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Schedule B. Schering-Ciba-Follicular harmones-Continued

Patent
No.

Date

Inventor

Title

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Method of Producing Dihydro Follicular
Hormones.

Germinal Gland Hormone Derivatives of
the Formula C18H28O2 and Method of
Making Same.

Saturated Alcohols of the Cyclopentano
Phenanthrene Series, and Method of
Producing the Same.

Method for the Production of Hydrogena-
tion Products of the Follicle Hormones.
Hydrogenation Products of Follicle Hor-

mones and Method of Producing Same. Method of Isolating the Follicle Hormone from the Urine of Pregnant Individuals. Method of Purifying Crude Extracts of the Germinal Gland Hormones and of Isolating the Latter Therefrom. Oestrogenous Products and Methods of Producing the Same.

Oestrogenous Products and Methods of
Producing the Same.

Method for Producing Acyl Derivatives
of the Dihydrofollicle Hormone and
Resulting Product.

Process for Separating Phenolic Bodies.

Method of Isolating Follicle Hormones
from the Urine of Pregnant Individuals.
Manufacture of Dihydrofollicle Hormones
by Fermentative Reduction.
Method of Producing Hormone Prepara-
tions of High Purity.

EXHIBIT No. 225

CIBA PHARMACEUTICAL PRODUCTS, INC., AND SCHERING CORPORATION—AGREEMENT

(Follicular Hormones)

AUGUST 1, 1939. AGREEMENT dated August 1, 1939, between CIBA PHARMAECUTICAL PRODUCTS, INC., a New Jersey corporation with its head office in Summit, New Jersey (the Licensor) and SCHERING CORPORATION, a New Jersey corporation with its head office in Bloomfield, New Jersey (the Licensee).

WHEREAS the Licensor is the sole owner of the letters patent and applications for letters patent of the United States set forth in Schedule A annexed hereto; and WHEREAS the Licensee wishes to acquire from the Licensor a license on the terms and conditions hereinafter stated.

NOW, THEREFORE, the parties hereto, each in consideration of the covenants of the other herein contained, hereby agree as follows:

1. Whenever used in this agreement the term "the Patents" means not only the patents and the applications listed in Schedule A annexed hereto but also all other United States patents and applications therefor in the female sex hormone field now owned by or that may hereafter on or before December 31, 1956, be issued to or acquired by the Licensor or in which the Licensor shall have the right to grant a license coterminous with the license hereby granted.

2. (a) The Licensor hereby grants to the Licensee upon the terms and conditions hereinafter stated a nonexclusive nonassignable license to manufacture, use, and sell the products described and claimed in the Patents and to practice the processes described and claimed therein throughout the United States of America, its territories and possessions, but only in the female sex hormone field, for a period beginning August 1, 1939, and ending at the end of the term for which the last expiring of the Patents is or shall be granted, or sooner as hereinafter provided.

(b) All United States patents and applications therefore in the female sex hormone field that shall be hereafter issued to or otherwise acquired by the Licensor or in which the Licensor shall hereafter acquire any right, title, or interest shall be promptly disclosed by the Licensor to the Licensee and upon such disclosure by the Licensor to the Licensee shall without more forthwith come under the license hereby granted.

3. (a) Neither party hereto shall, without the written consent of the other party first obtain in each instance, give any license or sublicense, or any right of exploitation covering any of the products of the Patents or of the processes relating thereto, except that the Licensor may without the Licensee's consent grant any such licensee and rights to Roche-Organon, Inc., Nutley, New Jersey.

(b) The Licensee shall manufacture under this license only in its own plant or plants located in the U. S. A. and distribution of products under this license shall be made only by the Licensee and only under a single corporate name and/or trade

name.

4. The "female sex hormone field" includes all products and preparations containing female sex hormones of natural or synthetic origin and/or such substances as increase the effectiveness thereof (activators), but activators only in so far as used as such. "Female sex hormones" means (i) hormones of the follicular (but not corpus luteum) hormone series (e. g., estrone, estradiol, or œstriol) or their derivatives, as well as other materials derived from the female sex organs having similar effects, and as well as (ii) compounds and materials with physiological and clinical effects analogous to those of female sex hormones, in so far as they may be used therapeutically like female sex hormones and the activators of such compounds and materials, but activators only in so far as they are used as such.

