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• Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death |
• Neuroleptic malignant syndrome (NMS): Call your healthcare provider or go to the nearest hospital emergency room right away if you have high fever, stiff muscles, confusion, increased sweating, or changes in breathing, heart rate, and blood pressure. These can be symptoms of a rare but potentially fatal side effect c... |
• Uncontrolled body movements (tardive dyskinesia or TD): VRAYLAR may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking VRAYLAR. Tardive dyskinesia may also start after you stop taking VRAYLAR |
• Late-occurring side effects: VRAYLAR stays in your body for a long time. Some side effects may not happen right away and can start a few weeks after starting VRAYLAR, or if your dose increases. Your healthcare provider should monitor you for side effects for several weeks after starting or increasing dose of VRAYLAR |
• Problems with your metabolism, such as: ■ High blood sugar and diabetes: Increases in blood sugar can happen in some people who take VRAYLAR. Extremely high blood sugar can lead to coma or death. Your healthcare provider should check your blood sugar before or soon after starting VRAYLAR and regularly during treatmen... |
• Low white blood cell count: Low white blood cell counts have been reported with antipsychotic drugs, including VRAYLAR. This may increase your risk of infection. Very low white blood cell counts, which can be fatal, have been reported with other antipsychotics. Your healthcare provider may do blood tests during the f... |
• Decreased blood pressure (orthostatic hypotension): You may feel lightheaded or faint when you rise too quickly from a sitting or lying position |
• Falls: VRAYLAR may make you sleepy or dizzy, may cause a decrease in blood pressure when changing position (orthostatic hypotension), and can slow thinking and motor skills, which may lead to falls that can cause fractures or other injuries |
• Seizures (convulsions) |
• Impaired judgment, thinking, and motor skills: Do NOT drive, operate machinery, or do other dangerous activities until you know how VRAYLAR affects you. VRAYLAR may make you drowsy |
• Increased body temperature: Do not become too hot or dehydrated during VRAYLAR treatment. Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water |
• Difficulty swallowing that can cause food or liquid to get into your lungs |
Who should not take VRAYLAR? Do not take VRAYLAR if you are allergic to any of its ingredients. Get emergency medical help if you are having an allergic reaction (eg, rash, itching, hives, swelling of the tongue, lip, face or throat). |
What should I tell my healthcare provider before taking VRAYLAR? Tell your healthcare provider about any medical conditions and if you: • have or have had heart problems or a stroke • have or have had low or high blood pressure • have or have had diabetes or high blood sugar in you or your family • have or have had hig... |
Tell your healthcare provider about all medicines that you take, including prescriptions, over-the-counter medicines, vitamins, and supplements. VRAYLAR may affect the way other medicines work, and other medicines may affect how VRAYLAR works. Do not start or stop any medicines while taking VRAYLAR without talking to y... |
What are the most common side effects of VRAYLAR? The most common side effects were difficulty moving or slow movements, tremors, uncontrolled body movements, restlessness and feeling like you need to move around, sleepiness, nausea, vomiting, and indigestion. |
These are not all possible side effects of VRAYLAR. |
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088. |
If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more. |
Please click here for Full Prescribing Information and Medication Guide for VRAYLAR. |
Globally, prescribing information varies; refer to the individual country product label for complete information. |
References: |
1. VRAYLAR (cariprazine) [package insert]. Madison, NJ: Allergan USA, Inc. |
Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking sta... |
### |
AbbVie Media: Frank Benenati +1 (847) 938-8745 Frank.Benenati@abbvie.com |
Richter Media: Zsuzsa Beke +36 1 431 4888 zs.beke@richter.hu |
AbbVie Investors: Liz Shea +1 (847) 935-2211 Liz.Shea@abbvie.com |
Richter Investors: Katalin Ördög +36 1 431 5680 k.ordog@richter.hu |
Schedule 10.2.1 |
Existing Patents |
None. |
Part A: Owned Patents |
None. |
Part B: In-Licensed Patents |
None. |
Schedule 12.9.1 |
Reversion Royalties Dispute Resolution |
"Royalty Dispute" means any dispute regarding the royalty rates for the licenses granted to Richter by AbbVie in Section 12.7.1(c) or Section 12.8(b) that have not been resolved by good faith negotiation and consultation between the Parties and have been referred for resolution under this Schedule 12.9.1 as set forth i... |
