Common use of Reporting of Adverse Drug Reactions (ADRs) Clause in Contracts

Reporting of Adverse Drug Reactions (ADRs). (i) The Parties shall keep each other informed on all safety matters related to the BEMA Fentanyl Products and on any information received from any source concerning any ADR coming to either Party’s (or any of its Affiliates’) actual knowledge with regard to the BEMA Fentanyl Products. (ii) Each Party is responsible for fulfilling its reporting obligations to the appropriate Competent Authorities with respect to the BEMA Fentanyl Products in accordance with the applicable national laws and regulations of the different countries. (iii) Independently of any national reporting requirements, the Parties hereto shall, in relation to the BEMA Fentanyl Products, report to each other all SAEs from clinical trials with a reasonable suspicion of causal relationship to the administered study medication and all serious spontaneously reported suspected ADRs within the ***, but not later than *** after having come to a Party’s attention including a case description and medical causality assessment on the International Adverse Event Report Form (“CIOMS Form”) in English. If required, follow up will be carried out by the Marketing Authorization holder on all SARs (listed and unlisted) and non-serious unlisted ADRs in the Territory according to its own internal procedures, which shall be commercially reasonable and consistent with industry standards. Upon assignment of the Current Product NDA to Collegium, non-serious listed ADRs in the Territory shall be followed up by Collegium if there is a safety concern; and pregnancy and in utero reports will be followed up by Collegium at the expected due date. Reasonable attempts shall be made by Collegium to obtain the required minimum information: identifiable patient, reporter, suspect drug, and AE. *** Confidential Information has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to this omitted information. (iv) Life-threatening or fatal SAEs originating from clinical trials in the Territory with a reasonable suspicion of causal relationship to the BEMA Fentanyl Products shall be reported by a Party to the other Party and, if and as required thereby, by the appropriate Party (as determined by Applicable Law) to appropriate Competent Authorities within ***, but not later than ***. In the case of incomplete or insufficient data available, an initial report has to be issued meeting the time frame, followed by reasonably prompt follow up report(s). Any ADRs originated by either Party are to be reported on CIOMS Form as soon as reasonably possible, but no later than *** days after first receipt. Collegium will report all other ADRs in tabular format (“CIOMS Line Listings”) in monthly intervals. (v) In any case where a change in the risk-benefit-ratio of the BEMA Fentanyl Products becomes evident or safety actions due to ADR seem to be necessary (e.g. change of the label, product information, special information/warnings to the medical profession, patients, or authorities, or Product Recall), the Parties hereto will inform each other without delay and use commercially reasonable efforts to harmonize further measures as appropriate. Such exchange of information is realized through direct contacts between the responsible departments. Therefore, both Parties undertake to inform each other on any change in the responsible persons, the address, telephone and fax-numbers in due time. If specific safety measures are to be taken with respect to any Licensed Products in the Territory following NDA Assignment, Collegium will ensure the implementation of such in the Territory within reasonable timeframes or according to regulatory obligations. (vi) Regulatory inquiries related to safety concerns for the Licensed Products received by either Party will be promptly forwarded to the other Party. The Parties shall work in good faith to develop a mutually agreeable response with respect to any such inquiry in the Territory at least *** before the response is required. The aforementioned information shall be addressed to: In case of BDSI: *** BioDelivery Sciences International, Inc. 0000 Xxxxxxxx Xxxxxx, Xxxxx #000 Xxxxxxx, Xxxxx Xxxxxxxx 00000 Tel.: *** Fax: 000-000-0000 Email: *** In case of Collegium: *** COLLEGIUM Pharmaceutical, Inc. 000 Xxxxxx Xxxxxx, Xxxxx 000 Xxxxxx, XX 00000 Tel.: *** | Fax.: 000.000.0000 Mobile: *** Main Tel.: 000.000.0000

