Terms & Conditions
The full Terms and Conditions of registering
Marketing Material License Terms and Conditions Welcome to Orexigen Therapeutics, Inc.’s Marketing Material microsite. Through your access to and use of this microsite, you accept, without limitation or qualification, the Terms and Conditions of the Agreement set forth below. Please review the following Terms and Conditions concerning your use of this microsite and any Marketing Material included herein. We reserve the right to change these Terms and Conditions from time to time at our sole discretion. In the case of any violation of these Terms and Conditions, we reserve the right to seek all remedies available by law and in equity for such violations. Orexigen Therapeutics, Inc. ("Orexigen") is willing to license our Marketing Materials and Licensed Marks to you as a healthcare practitioner or practice ("Licensee" or “Practice”) only on the condition that you accept all of the terms of this Agreement. The Terms and Conditions of this Agreement constitute a legal and enforceable contract between you and Orexigen. If you are an employee or agent of a healthcare practitioner or practice and you are entering into this Agreement to obtain the Marketing Materials for use by you and/or the Practice for your and/or its own business purposes, you hereby agree that you enter into this Agreement on behalf of the Practice and that you have the authority to bind the Practice to the Terms and Conditions of this Agreement. By using the Marketing Materials or signing below you acknowledge that you have read the Terms and Conditions of this Agreement, understand it, and agree to be bound by it. if you do not agree to any of these Terms and Conditions, Orexigen is unwilling to license the Marketing Materials and the Licensed Marks to you, and you should make no further use of the Marketing Materials and Licensed Marks, and you must destroy or return any Marketing Materials to Orexigen within thirty (30) days. 1. Definitions "Licensed Marks" means the trademarks, tradenames and/or service marks included in the Marketing Materials that belong to Orexigen; provided, however, that the appearance and/or style of the Licensed Marks may change from time to time in Orexigen’s sole discretion. "Marketing Materials" means the marketing materials for the Products (including Licensed Marks, names and logos contained therein) provided to the Licensee by Orexigen from time to time in electronic or physical format. "Products" means the products developed and sold by Orexigen that the Practice may promote. 2. License Subject to and in accordance with the terms and conditions of this Agreement, Orexigen grants the Licensee a limited, non-exclusive, royalty-free, non-transferable, and non-sublicensable, license to use the Marketing Material and the Licensed Marks included therein solely in connection with the promotion of the Products. 3. Ownership Orexigen grants no other right or license to any of its intellectual property to the Licensee by implication, estoppel, or otherwise. Licensee acknowledges that Orexigen owns all right, title, and interest in, to and under the Orexigen's Licensed Marks and that Licensee shall not acquire any proprietary rights therein. 4. Restrictions Licensee shall not alter, modify, or create any derivative works of the Marketing Materials except in accordance with this Agreement. Licensee shall not make additional copies of the Marketing Materials beyond what is required under the terms of this Agreement. Licensee shall not remove or obscure any Orexigen copyright or trademark notices on the Marketing Materials. 5. Use and Display of Marks Licensee agrees to use the Licensed Marks and Marketing Materials solely in the manner in which Orexigen shall specify from time to time in Orexigen's sole discretion. All usage by Licensee of the Licensed Marks shall include the registered trademark symbol ® or ™, as appropriate. 6. Standards of Use Upon Orexigen's request, Licensee shall furnish to Orexigen, at no expense to Orexigen, samples of all materials containing the Marketing Material and/or Licensed Marks that Licensee currently distributes or intends to distribute. If Orexigen believes that the Licensed Marks are being used in a manner that could violate the U.S. Food Drug and Cosmetics Act, and/or any related regulations, diminish Orexigen's rights in or protection of the Licensed Marks, Licensee agrees, at Licensee's sole cost and expense, to make whatever changes and/or corrections Orexigen deems necessary to prevent a violation and/or protect the Licensed Marks. Licensee shall cease using the Marketing Materials from time to time upon notice from Orexigen that such Marketing Materials are outdated or should no longer be utilized. Licensee agrees that it shall not engage, participate or otherwise become involved in any activity or course of action that diminishes and/or tarnishes the image and/or reputation of Orexigen or the Licensed Marks. Any use of the Marketing Materials or the Licensed Marks in connection with the advertisement or promotion of any product or service competitive to or incompatible with Orexigen or the Products is not authorized. 7. Indemnification Orexigen shall have no obligations to indemnify or defend Licensee or any of its representatives against any losses arising out of or resulting in whole or in part from infringement of claims relating to Licensee’s use of Orexigen’s Marketing Material and/or Licensed Marks. Licensee agrees to defend, indemnify and hold Orexigen harmless from any and all costs and expenses (including reasonable attorneys' fees), liabilities, damages or other loss arising out of Licensee's negligence, improper conduct, or breach of the terms of this Agreement. 8. Limitations of Liability Regardless of whether any remedy set forth herein fails of its essential purpose or otherwise, in no event will Orexigen be liable to Licensee or to any third party for any lost profits, lost data, interruption of business, or other special, indirect, incidental or consequential damages of any kind arising out of this Agreement or the use or inability to use the Marketing Materials or the Licensed Marks, even if Orexigen has been advised of the possibility of such loss or damages and whether or not such loss or damages are foreseeable. In no event shall the liability of Orexigen exceed any amount actually received by Orexigen from licensee under this Agreement or any related agreement to dispense or market any Orexigen Products. 