Prosecution of Patents (a) Licensed [***] Patents, Licensed Product Improvement Patents, and Joint Patents relating to Licensed Products. Except as otherwise provided in this Section 12.3(a), as between the Parties, Takeda shall have the sole right and authority to prepare, file, prosecute and maintain the Licensed [***] Patent, Licensed Product Improvement Patents, and, where relating to Licensed Products, Joint Patents (collectively, the “[***] Patent Prosecution”) on a worldwide basis (including the right to defend in patent office proceedings such as inter partes reviews, post grant reviews and oppositions).Takeda shall bear all costs of preparation, filing, prosecution and maintenance of the [***] Patent Prosecution in the Territory. Provided that Ultragenyx’s rights with respect to the applicable Licensed Product have not terminated, Takeda, upon Ultragenyx’s request, shall provide Ultragenyx a reasonable opportunity to review and comment on material communications from any patent authority in the Territory regarding the [***] Patent Prosecution and drafts of any material filings or responses to be made to such patent authorities in advance of submitting such filings or responses. Takeda shall consider Ultragenyx’s comments regarding such communications and drafts in good faith with a view to maximizing the Patent protection and scope in the Territory in the Ultragenyx Field. If Ultragenyx’s rights with respect to the applicable Licensed Product have not terminated and Takeda determines in its sole discretion to abandon or not maintain any Licensed [***] Patent, Licensed Product Improvement Patent, or, where relating to Licensed Products, Joint Patent that is being prosecuted or maintained by Takeda in the Territory and that is applicable to the in the Ultragenyx Field, then Takeda shall provide Ultragenyx with written notice of such determination within a period of time reasonably necessary to allow Ultragenyx to determine, in its sole discretion, its interest in such Patent(s) (which notice by Takeda shall be given no later than sixty (60) days prior to the final deadline for any pending action or response that may be due with respect to such Patent(s) with the applicable patent authority). If Ultragenyx provides timely written notice expressing its interest in continuing to support such Patent(s), Ultragenyx shall have the right to pursue the filing or support the continued prosecution or maintenance of such Patents and Takeda shall provide to Ultragenyx, subject to reimbursement of Takeda’s out-of-pocket costs, all unpublished patent applications and any other information and documents necessary to permit Ultragenyx to take such action to establish or preserve any such Patents. If Ultragenyx pursues the filing or support of such Patents and Takeda continues to pursue a Licensed [***] Product in the Takeda Field, it shall provide Takeda a reasonable opportunity to review and comment on material communications from any patent authority in the Territory regarding such Patents and drafts of any material filings or responses to be made to such patent authorities in advance of submitting such filings or responses. Ultragenyx shall consider Takeda’s comments regarding such communications and drafts in good faith.
Infringement and Litigation 11.1 Each party shall promptly notify the other in writing in the event that it obtains knowledge of infringing activity by third parties, or is sued or threatened with an infringement suit, in any country in the LICENSED TERRITORY as a result of activities that concern the LICENSED PATENTS, and shall supply the other party with documentation of the infringing activities that it possesses.
11.2 During the TERM of this Agreement:
(a) LICENSEE shall have the first right (but not the obligation) to defend the LICENSED PATENTS against infringement or interference in the FIELD and in the LICENSED TERRITORY by third parties. This right includes bringing any legal action for infringement and defending any counter claim of invalidity or action of a third party for declaratory judgment for non-infringement or non-interference. If, in the reasonable opinion of LICENSEE’s counsel, YALE is required to be a named party to any such suit for standing purposes, LICENSEE may join YALE as a party; provided, however, that (i) YALE shall not be the first named party in any such action, (ii) the pleadings and any public statements about the action shall state that the action is being pursued by LICENSEE and that LICENSEE has joined YALE as a party; and (iii) LICENSEE shall keep YALE reasonably apprised of all developments in any such action. LICENSEE may settle such suits solely in its own name and solely at its own expense and through counsel of its own selection; provided, however, that no settlement shall be entered without YALE’s prior written consent, such consent not to be unreasonably withheld. Without limiting the foregoing, YALE may withhold its consent to any settlement that would in any manner affect the validity, scope or enforceability of any LICENSED PATENT. LICENSEE shall bear the expense of such legal actions. Except for providing reasonable assistance (including joining such actions as described above), at the request and expense of LICENSEE, YALE shall have no obligation regarding the legal actions described in Article 11.2 unless required to participate by law. However, YALE shall have the right to participate in any such action through its own counsel and at its own expense. Any recovery shall first be applied to LICENSEE’s out of pocket expenses and second shall be applied to YALE’s out of pocket expenses, including legal fees. YALE shall recover [***]% of any excess recovery over those expenses.
