Master Alliance Provisions Guide (MAPGuide)

Visterra – Serum Institute of India, Dengue Fever Therapeutic, License and Collaboration Agreement

  • Intellectual property | Protection of IP

ARTICLE 9. INTELLECTUAL PROPERTY

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9.2. Disclosure of Inventions. Each Party shall promptly disclose to the other Party any invention disclosures, or other similar documents, submitted to it by its employees, agents or independent contractors describing inventions that are either Sole Inventions or Joint Inventions. Further, each Party shall promptly disclose to the other Party all Information relating to Joint Inventions to the extent necessary for the preparation, filing and maintenance of any Joint Patent with respect to such Joint Invention. Each Party shall ensure that its and its Affiliates’ employees, officers, and consultants engaged in the Development or Commercialization of the Product have executed agreements or have existing obligations under applicable Law requiring assignment to such Party or its Affiliate, as applicable, of all inventions made during the course of and as the result of their association with such Party/Affiliate and obligating the individual to maintain as confidential such Party’s Confidential Information as well as confidential information of other parties (including the other Party and its Affiliates) which such individual may receive, to the extent required to support such Party’s obligations under this Agreement.

9.3. Prosecution of Patents.

(a) Visterra Patents.

(i) Subject to Sections 9.3(a)(ii) and 9.3(a)(iii) and below, Visterra shall have the sole right to prepare, file, prosecute and maintain Visterra Patents and Joint Patents (collectively, the “Visterra Prosecuted Patents”). Visterra shall provide SIIL reasonable opportunity to review and comment on such prosecution efforts regarding such Visterra Prosecuted Patents in the Licensed Territory. Visterra shall provide SIIL with a copy of material communications from any patent authority in the Licensed Territory regarding such Visterra Prosecuted Patents, and shall provide drafts of any material filings or responses to be made to such patent authorities a reasonable amount of time in advance of submitting such filings or responses for SIIL’s review and comment. Visterra shall reasonably consider such comments by SIIL and shall include them unless Visterra has a reasonable objection in connection with the prosecution of Visterra Prosecuted Patents in the Licensed Territory.

(ii) The costs and expenses incurred after December 17, 2014, by Visterra in connection with the preparation, filing, prosecution and maintenance of Visterra Patents and Joint Patents under Section 9.3(a)(i) shall be allocated between the Parties as follows: (A) SIIL shall reimburse Visterra for all actual out-of-pocket costs (including reasonable attorneys’ fees) incurred by Visterra in connection with the preparation, filing, prosecution and maintenance of the Visterra Prosecuted Patents in the Licensed Territory and (B) Visterra shall bear all other fees and expenses.

(iii) If Visterra wishes to cease the prosecution or maintenance of any Visterra Prosecuted Patents in the Licensed Territory, it shall notify SIIL to that effect in writing, and SIIL may, at its discretion, assume the rights to the prosecution or maintenance of such Visterra Prosecuted Patents, at SIIL’s sole expense, by informing Visterra in writing within sixty (60) days after receiving such notification from Visterra.

(iv) Except with respect to commercially reasonable actions/inactions taken by Visterra with respect to the filing and maintenance of Joint Patents, if Visterra does not otherwise initiate actions for filing a Joint Patent in the Licensed Territory within [**] days of communication by SIIL or refuses to file the application for grant of a patent for any other reasons, then SIIL may initiate actions at its own cost to file a patent application, in which case, provided that such patent application/Joint Patent does not contain claims specific to the Product, such patent application/Joint Patent will then be a SIIL Patent solely owned and controlled by SIIL.

(b) SIIL Patents. SIIL shall have the sole right to prepare, file, prosecute and maintain SIIL Patents at SIIL’s costs and expense. If SIIL decides to cease the prosecution or maintenance of any SIIL Patents (except to the extent included within the SIIL Manufacturing Technology), it shall notify Visterra in writing sufficiently in advance. Visterra may, at its discretion, assume the rights to the prosecution or maintenance of such SIIL Patents, at Visterra’s sole expense by informing SIIL in writing within sixty(60) days after receiving such notification from SIIL.

(c) Cooperation in Prosecution. Each Party shall provide the other Party all reasonable assistance and cooperation with respect to the assumption of the prosecution and maintenance of Visterra Prosecuted Patents by SIIL or the assumption of the prosecution and maintenance of SIIL Patents by Visterra pursuant to Sections 9.3(a) or 9.3(b), as the case may be, including providing any documents necessary to conduct such activities.

9.4. Infringement of Patents by Third Parties.

(a) Notification. Each Party shall promptly notify the other Party in writing of any existing or threatened infringement of the Visterra Patents or Joint Patents through the Development or Commercialization of a Product in the Field in the Licensed Territory by a Third Party, of which such Party becomes aware, including any certification or the like in the Licensed Territory similar to “patent certification” of 21 U.S.C. §355(b)(2) or 21 U.S.C. §355(j)(2) and of any declaratory judgment, opposition, revocation, or similar action alleging the invalidity, unenforceability or non-infringement of any of the Visterra Patents (collectively “Product Infringement”).

(b) Product Infringement.

(i) For any Product Infringement in the Field in the Licensed Territory, each Party shall share with the other Party all Information available to it regarding such existing or threatened infringement. SIIL shall have the first right, but not the obligation, to bring an appropriate suit or other action against any person or entity engaged in such Product Infringement, subject to Section 9.4(b)(ii) through 9.4(b)(v). If SIIL fails to institute and prosecute an action or proceeding to abate such Product Infringement within a period of [**] days after the first notice under Section 9.4(a), then Visterra shall have the right, but not theobligation to, commence a suit or take action to enforce the applicable Visterra Patent or Joint Patent against such Third Party perpetrating such Product Infringement in the Licensed Territory at its own cost and expense. In this case, SIIL shall take appropriate actions, if any, in order to enable Visterra to commence a suit or take the actions set forth in the preceding sentence.