9. Termination Orexigen may terminate this Agreement in its sole discretion, at any time upon written notice. Upon termination of this Agreement, Licensee shall immediately cease to use any Marketing Materials or Licensed Marks, and as instructed by Orexigen, shall immediately return all copies of any Marketing Materials to Orexigen, or destroy all copies of Marketing Materials in Licensee's possession and certify to Orexigen in writing that Licensee has done so. The parties hereby agree that all provisions which operate to protect the rights of Orexigen shall survive and remain in force should termination occur. 10. Assignment Licensee may not assign any of its rights or obligations under this Agreement without the prior written consent of Orexigen. Any purported assignment without such consent shall be null and void. 11. Entire Agreement This Agreement is the complete and exclusive statement of the Marketing Materials licensing agreement between Licensee and Orexigen and supersedes any proposal or prior agreement, oral or written, and any other communications between Licensee and Orexigen in relation to the subject matter of this Agreement. 12. Amendments or Modifications Orexigen reserves the right to amend or modify the Terms and Conditions of this Agreement at any time, subject to notice to Licensee at any electronic or physical address provided by Licensee. Any other amendment or modification of this Agreement or any waiver of any breach of any term or condition of this Agreement must be in a writing signed by both parties in order to be effective and shall not be construed as a waiver of any continuing or succeeding breach of such term or condition, a waiver of the term or condition itself or a waiver of any right under this Agreement. 13. Severability If any term or provision of this Agreement is invalid, illegal, or unenforceable in any jurisdiction, , such provision will be changed and interpreted to accomplish the objectives of such provision to the greatest extent possible under applicable law. Additionally, such invalidity, illegality, or unenforceability shall not affect any other term or provision of this Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction. 14. Compliance with Laws Licensee agrees to comply with all applicable local, state, federal and international laws and, at all times, to conduct its activities under this Agreement in a lawful manner. 15. Applicable Law This Agreement shall be governed by the laws of the State of California, USA, excluding its conflict of laws principles. 16. Disputes You agree that any action at law or in equity arising out of or relating to these Terms and Conditions shall be filed only in the state or federal courts of San Diego County, California, USA, and that you hereby consent and submit to the exclusive jurisdiction and venue of such courts. No action arising under or relating to these Terms and Conditions may be brought by either party more than one year after the cause of action has occurred.
Important Safety Information for CONTRAVE
(naltrexone HCl and bupropion HCl) extended-release tablets
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Suicidality and Antidepressant Drugs
CONTRAVE® is not approved for use in the treatment of major depressive disorder or other psychiatric disorders. CONTRAVE contains bupropion, the same active ingredient as some other antidepressant medications (including, but not limited to, WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, and APLENZIN). Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects over age 24; there was a reduction in risk with antidepressant use in subjects aged 65 and older. In patients of all ages who are started on CONTRAVE, monitor closely for worsening, and for the emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. CONTRAVE is not approved for use in pediatric patients.
CONTRAVE is contraindicated in: uncontrolled hypertension; seizure disorder or a history of seizures; use of other bupropion-containing products; bulimia or anorexia nervosa, which increase the risk for seizure; chronic opioid or opiate agonist (eg, methadone) or partial agonist (eg, buprenorphine) use, or acute opiate withdrawal; patients undergoing an abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs; use during/within 14 days following treatment with monoamine oxidase inhibitors (MAOIs), as there is an increased risk of hypertensive reactions when CONTRAVE is used concomitantly with MAOIs, including reversible MAOIs such as linezolid or intravenous methylene blue; known allergy to any component of CONTRAVE, as anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported; and pregnancy.
WARNINGS AND PRECAUTIONS
Suicidal Behavior and Ideation
All patients being treated with antidepressants for any indication should be monitored and observed for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes.
Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of suicidality, anxiety, agitation, irritability, unusual changes in behavior, and other symptoms, and to report such symptoms immediately to healthcare providers.
Neuropsychiatric Adverse Events and Suicide Risk in Smoking Cessation Treatment
CONTRAVE is not approved for smoking cessation. Serious neuropsychiatric adverse events have been reported in patients taking bupropion for smoking cessation. These postmarketing reports have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide.
Some patients who stopped smoking may have been experiencing symptoms of nicotine withdrawal, including depressed mood. Depression, rarely including suicidal ideation, has been reported in smokers undergoing a smoking cessation attempt without medication. However, some of these adverse events occurred in patients taking bupropion who continued to smoke.