(b) In the event LICENSEE fails to initiate and pursue or participate in the actions described in Article 11.2(a) or in lieu of such actions to initiate negotiations for a sublicense of the infringer, and the infringement has not otherwise abated, within [***] of notification of infringement from YALE, YALE may, in its sole discretion, convert the LICENSE granted in Article 3 to a non-exclusive license. Additionally, YALE shall have the right to initiate legal action such as that described in Article 11.2(a) at its own expense. If, in the reasonable opinion of YALE’s counsel, LICENSEE is required to be a named party to any such suit for standing purposes, YALE may join LICENSEE as party plaintiff to uphold the LICENSED PATENTS, provided, however, that YALE shall keep LICENSEE reasonably apprised of all developments in any such action. In such case, LICENSEE shall provide reasonable assistance to YALE if requested to do so, at YALE’s expense. YALE may settle such actions solely through its own counsel any recovery shall be retained by YALE. YALE may terminate the LICENSE in the country where such legal action is taken.
(c) In the event LICENSEE is permanently enjoined from exercising its LICENSE under this Agreement pursuant to an infringement action brought by a third party, or if both LICENSEE and YALE elect not to undertake the defense or settlement of a suit alleging infringement for a period of [***] from notice of such suit, then either party shall have the right to terminate this Agreement in the country where the suit was filed with respect to the LICENSED PATENT following [***] written notice to the other party in accordance with the terms of Article 15.
INFRINGEMENT AND PATENT ENFORCEMENT 11.1 The NIH and the Licensee agree to notify each other promptly of each infringement or possible infringement of the Licensed Patent Rights, as well as, any facts which may affect the validity, scope, or enforceability of the Licensed Patent Rights of which either party becomes aware.
11.2 Pursuant to this Agreement and the provisions of 35 U.S.C. Chapter 29, the Licensee may:
(a) bring suit in its own name, at its own expense, and on its own behalf for. infringement of presumably valid claims in the Licensed Patent Rights; Second Amendment of L-164-2013/0 FINAL Aura Biosciences 9-16-15 Model 09-2006 (updated 8-20120 Page 1 of 17
(b) in any suit, enjoin infringement and collect for its use, damages, profits, and awards of whatever nature recoverable for the infringement;
(c) settle any claim or suit for infringement of the Licensed Patent Rights; and
(d) if the Licensee desires to initiate a suit for patent infringement, the Licensee shall notify the NIH in writing. If the NIH does not notify the Licensee of its intent to pursue legal action within ninety (90) days, the Licensee shall be free to initiate suit. The NIH shall have a continuing right to intervene in the suit. The Licensee shall take no action to compel the Government either to initiate or to join in any suit for patent infringement. The Licensee may request the Government to initiate or join in any suit if necessary, to avoid dismissal of the suit. Should the Government be made a party to any suit, the Licensee shall reimburse the Government for any costs, expenses, or fees which the Government incurs as a result of the motion or other action, including all costs incurred by the Government in opposing the motion or other action. In all cases, the Licensee agrees to keep the NIH reasonably apprised of the status and progress of any litigation. Before the Licensee commences an infringement action, the Licensee shall notify the NIH and give careful consideration to the views of the NIH and to any potential effects of the litigation on the public health in deciding whether to bring suit.
11.3 In the event that a declaratory judgment action alleging invalidity or noninfringement of any of the Licensed Patent Rights shall be brought against the Licensee or raised by way of counterclaim or affirmative defense in an infringement suit brought by the Licensee under Paragraph 11.2, pursuant to this Agreement and the provisions of 35 U.S.C. Part 29 or other statutes, the Licensee may:
(a) defend the suit in its own name, at its own expense, and on its own behalf for presumably valid claims in the Licensed Patent Rights;
(b) in any suit, ultimately to enjoin infringement and to collect for its use, damages, profits, and awards of whatever nature recoverable for the infringement;
(c) settle any claim or suit for declaratory judgment involving the Licensed Patent Rights,-provided, however, that the NIH shall have a continuing right to intervene in the suit; and
(d) respond to the legal action within ninety (90) days. The Licensee shall take no action to compel the Government either to initiate or to join in any declaratory judgment action. The Licensee may request the Government to initiate or to join any suit if necessary, to avoid dismissal of the suit. Should the Government be made a party to any suit by motion or any other action of the Licensee, the Licensee shall reimburse the Government for any costs, expenses, or fees, which the Government incurs as a result of the motion or other action. If the Licensee elects not to defend against the declaratory judgment action, the NIH, at its option, may do so at its own expense. In all cases, the Licensee agrees to keep the NIH reasonably apprised of the status and progress of any litigation. Before the Licensee commences an infringement action, the Licensee shall notify the NIH and give careful consideration to the views of the NIH and to any potential effects of the litigation on the public health in deciding whether to bring suit.
