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2. Purchase Price |
Pricing for the supply of a given Licensed Compound will be the cost of goods plus a mark-up of 5%. |
The Parties will collaborate in good faith to implement cost reductions in lieu of price increases. |
If AbbVie can at any time reasonably demonstrate that it will be able to Manufacture the Licensed Compound for a savings of twenty (20%) or more as compared with the supply price under the Richter Supply Agreement, then AbbVie will thereafter have the right to Manufacture up to twenty-five percent (25%) of the total am... |
3. Delivery Terms |
Delivery will be CIP (Incoterms 2020) at a first carrier location requested by AbbVie in accordance with then-current good distribution practices. Title and risk of loss will pass upon delivery at such location. |
4. Payment Terms |
Payment will be net 90 days from AbbVie's receipt and approval of invoice. |
5. Supply Terms |
On a Licensed Compound-by-Licensed Compound basis, no later than six (6) months prior to the anticipated First Commercial Sale for the first Licensed Product containing the Licensed Compound, Richter will establish and maintain a safety stock of the Licensed Compound for AbbVie's exclusive use that is sufficient to mee... |
the safety stock falls below the Minimum Safety Stock, then AbbVie will thereafter have the right to Manufacture up to one hundred (100%) of the total amount of Licensed Compounds required for Commercialization activities in the AbbVie Territory. |
6. Quality Agreement |
Prior to execution of the Richter Supply Agreement, the Parties will prepare and enter into a reasonable and customary quality assurance agreement that will set forth the terms and conditions upon which the parties will conduct their quality activities in connection with the Richter Supply Agreement (the "Quality Agree... |
7. Representations and Warranties |
Richter will represent, warrant and covenant that: (a) it will manufacture and deliver Licensed Compounds in accordance with the relevant Licensed Compounds specifications, which will be part of the Quality Agreement, the Company's Quality System requirements and all applicable law, and will deliver each batch of Licen... |
8. Indemnification |
Richter will indemnify, defend and hold AbbVie, its Affiliates and their employees, directors and officers ("AbbVie Indemnitees"), harmless from and against any and all Third Party claims, liabilities, damages and expenses, including reasonable attorneys fees and costs ("Liabilities"), resulting from or arising out of ... |
AbbVie will indemnify, defend and hold Richter, its Affiliates and their employees, directors and officers ("Richter Indemnitees"), harmless from and against any and all Liabilities resulting from or arising out of AbbVie Indemnitees' (a) gross negligence, recklessness, or willful misconduct; or (b) breach of the Richt... |
9. Term and Termination |
The Richter Supply Agreement will contain customary provisions regarding term and termination, including termination for breach and in the event of an insolvency event, and the consequences of termination or expiration. |
10. Assignment |
Section 13.4 of the Agreement will apply to the Richter Supply Agreement, mutatis mutandis. |
11. Choice of Law and Dispute Resolution |
Sections 13.6 and 13.7 of the Agreement will apply to the Richter Supply Agreement, mutatis mutandis. |
12. Additional Terms |
The Richter Supply Agreement will contain additional terms and conditions relating to commercial supply that are reasonable and customary in pharmaceutical supply agreements, including terms relating to: |
• Confidentiality |
• Data Security |
• Taxes |
• Inspection and acceptance/rejection procedures and remedies |
• Recalls |
• Audit rights (including rights to audit the Minimum Safety Stock levels) |
• Import/export controls and customs |
• Regulatory matters |
• Debarment and exclusion |
• Insurance |
• Force majeure |
Schedule 4.9.2(a) |
Principal Terms of AbbVie Supply Agreement |
1. Purpose and Scope of the Supply Agreement |
AbbVie will Manufacture, sell, and deliver to Richter, and Richter will purchase and take delivery of, such quantities of Licensed Product, in bulk containers suitable for product stability, for commercialization in the Richter Territory as may be ordered by Richter in accordance with the AbbVie Supply Agreement. |
Each Party is and will be solely liable for all of its own fees, costs, and other expenses in conjunction with preparation of the AbbVie Supply Agreement. |
2. Purchase Price |
Pricing for the supply of a given Licensed Product will be the cost of goods plus a mark-up of 5%. |
The Parties will collaborate in good faith to implement cost reductions in lieu of price increases. |
In addition, if Richter can at any time reasonably demonstrate that it will be able to Manufacture the Licensed Products for a savings of twenty (20%) or more as compared with the supply price under the AbbVie Supply Agreement, then Richter will thereafter have the right to Manufacture up to one hundred percent (100%) ... |
3. Delivery Terms |
Delivery will be CIP (Incoterms 2020) at a first carrier location requested by Richter in accordance with then-current good distribution practices. Title and risk of loss will pass upon delivery at such location. |
4. Payment Terms |
Payment will be net 90 days from Richter's receipt and approval of invoice. |
5. Supply Terms |
If AbbVie fails to deliver at least seventy-five percent (75%) of the committed volume within thirty (30) days of the committed date during a period of six (6) consecutive months, then Richter will thereafter have the right to Manufacture up to one hundred (100%) of the total amount of Licensed Products required for Co... |
6. Quality Agreement |
Prior to execution of the AbbVie Supply Agreement, the Parties will prepare and enter into a reasonable and customary quality assurance agreement that will set forth the terms and conditions upon which the parties will conduct their quality activities in connection with the AbbVie Supply Agreement (the "Quality Agreeme... |
