Provision Language
Definitions
“CMC Development” shall mean all research and development activities conducted in respect of the Manufacture of COVID Products, including chemistry, manufacturing and control (CMC), creation of master and working cell banks, test method development and stability testing, process development, manufacturing scale–up, qualification and validation, quality assurance and quality control processes and techniques.
“Development Data” shall mean: (i) CMC Development data (including records of Manufactured batches);(ii) any non–clinical or clinical findings, results and other research data relating to the COVID Products, in any format; and (iii) the formal reports of preclinical toxicology studies and Clinical Studies, such data in each case of (i), (ii) and (iii) required for the Development, Manufacture or Commercialization of the COVID Products, including but not limited to, INDs and other regulatory filings and registration dossiers.
9. Intellectual Property
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9.6 Filing, Prosecution, Maintenance and Defense
9.6.1 CureVac Program Patent Rights. CureVac shall have the first right, but not the obligation, at its sole expense, to file, prosecute, maintain and defend the Patent Rights Covering a CureVac Invention (each, a “CureVac Program Patent Right”) throughout the Territory. At the latest [*****] before filing, CureVac shall give GSK an opportunity to review and comment upon the text of any application with respect to any CureVac Program Patent Right, shall consult with GSK with respect thereto, shall not unreasonably refuse to address any of GSK’s comments and supply GSK with a copy of the application as filed, together with notice of its filing date and serial number. CureVac shall keep GSK reasonably informed, through the IP Sub Committee, of the status of the actual and prospective prosecution, maintenance and defense, including but not limited to any substantive communications with the competent patent offices that may affect the scope of such filings, and CureVac shall to the extent reasonably possible give GSK a timely, prior opportunity to review and comment upon any such substantive communication and shall consult with GSK with respect thereto, and shall not unreasonably refuse to address any of GSK’s comments. Notwithstanding the above, prior to filing any application for a CureVac Invention that may disclose, in part or in full, a GSK Invention, a Joint Product Invention or Joint Other Invention, CureVac shall provide GSK with a copy of the draft application and provide GSK with at least [*****] to review and comment upon the text of such draft application. If GSK notifies CureVac within the above [*****] deadline that GSK has decided to file an application for a GSK Invention, Joint Product Invention or Joint Other Invention, the Parties shall coordinate the filing of the application for a CureVac Invention with the filing of GSK’s application for such GSK Invention, Joint Product Invention or Joint Other Invention so that CureVac’s application and GSK’s application are filed on the same day or otherwise filed in a way that secures and protects each of the Parties’ interest. For the avoidance of doubt, CureVac will not include a GSK Invention, Joint Product Invention or Joint Other Invention in a separate patent claim of a patent application to be filed by CureVac without GSK’s prior written consent. CureVac shall promptly give notice to GSK of the grant, lapse, revocation, surrender or invalidation of any CureVac Program Patent Rights. CureVac shall as soon as reasonably practicable give notice to GSK of any final decision to not file patent applications claiming CureVac Program Patent Rights or to cease prosecution and/or maintenance and/or defense of CureVac Program Patent Rights on a country by country basis and, in such cases, shall permit GSK, in GSK’s sole discretion, to file such patent applications or to continue prosecution or maintenance or defense of such CureVac Program Patent Rights (in which case thereafter they will be deemed a GSK Program Patent Right) at its own expense and in its own name.
9.6.2 GSK Program Patent Rights. GSK shall have the sole right, but not the obligation, at its sole expense, to file, prosecute, maintain and defend the Patent Rights Covering a GSK Invention (each, a “GSK Program Patent Right”) throughout the Territory in good faith consistent with its customary patent policy and its reasonable business judgment and shall consider in good faith the reasonable interests of CureVac in so doing. GSK shall keep CureVac reasonably informed, through the IP Sub–Committee, of the status of the actual and prospective prosecution, maintenance and defense, of all GSK Program Patent Rights. Notwithstanding the above, prior to filing any application for a GSK Invention that may disclose, in part or in full, a CureVac Invention, Joint Product Invention or Joint Other Invention, GSK shall provide CureVac with a copy of the draft application and provide CureVac with at least [*****]to review and comment upon the text of such draft application. If CureVac notifies GSK within the above [*****] deadline that CureVac decides to file an application for a CureVac Invention, the Parties shall coordinate the filing of the application for a GSK Invention with the filing of CureVac’s application for such CureVac Invention so that CureVac’s application and GSK’s application are filed on the same day or otherwise filed in a way that secures and protects each of the Parties’ interest. For the avoidance of doubt, GSK will not include a CureVac Invention, Joint Product Invention or Joint Other Invention in a separate patent claim of a patent application to be filed by GSK without CureVac’s prior written consent. CureVac shall as soon as reasonably practicable give notice to GSK of any desire to cease prosecution and/or maintenance and/or defense of GSK Program Patent Rights on a country by country basis and, in such cases, shall permit CureVac, in CureVac’s sole discretion, to continue prosecution or maintenance or defense of such GSK Program Patent Rights (in which case thereafter they will be deemed a CureVac Program Patent Right) at its own expense and in its own name.