11.4 In any action under Paragraphs 11.2 or 11.3, the expenses, including costs, fees, attorney fees, and disbursements, shall be paid by the Licensee. The value of any recovery made by the Licensee, which exceeds the expenses incurred with prosecuting or defending any action therein, through court judgment or settlement, shall be treated as Net Sales and subject to earned royalties. The Licensee shall provide an accounting of any expenses that are deducted from Net Sales under this Paragraph 11.4. Second Amendment of L-164-2013/0 FINAL Aura Biosciences 9-16-15
11.5 The NIH shall cooperate fully with the Licensee in connection with any action under Paragraphs 11.2 or 11.
Prosecution and Maintenance of Patent Rights (a) At the initiative of ProPhase or Licensor, the Parties shall consult in good faith with each other regarding the filing, prosecution, and maintenance of all Licensed Patents. The Licensed Patents shall be diligently filed, prosecuted and maintained by Licensor using reputable counsel. Licensor shall keep ProPhase reasonably informed with regard to the preparation, filing, prosecution, and maintenance of the Licensed Patents, including by providing ProPhase (or its designee) copies of office actions issued from patent offices, proposed responses to such office actions, and any other patent related filings, to be made to such patent authority in the Territory sufficiently in advance of submitting such filings or responses so as to allow for a reasonable opportunity for ProPhase to review and comment thereon. Licensor shall consider in good faith any such comments for incorporation into such draft. Licensor represents that during the Term that (a) all Licensed Patents will be diligently prosecuted in the respective patent offices in the Territory in accordance with applicable laws, rules and regulations, (b) all Licensed Patents will be filed and maintained properly and correctly, (c) Licensor will pay all applicable fees on or before the due date for payment, and (d) all Licensed Patents will identify each and every inventor of the claims thereof as determined in accordance with the laws of the jurisdiction in which such Patent is filed. Prophase shall reimburse Global BioLife for reasonable attorney fees and patent office costs associated with the prosecution and maintenance of the Licensed Patents on a quarterly basis commencing on September 30, 2022.
(b) If, at any time during the Term, the Parties may mutually agree that it is undesirable, as to one or more countries, to file, prosecute or maintain any Licensed Patent, then Global BioLife shall have discretion to refrain from filing, prosecuting and/or maintaining any Licensed Patent or permitting the Licensed Patent to lapse.
(c) The Parties shall cooperate with each other and discuss, in good faith, the Patent Rights within the Licensed Patents Covering the Licensed Compound and Licensed Products to enable Prophase to make filings with Regulatory Authorities, as required or allowed in connection with (A) in the United States, the FDA’s Orange Book and (B) outside the United States, under the national implementations of Article 10.l(a)(iii) of Directive 2001/EC/83 or other international equivalents thereof. Global BioLife shall cooperate with Prophase’s reasonable requests in connection therewith, including meeting any submission deadlines, in each case, to the extent required or permitted by applicable law.
(d) The Parties shall cooperate in obtaining Patent Term Extensions pursuant to 35 U.S.C. § 156 and foreign counterparts and equivalents thereof, including supplementary protection certificates, to the extent such extensions are available with respect to the applicable Patent Rights (“Extension Activities”).