1. Referral to Executive Officers. All Royalty Disputes will first be referred to the Executive Officers for attempted resolution by good faith negotiation within thirty (30) days after receiving written notification of referral of such Royalty Dispute or such longer period of time as the Executive Officers may agree i... |
2. Final Offer. If the Executive Officers are unable to resolve a Royalty Dispute in accordance with paragraph 1, then each Party will (a) prepare a proposal of the royalty rates for the licenses granted to AbbVie to Richter under in Section 12.7.1(c) or Section 12.8(b), as applicable, to be considered by a Valuation E... |
3. Valuation Expert. If the Parties are unable to agree within the fifteen (15)-day period set forth above in paragraph 2 of this Schedule 12.9.1, then, upon written notice of a Party (a "Valuation Notice"), the Parties will engage one (1) independent, impartial and neutral Third Party valuation expert (a "Valuation Ex... |
4. Selection of One Final Offer. Within thirty (30) days after appointment of the Valuation Expert, each Party will deliver to the Valuation Expert and the other Party a copy of such Party's Final Offer for the applicable Royalty Dispute, which Final Offer will be identical to the Final Offer previously shared with the... |
summary explaining why its Final Offer is appropriate. The Valuation Expert will be instructed to review each Final Offer and summary proposed by each of the Parties within sixty (60) days following the receipt of the latter of such Final Offers and to select without modification the Final Offer that they determine mos... |
5. Fees for Arbitration. The fees for the Valuation Expert will be borne by the Party whose Final Offer is not selected by the Valuation Expert. |
6. Confidentiality of Proceedings. Except as set forth below, the Parties will keep confidential the engagement of the Valuation Expert, the dispute being resolved, and the decision of the Valuation Expert. Notwithstanding the foregoing, the Parties may disclose information about the proceeding to persons who have a ne... |
Schedule 13.7.3 |
ADR Procedures |
Any Dispute referred to ADR under this Agreement shall be resolved as follows: |
1. To begin an ADR proceeding, a Party shall provide written notice to the other Party of the Dispute to be resolved by ADR. Within fourteen (14) days after such notice is given, the other Party may, by written notice to the Party initiating the arbitration, add additional issues to be resolved within the same ADR. |
2. Within twenty-one (21) days following the initiation of the ADR proceeding, the Parties shall select a mutually acceptable independent, impartial and conflicts-free neutral to preside in the resolution of all issues in this ADR proceeding. If the Parties are unable to agree on a mutually acceptable neutral within su... |
3. No earlier than twenty-eight (28) days or later than fifty-six (56) days after selection, the Neutral shall hold a hearing to resolve each of the issues identified by the Parties. The ADR proceeding shall take place at a location agreed upon by the Parties. If the Parties cannot agree, the Neutral shall designate a ... |
4. At least seven (7) days prior to the 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) a list of any witnesses such Party intends to call at the hearing, and a short summary of the anticipated testimony of each witness; |
(c) a proposed ruling on each issue to be resolved, together with a request for a specific damage award, set of actions to be taken to cure the other Party's breach, or other remedy for each issue; such remedies being cumulative and not exclusive. The proposed ruling shall not contain any recitation of the facts, and t... |
(d) a brief in support of such Party's proposed rulings and remedies; provided, that the brief shall not exceed thirty (30) pages. This page limitation shall apply regardless of the number of issues raised in the ADR proceeding. |
Except as expressly set forth in subparagraphs 4(a) - 4(d), no discovery shall be required or permitted by any means, including depositions, interrogatories, requests for admissions, or production of documents. |
5. The hearing shall be conducted on two (2) consecutive days and shall be governed by the following rules: |
(a) Each Party shall be entitled to five (5) hours of hearing time to present its case. The Neutral shall determine whether each Party has had the five (5) hours to which it is entitled. |
(b) Each Party shall 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 shall occur immediately after their direct testimony, and cross-examinatio... |
(c) The Party initiating the ADR shall begin the hearing and, if it chooses to make an opening statement, shall address therein not only issues it raised but also any issues raised by the responding Party. The responding Party, if it chooses to make an opening statement, also shall address all issues raised in the ADR.... |
