Common use of Regulatory Affairs Clause in Contracts

Regulatory Affairs. From the point in time at which Novartis gives GW notice in writing that it wishes to take on responsibility for Regulatory Filings and Regulatory Approvals in the Territory, Novartis shall be responsible for all interactions with Regulatory Authorities in the Territory with respect to Regulatory Approvals as set forth in this Section 6.1, and including, filing and maintaining any required Regulatory Approvals, seeking necessary permits and/or scheduling or re-scheduling in controlled substance listings or de-scheduling of the Product from controlled substances listings in the Territory. (a) Where required, Novartis (or its applicable Affiliate or Sublicensee) will be responsible for arranging for the Product to be scheduled in any applicable controlled substance schedule(s) in countries in the Territory. GW agrees, without additional consideration, to give all necessary consents, declarations and documentation as are reasonably required to implement the foregoing and to provide Novartis with all assistance reasonably requested by Novartis (including attending meetings with Regulatory Authorities in any such country) for the purpose of arranging for such scheduling. (b) Subject to Section 6.1(g), Novartis (or its applicable Affiliate or Sublicensee) will file and hold all Regulatory Approvals for the Products in countries in the Territory in its own name and on its own behalf. Unless otherwise agreed by the Parties, within ten (10) Business Days following the Effective Date, GW will assign to Novartis all Regulatory Filings with any Regulatory Authority in the Territory at the Effective Date relating to any Product and Novartis will reimburse GW all fees paid by GW to Regulatory Authorities in such countries with respect to the submission of such Regulatory Filings. On request by Novartis, GW will deliver notices of such assignment to the applicable Regulatory Authorities. In addition, GW agrees to give all necessary consents, declarations and documentation as are reasonably required to implement the foregoing. (c) Subject to Sections 4.2 and 6.1(e), Novartis (or its applicable Affiliate or Sublicensee) will be responsible for conducting, at its sole expense, such activities directed towards obtaining and maintaining Regulatory Approvals for Products in the Territory as it determines appropriate in its sole discretion; provided, however, that Novartis agrees to submit Regulatory Filings for Marketing Approvals for a Product in each of the Key Countries. Thereafter, Novartis shall, on a Key Country-by-Key Country basis further prosecute all such Regulatory Filings in the Key Countries in a timely, professional and diligent manner, including by paying all required filing fees promptly and responding to correspondence and requests for further information from Regulatory Authorities in the Key Countries within a reasonable timeframe. Novartis shall share with GW its plans for obtaining Regulatory Approvals in the Key Countries at the first JSC meeting and thereafter shall supply GW with its updated plan from time to time. Novartis shall report its performance against this regulatory plan to the JSC each Calendar Quarter. (d) Novartis will: (A) determine the regulatory plans and strategies for the Products in the Territory; (B) (either itself or through its Affiliates or Sublicensees and subject to Section 6.1(g)) make and own all Regulatory Filings with respect to the Products in the Territory; and (C) will be responsible for obtaining and maintaining Regulatory Approvals with respect to the Products in the Territory in the name of Novartis or its Affiliates or Sublicensees. Accordingly: (i) Novartis, shall at its own cost write, assemble, otherwise prepare and file all Regulatory Filings required to obtain Regulatory Approvals for Products in the Territory; (ii) Novartis shall be the principal contact with all Regulatory Authorities on all matters pertaining to any Product, but shall consult regularly with GW regarding such matters, giving due regard to GW’s views; (iii) Novartis shall provide to GW copies of all substantive correspondence with Regulatory Authorities in the Territory related to any Product, and, to the extent practicable, shall consult with GW in advance of submitting any material correspondence related to any Product to any such Regulatory Authority; (iv) GW shall provide to Novartis copies of all substantive correspondence with the EMA related to any Product and, to the extent practicable, shall consult with Novartis in advance of submitting any material correspondence related to any Product to the EMA in circumstances where such correspondence could reasonably be expected to impact on the Commercialization and/or Regulatory Approvals of any Product in the Territory; (v) Novartis shall provide such notice to GW as is reasonably practicable under the circumstances of upcoming meetings related to any Product with Regulatory Authorities in the Territory. Subject to the consent of the relevant Regulatory Authority, GW shall be entitled to attend any such meetings as an observer, and Novartis may require GW’s attendance at any such meeting it deems to be potentially material; and (vi) Novartis shall pay all filing and maintenance costs of Regulatory Filings and Regulatory Approvals for the Product in the Territory during the Term. (e) GW shall, without additional consideration, fully cooperate with and provide assistance to Novartis in connection with filings to any Regulatory Authority relating to the Product(s) in the Territory in order to obtain or maintain Regulatory Approvals (including Pricing and/or Reimbursement Approvals, where applicable), including by (i) providing Novartis with an electronic copy of the registration dossier for the Product in the European Union as well as providing Novartis with an electronic copy of this registration dossier in eCTD format if and when available in eCTD format, and upon request by Novartis, an electronic copy of a draft of the registration dossier for the Product in the US as soon as such draft is made available to GW (if this draft is made available to GW in eCTD format GW will provide it to Novartis in eCID format); (ii) upon request by Novartis, providing Novartis with draft responses to any requests from Regulatory Authorities in the Territory related to the Development or manufacture of Products (including any requests related to the chemistry manufacturing and controls (CMC) section of any Regulatory Filing); and (iii) executing any required documents, providing access to personnel and providing Novartis with copies of all reasonably required documentation. To the extent requested by Novartis, GW shall also grant or cause to be granted to Novartis and its Affiliates or Sublicensees, within thirty (30) days of receipt of a written request from Novartis, cross-reference rights to any relevant drug master files and other filings submitted by GW or its Affiliates with any Regulatory Authority and any Regulatory Approval for Product issued by any Regulatory Authority to GW or its Affiliates. (f) Subject to Novartis having access to reimbursement data from outside the Territory, data generated by Novartis for reimbursement shall be available for GW and its ex-Territory licensees of the Products to use with respect to the Products outside the Territory. (g) In the event that (A) it is not possible under applicable Laws for Novartis to file for or hold Regulatory Approvals for the Product in any country in the Territory and/or (B) if requested by Novartis in writing to do so, to the extent permitted by applicable Laws and for the duration determined by Novartis, GW will file and/or hold all Regulatory Approvals for the Products in such country, at Novartis’s cost and expense (provided that all such costs and expenses shall be in accordance with a plan and budget agreed in writing by the Parties prior to GW making any such Regulatory Filing), and: (i) GW will be responsible for, and will use diligent efforts in, obtaining and maintaining all Regulatory Approvals necessary for the Commercialization of the Products in the country in question; (ii) GW will provide to Novartis copies of all substantive written communications between GW (or its Affiliates) and any Regulatory Authority in the Territory relating to any Product; (iii) Novartis shall have the right to review and comment upon any Regulatory Filings and correspondence from GW (or its Affiliates) to any Regulatory Authority in the Territory relating to any Product, and GW shall incorporate or address all such comments unless otherwise agreed between the Parties; (iv) GW will request and seek to arrange such meetings and consultations with Regulatory Authorities in the Territory which may be requested by Novartis, with respect to any Product; (v) To the extent permitted by the relevant Regulatory Authorities, Novartis shall have the right to have representatives of Novartis attend and participate in all meetings between GW (or its Affiliates) and any Regulatory Authority in the Territory relating to any Product; it being understood and agreed that to the extent permitted by the relevant Regulatory Authorities, Novartis will lead discussions with any such Regulatory Authority in the Territory. If the applicable Regulatory Authority does not permit Novartis to lead any such discussion, GW will lead the applicable discussions as directed by Novartis; and (vi) Novartis will reimburse GW any and all costs incurred pursuant to the foregoing and in accordance with the agreed plan and budget as follows. Within thirty (30) days after each Calendar Quarter during which GW has incurred any such costs and expenses, GW will provide to Novartis a detailed accounting of all such costs and expenses, and shall submit an invoice to Novartis substantially in the form of Exhibit C with respect to the amount of such costs and expenses. Unless disputed, Novartis shall pay such amount within sixty (60) days after receipt of such invoice. (h) Novartis hereby grants, and undertakes to cause its Affiliates and Sublicensees to grant, to GW and its Affiliates cross-reference rights to any Regulatory Filing for Product submitted by Novartis or its Affiliates or Sublicensees to any Regulatory Authority in the Territory and any Marketing Approval for Product issued by any Regulatory Authority in the Territory to Novartis or its Affiliates or Sublicensees. Novartis shall also grant such cross-reference rights to those of GW’s licensees of the Products for countries outside the Territory for which Novartis, its Affiliates and Sublicensees are granted corresponding cross-reference rights. (i) The Parties will discuss at the JSC the appropriate response to any request received by either Party from a Third Party academic institution to conduct any investigator initiated clinical study of a Product in the Territory. (j) If any information comes into GW’s Control that requires a change to the CMC section of Regulatory Filings or Regulatory Approvals, inside and outside the Territory, to avoid ‘regulatory drift’ GW will inform Novartis in writing of the required change (including by providing the necessary technical documentation in English) and Novartis will file such documentation with the relevant Regulatory Authorities as soon as practicable.

Regulatory Affairs. From (a) “[***]” shall have the point exclusive right and responsibility to prepare and implement plans and strategies for seeking Regulatory Approval for Collaboration Products in time at which Novartis gives GW notice the Field in writing that it wishes to take on responsibility the Territory, and shall own and be responsible for preparing, seeking, submitting and maintaining all Regulatory Filings and Regulatory Approvals for Collaboration Products in the Field in the Territory. “[***]” shall hold and manage the safety database for all Collaboration Products and will have global responsibility for all adverse event collection and reporting. At “[***]”s request, Intec Pharma shall cooperate with “[***]” in preparation of Regulatory Filings for the purpose of obtaining Regulatory Approval (including the preparation of the CMC portion of any Regulatory Filing) for Collaboration Products in the Field in the Territory, Novartis and “[***]” shall be responsible reimburse Intec Pharma for all interactions reasonable costs incurred in connection with Regulatory Authorities in the Territory with respect to Regulatory Approvals as set forth in this Section 6.1, and including, filing and maintaining any required Regulatory Approvals, seeking necessary permits and/or scheduling or re-scheduling in controlled substance listings or de-scheduling of the Product from controlled substances listings in the Territory. such cooperation. NOTE: PORTIONS OF THIS EXHIBIT ARE THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST BY THE REGISTRANT TO THE SECURITIES AND EXCHANGE COMMISSION (a) Where required, Novartis (or its applicable Affiliate or Sublicensee) will be responsible for arranging for the Product to be scheduled in any applicable controlled substance schedule(s) in countries in the Territory“COMMISSION”). GW agrees, without additional consideration, to give all necessary consents, declarations and documentation as are reasonably required to implement the foregoing and to provide Novartis with all assistance reasonably requested by Novartis (including attending meetings with Regulatory Authorities in any such country) for the purpose of arranging for such schedulingSUCH PORTIONS HAVE BEEN REDACTED AND FILED SEPARATELY WITH THE COMMISSION AND ARE MARKED WITH A “[***]” IN PLACE OF THE REDACTED LANGUAGE. (b) Subject “[***]” shall promptly inform Intec Pharma of any intended or actual inspection, written enquiry and/or visit to Section 6.1(g)its facilities by a Regulatory Authority in connection with any Collaboration Product, Novartis unless “[***]” has reason to believe that such inspection, enquiry and/or visit is not related to the Accordion Pill System as contained in any Collaboration Product, and promptly communicate to Intec Pharma copies of any correspondence from the Regulatory Authority relating thereto. “[***]” will use reasonable endeavors to ensure that Intec Pharma may have a representative present during any such inspection. “[***]” shall provide Intec Pharma with at least fifteen (or its applicable Affiliate or Sublicensee) will file and hold all Regulatory Approvals for the Products in countries in the Territory in its own name and on its own behalf. Unless otherwise agreed by the Parties, within ten (1015) Business Days following the Effective Date, GW will assign to Novartis all Regulatory Filings advance notice of any material meeting with any a Regulatory Authority in which is for the Territory at the Effective Date relating purpose of obtaining Regulatory Approval for any Collaboration Product. “[***]” shall provide Intec Pharma drafts of any material documents or correspondence pertaining to any Collaboration Product prepared for submission to the Regulatory Authority, including with respect to safety concerns and Novartis will reimburse GW all fees paid by GW SUSAR referred to Regulatory Authorities below, solely to the extent that such documents or correspondence relate to the Accordion Pill System as contained in such countries Collaboration Product, sufficiently in advance of submission so that Intec Pharma may review and comment on the substance of such material documents or correspondence. “[***]” shall promptly provide copies of any material documents or other correspondence received from the Regulatory Authority pertaining to Collaboration Products, unless such documents or correspondence are not related to the Accordion Pill System as contained in any Collaboration Product. “[***]” agrees to report to Intec Pharma any information from any source, including, without limitation, employees, distributors, agents, customers, user facilities, individuals, or medical or scientific literature, whether published or unpublished, that reasonably suggests that there may be a safety concern with respect to the submission Accordion Pill System as contained in a Collaboration Product, including a probability that the Accordion Pill System as contained in a Collaboration Product has caused or contributed to a death, or an event defined as “SUSAR” (Suspected Unexpected Serious Adverse Reactions), as promptly as possible and in any event simultaneously with any report of such information to a Regulatory Filings. On request by NovartisAuthority, GW will deliver notices and not later than fifteen (15) calendar days following receipt of information of such assignment to the applicable Regulatory Authoritiesevent. In addition, GW