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Schedule 10.2.1 |
Existing Patents |
Part A: Owned Patents |
[Table listing Application No., Country, Title, Category, and Inventor(s) for multiple patents] |
Part B: In-Licensed Patents |
None |
Schedule 12.8.1(f) |
Enforcement and Defense of AbbVie Grantback Patents |
The following Sections of this Schedule 12.8.1(f) shall apply only with respect to AbbVie Grantback Patents that are both (a) exclusively licensed to Licensor pursuant to Section 12.8.1(c) and (b) solely cover either (i) the Terminated Products and Terminated Antibodies as they exist as of the effective date of termina... |
A. Enforcement of Patents. |
1. Enforcement of AbbVie Grantback Patents. Each Party shall promptly notify the other Party in writing of any alleged, threatened or actual infringement of the AbbVie Grantback Patents by a Third Party in the Territory of which such Party becomes aware (including alleged, threatened or actual infringement based on the... |
2. Conduct of Patent Litigation Under the Biologics Price Competition and Innovation Act. If either Party receives a copy of an application submitted to the FDA under subsection (k) of Section 351 of the PHSA or equivalent in any other jurisdiction in the Territory (a "Biosimilar Application") naming a Terminated Produ... |
3. Cooperation. The Parties agree to cooperate fully in any infringement action pursuant to this Schedule 12.8.1(f). Where a Party brings such an action, the other Party shall, where necessary, furnish a power of attorney solely for such purpose or shall join in, or be named as a necessary party to, such action. Unless... |
4. Recovery. Except as otherwise agreed by the Parties in connection with a cost sharing arrangement, any recovery realized as a result of litigation described in Sections 1 and 2 above (whether by way of settlement or otherwise) shall be first, allocated to reimburse the Parties for their costs and expenses in making ... |
B. Infringement Claims by Third Parties. If the manufacture, sale, or use of a Terminated Antibody or Terminated Product in the Territory pursuant to this Agreement results in, or may result in, any claim, suit, or proceeding by a Third Party alleging patent infringement by Licensor (or its Affiliates or sublicensees),... |
C. Invalidity or Unenforceability Defenses or Actions. |
1. Notice. Each Party shall promptly notify the other Party in writing of any alleged or threatened assertion of invalidity or unenforceability of any AbbVie Grantback Patents by a Third Party in the Territory and of which such Party becomes aware. |
2. Right to Defend. Licensor shall have the first right, but not the obligation, to defend and control the defense of the validity and enforceability at its own expense of any AbbVie Grantback Patents that are subject to the exclusive license granted to Licensor under Section 12.8.1(c) in the Territory. AbbVie may part... |
3. Cooperation. Each Party shall assist and cooperate with the other Party as such other Party may reasonably request from time to time in connection with its activities set forth in this Section C of this Schedule 12.8.1(f) including by being joined as a party plaintiff in such action or proceeding, providing access t... |
Schedule 13.7.3 |
ADR Procedures |
Except as otherwise expressly provided in Section 13.7, any Dispute referred to ADR under this Agreement shall be resolved as follows: |
1. The arbitration shall be administered by the International Centre for Dispute Resolution in accordance with its then-current International Arbitration Rules as modified herein. For the avoidance of doubt, to the extent there is an inconsistency between the terms and procedures set forth in this Schedule 13.7.3 and t... |
2. Within twenty-one (21) days after commencement of the arbitration, the other Party shall submit its Answer to the Notice of Arbitration, including any counterclaims or additional issues to be resolved within the arbitration. |
3. Within twenty-one (21) days following the initiation of the arbitration proceeding, the Parties will select a mutually acceptable independent, impartial and conflicts-free neutral to preside in the resolution of all issues in this arbitration proceeding. If the Parties are unable to agree on a mutually acceptable ne... |
4. After the Neutral is appointed, at the earliest convenient date (not to exceed fourteen (14) days after the Neutral's appointment), the Neutral shall convene a preliminary conference with parties to fix the schedule for the arbitration and determine the discovery that shall take place. Discovery is to be completed w... |
5. Each Party shall be entitled to ten (10) document requests, one (1) expert deposition, and two (2) depositions of the opposing Party. Additional discovery shall be at the discretion of the Neutral subject to the limits specified below, where, (i) with respect to document requests, the document requests are reasonabl... |
6. Within five (5) days of the service of document requests, the Parties shall agree to defined search terms in order to search for responsive electronic documents as efficiently and economically as possible. If the Parties cannot agree to such search terms, the Neutral shall meet with the Parties within five (5) days ... |
7. The Neutral does not have the power to appoint its own independent expert. |