Neuropsychiatric adverse events occurred in patients without and with pre-existing psychiatric disease; some patients experienced worsening of their psychiatric illnesses. Observe patients for the occurrence of neuropsychiatric adverse events. Advise patients and caregivers that the patient should stop taking CONTRAVE and contact a healthcare provider immediately if agitation, depressed mood, or changes in behavior or thinking that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior. In many postmarketing cases, resolution of symptoms after discontinuation of bupropion was reported. However, the symptoms persisted in some cases, therefore, ongoing monitoring and supportive care should be provided until symptoms resolve.
Depression, suicide, attempted suicide, and suicidal ideation have been reported in the postmarketing experience with naltrexone used in the treatment of opioid dependence. No causal relationship has been demonstrated.
The risk of seizure is dose-related. Discontinue treatment and do not restart CONTRAVE in patients who experience a seizure. Use caution when prescribing CONTRAVE to patients with an elevated risk of seizure, including: history of head trauma or prior seizure, severe stroke, arteriovenous malformation, central nervous system tumor or infection, or metabolic disorders (eg, hypoglycemia, hyponatremia, severe hepatic impairment, and hypoxia); excessive use of alcohol or sedatives, addiction to cocaine or stimulants, or withdrawal from sedatives; patients with diabetes treated with insulin and/or oral diabetic medications (sulfonylureas and meglitinides) that may cause hypoglycemia; concomitant administration of medications that may lower the seizure threshold, including other bupropion products, antipsychotics, tricyclic antidepressants, theophylline, and systemic steroids.
Clinical experience with bupropion suggests that the risk of seizure may be minimized by adhering to the recommended dosing recommendations, including the avoidance of high-fat meals while taking CONTRAVE.
Patients Receiving Opioid Analgesics
CONTRAVE should not be administered to patients receiving chronic opioids. If chronic opiate therapy is required, CONTRAVE treatment should be stopped. In patients requiring intermittent opiate treatment, CONTRAVE therapy should be temporarily discontinued and lower doses of opioids may be needed. Patients should be alerted that they may be more sensitive to opioids, even at lower doses, after CONTRAVE treatment is discontinued.
An opioid-free interval of a minimum of 7 to 10 days is recommended for patients previously dependent on short-acting opioids, and those patients transitioning from buprenorphine or methadone may need as long as two weeks. Patients should be made aware of the risks associated with precipitated withdrawal and encouraged to give an accurate account of last opioid use.
Increase in Blood Pressure (BP) and Heart Rate (HR)
CONTRAVE can cause an increase in systolic BP, diastolic BP, and/or resting HR. These events were observed in both patients with and without evidence of preexisting hypertension. In clinical practice with other bupropion-containing products, hypertension, in some cases severe and requiring acute treatment, has been reported. Blood pressure and pulse should be monitored at regular intervals.
Anaphylactoid/anaphylactic reactions and symptoms suggestive of delayed hypersensitivity have been reported with bupropion, as well as rare spontaneous reports of erythema multiforme, Stevens-Johnson syndrome, and anaphylactic shock. Instruct patients to discontinue CONTRAVE and consult a healthcare provider if they develop an allergic or anaphylactoid/anaphylactic reaction.
Cases of hepatitis, clinically significant liver dysfunction, and transient asymptomatic hepatic transaminase elevations have been observed with naltrexone exposure. Warn patients of the risk of hepatic injury and advise them to discontinue CONTRAVE if they experience symptoms of acute hepatitis.
Activation of Mania
CONTRAVE treatment can precipitate a manic, mixed, or hypomanic episode. The risk appears to be increased in patients with bipolar disorder or who have risk factors for bipolar disorder. Prior to initiating CONTRAVE, screen patients for history of bipolar disorder and the presence of risk factors for bipolar disorder (eg, family history of bipolar disorder, suicide, or depression). CONTRAVE is not approved for use in treating bipolar depression.
The pupillary dilation that occurs following use of many antidepressant drugs, including bupropion, may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
Hypoglycemia with Use of Antidiabetic Medications
Weight loss may increase the risk of hypoglycemia in patients with type 2 diabetes mellitus treated with insulin and/or insulin secretagogues (eg, sulfonylureas). Measurement of blood glucose levels prior to starting CONTRAVE and during CONTRAVE treatment is recommended in patients with type 2 diabetes. Decreases in medication doses for antidiabetic medications that are non-glucose-dependent should be considered to mitigate the risk of hypoglycemia.
Most common adverse reactions (≥5%) include: nausea (32.5%), constipation (19.2%), headache (17.6%), vomiting (10.7%), dizziness (9.9%), insomnia (9.2%), dry mouth (8.1%), and diarrhea (7.1%).
Use caution when prescribing CONTRAVE concomitantly with dopaminergic drugs (levodopa and amantadine), drugs metabolized by CYP2D6, or drugs that lower the seizure threshold. Avoid concomitant use with MAOIs and CYP2B6 inducers. Reduce CONTRAVE dose when taken with CYP2B6 inhibitors. CONTRAVE can cause false positive urine test results for amphetamines.
CONTRAVE is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:
- 30 kg/m2 or greater (obese) or
- 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, or dyslipidemia)
Limitations of Use
The effect of CONTRAVE on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of CONTRAVE in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.