agrees “[***]” shall, within fifteen (15) days following the end of each Calendar Quarter, provide a written report to give all necessary consents, declarations and documentation as are reasonably required to implement Intec Pharma regarding the foregoingactivities undertaken by “[***]” during such Calendar Quarter in accordance with this Section 3.3.4. NOTE: PORTIONS OF THIS EXHIBIT ARE THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST BY THE REGISTRANT TO THE SECURITIES AND EXCHANGE COMMISSION (“COMMISSION”). SUCH PORTIONS HAVE BEEN REDACTED AND FILED SEPARATELY WITH THE COMMISSION AND ARE MARKED WITH A “[***]” IN PLACE OF THE REDACTED LANGUAGE. (c) Subject If Intec Pharma is Manufacturing any Collaboration Products under this Agreement, Intec Pharma shall promptly inform “[***]” of any intended or actual inspection, written enquiry and/or visit to Sections 4.2 its facilities by a Regulatory Authority in connection with any Collaboration Product, and 6.1(epromptly communicate to “[***]” copies of any correspondence from the Regulatory Authority relating thereto. Intec Pharma will use reasonable endeavors to ensure that “[***]” may have a representative present during any portions of such inspection relating to a Collaboration Product. Intec Pharma shall promptly provide copies of any material documents or other correspondence received from any Regulatory Authority pertaining to the manufacturing and safety of Accordion Pill System or any Collaboration Product. Intec Pharma agrees to report to “[***]” any information from any source, including, without limitation, employees, distributors, agents, customers, user facilities, individuals, or medical or scientific literature, whether published or unpublished, that reasonably suggests that there may be a safety concern with respect to the Accordion Pill System or any Collaboration Product, including a probability that the Accordion Pill System or any Collaboration Product has caused or contributed to a death, or an event defined as SUSAR, as promptly as possible and in any event no later than (i) one (1) Business Day following receipt of information of such event, if such event is a fatal event, or (ii) two (2) Business Days following receipt of information of such event, if such event is not a fatal event, in each case ((i) and (ii)), Novartis not to exceed four (or its applicable Affiliate or Sublicensee4) will be responsible for conducting, at its sole expense, such activities directed towards obtaining and maintaining Regulatory Approvals for Products in the Territory as it determines appropriate in its sole discretioncalendar days; provided, however, that Novartis agrees if any such information is subject to submit Regulatory Filings for Marketing Approvals for a Product in each any confidentiality obligations of Intec Pharma towards Third Parties, Intec Pharma shall provide redacted information with respect to the Key Countries. ThereafterAccordion Pill System to “[***]” without exposing information that Intec Pharma is legally or contractually precluded from disclosing and, Novartis shall, on a Key Country-by-Key Country basis further prosecute all such Regulatory Filings in the Key Countries in event that “[***]” requests any additional information that Intec Pharma is legally or contractually precluded from disclosing, Intec Pharma shall use reasonable efforts to seek a timely, professional and diligent manner, including by paying all required filing fees promptly and responding waiver of such confidentiality obligations so that Intec Pharma may disclose such additional information to correspondence and requests for further information from Regulatory Authorities in the Key Countries within a reasonable timeframe. Novartis shall share with GW its plans for obtaining Regulatory Approvals in the Key Countries at the first JSC meeting and thereafter shall supply GW with its updated plan from time to time. Novartis shall report its performance against this regulatory plan to the JSC each Calendar Quarter“[***]”. (d) Novartis will: (A) determine the regulatory plans and strategies for the Products in the Territory; (B) (either itself or through its Affiliates or Sublicensees and subject to Section 6.1(g)) make and own all Regulatory Filings with respect to the Products in the Territory; and (C) will be responsible for obtaining and maintaining Regulatory Approvals with respect to the Products in the Territory in the name of Novartis or its Affiliates or Sublicensees. Accordingly: (i) Novartis, shall at its own cost write, assemble, otherwise prepare and file all Regulatory Filings required to obtain Regulatory Approvals for Products in the Territory; (ii) Novartis shall be the principal contact with all Regulatory Authorities on all matters pertaining to At any Product, but shall consult regularly with GW regarding such matters, giving due regard to GW’s views; (iii) Novartis shall provide to GW copies of all substantive correspondence with Regulatory Authorities in the Territory related to any Product, and, to the extent practicable, shall consult with GW in advance of submitting any material correspondence related to any Product to any such Regulatory Authority; (iv) GW shall provide to Novartis copies of all substantive correspondence with the EMA related to any Product and, to the extent practicable, shall consult with Novartis in advance of submitting any material correspondence related to any Product to the EMA in circumstances where such correspondence could reasonably be expected to impact on the Commercialization and/or Regulatory Approvals of any Product in the Territory; (v) Novartis shall provide such notice to GW as is reasonably practicable under the circumstances of upcoming meetings related to any Product with Regulatory Authorities in the Territory. Subject to the consent of the relevant Regulatory Authority, GW shall be entitled to attend any such meetings as an observer, and Novartis may require GW’s attendance at any such meeting it deems to be potentially material; and (vi) Novartis shall pay all filing and maintenance costs of Regulatory Filings and Regulatory Approvals for the Product in the Territory time during the Term. , “[***]” shall have the right, on thirty (e30) GW shalldays’ advance written notice to Intec Pharma and during normal business hours, without additional consideration, fully cooperate with to inspect the manufacturing facilities of Intec Pharma and provide assistance to Novartis in connection with filings to any Regulatory Authority relating to the Product(s) in the Territory audit Intec Pharma’s applicable books and records in order to obtain or maintain Regulatory Approvals (including Pricing and/or Reimbursement Approvals, where applicable), including by (i) providing Novartis confirm compliance with an electronic copy of Applicable Laws and with the registration dossier for the Product in the European Union as well as providing Novartis with an electronic copy terms and conditions of this registration dossier Agreement. Intec Pharma shall respond in eCTD format if and when available in eCTD format, and upon request writing to “[***]” regarding any material items of concern identified by Novartis, an electronic copy of a draft of the registration dossier for the Product in the US as soon as “[***]” during such draft is made available to GW (if this draft is made available to GW in eCTD format GW will provide it to Novartis in eCID format); (ii) upon request by Novartis, providing Novartis with draft responses to any requests from Regulatory Authorities in the Territory related to the Development inspections or manufacture of Products (including any requests related to the chemistry manufacturing and controls (CMC) section of any Regulatory Filing); and (iii) executing any required documents, providing access to personnel and providing Novartis with copies of all reasonably required documentation. To the extent requested by Novartis, GW shall also grant or cause to be granted to Novartis and its Affiliates or Sublicensees, audits within thirty (30) days of receipt of a written request from Novartis, cross-reference rights to any relevant drug master files and other filings submitted by GW or its Affiliates with any Regulatory Authority and any Regulatory Approval for Product issued by any Regulatory Authority to GW or its Affiliates. (f) Subject to Novartis having access to reimbursement data from outside the Territory, data generated by Novartis for reimbursement shall be available for GW and its ex-Territory licensees “[***]”’s notice of the Products outcome of the audit or inspection and shall develop a plan, reasonably satisfactory to use with respect to the Products outside the Territory. (g) In the event that (A) it is not possible under applicable Laws for Novartis to file for or hold Regulatory Approvals for the Product in any country in the Territory and/or (B) if requested by Novartis in writing to do so“[***]”, to the extent permitted by applicable Laws and for the duration determined by Novartis, GW will file and/or hold all Regulatory Approvals for the Products in such country, at Novartis’s cost and expense remedy any items of noncompliance within ninety (provided that all such costs and expenses shall be in accordance with a plan and budget agreed in writing by the Parties prior to GW making any such Regulatory Filing), and: (i90) GW will be responsible for, and will use diligent efforts in, obtaining and maintaining all Regulatory Approvals necessary for the Commercialization days of the Products in the country in question; (ii) GW will provide to Novartis copies of all substantive written communications between GW notice thereof (or its Affiliates) and any Regulatory Authority more promptly if that can be accomplished in the Territory relating to any Product; (iii) Novartis shall have the right to review and comment upon any Regulatory Filings and correspondence from GW (or its Affiliates) to any Regulatory Authority in the Territory relating to any Product, and GW shall incorporate or address all such comments unless otherwise agreed between the Parties; (iv) GW will request and seek to arrange such meetings and consultations with Regulatory Authorities in the Territory which may be requested by Novartis, with respect to any Product; (v) To the extent permitted by the relevant Regulatory Authorities, Novartis shall have the right to have representatives of Novartis attend and participate in all meetings between GW (or its Affiliates) and any Regulatory Authority in the Territory relating to any Product; it being understood and agreed that to the extent permitted by the relevant Regulatory Authorities, Novartis will lead discussions with any such Regulatory Authority in the Territory. If the applicable Regulatory Authority does not permit Novartis to lead any such discussion, GW will lead the applicable discussions as directed by Novartis; and (vi) Novartis will reimburse GW any and all costs incurred pursuant to the foregoing and in accordance with the agreed plan and budget as follows. Within thirty (30) days after each Calendar Quarter during which GW has incurred any such costs and expenses, GW will provide to Novartis a detailed accounting of all such costs and expensescommercially reasonable manner), and shall submit an invoice to Novartis substantially remedy such items of noncompliance as set forth in the form of Exhibit C with respect such plan. Notwithstanding anything to the amount contrary, this Section 3.3.4(d) shall not apply during any period in which Intec Pharma is not Manufacturing supplies of such costs and expenses. Unless disputed, Novartis shall pay such amount within sixty (60) days after receipt of such invoiceCollaboration Products. (h) Novartis hereby grants, and undertakes to cause its Affiliates and Sublicensees to grant, to GW and its Affiliates cross-reference rights to any Regulatory Filing for Product submitted by Novartis or its Affiliates or Sublicensees to any Regulatory Authority in the Territory and any Marketing Approval for Product issued by any Regulatory Authority in the Territory to Novartis or its Affiliates or Sublicensees. Novartis shall also grant such cross-reference rights to those of GW’s licensees of the Products for countries outside the Territory for which Novartis, its Affiliates and Sublicensees are granted corresponding cross-reference rights. (i) The Parties will discuss at the JSC the appropriate response to any request received by either Party from a Third Party academic institution to conduct any investigator initiated clinical study of a Product in the Territory. (j) If any information comes into GW’s Control that requires a change to the CMC section of Regulatory Filings or Regulatory Approvals, inside and outside the Territory, to avoid ‘regulatory drift’ GW will inform Novartis in writing of the required change (including by providing the necessary technical documentation in English) and Novartis will file such documentation with the relevant Regulatory Authorities as soon as practicable.

Regulatory Affairs. From the point in time at which Novartis gives GW notice in writing that it wishes to take on responsibility for Regulatory Filings and Regulatory Approvals in the Territory, Novartis shall be responsible for all interactions with Regulatory Authorities in the Territory with respect to Regulatory Approvals as set forth in this Section 6.1, and including, filing and maintaining any required Regulatory Approvals, seeking necessary permits and/or scheduling or re-scheduling in controlled substance listings or de-scheduling of the Product from controlled substances listings in the Territory. (a) Where required, Novartis (or its applicable Affiliate or Sublicensee) will be responsible for arranging for the Product to be scheduled in any applicable controlled substance schedule(s) in countries in the Territory. GW agrees, without additional consideration, to give PFIZER shall determine all necessary consents, declarations and documentation as are reasonably required to implement the foregoing and to provide Novartis with all assistance reasonably requested by Novartis (including attending meetings with Regulatory Authorities in any such country) for the purpose of arranging for such scheduling. (b) Subject to Section 6.1(g), Novartis (or its applicable Affiliate or Sublicensee) will file and hold all Regulatory Approvals for the Products in countries in the Territory in its own name and on its own behalf. Unless otherwise agreed by the Parties, within ten (10) Business Days following the Effective Date, GW will assign to Novartis all Regulatory Filings with any Regulatory Authority in the Territory at the Effective Date relating to any Product and Novartis will reimburse GW all fees paid by GW to Regulatory Authorities in such countries with respect to the submission of such Regulatory Filings. On request by Novartis, GW will deliver notices of such assignment to the applicable Regulatory Authorities. In addition, GW agrees to give all necessary consents, declarations and documentation as are reasonably required to implement the foregoing. (c) Subject to Sections 4.2 and 6.1(e), Novartis (or its applicable Affiliate or Sublicensee) will be responsible for conducting, at its sole expense, such activities directed towards obtaining and maintaining Regulatory Approvals for Products in the Territory as it determines appropriate in its sole discretion; provided, however, that Novartis agrees to submit Regulatory Filings for Marketing Approvals for a Product in each of the Key Countries. Thereafter, Novartis shall, on a Key Country-by-Key Country basis further prosecute all such Regulatory Filings in the Key Countries in a timely, professional and diligent manner, including by paying all required filing fees promptly and responding to correspondence and requests for further information from Regulatory Authorities in the Key Countries within a reasonable timeframe. Novartis shall share with GW its plans for obtaining Regulatory Approvals in the Key Countries at the first JSC meeting and thereafter shall supply GW with its updated plan from time to time. Novartis shall report its performance against this regulatory plan to the JSC each Calendar Quarter. (d) Novartis will: (A) determine the regulatory plans and strategies for the Licensed Products (including Clinical Development Candidates) in the Field, and will own and be responsible for preparing, seeking, submitting and maintaining the investigator’s brochure and all regulatory filings and Regulatory Approvals for all Licensed Products in the Territory; (B) (either itself Field, including preparing all reports necessary as part of a regulatory filing or through its Affiliates or Sublicensees Regulatory