8. At least twenty (20) days prior to the evidentiary hearing, each Party shall submit the following to the other Party and the Neutral: |
(a) a copy of all exhibits on which such Party intends to rely in any oral or written presentation to the Neutral; |
(b) the entire direct examination (testimony under oath) in writing of any individuals expected to be called as fact witnesses (it being understood that in the hearing, direct testimony of fact witnesses will be limited to a brief summary of such testimony, followed by cross examination and re-direct examination of suc... |
(c) a proposed ruling on each issue to be resolved, together with a request for a specific damage award or other remedy for each issue. The proposed ruling shall not contain any recitation of the facts or any legal arguments, and the proposed remedy shall not include any punitive damages. The proposed ruling and the pr... |
(d) a brief in support of such Party's proposed rulings and remedies; provided that the brief will not exceed twenty-five (25) pages, provided that the Neutral may reasonably expand the page limit if it determines the number and complexity of issues warrant it. |
9. The hearing will be conducted on no more than five (5) consecutive days, unless the Neutral determines that the number of witnesses warrants additional hearing days, but in no event shall the hearing exceed an additional four (4) days. The hearing and will be governed by the following rules: |
(a) The Parties shall each receive equal time, using the chess clock approach. For illustrative purposes only, assuming a five (5) hour long hearing day and five (5) days of hearing, each Party will be entitled to twelve-and-on-half (12.5) hours of hearing time to present its case. The Neutral shall determine whether e... |
(b) Each Party will be entitled, but not required, to make an opening statement, to present regular and rebuttal testimony, documents, or other evidence, to cross-examine witnesses, and to make a closing argument. Cross-examination of witnesses will occur immediately after their direct testimony and cross-examination t... |
(c) Except when testifying, fact witnesses will be excluded from the hearing until closing arguments, unless otherwise agreed by the Parties. |
(d) Settlement negotiations, including any statements made therein, will not be admissible under any circumstances. As to all other matters, the Neutral will have sole discretion regarding the admissibility of any evidence. |
10. Within twenty (20) days following completion of the hearing, each Party may submit to the other Party and the Neutral a post-hearing brief in support of its proposed rulings and remedies; provided that such brief will not contain or discuss any new evidence and will not exceed twenty (20) pages; provided further th... |
11. Unless otherwise agreed by the Parties, the Neutral will issue an award on each disputed issue within thirty (30) days following completion of the hearing or the submission of post-hearing briefs, if any. Such ruling will adopt in its entirety the proposed ruling and remedy of one (1) of the Parties on each dispute... |
12. If the Neutral allows or if the Parties mutually agree upon extensions of the foregoing deadlines, such extensions will not render the award invalid, unenforceable or subject to being vacated. The Neutral, however, may impose appropriate sanctions and draw appropriate adverse inferences against a Party responsible ... |
13. The fees and expenses of the Neutral and the ICDR administrative fees, along with the reasonable legal fees and expenses of the prevailing Party (including all expert witness fees and expenses), the fees and expenses of a court reporter, and any expenses for a hearing room, will be fixed in the award as follows: |
(a) If the Neutral rules in favor of one (1) Party on all disputed issues in the arbitration, the losing Party will pay one hundred percent (100%) of such fees and expenses. |
(b) If the Neutral rules in favor of one (1) Party on some issues and the other Party on other issues, the Neutral's award will allocate such fees and expenses between the Parties in a way that bears a reasonable relationship to the outcome of the arbitration. |
14. The Neutral's award will be final and binding, non-reviewable, and non-appealable, and judgment on the award may be entered in any court having jurisdiction. |
15. Except as may be required by law or legal proceedings to confirm or enforce the award, the existence of the Dispute, any settlement negotiations, the arbitration proceeding, any submissions (including exhibits, testimony, proposed rulings, and briefs), and the award will be deemed to be Confidential Information of ... |
16. The seat of the arbitration shall be New York, New York and the language of the arbitration shall be English. |
EXECUTION VERSION |
COLLABORATION AND OPTION AGREEMENT |
by and between |
ANIMA BIOTECH INC. |
AND |
ABBVIE GLOBAL ENTERPRISES LTD. |
TABLE OF CONTENTS |
Page |
ARTICLE 1 DEFINITIONS ......................................................................................................................... 1 |
ARTICLE 2 DEVELOPMENT; LICENSE OPTION ................................................................................ 20 |
2.1 Overview .............................................................................................................................. 20 |
2.2 Target Program Slots............................................................................................................ 20 |
