Provision Language
Definitions
“Joint Know-How” shall mean Know-How that is made jointly by the Parties or their Affiliates or their Sublicensees in connection with any activity carried out pursuant to this Agreement.
“Joint Patent Rights” shall mean all Patent Rights Covering a Joint Invention.
“Roche Background Patent Rights” shall mean any and all Patent Rights, excluding the Roche Product Patent Rights and the excluded Patent Rights identified in Appendix 1.72, that are Controlled by Roche during the Agreement Term and either Cover a Product or relate to the discovery, manufacture, development or commercialization of a Product.
“Roche Product Patent Rights” shall mean any and all Patent Rights that are Controlled by Roche during the Agreement Term and that Cover the composition of matter or the method of use of a Product.
2. Foundation Obligations
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2.2 Specific Rights and Obligations
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2.2.2 Termination and Grant-back Provisions. Roche’s rights and licenses from PTC with respect to SRA Reversion Candidates, SRA Development Candidates and SRA Products will terminate upon an SRA Special Termination or PTC’s receipt of an SRA Reversion Notice or SRA Buy-Out Notice and Roche shall be obliged in such circumstances to grant the licenses and rights specified in Section 3 of the Second SRA Amendment and Section 6.1(c)(2) of the SRA (including licenses and rights to (A) all intellectual property that, if developed, acquired or otherwise SRA Controlled by PTC, rather than a member of the Roche Group, would be SRA Company Technology or SRA Data (“SRA Licensee Technology” and “SRA Licensee Data”, respectively) and (B) all SRA INDs, SRA NDAs or similar regulatory filings made or obtained by a member of the Roche Group with respect to the relevant SRA Reversion Candidates, SRA Development Candidates and SRA Products) and perform the activities specified therein in each case as if Roche were PTC. PTC shall use Commercially Reasonable Efforts to keep the SRA in full force and effect and not trigger an SRA Special Termination, SRA Reversion Notice or SRA Buy-Out Notice. For clarity, nothing in this Section 2.2.2 shall be interpreted as limiting PTC’s obligations pursuant to the SRA, including its obligations pursuant to Sections 3.2 and 6.1(c)(2) of the SRA.
20.Term and Termination
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20.2 SRA Special Termination, SRA Reversion Notice and SRA Buy-Out Notice. So that Roche may effectuate the granting of licenses and rights as set forth in Section 2.2.2, PTC will immediately notify Roche about any SRA Special Termination or PTC’s receipt of an SRA Reversion Notice or SRA Buy-Out Notice.
Notwithstanding anything in this Agreement to the contrary, PTC, following consultation with Roche, shall have the right to remedy any omission by Roche relating to Roche’s obligations under this Agreement that PTC reasonably believes is likely, should such omission continue for at least [**] days, to trigger an SRA Special Termination, SRA Reversion Notice, SRA Buy-Out Notice or Foundation’s right to terminate the SRA.
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20.4. Consequences of Termination
20.4.1 Termination by Roche for Convenience; Termination by PTC for Roche Breach, Insolvency Event, Pateny 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.