5. Each party hereto shall forthwith upon making, discovering, conceiving, or otherwise acquiring any other processes, whether secret or not, or any formulae, or any technical, clinical, experimental, or manufacturing data or any other discoveries in the female sex hormone field, disclose the same forthwith to the other party hereto and shall assist the other party in every way in the application and further development thereof, provided, however, that neither party shall be obligated to disclose to the other any information regarding its costs of manufacture, production, or distribution.

6. (a) Subject to the provisions of paragraph (b) of this Article 6, neither party shall sell or offer for sale any product made pursuant to any of the process claims of the Patents or any product coming within the product claims of the Patents, excepting in a form ready for use by the consumer, completely packed and packaged under its own name or trade-mark, nor shall either party sell or offer for sale or deliver, directly or indirectly, any product made pursuant to any of the process claims of the Patents or any product coming within any of the product claims of the Patents, to others for use by them in putting up such products in commercial form for resale by them, nor sell the said product in bulk. (b) The provisions of paragraph (a) of this Article 6 shall not apply to sales by the Licensor or the Licensee of any of the products mentioned therein to licensees under the Patents, nor shall such provisions apply to sales to others when written consent of both parties is first obtained.

7. (a) The Licensee shall cooperate with the Licensor to defend the rights under the Patents, including interferences and attacks of third parties upon the validity of the Patents.

(b) The Licensee shall not do any act or thing which might lessen or endanger said protection or unfavorably affect the full enjoyment of the Licensor's and Licensee's rights in and to said products and processes.

(c) The cost of prosecuting any actions instituted by the Licensor for infringement of the Patents and the cost of defending any suit instituted against any of the Patents shall be borne if the cost is incurred prior to December 31, 1942, 20% by the Licensor and 80% by the Licensee, and if incurred after January 1, 1943, in the proportion of the respective turn-overs of the Licensor and the Licensee of products in the female sex hormone field.

8. If and whenever either party hereto shall be in default in complying with any of the applicable terms of this agreement and the default shall continue unremedied or be repeated during a period of thirty days after the other party hereto shall have given to the defaulting party written notice specifying the default, then upon the expiration of the thirty-day period the party giving the notice of default shall have the right at its option to terminate this agreement and the license hereby granted by giving to the other party in default written notice to that effect; whereupon this agreement and the license hereby granted shall terminate forthwith, except that the party in default shall not thereby be discharged from any liability to the other party for damages or loss resulting from the default.

9. If a petition in bankruptcy or proceedings under the Bankruptcy Law shall be filed by or against Licensee, or if a receiver or trustee shall be appointed for the property of Licensee, or if the Licensee shall make a general assignment

or take the benefit of any insolvency act, or upon the liquidation or dissolution of Licensee, then, and upon the happening of any of the foregoing contingencies, the Licensor may at its option terminate this agreement and the license hereby granted by giving to the Licensee written notice to that effect; whereupon this agreement and the license hereby granted shall terminate forthwith.

10. On December 31, 1956, this agreement, if then in force, shall terminate, except that the Licensee, if not then in default, shall continue to have a free license to manufacture, use, and sell under the Patents until the expiration of the last now or hereafter granted patent under which the Licensee is hereby licensed. 11. For all purposes of this agreement any notice required or permitted to be given to a party hereto shall be effectively given if directed to the party at its lastknow head office and sent by registered mail.

12. The Licensee accepts the license hereby granted and agrees to comply with all the conditions of this agreement requiring compliance on the part of the Licensee,

13. The Licensor agrees to comply with all the conditions of this agreement requiring compliance on the part of the Licensor.

14. If any one or more provisions of this agreement shall be or become unenforceable, all other provisions shall nevertheless continue in full force and effect. IN WITNESS WHEREOF the parties hereto have executed this agreement in duplicate as of the date first above written.

CIBA PHARMACEUTICAL PRODUCTS, INC.
SCHERING CORPORATION.

Schedule A. Ciba-Schering-Follicular Hormones

Patent
No.

Date

Inventor

1,690, 932 Nov. 6, 1928

Max Hartmann

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Max Hartmann...

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Sigmund Fraenkel.

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Title

Manufacture of Physiologically Active
Substances From Ovaries, Corpus
Luteum, and Placenta.

Process for the Manufacture of Physio-
logically Active Substances from Female
Internal Secretory Sex Organs.

