Provision Language
Definitions
“Joint Patent Rights” shall mean all Patent Rights Covering a Joint Invention.
“PTC Base Patent Rights” shall mean any and all Patent Rights in the Territory that are Controlled by PTC as of the Effective Date and either Cover a Product or relate to the discovery, manufacture, development or commercialization of a Product, said Patent Rights being exhaustively listed in Appendix 1.63 of this Agreement.
“PTC Know-How” shall mean the Know-How that PTC Controls at the Effective Date and during the Agreement Term.
“PTC Patent Rights” shall mean any and all Patent Rights that are Controlled by PTC during the Agreement Term and that either Cover a Product or relate to the discovery, manufacture, development or commercialization of a Product. The term PTC Patent Rights shall include PTC Base Patent Rights.
“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.
7. Governance
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7.9 Joint Operational Teams
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7.9.4 Joint IP Team. The JSC shall form a JIPT consisting of at least [**] from each Party’s patent or legal department. It shall be the responsibility of the JIPT to (i) determine the need to license Third Party Patent Rights that are required or useful for the development and commercialization of Products and, subject to Section 11.5.4, the allocation of costs between the Parties in connection therewith, (ii) serve as a forum for the communication between the Parties regarding the Handling of Patent Rights, including but not limited to, with respect to any Joint Patent Right, determining which Party shall have the first right to Handle such Joint Patent Right, (iii) determine strategy for Handling Patent Rights, (iv) discuss the actual or suspected infringement that is the subject of an Infringement Notice, (v) determine the geographic scope of patent filings, including foreign filing decisions at the end of the priority year, PCT national/regional phase and European validations, and (vi) determine any matter regarding the enforcement or defense of the PTC Patent Rights, Roche Patent Rights or Joint Patent Rights. The JIPT shall meet as required to fulfill its duties as set forth in Sections 11.5.4, 15.5 and 15.8, or as otherwise mutually agreed by the Parties, and shall participate in and report to regular meetings of the JSC as requested by the JSC. The JIPT shall coordinate with Foundation to satisfy Foundation’s right, pursuant to Section 6.2(a) of the SRA to comment and consultation on all filing, prosecution and maintenance activities with respect to any Patent Right that claims or covers any SRA Compound, and shall promptly provide Foundation with copies of all summaries of JIPT meetings that are prepared. If the JIPT is unable to resolve any dispute, or unanimously agree on any other matter before it, then, notwithstanding anything to the contrary in Section 7.9.3, such dispute or other matter shall be referred to the chief patent counsels of each Party or their designees to be resolved by negotiation in good faith as soon as practicable but in no event later than [**] days (or sooner if necessity so dictates) after referral. If the chief patent counsels or their designees are unable to resolve such matter, then Roche shall have final decision- making authority except as to (a) the allocation of costs under clause (i) of this Section 7.9.4, and (b) any Consensus Matter as set forth in Section 7.7.3. For clarity, the authority of the JIPT shall be subject to the rights of Foundation pursuant to Section 6.2(c) of the SRA.
15. Intellectual Property
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15.3 Prosecution of Patent Rights Claiming PTC Inventions. Subject to Section 7.9.4, PTC shall (i) Handle all PTC Patent Rights, (ii) consult with Roche as to the Handling of such PTC Patent Rights, and (iii) furnish to Roche copies of all documents relevant to any such Handling. PTC shall furnish such documents and consult with Roche in sufficient time before any action by PTC is due to allow Roche to provide comments thereon, which comments PTC must consider. At PTC’s reasonable request, Roche shall cooperate in all reasonable ways with the Handling of all PTC Patent Rights. PTC shall not discontinue prosecution or maintenance of any PTC Patent Right (including but not limited to selection of countries for foreign filing or entry into the PCT National Stage) without at least [**] days’ prior written notice to Roche. If PTC decides to discontinue Handling any PTC Patent Right, Roche shall have the option to assume responsibility for Handling such PTC Patent Right and, in such case, except for a change in responsibility for Handling such PTC Patent Right under this Section 15.3, no changes in ownership or licensing terms pertaining to any PTC Patent Right shall occur. For clarity, the rights of the Parties pursuant to this Section 15.3 shall be subject to the rights of Foundation pursuant to Section 6.2(c) of the SRA.