(ii) Each Party shall provide to the Party enforcing the Visterra Patent or Joint Patent under this Section 9.4(b) reasonable assistance in such enforcement, at such enforcing Party’s request and expense, including joining such action as a party plaintiff if required by applicable Law to pursue such action. If any suit brought by SIIL must be brought in MIT’s name or MIT is joined as a party-plaintiff to any suit brought by SIIL, SIIL shall hold MIT harmless from and indemnify MIT against any costs, expenses or liability that MIT incurs in connection with such action on Visterra’s behalf. The enforcing Party with respect to any action under this Section 9.4(b) shall keep the other Party regularly informed of the status and progress of such enforcement efforts, shall reasonably consider the other Party’s comments on any such efforts, and shall seek consent of the other Party in any important aspects of such enforcement including determination of litigation strategy, filing of important papers to the competent court, which shall not be unreasonably withheld or delayed. If SIIL brings any action under this Section 9.4(b) involving existing or threatened infringement of the MIT Patents, SIIL shall consult with Visterra to seek input from MIT and shall consider the views of MIT regarding the advisability of the proposed action and its effect on the public interest, including without limitation, the availability and accessibility of Products at a reasonable price to people most in need within GAVI-Eligible Countries. Visterra shall cooperate with SIIL in facilitating all correspondence with MIT required under this Section 9.4(b)(ii).

(iii) If SIIL commences a Product Infringement action, it shall bear all internal and out-of-pocket costs and expenses incurred by both Parties in connection with such action. In the event that Visterra commences a Product Infringement action, it shall bear all internal and out-of-pocket costs and expenses incurred by both Parties in connection with such action.

(iv) The Party not bringing an action with respect to Product Infringement under this Section 9.4(b) shall be entitled to separate representation in such matter by counsel of its own choice and at its own expense, but such Party shall at all times cooperate fully with the Party bringing such action.

(v) Notwithstanding anything to the contrary contained herein, MIT shall have the first right to defend any Product Infringement involving a Patent Challenge with respect to the MIT Patents as set forth in Section 7.3 of the MIT Agreement, and Visterra shall consult with and keep SIIL reasonably informed with respect thereto.

(c) Infringement Other Than a Product Infringement. For any and all infringement of any Visterra Patent or Joint Patent other than a Product Infringement in the Field in the Licensed Territory, as between the Parties, Visterra shall have the sole and exclusive right to bring an appropriate suit or other action against any person or entity engaged in such other infringement, in its sole discretion, and as between the Parties shall bear all related expenses and retain all related recoveries.

(d) Settlement. SIIL shall not settle any claim, suit or action that it brought under this Section 9.4 involving Visterra Patents or Joint Patents in any manner that would negatively impact such Visterra Patents or Joint Patents or that would limit or restrict the ability of Visterra to Develop, make, import, use, offer for sale, sell or otherwise Commercialize Products anywhere in the Visterra Territory without the prior written consent of Visterra, which consent shall not be unreasonably withheld, conditioned or delayed. Nothing in this Article 9 shall require Visterra to consent to any settlement that is reasonably anticipated by Visterra to have a substantially adverse impact upon any Visterra Patent or Joint Patent in the Visterra Territory, or to the Development, Manufacture, Commercialization, use, importation, offer for sale or sale of the Product in the Visterra Territory. SIIL shall not enter into any settlement, consent judgment, or other voluntary final disposition of any infringement action involving existing or threatened infringement of the MIT Patents without the prior written consent of MIT. Visterra shall cooperate with SIIL in facilitating all correspondence with MIT required under this Section 9.4(d).

(e) Allocation of Recoveries. If either Party recovers monetary damages from any Third Party in a suit or action brought for a Product Infringement, such recovery shall be allocated first to the reimbursement of any expenses incurred by the Parties in such litigation (including, for this purpose, a reasonable allocation of expenses of internal counsel and any amounts owed to MIT for offsets under Section 7.4 of the MIT Agreement), and any remaining amounts shall be retained by the Party bringing suit, provided that, if SIIL is the Party bringing suit, such remaining amounts shall be included in the Net Sales subject to the royalty payment by SIIL to Visterra under Section 8.3 and; provided, further, that to the extent any such recoveries represent special or punitive damages recovered in a suit or action brought for infringement of the MIT Patents, [**] percent ([**]%) of such special or punitive damages shall be paid to MIT.

9.5. Infringement of Third Party Rights in the Licensed Territory. If any Product used or sold by SIIL or its Affiliates becomes the subject of a Third Party’s claim or assertion of infringement of a Patent granted by a jurisdiction within the Licensed Territory, SIIL shall promptly notify Visterra thereof (an “Infringement Claim”). In the case of any Infringement Claim, the Parties shall promptly, and within fifteen (15) days after written notice from either Party to the other thereof, discuss which Party shall control the response to such Infringement Claim, and if the Parties do not mutually agree upon which Party shall control, the Visterra shall control the defense and response to such Infringement Claim. Upon the request of the Party controlling the response to the Infringement Claim, the other Party shall reasonably cooperate with the controlling Party in the reasonable defense of such Infringement Claim. The other Party shall have the right to consult with the controlling Party concerning any Infringement Claim and to participate in and be represented by independent counsel in any associated litigation. If the Infringement Claim is brought against both Parties, then each Party shall have the right to defend against the Infringement Claim.

9.6. Marking of Products. To the extent commercially feasible and consistent with prevailing business practices, SIIL shall mark, and shall cause its Affiliates to mark, all Products that are Manufactured or sold under this Agreement with the number of each issued patent under the Visterra Patents that applies to such Product.