2.3 Collaboration Target Substitution ........................................................................................ 20 |
2.4 Gatekeeper ........................................................................................................................... 21 |
2.5 Selection of Available Targets ............................................................................................. 21 |
2.6 Collaboration Plans .............................................................................................................. 22 |
2.7 Conduct of Collaboration Activities .................................................................................... 22 |
2.8 IP Assignment Obligation .................................................................................................... 24 |
2.9 License Option ..................................................................................................................... 24 |
2.10 Conduct of Post-License Option Exercise Activities ........................................................... 25 |
2.11 HSR. ..................................................................................................................................... 25 |
2.12 No Exercise of License Option ............................................................................................ 26 |
ARTICLE 3 MANAGEMENT OF THE COLLABORATION ................................................................. 26 |
3.1 Joint Governance Committee ............................................................................................... 26 |
3.2 Responsibilities .................................................................................................................... 27 |
3.3 Meetings and Minutes .......................................................................................................... 27 |
3.4 Procedural Rules .................................................................................................................. 28 |
3.5 Decision-Making .................................................................................................................. 28 |
3.6 Limits on Decision-Making ................................................................................................. 29 |
3.7 Alliance Managers ............................................................................................................... 29 |
3.8 Discontinuation of Committees ............................................................................................ 29 |
3.9 Interactions Between a Committee and Internal Teams ....................................................... 30 |
3.10 Subcommittees ..................................................................................................................... 30 |
3.11 Expenses ............................................................................................................................... 30 |
3.12 Authority .............................................................................................................................. 30 |
ARTICLE 4 GRANT OF LICENSES ........................................................................................................ 30 |
4.1 Licenses to AbbVie .............................................................................................................. 30 |
4.2 Sublicensing Rights .............................................................................................................. 31 |
4.3 UPenn Rights ....................................................................................................................... 31 |
4.4 No Other Rights ................................................................................................................... 32 |
4.5 Confirmatory Patent License ................................................................................................ 32 |
4.6 In-License Agreements ........................................................................................................ 32 |
4.7 Rights in Bankruptcy............................................................................................................ 32 |
ARTICLE 5 POST-LICENSE OPTION EXERCISE ACTIVITIES .......................................................... 33 |
5.1 Anima Transition Obligation Upon License Option Exercise ............................................. 33 |
5.2 AbbVie Development and Commercialization .................................................................... 33 |
5.3 AbbVie Diligence Obligation .............................................................................................. 33 |
ARTICLE 6 GENERAL PROVISIONS RELATING TO ACTIVITIES .................................................. 34 |
6.1 Compliance .......................................................................................................................... 34 |
6.2 Regulatory Activities ........................................................................................................... 34 |
6.3 Performance by Affiliates and Sublicensees ........................................................................ 34 |
6.4 Subcontracting ..................................................................................................................... 34 |
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