9.7 Joint Patent Rights. GSK shall have the first right, but not the obligation, to file, prosecute, maintain and defend Patent Rights relating to Joint Product Inventions or Joint Other Inventions (“Joint Patent Rights”) throughout the Territory, at its sole expense, and GSK shall give timely notice to CureVac of any final decision to not file patent applications claiming Joint Patent Rights or to cease prosecution and/or maintenance of Joint Patent Rights on a country–by–country basis and, in such cases, shall permit CureVac, in CureVac’s sole discretion, to file such patent applications or to continue prosecution, maintenance or defense of such Joint Patent Rights at its own expense. At the latest [*****] before filing, the prosecuting Party shall give the non–prosecuting Party an opportunity to review and comment upon the text of any application with respect to such Joint Patent Right, shall consult with the non–prosecuting Party with respect thereto, shall not unreasonably refuse to address any of the non–prosecuting Party’s comments and supply the non–prosecuting Party with a copy of the application as filed, together with notice of its filing date and serial number. The prosecuting Party shall keep the non–prosecuting Party reasonably informed of the status of the actual and prospective prosecution, and maintenance, including but not limited to any substantive communications with the competent patent offices that may affect the scope of such filings, and the prosecuting Party shall give the non–prosecuting Party a timely, prior opportunity to review and comment upon any such substantive communication and shall consult with such non–prosecuting Party with respect thereto, and shall not unreasonably refuse to address any of such non–prosecuting Party’s comments.
9.8 Patent Term Extension and Supplementary Protection. The IP Sub Committee shall decide on any patent term extensions, including supplementary protection certificates and any other extensions, including pediatric extensions, for a COVID Product that are now or become available in the future, wherever applicable, in order to secure the optimal protection for the COVID Products available under Applicable Laws. The Party holding the marketing authorization for the COVID Product Covered by any Patent Rights shall have the obligation for applying for any such extension or supplementary protection certificate, and such Party shall keep the other Party fully informed of its efforts to obtain such extension or supplementary protection certificate. The other Party shall provide prompt and reasonable assistance, as requested by the applying Party. GSK shall pay all expenses for obtaining and maintaining any extension or supplementary protection certificate in respect of a COVID Product in the GSK Territory.
9.9 Development Data. Subject to Section 11, the Development Data shall be treated as Confidential Information of the Party or Parties owning it. Each Party may use, and allow its Affiliates to use, the Development Data for the purpose of obtaining adequate protection and prosecution of their respective Know-How and Patent Rights, or as provided for otherwise in accordance with this Agreement, provided that in each case it provides the other Party with prior written notice of its intent to use the Development Data for such purpose. The other Party may, within a reasonable time following receipt of such notice, request the notifying Party to delay the use of the Development Data, in order to safeguard the protection and prosecution of other Know-How and Patent Rights. Following such request, the Parties shall cooperate in good faith to align the protection and prosecution of each Party’s Know-How and Patent Rights. For the avoidance of doubt, the terms and conditions of this Section 9 shall govern the intellectual property rights of the Parties in the Development Data.