documentation control, calibration, preventive maintenance, validation program, AbbVie's quality, environmental control program, components and commodity procurement, material control, laboratory controls, Licensed Product release testing, reference samples, stability, complaints, Licensed Product reviews (PQRs), manag... |
7. Representations and Warranties |
AbbVie will represent, warrant and covenant that: (a) it will manufacture and deliver Licensed Products in accordance with the relevant Licensed Product specifications, which will be part of the Quality Agreement, the Company's Quality System requirements and all applicable law; (b) Licensed Products will be free from ... |
promise or authorize the giving of anything of value to a government official or other person to obtain or retain business or gain a business advantage; and (h) such other representations and warranties agreed upon by the Parties in the Quality Agreement. |
8. Indemnification |
AbbVie will indemnify, defend and hold Richter, its Affiliates and their employees, directors and officers ("Richter Indemnitees"), harmless from and against any and all Third Party claims, liabilities, damages and expenses, including reasonable attorneys fees and costs ("Liabilities"), resulting from or arising out of... |
Richter will indemnify, defend and hold AbbVie, its Affiliates and their employees, directors and officers ("AbbVie Indemnitees"), harmless from and against any and all Liabilities resulting from or arising out of Richter Indemnitees' (a) gross negligence, recklessness, or willful misconduct; or (b) breach of the AbbVi... |
9. Term and Termination |
The AbbVie Supply Agreement will contain customary provisions regarding term and termination, including termination for breach and in the event of an insolvency event, and the consequences of termination or expiration. |
10. Assignment |
Section 13.4 of the Agreement will apply to the AbbVie Supply Agreement, mutatis mutandis. |
11. Choice of Law and Dispute Resolution |
Sections 13.6 and 13.7 of the Agreement will apply to the AbbVie Supply Agreement, mutatis mutandis. |
12. Additional Terms |
The AbbVie Supply Agreement will contain additional terms and conditions relating to commercial supply that are reasonable and customary in pharmaceutical supply agreements, including terms relating to: |
• Confidentiality |
• Data Security |
• Taxes |
• Inspection and acceptance/rejection procedures and |
remedies |
• Recalls |
• Audit rights |
• Import/export controls and customs |
• Regulatory matters |
• Debarment and exclusion |
• Insurance |
• Force majeure |
Schedule 9.5 |
Form of Press Release |
PRESS RELEASE AbbVie and Gedeon Richter Announce Collaboration in Neuropsychiatric Diseases |
– Companies will research, develop and commercialize novel dopamine receptor modulators for potential treatment of neuropsychiatric conditions – Agreement builds on 15 years of successful collaboration between AbbVie and Richter, including globally launched cariprazine products (VRAYLAR® / REAGILA®) |
NORTH CHICAGO, Ill. and BUDAPEST, Hungary, March 11, 2022 – AbbVie (NYSE: ABBV) and Gedeon Richter Plc. ('Richter') today announced a new co-development and license agreement to research, develop and commercialize novel dopamine receptor modulators for the potential treatment of neuropsychiatric diseases. The collabora... |
"In collaboration with Richter, we will continue to build on our research that seeks to provide additional insights into our understanding of cariprazine's clinical pharmacology and explore novel chemistry to identify new dopamine receptor modulators," said Tom Hudson, MD, senior vice president, R&D, chief scientific o... |
"I am very pleased to extend our existing co-operation under this new collaboration with AbbVie as it opens the way towards new products that could help alleviate the debilitating psychiatric and cognitive symptoms of many neuropsychiatric conditions, leading to an improved quality of life for patients suffering from t... |
Under the terms of the agreement, the collaboration includes both preclinical and clinical R&D activities with shared financing by the parties. Richter will receive an upfront cash payment, along with potential future development, regulatory and commercialization milestones. In addition, Richter may also receive sales-... |
The transaction is expected to close in the second quarter of 2022, subject to the satisfaction of customary closing conditions, including applicable regulatory approvals. |
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women... |
About Richter Gedeon Richter Plc. (www.gedeonrichter.com ), headquartered in Budapest/Hungary, is a major pharmaceutical company in Central Eastern Europe, with an expanding direct presence in Western Europe, in China and in Latin America. Having reached a market capitalization of EUR 4.4 billion (USD 5.0 billion) by t... |
VRAYLAR (cariprazine) U.S. Uses and Important Safety Information1 |
INDICATIONS AND USAGE |
VRAYLAR is a prescription medicine used in adults: • to treat schizophrenia • for short-term (acute) treatment of manic or mixed episodes that happen with bipolar I disorder • to treat depressive episodes that happen with bipolar I disorder (bipolar depression) |
It is not known if VRAYLAR is safe and effective in children. |
What is the most important information I should know about VRAYLAR? |
Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) taking medicines like VRAYLAR are at an increased risk of death. VRAYLAR is not approved for treating patients with dementia-related psychosis. |
Antidepressants may increase suicidal thoughts or actions in some children and young adults within the first few months of treatment and when the dose is changed. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Patients on antidepressants and their families ... |
VRAYLAR may cause serious side effects, including: |
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