Approval and subject to Section 6.1(g)) make and own for all communications with Regulatory Filings with respect to the Authorities for such Licensed Products in the Territory; Field. ATHERSYS shall have the right, at its cost and (C) will be responsible without delay to the progression of Regulatory Approvals, to participate as a direct observer in significant regulatory activities, including interactions with Regulatory Authorities. Without limiting ATHERSYS’ obligations pursuant to Section 2.7 and Schedule 2.7, ATHERSYS agrees to cooperate and assist Pfizer in the provision of any documentation required for obtaining and maintaining any regulatory filings for Regulatory Approvals for Licensed Products in the Field. (b) ATHERSYS shall keep PFIZER regularly and promptly informed of all material regulatory filings, Regulatory Approvals and all material communications, interfaces and other actions to, with respect or from Regulatory Authorities relating to MultiStem Products outside the Field and shall ensure that all such filings, Regulatory Approvals, communications, interfaces and actions are materially made by ATHERSYS in accordance with the global clinical and regulatory strategy approved by the Development & Regulatory Committee from time to time for the Licensed Products in the Field. Additionally, ATHERSYS shall take in to account in good faith any concerns or input raised by PFIZER in relation to such regulatory filings, Regulatory Approvals, communications, interfaces and actions. (c) Without limiting the provisions of Section 3.6(a) and Section 2.5, the safety reporting units from each of the parties shall meet and agree upon a written agreement for exchanging adverse event and other safety and other pharmacovigilance information relating to MultiStem Products prior to initiation of any clinical activity in the Field implicating pharmacovigilance obligations for the MultiStem Products in the Territory in (the name “Pharmacovigilance Agreement”). Such Pharmacovigilance Agreement shall ensure that adverse events and other safety information is exchanged upon terms that will permit each party to comply with Laws and requirements of Novartis or its Affiliates or Sublicensees. Accordingly:Regulatory Authorities. (id) Novartis, shall at its own cost write, assemble, otherwise prepare and file all Regulatory Filings required Any regulatory affairs matter relating to obtain Regulatory Approvals any Athersys Device to be used for MultiStem Products in the Territory; (ii) Novartis Field shall be discussed initially by the principal contact JSC, Development & Regulatory Committee, with all Regulatory Authorities on all matters pertaining to any Productappropriate regulatory experts from the parties present at that meeting, but shall consult regularly with GW regarding for the purposes of determining the appropriate regulatory strategy for use of such matters, giving due regard to GW’s views; (iii) Novartis shall provide to GW copies of all substantive correspondence with Regulatory Authorities Device in the Territory related to any Product, and, to the extent practicable, shall consult with GW in advance of submitting any material correspondence related to any Product to any such Regulatory Authority; (iv) GW shall provide to Novartis copies of all substantive correspondence with the EMA related to any Product and, to the extent practicable, shall consult with Novartis in advance of submitting any material correspondence related to any Product to the EMA in circumstances where such correspondence could reasonably be expected to impact on the Commercialization and/or Regulatory Approvals of any Product in the Territory; (v) Novartis shall provide such notice to GW as is reasonably practicable under the circumstances of upcoming meetings related to any Product with Regulatory Authorities in the Territory. Subject to the consent of the relevant Regulatory Authority, GW shall be entitled to attend any such meetings as an observer, and Novartis may require GW’s attendance at any such meeting it deems to be potentially material; and (vi) Novartis shall pay all filing and maintenance costs of Regulatory Filings and Regulatory Approvals for the Product in the Territory during the TermField. (e) GW shall, without additional consideration, fully cooperate with and provide assistance to Novartis in connection with filings to any Regulatory Authority relating to the Product(s) in the Territory in order to obtain or maintain Regulatory Approvals (including Pricing and/or Reimbursement Approvals, where applicable), including by (i) providing Novartis with an electronic copy of the registration dossier for the Product in the European Union as well as providing Novartis with an electronic copy of this registration dossier in eCTD format if and when available in eCTD format, and upon request by Novartis, an electronic copy of a draft of the registration dossier for the Product in the US as soon as such draft is made available to GW (if this draft is made available to GW in eCTD format GW will provide it to Novartis in eCID format); (ii) upon request by Novartis, providing Novartis with draft responses to any requests from Regulatory Authorities in the Territory related to the Development or manufacture of Products (including any requests related to the chemistry manufacturing and controls (CMC) section of any Regulatory Filing); and (iii) executing any required documents, providing access to personnel and providing Novartis with copies of all reasonably required documentation. To the extent requested by Novartis, GW shall also grant or cause to be granted to Novartis and its Affiliates or Sublicensees, within thirty (30) days of receipt of a written request from Novartis, cross-reference rights to any relevant drug master files and other filings submitted by GW or its Affiliates with any Regulatory Authority and any Regulatory Approval for Product issued by any Regulatory Authority to GW or its Affiliates. (f) Subject to Novartis having access to reimbursement data from outside the Territory, data generated by Novartis for reimbursement shall be available for GW and its ex-Territory licensees of the Products to use with respect to the Products outside the Territory. (g) In the event that (A) it is not possible under applicable Laws for Novartis to file for or hold Regulatory Approvals for the Product in any country in the Territory and/or (B) if requested by Novartis in writing to do so, to the extent permitted by applicable Laws and for the duration determined by Novartis, GW will file and/or hold all Regulatory Approvals for the Products in such country, at Novartis’s cost and expense (provided that all such costs and expenses shall be in accordance with a plan and budget agreed in writing by the Parties prior to GW making any such Regulatory Filing), and: (i) GW will be responsible for, and will use diligent efforts in, obtaining and maintaining all Regulatory Approvals necessary for the Commercialization of the Products in the country in question; (ii) GW will provide to Novartis copies of all substantive written communications between GW (or its Affiliates) and any Regulatory Authority in the Territory relating to any Product; (iii) Novartis shall have the right to review and comment upon any Regulatory Filings and correspondence from GW (or its Affiliates) to any Regulatory Authority in the Territory relating to any Product, and GW shall incorporate or address all such comments unless otherwise agreed between the Parties; (iv) GW will request and seek to arrange such meetings and consultations with Regulatory Authorities in the Territory which may be requested by Novartis, with respect to any Product; (v) To the extent permitted by the relevant Regulatory Authorities, Novartis shall have the right to have representatives of Novartis attend and participate in all meetings between GW (or its Affiliates) and any Regulatory Authority in the Territory relating to any Product; it being understood and agreed that to the extent permitted by the relevant Regulatory Authorities, Novartis will lead discussions with any such Regulatory Authority in the Territory. If the applicable Regulatory Authority does not permit Novartis to lead any such discussion, GW will lead the applicable discussions as directed by Novartis; and (vi) Novartis will reimburse GW any and all costs incurred pursuant to the foregoing and in accordance with the agreed plan and budget as follows. Within thirty (30) days after each Calendar Quarter during which GW has incurred any such costs and expenses, GW will provide to Novartis a detailed accounting of all such costs and expenses, and shall submit an invoice to Novartis substantially in the form of Exhibit C with respect to the amount of such costs and expenses. Unless disputed, Novartis shall pay such amount within sixty (60) days after receipt of such invoice. (h) Novartis hereby grants, and undertakes to cause its Affiliates and Sublicensees to grant, to GW and its Affiliates cross-reference rights to any Regulatory Filing for Product submitted by Novartis or its Affiliates or Sublicensees to any Regulatory Authority in the Territory and any Marketing Approval for Product issued by any Regulatory Authority in the Territory to Novartis or its Affiliates or Sublicensees. Novartis shall also grant such cross-reference rights to those of GW’s licensees of the Products for countries outside the Territory for which Novartis, its Affiliates and Sublicensees are granted corresponding cross-reference rights. (i) The Parties will discuss at the JSC the appropriate response to any request received by either Party from a Third Party academic institution to conduct any investigator initiated clinical study of a Product in the Territory. (j) If any information comes into GW’s Control that requires a change to the CMC section of Regulatory Filings or Regulatory Approvals, inside and outside the Territory, to avoid ‘regulatory drift’ GW will inform Novartis in writing of the required change (including by providing the necessary technical documentation in English) and Novartis will file such documentation with the relevant Regulatory Authorities as soon as practicable.

Regulatory Affairs. From [*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the point in time at which Novartis gives GW notice in writing that it wishes to take on responsibility for Regulatory Filings Securities and Regulatory Approvals in the Territory, Novartis shall be responsible for all interactions with Regulatory Authorities in the Territory with respect to Regulatory Approvals as set forth in this Section 6.1, and including, filing and maintaining any required Regulatory Approvals, seeking necessary permits and/or scheduling or re-scheduling in controlled substance listings or de-scheduling of the Product from controlled substances listings in the TerritoryExchange Commission. (a) Where Commencing on (1) the Amendment No. 2 Effective Date with respect to the Pfizer 2012 Exclusive Territory and (2) the Amendment No. 4 Effective Date with respect to the Pfizer 2015 Exclusive Territory, COLLABORATOR shall have the sole and exclusive right to determine and to develop all regulatory plans and strategies and will be solely responsible for and have final decision-making authority with respect to the day-to-day implementation of all regulatory activities and all costs and expenses required to obtain Regulatory Approval of an Apixaban Product in the Pfizer Exclusive Territory, which such activities shall include (i) subject to clause 3A.3(c) below, preparing, seeking, submitting and maintaining all regulatory filings and Regulatory Approvals for all Apixaban Products in each country in the Pfizer Exclusive Territory, including but not limited to, (x) serving the roles of Lead Regulatory Party, Medical Affairs Lead for Regulatory Matters and MAH in each country in the Pfizer Exclusive Territory, subject to clause 3A.3(c) below, (y) preparing all reports necessary as part of a regulatory filing or Regulatory Approval in each country in the Pfizer Exclusive Territory and (z) carrying out any work or studies that are required, Novartis requested or advised by a Regulatory Authority in the Pfizer Exclusive Territory to be performed following the receipt of Regulatory Approval, (or its applicable Affiliate or Sublicenseeii) will preparing for and attending all pricing and reimbursement approval proceedings and regulatory discussions relating to such pricing and reimbursement proceedings in the Pfizer Exclusive Territory; provided, that (A) such regulatory plans and strategies shall be responsible for arranging consistent in all material respects with the regulatory plans and strategies, but not the budget plan, set forth in each then-current Approved Plan and/or the Core Data Sheet, (B) the local labeling for the finished Product, including issues such as whether the label for the finished Product should contain a contraindication or warning with respect to a particular risk or whether any warning in such label should be scheduled a boxed warning, shall be consistent in any applicable controlled substance schedule(sall material respects with the Core Data Sheet; and (C) in countries in the Territory. GW agrees, without additional consideration, to give all necessary consents, declarations and documentation as are reasonably required to implement the foregoing and to provide Novartis with all assistance reasonably requested by Novartis Specifications (including attending meetings with Regulatory Authorities in any such countrymethods of testing) for the purpose finished Product (or API) to be used in any given country in the Pfizer Exclusive Territory shall be consistent in all material respects with the Specifications (including methods of arranging testing) for such schedulingthe finished Product (or the active pharmaceutical ingredient) that have been approved by a Regulatory Authority in the U.S. or the EU. (b) Subject In the event that COLLABORATOR determines in its sole discretion that its plans or strategies are not consistent in a material respect with the activities or strategies set forth in the then-current Approved Plans and/or Core Data Sheet and/or Specifications (pursuant to clause 3A.3(a)(C) above), COLLABORATOR shall communicate its plans and strategies to the JWWBT for review. Disputes with respect to regulatory activities conducted by COLLABORATOR in the Pfizer Exclusive Territory shall be resolved as follows: (i) In the event of any dispute between the Parties as to whether a particular regulatory activity conducted or proposed in the Pfizer [*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. Exclusive Territory is consistent in all material respects with the regulatory plans and strategies, but not the budget plan, set forth in the then-current Approved Plans and/or Core Data Sheet and/or Specifications (pursuant to clause 3A.3(a)(C) above), then such dispute shall be considered an Expert Matter and shall be referred to the JWWBT to be decided by Joint Committee Consent or the Parties’ applicable regulatory leaders for resolution, as appropriate. In the event that the dispute is not resolved by the JWWBT or the Parties’ applicable regulatory leaders, as appropriate, then it shall, at the election of either Party, be referred to the JEC for resolution. In the event of a disagreement between the designees of BMS and COLLABORATOR on the JEC as to resolution of the dispute, such dispute shall, at the election of either Party, be referred for resolution pursuant to Section 6.1(g13.1, and failing resolution of the dispute, such dispute shall be determined by an Expert pursuant to Section 13.2; and (ii) In the event of a dispute between the Parties as to whether COLLABORATOR can conduct a particular regulatory activity in the Pfizer Exclusive Territory that either (x) COLLABORATOR in its sole discretion or (y) an Expert pursuant to clause (i) above, has determined to be inconsistent in a material respect with the regulatory plans and strategies, but not the budget plan, set forth in the then-current Approved Plans and/or Core Data Sheet and/or Specifications (pursuant to clause 3A.3(a)(C) above), Novartis such matter shall be referred to the JWWBT to be decided by Joint Committee Consent or to the Parties’ applicable regulatory leaders for resolution, as appropriate. In the event that the dispute is not resolved by the JWWBT or the Parties’ applicable development leaders, as applicable, then it shall, at the election of either Party, be referred to the JEC for resolution. In the event of a disagreement between the designees of BMS and COLLABORATOR on the JEC as to resolution of the dispute, then COLLABORATOR shall have final-decision making authority with respect