9.10 Challenges to CureVac Patent Rights, Patent Rights included in the LNP Technology or GSK Patent Rights. If GSK or any of its Affiliates (directly or indirectly, individually or in association with any other person or entity) intends to challenge the validity of the CureVac Patent Rights or the Patent Rights included in the LNP Technology, or supports a Third Party in the challenge of a CureVac Patent Right or a Patent Right included in the LNP Technology in such legal proceeding, it shall promptly, and in no event later than [*****]prior to initiating such challenge (or such shorter period as required due to a court’s, patent office’s or other filing deadline associated with the relevant triggering event giving rise to the challenge, but in any event not less than [*****]prior to initiating such challenge), notify CureVac hereof. If CureVac or any of its Affiliates (directly or indirectly, individually or in association with any other person or entity) intends to challenge the validity of the GSK Patent Rights in a legal proceeding, or supports a Third Party in the challenge of a GSK Patent Right in such legal proceeding, it shall promptly, and in no event later than [*****]prior to initiating such challenge (or such shorter period as required due to the court or other filing deadline associated with the relevant triggering event giving rise to the challenge, but in any event not less than [*****]prior to initiating such challenge), notify GSK thereof. The Parties, through the IP Sub–Committee, shall promptly discuss any such issue in good faith, including the grant of a freedom to operate license at terms to be negotiated, and, if they cannot find an agreement, escalate the issue to the Executive Officers. If the Executive Officers despite good faith negotiations cannot find a solution, and a CureVac Patent Right or Patent Right within the LNP Technology is not granted or is declared invalid upon a successful challenge by GSK or any of its Affiliates (either alone or with a Third Party), such CureVac Patent Right or Patent Right within the LNP Technology shall be deemed to have been granted or shall be deemed valid until the expiry of regular patent protection for such CureVac Patent Right that would have applied if such CureVac Patent Right or Patent Right within the LNP Technology had been granted or had not been successfully declared invalid for the purposes of Section 1.179 (Valid Claim) and Section 8.3.2 (Royalty Term).
9.11 Challenges to Third Party Patent Rights. If either Party or any of its Affiliates (directly or indirectly, individually or in association with any other person or entity) intends to challenge the validity of any Third Party Patent Rights potentially Covering the Development, Manufacture or Commercialization of a COVID Product (including, but not limited to, any request for, or filing or declaration of, any invalidity proceedings, interference, deviation proceeding, opposition, inter partes review, post–grant review, third party observations or re–examination), it shall, prior to initiating such challenge, notify the other Party through the IP Sub–Committee. The Parties, through the IP Sub–Committee shall discuss the strategy for such challenge. If the Parties agree to pursue a joint challenge, (i) the Parties shall collaborate with respect to such challenge, (ii) the Parties shall [*****], and (iii) the Parties shall [*****] all costs and expenses of such challenge, provided that if the total costs and expenses exceed [*****]. Either Party and its Affiliates shall also be entitled, if agreed by the Parties, or if the IP Sub–Committee does not agree on a joint challenge, without the other Party, to challenge the validity of any Third Party Patent Rights. In this case, the Party bringing the challenge (i) shall have no obligation to consult with the other Party regarding its strategy and (ii) shall bear all the costs and expenses of such challenge.
10. Enforcement And Defense
10.1 Enforcement
10.1.1 Notice. Each Party shall promptly provide the other Party with written notice reasonably detailing any known or alleged infringement by a Third Party of any CureVac Patent Rights, GSK Patent Rights or Joint Patent Rights which competes with the Development, Manufacture or Commercialization of COVID Products in the Territory (collectively “Third Party Infringement”).
10.1.2 GSK Rights. Subject to Section 10.1.3, GSK shall have the primary right to determine and control a course of action designed to curtail a Third Party Infringement in the Field in the Territory at its own expense. GSK shall keep CureVac closely informed as to any legal courses of action it pursues pursuant to this Section 10.1.2, and the Parties shall consult with each other, and agree on strategic decisions and their implementation in connection with such action.
10.1.3 CureVac Rights. On a COVID Product–by–COVID Product basis, for as long as CureVac holds the exclusive right to Commercialize a COVID Product in the CureVac Territory pursuant to Section 6, CureVac shall have the primary right to determine and control a course of action designed to curtail a Third Party Infringement in the Field in the CureVac Territory at its own expense. CureVac shall keep GSK closely informed as to any legal courses of action it pursues pursuant to this Section 10.1.2, and the Parties shall consult with each other, and agree on strategic decisions and their implementation in connection with such action.
10.1.4 Taking over. If the Party having the primary right to enforce its rights against such Third Party Infringement pursuant to Sections 10.1.2 or 10.1.3, respectively, elects not to enforce its rights against such Third Party Infringement or not to further pursue the enforcement of its rights, such Party shall notify the other Party of such decision as soon as reasonably practicable and in any event within [*****]after receipt of the Third Party Infringement notice or after the decision not to further pursue the enforcement of its rights. If after the expiry of the [*****] period (or, if earlier, the date upon which the Party which has the primary right to enforce its rights against such Third Party Infringement provides written notice that it has decided not to or to no longer enforce its rights against such Third Party Infringement), the Party which has the primary right to enforce its rights against such Third Party Infringement has neither obtained a discontinuance of the Third Party Infringement, nor filed suit with regard to such Third Party Infringement, then the other Party shall have the right, but not the obligation, to take action or bring suit with respect to such Third Party Infringement at its own expense.