Patent Prosecution 6.1 UNIVERSITY has or shall apply for and seek prompt issuance of and maintain during the term of this Agreement the PATENT RIGHTS in the United States and in such foreign countries as may be designated by LICENSEE in a written notice to UNIVERSITY within a reasonable time in advance of the required foreign filing dates. LICENSEE shall have the opportunity to advise and cooperate with UNIVERSITY in the prosecution, filing and maintenance of such patents. If UNIVERSITY decides to abandon the preparation, filing, prosecution or maintenance of any patent or patent application covered by the PATENT RIGHTS, then UNIVERSITY shall provide written notice to LICENSEE, and LICENSEE shall have the right at its sole expense to assume control of the preparation, filing, prosecution and maintenance of such patent application or patent. If LICENSEE no longer wishes to support the prosecution or maintenance of any patent or patent application covered by the PATENT RIGHTS, then LICENSEE shall provide written notice to UNIVERSITY, and LICENSEE shall not be responsible for such corresponding patent expenses that are incurred subsequent to the date of receipt by UNIVERSITY of such written notice by LICENSEE; such returned patent or patent application shall be excluded from the PATENT RIGHTS. LICENSEE shall notify UNIVERSITY immediately if, at any time during the term of this Agreement, LICENSEE or any of its sublicensees does not qualify as a “Small Entity” as provided by the United States Patent and Trademark Office.
6.2 All fees and costs including attorneys’ fees relating to the filing, prosecution and maintenance of the PATENT RIGHTS whether incurred prior to or after the EFFECTIVE DATE of this Agreement shall be the responsibility of LICENSEE. LICENSEE shall not be required to reimburse the UNIVERSITY for any fees under this section that have been paid to the UNIVERSITY by prior licensees or any other third party. Fees and costs shall be paid by LICENSEE within thirty (30) days after receipt of UNIVERSITY’S invoice therefore. Payments pursuant to this Section 6.2 are not creditable against royalties.
6.3 LICENSEE shall own any new patent application, and any patent that issues therefrom, or new technology in the SLE FIELD developed independently of the UNIVERSITY and UNIVERSITY employees and shall not owe the UNIVERSITY any fee or royalty under section 4 relating to such a new patent application, and any patent that issues therefrom, or new technology.
Prosecution and Maintenance of Patents (a) Subject to any Adolor third party agreements, Adolor shall prepare, file prosecute and maintain in the Territory and at its own costs, upon consultation with Santen, the Adolor Patents and any jointly owned patents. Adolor shall notify Santen of the status of all patent filings (including, without limitation, the grant of any Adolor Patents) and, upon the request of Santen, shall provide advance copies of any papers relating to the filing, prosecution, or maintenance of such Adolor Patents. For Adolor Patents and patent applications, and for jointly owned patents and patent applications, Santen shall reimburse Adolor for one-half of any and all costs for the filing, prosecution, or maintenance of such patents and patent applications incurred by Adolor. Adolor shall submit an invoice for reimbursement of such patent costs to Santen and Santen shall pay such invoice within thirty (30) days of submission by Adolor. Santen shall have the right to audit the patent costs subject to reimbursement once per year. Such audit rights shall expire twenty- four (24) months after an invoice is submitted by Adolor for payment.
(b) Subject to Section 8.04 (b), all amounts for patent applications paid by Santen under Section 8.02
(a) for each country of the Territory shall be creditable on a country-by-country basis against future Royalties payable to Adolor by Santen for each such country; provided, however, that no more than **% of the Royalties payable for any period in such country shall be paid by crediting amounts paid by Santen under Section 8.02(a), and further **=Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. provided that Santen may carry forward all amounts paid under Section 8.02(a) for crediting against future Royalties in such country under this Section 8.02(b) until such amounts are exhausted.
Claims relating to Intellectual Property Rights 29.1. The Contractor must not infringe any Intellectual Property Rights of any third party in providing the Services or otherwise performing its obligations under the Framework Agreement and must ensure that the provision of the Services and the use or possession of the Deliverables does not infringe such Intellectual Property Rights.
29.2. The Contractor must promptly notify the Authority if any claim or demand is made or action brought against the Contractor for infringement or alleged infringement of any Intellectual Property Right which may affect the use or possession of the Deliverables or which may affect the provision of the Services.
29.3. Where a claim to which this clause applies is made, the Contractor must, at its expense, use its best endeavours to:
29.3.1. modify the Services or Deliverables or substitute alternative Services or Deliverables (in any case without reducing performance or functionality) so as to avoid the infringement or alleged infringement of the Intellectual Property Rights; or
29.3.2. procure the grant of a licence or licences from the pursuer, claimant or complainer, on terms acceptable to the Authority, so as to avoid the infringement or alleged infringement of the Intellectual Property Rights of the pursuer, claimant or complainer.
