes subject to debarment. 8.8 Aveva shall retain (or cause any relevant Third Party contractors to retain) a reasonably sufficient quantity of each batch of Products to perform quality control testing. BDSI Aveva shall maintain samples of each batch in a reasonably suitable storage facility until at least the first anniversary of the end of the approved shelf life of the Product, or such longer period as may be required under applicable laws, rules, and regulationsregulations (including but not limited to the Product Approvals). Portions of all such samples shall be made reasonably available for testing by Meda, at Meda’s expense, Arius upon request. 5.6 BDSI 8.9 Aveva shall maintain (or shall use commercially reasonable efforts to ensure that any relevant Third Party contractors maintain) all records as are necessary to comply with manufacturing regulations imposed by any regulatory authority, including but not limited to all records reasonably necessary to support all applicable GLP and GMP guidelines and requirements. All such records shall be available for inspection and audit by Arius, its representatives, and any regulatory authorities upon reasonable request during normal business hours. All such records shall be maintained for a period as required under the laws of the countries of manufacture and sale (including but not limited to the United States), provided that all records relating to the manufacture, stability and quality control of each batch of Products shall be retained at least until the first anniversary of the end of the approved shelf life for all Products from such batch. 5.7 8.10 Each Party party agrees to notify the other forthwith of its knowledge or receipt of notice of the initiation of any inquiries, notices or inspection activity by any governmental or regulatory authority with respect to the Products and shall provide the other with a reasonable description of any such inquiries and documentation (including but not limited to any FDA Establishment Inspection Report Form 483 or FDA warning letter) not later than *** five (5) working days after such visit or inquiry. 5.8 BDSI 8.11 Aveva shall reasonably assist Arius in the finalization of, the chemistry, manufacturing, and controls portion of any and all Regulatory Filings or correspondence, as requested by Arius in conjunction with its preparation and submission of such materials to appropriate regulatory authorities (including but not limited to the FDA) with respect to Products. Aveva shall provide Arius with all manufacturing procedures, controls for inactive ***CONFIDENTIAL TREATMENT REQUESTED*** Note: The portions hereof for which confidential treatment are being requested are denoted with “*****”. ingredients and finished dosage forms, chemistry and stability information, and any other information reasonably necessary for the preparation of Product Approvals. 8.12 Aveva shall be responsible for assisting Meda Arius in investigating complaints and “Lack of Effect” reports relating to the manufacture and/or packaging of Products which are supplied by BDSIAveva. BDSI Aveva shall, as reasonably directed by Meda and at Meda’s expenseArius, evaluate the nature of the complaint and document the evaluation on Products manufactured and/or packaged by BDSI Aveva for MedaArius. This evaluation may include but is not limited to providing assessments of: (i) returned sample(s) (where appropriate); (ii) retained samples; (iii) the manufacturing process; (iv) release tests; (v) receiving tests; (vi) complaint history; and (vii) conclusion/summary. The documented evaluation of the complaint will be provided by BDSI Aveva to Meda Arius within *** thirty (30) calendar days from the date of BDSIAveva’s receipt of the complaint. 5.9 Promptly following 8.13 Aveva shall enter into a Quality Agreement, in the form attached hereto as Exhibit E, immediately upon execution of this Agreement, BDSI and Meda shall negotiate in good faith and enter into a mutually-agreeable Quality Agreement, which Quality Agreement shall be attached hereto as Exhibit C. . In the event the terms of this Agreement and the Quality Agreement conflict, the terms of this Agreement shall govern.