10.1.5 Collaboration. If such course of action includes litigation, the enforcing Party shall notify the non–enforcing Party of the commencement of that litigation and shall have the right and standing to use and sue in the other Party’s name. Notwithstanding the first sentence of this paragraph, irrespective of which Party brings an action with respect to a Third Party Infringement hereunder, (i) the Parties shall collaborate with respect to such action; (ii) the non–enforcing Party shall have the right, at its own expense, to be represented by independent counsel in any such litigation; and (iii) the Parties shall consult with each other regarding, and agree on strategic decisions and their implementation in connection with such action. Except as set forth otherwise herein, the Party bringing the action shall bear all costs and expenses of such action.
10.1.6 Recoveries. Any recoveries obtained by either Party as a result of any proceeding with regard to a Third Party Infringement (other than any Third Party Infringement of intellectual property rights subsisting in any Pathogen Combination Product) under this Section 10.1 shall be allocated as follows:
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- such recovery shall first be used to reimburse the Party or Parties bringing the action for all reasonable costs incurred in connection with such proceeding;
- the remaining portion of such recovery, if any, shall be [*****] between CureVac and GSK.
In relation to any Pathogen Combination Product: (A) such recovery shall first be used to reimburse each Party for all reasonable costs incurred in connection with such proceeding; (B) such recovery shall then be used to compensate each Party for the respective damages suffered from the Third Party Infringement (in the case of damage suffered by CureVac, as calculated at the Royalty Rate), provided that in the event the remaining portion of the recovery is not sufficient to compensate each Party’s damages, such compensation shall be shared on a pro–rata basis depending on the amount of the respective damages suffered; and (C) the remaining portion of such recovery, if any, shall be equally shared between CureVac and GSK.
10.1.7 Settlements. Neither Party shall settle any claim or demand in any such litigation that materially negatively impacts the other Party’s rights or interests under this Agreement without the prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed. In addition to the foregoing, to the extent any action initiated by GSK involves any infringement of CureVac Patent Rights and/or Joint Patent Rights, as the case may be, and is reasonably likely to relate to technologies other than a COVID Product, GSK will consult with CureVac regarding issues relating to such CureVac Patent Rights, Joint Patent Rights, and/or CureVac’s products and technologies, and the Parties will mutually agree on strategic litigation decisions regarding such issues.
10.1.8 Assistance. The non–enforcing Party shall provide such assistance as the enforcing Party reasonably requests in connection with any action or suit hereunder to prevent or enjoin a Third Party Infringement at its own cost (or the enforcing Party’s cost, in relation to any Pathogen Combination Product). At the request of the enforcing Party, the non–enforcing Party shall provide reasonable assistance to the enforcing Party, at the non–enforcing Party’s expense (or the enforcing Party’s expense, in relation to any Pathogen Combination Product), in connection with such enforcement, including by executing reasonably appropriate documents, and joining as a party to the action. The Parties agree that, irrespective of which Party brings the action or suit pursuant to this Section 10.1, the Parties will update each other as to the status of such actions through the IP Sub–Committee and the enforcing Party will not unreasonably reject comments from the other Party relating to the management of such litigation.
10.2 Defense
10.2.1 Notice. If the Development, Manufacture or Commercialization of any COVID Product in any country in accordance with this Agreement or other activity of either of the Parties pursuant to the Agreement is alleged by a Third Party to infringe a Third Party’s Patent Right, the Party becoming aware of such allegation shall promptly notify the other Party.
10.2.2 Control. CureVac has the first right, but not the obligation, to control any defense of any such claim involving an alleged infringement of Third Party rights by (i) the exploitation or use of the CureVac Technology, where such alleged infringement is allegedly not caused solely by the Development, Manufacturing or the Commercialization of one or more COVID Products or (ii) CureVac’s activities under this Agreement (including Development, Manufacturing or the Commercialization of one or more COVID Products, and the Commercialization of COVID Products in the CureVac Territory), by counsel of its own choice, and the costs of such defense shall be equally shared between the Parties; and GSK may choose to be represented with respect to any such claim at its own expense and by counsel of its own choice. GSK has the first right, but not the obligation, to control any defense of any such claim other than where CureVac has the first right to control the defense of a claim, by counsel of its own choice, and the costs of such defense shall be equally shared between the Parties; and CureVac may choose to be represented with respect to any such claim at its own expense and by counsel of its own choice.