15.4 Prosecution of Patent Rights Claiming Roche Inventions. Subject to Section 7.9.4, Roche shall (i) Handle all Roche Patent Rights, (ii) consult with PTC as to the Handling of such Roche Patent Rights, and (iii) furnish to PTC copies of all documents relevant to any such Handling. Roche shall furnish such documents and consult with PTC in sufficient time before any action by Roche is due to allow PTC to provide comments thereon, which comments Roche must consider. At Roche’s expense and reasonable request, PTC shall cooperate, in all reasonable ways with the Handling of all Roche Patent Rights. Roche shall not discontinue Handling any Roche Patent Right (including but not limited to selection of countries for foreign filing or entry into the PCT National Stage) without at least [**] days’ prior written notice to PTC. If Roche decides to discontinue Handling any Roche Patent Right, PTC shall have the option to assume responsibility for prosecuting and maintaining such Roche Patent Right, at PTC’s sole expense, and in such case, except for a change in responsibility for Handling such Roche Patent Right under this Section 15.4, no changes in ownership or licensing terms pertaining to any Roche Patent Right shall occur. For clarity, the rights of the Parties pursuant to this Section 15.4 shall be subject to the rights of Foundation pursuant to Section 6.2(c) of the SRA.
15.5 Prosecution of Patent Rights Claiming Joint Inventions. On a Joint Invention-by-Joint Invention basis, the JIPT shall determine which Party shall be responsible for Handling each Joint Patent Right with respect to such Joint Invention. Each Party shall keep the other Party informed of the status of all pending applications disclosing the Joint Patent Rights for which it has Handling responsibility, and shall consider in good faith all of the other Party’s comments regarding any aspect of such patent Handling. Neither Party shall discontinue Handling of any Joint Patent Right (including but not limited to selection of countries for foreign filing or entry into the PCT National Stage) without at least [**] days’ prior written notice to the other Party. If a Party decides to discontinue Handling any Joint Patent Right, then the other Party shall have the option to continue to Handle such Joint Patent Right, at such other Party’s sole expense, and in such case, except for the change in responsibility for Handling such Joint Patent Right under this Section 15.5, no changes in ownership or licensing terms pertaining to any Joint Patent Right shall occur.
15.6 Prosecution Costs. Except as otherwise expressly provided hereunder, Roche shall bear all out-of-pocket costs and expenses of Handling PTC Patent Rights, Roche Patent Rights and Joint Patent Rights, and shall reimburse PTC for any such costs PTC incurs in connection therewith within [**] days after receipt of an invoice from PTC therefor.
15.8 Infringement. Each Party shall promptly provide written notice (“Infringement Notice”) to the other Party during the term of this Agreement of any (i) known infringement or suspected infringement by a Third Party of any PTC Patent Right, Roche Patent Right or Joint Patent Right, or (ii) known or suspected unauthorized use or misappropriation by a Third Party of any PTC Know-How, Roche Know-How or Joint Know-How, and shall provide the other Party with all evidence in its possession supporting such infringement or unauthorized use or misappropriation.
As soon as possible after receiving an Infringement Notice, the Parties will convene a meeting of the JIPT at which the JIPT may discuss in good faith all available evidence of such infringement, use or misappropriation, and the appropriate manner of addressing such infringement, use or misappropriation, including without limitation preventing or stopping infringing activities (for example, by seeking a preliminary injunction), preserving the Parties’ rights to past and future damages (for example, by sending a cease and desist letter) defending against declaratory judgment actions with respect thereto, or taking any other action, or no action, as the Parties shall determine. The JIPT shall take into account each Party’s interest in formulating the response, if any, to infringement or threatened infringement of such PTC Patent Rights, Roche Patent Rights, or Joint Patent Rights or known or suspected unauthorized use or misappropriation of such PTC Know-How, Roche Know-How or Joint Know-How, including without limitation the relative merits of patent litigation versus the nature, scope and potential economic consequences of the infringement. Unless otherwise determined by the JIPT, Roche shall have the right initiate a suit or action to address such infringement, use or misappropriation, and shall and shall provide written notice to PTC of its decision (“Suit Notice”) within [**] days after Roche provides or receives the Infringement Notice (“Decision Period”).