to the conduct of such activity, unless such dispute relates to clause 3A.3(a)(B) or 3A.3(a)(C), in which case [*]. The Parties agree that any material correspondence from a Regulatory Authority that indicates a material issue relating to the Apixaban Product, or approval or rejection of an Apixaban Product or notification thereof, shall be subject to the reporting requirements set forth in Section 3.2(d). (c) With respect to any country in the Pfizer Exclusive Territory that is (or its applicable Affiliate or Sublicenseebecomes) will file subject to the regulatory regime of the EMA, then the terms and hold all Regulatory Approvals for provisions of clauses (a) and (b) above shall still apply except that, unless [*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Products in countries in the Territory in its own name Securities and on its own behalfExchange Commission. Unless otherwise agreed by the Parties, within ten the European Entity will remain (10or become) Business Days following the Effective Date, GW will assign to Novartis all Regulatory Filings with any Regulatory Authority in the Territory at the Effective Date relating to any Product and Novartis will reimburse GW all fees paid by GW to Regulatory Authorities in such countries MAH with respect to the submission of such Regulatory Filingscountry. On request by NovartisFor clarity, GW will deliver notices of such assignment to the applicable Regulatory Authorities. In addition, GW agrees to give all necessary consents, declarations and documentation as are reasonably required to implement the foregoing. (c) Subject to Sections 4.2 and 6.1(e), Novartis (or its applicable Affiliate or Sublicensee) COLLABORATOR will be responsible for conducting, at its sole expense, all costs and activities relating to any such activities directed towards obtaining and maintaining Regulatory Approvals for Products regulatory change in the Territory as it determines appropriate in its sole discretion; provided, however, that Novartis agrees to submit Regulatory Filings for Marketing Approvals for a Product in each of the Key Countries. Thereafter, Novartis shall, on a Key Country-by-Key Country basis further prosecute all such Regulatory Filings in the Key Countries in a timely, professional and diligent manner, including by paying all required filing fees promptly and responding to correspondence and requests for further information from Regulatory Authorities in the Key Countries within a reasonable timeframe. Novartis shall share with GW its plans for obtaining Regulatory Approvals in the Key Countries at the first JSC meeting and thereafter shall supply GW with its updated plan from time to time. Novartis shall report its performance against this regulatory plan to the JSC each Calendar QuarterPfizer Exclusive Territory. (d) Novartis will: (AThe Parties shall take all actions, including executing appropriate, mutually acceptable agreements and providing necessary data and information regarding the Apixaban Product, as may be reasonably necessary under Applicable Law or desirable to permit COLLABORATOR to perform its rights under the foregoing subclause 3A.3(a) determine and its right to Commercialize the regulatory plans and strategies for the Products Apixaban Product in the Pfizer Exclusive Territory; , including but not limited to, the provision to COLLABORATOR by BMS of all (Bi) safety, pharmacovigilance, clinical and CMC data (either itself or through its Affiliates or Sublicensees and subject to Section 6.1(g)the terms and conditions of, and processes set forth in, the Safety Data Exchange Agreement between the Parties) make in a format consistent with the format supplied to COLLABORATOR with respect to countries where COLLABORATOR is the marketing authorization holder, (ii) relevant medical information, (iii) data and own all Regulatory Filings information from any investigator-initiated research, and (iv) information from any current compassionate use programs, each to be provided as soon as practicable after (1) the Amendment No. 2 Effective Date with respect to the Products in the Territory; Pfizer 2012 Exclusive Territory and (C2) will be responsible for obtaining and maintaining Regulatory Approvals the Amendment No. 4 Effective Date with respect to the Products in the Territory in the name of Novartis or its Affiliates or Sublicensees. Accordingly: (i) Novartis, shall at its own cost write, assemble, otherwise prepare and file all Regulatory Filings required to obtain Regulatory Approvals for Products in the Pfizer 2015 Exclusive Territory; (ii) Novartis shall be the principal contact with all Regulatory Authorities on all matters pertaining to any Product, but shall consult regularly with GW regarding such matters, giving due regard to GW’s views; (iii) Novartis shall provide to GW copies of all substantive correspondence with Regulatory Authorities in the Territory related to any Product, and, to the extent practicable, shall consult with GW in advance of submitting any material correspondence related to any Product to any such Regulatory Authority; (iv) GW shall provide to Novartis copies of all substantive correspondence with the EMA related to any Product and, to the extent practicable, shall consult with Novartis in advance of submitting any material correspondence related to any Product to the EMA in circumstances where such correspondence could reasonably be expected to impact on the Commercialization and/or Regulatory Approvals of any Product in the Territory; (v) Novartis shall provide such notice to GW as is reasonably practicable under the circumstances of upcoming meetings related to any Product with Regulatory Authorities in the Territory. Subject to the consent of the relevant Regulatory Authority, GW shall be entitled to attend any such meetings as an observer, and Novartis may require GW’s attendance at any such meeting it deems to be potentially material; and (vi) Novartis shall pay all filing and maintenance costs of Regulatory Filings and Regulatory Approvals for the Product in the Territory during the Term. (e) GW shall, without additional consideration, fully cooperate with and provide assistance to Novartis in connection with filings to any Regulatory Authority relating to the Product(s) in the Territory in order to obtain or maintain Regulatory Approvals (including Pricing and/or Reimbursement Approvals, where applicable), including by (i) providing Novartis with an electronic copy of the registration dossier for the Product in the European Union as well as providing Novartis with an electronic copy of this registration dossier in eCTD format if and when available in eCTD format, and upon request by Novartis, an electronic copy of a draft of the registration dossier for the Product in the US as soon as such draft is made available to GW (if this draft is made available to GW in eCTD format GW will provide it to Novartis in eCID format); (ii) upon request by Novartis, providing Novartis with draft responses to any requests from Regulatory Authorities in the Territory related to the Development or manufacture of Products (including any requests related to the chemistry manufacturing and controls (CMC) section of any Regulatory Filing); and (iii) executing any required documents, providing access to personnel and providing Novartis with copies of all reasonably required documentation. To the extent requested by Novartis, GW shall also grant or cause to be granted to Novartis and its Affiliates or Sublicensees, within thirty (30) days of receipt of a written request from Novartis, cross-reference rights to any relevant drug master files and other filings submitted by GW or its Affiliates with any Regulatory Authority and any Regulatory Approval for Product issued by any Regulatory Authority to GW or its Affiliates. (f) Subject to Novartis having access to reimbursement data from outside the Territory, data generated by Novartis for reimbursement shall be available for GW and its ex-Territory licensees of the Products to use with respect to the Products outside the Territory. (g) In the event that (A) it is not possible under applicable Laws for Novartis to file for or hold Regulatory Approvals for the Product in any country in the Territory and/or (B) if requested by Novartis in writing to do so, to the extent permitted by applicable Laws and for the duration determined by Novartis, GW will file and/or hold all Regulatory Approvals for the Products in such country, at Novartis’s cost and expense (provided that all such costs and expenses shall be in accordance with a plan and budget agreed in writing by the Parties prior to GW making any such Regulatory Filing), and: (i) GW will be responsible for, and will use diligent efforts in, obtaining and maintaining all Regulatory Approvals necessary for the Commercialization of the Products in the country in question; (ii) GW will provide to Novartis copies of all substantive written communications between GW (or its Affiliates) and any Regulatory Authority in the Territory relating to any Product; (iii) Novartis shall have the right to review and comment upon any Regulatory Filings and correspondence from GW (or its Affiliates) to any Regulatory Authority in the Territory relating to any Product, and GW shall incorporate or address all such comments unless otherwise agreed between the Parties; (iv) GW will request and seek to arrange such meetings and consultations with Regulatory Authorities in the Territory which may be requested by Novartis, with respect to any Product; (v) To the extent permitted by the relevant Regulatory Authorities, Novartis shall have the right to have representatives of Novartis attend and participate in all meetings between GW (or its Affiliates) and any Regulatory Authority in the Territory relating to any Product; it being understood and agreed that to the extent permitted by the relevant Regulatory Authorities, Novartis will lead discussions with any such Regulatory Authority in the Territory. If the applicable Regulatory Authority does not permit Novartis to lead any such discussion, GW will lead the applicable discussions as directed by Novartis; and (vi) Novartis will reimburse GW any and all costs incurred pursuant to the foregoing and in accordance with the agreed plan and budget as follows. Within thirty (30) days after each Calendar Quarter during which GW has incurred any such costs and expenses, GW will provide to Novartis a detailed accounting of all such costs and expenses, and shall submit an invoice to Novartis substantially in the form of Exhibit C with respect to the amount of such costs and expenses. Unless disputed, Novartis shall pay such amount event within sixty (60) days after receipt of any written request by COLLABORATOR to BMS. Furthermore, BMS shall provide support and relevant documentation and data as reasonably requested by COLLABORATOR in the Pfizer Exclusive Territory, in a timely manner given such invoice. request, for the following: (hx) Novartis hereby grantsCOLLABORATOR’s filings with Regulatory Authorities for approval of the Initial Indications and Additional Indications, (y) responses to queries from Regulatory Authorities with respect to COLLABORATOR’s submissions, and undertakes (z) lifecycle management and post-approval activities, including but not limited to cause its Affiliates CMC variations, label updates, product defense and Sublicensees renewals of marketing authorizations. Upon request by COLLABORATOR, and to grantthe extent not already completed, BMS shall provide reasonable technical training at BMS’s facilities to GW a reasonable number of COLLABORATOR personnel with respect to navigation and its Affiliates cross-reference rights usage of the Secure Information Exchange and the Joint Platform (1) at least sixty (60) days prior to any Regulatory Filing for the first Launch of the Apixaban Product submitted by Novartis or its Affiliates or Sublicensees with respect to any Regulatory Authority countries in the Pfizer 2012 Exclusive Territory and any Marketing Approval for Product issued by any Regulatory Authority in the Territory to Novartis or its Affiliates or Sublicensees. Novartis shall also grant such cross-reference rights to those of GW’s licensees of the Products for countries outside the Territory for which Novartis, its Affiliates and Sublicensees are granted corresponding cross-reference rights. (i2) The Parties will discuss at the JSC the appropriate response to any request received by either Party from a Third Party academic institution to conduct any investigator initiated clinical study of a Product in the Territory. (j) If any information comes into GW’s Control that requires a change to the CMC section of Regulatory Filings or Regulatory Approvals, inside and outside the Territory, to avoid ‘regulatory drift’ GW will inform Novartis in writing of the required change (including by providing the necessary technical documentation in English) and Novartis will file such documentation with the relevant Regulatory Authorities as soon as practicablepracticable after the Amendment No. 4 Effective Date with respect to the Pfizer 2015 Exclusive Territory, and shall provide access to and rights to use such platform to COLLABORATOR as reasonably necessary in order for COLLABORATOR to perform its obligations and exercise its rights under this Agreement, including any obligations to answer queries from a Regulatory Authority or conduct biostatistical analyses.

Regulatory Affairs. From (a) Commencing on the point Amendment No. 2 Effective Date, COLLABORATOR shall have the sole and exclusive right to determine and to develop all regulatory plans and strategies and will be solely responsible for and have final decision-making authority with respect to the day-to-day implementation of all regulatory activities and all costs and expenses required to obtain Regulatory Approval of an Apixaban Product in time at the Pfizer Exclusive Territory, which Novartis gives GW notice in writing that it wishes such activities shall include (i) subject to take on responsibility for Regulatory Filings clause 3A.3(c) below, preparing, seeking, submitting and maintaining all regulatory filings and Regulatory Approvals for all Apixaban Products in each country in the Pfizer Exclusive Territory, Novartis including but not limited to, (x) serving the roles of Lead Regulatory Party, Medical Affairs Lead for Regulatory Matters and MAH in each country in the Pfizer Exclusive Territory, subject to clause 3A.3(c) below, (y) preparing all reports necessary as part of a regulatory filing or Regulatory Approval in each country in the Pfizer Exclusive Territory and (z) carrying out any work or studies that are required, requested or [*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. advised by a Regulatory Authority in the Pfizer Exclusive Territory to be performed following the receipt of Regulatory Approval, (ii) preparing for and attending all pricing and reimbursement approval proceedings and regulatory discussions relating to such pricing and reimbursement proceedings in the Pfizer Exclusive Territory; provided, that (A) such regulatory plans and strategies shall be responsible consistent in all material respects with the regulatory plans and strategies, but not the budget plan, set forth in each then-current Approved Plan and/or the Core Data Sheet, (B) the local labeling for all interactions with Regulatory Authorities in the Territory finished Product, including issues such as whether the label for the finished Product should contain a contraindication or warning with respect to Regulatory Approvals as set forth a particular risk or whether any warning in this Section 6.1such label should be a boxed warning, shall be consistent in all material respects with the Core Data Sheet; and including, filing and maintaining any required Regulatory Approvals, seeking necessary permits and/or scheduling or re-scheduling in controlled substance listings or de-scheduling of (C) the Product from controlled substances listings in the Territory. (a) Where required, Novartis (or its applicable Affiliate or Sublicensee) will be responsible for arranging for the Product to be scheduled in any applicable controlled substance schedule(s) in countries in the Territory. GW agrees, without additional consideration, to give all necessary consents, declarations and documentation as are reasonably required to implement the foregoing and to provide Novartis with all assistance reasonably requested by Novartis Specifications (including attending meetings with Regulatory Authorities in any such countrymethods of testing) for the purpose finished Product (or API) to be used in any given country in the Pfizer Exclusive Territory shall be consistent in all material respects