29.4. The Contractor must not without the consent of the Authority make any admissions which may be prejudicial to the defence or settlement of any claim to which this clause applies.
Defense of Infringement Claims In the event Licensee or Licensor becomes aware that Licensee’s or any of its Affiliates’ or any Sublicensees’ practice of the Licensed Patents is the subject of a claim for patent infringement by a Third Party, that Party shall promptly notify the other, and the Parties shall consider the claim and the most appropriate action to take. Licensee shall cause each of its Affiliates and each Sublicensee to notify Licensee promptly in the event such entity becomes aware that its practice of the Licensed Patents is the subject of a claim of patent infringement by another. To the extent Licensor takes any action, Licensor (or the ReGenX Licensors) shall have the right to require Licensee’s reasonable cooperation in any such suit, upon written notice to Licensee; and Licensee shall have the obligation to participate upon Licensor’s request, in which event, Licensor shall bear the cost of Licensee’s participation. Without Licensor’s prior written permission, Licensee must not settle or compromise any such suit in a manner that imposes any material obligations or restrictions on Licensor or the ReGenX Licensors or grants any rights to the Licensed Patents other than rights that Licensee has the right to grant under this Agreement.
Infringement Proceedings Each Party agrees to promptly notify the other Party of any unauthorized use of the other Party's Marks of which it has actual knowledge. Each Party will have the sole right and discretion to bring proceedings alleging infringement of its Marks or unfair competition related thereto; provided, however, that each Party agrees to provide the other Party with its reasonable cooperation and assistance with respect to any such infringement proceedings.
Patent Prosecution and Maintenance 14.1 REGENTS will diligently prosecute and maintain the United States and foreign patent applications and patents under REGENTS' PATENT RIGHTS, subject to LICENSEE’S reimbursement REGENTS’ out of pocket costs under Paragraph 14.3 below, and all patent applications and patents under REGENTS’ PATENT RIGHTS will be held in the name of REGENTS. REGENTS will have sole responsibility for retaining and instructing patent counsel, but continued use of such counsel at any point in the patent prosecution process subsequent to initial filing of a U.S. patent application covering the INVENTION shall be subject to the approval of LICENSEE. If LICENSEE rejects three of REGENTS’ choice of prosecution counsel, then REGENTS may select new prosecution counsel without LICENSEE’s consent. REGENTS shall promptly provide LICENSEE with copies of all relevant documentation so that LICENSEE may be currently informed and apprised of the continuing prosecution and LICENSEE agrees to keep this documentation confidential in accordance with Article 26. LICENSEE may comment upon such documentation, provided, however, that if LICENSEE has not commented upon such documentation in reasonable time for REGENTS to sufficiently consider LICENSEE’s comments prior to the deadline for filing a response with the relevant government patent office, REGENTS will be free to respond appropriately without consideration of LICENSEE's comments. LICENSEE and LICENSEE's patent counsel will have the right to consult with patent counsel chosen by REGENTS.
14.2 REGENTS will use reasonable efforts to prepare or amend any patent application to include claims reasonably requested by LICENSEE to protect the LICENSED PRODUCTS contemplated to be SOLD or to be practiced under this AGREEMENT.
14.3 Subject to Paragraphs 14.4 all past, present, and future costs for preparing, filing, prosecuting, and maintaining all United States and foreign patent applications, and patents under REGENTS’ PATENT RIGHTS will be borne by LICENSEE, so long as the licenses granted to LICENSEE herein are exclusive. Payments are due within thirty (30) days after receipt of invoice from REGENTS. If, however, REGENTS reduces the exclusive licenses granted herein to non-exclusive licenses pursuant to Paragraphs 7.3, 7.4, or 7.5 and REGENTS grants additional license(s), the costs of preparing, filing, prosecuting and maintaining such patent applications and patents will be divided equally among the licensed parties from the effective date of each subsequently granted license AGREEMENT.
14.4 LICENSEE's obligation to underwrite and to pay all domestic and foreign patent filing, prosecution, and maintenance costs will continue for so long as this AGREEMENT remains in effect, provided, however, that LICENSEE may terminate its obligations with respect to any given patent application or patent in any or all designated countries upon three (3) months’ written notice to REGENTS. REGENTS will use its best efforts to curtail patent costs when such a notice is received from LICENSEE. REGENTS may continue prosecution and/or maintenance of such applications or patents at its sole discretion and expense; provided, however, that LICENSEE will have no further right or licenses thereunder.