If Roche decides to bring a suit or take action, once Roche provides Suit Notice, Roche may immediately commence such suit or take such action. In the event that Roche (i) does not in writing advise PTC within the Decision Period that Roche will commence suit or take action, or (ii) fails to commence suit or take action within a reasonable time after providing Suit Notice, PTC shall thereafter have the right to commence suit or take action in the Territory and shall provide written notice to Roche of any such suit commenced or action taken by PTC.
Upon written request, the Party bringing suit or taking action (“Initiating Party”) shall keep the other Party informed of the status of any such suit or action and shall provide the other Party with copies, to the extent the Initiating Party is lawfully permitted to do so, of all substantive documents or communications filed in such suit or action. The Initiating Party shall have the sole and exclusive right to select counsel for any such suit or action.
The Initiating Party shall, except as provided below, pay all expenses of the suit or action, including without limitation the Initiating Party’s attorneys’ fees and court costs. Any damages, settlement fees or other consideration received as a result of such suit or action shall be allocated as follows:
(a) First, to reimburse the Initiating Party for its costs and, if any remains, to the other Party for any advisory counsel fees and costs; and
(b) Second, the balance, if any, shall be allocated [**] percent ([**]%) to the Initiating Party, and [**] percent ([**]%) to the other Party.
If the Initiating Party believes it is reasonably necessary or desirable to obtain an effective remedy, upon written request the other Party agrees to be joined as a party to the suit or action but shall be under no obligation to participate except to the extent that such participation is required as the result of its being a named party to the suit or action. At the Initiating Party’s written request, the other Party shall offer reasonable assistance to the Initiating Party in connection therewith at no charge to the Initiating Party except for reimbursement of reasonable out-of-pocket expenses incurred by the other Party in rendering such assistance. The other Party shall have the right to participate and be represented in any such suit or action by its own counsel at its own expense.
The Initiating Party may settle, consent to judgment or otherwise voluntarily dispose of the suit or action (“Settlement”) without the written consent of the other Party but only if such Settlement can be achieved without adversely affecting the other Party (including without limitation any of its Patent Rights or Know-How). If a Settlement could adversely affect the other Party, then the written consent of the other Party would be required, which consent shall not be unreasonably withheld.
15.9 Defense. If an action for infringement is commenced against either Party, its licensees or its sub-licensees related to PTC’s conduct of the Research Program within the scope of the Research Plan or the discovery, development, manufacture, use or sale of a Product, then Roche shall defend such action at its own expense, and PTC shall assist and cooperate with Roche, at Roche’s expense, to the extent necessary in the defense of such suit. Roche shall have the right to settle the suit or consent to an adverse judgment thereto, in its sole discretion, so long as such settlement or adverse judgment does not adversely affect the rights of PTC and its Affiliates (including without limitation any Patent Right or Know-How Controlled by any of them). Roche shall assume full responsibility for the payment of any award for damages, or any amount due pursuant to any settlement entered into by it with such Third Party.
If the manufacture, use, importation, offer for sale or sale of any Product pursuant to this Agreement results in any claim, suit or proceeding alleging patent infringement or trade secret misappropriation against PTC or a member of the Roche Group, then PTC or Roche, respectively, shall promptly notify the other Party hereto. The Parties shall cooperate with each other in connection with any such claim, suit or proceeding and shall keep each other reasonably informed of all material developments in connection with any such claim, suit or proceeding.