with the Specifications (including methods of arranging testing) for such schedulingthe finished Product (or the active pharmaceutical ingredient) that have been approved by a Regulatory Authority in the U.S. or the EU. (b) Subject In the event that COLLABORATOR determines in its sole discretion that its plans or strategies are not consistent in a material respect with the activities or strategies set forth in the then-current Approved Plans and/or Core Data Sheet and/or Specifications (pursuant to clause 3A.3(a)(C) above), COLLABORATOR shall communicate its plans and strategies to the JDC for review. Disputes with respect to regulatory activities conducted by COLLABORATOR in the Pfizer Exclusive Territory shall be resolved as follows: (i) In the event of any dispute between the Parties as to whether a particular regulatory activity conducted or proposed in the Pfizer Exclusive Territory is consistent in all material respects with the regulatory plans and strategies, but not the budget plan, set forth in the then-current Approved Plans and/or Core Data Sheet and/or Specifications (pursuant to clause 3A.3(a)(C) above), then such dispute shall be considered an Expert Matter and shall be decided by the JDC by Joint Committee Consent. In the event that the dispute is not resolved by the JDC, then it shall, at the election of either Party, be referred to the JEC for resolution. In the event of a disagreement between the designees of BMS and COLLABORATOR on the JEC as to resolution of the dispute, such dispute shall, at the election of either Party, be referred for resolution pursuant to Section 6.1(g13.1, and failing resolution of the dispute, such [*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. dispute shall be determined by an Expert pursuant to Section 13.2; and (ii) In the event of a dispute between the Parties as to whether COLLABORATOR can conduct a particular regulatory activity in the Pfizer Exclusive Territory that either (x) COLLABORATOR in its sole discretion or (y) an Expert pursuant to clause (i) above, has determined to be inconsistent in a material respect with the regulatory plans and strategies, but not the budget plan, set forth in the then-current Approved Plans and/or Core Data Sheet and/or Specifications (pursuant to clause 3A.3(a)(C) above), Novartis such matter shall be decided by the JDC by Joint Committee Consent. In the event that the dispute is not resolved by the JDC, then it shall, at the election of either Party, be referred to the JEC for resolution. In the event of a disagreement between the designees of BMS and COLLABORATOR on the JEC as to resolution of the dispute, then COLLABORATOR shall have final-decision making authority with respect to the conduct of such activity, unless such dispute relates to clause 3A.3(a)(B) or 3A.3(a)(C), [*]. The Parties agree that any material correspondence from a Regulatory Authority that indicates a material issue relating to the Apixaban Product, or approval or rejection of an Apixaban Product or notification thereof, shall be subject to the reporting requirements set forth in Section 3.2(d). (or its applicable Affiliate or Sublicenseec) will file and hold all Regulatory Approvals for In the Products in countries event that a country in the Pfizer Exclusive Territory in its own name becomes subject to the regulatory regime of the EMEA, then the terms and on its own behalf. Unless provisions of clauses (a) and (b) above shall still apply and, unless otherwise agreed by the Parties, within ten (10) Business Days following the Effective Date, GW will assign to Novartis all Regulatory Filings with any Regulatory Authority in European Entity would thereafter become the Territory at the Effective Date relating to any Product and Novartis will reimburse GW all fees paid by GW to Regulatory Authorities in such countries MAH with respect to the submission of such Regulatory Filings. On request by Novartis, GW will deliver notices of such assignment to the applicable Regulatory Authorities. In addition, GW agrees to give all necessary consents, declarations and documentation as are reasonably required to implement the foregoing. (c) Subject to Sections 4.2 and 6.1(e), Novartis (or its applicable Affiliate or Sublicensee) will be responsible for conducting, at its sole expense, such activities directed towards obtaining and maintaining Regulatory Approvals for Products in the Territory as it determines appropriate in its sole discretion; provided, however, that Novartis agrees to submit Regulatory Filings for Marketing Approvals for a Product in each of the Key Countries. Thereafter, Novartis shall, on a Key Country-by-Key Country basis further prosecute all such Regulatory Filings in the Key Countries in a timely, professional and diligent manner, including by paying all required filing fees promptly and responding to correspondence and requests for further information from Regulatory Authorities in the Key Countries within a reasonable timeframe. Novartis shall share with GW its plans for obtaining Regulatory Approvals in the Key Countries at the first JSC meeting and thereafter shall supply GW with its updated plan from time to time. Novartis shall report its performance against this regulatory plan to the JSC each Calendar Quartercountry. (d) Novartis will: (AThe Parties shall take all actions, including executing appropriate, mutually acceptable agreements and providing necessary data and information regarding the Apixaban Product, as may be reasonably necessary under Applicable Law or desirable to permit COLLABORATOR to perform its rights under the foregoing subclause 3A.3(a) determine and its right to Commercialize the regulatory plans and strategies for the Products Apixaban Product in the Pfizer Exclusive Territory; (B) (either itself or through its Affiliates or Sublicensees and subject , including but not limited to, the provision to Section 6.1(g)) make and own COLLABORATOR by BMS of all Regulatory Filings with respect to the Products in the Territory; and (C) will be responsible for obtaining and maintaining Regulatory Approvals with respect to the Products in the Territory in the name of Novartis or its Affiliates or Sublicensees. Accordingly: (i) Novartissafety, shall at its own cost writepharmacovigilance and CMC data (subject to the terms and conditions of, assembleand processes set forth in, otherwise prepare and file all Regulatory Filings required to obtain Regulatory Approvals for Products in the Territory; Safety Data Exchange Agreement between the Parties), (ii) Novartis shall be the principal contact with all Regulatory Authorities on all matters pertaining to any Productrelevant medical information, but shall consult regularly with GW regarding such matters, giving due regard to GW’s views; (iii) Novartis shall provide to GW copies of all substantive correspondence with Regulatory Authorities in the Territory related to data and information from any Productinvestigator-initiated research, and, to the extent practicable, shall consult with GW in advance of submitting any material correspondence related to any Product to any such Regulatory Authority; and (iv) GW shall provide information [*] = Portions of this exhibit have been omitted pursuant to Novartis copies a confidential treatment request. An unredacted version of all substantive correspondence this exhibit has been filed separately with the EMA related to Securities and Exchange Commission. from any Product andcurrent compassionate use programs, to the extent practicable, shall consult with Novartis in advance of submitting any material correspondence related to any Product to the EMA in circumstances where such correspondence could reasonably be expected to impact on the Commercialization and/or Regulatory Approvals of any Product in the Territory; (v) Novartis shall provide such notice to GW as is reasonably practicable under the circumstances of upcoming meetings related to any Product with Regulatory Authorities in the Territory. Subject to the consent of the relevant Regulatory Authority, GW shall be entitled to attend any such meetings as an observer, and Novartis may require GW’s attendance at any such meeting it deems each to be potentially material; and (vi) Novartis shall pay all filing and maintenance costs of Regulatory Filings and Regulatory Approvals for the Product in the Territory during the Term. (e) GW shall, without additional consideration, fully cooperate with and provide assistance to Novartis in connection with filings to any Regulatory Authority relating to the Product(s) in the Territory in order to obtain or maintain Regulatory Approvals (including Pricing and/or Reimbursement Approvals, where applicable), including by (i) providing Novartis with an electronic copy of the registration dossier for the Product in the European Union as well as providing Novartis with an electronic copy of this registration dossier in eCTD format if and when available in eCTD format, and upon request by Novartis, an electronic copy of a draft of the registration dossier for the Product in the US provided as soon as such draft is made available to GW (if this draft is made available to GW in eCTD format GW will provide it to Novartis in eCID format); (ii) upon request by Novartis, providing Novartis with draft responses to any requests from Regulatory Authorities in practicable after the Territory related to the Development or manufacture of Products (including any requests related to the chemistry manufacturing Amendment No. 2 Effective Date and controls (CMC) section of any Regulatory Filing); and (iii) executing any required documents, providing access to personnel and providing Novartis with copies of all reasonably required documentation. To the extent requested by Novartis, GW shall also grant or cause to be granted to Novartis and its Affiliates or Sublicensees, within thirty (30) days of receipt of a written request from Novartis, cross-reference rights to any relevant drug master files and other filings submitted by GW or its Affiliates with any Regulatory Authority and any Regulatory Approval for Product issued by any Regulatory Authority to GW or its Affiliates. (f) Subject to Novartis having access to reimbursement data from outside the Territory, data generated by Novartis for reimbursement shall be available for GW and its ex-Territory licensees of the Products to use with respect to the Products outside the Territory. (g) In the event that (A) it is not possible under applicable Laws for Novartis to file for or hold Regulatory Approvals for the Product in any country in the Territory and/or (B) if requested by Novartis in writing to do so, to the extent permitted by applicable Laws and for the duration determined by Novartis, GW will file and/or hold all Regulatory Approvals for the Products in such country, at Novartis’s cost and expense (provided that all such costs and expenses shall be in accordance with a plan and budget agreed in writing by the Parties prior to GW making any such Regulatory Filing), and: (i) GW will be responsible for, and will use diligent efforts in, obtaining and maintaining all Regulatory Approvals necessary for the Commercialization of the Products in the country in question; (ii) GW will provide to Novartis copies of all substantive written communications between GW (or its Affiliates) and any Regulatory Authority in the Territory relating to any Product; (iii) Novartis shall have the right to review and comment upon any Regulatory Filings and correspondence from GW (or its Affiliates) to any Regulatory Authority in the Territory relating to any Product, and GW shall incorporate or address all such comments unless otherwise agreed between the Parties; (iv) GW will request and seek to arrange such meetings and consultations with Regulatory Authorities in the Territory which may be requested by Novartis, with respect to any Product; (v) To the extent permitted by the relevant Regulatory Authorities, Novartis shall have the right to have representatives of Novartis attend and participate in all meetings between GW (or its Affiliates) and any Regulatory Authority in the Territory relating to any Product; it being understood and agreed that to the extent permitted by the relevant Regulatory Authorities, Novartis will lead discussions with any such Regulatory Authority in the Territory. If the applicable Regulatory Authority does not permit Novartis to lead any such discussion, GW will lead the applicable discussions as directed by Novartis; and (vi) Novartis will reimburse GW any and all costs incurred pursuant to the foregoing and in accordance with the agreed plan and budget as follows. Within thirty (30) days after each Calendar Quarter during which GW has incurred any such costs and expenses, GW will provide to Novartis a detailed accounting of all such costs and expenses, and shall submit an invoice to Novartis substantially in the form of Exhibit C with respect to the amount of such costs and expenses. Unless disputed, Novartis shall pay such amount event within sixty (60) days after receipt of such invoice. (h) Novartis hereby grantsany written request by COLLABORATOR to BMS. Upon request by COLLABORATOR, and undertakes to cause its Affiliates the extent not already completed, BMS shall provide reasonable technical training at BMS’s facilities to a reasonable number of COLLABORATOR personnel with respect to navigation and Sublicensees to grant, to GW and its Affiliates cross-reference rights to any Regulatory Filing for Product submitted by Novartis or its Affiliates or Sublicensees to any Regulatory Authority in the Territory and any Marketing Approval for Product issued by any Regulatory Authority in the Territory to Novartis or its Affiliates or Sublicensees. Novartis shall also grant such cross-reference rights to those of GW’s licensees usage of the Products for countries outside Secure Information Exchange and the Territory for which Novartis, its Affiliates and Sublicensees are granted corresponding cross-reference rights. Joint Platform at least sixty (i60) The Parties will discuss at days prior to the JSC first Launch of the appropriate response to any request received by either Party from a Third Party academic institution to conduct any investigator initiated clinical study of a Apixaban Product in the TerritoryPfizer Exclusive Territory and shall provide access to and rights to use such platform to COLLABORATOR as reasonably necessary in order for COLLABORATOR to perform its obligations and exercise its rights under this Agreement, including any obligations to answer queries from a Regulatory Authority or conduct biostatistical analyses. (j) If any information comes into GW’s Control that requires a change to the CMC section of Regulatory Filings or Regulatory Approvals, inside and outside the Territory, to avoid ‘regulatory drift’ GW will inform Novartis in writing of the required change (including by providing the necessary technical documentation in English) and Novartis will file such documentation with the relevant Regulatory Authorities as soon as practicable.

