Provision Language
20. Term and Termination
20.4. Consequences of Termination
20.4.1 Termination by Roche for Convenience; Termination by PTC for Roche Breach, Insolvency Event, Patent Challenge or Post-Change of Control Material Change. If this Agreement is terminated by Roche pursuant to Section 20.3.3 (Termination Without a Cause), or by PTC pursuant to Section 20.3.1 (Termination for Breach), Section 20.3.4 (Termination for Patent Challenge) or Section 20.3.5 (Termination for Post-Change of Control Material Change), then, in addition to the consequences set forth in Section 20.3.4 with respect to Patent Challenge and the consequences set forth in Sections 20.4.3 and 20.5, and subject to Section 20.4.1.8:
20.4.1.1 Termination of Licenses. The licenses granted by PTC to Roche pursuant to Section 3.1 shall terminate;
20.4.1.2 Regulatory Matters. Promptly following receipt of PTC’s written notice that it intends to continue development and commercialization of Compounds and Products, Roche shall transfer and assign to PTC ownership of:
(i) all regulatory filings and Regulatory Approvals in Roche’s or its Affiliates’ possession or control relating to all Compounds and Products; and
(ii) any regulatory dossiers containing information necessary or useful to Roche in connection with its regulatory filings for all Products, including, but not limited to clinical trial dossiers, regulatory correspondence, Regulatory Authority meeting minutes and study reports from completed non-clinical studies. For all completed study reports, Roche shall provide necessary documentation to confirm data reliability, as required by Article 43 of the Japanese Pharmaceutical Affairs Law Enforcement Regulations and related notifications, including, but not limited to original author signatures, raw data lists, GLP and GCP compliance information. All documentation is to be provided in English.
20.4.1.3 Preclinical and Clinical Matters. Promptly following receipt of PTC’s written notice that it intends to continue development and commercialization of Compounds and Products, Roche shall assign to PTC its entire right, title, and interest in and to all preclinical and clinical data, including but not limited to pharmacology and biology data, in Roche’s or its Affiliates’ possession or control relating to and to the extent necessary for PTC to continue the research, development or commercialization of Compounds and Products;
20.4.1.4 Manufacturing Matters. Promptly following receipt of PTC’s written notice that it intends to continue development and commercialization of Compounds and Products, Roche shall:
(i) assign each manufacturing agreement entered into by any member of the Roche Group that is specific to Compounds or Products to PTC, if such agreement is then in effect and such assignment is permitted under such agreement or by the applicable counterparty;
(ii) cooperate with PTC to transfer manufacturing documents and materials that are used (at the time of the termination) by any member of the Roche Group or Third Party contract manufacturers in the manufacture of Compounds and Products, to the extent such manufacturing documents and materials are not obtained by PTC pursuant to the assignment of agreements pursuant to Section 20.4.1.4(i);
(iii) for a period of up to [**] months after the effective date of termination, subject to the then-existing obligations to Third Parties, cooperate with PTC to transfer to PTC, in a manner consistent with the guidelines set forth in Appendix 8.2.2, manufacturing technologies and all associated Know-How that are used (at the time of the termination) by any member of the Roche Group or Third Party contract manufacturers in the manufacture of Compounds and Products including, without limitation,providing, following reasonable advance request by PTC, [**] of up to [**] days duration of one Roche full-time equivalent to provide technical assistance in transferring technology required for the manufacture of a Compound at a PTC, PTC Affiliate, or subcontract or manufacturing facility; provided that PTC shall reimburse Roche for Roche’s reasonable out-of-pocket expenses to provide such requested assistance, to the extent such manufacturing technologies are not obtained by PTC pursuant to Section 20.4.1.4(i);
(iv) sell the Roche Group’s then-existing inventory of Compounds and Products to PTC, at Roche’s FBMC plus [**] percent ([**]%); and
(v) if this Agreement is terminated after Initiation of a Pivotal Trial of a Product, use Commercially Reasonable Efforts to manufacture or have manufactured and supply PTC’s requirements of such Product for a period of up to [**] months after the effective date of termination, at Roche’s FBMC plus [**] percent ([**]%).
20.4.1.5 License Grants to PTC. Subject to the then-existing obligations to Third Parties, Roche hereby grants to PTC:
(a) a non-exclusive, perpetual right and license under Roche’s interest in the Roche Background Patent Rights and Roche Know-How; and
(b) an exclusive, perpetual right and license under Roche’s interest in the Roche Product Patent Rights and Roche’s interest in the Joint Patent Rights and Joint Know-How;
in each case ((a) and (b)), with the right to grant sublicenses, to develop, have developed, register, have registered, use, have used, make,have made, import, have imported, export, have exported, market, have marketed, distribute, have distributed, sell and have sold Compounds and Products then being developed or commercialized by Roche in the Field in the Territory.