If a Third Party asserts that Patent Rights owned by or licensed to it are infringed by the development, manufacture, use, importation, offer for sale or sale of Products by a member of the Roche Group, or that its trade secrets were misappropriated in connection with such activity, then Roche shall have the exclusive right and responsibility to resolve any such claim, whether by obtaining a license from such Third Party, by defending against such Third Party’s claims or otherwise, and shall be solely responsible for the defense of any such action, any and all costs incurred in connection with such action (including, without limitation, attorneys’ and expert fees) and all liabilities incurred in connection therewith. Notwithstanding the above, Roche shall not enter into any settlement of any such claim without the prior written consent of PTC if such settlement would require PTC to be subject to an injunction or to make any monetary payment to Roche or any Third Party, or admit any wrongful conduct by PTC or its Affiliates, or would limit or restrict the claims of or admit any invalidity and/or unenforceability of any of the Patent Rights Controlled by PTC, or have any impact on activities outside the Field.
15.10 Common Interest Disclosures. With regard to any information or opinions disclosed pursuant to this Agreement by one Party to each other regarding intellectual property and/or technology owned by Third Parties, the Parties agree that they have a common legal interest in determining whether, and to what extent, Third Party intellectual property rights may affect the conduct of the Research Program and/or the development and/or commercialization of Compounds and/or Products, and have a further common legal interest in defending against any actual or prospective Third Party claims based on allegations of misuse or infringement of intellectual property rights relating to the conduct of the Research Program and/or the development and/or commercialization of Compounds and/or Products. The Parties anticipate that each of them will have legal counsel involved in such determinations. Accordingly, the Parties agree that all such information and materials obtained by PTC and Roche from each other will be used solely for purposes of the Parties’ common legal interests with respect to the conduct of the Agreement. All information and materials will be treated as protected by the attorney-client privilege, the work product privilege, and any other privilege or immunity that may otherwise be applicable. By sharing any such information and materials, neither Party intends to waive or limit any privilege or immunity that may apply to the shared information and materials. Neither Party shall have the authority to waive any privilege or immunity on behalf of the other Party without such other Party’s prior written consent, nor shall the waiver of privilege or immunity resulting from the conduct of one Party be deemed to apply against any other Party.
15.11 Hatch-Waxman. Notwithstanding anything herein to the contrary, should a Party receive a certification for a Product pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417, known as the Hatch-Waxman Act), as amended, or its equivalent in a country other than the US, then such Party shall immediately provide the other Party with a copy of such certification. Roche shall have [**] days after the date on which it receives or provides a copy of such certification to provide written notice to PTC (“ H-W Suit Notice ”) whether Roche will bring suit, at its expense, within a [**] day period after the date of such certification. Should such [**] day period expire without Roche bringing suit or providing such H-W Suit Notice, then PTC shall be free to immediately bring suit in its name. The provisions of Section 15.8 (except for paragraphs 1-3 thereof) shall apply with respect to any such suit.
15.12 Patent Term Extensions. The Parties shall use Commercially Reasonable Efforts to obtain all available patent term extensions, adjustments or restorations, or supplementary protection certificates (“SPCs”, and together with patent term extensions, adjustments and restorations, “Patent Term Extensions”). PTC shall execute such authorizations and other documents and take such other actions as may be reasonably requested by Roche to obtain such Patent Term Extensions, including designating Roche as its agent for such purpose as provided in 35 U.S.C. §156. All filings for such Patent Term Extensions shall be made by Roche; provided , that in the event that Roche elects not to file for a Patent Term Extension, Roche shall (a) promptly inform PTC of its intention not to file and (b) grant PTC the right to file for such Patent Term Extension. Each Party shall execute such authorizations and other documents and take such other actions as may be reasonably requested by the other Party to obtain such extensions. The Parties shall cooperate with each other in gaining patent term restorations, extensions and/or SPCs wherever applicable to PTC Patent Rights, Roche Patent Rights and Joint Patent Rights.