Regulatory Affairs. From (a) Biogen shall have the point exclusive right and responsibility to prepare and implement plans and strategies for seeking Regulatory Approval for Collaboration Products in time at which Novartis gives GW notice the Field in writing that it wishes to take on responsibility the Territory, and shall own and be responsible for preparing, seeking, submitting and maintaining all Regulatory Filings and Regulatory Approvals for Collaboration Products in the Field in the Territory. Biogen shall hold and manage the safety database for all Collaboration Products and will have global responsibility for all adverse event collection and reporting. At Biogen’s request, Intec Pharma shall cooperate with Biogen in preparation of Regulatory Filings for the purpose of obtaining Regulatory Approval (including the preparation of the CMC portion of any Regulatory Filing) for Collaboration Products in the Field in the Territory, Novartis and Biogen shall be responsible reimburse Intec Pharma for all interactions reasonable costs incurred in connection with Regulatory Authorities in the Territory with respect to Regulatory Approvals as set forth in this Section 6.1, and including, filing and maintaining any required Regulatory Approvals, seeking necessary permits and/or scheduling or re-scheduling in controlled substance listings or de-scheduling of the Product from controlled substances listings in the Territory. such cooperation. NOTE: PORTIONS OF THIS EXHIBIT ARE THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST BY THE REGISTRANT TO THE SECURITIES AND EXCHANGE COMMISSION (a) Where required, Novartis (or its applicable Affiliate or Sublicensee) will be responsible for arranging for the Product to be scheduled in any applicable controlled substance schedule(s) in countries in the Territory“COMMISSION”). GW agrees, without additional consideration, to give all necessary consents, declarations and documentation as are reasonably required to implement the foregoing and to provide Novartis with all assistance reasonably requested by Novartis (including attending meetings with Regulatory Authorities in any such country) for the purpose of arranging for such schedulingSUCH PORTIONS HAVE BEEN REDACTED AND FILED SEPARATELY WITH THE COMMISSION AND ARE MARKED WITH A “[***]” IN PLACE OF THE REDACTED LANGUAGE. (b) Subject Biogen shall promptly inform Intec Pharma of any intended or actual inspection, written enquiry and/or visit to Section 6.1(g)its facilities by a Regulatory Authority in connection with any Collaboration Product, Novartis unless Biogen has reason to believe that such inspection, enquiry and/or visit is not related to the Accordion Pill System as contained in any Collaboration Product, and promptly communicate to Intec Pharma copies of any correspondence from the Regulatory Authority relating thereto. Biogen will use reasonable endeavors to ensure that Intec Pharma may have a representative present during any such inspection. Biogen shall provide Intec Pharma with at least fifteen (or its applicable Affiliate or Sublicensee) will file and hold all Regulatory Approvals for the Products in countries in the Territory in its own name and on its own behalf. Unless otherwise agreed by the Parties, within ten (1015) Business Days following the Effective Date, GW will assign to Novartis all Regulatory Filings advance notice of any material meeting with any a Regulatory Authority in which is for the Territory at the Effective Date relating purpose of obtaining Regulatory Approval for any Collaboration Product. Biogen shall provide Intec Pharma drafts of any material documents or correspondence pertaining to any Collaboration Product prepared for submission to the Regulatory Authority, including with respect to safety concerns and Novartis will reimburse GW all fees paid by GW SUSAR referred to Regulatory Authorities below, solely to the extent that such documents or correspondence relate to the Accordion Pill System as contained in such countries Collaboration Product, sufficiently in advance of submission so that Intec Pharma may review and comment on the substance of such material documents or correspondence. Biogen shall promptly provide copies of any material documents or other correspondence received from the Regulatory Authority pertaining to Collaboration Products, unless such documents or correspondence are not related to the Accordion Pill System as contained in any Collaboration Product. Biogen agrees to report to Intec Pharma any information from any source, including, without limitation, employees, distributors, agents, customers, user facilities, individuals, or medical or scientific literature, whether published or unpublished, that reasonably suggests that there may be a safety concern with respect to the submission Accordion Pill System as contained in a Collaboration Product, including a probability that the Accordion Pill System as contained in a Collaboration Product has caused or contributed to a death, or an event defined as “SUSAR” (Suspected Unexpected Serious Adverse Reactions), as promptly as possible and in any event simultaneously with any report of such information to a Regulatory Filings. On request by NovartisAuthority, GW will deliver notices and not later than fifteen (15) calendar days following receipt of information of such assignment to the applicable Regulatory Authoritiesevent. In addition, GW agrees Biogen shall, within fifteen (15) days following the end of each Calendar Quarter, provide a written report to give all necessary consents, declarations and documentation as are reasonably required to implement Intec Pharma regarding the foregoingactivities undertaken by Biogen during such Calendar Quarter in accordance with this Section 3.3.4. NOTE: PORTIONS OF THIS EXHIBIT ARE THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST BY THE REGISTRANT TO THE SECURITIES AND EXCHANGE COMMISSION (“COMMISSION”). SUCH PORTIONS HAVE BEEN REDACTED AND FILED SEPARATELY WITH THE COMMISSION AND ARE MARKED WITH A “[***]” IN PLACE OF THE REDACTED LANGUAGE. (c) Subject If Intec Pharma is Manufacturing any Collaboration Products under this Agreement, Intec Pharma shall promptly inform Biogen of any intended or actual inspection, written enquiry and/or visit to Sections 4.2 its facilities by a Regulatory Authority in connection with any Collaboration Product, and 6.1(epromptly communicate to Biogen copies of any correspondence from the Regulatory Authority relating thereto. Intec Pharma will use reasonable endeavors to ensure that Biogen may have a representative present during any portions of such inspection relating to a Collaboration Product. Intec Pharma shall promptly provide copies of any material documents or other correspondence received from any Regulatory Authority pertaining to the manufacturing and safety of Accordion Pill System or any Collaboration Product. Intec Pharma agrees to report to Biogen any information from any source, including, without limitation, employees, distributors, agents, customers, user facilities, individuals, or medical or scientific literature, whether published or unpublished, that reasonably suggests that there may be a safety concern with respect to the Accordion Pill System or any Collaboration Product, including a probability that the Accordion Pill System or any Collaboration Product has caused or contributed to a death, or an event defined as SUSAR, as promptly as possible and in any event no later than (i) one (1) Business Day following receipt of information of such event, if such event is a fatal event, or (ii) two (2) Business Days following receipt of information of such event, if such event is not a fatal event, in each case ((i) and (ii)), Novartis not to exceed four (or its applicable Affiliate or Sublicensee4) will be responsible for conducting, at its sole expense, such activities directed towards obtaining and maintaining Regulatory Approvals for Products in the Territory as it determines appropriate in its sole discretioncalendar days; provided, however, that Novartis agrees if any such information is subject to submit Regulatory Filings for Marketing Approvals for a Product in each any confidentiality obligations of Intec Pharma towards Third Parties, Intec Pharma shall provide redacted information with respect to the Key Countries. ThereafterAccordion Pill System to Biogen without exposing information that Intec Pharma is legally or contractually precluded from disclosing and, Novartis shall, on a Key Country-by-Key Country basis further prosecute all such Regulatory Filings in the Key Countries in event that Biogen requests any additional information that Intec Pharma is legally or contractually precluded from disclosing, Intec Pharma shall use reasonable efforts to seek a timely, professional and diligent manner, including by paying all required filing fees promptly and responding waiver of such confidentiality obligations so that Intec Pharma may disclose such additional information to correspondence and requests for further information from Regulatory Authorities in the Key Countries within a reasonable timeframe. Novartis shall share with GW its plans for obtaining Regulatory Approvals in the Key Countries at the first JSC meeting and thereafter shall supply GW with its updated plan from time to time. Novartis shall report its performance against this regulatory plan to the JSC each Calendar QuarterBiogen. (d) Novartis will: (A) determine the regulatory plans and strategies for the Products in the Territory; (B) (either itself or through its Affiliates or Sublicensees and subject to Section 6.1(g)) make and own all Regulatory Filings with respect to the Products in the Territory; and (C) will be responsible for obtaining and maintaining Regulatory Approvals with respect to the Products in the Territory in the name of Novartis or its Affiliates or Sublicensees. Accordingly: (i) Novartis, shall at its own cost write, assemble, otherwise prepare and file all Regulatory Filings required to obtain Regulatory Approvals for Products in the Territory; (ii) Novartis shall be the principal contact with all Regulatory Authorities on all matters pertaining to At any Product, but shall consult regularly with GW regarding such matters, giving due regard to GW’s views; (iii) Novartis shall provide to GW copies of all substantive correspondence with Regulatory Authorities in the Territory related to any Product, and, to the extent practicable, shall consult with GW in advance of submitting any material correspondence related to any Product to any such Regulatory Authority; (iv) GW shall provide to Novartis copies of all substantive correspondence with the EMA related to any Product and, to the extent practicable, shall consult with Novartis in advance of submitting any material correspondence related to any Product to the EMA in circumstances where such correspondence could reasonably be expected to impact on the Commercialization and/or Regulatory Approvals of any Product in the Territory; (v) Novartis shall provide such notice to GW as is reasonably practicable under the circumstances of upcoming meetings related to any Product with Regulatory Authorities in the Territory. Subject to the consent of the relevant Regulatory Authority, GW shall be entitled to attend any such meetings as an observer, and Novartis may require GW’s attendance at any such meeting it deems to be potentially material; and (vi) Novartis shall pay all filing and maintenance costs of Regulatory Filings and Regulatory Approvals for the Product in the Territory time during the Term. , Biogen shall have the right, on thirty (e30) GW shalldays’ advance written notice to Intec Pharma and during normal business hours, without additional consideration, fully cooperate with to inspect the manufacturing facilities of Intec Pharma and provide assistance to Novartis in connection with filings to any Regulatory Authority relating to the Product(s) in the Territory audit Intec Pharma’s applicable books and records in order to obtain or maintain Regulatory Approvals (including Pricing and/or Reimbursement Approvals, where applicable), including by (i) providing Novartis confirm compliance with an electronic copy of Applicable Laws and with the registration dossier for the Product in the European Union as well as providing Novartis with an electronic copy terms and conditions of this registration dossier Agreement. Intec Pharma shall respond in eCTD format if and when available in eCTD format, and upon request writing to Biogen regarding any material items of concern identified by Novartis, an electronic copy of a draft of the registration dossier for the Product in the US as soon as Biogen during such draft is made available to GW (if this draft is made available to GW in eCTD format GW will provide it to Novartis in eCID format); (ii) upon request by Novartis, providing Novartis with draft responses to any requests from Regulatory Authorities in the Territory related to the Development inspections or manufacture of Products (including any requests related to the chemistry manufacturing and controls (CMC) section of any Regulatory Filing); and (iii) executing any required documents, providing access to personnel and providing Novartis with copies of all reasonably required documentation. To the extent requested by Novartis, GW shall also grant or cause to be granted to Novartis and its Affiliates or Sublicensees, audits within thirty (30) days of receipt of a written request from Novartis, cross-reference rights to any relevant drug master files and other filings submitted by GW or its Affiliates with any Regulatory Authority and any Regulatory Approval for Product issued by any Regulatory Authority to GW or its Affiliates. (f) Subject to Novartis having access to reimbursement data from outside the Territory, data generated by Novartis for reimbursement shall be available for GW and its ex-Territory licensees Biogen’s notice of the Products outcome of the audit or inspection and shall develop a plan, reasonably satisfactory to use with respect to the Products outside the Territory. (g) In the event that (A) it is not possible under applicable Laws for Novartis to file for or hold Regulatory Approvals for the Product in any country in the Territory and/or (B) if requested by Novartis in writing to do soBiogen, to the extent permitted by applicable Laws and for the duration determined by Novartis, GW will file and/or hold all Regulatory Approvals for the Products in such country, at Novartis’s cost and expense remedy any items of noncompliance within ninety (provided that all such costs and expenses shall be in accordance with a plan and budget agreed in writing by the Parties prior to GW making any such Regulatory Filing), and: (i90) GW will be responsible for, and will use diligent efforts in, obtaining and maintaining all Regulatory Approvals necessary for the Commercialization days of the Products in the country in question; (ii) GW will provide to Novartis copies of all substantive written communications between GW notice thereof (or its Affiliates) and any Regulatory Authority more promptly if that can be accomplished in the Territory relating to any Product; (iii) Novartis shall have the right to review and comment upon any Regulatory Filings and correspondence from GW (or its Affiliates) to any Regulatory Authority in the Territory relating to any Product, and GW shall incorporate or address all such comments unless otherwise agreed between the Parties; (iv) GW will request and seek to arrange such meetings and consultations with Regulatory Authorities in the Territory which may be requested by Novartis, with respect to any Product; (v) To the extent permitted by the relevant Regulatory Authorities, Novartis shall have the right to have representatives of Novartis attend and participate in all meetings between GW (or its Affiliates) and any Regulatory Authority in the Territory relating to any Product; it being understood and agreed that to the extent permitted by the relevant Regulatory Authorities, Novartis will lead discussions with any such Regulatory Authority in the Territory. If the applicable Regulatory Authority does not permit Novartis to lead any such discussion, GW will lead the applicable discussions as directed by Novartis; and (vi) Novartis will reimburse GW any and all costs incurred pursuant to the foregoing and in accordance with the agreed plan and budget as follows. Within thirty (30) days after each Calendar Quarter during which GW has incurred any such costs and expenses, GW will provide to Novartis a detailed accounting of all such costs and expensescommercially reasonable manner), and shall submit an invoice to Novartis substantially remedy such items of noncompliance as set forth in the form of Exhibit C with respect such plan. Notwithstanding anything to the amount contrary, this Section 3.3.4(d) shall not apply during any period in which Intec Pharma is not Manufacturing supplies of such costs and expenses. Unless disputed, Novartis shall pay such amount within sixty (60) days after receipt of such invoiceCollaboration Products. (h) Novartis hereby grants, and undertakes to cause its Affiliates and Sublicensees to grant, to GW and its Affiliates cross-reference rights to any Regulatory Filing for Product submitted by Novartis or its Affiliates or Sublicensees to any Regulatory Authority in the Territory and any Marketing Approval for Product issued by any Regulatory Authority in the Territory to Novartis or its Affiliates or Sublicensees. Novartis shall also grant such cross-reference rights to those of GW’s licensees of the Products for countries outside the Territory for which Novartis, its Affiliates and Sublicensees are granted corresponding cross-reference rights. (i) The Parties will discuss at the JSC the appropriate response to any request received by either Party from a Third Party academic institution to conduct any investigator initiated clinical study of a Product in the Territory. (j) If any information comes into GW’s Control that requires a change to the CMC section of Regulatory Filings or Regulatory Approvals, inside and outside the Territory, to avoid ‘regulatory drift’ GW will inform Novartis in writing of the required change (including by providing the necessary technical documentation in English) and Novartis will file such documentation with the relevant Regulatory Authorities as soon as practicable.