Hormone and the Process of Obtaining
Same.

Karl Miescher & Caesar Scholz... Estradiol Esters Esterified in 3-Position
and Process of Making Same.

Karl Miescher & Caesar Scholz... Partially Esterified Compounds of the
Dihydro-Estrin Series and Process of
Making Same.

Karl Miescher & Albert Wett-
stein.

Karl Miescher & Albert Wett-
stein.

Karl Miescher, Albert Wettstein
& Werner Fischer.

Hydantoins Containing the Sterol Nucleus.

Preparation Having Enhanced Sexual Hor

mone Action and Process of Making
Same.

Carbonyl Compounds of Steroids and
Process for the Manufacture Thereof.

EXHIBIT No. 226

SCHERING CORPORATION AND CIBA PHARMACEUTICAL PRODUCTS, INC.-LICENSE

AGREEMENT

(Corpus Luteum Hormones)

JULY 1, 1938.

AGREEMENT dated July 1, 1938, between SCHERING CORPORATION, a New Jersey corporation with its head office at Bloomfield, New Jersey (the Licensor) and CIBA PHARMACEUTICAL PRODUCTS, INC., a New Jersey corporation, with its head office at Summit, New Jersey (the Licensee).

WHEREAS the Licensor is the sole owner of United States Patent Application No. 34,599, filed August 3, 1935, and No. 267,182, filed April 10, 1939, and of United States letters patent and other patent applications relating to corpus luteum hormones as hereinafter defined; and

WHEREAS the Licensee wishes to acquire from the Licensor a license under the said application for Letters Patent No. 34,599 and No. 267,182 and under the letters patent and other patent applications now owned by the Licensor and under

such other patents and applications as the Licensor may from time to time acquire in the corpus luteum hormone field, upon the terms and conditions hereinafter stated;

NOW, THEREFORE, the parties hereto each in consideration of the covenants of the other herein contained, hereby agree as follows:

1. (a) The Licensor hereby grants to the Licensee upon the terms and conditions hereinafter stated a nonexclusive, nonassignable license to manufacture, use, and sell the products described and claimed in the said application for Letters Patent No. 34,599 and No. 267,182 and to practice the processes described and claimed therein and in any Letters Patent that may issue upon said applications throughout the United States of America, its territories and possessions, but only in the corpus luteum hormone field, for a period beginning July 1, 1938, and ending at the end of the term for which the last expiring patent that may be included in this license is or shall be granted, or sooner as hereinafter provided.

(b) The Licensor shall give to the Licensee written notice at least three months prior to offering for sale any product described or claimed in or made in accordance with any process described or claimed in any United States letters patent or application therefor now owned or hereafter acquired by the Licensor in the corpus luteum hormone field (other than application for United States Letters Patent No. 34,599 and No. 267,182); and the Licensor shall specify in said notice the prices, forms, and standards for the sale of the product as provided in Article 7 of this Agreement; and thereupon the said letters patent or the said application and the letters patent issuing thereon shall forthwith become included in the license hereby granted.

2. (a) Neither party hereto shall, without the written consent of the other party first obtained in each instance, give any license or sublicense, or any right of exploitation covering any of the products of said patent applications or the Letters Patent to be issued thereon or of any other letters patent or applications therefor covered by this license or of the processes relating thereto, except that the Licensor may without the Licensee's consent grant any such license or right to Roche-Organon, Inc., Nutley, New Jersey.

(b) The Licensee shall manufacture under this license only in its own plant or plants located in the United States of America and distribution of products under this license shall be made only by the Licensee and only under a single corporate name and/or trade name.

(c) The Licensor shall pay unto the Licensee during the period commencing January 1, 1939, and ending December 31, 1956, fifteen percent (15%) of all the royalties received by the Licensor from all licenses granted to the said RocheOrganon, Inc., Nutley, N. J., in the corpus luteum hormone field and thirty percent (30%) of all the royalties received by the Licensor from all licenses granted to others than the Licensee and Roche-Organon in the corpus luteum hormone field.

