Subject to the conditions listed below, Eli Lilly and Company (“Lilly”) accepts returns of its pharmaceutical products for disposal and/or reimbursement.
This Return Goods Policy applies to all entities other than Lilly-authorized wholesalers and entities that have entered into contracts with Lilly governing returns.
PROCEDURE FOR RETURNING PRODUCT
1. Any licensed distributor, licensed pharmacy, or other entity licensed to dispense or administer Lilly and Dista product may return Lilly and Dista product for disposal and/or reimbursement with prepaid postage to:
Eli Lilly and Company
MS204
1301 South White River Parkway, East Drive
Indianapolis, Indiana 46225
2. Lilly and Dista products that require reconstitution and have been reconstituted must be destroyed.
3. Lilly and Dista products, except products that require reconstitution AND have been reconstituted, must be returned to Eli Lilly and Company at the address listed above by a licensed distributor, licensed pharmacy, or other entity licensed to dispense or administer Lilly or Dista product (or any authorized agent or representative thereof).
4. Returns should be packed carefully and in compliance with all applicable federal, state, and local laws, regulations and statutes and sent to Eli Lilly and Company at the address listed above prepaid by the customer returning the merchandise.
5. Reimbursable returns should be insured since Lilly is not responsible for loss or damage in transit.
6. When product is returned via Third Party Processors, Lilly is not accountable for lost returns sent via multiple cartons under one Proof Of Delivery (POD).
7. Lilly is not responsible for additional processing fees and expenses.
8. All returns must be accompanied with the applicable and appropriate forms –the Universal Lilly Return Goods Claim Form, the Reconstituted or Filtered Product Claim Form, Request for Return of Schedule II Substance Items, or a form that contains equivalent data.
9. The source (originating customer) and any licensed third party returns processor preparing the return MUST be identified on accompanying required documentation with the returned product.
10. For Schedule II Controlled Substance Items, call 1-800-228-0904 to obtain a Request for Return of Schedule II Substance Items. Schedule II Controlled Substances are subject to the same eligibility rules governing other return merchandise.
11. Lilly has the sole discretion to make the final determination of reimbursement for all returns sent to Lilly.
REIMBURSABLE MERCHANDISE
1. Any amount of expired Lilly or Dista merchandise returned from a licensed distributor, licensed pharmacy, or other entity licensed to dispense or administer Lilly product to Eli Lilly and Company within one (1) year past expiration date are eligible for reimbursement including products with additional labels or markings other than prescription labels, such as price/inventory stickers, returned in original Lilly packaging with label intact.
2. Reconstituted/Filtered Products Eligible for Reimbursement. Bona-fide End-Customers who meet the other requirements identified in this section may receive reimbursement for products requiring reconstitution and administration. For purposes of this policy the term “Bona-fide End-Customer” specifically excludes licensed distributors, licensed pharmacies, third party processors and/or similar entities.
i. Eligible products under this policy:
a. Alimta (permetrexed)
b. Gemzar (gemcitabine hydrochloride) – Gemzar shall be removed from eligibility under this section effective December 31, 2010. No claims submitted after December 31, 2010 under this section will be considered for reimbursement.
c. Reopro (aciximab)
d. Xigris (drotrecogin alpha [activated])
e. Zyprexa Relprevv (olanzapine) For Extended Release Injectable Suspension
ii. These products require:
a. Reconstitution; AND
b. Administration by a healthcare professional.
iii. These products will be reimbursed only in instances where the product:
a. was reconstituted/filtered;
b. was not administered to any patient;
c. was not billed for or reimbursed;
d. is deemed unusable AND
e. a signed and completed Reconstituted or Filtered Product Claim Form OR Zyprexa Relprevv Replacement Product Claim Form, as applicable, has been submitted for review.
iv. Products will be deemed unusable when:
a. Product is received directly from Lilly in a condition that makes administration impossible, if the receipt of the product is from a wholesaler, please contact the wholesaler under its return policy;
b. Reconstitution was attempted but product could not be safely used at the time of the return request; or
c. In accordance with FDA Prescribing Information, Zyprexa Relprevv could not be safely used as a result of aspiration of blood in the syringe resulting from the process associated with the administration of Zyprexa Relprevv.
v. If aspiration of blood resulted from administration of Zyprexa Relprevv, contact the Zyprexa Relprevv Coordinating Center at 1-877-772-9390 for reimbursement or replacement.