20.4.1.6 Prosecution and Enforcement. The provisions of Sections 15.5 (Prosecution of Patent Rights Claiming Joint Inventions) and 15.8 (Infringement) shall remain in effect with respect to the Joint Patent Rights and Joint Know-How licensed to PTC under Section 20.4.1.5;
20.4.1.7 Assignment of Trademark. Promptly following receipt of PTC’s written notice that it intends to continue development and commercialization of Compounds and Products, Roche shall assign to PTC Roche’s and its Affiliates’ entire right, title and interest in, to and under any trademark used by any member of the Roche Group exclusively in connection with the commercialization of a Product, it being understood that such assignment shall not include the Roche name or trademark for the Roche company itself; and
20.4.1.8 Remaining Products, Countries and Patent Rights. If PTC terminates this Agreement pursuant to Section 20.3.1 with respect to a specific country(ies), or pursuant to Section 20.3.4 with respect to a specific PTC Patent Right or Joint Patent Right, or Roche terminates this Agreement pursuant to Section 20.3.3 with respect to a specific country(ies) or Product(s), then this Agreement shall remain in full force and effect for the non-terminated country(ies), Patent Right(s) and/or Product(s) (as the case may be), and all of the consequences set forth in this Section 20.4.1 shall apply solely with respect to the terminated country(ies), Patent Right(s) and/or Product(s).
20.4.1.9 Assumption by Foundation. If Roche has not received written notice from PTC pursuant to Section 20.4.1.2, 20.4.1.3, 20.4.1.4, or 20.4.1.7 by [**] days after the effective date of termination of this Agreement, then Roche shall promptly notify Foundation and Foundation shall have the right, upon notice to Roche, to require Roche to provide to Foundation or its designee all items and actions that Roche would have been obligated to provide to PTC if PTC had provided such notice.
20.4.2 Termination by Roche for Breach by PTC. Upon any termination by Roche for breach by PTC, the licenses granted to Roche pursuant to Section 3.1 shall continue solely with respect to Compounds and Products, subject to Roche’s continued compliance with Roche’s payment and other obligations under Articles 11, 12, 13 and 14 and further subject to Section 2.2.2.
20.4.3 Other Obligations.
20.4.3.1 Obligations Related to Ongoing Activities. From the date of notice of termination until the effective date of termination, Roche shall continue activities, including but not limited to preparatory activities, ongoing as of the date of notice of termination and shall be responsible for all of its uncancelable obligations. However, Roche shall not be obliged to initiate any new activities not ongoing at the date of notice of termination. In any case, after the effective date of termination, Roche shall not have any obligation to perform and/or complete any activities or to make any payments for performing or completing any activities under this Agreement. Notwithstanding the foregoing, in case of termination by PTC under Section 20.3.1, 20.3.2, 20.3.4 or 20.3.5, or by Roche under Section 20.3.3, upon the request of PTC or Foundation, Roche shall complete any Clinical Studies related to the Product that are being conducted under its IND for the Product and are ongoing as of the effective date of termination; provided, however, that Roche may agree but shall have no obligation to recruit or enroll any additional patients after the date of termination.
20.4.3.2 Royalty and Payment Obligations.
(a) Termination of this Agreement by a Party, for any reason, shall not release Roche from any obligation to pay royalties or make any payments to PTC that are due and payable prior to the effective date of termination.
(b) In consideration for the value added by Roche with respect to Compounds and Products and for the licenses granted in Section 20.4.1.5, PTC shall pay to Roche in the event this Agreement is terminated for any reason other than a material breach by Roche, royalties during the applicable Royalty Term on Products as follows: [TABLE REDACTED]
(c) If PTC receives any payment from Foundation as the result of Foundation’s right to commercialize Products, then, in lieu of royalties under Section 20.4.3.2(b), PTC shall pay to Roche [**] percent ([**]%) of any such payment received from Foundation; provided , however, that Roche shall not be entitled to any payment under this Section 20.4.3.2 if Foundation’s right to commercialize Products was triggered by Roche’s breach of any of its obligations under this Agreement.
(d) All amounts payable from PTC to Roche under this Section 20.4.3.2 shall be subject to the provisions of Sections 11.5.2, 11.5.3, 11.5.4, 11.5.5, 11.5.6 and Articles 12, 13 and 14, and any defined terms referenced therein, mutatis mutandis . (e) For clarity, nothing in this Section 20.4.3.2 shall modify Foundation’s rights or PTC’s obligations under the SRA or trigger any payment obligation of Foundation to Roche.
20.5 Survival. Article 1 (Definitions), Section 2.2.2 (Termination and Grant-back Provisions), Section 3.4 (Rights Retained by the Parties), Article 12 (Accounting and Reporting), Article 13 (Taxes), Article 14 (Auditing), Section 15.1 (Ownership of Inventions), Article 17 (Indemnification), Article 18 (Disclaimer), Article 19 (Obligation Not to Disclose Confidential Information), Section 20.4 (Consequences of Termination), Section 20.5 (Survival), Article 22 (Miscellaneous) shall survive any expiration or termination of this Agreement for any reason, other than a termination pursuant to Section 20.3.6 (Termination for Delay in Effective Date).