Regulatory Affairs. From the point in time at which Novartis gives GW notice in writing that it wishes to take on responsibility for Regulatory Filings and Regulatory Approvals in the Territory, Novartis shall be responsible for all interactions with Regulatory Authorities in the Territory with respect to Regulatory Approvals as set forth in this Section 6.1, and including, filing and maintaining any required Regulatory Approvals, seeking necessary permits and/or scheduling or re-scheduling in controlled substance listings or de-scheduling of the Product from controlled substances listings in the Territory. (a) Where requiredFollowing Option Exercise for a Collaboration Program, Novartis (or its applicable Affiliate or Sublicensee) will Allergan shall own, and be responsible for arranging for the Product to be scheduled in any applicable controlled substance schedule(s) in countries in the Territory. GW agrees, without additional consideration, to give all necessary consents, declarations and documentation as are reasonably required to implement the foregoing and to provide Novartis with all assistance reasonably requested by Novartis (including attending meetings with Regulatory Authorities in any such country) for the purpose of arranging for such scheduling. (b) Subject to Section 6.1(g), Novartis (or its applicable Affiliate or Sublicensee) will file and hold all Regulatory Approvals for the Products in countries in the Territory in its own name and on its own behalf. Unless otherwise agreed by the Parties, within ten (10) Business Days following the Effective Date, GW will assign to Novartis all Regulatory Filings with any Regulatory Authority in the Territory at the Effective Date relating to any Product and Novartis will reimburse GW all fees paid by GW to Regulatory Authorities in such countries with respect to the submission of such Regulatory Filings. On request by Novartis, GW will deliver notices of such assignment to the applicable Regulatory Authorities. In addition, GW agrees to give all necessary consents, declarations and documentation as are reasonably required to implement the foregoing. (c) Subject to Sections 4.2 and 6.1(e), Novartis (or its applicable Affiliate or Sublicensee) will be responsible for conductingsolely responsible, at its sole expense, for preparing, seeking, submitting and maintaining, all Regulatory Documentation for each Licensed Product arising out of or from such activities directed towards obtaining Collaboration Program, and maintaining Regulatory Approvals for Products in the Territory as it determines appropriate shall, in its sole discretion; provided, however, that Novartis agrees to submit determine where such regulatory filings shall be submitted and the content thereof. All Regulatory Filings for Marketing Approvals for a Product in each of the Key Countries. Thereafter, Novartis shall, on a Key Country-by-Key Country basis further prosecute all such Regulatory Filings in the Key Countries in a timely, professional and diligent manner, including by paying all required filing fees promptly and responding to correspondence and requests for further information from Regulatory Authorities in the Key Countries within a reasonable timeframe. Novartis shall share with GW its plans for obtaining Regulatory Approvals in the Key Countries at the first JSC meeting and thereafter shall supply GW with its updated plan from time to time. Novartis shall report its performance against this regulatory plan Documentation relating to the JSC each Calendar Quarter. (d) Novartis will: (A) determine Licensed Products shall be owned by and shall be the regulatory plans sole property and strategies for the Products in the Territory; (B) (either itself or through its Affiliates or Sublicensees and subject to Section 6.1(g)) make and own all Regulatory Filings with respect to the Products in the Territory; and (C) will be responsible for obtaining and maintaining Regulatory Approvals with respect to the Products in the Territory held in the name of Novartis Allergan or its Affiliates designated Affiliate, Sublicensee or Sublicenseesdesignee. Accordingly:Allergan shall have the sole right to conduct and control all interactions and communications with any Governmental Authority relating to any Licensed Product, or the Exploitation thereof. (ib) NovartisIf, shall during the Research Term or at its own cost write, assemble, otherwise prepare and file all Regulatory Filings required to obtain Regulatory Approvals for Products in the Territory; (ii) Novartis shall be the principal contact with all Regulatory Authorities on all matters pertaining to any Product, but shall consult regularly with GW regarding such matters, giving due regard to GW’s views; (iii) Novartis shall provide to GW copies of all substantive correspondence with Regulatory Authorities in the Territory time that Exicure is performing activities related to a Collaboration Program following Option Exercise with respect thereto, any ProductGovernmental Authority conducts, andor gives notice to Exicure of its intent to conduct, an inspection or audit at any investigational site or any Exicure office or facility or to the extent practicabletake any other regulatory action, shall consult or otherwise makes an inquiry, in each case with GW in advance of submitting any material correspondence related respect to any Product to any such Regulatory Authority; (iv) GW shall provide to Novartis copies of all substantive correspondence with the EMA related to any Product and, to the extent practicable, shall consult with Novartis in advance of submitting any material correspondence related to any Product to the EMA in circumstances where such correspondence could or involving or that would otherwise reasonably be expected to impact on adversely affect any Licensed Product or the Commercialization and/or Regulatory Approvals conduct of any Product a Development Plan, Exicure shall, unless prohibited from doing so by applicable Law, notify Allergan within three Business Days after Exicure first learns of such governmental inspection or audit, and, where reasonably practicable, consult with Allergan in the Territory; (v) Novartis shall provide such notice to GW as is reasonably practicable under the circumstances advance of upcoming meetings related to any Product with Regulatory Authorities in the Territory. Subject to the consent of the relevant Regulatory Authority, GW shall be entitled to attend any such meetings as an observerimplementing, and Novartis may require GW’s attendance at permit Allergan to comment on, any proposed plan of action for responding to or complying with any associated demand or request of such meeting it deems to be potentially material; and (vi) Novartis shall pay all filing and maintenance costs of Regulatory Filings and Regulatory Approvals for the Product in the Territory during the Term. (e) GW shall, without additional consideration, fully cooperate with and provide assistance to Novartis in connection with filings to any Regulatory Authority relating to the Product(s) in the Territory in order to obtain or maintain Regulatory Approvals (including Pricing and/or Reimbursement Approvals, where applicable), including by (i) providing Novartis with an electronic copy of the registration dossier for the Product in the European Union as well as providing Novartis with an electronic copy of this registration dossier in eCTD format if and when available in eCTD formatGovernmental Authority. Wherever possible, and upon request by Novartis, an electronic copy of a draft of the registration dossier for the Product in the US as soon as such draft is made available to GW (if this draft is made available to GW in eCTD format GW will provide it to Novartis in eCID format); (ii) upon request by Novartis, providing Novartis with draft responses to any requests from Regulatory Authorities in the Territory related to the Development or manufacture of Products (including any requests related to the chemistry manufacturing and controls (CMC) section of any Regulatory Filing); and (iii) executing any required documents, providing access to personnel and providing Novartis with copies of all reasonably required documentation. To the extent requested by Novartis, GW shall also grant or cause to be granted to Novartis and its Affiliates or Sublicensees, within thirty (30) days of receipt of a written request from Novartis, cross-reference rights to any relevant drug master files and other filings submitted by GW or its Affiliates with any Regulatory Authority and any Regulatory Approval for Product issued by any Regulatory Authority to GW or its Affiliates. (f) Subject to Novartis having access to reimbursement data from outside the Territory, data generated by Novartis for reimbursement shall be available for GW and its ex-Territory licensees of the Products to use with respect to the Products outside the Territory. (g) In the event that (A) it is not possible under applicable Laws for Novartis to file for or hold Regulatory Approvals for the Product in any country in the Territory and/or (B) if requested by Novartis in writing to do so, to the extent permitted by under applicable Laws and for Law, Exicure shall provide Allergan with the duration determined by Novartis, GW will file and/or hold all Regulatory Approvals for the Products in such country, at Novartis’s cost and expense (provided that all such costs and expenses shall be in accordance with a plan and budget agreed in writing by the Parties prior to GW making any such Regulatory Filing), and: opportunity (i) GW will be responsible for, to have a representative present at any such governmental inspection or audit to the extent relating to a Licensed Product and will use diligent efforts in, obtaining and maintaining all Regulatory Approvals necessary for the Commercialization of the Products in the country in question; (ii) GW will provide to Novartis copies of all substantive written communications between GW (or its Affiliates) and any Regulatory Authority in the Territory relating to any Product; (iii) Novartis shall have the right to review in advance and comment upon on any Regulatory Filings and correspondence from GW (communications or its Affiliates) submissions proposed to be made by Exicure to any Regulatory Authority in the Territory relating relation to any Productsuch inquiry, and GW inspection or audit. Exicure shall incorporate not unreasonably reject any comments provided by Allergan under this Section 5.1.4. Following any THE COMPANY HAS REQUESTED AN ORDER FROM THE SECURITIES AND EXCHANGE COMMISSION (THE “COMMISSION”) PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. ACCORDINGLY, THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, AND HAVE BEEN FILED SEPARATELY WITH THE COMMISSION. OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH “*****”. such inquiry, inspection or address all such comments unless otherwise agreed between the Parties; (iv) GW will request and seek audit, Exicure shall provide to arrange such meetings and consultations with Regulatory Authorities in the Territory which may be requested by Novartis, Allergan a copy of any report with respect to any Product; (v) To the extent permitted thereto issued by the relevant Regulatory Authorities, Novartis shall have the right to have representatives of Novartis attend and participate in all meetings between GW (or its Affiliates) and any Regulatory Authority in the Territory relating to any Product; it being understood and agreed that to the extent permitted by the relevant Regulatory Authorities, Novartis will lead discussions with any such Regulatory Authority in the Territory. If the applicable Regulatory Authority does not permit Novartis to lead any such discussion, GW will lead the applicable discussions as directed by Novartis; and (vi) Novartis will reimburse GW any and all costs incurred pursuant to the foregoing and in accordance with the agreed plan and budget as follows. Within thirty (30) days after each Calendar Quarter during which GW has incurred any such costs and expenses, GW will provide to Novartis a detailed accounting of all such costs and expenses, and shall submit an invoice to Novartis substantially in the form of Exhibit C with respect to the amount of such costs and expenses. Unless disputed, Novartis shall pay such amount within sixty (60) days after receipt of such invoiceGovernmental Authority. (h) Novartis hereby grants, and undertakes to cause its Affiliates and Sublicensees to grant, to GW and its Affiliates cross-reference rights to any Regulatory Filing for Product submitted by Novartis or its Affiliates or Sublicensees to any Regulatory Authority in the Territory and any Marketing Approval for Product issued by any Regulatory Authority in the Territory to Novartis or its Affiliates or Sublicensees. Novartis shall also grant such cross-reference rights to those of GW’s licensees of the Products for countries outside the Territory for which Novartis, its Affiliates and Sublicensees are granted corresponding cross-reference rights. (i) The Parties will discuss at the JSC the appropriate response to any request received by either Party from a Third Party academic institution to conduct any investigator initiated clinical study of a Product in the Territory. (j) If any information comes into GW’s Control that requires a change to the CMC section of Regulatory Filings or Regulatory Approvals, inside and outside the Territory, to avoid ‘regulatory drift’ GW will inform Novartis in writing of the required change (including by providing the necessary technical documentation in English) and Novartis will file such documentation with the relevant Regulatory Authorities as soon as practicable.

Regulatory Affairs. From (a) Enzon shall use Diligent Efforts to obtain Regulatory Approvals for at least one Product in the point Enzon Territory, including compiling, submitting and prosecuting in time at which Novartis gives GW notice a timely manner all necessary data, documents and BLAs (including labeling), in writing that it wishes a format acceptable to take on responsibility for the applicable Regulatory Filings Authorities in the Enzon Territory, maintaining and renewing the Regulatory Approvals in the Territory, Novartis shall be responsible for Enzon Territory and paying all interactions with Regulatory Authorities in the Territory with respect user fees and other costs required to Regulatory Approvals as set forth in this Section 6.1, obtain and including, filing and maintaining any required maintain such Regulatory Approvals, seeking necessary permits and/or scheduling or re-scheduling in controlled substance listings or de-scheduling of the Product from controlled substances listings in the Territory. (a) Where required, Novartis (or its applicable Affiliate or Sublicensee) will be responsible for arranging for the Product to be scheduled in any applicable controlled substance schedule(s) in countries in the Territory. GW agrees, without additional consideration, to give all necessary consents, declarations and documentation as are reasonably required to implement the foregoing and to provide Novartis with all assistance reasonably requested by Novartis (including attending meetings with Regulatory Authorities in any such country) for the purpose of arranging for such scheduling. (b) Subject Enzon shall grant NatImmune, its Affiliates and licensees the exclusive right to Section 6.1(g)use and cross-reference any Regulatory Filings as may be required solely to allow NatImmune, Novartis (or its applicable Affiliate or Sublicensee) will file Affiliates and hold all Regulatory Approvals for licensees to sell the Products in countries the NatImmune Territory and to allow NatImmune, its Affiliates and its licensees to Commercialize the Products in the NatImmune Territory in to the extent otherwise permitted under this Agreement. Enzon shall transfer to NatImmune, its own name and on its own behalf. Unless otherwise agreed by Affiliates or licensees a copy of the Parties, within ten (10) Business Days following the Effective Date, GW will assign to Novartis all Regulatory Filings with any Regulatory Authority in the Territory at the Effective Date relating to any Product and Novartis will reimburse GW all fees paid submitted by GW to Regulatory Authorities in such countries with respect Enzon to the submission of such Regulatory Filings. On request by NovartisFDA, GW will deliver notices of such assignment to the EMEA and any other applicable Regulatory Authorities. In addition, GW agrees to give all necessary consents, declarations and documentation as are reasonably required to implement the foregoing. (c) Subject Enzon shall grant NatImmune the right to Sections 4.2 use and 6.1(e), Novartis (reference the results generated from Phase IV Trials conducted by or its applicable Affiliate or Sublicensee) will be responsible for conducting, at its sole expense, such activities directed towards obtaining and maintaining Regulatory Approvals for Products in the Territory as it determines appropriate in its sole discretion; provided, however, that Novartis agrees to submit Regulatory Filings for Marketing Approvals Enzon for a Product in each connection with the Commercialization of the Key Countries. Thereafter, Novartis shall, on a Key Country-by-Key Country basis further prosecute all such Regulatory Filings Products in the Key Countries in a timely, professional and diligent manner, including by paying all required filing fees promptly and responding to correspondence and requests for further information from Regulatory Authorities in the Key Countries within a reasonable timeframe. Novartis shall share with GW its plans for obtaining Regulatory Approvals in the Key Countries at the first JSC meeting and thereafter shall supply GW with its updated plan from time to time. Novartis shall report its performance against this regulatory plan to the JSC each Calendar QuarterNatImmune Territory. (d) Novartis willIn conducting any Development activities hereunder, each Party shall: (Ai) determine the ensure that its employees, agents, clinical institutions and clinical investigators comply with all FDA statutory and regulatory plans and strategies for the Products in the Territory; (B) (either itself or through its Affiliates or Sublicensees and subject to Section 6.1(g)) make and own all Regulatory Filings requirements with respect to Products, including: the Products in Federal Food, Drug and Cosmetic Act, as amended (FFDCA), the TerritoryPublic Health Service Act (PHSA), regulatory provisions regarding protection of human subjects, financial disclosure by clinical investigators, Institutional Review Boards (IRB), GCP, GLP, IND regulations, and any conditions imposed by a reviewing IRB or the FDA; and (Cii) will be responsible not utilize, in conducting studies on Products any person or entities that at such time are debarred by FDA, or that, at such time, are under investigation by FDA for obtaining and maintaining Regulatory Approvals with respect debarment action pursuant to the Products in the Territory in the name of Novartis or its Affiliates or Sublicensees. Accordingly: (i) Novartis, shall at its own cost write, assemble, otherwise prepare and file all Regulatory Filings required to obtain Regulatory Approvals for Products in the Territory; (ii) Novartis shall be the principal contact with all Regulatory Authorities on all matters pertaining to any Product, but shall consult regularly with GW regarding such matters, giving due regard to GW’s views; (iii) Novartis shall provide to GW copies of all substantive correspondence with Regulatory Authorities in the Territory related to any Product, and, to the extent practicable, shall consult with GW in advance of submitting any material correspondence related to any Product to any such Regulatory Authority; (iv) GW shall provide to Novartis copies of all substantive correspondence with the EMA related to any Product and, to the extent practicable, shall consult with Novartis in advance of submitting any material correspondence related to any Product to the EMA in circumstances where such correspondence could reasonably be expected to impact on the Commercialization and/or Regulatory Approvals of any Product in the Territory; (v) Novartis shall provide such notice to GW as is reasonably practicable under the circumstances of upcoming meetings related to any Product with Regulatory Authorities in the Territory. Subject to the consent provisions of the relevant Regulatory Authority, GW shall be entitled to attend any such meetings as an observer, and Novartis may require GW’s attendance at any such meeting it deems to be potentially material; and Generic Drug Enforcement Act of 1992 (vi) Novartis shall pay all filing and maintenance costs of Regulatory Filings and Regulatory Approvals for the Product in the Territory during the Term21 U.S.C. Section 335). (e) GW shallCommencing upon the Effective Date, without additional consideration, fully cooperate with and provide assistance NatImmune will use commercially reasonable efforts to Novartis assist Enzon in connection with filings Enzon’s response to any Regulatory Authority relating current and future FDA inquiries about the Products with the goal of enabling Enzon to the Product(s) in the Territory in order to obtain or maintain Regulatory Approvals (including Pricing and/or Reimbursement Approvals, where applicable), including by (i) providing Novartis with file an electronic copy of the registration dossier for the Product in the European Union as well as providing Novartis with an electronic copy of this registration dossier in eCTD format if and when available in eCTD format, and upon request by Novartis, an electronic copy of a draft of the registration dossier for the Product in the US IND as soon as such draft is made available to GW (if this draft is made available to GW in eCTD format GW will provide it to Novartis in eCID format); (ii) upon request by Novartis, providing Novartis with draft responses to any requests from Regulatory Authorities in the Territory related to the Development or manufacture of Products (including any requests related to the chemistry manufacturing and controls (CMC) section of any Regulatory Filing); and (iii) executing any required documents, providing access to personnel and providing Novartis with copies of all reasonably required documentation. To the extent requested by Novartis, GW shall also grant or cause to be granted to Novartis and its Affiliates or Sublicensees, within thirty (30) days of receipt of a written request from Novartis, cross-reference rights to any relevant drug master files and other filings submitted by GW or its Affiliates with any Regulatory Authority and any Regulatory Approval for Product issued by any Regulatory Authority to GW or its Affiliates. (f) Subject to Novartis having access to reimbursement data from outside the Territory, data generated by Novartis for reimbursement shall be available for GW and its ex-Territory licensees of the Products to use with respect to the Products outside the Territory. (g) In the event that (A) it is not possible under applicable Laws for Novartis to file for or hold Regulatory Approvals for the Product in any country in the Territory and/or (B) if requested by Novartis in writing to do so, to the extent permitted by applicable Laws and for the duration determined by Novartis, GW will file and/or hold all Regulatory Approvals for the Products in such country, at Novartis’s cost and expense (provided that all such costs and expenses shall be in accordance with a plan and budget agreed in writing by the Parties prior to GW making any such Regulatory Filing), and: (i) GW will be responsible for, and will use diligent efforts in, obtaining and maintaining all Regulatory Approvals necessary for the Commercialization of the Products in the country in question; (ii) GW will provide to Novartis copies of all substantive written communications between GW (or its Affiliates) and any Regulatory Authority in the Territory relating to any Product; (iii) Novartis shall have the right to review and comment upon any Regulatory Filings and correspondence from GW (or its Affiliates) to any Regulatory Authority in the Territory relating to any Product, and GW shall incorporate or address all such comments unless otherwise agreed between the Parties; (iv) GW will request and seek to arrange such meetings and consultations with Regulatory Authorities in the Territory which may be requested by Novartis, with respect to any Product; (v) To the extent permitted by the relevant Regulatory Authorities, Novartis shall have the right to have representatives of Novartis attend and participate in all meetings between GW (or its Affiliates) and any Regulatory Authority in the Territory relating to any Product; it being understood and agreed that to the extent permitted by the relevant Regulatory Authorities, Novartis will lead discussions with any such Regulatory Authority in the Territory. If the applicable Regulatory Authority does not permit Novartis to lead any such discussion, GW will lead the applicable discussions as directed by Novartis; and (vi) Novartis will reimburse GW any and all costs incurred pursuant to the foregoing and in accordance with the agreed plan and budget as follows. Within thirty (30) days after each Calendar Quarter during which GW has incurred any such costs and expenses, GW will provide to Novartis a detailed accounting of all such costs and expenses, and shall submit an invoice to Novartis substantially in the form of Exhibit C with respect to the amount of such costs and expenses. Unless disputed, Novartis shall pay such amount within sixty (60) days after receipt of such invoice. (h) Novartis hereby grants, and undertakes to cause its Affiliates and Sublicensees to grant, to GW and its Affiliates cross-reference rights to any Regulatory Filing for Product submitted by Novartis or its Affiliates or Sublicensees to any Regulatory Authority in the Territory and any Marketing Approval for Product issued by any Regulatory Authority in the Territory to Novartis or its Affiliates or Sublicensees. Novartis shall also grant such cross-reference rights to those of GW’s licensees of the Products for countries outside the Territory for which Novartis, its Affiliates and Sublicensees are granted corresponding cross-reference rights. (i) The Parties will discuss at the JSC the appropriate response to any request received by either Party from a Third Party academic institution to conduct any investigator initiated clinical study of a Product in the Territory. (j) If any information comes into GW’s Control that requires a change to the CMC section of Regulatory Filings or Regulatory Approvals, inside and outside the Territory, to avoid ‘regulatory drift’ GW will inform Novartis in writing of the required change (including by providing the necessary technical documentation in English) and Novartis will file such documentation with the relevant Regulatory Authorities as soon as practicable.

