Exhibit 10.1

 

Execution Copy

 

FOURTH AMENDMENT TO AGREEMENT

 

This Fourth Amendment to the Agreement (hereinafter referred to as this
“Amendment”) is made and effective as of the 1st day of July, 2013 (hereinafter
referred to as the “Amendment Effective Date”) by and between MITSUBISHI TANABE
PHARMA CORPORATION, a corporation with its principal office at 6-18, Kitahama
2-chome, Chuo-ku, Osaka, 541-8505, Japan (hereinafter referred to as “MTPC”),
and VIVUS, INC., a corporation with its principal office at 351 E Evelyn Avenue,
Mountain View, California, 94041, United States of America (hereinafter referred
to as “VIVUS”).

 

Capitalized terms used herein shall have the same meanings as defined in the
AGREEMENT (as hereinafter defined), unless otherwise defined in this Amendment.

 

WHEREAS, VIVUS and MTPC entered into certain AGREEMENT dated as of the 28th day
of December, 2000, as amended to date (hereinafter referred to as the
“AGREEMENT”), under which MTPC has granted to VIVUS the exclusive right to
develop and to market pharmaceutical products that contain a selective PDE5
INHIBITOR compound referred to by MTPC as “TA-1790”; and

 

WHEREAS, the Parties desire to amend and supplement certain terms and conditions
as set forth in the AGREEMENT to facilitate the commercial launch of the PRODUCT
in the United States, European Union and other emerging markets within the
TERRITORY;

 

NOW, THEREFORE, in consideration of the mutual agreements herein contained, the
Parties agree as follows:

 

1.     Subsections (a) and (b) of Section 1.24 of the AGREEMENT shall be deleted
in its entirety and replaced by the following;

 

“(a) with respect to a PRODUCT, the amount invoiced by VIVUS, its AFFILIATES and
their SUBLICENSEES (each, “SELLER”) for sales of a PRODUCT to a CUSTOMER (as
defined below), less estimates which will be adjusted to actual on a periodic
basis of:

 

1.              Sales returns (to the extent that customary practice is to allow
CUSTOMER to return SELLER a PRODUCT expired or will expire unsold, or in the
event of a PRODUCT recall, rejections or damaged PRODUCT);

2.              Discounts (including, prompt pay cash discounts, patient cash
discounts, price reductions and incentive programs, rebates, trade and quantity
discounts, purchase volume discounts, patient co-pay assistance, price reduction

 

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programs, retroactive price adjustments, sales coupons, etc.) to managed care
organizations, or to federal, state and local governments, or to CUSTOMER;

3.              Wholesaler fees, inventory management agreement fees and
specialty pharmacy fees, which are commercially reasonable and customary fees
paid by SELLER to CUSTOMER;

4.              Chargebacks incurred or paid by SELLER to government entities
(SELLER’s programs with government entities whereby pricing on a PRODUCT by
SELLER to the participating entities is extended below wholesaler list price);

5.              Managed health care rebates and other contract discounts
(including rebates, administrative fees, reimbursements and discounts to managed
health care and pharmacy benefit organizations which manage prescription drug
programs and prescription drug plans covering the Medicare Part D drug benefit
or similar government programs in addition to their commercial plans, as well as
other contract counterparties such as hospitals and group purchasing
organizations);

6.              Medicaid or similar government rebates (local, state and federal
government-managed Medicaid or similar programs as well as certain other
qualifying Federal, state and local government programs (or their respective
agencies, purchasers and reimbursers) whereby discounts and rebates are provided
by SELLER to participating federal, state and local government entities);

7.              Taxes, duties and other governmental charges levied on, absorbed
or otherwise imposed on sale of a PRODUCT, including value-added taxes, or other
governmental charges otherwise measured by the billing amount, when separately
included on a billing by SELLER to CUSTOMER, as adjusted for rebates and
refunds, but specifically excluding taxes based on net income of SELLER;

8.              Freight, postage, shipping and insurance charges actually
allowed or paid for delivery of PRODUCT, to the extent billed as a separate line
item by SELLER to CUSTOMER; and

9.              Customs duties, surcharges and other governmental charges
incurred in connection with the exportation or importation of a PRODUCT, to the
extent billed as a separate line item by SELLER to CUSTOMER.

 

(b) It is understood and agreed that (x) sales or transfers of PRODUCTS between
VIVUS, its AFFILIATES and their SUBLICENSEES shall not constitute “NET SALES”
unless such party is an end-user of such PRODUCTS and (y) “CUSTOMER” shall mean
a THIRD PARTY that is invoiced by SELLER in a commercial arms length transaction
for the sale of PRODUCT in the TERRITORY.”

 

2.     VIVUS shall send MTPC the reports set forth in Section 12.1 of the
AGREEMENT,

 

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along with the amount of deduction on item-by-item basis as set forth in Section
1.24 of the AGREEMENT.

 

3.              This Amendment may be executed in one (1) or more counterparts,
each of which shall for all purposes be deemed to be an original and all of
which shall constitute the same instrument. This Amendment may be executed by
facsimile signature, which shall be effective. Upon the execution of this
Amendment by MTPC and VIVUS, this Amendment shall be binding upon the Parties to
the AGREEMENT.

 

4.              Except as set forth in this Amendment, the remainder of the
AGREEMENT shall remain in full force and effect and shall be binding on all
parties thereto; provided, however, that to the extent a provision in this
Amendment conflicts with a provision in the AGREEMENT, then the provision in
this Amendment shall control.

 

5.              This Amendment is entered into in the English language. In the
event of any dispute concerning the construction or meaning of this Amendment,
reference shall be made only to this Amendment as written in English and not to
any translation into any other language.

 

[Signature Page Follows]

 

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IN WITNESS WHEREOF, the Parties have executed this Amendment on the Amendment
Effective Date.

 

 

MITSUBISHI TANABE PHARMA
CORPORATION

 

VIVUS, INC.

 

 

 

/s/ Michihiro Tsuchiya

 

/s/ Peter Y. Tam

By:

Michihiro Tsuchiya

 

By:

Peter Y. Tam

Title:

President and
Chief Executive Officer
Representative Director

 

Title:

President

Date:

7/23/2013

 

Date:

7/17/2013

 

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