Reporting of Adverse Drug Reactions (ADRs). (i) i. The Parties shall keep each other informed on all safety matters related to the BEMA Fentanyl Licensed Products and on any information received from any source concerning any ADR coming to either Party’s (or any of its Affiliates’) actual knowledge with regard to the BEMA Fentanyl Licensed Products. (ii) . Each Party is responsible for fulfilling its reporting obligations to the appropriate Competent Authorities regulatory authorities with respect to the BEMA Fentanyl Licensed Products in accordance with the applicable national laws and regulations of the different countries. (iii) . Independently of any national reporting requirements, the Parties hereto shall, shall in relation to the BEMA Fentanyl Products, Licensed Products report to each other all SAEs from clinical trials with a reasonable suspicion of causal relationship to the administered study medication and all serious spontaneously reported suspected ADRs within the first ***, but not later than *** after having come to a Party’s attention including a case description and medical causality assessment on the International Adverse Event Report Form (“CIOMS Form”form) in English. If required, follow up will be carried out by the Marketing Market Authorization holder on all SARs (listed and unlisted) and non-serious unlisted ADRs in the Territory according to its own internal procedures, which shall be commercially reasonable and consistent with industry standards. Upon assignment of the Current Product NDA to CollegiumFollowing Governmental Approval, non-serious listed ADRs in the Territory shall be followed up by Collegium Meda if there is a safety concern; , and pregnancy and in utero reports will be followed up by Collegium Meda at the expected due date. Reasonable attempts shall be made by Collegium Meda to obtain the required minimum information: identifiable patient, reporter, suspect drug, and AE. *** Confidential Information has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to this omitted information. (iv) . Life-threatening or fatal SAEs originating from clinical trials in the Territory with a reasonable suspicion of causal relationship to the BEMA Fentanyl Licensed Products shall be reported by a Party to the other Party and, if and as required thereby, by the appropriate Party (as determined by Applicable Law) to appropriate Competent Authorities within ***, but not later than ***. In the case of incomplete or insufficient data available, an initial report has to be issued meeting the time frame, followed by reasonably prompt follow up report(s). Any ADRs originated by either Party are to be reported on CIOMS Form form as soon as reasonably possible, but no later than *** days after first receipt. Collegium Meda will report all other ADRs in tabular format (“CIOMS Line Listings”line listings) in monthly intervals. (v) v. In any case where a change in the risk-benefit-ratio of the BEMA Fentanyl Licensed Products becomes evident or safety actions due to ADR seem to be necessary (e.g. change of the label, product information, special information/warnings to the medical profession, patients, or authorities, authorities or Product RecallRecall ), the Parties hereto will inform each other without delay and use commercially reasonable efforts to harmonize further measures as appropriate. Such exchange of information is realized through direct contacts between the responsible departments. Therefore, both Parties undertake to inform each other on any change in the responsible persons, the address, telephone and fax-numbers in due time. If specific safety measures are to be taken with respect to any Licensed Products in the Territory following NDA AssignmentGovernmental Approval thereof, Collegium Meda will ensure the implementation of such in the Territory within reasonable mutually agreed timeframes or according to regulatory obligations. (vi) . Regulatory inquiries related to safety concerns for the Licensed Products received by either Party will be promptly forwarded to the other Party. The Parties shall work in good faith to develop a mutually agreeable response with respect to any such inquiry in the Territory at least *** before the response is required. The aforementioned information shall be addressed to: In case of BDSI: *** Director, Regulatory Affairs BioDelivery Sciences International, Inc. 0000 Xxxxxxxx Xxxxxx, Xxxxx #000 Xxxxxx Xxxxxx Xxxxxxx, Xxxxx Xxxxxxxx 00000 000 Xxxxxxxxxxx, XX 00000, XXX Tel.: *** 000-000-0000 Fax: 000-000-0000 Email: *** xxxxxxxx@xxxxxxxxxxxxxxxx.xxx In case of CollegiumMeda: *** COLLEGIUM PharmaceuticalMEDA GmbH & Co. KG Corporate Pharmacovigilance Xxxxxxxxxxx 0 D-61352 Bad Homburg v.d.H., Inc. 000 Xxxxxx Xxxxxx, Xxxxx 000 Xxxxxx, XX 00000 Germany Tel.: *** | +00-0000-000-0000 Fax.: 000.000.0000 Mobile+00-0000-000-0000 Email: *** Main Tel.: 000.000.0000xxxx-xxxxxx@xxxxxxxxxx.xx