Regulatory Affairs. From (a) Enzon shall use Diligent Efforts to obtain Regulatory Approvals for at least one Product in the point Enzon Territory, including compiling, submitting and prosecuting in time at which Novartis gives GW notice a timely manner all necessary data, documents and BLAs (including labeling), in writing that it wishes a format acceptable to take on responsibility for the applicable Regulatory Filings Authorities in the Enzon Territory, maintaining and renewing the Regulatory Approvals in the Territory, Novartis shall be responsible for Enzon Territory and paying all interactions with Regulatory Authorities in the Territory with respect user fees and other costs required to Regulatory Approvals as set forth in this Section 6.1, obtain and including, filing and maintaining any required maintain such Regulatory Approvals, seeking necessary permits and/or scheduling or re-scheduling in controlled substance listings or de-scheduling of the Product from controlled substances listings in the Territory. (a) Where required, Novartis (or its applicable Affiliate or Sublicensee) will be responsible for arranging for the Product to be scheduled in any applicable controlled substance schedule(s) in countries in the Territory. GW agrees, without additional consideration, to give all necessary consents, declarations and documentation as are reasonably required to implement the foregoing and to provide Novartis with all assistance reasonably requested by Novartis (including attending meetings with Regulatory Authorities in any such country) for the purpose of arranging for such scheduling. (b) Subject Enzon shall grant NatImmune, its Affiliates and licensees the exclusive right to Section 6.1(g)use and cross-reference any Regulatory Filings as may be required solely to allow NatImmune, Novartis (or its applicable Affiliate or Sublicensee) will file Affiliates and hold all Regulatory Approvals for licensees to sell the Products in countries the NatImmune Territory and to allow NatImmune, its Affiliates and its licensees to Commercialize the Products in the NatImmune Territory in to the extent otherwise permitted under this Agreement. Enzon shall transfer to NatImmune, its own name and on its own behalf. Unless otherwise agreed by Affiliates or licensees a copy of the Parties, within ten (10) Business Days following the Effective Date, GW will assign to Novartis all Regulatory Filings with any Regulatory Authority in the Territory at the Effective Date relating to any Product and Novartis will reimburse GW all fees paid submitted by GW to Regulatory Authorities in such countries with respect Enzon to the submission of such Regulatory Filings. On request by NovartisFDA, GW will deliver notices of such assignment to the EMEA and any other applicable Regulatory Authorities. In addition, GW agrees to give all necessary consents, declarations and documentation as are reasonably required to implement the foregoing. (c) Subject Enzon shall grant NatImmune the right to Sections 4.2 use and 6.1(e), Novartis (reference the results generated from Phase IV Trials conducted by or its applicable Affiliate or Sublicensee) will be responsible for conducting, at its sole expense, such activities directed towards obtaining and maintaining Regulatory Approvals for Products in the Territory as it determines appropriate in its sole discretion; provided, however, that Novartis agrees to submit Regulatory Filings for Marketing Approvals Enzon for a Product in each connection with the Commercialization of the Key Countries. Thereafter, Novartis shall, on a Key Country-by-Key Country basis further prosecute all such Regulatory Filings Products in the Key Countries in a timely, professional and diligent manner, including by paying all required filing fees promptly and responding to correspondence and requests for further information from Regulatory Authorities in the Key Countries within a reasonable timeframe. Novartis shall share with GW its plans for obtaining Regulatory Approvals in the Key Countries at the first JSC meeting and thereafter shall supply GW with its updated plan from time to time. Novartis shall report its performance against this regulatory plan to the JSC each Calendar QuarterNatImmune Territory. (d) Novartis willIn conducting any Development activities hereunder, each Party shall: (Ai) determine the ensure that its employees, agents, clinical institutions and clinical investigators comply with all FDA statutory and regulatory plans and strategies for the Products in the Territory; (B) (either itself or through its Affiliates or Sublicensees and subject to Section 6.1(g)) make and own all Regulatory Filings requirements with respect to Products, including : the Products in Federal Food, Drug and Cosmetic Act, as amended (FFDCA), the TerritoryPublic Health Service Act (PHSA), regulatory provisions regarding protection of human subjects, financial disclosure by clinical investigators, Institutional Review Boards (IRB), GCP, GLP, IND regulations, and any conditions imposed by a reviewing IRB or the FDA; and (Cii) will be responsible not utilize, in conducting studies on Products any person or entities that at such time are debarred by FDA, or that, at such time, are under investigation by FDA for obtaining and maintaining Regulatory Approvals with respect debarment action pursuant to the Products in the Territory in the name of Novartis or its Affiliates or Sublicensees. Accordingly: (i) Novartis, shall at its own cost write, assemble, otherwise prepare and file all Regulatory Filings required to obtain Regulatory Approvals for Products in the Territory; (ii) Novartis shall be the principal contact with all Regulatory Authorities on all matters pertaining to any Product, but shall consult regularly with GW regarding such matters, giving due regard to GW’s views; (iii) Novartis shall provide to GW copies of all substantive correspondence with Regulatory Authorities in the Territory related to any Product, and, to the extent practicable, shall consult with GW in advance of submitting any material correspondence related to any Product to any such Regulatory Authority; (iv) GW shall provide to Novartis copies of all substantive correspondence with the EMA related to any Product and, to the extent practicable, shall consult with Novartis in advance of submitting any material correspondence related to any Product to the EMA in circumstances where such correspondence could reasonably be expected to impact on the Commercialization and/or Regulatory Approvals of any Product in the Territory; (v) Novartis shall provide such notice to GW as is reasonably practicable under the circumstances of upcoming meetings related to any Product with Regulatory Authorities in the Territory. Subject to the consent provisions of the relevant Regulatory Authority, GW shall be entitled to attend any such meetings as an observer, and Novartis may require GW’s attendance at any such meeting it deems to be potentially material; and Generic Drug Enforcement Act of 1992 (vi) Novartis shall pay all filing and maintenance costs of Regulatory Filings and Regulatory Approvals for the Product in the Territory during the Term21 U.S.C. Section 335). (e) GW shallCommencing upon the Effective Date, without additional consideration, fully cooperate with and provide assistance NatImmune will use commercially reasonable efforts to Novartis assist Enzon in connection with filings Enzon’s response to any Regulatory Authority relating current and future FDA inquiries about the Products with the goal of enabling Enzon to the Product(s) in the Territory in order to obtain or maintain Regulatory Approvals (including Pricing and/or Reimbursement Approvals, where applicable), including by (i) providing Novartis with file an electronic copy of the registration dossier for the Product in the European Union as well as providing Novartis with an electronic copy of this registration dossier in eCTD format if and when available in eCTD format, and upon request by Novartis, an electronic copy of a draft of the registration dossier for the Product in the US IND as soon as such draft is made available to GW (if this draft is made available to GW in eCTD format GW will provide it to Novartis in eCID format); (ii) upon request by Novartis, providing Novartis with draft responses to any requests from Regulatory Authorities in the Territory related to the Development or manufacture of Products (including any requests related to the chemistry manufacturing and controls (CMC) section of any Regulatory Filing); and (iii) executing any required documents, providing access to personnel and providing Novartis with copies of all reasonably required documentation. To the extent requested by Novartis, GW shall also grant or cause to be granted to Novartis and its Affiliates or Sublicensees, within thirty (30) days of receipt of a written request from Novartis, cross-reference rights to any relevant drug master files and other filings submitted by GW or its Affiliates with any Regulatory Authority and any Regulatory Approval for Product issued by any Regulatory Authority to GW or its Affiliates. (f) Subject to Novartis having access to reimbursement data from outside the Territory, data generated by Novartis for reimbursement shall be available for GW and its ex-Territory licensees of the Products to use with respect to the Products outside the Territory. (g) In the event that (A) it is not possible under applicable Laws for Novartis to file for or hold Regulatory Approvals for the Product in any country in the Territory and/or (B) if requested by Novartis in writing to do so, to the extent permitted by applicable Laws and for the duration determined by Novartis, GW will file and/or hold all Regulatory Approvals for the Products in such country, at Novartis’s cost and expense (provided that all such costs and expenses shall be in accordance with a plan and budget agreed in writing by the Parties prior to GW making any such Regulatory Filing), and: (i) GW will be responsible for, and will use diligent efforts in, obtaining and maintaining all Regulatory Approvals necessary for the Commercialization of the Products in the country in question; (ii) GW will provide to Novartis copies of all substantive written communications between GW (or its Affiliates) and any Regulatory Authority in the Territory relating to any Product; (iii) Novartis shall have the right to review and comment upon any Regulatory Filings and correspondence from GW (or its Affiliates) to any Regulatory Authority in the Territory relating to any Product, and GW shall incorporate or address all such comments unless otherwise agreed between the Parties; (iv) GW will request and seek to arrange such meetings and consultations with Regulatory Authorities in the Territory which may be requested by Novartis, with respect to any Product; (v) To the extent permitted by the relevant Regulatory Authorities, Novartis shall have the right to have representatives of Novartis attend and participate in all meetings between GW (or its Affiliates) and any Regulatory Authority in the Territory relating to any Product; it being understood and agreed that to the extent permitted by the relevant Regulatory Authorities, Novartis will lead discussions with any such Regulatory Authority in the Territory. If the applicable Regulatory Authority does not permit Novartis to lead any such discussion, GW will lead the applicable discussions as directed by Novartis; and (vi) Novartis will reimburse GW any and all costs incurred pursuant to the foregoing and in accordance with the agreed plan and budget as follows. Within thirty (30) days after each Calendar Quarter during which GW has incurred any such costs and expenses, GW will provide to Novartis a detailed accounting of all such costs and expenses, and shall submit an invoice to Novartis substantially in the form of Exhibit C with respect to the amount of such costs and expenses. Unless disputed, Novartis shall pay such amount within sixty (60) days after receipt of such invoice. (h) Novartis hereby grants, and undertakes to cause its Affiliates and Sublicensees to grant, to GW and its Affiliates cross-reference rights to any Regulatory Filing for Product submitted by Novartis or its Affiliates or Sublicensees to any Regulatory Authority in the Territory and any Marketing Approval for Product issued by any Regulatory Authority in the Territory to Novartis or its Affiliates or Sublicensees. Novartis shall also grant such cross-reference rights to those of GW’s licensees of the Products for countries outside the Territory for which Novartis, its Affiliates and Sublicensees are granted corresponding cross-reference rights. (i) The Parties will discuss at the JSC the appropriate response to any request received by either Party from a Third Party academic institution to conduct any investigator initiated clinical study of a Product in the Territory. (j) If any information comes into GW’s Control that requires a change to the CMC section of Regulatory Filings or Regulatory Approvals, inside and outside the Territory, to avoid ‘regulatory drift’ GW will inform Novartis in writing of the required change (including by providing the necessary technical documentation in English) and Novartis will file such documentation with the relevant Regulatory Authorities as soon as practicable.