(d) Except when testifying, witnesses shall be excluded from the hearing until closing arguments. |
(e) Settlement negotiations, including any statements made therein, shall not be admissible under any circumstances. Affidavits prepared for purposes of the ADR hearing shall be admissible. As to all other matters, the Neutral shall follow the Federal Rules of Evidence then-applicable in the United States of America. |
6. Within seven (7) 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, including without limitation actions to be taken to cure the breach; provided, that such brief shall not contain or discuss any new... |
7. The Neutral shall rule on each disputed issue within fourteen (14) days following completion of the hearing. Such ruling shall adopt in its entirety the proposed ruling and remedy of one (1) of the Parties on each disputed issue but may adopt one (1) Party's proposed rulings and remedies on some issues and the other... |
remedies on other issues. The Neutral shall not issue any written opinion or otherwise explain the basis of the ruling. |
8. The Neutral shall be paid a reasonable fee plus expenses. These fees and expenses, 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, shall be paid as follows: |
(a) If the Neutral rules in favor of one (1) Party on all disputed issues in the ADR, the losing Party shall 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 shall issue with the rulings a written determination as to how such fees and expenses shall be allocated between the Parties. The Neutral shall allocate fees and expenses in a way that bears a reasonable r... |
9. The rulings of the Neutral and the allocation of fees and expenses shall be binding, non-reviewable, and non-appealable, and may be entered as a final judgment in the Courts of the State of New York, New York County, or, if it has or may acquire subject matter jurisdiction, the United States District Court for the S... |
10. Except as provided in paragraph 9 or as required by law, the existence of the Dispute, any settlement negotiations, the ADR proceeding, any submissions (including exhibits, testimony, proposed rulings, and briefs), and the rulings shall be deemed to be Confidential Information of both Parties. The Neutral shall hav... |
11. All ADR proceedings shall be conducted in the English language. |
12. Each Party shall have the right to be represented by counsel in all aspects of any ADR proceeding. |
EXECUTION VERSION |
AMENDED AND RESTATED COLLABORATION AND OPTION AGREEMENT |
between |
CAPSIDA BIOTHERAPEUTICS, INC. |
and |
ABBVIE GLOBAL ENTERPRISES LTD. |
Dated as of February 17, 2023 |
TABLE OF CONTENTS |
Page |
ARTICLE 1 DEFINITIONS ........................................................................................................... 2 |
ARTICLE 2 RESEARCH PROGRAM ........................................................................................ 42 |
2.1 General. ................................................................................................................. 42 |
2.2 Research Plans. ..................................................................................................... 43 |
2.3 Capsid Generation, Optimization and Screening. ................................................. 44 |
2.4 AbbVie Materials. ................................................................................................. 50 |
2.5 Program Activities and Efforts. ............................................................................ 50 |
2.6 Performance of Research Program and other Activities. ...................................... 51 |
2.7 Research Program Costs. ...................................................................................... 52 |
2.8 Transferred Materials. ........................................................................................... 53 |
2.9 No Guarantee. ....................................................................................................... 53 |
2.10 Specific Performance. ........................................................................................... 53 |
ARTICLE 2A OPHTHALMOLOGY RESEARCH PROGRAM ................................................ 53 |
2.11 General. ................................................................................................................. 53 |
2.12 Ophthalmology Research Plan. ............................................................................. 55 |
2.13 Ophthalmology Research Program Activities. ..................................................... 56 |
2.14 Target Selection. ................................................................................................... 64 |
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