3. (a) The Licensee shall pay unto the Licensor a royalty or license fee of 6% of the Licensee's turn-over in the United States during the period commencing January 1, 1939, and ending December 17, 1952, of all products and preparations containing corpus luteum hormones except on its preparations Agomensin and Sistomensin and except as otherwise provided in subdivision (c) of this Article 3. The royalty or license fee shall be payable as herein provided regardless whether or not the process described and claimed in said patent applications and the Letters Patent to be issued thereon or in any other letters patent or applications therefor is used for the manufacture of corpus luteum hormone products or preparations and regardless whether or not or to what extent patent protection shall be maintained for said products or preparations in the United States of America, its territories and possessions.

(b) The "corpus luteum hormone field" includes all products and preparations containing corpus luteum hormones of natural or synthetic origin and/or such substances as increase the effectiveness thereof (activators), but activators only insofar as used as such. "Corpus luteum hormones" means (1) hormones of the corpus luteum hormone series (but not of the follicular hormone series) or their derivatives, as well as other materials derived from the female sex organs having similar effects, and as well as (ii) compounds and materials with physiological and clinical effects analogous to those of corpus luteum hormones, insofar as they may be used therapeutically like corpus luteum hormones and the activators of such compounds and materials, but activators only insofar as they are used as such.

(c) Any product or preparation in the corpus luteum hormone field shall be subject to royalty if it is sold or distributed under a trade-mark used or formerly used by the Licensee for a corpus luteum hormone product or preparation.

(d) The turn-over subject to royalty shall be determined by deducting from the sum of all invoices sent out by the Licensee during the period (whether such invoices are paid or not) 2% of such invoices as representing the cost of the outer shipping or mailing containers; ordinary trade discounts incurred, allowed, or paid by Licensee; stamp taxes and other public taxes directly imposed on the sale of said products; and all credits made by the Licensee in the same period for cancelled invoices.

4. (a) Each party hereto shall render to the other party within two (2) months after the close of each calendar quarter a statement showing separately the turn-over of products containing corpus luteum hormones for each preparation during the preceding quarter.

(b) Each party shall render to the other within three calendar months after the end of each calendar year a statement setting forth the royalty payable for the preceding calendar year by the party rendering the statement. The Licensor's statement shall set forth the royalties received by the Licensor from others than the Licensee. Royalties due from either party hereto to the other for any calendar year shall be paid on or before the 30th day of April following the close of that calendar year.

5. Each party hereto shall keep on file accurate records of its sales and shall permit such records and its books of account to be inspected at all reasonable times by reputable certified public accountants representing but not regularly employed by the other party; but such accountants shall not have access to accounts pertaining to matters not covered by this agreement and the extracts or notes taken by them shall relate exclusively to the subject matter of this agreement and shall contain no reference to names or addresses of customers or to extraneous matters.

6. Each party hereto shall forthwith upon making, discovering, conceiving, or otherwise acquiring any other processes whether secret or not, or any formulae, or any technical, clinical, experimental, and manufacturing data, and any other discoveries in the corpus luteum hormone field, disclose the same forthwith to the other party hereto and shall assist the other party in every way in the application and further development thereof, provided, however, that neither party shall be obligated to disclose to the other any information regarding its costs of manufacture, production, or distribution.

7. (a) Subject to the provisions of Article 9, the Licensee shall not sell or offer for sale any product described and claimed in any letters patent covered by this license embodying and made in accordance with and by use of any of the inventions of the said letters patent, as long as such product is covered by letters patent, at a price lower, or with a discount greater, or on terms and conditions in any respect more favorable to the purchaser, than as fixed therefor by the Licensor and followed by the Licensor in making its sales. Until changed by the Licensor as hereinafter provided the prices, discounts, terms, and conditions fixed by the Licensor are those set forth in Schedule A annexed hereto.

(b) The prices, discounts, terms, and conditions set forth in Schedule A may be changed by the Licensor from time to time upon two months written notice to the Licensee.

The Licensee shall not sell or offer for sale any product made pursuant to any of the process claims or any product coming within the product claims of the said letters patent in forms other than as tablets, ampules, ointments, solution, or suppositories, and other therapeutic forms and for each of such forms the Licensee will adhere to the standards as now established, or hereafter established by the Licensor with respect to units or quantity per package, to dosage or strength per unit, and to designation of units. The forms in which the Licensor now sells such products and the Licensor's established standards for use thereof (which are to be adhered to by the Licensee) are as follows:

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(d) The Licensor may from time to time change the dosage, units, quantities, and/or forms of said products contained in the individual tablets, ampules, oint

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