Reporting of Adverse Drug Reactions (ADRs). (i) The Parties shall keep each other informed on all safety matters related to the BEMA Fentanyl Products and on any information received from any source concerning any ADR coming to either Party’s (or any of its Affiliates’) actual knowledge with regard to the BEMA Fentanyl Products. (ii) Each Party is responsible for fulfilling its reporting obligations to the appropriate Competent Authorities with respect to the BEMA Fentanyl Products in accordance with the applicable national laws and regulations of the different countries. (iii) Independently of any national reporting requirements, the Parties hereto shall, in relation to the BEMA Fentanyl Products, report to each other all SAEs from clinical trials with a reasonable suspicion of causal relationship to the administered study medication and all serious spontaneously reported suspected ADRs within the ***, but not later than *** after having come to a Party’s attention including a case description and medical causality assessment on the International Adverse Event Report Form (“CIOMS Form”) in English. If required, follow up will be carried out by the Marketing Authorization holder on all SARs (listed and unlisted) and non-serious unlisted ADRs in the Territory according to its own internal procedures, which shall be commercially reasonable and consistent with industry standards. Upon assignment of the Current Product NDA to Collegium, non-serious listed ADRs in the Territory shall be followed up by Collegium if there is a safety concern; and pregnancy and in utero reports will be followed up by Collegium at the expected due date. Reasonable attempts shall be made by Collegium to obtain the required minimum information: identifiable patient, reporter, suspect drug, and AE. *** Confidential Information has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to this omitted information. (iv) Life-threatening or fatal SAEs originating from clinical trials in the Territory with a reasonable suspicion of causal relationship to the BEMA Fentanyl Products shall be reported by a Party to the other Party and, if and as required thereby, by the appropriate Party (as determined by Applicable Law) to appropriate Competent Authorities within ***, but not later than ***. In the case of incomplete or insufficient data available, an initial report has to be issued meeting the time frame, followed by reasonably prompt follow up report(s). Any ADRs originated by either Party are to be reported on CIOMS Form as soon as reasonably possible, but no later than *** days after first receipt. Collegium will report all other ADRs in tabular format (“CIOMS Line Listings”) in monthly intervals. (v) In any case where a change in the risk-benefit-ratio of the BEMA Fentanyl Products becomes evident or safety actions due to ADR seem to be necessary (e.g. change of the label, product information, special information/warnings to the medical profession, patients, or authorities, or Product Recall), the Parties hereto will inform each other without delay and use commercially reasonable efforts to harmonize further measures as appropriate. Such exchange of information is realized through direct contacts between the responsible departments. Therefore, both Parties undertake to inform each other on any change in the responsible persons, the address, telephone and fax-numbers in due time. If specific safety measures are to be taken with respect to any Licensed Products in the Territory following NDA Assignment, Collegium will ensure the implementation of such in the Territory within reasonable timeframes or according to regulatory obligations. (vi) Regulatory inquiries related to safety concerns for the Licensed Products received by either Party will be promptly forwarded to the other Party. The Parties shall work in good faith to develop a mutually agreeable response with respect to any such inquiry in the Territory at least *** before the response is required. The aforementioned information shall be addressed to: In case of BDSI: *** BioDelivery Sciences International, Inc. 0000 Xxxxxxxx Xxxxxx, Xxxxx #000 Xxxxxxx, Xxxxx Xxxxxxxx 00000 Tel.: *** Fax: 000-000-0000 Email: *** In case of Collegium: *** COLLEGIUM Pharmaceutical, Inc. 000 Xxxxxx Xxxxxx, Xxxxx 000 Xxxxxx, XX 00000 Tel.: *** | Fax.: 000.000.0000 Mobile: *** Main Tel.: 000.000.0000