ITEMS NOT ELIGIBLE FOR REIMBURSEMENT
Unless otherwise explicitly authorized by this policy or otherwise required by law, the following items are not eligible for reimbursement:
1. Products returned more than twelve (12) months beyond expiration.
2. Products with unknown or unidentifiable batch/lot numbers.
3. Products containing prescription labels.
4. Products not in original Lilly or Dista containers.
5. Broken, shattered or smashed bottles, vials or containers where such damages occurs at the time of the customer's or the wholesaler's possession of the product; if the damage has occurred prior to receipt of the product from the wholesaler, please contact the wholesaler under its return policy.
6. Products damaged from such perils as are normally insured including, without limitation, extended coverage, vandalism, and malicious mischief, will not be reimbursed by Lilly.
7. Products damaged by careless handling or insufficient packaging.
8. Products damaged while in the customer's possession.
9. All opened liquid or reconstituted/filtered products, except for Reconstituted/Filtered Products Eligible for Reimbursement.
10. Products ordered in error or shipped in error by wholesale distributors. In such circumstances, wholesalers are expected to make proper adjustments according to the wholesaler's policy and in accordance with state and federal law.
11. Overages – Lilly or Dista containers over-packed for return (e.g., 40 tablets in a container labeled as containing 30 tablets).
12. Product inside containers molded into large clumps or broken pills/capsules.
13. Products marked "Non-Returnable," "Professional Sample," "Professional Package," "Clinical Trial Package," or with similar markings or special labels.
14. Distressed merchandise, such as items purchased from bankruptcy sales, going-out-of-business sales, fire sales, or other merchandise generally considered under the classification "distressed merchandise" will not qualify for return or exchange under the general provision of this return goods policy.
15. Merchandise obtained illegally or via diverted means including, without limitation, products imported from countries outside the United States.
16. Counterfeit, diverted, or product obtained from suspected counterfeit distributors as determined by Lilly.
17. Batched returns will not be accepted for processing and reimbursement without associated originating customer detail required to ensure accurate credit reimbursement.
REIMBURSEMENT
1. The exchange will be valued at ninety percent (90%) of the lower of the net wholesale price or the contracted price. For out-of date products, the contracted price in effect at the time of lot expiration, as determined by Lilly, will be used.
2. For opened packages of expired product otherwise eligible for reimbursement, reimbursement value will be based upon quantity of unused product returned.
3. Eligible returns for reimbursement are exchangeable for either a check from Lilly or a credit with a Lilly-authorized wholesaler of your choice as designated on the Universal Lilly Return Goods Claim Form or Reconstituted or Filtered Product Claim Form. If there is no designation, credit will be issued to the source of the return.
4. Expired product return must be accompanied by a completed Universal Lilly Return Goods Claim Form to be eligible for reimbursement.
5. A complete and signed Reconstituted or Filtered Product Claim Form is required to obtain reimbursement for Reconstituted/Filtered Product Eligible for Reimbursement.
PRODUCT RECALLS
In the event of a product recall, only Lilly-authorized recalls will be honored for return of product for credit. Specific instructions for each recall shall be disseminated to the appropriate entities. To qualify for a credit or product replacement, the returned product must meet the criteria noted in the recall notification issued by Lilly. The issuance of credit or product replacement is at the discretion of Lilly.
QUESTIONS ABOUT RETURNS
For specific questions about returns, please call 1-800-228-0904. Any exception to this policy must be authorized by the Senior Director of B2B Contract Management and Analytics subject to the Trade Account Management’s formal Returns Exception Process.
Please note that Product not eligible for reimbursement under this policy may nevertheless be returned for disposal following the procedures outlined in this policy.
APPLICATION OF POLICY
Lilly reserves the right to modify this policy and its implementation at any time, without notice, for any reason including, without limitation, to comply with any applicable local laws and regulations in force from time to time.
Policy current as of December 1, 2011