Quality; Regulatory. 5.1 BDSI 6.1 LTS warrants that all Products supplied pursuant to this Agreement shall on the date of delivery (i) comply have been manufactured in accordance with the Product Specifications, Packaging Specifications and all applicable legal and regulatory requirements at the place of manufacture (including including, but not limited to to, those included in applicable Governmental Approvals 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 . The 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 only with the regulatory requirements necessary to obtain and maintain Governmental Approvals with respect to the Products in the reasonable discretion prior written consent 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 LTS which do shall not meet the foregoing warranty. Replacement or refund, as elected by BDSI in its sole discretion, shall unreasonably be Meda’s sole remedy for breach of such warranty unless such breach is the result of BDSI’s gross negligence or willful misconductwithheld. 5.2 BDSI 6.2 LTS shall, as soon as reasonably possible, provide written notice of any significant changes proposed by BDSI LTS 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 Product(s)-related changes shall be entitled subject 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 deemed amended in accordance with such change), no such change shall be implemented without MedaBDSI’s prior written approval, which shall consent not to be unreasonably withheld. If the approval of Competent Authorities is required for any such change, the The time and costs for implementing such changes shall be reasonably agreed between the Parties in order to enable Meda to obtain, and Meda shall use commercially reasonable efforts to obtain, the relevant regulatory approvals prior to such implementation, provided that in any and all events, the period of time required for such implementation shall be no less than the length of time required by BDSI’s supplier of the ProductParties. 5.3 BDSI 6.3 LTS shall provide Meda BDSI (or its designee) with certificates LTS’ Certificates of quality assurance and quality control analysis Analysis with respect to all deliveries of the Products, as customary in the industrypharmaceutical industry and consistent with any applicable legal or regulatory requirements, and with manufacturing and export documents as necessary for for (i) import and export of the Products and and (ii) compliance with all applicable regulatory requirements. BDSI LTS shall keep complete, accurate and authentic accounts, notes, data and records of the work performed by it under this Agreement and shall maintain complete and adequate records pertaining to the methods and facilities used by it for the manufacture, processing, testing, packing, labeling, holding and distribution of Products in accordance with the applicable regulations. 5.4 BDSI shall, as between the Parties, 6.4 LTS shall be responsible for handling and responding to any appropriate governmental or regulatory agency inspections with respect to manufacturing of Products during the term of this Agreement. To the extent available to BDSILTS, BDSI LTS shall promptly as soon as is reasonably possible, provide to Meda BDSI copies of any any (ia) request or inquiry made by any regulatory agency with respect to Products or their manufacture or storage and and (iib) any response thereto or information provided in response with respect to the foregoing, provided that, to the extent reasonably practicable and permissible under any relevant contracts between BDSI LTS and Third Parties, Meda BDSI shall be provided an opportunity to review and comment on any and all such responses. BDSI LTS shall use commercially reasonable efforts to promptly Commercially Reasonable Efforts to (i) advise Meda BDSI of any requests by any Competent Authority(iesgovernmental or regulatory authority(ies) for any inspections with respect to the manufacturing of Products and and (ii) provide Meda BDSI with copies of any relevant correspondence related theretothereto in due time. 5.5 6.5 LTS and BDSI shall retain (or cause any relevant Third Party contractors to retain) a reasonably sufficient quantity of each batch of Products to perform quality control testing. BDSI shall maintain samples of each batch in a reasonably suitable storage facility until at least the first anniversary of the end of the approved shelf life of the Product, or such longer period as may be required under applicable laws, rules, due time negotiate and regulations. Portions of all such samples shall be made reasonably available for testing by Meda, at Meda’s expense, upon request. 5.6 BDSI shall maintain (or shall use commercially reasonable efforts to ensure that any relevant Third Party contractors maintain) all records as necessary to comply with manufacturing regulations imposed by any regulatory authority. 5.7 Each Party agrees to notify the other forthwith of its knowledge or receipt of notice of the initiation of any inquiries, notices or inspection activity by any governmental or regulatory authority with respect to the Products and shall provide the other with a reasonable description of any such inquiries and documentation not later than *** after such visit or inquiry. 5.8 BDSI shall be responsible for assisting Meda in investigating complaints and “Lack of Effect” reports relating to the manufacture and/or packaging of Products which are supplied by BDSI. BDSI shall, as reasonably directed by Meda and at Meda’s expense, evaluate the nature of the complaint and document the evaluation on Products manufactured and/or packaged by BDSI for Meda. This evaluation may include but is not limited to providing assessments of: (i) returned sample(s) (where appropriate); (ii) retained samples; (iii) the manufacturing process; (iv) release tests; (v) receiving tests; (vi) complaint history; and (vii) conclusion/summary. The documented evaluation of the complaint will be provided by BDSI to Meda within *** from the date of BDSI’s receipt of the complaint. 5.9 Promptly following the execution of this Agreement, BDSI and Meda shall negotiate agree in good faith and enter into a mutuallyupon an appropriate Quality Assurance Agreement (according to EU-agreeable Quality AgreementGMP Legislation Art. 12 2003/94/EC, which Quality Agreement shall be attached hereto related national laws such as Exhibit C. § 9 AMWHV). In the event the terms of this Agreement and the Quality Assurance Agreement conflict, the terms of this Agreement shall govern. In furtherance of LTS’ efforts in quality assurance and subject to a separate commercial agreement, if executed by the parties, LTS shall also perform any ongoing stability testing. 6.6 Nothing in this Agreement, however, shall be construed as limiting the right of LTS to develop and/or manufacture for Third Parties any product, other than a Product, developed by LTS and/or a Third Party independently of BDSI or the BEMA technology, whether or not such product contains the Active Principle, or is used for the same indication as Product, provided that the foregoing shall not be construed as any license, grant of rights, or covenant not to xxx for the benefit of LTS or any Third Party with respect to any of the BDSI Technology or any other patents or intellectual property rights of BDSI.