Reporting of Adverse Drug Reactions (ADRs). (i) i. The Parties parties shall keep each other informed on all safety matters related to the BEMA Fentanyl Products Licensed Product and on any information received from any source concerning any ADR coming to either Party’s (or any of its Affiliates’) actual knowledge with regard to the BEMA Fentanyl ProductsLicensed Product. (ii) . Each Party is responsible for fulfilling its the reporting obligations to the appropriate Competent Authorities regulatory authorities with respect to the BEMA Fentanyl Products Licensed Product in accordance with the applicable national laws and regulations of the different countriescountries (e.g. Meda within the Territory, BDSI outside the Territory). (iii) . Independently of any national reporting requirements, the Parties parties hereto shall, shall in relation to the BEMA Fentanyl Products, Licensed Product report to each other all SAEs from clinical trials with a reasonable suspicion of causal relationship to the administered study medication and all serious spontaneously reported suspected ADRs within the first ***, but not later than *** after having come to a Party’s attention including a case description and medical causality assessment on the International Adverse Event Report Form (“CIOMS Form”form) in English. If required, follow up will be carried out by the Marketing Market Authorization holder on all SARs (listed and unlisted) and non-serious unlisted ADRs in the Territory according to its their own internal procedures, which shall be commercially reasonable and consistent with industry standards. Upon assignment of the Current Product NDA to Collegium, nonNon-serious listed ADRs in the Territory shall be followed up by Collegium Meda if there is a safety concern; and pregnancy . Pregnancy and in utero reports will be followed up by Collegium Meda at the expected due date. Reasonable attempts shall be made by Collegium Meda to obtain the required minimum information: identifiable patient, reporter, suspect drug, and AE. *** Confidential Information has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to this omitted information. (iv) . Life-threatening or fatal SAEs originating from clinical trials in the Territory with a reasonable suspicion of causal relationship to the BEMA Fentanyl Products Licensed Product shall be reported by a Party to the other Party and, if and as required thereby, by the appropriate Party (as determined by Applicable Law) to appropriate Competent Authorities within ***, but not later than ***. In the case of incomplete or insufficient data available, an initial report has to be issued meeting the time frame, followed by reasonably prompt follow up report(s). Any ADRs originated by either Party BDSI are to be reported on CIOMS Form form as soon as reasonably possible, but no later than *** days after first receipt. Collegium Meda will report all other ADRs in tabular format (“CIOMS Line Listings”line listings) in monthly intervals. (v) v. In any case where a change in the risk-benefit-ratio of the BEMA Fentanyl Products Licensed Product becomes evident or safety actions due to ADR seem to be necessary (e.g. change of the label, product information, special information/warnings to the medical profession, patients, or authorities, authorities or Product RecallRecall ), the Parties hereto will inform each other without delay and use commercially reasonable efforts to harmonize further measures as appropriate. Such exchange of information is realized through direct contacts between the responsible departments. Therefore, both Parties parties undertake to inform each other on any change in the responsible persons, the address, telephone and fax-numbers in due time. If specific safety measures are to be taken with respect to any the Licensed Products in the Territory following NDA AssignmentProduct, Collegium Meda will ensure the implementation of such in the Territory and BDSI outside the Territory within reasonable mutually agreed timeframes or according to regulatory obligations. (vi) . Regulatory inquiries related to safety concerns for the Licensed Products Product received by either Party will be promptly forwarded to the other Party. The Parties shall work in good faith to develop a mutually agreeable response with respect to any such inquiry in the Territory at least *** before the response is required. The aforementioned information shall be addressed to: In case of BDSI: *** Director, Regulatory Affairs BioDelivery Sciences International, Inc. 0000 Xxxxxxxx Xxxxxx, Xxxxx #000 Xxxxxx Xxxxxx Xxxxxxx, Xxxxx Xxxxxxxx 00000 000 Xxxxxxxxxxx, XX 00000, XXX Tel.: *** 000-000-0000 Fax: 000-000-0000 Email: *** xxxxxxxxx@xxxxxxxxxxxxxxxx.xxx In case of CollegiumMeda: *** COLLEGIUM PharmaceuticalMEDA GmbH & Co. KG Corporate Pharmacovigilance Xxxxxxxxxxx 0 D-61352 Bad Homburg v.d.H., Inc. 000 Xxxxxx Xxxxxx, Xxxxx 000 Xxxxxx, XX 00000 Germany Tel.: *** | +00-0000-000-0000 Fax.: 000.000.0000 Mobile+00-0000-000-0000 Email: *** Main Tel.: 000.000.0000xxxx-xxxxxx@xxxxxxxxxx.xx